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The Sonicision™ Curved Jaw Cordless Ultrasonic Dissection Device is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The Device can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space), and other open and endoscopic procedures. The Sonicision™ Cordless Ultrasonic Dissection Device can be used to coagulate isolated vessels up to and including 5 mm in diameter.

The Sonicision 13 cm device is also indicated for use in otorhinolaryngologic (ENT) procedures.

This is a bundled 510(k) that includes multiple individual component devices, as indicated in the table below.

A functional Sonicision™ Curved Jaw Cordless Ultrasonic Dissection device is assembled by the user within the operating room. The functional device is assembled from the following three components: (1) a sterile, single-use dissector (SCDAxx), (2) a user cleaned and sterilized reusable generator (SCGAA), and (3), a user cleaned and disinfected reusable battery (SCBA). There are four different lengths of sterile single-use dissectors to allow surgeons a range of options to meet the needs of each specific surgical case.

The assembled functional device is a hand-held, battery-powered device used to dissect through tissues and to coagulate vessels up to and including 5 mm in diameter. The clinical intended use is achieved by the surgeon when pressure is applied to tissue placed between the clamping jaw and the exposed portion of the probe while activating ultrasonic energy by pressing a button on the handpiece.

The 510(k) submission includes two accessories. The first is the Battery Insertion Guide (SCBIGA), a reusable, user-sterilized device that facilitates the assembly process.

The second accessory is a custom battery charger (CBCA). The charger is able to charge up to four SCBA batteries at a time. It provides the user with an indication of the charging progress. It also monitors battery health and the number of surgical uses the battery has gone through. It disables batteries that have reached end of life or that are out of specification.

This document is a 510(k) Premarket Notification for a medical device and therefore describes a device comparison study rather than a study aimed at proving a new AI/software-as-a-medical-device (SaMD) meets acceptance criteria. The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to define and meet new performance acceptance criteria in the same way an AI/SaMD might.

However, based on the provided text, we can extract information regarding performance testing conducted to support the claim of substantial equivalence. I will frame the response by identifying what would traditionally be acceptance criteria for a new device and then describe the performance testing done in this 510(k) to demonstrate comparable performance to the predicate device.

Device: Sonicision™ Curved Jaw Cordless Ultrasonic Dissection Device

Study Purpose: To demonstrate substantial equivalence to the predicate device (Sonicision™ Cordless Ultrasonic Dissection Device family and accessories) by showing comparable performance.

The document does not explicitly state "acceptance criteria" in the traditional sense for a new device's performance benchmarks. Instead, the study aims to show that the proposed device performs comparably to the predicate device. The "acceptance criteria" can be inferred as performance that is not statistically or clinically meaningfully worse than the predicate device for key characteristics.

Here's how the information aligns with your requested format, interpreting "acceptance criteria" as "comparable performance to the predicate":

1. Table of Acceptance Criteria (Inferred as Demonstrating Comparability to Predicate) and Reported Device Performance

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

The document does not specify exact sample sizes for each test (e.g., number of vessels tested, number of mesentery activations). It broadly refers to "several bench and animal tests."

• Test Set Sample Size: Not specified quantitatively.
• Data Provenance: The tests are described as "ex vivo burst testing," "ex vivo tissue testing," "acute in vivo testing," and "chronic in vivo testing." This indicates the use of biological tissues (likely from animal models or perhaps excised human tissues, though species not specified) and live animal subjects for the in vivo studies. The country of origin of the data is not specified in the provided text. The studies would be considered prospective as they were conducted specifically for this submission.

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

The concept of "experts establishing ground truth" as typically seen in AI/SaMD studies (e.g., radiologists labeling images) is not directly applicable here. This is a medical device performance study.

• For Human Factors and Usability validation, the text mentions "Extensive human factors evaluation with operating room nurses and surgical technicians, surgeons, and central processing." While these are experts in their fields, their role is to evaluate usability rather than to establish a 'ground truth' in the diagnostic sense. The number of such participants is not specified.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1 consensus) are typically used for establishing ground truth in diagnostic studies (like image interpretation by multiple readers). This type of adjudication is not relevant to the performance tests conducted for this ultrasonic dissection device (e.g., burst strength, temperature measurement, hemostasis rates).

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

No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for AI applications where multiple human readers interpret patient cases, often with and without AI assistance, to measure diagnostic performance change. This document describes performance testing of a surgical device, not a diagnostic AI tool.

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

Not applicable. This device is a surgical instrument operated by a human, not an AI algorithm performing a task without human intervention. The performance tests ("ex vivo," "in vivo") are of the device's physical performance in the hands of users or under simulated conditions, not a standalone algorithm.

7. Type of Ground Truth Used

The "ground truth" for this type of device performance study is established through highly controlled experimental measurements and observations:

• Quantitative Measurements: Burst strength, temperature, hemostasis rates, lateral thermal spread. These are direct physical measurements and observable outcomes from the bench and animal studies.
• Qualitative Observations: Healing responses in chronic in vivo testing, user feedback on usability. These are assessed based on established biological and usability criteria.
• The comparison is primarily against the performance of the predicate device.

