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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 K500 Ultrasonic Surgical System is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The scalpel can be used as an adjunct or substitute for electrosurgery, laser and steel scalpels.

Ultrasonic Surgical System consists of a generator, a foot switch, a scalpel and a hand piece. In addition, a cart is provided as an optional component. The electrical energy supplied by the generator will be converted into mechanical motion by the transducer in hand piece, which will drive the scalpel vibrate longitudinally. The foot switch is used to control the activation of energy output. The scalpels are used to cut and coagulate soft bodily tissues and structures in many surgery procedures.

The provided text describes a 510(k) submission for the K500 Ultrasonic Surgical System, asserting its substantial equivalence to predicate devices. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML-driven device.

The study described is a non-clinical performance comparison test to ensure that the proposed device, an ultrasonic surgical system, meets its design specifications and is substantially equivalent to a predicate device. This is a traditional medical device submission, not specifically an AI/ML device submission that would involve human-in-the-loop performance or standalone algorithm performance testing.

Therefore, many of the requested categories related to AI/ML device performance and ground truth establishment cannot be fulfilled from the provided document.

Here's a breakdown of the available information based on the provided text, acknowledging that it's for a traditional medical device and not an AI/ML device performance study:

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

The document does not explicitly state "acceptance criteria" in a quantitative table for device performance in the way one would for an AI/ML model (e.g., sensitivity, specificity thresholds). Instead, it describes performance comparison tests to demonstrate substantial equivalence to a predicate device.

Table 1: Non-Clinical Performance Testing and Outcomes

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified for any of the non-clinical tests (e.g., number of vessels, number of animals).
• Data Provenance: Not specified. "Animal study" mentioned without country or specific details. The manufacturer is Miconvey Technologies Co., Ltd. from Chongqing, China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the study described is a non-clinical performance and biocompatibility study for a surgical device, not a diagnostic or AI/ML study requiring expert ground truth for interpretation.

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

Not applicable for this type of non-clinical device performance study.

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. This is not an AI/ML device or a diagnostic device where human readers would be involved in interpreting data assisted by AI.

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

Not applicable. This is not an AI/ML device. The "device" is an ultrasonic surgical system, a physical tool.

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

For the non-clinical performance tests:

• Performance Metrics: Measured directly (e.g., burst pressure, thermal spread, physical dimensions) against established engineering specifications and comparison to the predicate device's known performance.
• Biocompatibility: Assessed against ISO standards (e.g., presence/absence of irritation, cytotoxicity).
• Animal Studies: Observed physiological effects and outcomes (e.g., vessel sealing success, survival).

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. This is not an AI/ML device.

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Ultrasonic System is an ultrasonic surgical system consisting of a handpiece and associated tips for cutting bone. osteotomy, osteoplasty and drilling in a variety of surgical procedures, including but not limited to:

• · Otolaryngology
• Oral/maxillofacial
• · Hand and foot
• · Neurosurgery
• · Spine
• · Plastic/reconstructive.

Ultrasonic Surgical System consists of a console (control unit) with an integrated peristaltic pump, a handpiece with a connecting cord, a range of tip inserts, a torque wrench, a footswitch, and an irrigation set (liquid-flow tube and liquid-flow sleeve).
The console has a touch panel that allows the surgeon to control device operation. The console activates and controls the ultrasound vibration, controls irrigation flow, and displays system condition. Inside the console are located the ultrasonic generator, the electrical power supply module, and the micro-processor electronic board that controls and supervises the functional parameters of the device.
The console is connected to the main power by an electrical cord. It includes connectors for the handpiece and for the footswitch. The console incorporates a peristaltic pump which provides, through the irrigation tubing set, a sterile fluid supply to the surgical site. Ultrasonic power and irrigation flow to the handpiece are activated by pressing the footswitch. The handpiece contains a piezoelectric ultrasonic transducer which attaches to the generator (inside the console) by a cable at one end of the handpiece. Tip inserts are attached to the other end of the handpiece.
Ultrasonic Surgical System uses ultrasonic technology to generate mechanical microvibrations of the tip insert connected to the handpiece, the piezoelectric transducer converting the electrical voltage supplied by the ultrasonic generator into mechanical energy that induces vibration of the tip insert at the resonant frequency of the tip insert.
The tips are used to fragment and reshape bone and soft tissue through longitudinal and (for bone drilling) rotational vibration at high frequency and small amplitude, while keeping the soft tissues with elastic properties free of damage.
Ultrasonic Surgical System comes with separate handpieces for Ultrasonic Surgical Bone Cutting and Ultrasonic Surgical Bone Drilling.
The handpieces are reprocessed through cleaning and disinfection before each use. The ultrasonic tips, irrigation tubing, and water injection sleeves are provided sterile for single use.

