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SA10 Portable Controller is intended to provide power to drive SanAgile™ Ultrasonic Surgery Advanced Dissectors that are indicated for vessel sealing and soft tissue incisions when bleeding control and minimal thermal injury are desired.

SanAgile™ Ultrasonic Surgery Advanced Dissectors are indicated for vessel sealing and soft tissue incisions when bleeding control and minimal thermal injury are desired in general, sealing and transection of lymphatic vessels, and other open or laparoscopic procedures.

The dissectors can be used to coagulate isolated vessels up to and including 5 mm in diameter, using the MIN button.

The SanAgile™ Ultrasonic Surgery Advanced Dissector and Portable Controller consists of two interdependent devices: portable controller (Cat. # SA10) and single patient use dissector (Cat. #s SASD14, SASD23, SASD36 and SASD45). The SA10 Portable Controller is a compact portable generator and provides power to drive the dissectors for dissection, coagulation, and cutting tissues in open or laparoscopic procedures.

The SanAgile™ Ultrasonic Surgery Advanced Dissector and Portable Controller is intended to be used by qualified medical professionals trained in the techniques and surgical procedures, such as surgeons and nurses, in hospital operation rooms. SA10 Portable Controller is also intended to be maintained by trained service or biomedical engineers and validated for cleaning and disinfection between surgeries. The Advanced Dissector is integrated with a transducer for single use; therefore, no dissector-transducer assembly is required prior to surgery.

Based on the provided 510(k) Clearance Letter, the device is the SanAgile™ Ultrasonic Surgery Advanced Portable Controller and Dissectors. This document outlines the regulatory clearance and states that no clinical data was necessary to determine the substantial equivalence of this device.

Therefore, there is no information in this document regarding:

• Acceptance criteria for performance based on clinical data.
• A study that proves the device meets the acceptance criteria through clinical performance.
• Sample sizes used for test sets.
• Number of experts used to establish ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Types of ground truth used (expert consensus, pathology, outcomes data).
• Sample sizes for training sets.
• How ground truth for training sets was established.

The "Non-Clinical Performance Data" section lists various non-clinical tests performed, such as biocompatibility, electrical safety, EMC, software verification and validation, dimensional verification, sterilization validation, shelf-life testing, transportation testing, ex vivo burst pressure study, and acute and chronic animal studies. These tests confirmed that the device met design inputs and performance specifications, supporting its safety and effectiveness relative to the predicate device.

In summary, the provided FDA 510(k) clearance letter for the SanAgile™ Ultrasonic Surgery Advanced Portable Controller and Dissectors does not contain the specific information requested about acceptance criteria and study data for an AI/software device, because it explicitly states that no clinical data was necessary for its substantial equivalence determination. The clearance was based on similarity to predicate devices and non-clinical performance data.

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The Sonopet iQ Ultrasonic Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated Organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery, and Thoracoscopic surgery.

CONTRAINDICATION: This ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids.

The Sonopet iQ Ultrasonic Aspirator System is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. It allows the selective resection of target tissue while preserving vessels, ducts, and other delicate structures. The system consists of a console which provides control and power functions, a surgical handpiece to provide ultrasonic energy (25kHz), sixteen (16) titanium tips with irrigation sleeves, and an Irrigation Suction Cassette.

Modifications to the device console software allow for inter-device communications with compatible Stryker devices, and the implementation of Stryker's proprietary communications protocol 'DCM' (Device Communication Module) to support these communications.

RISE (Reimagining Integrated Surgical Experience) is an optional software functionality that allows for ethernet-based communication between compatible Stryker devices (i.e., Connected OR Hub, SDC4K Information Management System (SDC4K), and CORE 2 consoles) and utilizes the DCM communications protocol.

The RISE functionality is built into the Sonopet iQ console software but can only be accessed via a Stryker-provided activation license.

RISE provides for an integrated OR (Operating Room) solution to healthcare facilities that simplifies workflows and reduces OR clutter. In a RISE configuration, adjustment of the Sonopet iQ power, suction, irrigation, and pulse control settings can now be made directly on the Connected OR Hub / SDC4K GUI, thereby allowing the user to input commands via a single console.

RISE functionality also features optional foot pedal assignment, which provides users the opportunity to use a single foot pedal to control multiple handpieces.

The Sonopet iQ Ultrasonic Aspirator System (K243930) is substantially equivalent to its predicate device (K213824). The key difference between the two devices is the addition of an optional 'RISE' software functionality in the subject device, which enables inter-device communication and allows for adjustment of Sonopet iQ settings via compatible Stryker devices like the Connected OR Hub and SDC4K.

Here is a summary of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in terms of patient data. The non-clinical testing conducted involved:

• Software and wireless technology testing
• EMC and Electrical Safety testing
• Bench testing
• Simulated use testing
• Human factors testing

These tests are performed on the device itself and its software, not on patient data. Therefore, there is no mention of country of origin or retrospective/prospective nature of data for a "test set" in the context of this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. As described above, the testing involved engineering and system performance evaluations, not diagnostic interpretation or clinical outcomes requiring expert ground truth establishment for a test set.

4. Adjudication Method for the Test Set

Not applicable. The testing did not involve adjudication of clinical cases or data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. The device is an ultrasonic aspirator system, and the changes involve software for control and communication, not an AI-driven image analysis or diagnostic aid that would typically warrant such a study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The regulatory filing focuses on the safety and effectiveness of the device as a whole, including the software's functionality. While the software components were tested, the concept of "standalone" performance typically applies to diagnostic algorithms. For a surgical device with control software, the software's functionality is inherently part of the "human-in-the-loop" (surgeon operating the device) performance, as it controls the device's actions based on user input.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing was established by:

• Compliance with recognized standards (e.g., for EMC, electrical safety, software, human factors).
• Adherence to internal protocols for bench and simulated use testing, which would define acceptable functional performance parameters.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML model in the typical sense that requires a "training set" of data for learning. The software modifications are functional enhancements (inter-device communication) rather than algorithms that learn from data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set was used.

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The Tenex® 2nd Generation System is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of both soft and hard (e.g.: bone) tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery, and Plastic and Reconstructive Surgery.

