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The Reprocessed HARMONIC ACE®+7, 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, plastic, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Advanced Hemostasis hand control button.

Reprocessed HARMONIC ACE®+7, 5mm Diameter Shears with Advanced Hemostasis are used for coagulation and mechanical transection of soft tissue during laparoscopic and open procedures. The devices consist of an ergonomic handle and 3 hand-controlled activation buttons. The handle includes a mechanism that provides both audible and tactile feedback indicating full closure. The instruments utilize Adaptive Tissue Technology which provides the generator with the ability to identify and monitor the instrument during use and enables the generator to modulate and adjust its power output as well as provide audible feedback to the user as appropriate. Each instrument is shipped with one sterile, single-use, disposable torque wrench.

The provided text describes a 510(k) premarket notification for a reprocessed medical device, specifically "Reprocessed HARMONIC ACE®+7, 5 mm Diameter Shears with Advanced Hemostasis". This document details the comparison to a predicate device and various tests conducted to demonstrate substantial equivalence, rather than a clinical study evaluating a diagnostic or AI-driven device's performance against specific acceptance criteria like accuracy, sensitivity, or specificity.

Therefore, the requested information regarding acceptance criteria, reported device performance in those terms, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, and types of ground truth for a diagnostic AI device is not applicable to this document.

The document focuses on demonstrating that the reprocessed surgical shears are as safe and effective as the original, legally marketed predicate device through a series of engineering and performance tests.

Here's what can be extracted regarding the device's performance demonstration:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines functional performance tests and other validations, rather than specific diagnostic accuracy metrics. The "acceptance criteria" are implied to be achieving performance comparable to the predicate device and meeting safety standards.

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

• This document does not specify exact sample sizes for each test. It generally states that "Bench and laboratory testing was conducted" and includes "verification/comparative testing (to the predicate device)."
• Data provenance: Not explicitly stated, but assumed to be internal laboratory testing by Stryker Sustainability Solutions. It is not clinical data from specific countries or indicated as retrospective/prospective in a diagnostic sense.

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

• Not applicable. This is not a diagnostic device relying on expert interpretation for ground truth.

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

• Not applicable. This is not a diagnostic device requiring adjudication of interpretations.

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 reprocessed surgical instrument, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a reprocessed surgical instrument, not an algorithm.

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

• For the performance tests, the "ground truth" would be established by engineering specifications, validated test methods, and comparison against the performance of the original, new predicate device. For animal studies, the "ground truth" would be physiological outcomes observed by veterinarians or pathologists.

8. The sample size for the training set:

• Not applicable. This is a reprocessed physical device, not an AI model requiring a training set.

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

• Not applicable. See point 8.

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The Reprocessed HARMONIC ACE®+7, 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, plastic, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Advanced Hemostasis hand control button.

Reprocessed HARMONIC ACE®+7, 5mm Diameter Shears with Advanced Hemostasis are used for coaqulation and mechanical transection of soft tissue during laparoscopic and open procedures. The devices consist of an erqonomic handle and 3 hand-controlled activation buttons. The handle includes a mechanism that provides both audible and tactile feedback indicating full closure. The instruments utilize Adaptive Tissue Technology which provides the generator with the ability to identify and monitor the instrument during use and enables the generator to modulate and adjust its power output as well as provide audible feedback to the user as appropriate. The only difference between the three (3) model numbers subject of this submission is the shaft length detailed in the table below.

The provided text describes a 510(k) premarket notification for a reprocessed medical device, the Reprocessed HARMONIC ACE®+7, 5mm Diameter Shears with Advanced Hemostasis. This is crucial as the acceptance criteria and supporting studies are focused on demonstrating that the reprocessed device is substantially equivalent to the original, legally marketed predicate device, and operates as originally intended.

Therefore, the studies and acceptance criteria are not about establishing the primary clinical efficacy of a new device, but rather validating the safety and functionality of a reprocessed version against an established benchmark.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific quantitative acceptance criteria or detailed reported performance values for each test. Instead, it broadly states that the performance testing "demonstrates that reprocessed devices are as safe and effective as the predicates and operate as originally intended."

The types of tests conducted suggest the implicit acceptance criteria would be that the reprocessed device's performance is comparable or equivalent to the predicate device within acceptable limits for:

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

• Sample Size for Test Set: The document does not specify exact sample sizes for each test. It generally refers to "bench and laboratory testing" and "acute and chronic pre-clinical testing."
• Data Provenance: The studies were conducted as part of a 510(k) submission by Stryker Sustainability Solutions. The data would be internally generated through laboratory and pre-clinical animal studies. No information is provided regarding the country of origin of the data beyond the applicant company's location (Tempe, Arizona, USA). These studies are inherently prospective as they are specifically designed and executed to support the regulatory submission for the reprocessed device.

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

This information is not applicable in the context of this 510(k) submission. For reprocessed devices, the "ground truth" for performance is typically established by comparing the reprocessed device's objective physical and functional parameters against those of the original, new predicate device, and ensuring it meets its performance claims. This involves engineering and scientific testing rather than expert-derived ground truth based on cases (e.g., in medical image analysis).

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like "2+1" or "3+1" are relevant in studies where human readers are interpreting data (e.g., medical images) and their decisions need to be reconciled to form a consensus ground truth. The studies described here are primarily objective, bench, and pre-clinical tests comparing device performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used for diagnostic or screening devices (e.g., AI in radiology) to evaluate the impact of a system on human reader performance. This submission is for a reprocessed surgical instrument.

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

This concept is not directly applicable in the way it's typically understood for AI/software devices. The device is a surgical instrument. However, the "Functional Performance Tests" and "Electrical Safety Testing," "Electromagnetic Compatibility Testing," and "Software Validation" can be considered "standalone" evaluations of the device's inherent physical and functional properties, independent of a human operator, to ensure it meets its specifications.

7. The type of ground truth used

The "ground truth" for the performance evaluations performed for this reprocessed device is established through:

• Engineering and Scientific Measurements: Objective laboratory measurements of device characteristics (e.g., thermal spread, transection time, burst pressure, electrical parameters).
• Pre-clinical Animal Model Observations: Direct observation of the device's effects in acute and chronic animal studies (e.g., hemostasis, tissue effects).
• Comparison to Predicate Device Performance: The underlying ground truth is that the reprocessed device must perform equivalently to the original predicate device (HARMONIC ACE+ Shears with Advanced Hemostasis, K132612) and meet its stated indications.

8. The Sample Size for the Training Set

This information is not applicable. This device is a reprocessed physical medical instrument, not an AI/ML algorithm that requires a "training set" of data.

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

This information is not applicable per the reason stated in point 8.

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