8. The Sample Size for the Training Set

Not applicable. This is a medical device performance study, not an AI/Machine Learning study involving training data sets.

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

Not applicable, as there is no training set mentioned or implied in this 510(k) submission.

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The Sonicision™ Cordless Ultrasonic Dissection Device is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The device can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures. The Sonicision Cordless Ultrasonic Dissection Device can be used to coagulate isolated vessels up to 5 mm in diameter.

The Sonicision™ Cordless Ultrasonic Dissection Device is a hand-held surgical device consisting of three interdependent components that, when assembled, enable ultra high-frequency mechanical motion (ultrasonic energy) to transect, dissect, and coagulate tissue. The Sonicision device is designed to be both ergonomic and intuitive for the user. It can coagulate vessels up to and including 5 mm in diameter and is designed to be inserted and extracted through a compatible 5 mm trocar, when used endoscopically/laparoscopically. A unique characteristic of the device is that it functions without the need for external power cords and transducer cables. Sonicision generators and batteries are prepared by the facility and attached to the dissector (disposable component). When assembled, electrical power supplied by the battery pack is available to be converted to ultrasonic energy in the generator. The clinical intended use is achieved by the surgeon when pressure is applied to tissue placed between the clamping jaw and the exposed portion of the probe while activating ultrasonic energy through the use of a two-stage button. The system is comprised of single-use and reusable components.

The provided text describes the 510(k) summary for the Sonicision™ Cordless Ultrasonic Dissection Device. It details the device's description, intended use, and technological/performance characteristics, along with a summary of non-clinical/preclinical performance. However, it does not contain specific acceptance criteria tables nor comparative study results with human readers or standalone algorithm performance as requested in the prompt. The information provided is primarily for demonstrating substantial equivalence to predicate devices, focusing on design features and non-clinical testing.

Therefore, many of the requested details cannot be extracted from the provided document.

Here's a summary of what can be extracted and what cannot:

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

The document describes various performance aspects that were evaluated to demonstrate substantial equivalence, but it does not present them in a formal table with specific acceptance criteria (e.g., "burst pressure > X mmHg") and corresponding reported values. Instead, it states that the device "performs at least as well as (not inferior to) the predicate ultrasonic device."

• Evaluated areas: Active blade displacement, frequency, grasping and pulling force, shaft deflection, distal seal leakage, button activation force, jaw clamping force, temperature, isolated vessel burst pressures/hemostasis, coagulation and dissection speed, qualitative ratings of sealed tissue, thermal spread, and enterotomy formation speed and hemostasis.
• Performance Outcome: "performs at least as well as (not inferior to) the predicate ultrasonic device (Harmonic ACE36E)"

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

• Sample Size for Test Set: Not specified for individual tests. The preclinical studies used "porcine" models.
• Data Provenance: Porcine (animal) studies for preclinical evaluations. The document does not specify a country of origin for the studies.
• Retrospective or Prospective: These were primarily prospective preclinical studies using animal models.

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. The "ground truth" here is based on objective measurements and observations in bench and animal studies (e.g., vessel burst pressure, tissue integrity), not on expert interpretations of medical images or data.

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

Not applicable. This type of adjudication method is used for establishing ground truth in expert-based studies, which is not what was performed here.

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 a surgical instrument, not an AI diagnostic tool. No MRMC study or AI assistance evaluation was performed.

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

Not applicable. This is a physical surgical device, not an algorithm. Performance was evaluated in non-clinical, preclinical (bench/animal), and usability studies, which involve the device in operation.

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

The "ground truth" in this context was established through:

• Objective measurements in non-clinical (electrical/mechanical/functional) testing: e.g., direct measurements of active blade displacement, frequency, forces, leakage.
• Preclinical (bench tissue/animal) evaluations: using direct observation, measurement, and histological assessment of tissue effects (e.g., isolated vessel burst pressures, coagulation speed, thermal spread, enterotomy formation).

8. The sample size for the training set:

Not applicable. The device is not an AI algorithm that requires a training set. Its development and validation are based on engineering design, material science, and physical testing.

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

Not applicable, as there is no training set for an AI algorithm.

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The iDrive Intelligent Power Unit with iConsole, when used with:

a) compatible Intelligent Surgical Instrument Linear Staplers , have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, creation of anastomoses, and for open occlusion of the heart's left atrial appendage.

b) compatible Intelligent Delivery Systems (iStraight, iFlex, iCurve) and Right Angle or Power Linear Cutter Digital Loading Units®, has applications in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, and creation of anastomoses.

c) compatible Intelligent Delivery Systems and Circular Stapler Digital Loading Units®, has applications for use throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.

d) compatible Vascular Intelligent Surgical Instruments or Intelligent Delivery Systems with Vascular Digital Loading Units®, has applications for general and endoscopic surgery including multiple open and minimally invasive general, gynecological, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures for resection, transection, and/or creation of anastomoses. They can be used with staple line buttressing material such as bovine pericardium.