The Tenex® 2nd Generation System is also indicated for use in the debridement of wounds, such as, but not limited to diabetic ulcers, in application, in which, in the physician's judgement would require the use of an ultrasonic aspirator with sharp debridement.

The Tenex 2nd generation system is an ultrasonic surgical instrument that fragments, emulsifies and aspirates soft and hard tissue. It also provides sharp debridement of soft and hard tissue in wounds such as neuropathic diabetic ulcers. The Tenex 2nd generation system is intended for use in an office-based setting, clinical or hospital environment. The system consists of a Console, ultrasonic MicroTips, a Foot Switch and a number of accessories.

The Console includes a touch screen tablet with a graphical user interface, motors to drive diaphragm pumps in the MicroTip, ultrasonic driver electronics and Software. The Console generates the ultrasonic energy required to operate the MicroTips and manages irrigation fluids. The Console is non-sterile when used and does not require processing.

The MicroTips connect to the Console for electrical power and to facilitate the transfer of irrigation fluid from the saline bag to the surgical site, and then aspirate the emulsified tissue and fluid to a collection bag incorporated into single use, disposable the MicroTip assembly. Motors in the Console couple to the diaphragm pumps in the MicroTips to control the fluid flows. The MicroTips are constructed from various biocompatible polymers and metals. The MicroTip tubing is made of biomedical grade PVC and silicone.

The MicroTips are single use and sterile packaged. They are sterilized via gamma irradiation. The MicroTips are the ultrasonic surgical hand pieces that house the transducers, horns and needles with beveled tips.

The Foot Switch is used by the user to remotely control the Console. It connects to the back of the Console via an electrical cable. It provides on/off functionality for cutting, irrigation, and aspiration. The Foot Switch is IPX8 rated for protection against liquids.

The System includes additional components. a Packaging Hard Case is provided for shipping, handling. and storage of the Console, and a power cord is provided for connecting the Console to facility electrical power to operate the device. These items are non-sterile when used and do not require processing.

Associated accessories include: a USB Flash Drive for saving procedure information, USBC-HDMI cable for connecting to an external display, and a USB-Smartphone adaptor for connecting USB output to a smartphone.

The provided text is a 510(k) summary for the Tenex® 2nd Generation System, an ultrasonic surgical instrument. It details the device's characteristics, intended use, and non-clinical performance testing. However, it does not include specific acceptance criteria or a study that directly proves the device meets those criteria in a format allowing a table of acceptance criteria vs. reported performance.

The document focuses on demonstrating substantial equivalence to a predicate device (Tenex Health TX System with the TXP MicroTip, K181367) through a comparison of technical characteristics and non-clinical performance testing against various standards.

Here's an attempt to extract and interpret the requested information based on the provided text, while noting what is not present:

Missing Information in the Provided Text:

• Specific Quantitative Acceptance Criteria: The document describes types of tests performed (e.g., Aspiration, Irrigation, MicroTip strength) and mentions the system "met requirements" or "met the standards," but it does not specify the quantitative performance metrics (e.g., "Aspiration volume must be >X cc/min" or "MicroTip strength must withstand Y force").
• Reported Device Performance against specific criteria: Without specific acceptance criteria, corresponding reported device performance against those criteria cannot be tabulated directly.
• Detailed Study Protocol for Performance Evaluation: The text lists various non-clinical performance tests but does not provide details of a single, comprehensive study with a defined sample size, ground truth, or expert involvement to "prove" the device meets acceptance criteria in a comparative sense.
• Sample size for test set with data provenance: While "simulated use testing in bovine tissue" and "simulated use testing in cadaver" are mentioned, the specific sample sizes for these tests are not provided. Data provenance is implied to be laboratory/simulated.
• Number of experts and qualifications for ground truth: Not mentioned, as the focus is on engineering and standard compliance rather than clinical interpretation.
• Adjudication method: Not applicable as no expert review process for ground truth is described.
• Multi Reader Multi Case (MRMC) comparative effectiveness study: Not mentioned and not likely relevant for a device of this type, which is a surgical instrument rather than an AI-powered diagnostic tool.
• Standalone (algorithm-only) performance: Not mentioned. The device's software is for control and interface, not for standalone diagnostic or analytical performance.
• Type of ground truth used: For the non-clinical tests, the "ground truth" would be the known physical properties and performance characteristics of the materials and systems under test, not clinical outcomes or pathology.
• Sample size for training set: Not applicable, as this is not an AI/ML device in the context of a training set for a diagnostic algorithm.
• How ground truth for training set was established: Not applicable.

Extracted Information (with caveats):

1. A table of acceptance criteria and the reported device performance

As noted, explicit quantitative acceptance criteria are not provided. The document states that the Tenex® 2nd Generation System "met all specified performance requirements" and "adheres to industry standards." The table below attempts to infer criteria based on the comparisons made with the predicate device and the non-clinical tests.

2. Sample sized used for the test set and the data provenance

• Sample Size: Not explicitly stated for any of the non-clinical tests (e.g., number of bovine tissue samples, number of cadavers, or number of units tested for electro-mechanical benchmarks).
• Data Provenance: The data originates from internal non-clinical performance testing conducted by the manufacturer (Trice Medical, Inc.), involving simulated environments (bovine tissue, cadaver) and laboratory bench tests. Implied to be prospective testing for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts/Qualifications: Not specified. For this type of device, ground truth for bench testing refers to engineering specifications and standard compliance, not clinical expert consensus. For usability testing (simulated use in cadaver), it implies evaluation by users (e.g., surgeons), but specific numbers or qualifications are not provided.

4. Adjudication method for the test set

• Adjudication method: Not applicable/not described as there isn't a stated panel review process for establishing ground truth in the context of this submission. The tests are against predefined engineering and regulatory standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically for diagnostic imaging software or AI tools, not for a surgical instrument.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: No, a standalone (algorithm only) performance study was not conducted. The software in the Tenex® 2nd Generation System operates the device and interfaces with the user, it does not perform an independent function that would require "standalone" performance evaluation in the context of diagnostic AI.

7. The type of ground truth used

• Type of Ground Truth: For the non-clinical performance tests, the "ground truth" is based on:
  • Engineering specifications and requirements: For electro-mechanical bench testing, software V&V.
  • International standards: For EMC, electrical safety, biocompatibility, sterilization, packaging, and shelf-life validation.
  • Expected physical and functional performance: For simulated use testing in bovine tissue and cadaver, validating that the device performs its intended functions (fragmentation, emulsification, aspiration) effectively and is usable.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This device is an electromechanical surgical instrument with controlling software, not an AI/ML diagnostic system that requires a "training set."