The provided text is a 510(k) summary for the MediSonic Technology Co's "Ultrasonic Surgical System." It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study design with acceptance criteria for device performance in a clinical or AI-assisted context.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets them in the context of device performance as understood in questions 1-9 (e.g., accuracy, effect size with human readers, standalone performance, ground truth establishment). The document describes non-clinical bench testing for aspects like electrical safety, biocompatibility, sterilization, and software validation, which are about assuring the device itself is safe and functions as designed, not about its clinical efficacy or how it assists human users.

Here's what can be extracted based on the provided text, addressing the points where information is available or noting its absence:

Acceptance Criteria and Device Performance (Based on "Performance Testing" section):

The document lists various non-clinical bench tests performed according to FDA-recognized standards. The description states that "the device passed each test." This implies that the acceptance criterion for each of these tests was simply compliance with the respective FDA-recognized standard. The "reported device performance" is implicitly that it met these standards.

Here's a breakdown of the specific questions based only on the provided text:

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

   • Acceptance Criteria: As detailed in the table above, the acceptance criteria were compliance with the specified FDA-recognized standards for non-clinical bench testing.
   • Reported Device Performance: The document states that "the device passed each test" and that "all necessary testing has been performed and the results support the conclusion that Ultrasonic Surgical System is substantially equivalent."

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

   • This document describes non-clinical bench testing (e.g., electrical, biocompatibility, sterilization, software validation). It does not involve a "test set" in the sense of patient data or clinical images.
   • Sample size: Not applicable for this type of testing (no human or patient data samples).
   • Data provenance: Not applicable. The tests are laboratory-based demonstrations against engineering and safety standards.

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

   • Not applicable. Ground truth, in the context of clinical device performance, usually refers to a definitive diagnosis or outcome confirmed by expert consensus, pathology, or long-term follow-up. This document focuses on demonstrating the safety and fundamental functionality of the surgical system itself through non-clinical testing, not diagnostic or clinical accuracy.

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

   • Not applicable. There is no mention of human adjudication for a test set.

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. This device is an "Ultrasonic Surgical System" for cutting bone, osteotomy, osteoplasty, and drilling. It is a surgical tool, not an AI-powered diagnostic or assistive tool that would typically be evaluated in an MRMC study comparing human reader performance.

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

   • Not applicable. This is a hardware surgical device, not a standalone algorithm. Its "performance" refers to its physical and functional capabilities, not an algorithmic output.

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

   • The "ground truth" for the tests performed relates to compliance with engineering and safety standards rather than clinical outcomes. For example, for biocompatibility, the ground truth is whether the materials elicit specific biological responses as defined by ISO standards. For electrical safety, it's whether the device meets insulation and leakage current limits. This is established by specific test methodologies outlined in the referenced standards.

8. The sample size for the training set:

   • Not applicable. This device is not an AI/ML product developed with a training set.

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

   • Not applicable.