The iDrive with iConsole is used in conjunction with the Intelligent Delivery Systems and Intelligent Surgical Instruments in order to resect tissue, transect tissue and create anastomoses between structures. The iDrive was previously cleared to market via K073001 and was subsequently cleared to market with additional vascular indications via K073148. The iDrive is a handpiece with integrated controls that operate the attached Intelligent Delivery Systems and Intelligent Surgical Instruments.

Here's an analysis of the provided text regarding the acceptance criteria and study for the iDrive Intelligent Power Unit with iConsole:

Unfortunately, the provided text does not contain information about specific acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) premarket notification summary, which focuses on establishing substantial equivalence to predicate devices rather than reporting on performance studies against defined criteria.

Here's a breakdown of what is and is not available in the given input, organized according to your requested points:

Acceptance Criteria and Study for iDrive Intelligent Power Unit with iConsole

Summary of the Provided Document:

The provided document is a 510(k) premarket notification for the iDrive Intelligent Power Unit with iConsole. The core of this submission is to demonstrate substantial equivalence to previously cleared predicate devices (K073001, K073148, K071708).

The "study" in this context is the comparison made to the predicate devices. The document states:

• "The iDrive with iConsole, when used in conjunction with the Intelligent Delivery Systems and Intelligent Surgical Instruments, functions identically to the predicate devices..." (Page 2, Section 5 - Device Modification)
• "The iDrive with iConsole is used in conjunction with the Intelligent Delivery Systems and Intelligent Surgical Instruments and functions identically to the predicate devices. The electronics, power configuration, and internal gearing & transmission are common to both predicate and subject devices. Both the predicate and subject devices are powered mechanically by rotational energy. In both the predicate and the subject device, a clamp shaft drives a clamp screw, which causes the anvil to close and compress tissue. The same is true for firing." (Page 3, Section 7 - Comparison to Predicate Devices)

This means the "proof" that the device meets acceptance criteria (implied to be "performs as safely and effectively as the predicate devices") is based on a technical comparison and functional assessment showing that the modifications (making the instruments detachable) do not change the fundamental operation, electronics, power configuration, or tissue manipulation mechanism that were validated in the predicate devices. This is a common approach for 510(k) submissions for device modifications.

No new clinical or performance studies with specific acceptance criteria, test sets, or ground truth establishment are detailed in this 510(k) summary.

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The Intelligent Articulating Endoscopic Linear Cutters Reverse with Reloads have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdomihal and thoracic surgical procedures for resection, transection, and creation of anastomoses.

The Intelligent Articulating Endoscopic Linear Cutter Reverse with Reloads has identical technological features as the predicate device, i45/160 (K071708). The modification made to the device was that the pivot point for the jaws was translated distally, which enables the device to open in Reverse. Both the subject device and the predicate device deliver stapling/cutting action to create anastomoses.

The provided FDA 510(k) summary (K083527) is for a medical stapling device, the "Intelligent Articulating Endoscopic Linear Cutter Reverse with Reloads." This submission details modifications to an existing predicate device (K071708) and asserts substantial equivalence based on identical technological features except for a pivot point translation.

Based on the provided document, the typical detailed acceptance criteria and study data for a device with an AI component are not present. This is because the device described is a mechanical stapling device, not an AI/software-as-a-medical-device (SaMD) or AI-augmented device in the modern sense. The term "Intelligent" in its name likely refers to its design or features at the time of its 2008 submission, rather than AI capabilities for diagnosis, prediction, or data analysis.

Therefore, many of the requested points related to AI performance, ground truth, expert consensus, and comparative effectiveness studies are not applicable or cannot be extracted from this document, as they are typically associated with devices that use algorithms for analytical or interpretive functions.

However, I can still extract the information relevant to a traditional medical device submission, focusing on the device's functional equivalence and indications for use.

Acceptance Criteria and Device Performance (for a Mechanical Device)

For a device like this, the "acceptance criteria" and "performance" would typically revolve around mechanical tests, bench testing, and potentially animal or cadaver studies to demonstrate:

• Tissue compression force
• Staple formation consistency and strength
• Cutting performance
• Leakage rates (if relevant to the application)
• Durability and fatigue testing of components
• Biocompatibility of materials

The provided 510(k) summary does not contain specific numerical acceptance criteria or detailed study results for these types of mechanical performance, as is common in a 510(k) summary which focuses on demonstrating substantial equivalence rather than providing full study reports. The summary notes that the modified device has "identical technological features as the predicate device" (K071708) and "functions the same as the predicate device."

Table of Acceptance Criteria and Reported Device Performance (Conceptual, as details are not provided in the document):

Information (Not Applicable or Not Provided for an AI Device)

2. Sample size used for the test set and the data provenance: Not applicable/provided. This device is mechanical; performance is typically demonstrated through bench testing or animal studies, not a "test set" of patient data for an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI models (e.g., expert radiological reads, pathology reports) is not relevant for this mechanical stapler.

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 is not an AI-assisted diagnostic or interpretive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI device. For a mechanical device, "ground truth" might refer to physical measurements of staple line integrity or tissue compression, demonstrated through standard engineering tests.

8. The sample size for the training set: Not applicable. There is no AI model that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

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