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.

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The CUSA® Clarity Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable. The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in:

Plastic and Reconstructive surgery, Orthopedic Surgery and Thoracic Surgery and the following specific uses:

Neurosurgery - including removal of primary and secondary malignant and spinal tumors, including but not limited to meningiomas and gliomas

Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy

Urological surgery- including removal of renal parenchyma during nephrectomy or partial nephrectomy

General Surgery - including removal of benign or malignant tumors or other unwanted soft or hard tissue in open or minimally invasive general surgical procedures

Laparoscopic Surgery - including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy

Gynecological Surgery - including removal of dysplastic genital epithelial tissue including vulvar and vaginal intraepithelial neoplasia, removal of condyloma, debulking of metastatic uterine, ovarian, fallopian tube or primary peritoneal carcinoma, and open or laparoscopic excision of tissue and adhesions associated with endometriosis

The CUSA Clarity Ultrasonic Surgical Aspirator System (CUSA Clarity) is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. It allows the selective dissection of target tissue while preserving vessels, ducts and other delicate structures. The CUSA Clarity consists of a console that provides power and control of the ultrasonic, aspiration and irrigation functions, two surgical handpieces that provide ultrasonic mechanical energy (23 kHz and 36 kHz), a footswitch to allow user control over the ultrasonics, titanium surgical tips (variety of models), irrigation flues, suction/irrigation system (manifold tubing and vacuum canister) and accessories used for assembly/disassembly and reprocessing. The CUSA Clarity may also be optionally used with the CUSA Electrosurgical Modules which provide optional electrosurgical capability.

The information provided describes a 510(k) premarket notification for the CUSA® Clarity Ultrasonic Surgical Aspirator System, primarily focusing on a modification to its Indications for Use to include more specific gynecological surgery indications. The submission claims substantial equivalence to a predicate device (K182809) and did not involve any design or technological changes to the device itself. Therefore, the "acceptance criteria" and "device performance" in the traditional sense of a new or modified device's functional characteristics are not directly presented as a series of quantitative benchmarks met by a specific study on the device's technical performance. Instead, the "acceptance criteria" here refer to demonstrating that the expanded indications for use for gynecological surgery are safe and effective, supported by existing literature and showing no new safety or effectiveness concerns compared to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The "test set" in this context refers to the body of clinical evidence reviewed to support the expanded indications.

• Sample Size: 1,465 patients. This total is comprised of:
  • 272 patients for dysplasia or condyloma.
  • 630 patients for debulking procedures (cancers).
  • 18 patients for endometriosis.
  • The remaining patients likely fall into categories not specifically broken down or represent overlaps in articles.
• Data Provenance: The data was derived from an "analysis of peer-reviewed articles." This indicates a retrospective review of published clinical literature. The country of origin of the data is not specified but would likely span various international institutions given the nature of peer-reviewed publications over an extended period.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable in the typical sense. This was a literature review, not a study where experts established ground truth for a novel dataset. The "ground truth" is implicitly established by the reported outcomes in the published clinical studies themselves, which are conducted by various medical professionals (surgeons, pathologists, etc.) in their respective fields. The submission does not specify an independent panel of experts reviewing the collected literature to establish a "ground truth" for the purpose of this 510(k).

4. Adjudication method for the test set

Not applicable. There was no explicit adjudication method for a test set as this was a review of existing peer-reviewed literature. The outcomes reported in the individual studies within the literature served as the evidence.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The device is an ultrasonic surgical aspirator system, not an AI or imaging diagnostic device that involves human "readers" interpreting output. This submission focuses on the safety and effectiveness of the existing device for expanded (gynecological) indications.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The CUSA Clarity is a surgical instrument used by a surgeon, not a standalone algorithm.

7. The type of ground truth used

The "ground truth"-like evidence used was outcomes data and reported effectiveness/safety from published clinical studies. This includes:

• Achievement of desired treatment outcomes (e.g., successful removal of tissue).
• Reported presence or absence of postoperative complications.
• Preservation of vessels and nerves.
• Comparison of procedure durations.

8. The sample size for the training set

Not applicable. This was a 510(k) submission for an existing device with expanded indications, not an AI/algorithm development where a training set would be used. The "evidence" supporting the expanded indications comes from published literature.

9. How the ground truth for the training set was established

Not applicable. As above, there was no training set for an algorithm.

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The Ultrasonic System is intended to be used to transect, dissect, and coagulate tissue. The instruments are indicated for use in open and endoscopic general surgical procedures where bleeding control and minimal thermal injury to tissue are desired. The instruments allow for the coagulation of vessels (veins and arteries) up to 3 mm in diameter.

Ultrasonic Surgical System is an ultrasonic dissection and coagulation system composed of four components: Ultrasonic Generator (HD-CSD01), Hand Piece (HD-CSH01), a disposable Ultrasonic Shears includes 4 shaft lengths (HD-CS-DJ45, HD-CS-DJ36, HD-CS-DJ22, HD-CS-DJ14) and foot switch (HRF-M52).

A disposable Ultrasonic Shears is a sterile component that has undergone EO sterilization, including an ultrasonic horn, jaws, main shaft, axis rotation, handle, operating handle, and control switch. The operating handle is used to open and close the jaws that grip the tissue. The Ultrasonic Surgical System can simultaneously cut and coagulate tissues by setting different output power levels. The high-power range allows for faster tissue cutting, while the low-power range allows for better tissue closure. The ultrasonic frequency current in the ultrasonic generator is transmitted to the hand piece, which converts electrical energy into mechanical energy for forward and backward vibration. Through the transmission and release of the blade, the end of the blade vibrates at a certain frequency. The heat generated by friction causes water vaporization in the tissue cells that come into contact with the blade, protein hydrogen bonds break, cells collapse and the tissue is cut open after solidification; When cutting blood vessels, the knife head contacts with Histone and generates heat through mechanical vibration, leading to the destruction of the collagen structure in the tissue, causing the protein to coagulate, and then sealing the blood vessels to stop bleeding. The disposable ultrasonic shears are EO sterilized, but the other parts are non-sterilized packaging, and the hand piece must be cleaned and sterilized by the user before being used for surgery.