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Lotus Series 4 Ultrasonic Surgical System & Accessories are indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. Lotus Series 4 Ultrasonic Surgical System and Accessories may be used as an adjunct to or substitute for electrosurgery, laser surgery, and traditional scalpels in general, gynecological, thoracic surgery, and exposure to orthopedic structures (such as hip joint)

The SRA Developments Lotus Series 4 Ultrasonic Surgical System and Accessories consists of 3 main components - the power module which generates the ultrasonic energy and provides overall control of the device, the reusable part of the handset (Transducer and waveguide); and the disposable part of the handset (Handpiece). The Lotus Series 4 Ultrasonic Surgical System and Accessories employs torsional mode ultrasound at 35.8-36.6kHz to cut and coagulate soft tissue during laparoscopic or open surgery.

This document describes the 510(k) summary for the Lotus Series 4 Ultrasonic Surgical System & Accessories. It details the device's improvements, its legally marketed predicate device, and the performance testing conducted to demonstrate substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) summary for a medical device (ultrasonic surgical system), the "acceptance criteria" and "device performance" are typically framed in terms of demonstrating equivalence to a predicate device, rather than specific quantitative performance metrics against a defined threshold for AI/diagnostic algorithms. The study conducted here is a series of bench tests to demonstrate this equivalence.

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

• Generator Output Equivalence: The document states "a Transducer was driven by each generator in turn". The exact number of transducers or measurements is not specified.
• New Waveguide Design (Cutting, Hemostasis, Fatigue):
  • Cutting Speed: Tested using "our standard production cutting test". The number of waveguides or tests is not specified.
  • Hemostasis/Bleeding Control: Tested on "porcine tissue". The number of samples or tests is not specified.
  • Fatigue Resistance: Refers to "50 surgical uses" per device. "All devices" suggests more than one, but the exact number of tested waveguides is not specified.
• Handpiece Durability: "The handpieces were subjected to 600 clamping operations... All devices passed the test." The exact number of handpieces tested is not specified, but "all devices" suggests at least multiple.

Data Provenance: The studies were conducted by SRA Developments LTD, based in the United Kingdom. The tests are described as bench testing and in vitro (e.g., porcine tissue for hemostasis), indicating they are prospective tests performed in a controlled laboratory environment for the purpose of this submission. The origin of the tissue (e.g., country for porcine tissue) is not specified.

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

This type of submission for an ultrasonic surgical system does not typically involve "experts establishing ground truth" in the way an AI diagnostic algorithm for image analysis would. The ground truth for performance is established through direct physical measurements (e.g., amplitude, cutting speed, visual assessment of hemostasis, functional testing for durability and fatigue). No human experts or their qualifications are mentioned in this context.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication by experts or a consensus method. Performance is determined by objective physical measurements and functional tests.

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. This is a 510(k) submission for a surgical instrument, not an AI-assisted diagnostic tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

Not applicable. This is a surgical instrument, not an algorithm, so "standalone" performance in the context of AI is not relevant. The device operates independently of human "reading" or AI interpretation.

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

The ground truth for the performance tests was based on objective physical measurements and functional parameters such as:

• Amplitude measurements for generator output.
• Measured cutting speed.
• Observed hemostasis (bleeding control) on porcine tissue.
• Continued functionality after simulated usage cycles for fatigue resistance and durability.
• Compliance with electrical safety and EMC standards.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is an ultrasonic surgical system and not an AI/machine learning algorithm.

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

Not applicable, as there is no training set for this type of device.

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These instruments (ultrasonic surgical instruments, ultrasonic generator, and transducers) have been designed to be used together to cut and coagulate soft tissue in bariatric procedures which include: laparoscopic and general (open) surgery in intraabdominal, obstetric/gynecologic, thoracic and urologic procedures. The ultrasonic surgical instruments are also compatible for use with an electrosurgical unit

The major components of this system are the generator, handpiece, and accessories. The generator supplies electrical energy for ultrasonic vibration of the handpiece (transducer). The ultrasonic vibration is transferred to the tip of probe. Soft body tissue is incised and coagulated through the ultrasonic energy delivered by the handpiece.

