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The Sterilmed Reprocessed HARMONIC ACE®+ 7 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.

The Sterilmed Reprocessed HARMONIC ACE+7 Shears with Advanced Hemostasis 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 a 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 two models are identical to each other in materials, form, fit and function except for the length of the shafts which are 23cm and 36 cm.

This document describes the validation of reprocessed HARMONIC ACE®+ 7 Shears with Advanced Hemostasis, demonstrating their substantial equivalence to the original equipment manufacturer (OEM) predicate device. Given that the provided text is a 510(k) summary for a reprocessed medical device (surgical shears), the acceptance criteria and study design are focused on demonstrating that the reprocessed device performs as safely and effectively as the original device. This is a non-clinical submission, thus the information regarding AI/human reader studies, expert consensus on images, etc., is not applicable here.

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

Acceptance Criteria and Reported Device Performance

The acceptance criteria for a reprocessed device are fundamentally centered on demonstrating that it performs equivalently to the new, original device in terms of safety and functional effectiveness. The performance of the reprocessed device is compared against the OEM predicate device. Specific quantitative acceptance criteria or threshold values are not explicitly listed in this summary, but the general principle is that the reprocessed device "performs as originally intended" and is "substantially equivalent" to the predicate.

Study Details

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

• Sample Size: The document states that "representative samples of reprocessed devices were tested," and for functional testing, "all products produced" undergo visual and validated functional testing. However, specific numerical sample sizes for each test (e.g., how many devices were tested for vein seal burst, or fatigue testing) are not provided in this summary.
• Data Provenance: The testing was conducted by Sterilmed, Inc., a reprocessor based in Plymouth, MN, and Maple Grove, MN, USA. The data is from prospective bench testing and validation studies of their reprocessed devices. It is not human clinical 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):

This information is not applicable as this is a submission for reprocessed surgical shears based on non-clinical, bench testing, and engineering validation, not an AI or imaging-based device. No "experts" in the sense of medical professionals interpreting images were used to establish ground truth for the device's functional performance. Ground truth was established through validated engineering and laboratory test methods, often comparing performance against the OEM predicate.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving multiple human readers interpreting data, typically in diagnostic imaging. For a reprocessed surgical device, the "adjudication" is inherent in the robust, validated test methods and comparison to established predicate performance. If a test failed, it would need to be investigated and resolved, but there isn't a "reader-based" adjudication process.

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:

This is not applicable. MRMC studies are specific to diagnostic imaging devices, often involving AI, where human readers evaluate cases. This submission is for reprocessed surgical shears, which do not involve human readers for diagnostic interpretation.

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

This is not applicable. This device is a mechanical/ultrasonic surgical instrument, not an algorithm.

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

The "ground truth" for this device's performance is established by:

• Engineering specifications and performance characteristics of the OEM predicate device (Ethicon HARMONIC ACE®+7 Shears with Advanced Hemostasis, K132612).
• Validated industry standards and test methods (e.g., ISO 10993, ASTM standards for packaging, electrical safety).
• Successful functional performance benchmarks (e.g., vein/artery seal burst pressure, thermal spread, grasping force), which show the device "performs as originally intended."
  In essence, the ground truth is that the reprocessed device must meet or exceed the safety and functional performance of the new, original device.

8. The sample size for the training set:

This is not applicable. This is not an AI/machine learning device; there is no "training set" in the computational sense. The "training" for the manufacturing process involves process validation and quality control measures to ensure consistent reprocessing.

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

This is not applicable for the same reason as point 8. The "ground truth" for the overall manufacturing and reprocessing process is established through rigorous validation of cleaning, sterilization, packaging, and functional testing protocols to ensure the device is consistently reprocessed to meet its intended performance specifications.

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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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