This device is intended to be used in the hospital environment, such as surgical operation room and imaging intervention room.

The provided text is a 510(k) Summary for a medical device called "Ultrasonic Surgical System." It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain details about specific acceptance criteria for performance tests or the detailed study results that would typically prove a device meets those criteria in a format directly applicable to the table requested.

The document mentions "Performance test and functional tests were conducted on the proposed device in accordance with product design specifications. Data generated from the test met the predetermined acceptance criteria." but does not list those criteria or the specific performance data against them.

It also includes results from animal testing (burst pressure, acute, and chronic animal studies) but these are comparative to a predicate device rather than against predefined, quantitative acceptance criteria for the subject device itself.

Therefore, many of the requested fields cannot be filled directly from the provided text.

Based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly detailed in the provided document. The document states that "Data generated from the test met the predetermined acceptance criteria" but does not list the specific criteria or the exact performance data against them for each test.

2. Sample Size Used for the Test Set and Data Provenance

• The document specifies a "porcine model" for animal testing.
• It does not specify the sample size for the burst pressure, acute, or chronic animal studies (e.g., number of animals or number of vessels tested per animal/group).
• The data is prospective, generated from the animal study using the subject device and a predicate device.
• The country of origin of the data is not specified, but the applicant (Hunan Handlike Minimally Invasive Surgery Co., Ltd.) is from China.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not provided in the document. The animal studies would typically involve veterinarians and potentially pathologists, but their number and specific qualifications are not mentioned.

4. Adjudication Method for the Test Set

• This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC study was done, as this is a surgical device, not an imaging/diagnostic AI device that would typically involve human readers interpreting cases. The comparative effectiveness assessment was against a predicate device in animal models.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Not applicable, as this is a physical surgical device, not a standalone algorithm. The device itself is evaluated.

7. The Type of Ground Truth Used

• For the animal studies, the "ground truth" would be established through direct observation during the procedures, histological examination of tissue samples, and measurements (e.g., burst pressure). These are effectively pathology and direct physiological measurements/observations.

8. The Sample Size for the Training Set

• Not applicable, as this is a physical surgical device, not an AI/ML algorithm that requires a training set in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as this is a physical surgical device.

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The CUSA® Clarity Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable.

The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in:
Plastic and Reconstructive surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses:
Neurosurgery - including removal of primary and secondary malignant and benign brain and spinal tumors, including but not limited to meningiomas and gliomas
Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy
Urological surgery- including removal of renal parenchyma during nephrectomy or partial nephrectomy
General Surgery - including removal of benign or malignant tumors or other unwanted soft or hard tissue in open or minimally invasive general surgical procedures
Laparoscopic Surgery - including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy

The device within the scope of this premarket notification is the optional CUSA® Electrosurgery Module (CEM) accessory that is intended to be used with the 23 kHz components of the CUSA® Clarity Ultrasonic Surgical Aspirator System.

The purpose of this submission is to modify the CEM nosecone accessory currently offered with CUSA Clarity to allow for connection with additional electrosurgical generators, to continue to provide electrosurgical capabilities to the user. The additional electrosurgical generators that the modified CEM Nosecone may be used with include the Medtronic FT10 (K191601), Medtronic FX8 (K181389), Erbe VIO 300D (K083452), and Erbe VIO 3 (K190823). Compatibility with the Medtronic Force FX (K143161) will be maintained as well.

The CUSA Clarity 23kHz Expanded CEM Nosecone has the same intended use and technological characteristics as the predicate CUSA Clarity 23 kHz CEM Nosecone (K190180). The subject CEM nosecone will continue to allow the surgeon to apply immediate electrosurgical coagulation to bleeding tissue at the surgical site, with the same handpiece assembly that is removing unwanted tissue.

The provided text describes the CUSA Clarity Ultrasonic Surgical Aspirator System, specifically focusing on a modified CEM nosecone accessory for the 23 kHz components. This submission is a 510(k) premarket notification claiming substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a quantitative table format with corresponding device performance values. Instead, it describes various non-clinical tests undertaken to ensure the safety and efficacy of the device and its substantial equivalence to the predicate.

The reported device performance is broadly stated as:

• "Testing was determined successful and supports the conclusion that all product specifications and design inputs have been met."
• "The results of the non-clinical testing indicate that the intended use of the device, fundamental scientific technology, and performance of the CUSA Clarity 23 kHz Expanded CEM Nosecone is substantially equivalent to the predicate device."

Therefore, a table of quantitative acceptance criteria and specific reported device performance cannot be generated from the provided text. The information indicates that all tests were passed and specifications met, implying the device performed within acceptable limits.

2. Sample Size Used for the Test Set and Data Provenance

The document describes non-clinical testing but does not specify a "test set" in terms of subject or patient data. The tests are focused on device characteristics rather than clinical outcomes with a patient population.

• Sample size for test set: Not applicable in the context of device performance testing described. The tests are on the device itself (e.g., handpiece life, functionality, mechanical properties).
• Data provenance: Not applicable in the context of patient data. The provenance is from internal testing conducted by Integra LifeSciences Corporation. There is no mention of country of origin for data related to clinical or patient studies, as none were performed. The tests are prospective as they were conducted as part of the submission process.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of experts: Not applicable. The "ground truth" for the non-clinical tests is established by engineering specifications, recognized standards (FDA guidance documents, ISO standards for biocompatibility, EMC, and electrical safety), and comparison to the predicate device's established performance.
• Qualifications of experts: Not specified as a separate set of experts for ground truth. However, the development and testing would have been overseen by Integra LifeSciences Corporation's engineering and regulatory teams.