This document is a 510(k) summary for the Olympus Ultrasonic Surgical System SonoSurg, which is a premarket notification to the FDA to market a medical device. This type of submission is for proving substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials.

Therefore, the provided text does not contain acceptance criteria or a study proving the device meets acceptance criteria in the typical sense of a clinical or performance study for a novel device.

The relevant sections of the document explicitly state:

• G. REASON FOR NOT REQUIRING CLINICAL DATA: "When compared to the predicate device, the Ultrasonic Surgical System SonoSurg does not incorporate any significant change that impacts safety and efficacy in comparison to the predicate device. Therefore, clinical data is not necessary to establish the subject device."

Instead of a study proving performance against acceptance criteria, the submission focuses on demonstrating:

• Substantial Equivalence: The primary "study" here is a comparison to predicate devices, showing that the new device has the same intended use, similar technological characteristics, and does not raise new questions of safety or effectiveness.
• Compliance with Voluntary Safety Standards: The document states, "The Olympus SonoSurg Generator SonoSurg-G2 has been designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirement of IEC 60601-1: 1995, IEC 60601-1-1:2000 and IEC 60601-2-18:1996, Amendment:2000." These standards serve as the "acceptance criteria" for electrical safety and EMC, and the "study" is the testing performed to demonstrate compliance.

Given this, I cannot fill out the requested table and answer the study-related questions as if a clinical or performance study was conducted to prove specific accuracy or effectiveness metrics. The information is simply not present in a 510(k) summary for a substantially equivalent device that does not require clinical data.

I can, however, extract the information about the predicate devices for context:

Predicate Devices:

Summary of Device and Claim for Equivalence:

• Intended Use: These instruments (ultrasonic surgical instruments, ultrasonic generator, and transducers) have been designed to be used together to cut and coagulate soft tissue in bariatric procedures which include: laparoscopic and general (open) surgery in intraabdominal, obstetric/gynecologic, thoracic and urologic procedures. The ultrasonic surgical instruments are also compatible for use with an electrosurgical unit.
• Technological Characteristics: The mechanism of this system is that the electrical energy employed in the main unit is changed to mechanical energy by ultrasonic vibration. This is the same as the referenced Olympus predicate devices.
• Materials: All of the patient contacting materials used in the components of the "Olympus Ultrasonic Surgical System SonoSurg" are identical materials used in legally marketed Olympus devices.

The "study" proving acceptance criteria here is the demonstration of substantial equivalence to already cleared devices and compliance with relevant safety standards, not a new clinical performance study.

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The SonoSurg Ultrasonic Surgical System is indicated for use in surgical procedure in neurosurgery where dissection, fragmentation, emulsification and aspiration of soft tissue are desirable.

This system consists of the SonoSurg Generator (SonoSurg-G2 set), SonoSurg Irrigation Unit (SonoSurg-IU), SonoSurg Transducer (SonoSurg-T2L-MS), and SonoSurg ultrasonic surgical instruments, and is designed to be used with a separate surgical suction source. Do not use this system for any purpose other than its intended use.

The subject SonoSurg is an ultrasonic surgical device designed to be used with Generator Irrigation Unit and Transducer and ultrasonic surgical instruments to dissect, fragment, enulsify and aspirate tissue in the neurosurgical field. This system consists of the SonoSurg Senerator (SonoSurg-G2 set), SonoSurg Imigation Unit (SonoSurg-IU), SonoSurg-Transducer(SonoSurg-T2L-MS), and SonoSurg ultrasonic surgical instruments, and is designed to be used with a separate surgical suction source.

This submission is for a 510(k) premarket notification for the SonoSurg Ultrasonic Surgical System. The document does not describe a study to establish acceptance criteria or demonstrate device performance through clinical trials or specific performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on non-clinical tests.

