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The Reprocessed Harmonic Shears with Adaptive Tissue Technology 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) and other open and endoscopic procedures.

The Reprocessed Harmonic Shears with Adaptive Tissue Technology are used for coagulation and mechanical transection of soft tissue during laparoscopic and open procedures. The devices allow the surgeon to grasp, coagulate and transect soft tissue with a single instrument. The devices are hand-actuated with shaft and tissue effector that can be rotated. The energy delivery can be activated with hand activation or with an optional generator foot switch. The device includes a torque wrench as an accessory piece (the torque wrench is designed to ensure that the hand piece is properly secured to the device.

The provided text describes the 510(k) summary for Sterilmed's Reprocessed Harmonic Shears with Adaptive Tissue Technology. It details various tests conducted to demonstrate substantial equivalence to the predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it states that "Performance testing shows the reprocessed Harmonic Shears with Adaptive Tissue Technology to perform as originally intended" and "Results demonstrated substantial equivalence to the predicate devices with respect to safety and effectiveness."

The types of tests performed, which imply the areas where performance was assessed, are listed under "Summary of Non-Clinical Tests Conducted" and "Functional and Safety Testing." These tests aimed to demonstrate that the reprocessed devices perform as well as the original predicate devices.

• Electrical Safety
• Device Functionality
• Vessel Seal Burst (Static and Burst Pressure)
• Vessel Seal Thermal Spread
• Drop
• Fluid Ingress
• Pad Retention
• Pad Failure
• Clamp Force |
  | Biocompatibility (meeting ISO 10993-1 for short duration contact with blood) | Passed tests for:
• Cytotoxicity
• Sensitization
• Irritation/Intracutaneous Reactivity
• Acute Systemic Toxicity
• Hemocompatability
• Chemical Pyrogens
• Hemolysis
• Immune Response |

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

The document mentions "Representative samples of reprocessed devices were tested" for functional characteristics. However, specific sample sizes for each test are not provided in this summary.

The data provenance is from non-clinical tests conducted by Sterilmed, Inc., a reprocessing company. This is an in-house prospective testing of their reprocessed devices. The country of origin is implicitly the USA where Sterilmed is located and where the FDA regulatory submission was made.

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

This type of information is not applicable to this document. The "ground truth" for this device (a reprocessed surgical instrument) is established by objective engineering and safety standards (e.g., sterilization parameters, mechanical performance, biocompatibility) rather than expert interpretation of data like images or patient outcomes. The performance is compared against the original (predicate) device.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation is based on objective measurements against engineering standards and comparison to a predicate device, not on subjective assessments requiring adjudication among experts.

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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is a surgical instrument, not an AI-powered diagnostic or assistive technology that would involve human readers or AI.

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

This question is not applicable as the device is a reprocessed surgical instrument and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on defined engineering specifications, performance standards, regulatory requirements (e.g., ISO for biocompatibility and residuals), and the performance characteristics of the legally marketed predicate device. The goal is to demonstrate that the reprocessed device performs identically or equivalently to the new/original device.

8. The Sample Size for the Training Set

This question is not applicable. This is a reprocessed medical device, not an AI or machine learning algorithm that requires a "training set."

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

This question is not applicable for the same reason as above.

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The reprocessed harmonic shears are intended to be used for cutting soft tissue and when control of bleeding and minimal thermal injury is desired. The instruments can be used as un udjunct to or a substitute for clectrosurgery, lasers, and steel scalpels in general, plastic, pediatic, gyncoologic, thoracic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.

The harmonic shears are used in combination with a handpiece, generator and torque wrench and are intended to be used for cutting and coagulation of soft tissue during laparoscopic and open procedures. The instruments allow the surgeon to grasp, coagulate and cut soft tissue with one instrument. The instruments allow for the coagulation of vessels up to and including 5 mm in diameter. The instruments are hand-actuated with a shaft and distal tip that can be rotated 360°. The ultrasonic energy is delivered by hand activation or with an optional generator foot switch.

The provided document pertains to the reprocessed Harmonic Shears and does not describe a study involving an AI device or its acceptance criteria. The document is a 510(k) summary for a medical device (reprocessed harmonic shears) and focuses on demonstrating substantial equivalence to predicate devices, rather than the performance of an AI algorithm.

Therefore, I cannot provide the requested information regarding AI device acceptance criteria and study details based on the provided text.

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