4. Adjudication Method for the Test Set

• Adjudication method: Not applicable. The testing described is objective device performance (e.g., sterilization, biocompatibility, electrical safety, mechanical, thermal effects). Success or failure is determined by meeting predefined engineering specifications and regulatory standards, not by an adjudication process between human experts on a specific outcome.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC study: No. The document explicitly states: "No clinical studies were performed or required as all conducted performance tests appropriately support a determination of substantial equivalence compared with the predicate device."
• Effect size of human readers with/without AI assistance: Not applicable, as no MRMC study or study involving human readers with or without AI assistance was conducted. The device is a surgical aspirator system, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone study: Not applicable. The CUSA Clarity Ultrasonic Surgical Aspirator System is a physical medical device, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for the device's acceptable performance is based on:

• Established engineering specifications and design inputs: Ensuring the device functions as intended.
• Compliance with FDA guidance documents and recognized standards: Such as those for sterilization, biocompatibility, EMC, electrical safety, thermal effects, and capacitive coupling.
• Substantial equivalence to the legally marketed predicate device (CUSA® Clarity Ultrasonic Surgical Aspirator System K190180): This implies that the predicate's established safety and effectiveness profile serves as a benchmark for the new component.

8. The Sample Size for the Training Set

• Sample size for training set: Not applicable. This device is not an AI/ML algorithm that requires a training set. The performance is assessed through traditional engineering and regulatory compliance testing.

9. How the Ground Truth for the Training Set Was Established

• How ground truth for training set was established: Not applicable, as there is no training set for this type of device.

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The Misonix Inc. neXus® Ultrasonic System is intended for the fragmentation, emulsification and aspiration of both soft and hard (i.e., bone) tissue.

The indications for use for the Standard Handpiece in combination with BoneScalpel® and SonicOne® OR probe kit accessory configurations, the SonaStar® Long and Short handpieces in combination with SonaStar® probe kit accessory configurations, the BoneScalpel Access® handpiece with BoneScalpel Access® probe kit accessory configurations, and the SonaStar Elite Handpiece with probe kit accessory configurations are listed below.

Standard Handpiece with BoneScalpel Probe Kit
Indicated for use in the fragmentation, emulsification of soft and hard (e.g., bone) tissue in the following surgical specialties:

• · Neurosurgery
• · Gastrointestinal and Affiliated Organ Surgery
• · Urological Surgery
• · Plastic and Reconstructive Surgery
• · General Surgery
• · Orthopedic Surgery
• · Gynecology
  External genitalia - condyloma - benign tumors (lipomas, fibromas, and leiomyomas) - malignant primary and metastatic tumors of all types and the following cystic lesions: Bartholin's cysts, Vestibular adenitis, Inclusion cysts, Sebaceous cysts
  Abdominal area - any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopian tube, uterus, or the supporting structures of the uterus except as contraindicated for uterine fibroids.
• · Thoracic Surgery
  Limited pulmonary resection such as segmentectomical subsegmentectomies and metastatectomies. · Wound Care
  The neXus Ultrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement.

Standard Handpiece with SonicOne Probe Kits
Indicated for use in the fragmentation and aspiration of soft and hard tissue (i.e. bone) in the following surgical specialty:
· Wound Care
The neXus Ultrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement. · Plastic and Reconstructive Surgery

neXus SonaStar Handpieces with SonaStar Probe Kits
Indicated for use in the fragmentation and aspiration of both soft and hard (i.e., bone) tissue in the following surgical specialties:
· Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy
· Urological Surgery - including removal of renal parenchyma during nephrectomy or partial nephrectomy

• · Plastic and Reconstructive Surgery
  · General Surgery - including removal of benign or malignant tumors or other unwanted tissue in open or minimally invasive general surgical procedures
• · Orthopedic Surgery
• · Gynecological Surgery except as contraindicated for uterine fibroids.
• · Thoracic Surgery
  · Laparoscopic Surgery – including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy
  · Thoracoscopic Surgery
  The SonaStar Handpieces may also be combined with electrosurgery using optional RF surgery interface components.

Bone Scalpel Access Handpiece with BoneScalpel Access Probe Kits
Indicated for use in the fragmentation of soft and hard (e.g., bone) tissue in the following surgical specialties:

• · Neurosurgery
• · Gastrointestinal and Affiliated Organ Surgery
• · Urological Surgery
• · Plastic and Reconstructive Surgery
• · General Surgery
• Orthopedic Surgery
• · Gynecology
  External genitalia - condyloma - benign tumors (lipomas, and leiomyomas) - malignant primary and metastatic tumors of all types and the following cystic lesions: Bartholin's cysts, Vestibular adentis, Inclusion cysts, Sebaceous cysts Abdominal area - any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopian tube, uterus, or the supporting structures of the uterus except as contraindicated for uterine fibroids.
  · Thoracic Surgery
  Limited pulmonary resection such as segmentectomical subsegmentectomies and metastatectomies.

SonaStar Elite Handpiece with SonaStar Elite Probe Kits
Indicated for use in the fragmentation of soft and hard (e.g., bone) tissue in the following surgical specialties:

• · Neurosurgery
  · Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy
• · Urological Surgery including removal of renal parenchyma during nephrectomy or partial nephrectomy
• · Plastic and Reconstructive Surgery
  · General Surgery - including removal of benign or malignant tumors or other unwanted tissue in open or minimally invasive general surgical procedures
• Orthopedic Surgery
• · Gynecological Surgery except as contraindicated for uterine fibroids.
• · Thoracic Surgery
  · Laparoscopic Surgery – including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy
  · Thoracoscopic Surgery
  The system may also be combined with electrosurgery using optional RF surgery interface components.

The neXus Ultrasonic Surgical Aspirator System is intended for fragmentation, emulsification and aspiration of both soft and hard (i.e.bone) tissue. The system includes a generator housed inside the console. A reusable handpiece is plugged directly into the front panel of the console.

The generator and handpiece are compatible with various single use disposable "probes" which are selected and attached to the handpiece by the end user. An irrigation system provides sterile irrigant to the operative site. An aspiration system removes the fragmented, emulsified material and waste liquids from the operative site.

Accessories include a wireless footswitch, various probe tip combinations, sterilization trays, probe covers, assembly & disassembly wrenches, irrigation tubing sets, disposable electrocautery cable, and waste collection canisters.

Here's an analysis of the provided text to fulfill your request regarding acceptance criteria and device performance.

Important Note: The provided document is an FDA 510(k) K231117 clearance letter for the "neXus Ultrasonic Surgical Aspirator System." This type of document is a summary of the FDA's decision and the manufacturer's provided information. It does not present a detailed study report that would typically include all the specific parameters requested (like sample size for test/training sets, experts, adjudication methods, MRMC studies, effect sizes, etc.).