Here's a breakdown of the requested information based on the provided text:

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

The provided documentation does not include a table of acceptance criteria or specific performance metrics with reported results for the SonoSurg Ultrasonic Surgical System. The demonstration of safety and effectiveness is primarily through substantial equivalence to predicate devices, supported by non-clinical tests for design and materials.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The submission relies on non-clinical tests and a comparison with predicate devices, rather than a test set with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There is no test set in the conventional sense that would require expert-established ground truth.

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

Not applicable.

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. This device is an ultrasonic surgical system, not an AI-assisted diagnostic or imaging device that would typically involve human readers.

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

Not applicable. This device is an ultrasonic surgical system, not an algorithm, and is intended for use with a human medical professional.

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

Not applicable. The evaluation is based on non-clinical tests and comparison to predicate devices, not on a ground truth derived from clinical data.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable.

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OLYMPUS Ultrasonic Surgical System has been designed to be used with the Olympus SonoSurg generator Set (SonoSurg-G2 Set) and an electrosurgical unit to cut and coagulate soft tissue for laparoscopic and intraabdominal procedures in general (open) surgery. It is also designed to cut and coagulate soft tissue for open and endoscopic procedures in urologic surgery.

The Olympus Ultrasonic Surgical System is composed of three sections, (1), (2), and (3).

• (1) Olympus SonoSurg Scissors 5mm O.D. T3050" or "Olympus SonoSurg Long Hook 5mm O.D. T3060" or "Olympus SonoSurg Long Scissors 5mm O.D. T3070", or "Olympus SonoSurg Scissors 5mm O.D., HF Series.
• (2) Olympus SonoSurg Transducer SonoSurg-T2H.
• (3) Olympus SonoSurg Generator Set SonoSurg-G2 Set (SonoSurg-G2, MAJ-51).
  This device is intended to cut and coagulate soft tissue for open and endoscopic procedures in urologic surgery.

This medical device submission for the Olympus Ultrasonic Surgical System (K031523) does not contain acceptance criteria or a study demonstrating the device meets such criteria in the context of an AI/ML algorithm evaluation.

The provided documents describe a traditional medical device (an ultrasonic surgical system) and its substantial equivalence to predicate devices based on technological characteristics and intended use. The submission explicitly states:

"G. Reason for not requiring clinical data: When compared to the predicate devices, 'Olympus Ultrasonic Surgical System' does not incorporate any significant changes that would effect safety or efficacy. Therefore clinical data is not necessary for its evaluation of safety."

This indicates that the approval was based on a comparison to existing devices, not on a performance study against specific acceptance criteria for an AI/ML component.

Therefore, I cannot provide the requested information for an AI/ML study because it is not present in the provided text.

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OLYMPUS Ultrasonic Surgical System has been designed to be used with the Olympus SonoSurg generator Set (SonoSurg-G2 Set) and an electrosurgical unit to cut and coagulate soft tissue for laparoscopic and intrabdominal procedures in general (open) surgery. Also it has been designed to be used with them to cut and coagulate soft tissue for open and endoscopic procedures in ENT(Ears, Nose, Throat) surgery.

The Olympus Ultrasonic Surgical System is composed of three sections, (1), (2), and (3).

• (1) Olympus SonoSurg Scissors 5mm O.D. T3050" or "Olympus SonoSurg Long Hook 5mm O.D. T3060" or "Olympus SonoSurg Long Scissors 5mm O.D. T3070", or "Olympus SonoSurg Scissors 5mm O.D., HF Series.
• (2) Olympus SonoSurg Transducer SonoSurg-T2H.
• (3) Olympus SonoSurg Generator Set SonoSurg-G2 Set (SonoSurg-G2, MAJ-51).
  This device is intended to cut and coagulate soft tissue for open and endoscopic procedures in ENT(Ears, Nose, Throat) surgery.