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K221235). The "performance data" section primarily refers to verification and validation activities rather than a comparative clinical trial or large-scale evaluation of a new AI algorithm.

Therefore, for many of your requested points, the answer will be "Not Applicable" or "Information Not Provided in this Document," as this submission is for a modified traditional medical device, not an AI/ML-driven diagnostic or treatment planning system that would typically undergo the stringent evaluation methods you've outlined.

Acceptance Criteria and Reported Device Performance

The core of this submission is to demonstrate that the modified neXus Ultrasonic Surgical Aspirator System is substantially equivalent to its predicate device (K221235). The "acceptance criteria" here are implicitly tied to maintaining the safety and effectiveness profile of the predicate device, particularly regarding the added "Pulsed Wave, NEW" feature for the vibration system and "DTC (DYNAMIC TISSUE RESPONSE)" capability.

1. Table of Acceptance Criteria and Reported Device Performance:

Given the nature of this 510(k) summary, the acceptance criteria are not presented in a quantitative table with specific targets as one might see for an AI/diagnostic device. Instead, they are framed as demonstrating continued functionality, safety, and equivalence to the predicate. The "reported device performance" is largely qualitative, indicating that the new features function as intended and that the overall system still meets the established performance of the predicate.

Key Difference/New Feature: Vibration System: "Pulsed Wave, NEW" (p. 10).
New GUI Setting: "DTC (DYNAMIC TISSUE RESPONSE): Off" (default) and adjustable range 1-6 (p. 16). |
| Biocompatibility | No new patient-contacting materials; existing biocompatibility data remains valid. | "Not applicable. There have been no modifications related to patient contacting materials, therefore the biocompatibility testing submitted under K221235 remains valid." (p. 17) |
| Electrical Safety & EMC | Continued compliance with relevant safety and EMC standards; minor software update does not impact electrical safety or EMC. | "No re-testing required. The change to the neXus console is considered a minor software update only. The safety and performance of the device has been validated and verified through software testing in accordance with IEC62304. There have been no device modifications related to the construction of the console or handpiece, therefore the electrical safety and EMC testing submitted under K221235 remains valid." (p. 18) |
| Software V&V | Software performs as intended, new features function correctly, regression testing confirms no adverse impact elsewhere. Software classification remains "major level of concern." | "Software verification and validation testing was conducted and a summary of testing provided."

Specific verification tests conducted: "DTC DSP pulse mode verification," "DTC GUI verification," "Fault detection and response test using the SonaStar Elite handpiece," "neXus test and calibration (Regression testing)," "System performance verification (Regression testing)," "SonaStar Elite GUI verification (Regression testing)." (p. 18) |
| Bench Testing | New features function as intended and device maintains performance characteristics (e.g., tissue removal) of the predicate. | "Tissue removal test using the SonaStar Elite handpiece," "DTC mode vibration test using the SonaStar Elite handpiece." (p. 18) |

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated in terms of number of "cases" or "samples" as might be seen for a diagnostic AI. For a surgical aspirator, "test set" typically refers to the physical devices and materials (e.g., tissue phantoms, actual tissue samples for bench testing) used for verification and validation. The document does not specify the quantity of these for bench testing.
• Data Provenance: Not applicable in the conventional sense of patient data. The "data" here comes from internal engineering and quality testing (software V&V, electrical safety, biological compatibility assessments, and bench performance testing). These are typically conducted in a controlled lab environment by the manufacturer. No country of origin for a patient dataset. The tests are prospective as they are conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts/Qualifications: Not applicable for this type of device submission. Ground truth for a surgical tool's performance is established through engineering specifications, physical measurements, and performance against defined test methods (e.g., how effectively it removes tissue from a phantom, its vibration amplitude). Clinical "experts" (like radiologists) are not used to establish this type of ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Adjudication Method: Not applicable. This concept applies to human consensus on complex subjective data (e.g., image interpretation). For an ultrasonic surgical aspirator, performance testing involves objective measurements (e.g., output power, vibration frequency, tissue removal efficiency, software function).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• MRMC Study: No. This is not an AI-driven diagnostic or image-interpretation device, so MRMC studies are not relevant. This device is a surgical tool.
• Effect Size of Human Improvement with AI: Not applicable for this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Standalone Performance: Not applicable as this is not an AI algorithm but a physical medical device. The "software" component is for controlling the device's functions (e.g., vibration, irrigation, aspiration). The software's performance is verified through testing its functionalities and its impact on the device's physical outputs, but not as a "standalone" interpretation tool.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.):

• Type of Ground Truth: For this device, ground truth is established through:
  • Engineering specifications and design requirements: The device's components and software features are designed to meet specific physical and functional performance parameters.
  • Validated test methods: Performance is measured against established procedures using instruments and materials (e.g., tissue phantoms) to quantify characteristics like vibration, flow rates, and tissue ablation effectiveness.
  • Comparison to predicate device: The predicate device itself acts as a "ground truth" for acceptable performance for the intended use.
  • Compliance with recognized standards: Adherence to standards like IEC62304 for software and electrical safety standards.

8. The sample size for the training set:

• Sample Size: Not applicable. This is not an AI/ML device that requires a "training set" of data for model development. The software is deterministic control software, subject to traditional software development and verification processes.

9. How the ground truth for the training set was established:

• Ground Truth Establishment: Not applicable, as there is no training set in the context of AI/ML.

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The HARMONIC 700, 5 mm Diameter Shears with Advanced Hemostasis are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, pediatric, gynecologic, urologic, thoracic procedures, and sealing and transection of lymphatic vessels. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Advanced Hemostasis hand control button.

The HARMONIC 700, 5 mm Diameter Shears with Advanced Hemostasis are intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments are sterile, single-patient-use instruments consisting of an ergonomic grip housing assembly with hand control buttons (MIN for minimum power level, MAX for maximum power level, and Advanced Hemostasis for large vessel sealing). An integrated audible and tactile mechanism in the grip housing indicates full trigger closure. The instruments have a clamp arm and coated curved blade that are designed to work through a 5 mm trocar, through a 5 mm reducer cap in a larger diameter trocar, or through an incision without the use of a trocar. The instrument shafts can be rotated 360° to facilitate visualization and access to targeted tissue. The three dashes on the instrument are intended to represent relative vessel size. The MAX button is typically used for smaller vessels where cutting speed is the fastest. The MIN button is typically used in slightly larger vessels and has reduced cutting speed. It is indicated for vessels up to 5 mm in size. The Advanced Hemostasis button is designed for larger vessels and is indicated for vessels up to 7 mm in size. In this mode, cutting speed is further reduced and hemostasis is maximized. This design is common to both subject and predicate devices and has been evaluated by FDA in K132612 (predicate device), K160752 (HARMONIC HD1000i), and K200841 (HARMONIC 1100). The instruments utilize Adaptive Tissue Technology. This provides the generator with the ability to identify and monitor the instrument during use, which enables the generator to modulate and adjust its power output as well as provide audible feedback to the user as appropriate. The HARMONIC 700, 5 mm Diameter Shears with Advanced Hemostasis are designed for use exclusively with the Generator G11 (GEN11) software version 2018-1 or later, last cleared under K200841 on 11 May 2020.

The provided text describes the HARMONIC 700 Shears and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and supporting studies as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set (Preclinical Studies)

• Acute Animal Testing: Performed in three acute porcine studies. The document does not specify the exact number of animals or vessels tested within these studies, but it mentions evaluating "arteries, veins, and pedicles of various sizes."
  • Data Provenance: Porcine (animal) models. This is a form of prospective data collection for preclinical evaluation.
• Chronic Animal Testing: Performed in a survival study. The document does not specify the exact number of animals or vessels tested.
  • Data Provenance: Animal (survival) model. This is a form of prospective data collection for preclinical evaluation.

3. Number of Experts and Qualifications for Ground Truth of Test Set

The document does not mention the use of human experts to establish ground truth for the test set in the context of the preclinical (animal) studies. The evaluation metrics (e.g., vessel burst pressure, thermal spread, intra-operative tissue effects, post-operative performance) are typically measured objectively by research staff or specific equipment.

4. Adjudication Method for Test Set

Not applicable, as ground truth for the preclinical studies was based on objective measurements rather than human reader interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "This premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence." The comparison is between the subject device and a predicate device through bench and animal testing.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a surgical instrument, not an AI or algorithm-based diagnostic/screening tool. The "Adaptive Tissue Technology" mentioned gives the generator "the ability to identify and monitor the instrument during use, which enables the generator to modulate and adjust its power output as well as provide audible feedback," which is an integrated system feature, not a standalone algorithm being evaluated for performance against a ground truth.

7. Type of Ground Truth Used (for preclinical studies)

The ground truth for the preclinical studies was based on objective biological and mechanical outcomes measured in animal models (porcine).

• Acute Studies: Evaluation of "intra-operative tissues effects," "thermal spread," and the ability to "transected and sealed" vessels and pedicles.
• Chronic Studies: Evaluation of the long-term performance of "transected and sealed" blood vessels and blood vessel pedicles in a survival setting.
• Bench Testing: Direct physical measurements such as Tissue Pad Life, Tissue Pad Removal Force, Instrument Grasping Force, Sealed Vessel Burst Pressure, and objective measurements of thermal spread.

8. Sample Size for the Training Set

Not applicable. This device is a physical surgical instrument and does not involve AI/machine learning models that require a separate "training set" of data in the conventional sense for performance evaluation in this 510(k) submission. The "Adaptive Tissue Technology" is a functional design feature, not a trainable AI model in the context of this submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" as understood in AI/machine learning contexts for this device submission.

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The 37cm iQ Large tip and sleeve sets, when used with the appropriate Sonopet iQ handpiece, are intended for use in surgical procedures where fragmentation, emulsification, and aspiration of tissue is desirable.
The 37cm iQ Large tip and sleeve sets intended for soft tissue may be used in surgical procedures including gastrointestinal and affiliated organ surgery, urological surgery, general surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and thoracoscopic surgery.
CONTRAINDICATION: This ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids.

The Sonopet iQ Ultrasonic Aspirator System is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, emulsifies fragments and removes unwanted tissue. The system consists of a console to provide control and power functions, a surgical handpiece to provide ultrasonic mechanical energy (25kHz), sixteen (16) tips with irrigation sleeves and a cassette for irrigation and suction. Users may choose from three different styles of foot pedals. The sixteen tips and sleeves consist of a soft tissue family and a hard tissue family.
The Sonopet iQ 37cm iQ Large (5500-25S-601) is the subject device of this submission and is an extension to the family of Sonopet iQ soft tissue tips and sleeves which are commercially available in the United States. The Sonopet iQ 37cm iQ Large is a single use device that forms part of the Sonopet iQ Ultrasonic Aspirator System.

This document is a 510(k) premarket notification for the Stryker Sonopet iQ 37cm iQ Large ultrasonic surgical aspirator. It describes the device, its intended use, and the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "All pre-defined acceptance criteria for the above tests have been met." However, it does not provide specific quantitative acceptance criteria or detailed reported performance for each test. It only lists the categories of non-clinical testing performed.

2. Sample Size for the Test Set and Data Provenance:

The document does not provide details on the sample size used for the test set for any of the non-clinical tests. It also does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective) for these tests. All testing appears to be non-clinical, implying laboratory-based or simulated environments, rather than human clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. Given that the testing is non-clinical (engineering, simulated use), the concept of "experts establishing ground truth" in the clinical sense (e.g., radiologists interpreting images) is not directly applicable here. "Ground truth" for engineering tests would typically be established by validated measurement techniques, standards, or specifications defined by engineers/designers.

4. Adjudication Method for the Test Set:

This information is not provided as it's not relevant to non-clinical engineering and performance testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical testing was not required for this traditional 510(k)." The device is an ultrasonic surgical aspirator, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device is a physical surgical instrument, not an algorithm. Therefore, the concept of "standalone algorithm performance" is not applicable. The performance evaluated related to the physical characteristics and function of the device in a surgical context, specifically its fragmentation, emulsification, and aspiration capabilities. The "Simulated Use Validations" would assess the device's performance in a simulated surgical environment.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical tests listed (Sterilization, Biocompatibility, EMC/Electrical Safety, Design Verification, Human Factors, Simulated Use), the "ground truth" would be established by:

• Sterilization and Package Integrity: Industry standards (e.g., ISO standards), validated sterilization cycles, and package testing specifications.
• Biocompatibility: ISO 10993 series of standards and associated tests.
• EMC and Electrical Safety: IEC 60601 series of standards.
• Design Verification: Engineering specifications, design requirements, and validated test methods.
• Human Factors and Usability: Usability standards (e.g., IEC 62366) and defined user tasks with performance metrics.
• Simulated Use Validations: Performance specifications (e.g., tissue fragmentation rate, aspiration efficiency) evaluated against realistic simulated tissue or models.