This document is a 510(k) summary for the Olympus Ultrasonic Surgical System. It's a premarket notification for a medical device seeking clearance from the FDA, asserting substantial equivalence to previously cleared devices.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the device's design and technological characteristics but does not explicitly state specific acceptance criteria (e.g., performance thresholds of a certain metric). Instead, it focuses on demonstrating that the device meets safety standards and operates on the same principles as its predicate devices.

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

The document explicitly states: "When compared to the predicate devices, "Olympus Ultrasonic Surgical System" does not incorporate any significant changes that would effect safety or efficacy. Therefore clinical data is not necessary for its evaluation of safety."

This means:

• Sample size for the test set: Not applicable, as no external test set or clinical study was conducted for this 510(k) submission.
• Data provenance: Not applicable.

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

Not applicable, as no clinical study or test set requiring expert ground truth was conducted for this 510(k) submission.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical study or test set requiring adjudication was conducted.

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

No, an MRMC comparative effectiveness study was not done. The submission explicitly states that clinical data was not necessary due to substantial equivalence to predicate devices.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is a surgical instrument system, not an AI algorithm. Its performance is inherent to its physical design, materials, and operating principle, which are compared to existing, cleared devices.

7. Type of Ground Truth Used:

Not applicable. The "ground truth" in this context is the safety and efficacy established for the predicate devices through prior regulatory clearances and adherence to recognized safety standards. The new device demonstrates equivalence to this established performance.

8. Sample Size for the Training Set:

Not applicable, as this is a physical medical device and not an AI/machine learning algorithm that requires a training set.

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

Not applicable.

In summary:

This 510(k) submission for the Olympus Ultrasonic Surgical System relies on demonstrating substantial equivalence to already cleared predicate devices. The core argument is that the device has the same intended use, similar technological characteristics, and adheres to the same safety standards, with no significant changes to safety or efficacy. Therefore, no new clinical studies, test sets, or ground truth establishment (as would be typical for a novel diagnostic or AI device) were deemed necessary by the submitter and subsequently agreed upon by the FDA for clearance.

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The Olympus Ultrasonic System has been designed to be used with the Olympus SonoSurg Generator Set (SonoSurg-G2 Set) and an electrosurgical unit to cut and coagulate soft tissue for laparoscopic and intrabdominal procedures in general(open) surgery. Also it has been designed to be used with them to cut and coagulate soft tissue for open and endoscopic procedures in thoracic surgery.

The Olympus Ultrasonic Surgical System is composed of three sections, (1), (2), and (3).

• (1) Olympus SonoSurg Scissors 5mm O.D. T3050" or "Olympus SonoSurg Long Hook 5mm O.D. T3060" or "Olympus SonoSurg Long Scissors 5mm O.D. T3070", or "Olympus SonoSurg Scissors 5mm O.D., HF Series.
• (2) Olympus SonoSurg Transducer SonoSurg-T2H.
• (3) Olympus SonoSurg Generator Set SonoSurg-G2 Set (SonoSurg-G2, MAJ-51).
  This device is intended to cut and coagulate soft tissue for open and endoscopic procedures in thoracic surgery.

The provided document is a 510(k) summary for the Olympus Ultrasonic Surgical System. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data from extensive clinical studies with acceptance criteria in the manner typically seen for novel medical devices or software.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth procedures, and MRMC studies for device performance is largely not applicable in this context.

Here's why and what information can be extracted or inferred:

• No explicit acceptance criteria for device performance are listed. The submission relies on demonstrating that the device meets existing safety standards and has technological characteristics "the same as the Predicate Devices."
• No clinical study demonstrating the device meets acceptance criteria is presented. The document explicitly states: "When compared to the predicate devices, 'Olympus Ultrasonic Surgical System' does not incorporate any significant changes that would effect safety or efficacy. Therefore clinical data is not necessary for its evaluation of safety."
• This is not an AI/Software as a Medical Device (SaMD) submission. Therefore, questions related to AI performance metrics (like MRMC studies, standalone algorithm performance, training/test set details, ground truth establishment for AI) are irrelevant.

However, I can provide a table based on the safety standards the device complies with, which function as "acceptance criteria" for the device's design and manufacture.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
Not applicable. This is not a study requiring a test set of data. The device's safety and efficacy are established through comparison to predicate devices and compliance with recognized consensus standards for design and manufacturing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There was no test set requiring expert ground truth for device performance evaluation in this 510(k) submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication was presented.

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. This is not an AI/SaMD device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/SaMD device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this type of device and submission, "ground truth" relates to compliance with safety standards and functional equivalence to predicate devices, rather than diagnostic accuracy or patient outcomes.

8. The sample size for the training set
Not applicable. This is not an AI/SaMD device.

9. How the ground truth for the training set was established
Not applicable. This is not an AI/SaMD device.

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OLYMPUS Ultrasonic Surgical System has been designed to be used with the Olympus SonoSurg Generator Set (SonoSurg-G2 Set) and an electrosurgical unit to cut and coagulate soft tissue for open and endoscopic procedures in general surgery. Also it has been designed to be used with them to cut and coagulate soft tissue for obstetric/gynecologic surgery, and for open and laparoscopic surgery.

The Olympus Ultrasonic Surgical System is composed of three sections, (1), (2), and (3).

• (1) Olympus SonoSurg Scissors 5mm O.D. T3050" or "Olympus SonoSurg Long Hook 5mm O.D. T3060" or "Olympus SonoSurg Long Scissors 5mm O.D. T3070", or "Olympus SonoSurg Scissors 5mm O.D., HF Series.
• (2) Olympus SonoSurg Transducer SonoSurg-T2H.
• (3) Olympus SonoSurg Generator Set SonoSurg-G2 Set (SonoSurg-G2, MAJ-51).
  This device is intended to cut and coagulate soft tissue for obstetric/ gynecologic surgery, and for open and laparoscopic surgery.

This 510(k) summary for the Olympus Ultrasonic Surgical System (K021962) explicitly states that clinical data was not required for its evaluation of safety and efficacy.

Therefore, the study that proves the device meets acceptance criteria, and many of the associated details you requested, are not provided in this document. The decision was based on a finding of "substantial equivalence" to predicate devices, implying that the new device does not incorporate any significant changes that would affect safety or efficacy when compared to existing, legally marketed devices.

Here's a breakdown of what can be extracted from the provided text according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable/Not provided. The document states: "When compared to the predicate devices, "Olympus Ultrasonic Surgical System" does not incorporate any significant changes that would effect safety or efficacy. Therefore clinical data is not necessary for its evaluation of safety."

The "acceptance criteria" are implied to be the standards met by the predicate devices and the voluntary safety standards the new device complies with.

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

Not applicable/Not provided. No clinical test set was used. The substantial equivalence determination was based on design, materials, and functional characteristics compared to predicate devices.

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

Not applicable/Not provided. No clinical test set or ground truth established by experts was used.

4. Adjudication method for the test set

Not applicable/Not provided. No clinical test set.

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/Not provided. This device is an ultrasonic surgical system, not an AI-assisted diagnostic or interpretative tool that would involve human readers.

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

Not applicable/Not provided. This is a surgical device, not an algorithm.

7. The type of ground truth used

Not applicable/Not provided. No clinical ground truth was established as no clinical study was performed. The "ground truth" for the device's acceptable performance is its substantial equivalence to previously cleared devices and compliance with relevant safety standards.

8. The sample size for the training set

Not applicable/Not provided. No AI/machine learning model, therefore no training set.

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

Not applicable/Not provided. No AI/machine learning model, therefore no training set or ground truth for it.

In summary: The Olympus Ultrasonic Surgical System (K021962) received 510(k) clearance based on its substantial equivalence to existing predicate devices and adherence to recognized safety standards (IEC 60601 series). No specific clinical study or data related to acceptance criteria, test sets, or expert-established ground truth was required or performed for this premarket notification.

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