The document does not detail specific ground truth criteria for each test but indicates they were "pre-defined acceptance criteria."

8. The Sample Size for the Training Set:

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable for the same reason as point 8.

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LOTUS Enhanced Shears are indicated for soft tissue surgical incisions when bleeding control and minimal injury are important. They may be used as an adjunct to or substitute for electrosurgery, and traditional scalpels in general, gynecological, thoracic surgery, and exposure to orthopedic structures (such as hip joint).

The Lotus Series 5 is indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. It may be used as an adjunct to or substitute for electrosurgery, and traditional scalpels in general, gynecological, thoracic surgery, and exposure to orthopedic structures (such as hip joint)

LOTUS Series 4 Enhanced Shears: The LOTUS Series 4 Enhanced Shears consist of a reusable Transducer and a Single use Handpiece and are designed to use torsional ultrasound in the 35.4-36.6kHz range to cut and coagulate soft tissue during laparoscopic, open or bariatric surgery. The 2 types of LOTUS Series 4 Enhanced Shears subject to this application are the ES4-200CT transducer (with DS4-200CD Handpiece) that is designed for use in open surgery and the ES4-500CT transducer (with DS4-500CD Handpiece) that is designed for bariatric surgery. The new LOTUS Series 4 Enhanced Shears transducers have a similar waveguide and blade form to that of the ES4-400CT that was previously cleared as part of the Lotus Series 4 Ultrasonic Surgical System and Accessories (K151101). The LOTUS Series 4 Enhanced shears use an identical transducer stack and casing and the same LG4 generator cleared as part of K151101. The Handpieces are identical in function as those cleared as part of K151101. They are identical to the DS4-200SD and DS4-500SD except that they use the same curved jaw as the DS4-400CD. All of these devices are described in detail in K151101. All Transducers are reusable up to 50 times and the Handpieces are single use and provided sterile.

LOTUS Series 5: The LOTUS Series 5 is a modification to the Lotus Series 4 Ultrasonic Surgical System and Accessories. LOTUS Series 5 consists of new Transducers and Handpieces but are driven by the same generator as in the predicate - the LG4. The Transducers and Handpieces offer the improved feature of 360° rotation, whereas the predicate has rotation limited to 240°. To facilitate this feature, it has been necessary to redesign the transducer so that it sits axially in the plane of the waveguide. It still uses torsional ultrasound in the 35.4-36.6kHz range at the waveguide blade to perform its surgical function. The output at the waveguide blade is substantially equivalent to that of the predicate. The Handpieces of LOTUS Series 5 have had the area where the transducer fits to the Handpiece altered to allow for the 360° rotation, but the outer appearance of the Handpieces remains unchanged from the predicate. All Transducers are reusable up to 50 times and the Handpieces are single use and provided sterile.

The provided text describes two medical devices, LOTUS Series 4 Enhanced Shears and LOTUS Series 5, and their substantial equivalence to a predicate device (Lotus Series 4 Ultrasonic Surgical System and Accessories, K151101). The document details the devices' intended use, technological characteristics, and performance testing, but it does not provide traditional acceptance criteria in the form of numerical thresholds or comparative statistics that are typically found in studies for AI/ML devices or diagnostic tools.

Instead, the acceptance criteria are implicitly defined by demonstrating that the new devices are "substantially equivalent" to an existing predicate device, meaning they perform as safely and effectively. The studies conducted are primarily bench testing to confirm this equivalence in performance.

Here's the breakdown based on your request, focusing on what can be extracted from the document:

LOTUS Series 4 Enhanced Shears & LOTUS Series 5

1. Table of Acceptance Criteria and Reported Device Performance:

Since explicit numerical acceptance criteria for performance metrics (like sensitivity, specificity, accuracy, or effect size) are not provided in this regulatory document, the table reflects the comparison points used to establish substantial equivalence. The "Acceptance Criteria" column indicates that the performance should be "Equivalent to Predicate," meaning it must meet or not negatively deviate from the established performance of the legally marketed predicate device (LOTUS Series 4 Ultrasonic Surgical System and Accessories K151101).

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated as a number of samples in the typical sense (e.g., patient cases). The testing involved bench testing of the devices themselves.
  • For LOTUS Series 4 Enhanced Shears: "Performance testing cut times" and "Transducer lifetime" were tested.
  • For LOTUS Series 5: "Acoustic performance cut times, maximum average power and frequency tracking," "Thermal spread in 3 types of tissue (muscle, kidney and liver)," "Length of dissection," and "Transducer lifetime" were tested.
• Data Provenance: The document only mentions "bench testing" and "No animal testing has been undertaken." This suggests testing performed in a laboratory setting on the physical devices or tissue models, rather than clinical data from specific countries or patient populations. The tests were likely conducted by the manufacturer, SRA Developments Ltd (United Kingdom).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

• Not Applicable. This submission is for surgical instruments, not for diagnostic or AI/ML devices that require ground truth established by human experts. The performance is assessed through objective engineering and biological bench tests (e.g., cut times, thermal spread in tissue).

4. Adjudication Method for the Test Set:

• Not Applicable. As there are no human experts establishing a "ground truth" for diagnostic or AI/ML performance, no adjudication method is relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This device is a surgical instrument (ultrasonic shears), not an AI-assisted diagnostic or imaging system. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are irrelevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

• The "ground truth" for these devices is established by objective physical measurements and biological effects (e.g., precise timing of cuts, calibrated temperature measurements for thermal spread in animal tissues, mechanical displacement measurements) as compared to the performance of the legally marketed predicate device. It's not expert consensus, pathology, or outcomes data in the typical sense, but rather engineering and pre-clinical performance data.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable. As there is no training set, there is no ground truth establishment for it.

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