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The Reprocessed Surgical Electric Instrument (hereinafter sealer/divider) is indicated for use in open surgical procedures to seal vessels up to and including 7 mm, lymphatics, and tissue bundles. When used with the ForceTriad™ energy platform the sealer/divider can also be used to seal pulmonary vasculature. The sealer/divider should not be used for tubal sterilization or tubal coagulation as it has not been shown effective for sterilization procedures.

The sealer/divider is for use in open surgical procedures to seal vessels up to and including 7 mm, lymphatics, and tissue bundles. The sealer/divider can be used to seal pulmonary vasculature when used with the ForceTriad™ energy platform. The sealer/divider has an 18 cm shaft with a 13.5 mm diameter and can be rotated 180 degrees. The curved jaw is 36 mm long with a 34 mm cutting length. The sealer/divider is activated by pulling the handle until latched and pressing the button on the device or depressing the foot switch.

This document describes the 510(k) Premarket Notification for a Reprocessed Surgical Electric Instrument (sealer/divider) by SterilMed, Inc. It's a submission to demonstrate substantial equivalence to a predicate device, not to prove novel device performance using clinical studies against acceptance criteria in the traditional sense. Therefore, many of the requested elements for a clinical study on a novel device's performance against acceptance criteria are not directly applicable or available in this document.

However, I can extract information related to the functional and safety testing performed to support the substantial equivalence claim, which serves as a form of acceptance criteria for a reprocessed device.

Summary of Acceptance Criteria and Reported Device Performance for Reprocessed Surgical Electric Instrument

This submission focuses on demonstrating that a reprocessed surgical electric instrument is substantially equivalent to its predicate device. The "acceptance criteria" here are defined by the required functional and safety performance of the reprocessed device to ensure it performs as intended and is as safe and effective as the original, single-use device. The "study" involves various non-clinical tests to validate the reprocessing procedures and the performance of the reprocessed device.

1. Table of Acceptance Criteria and Reported Device Performance:

• Visual Inspection: Part of manufacturing process.
• Fatigue Testing: To assess durability and material integrity over its reprocessed lifespan.
• Function Testing: Part of manufacturing process. | "Performance testing shows the reprocessed sealer/dividers to perform as intended." "Representative samples of reprocessed sealer/dividers were tested to demonstrate appropriate functional characteristics." "Manufacturing process includes visual and validated functional testing of all products produced." "The reprocessed surgical electric instruments are identical to the predicate devices in design, materials... performance specifications, or method of operation." |

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

• Sample Size: The document repeatedly mentions "representative samples" for the various non-clinical tests (e.g., for functional performance, cleaning validation, sterilization validation). However, specific numerical sample sizes for each test are not provided in this summary section.
• Data Provenance: The tests are described as "non-clinical tests" and "bench testing." The simulated use on "beef tissue" suggests laboratory-based, pre-clinical testing. There is no mention of human or animal subjects for these tests. The country of origin for the data is not explicitly stated, but as the submitter (SterilMed, Inc.) is based in Maple Grove, MN, and the submission is to the FDA, it is highly likely the tests were conducted in the US or by US-affiliated testing facilities. The data generated is prospective in the sense that it was specifically generated for this 510(k) submission to demonstrate the performance of the reprocessed devices.

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

• This information is not applicable or provided in this 510(k) summary. For non-clinical, bench-testing of a reprocessed medical device, the "ground truth" is typically established by physical measurements, chemical analyses, and direct observation of functional performance against established engineering and regulatory standards (e.g., ISO standards, ASTM standards). Expert consensus in the human interpretation sense (like for radiology image analysis) is not relevant here.

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving multiple human readers interpreting data (e.g., medical images) where discrepancies need resolution. The tests described are objective, non-clinical measurements and validations against predefined technical specifications and standards.

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

• No. An MRMC study is a clinical study designed to evaluate and compare the diagnostic performance of multiple readers on multiple cases, often with and without aid from a device (like AI). The current submission is for a reprocessed surgical instrument and involves non-clinical validation, not a diagnostic imaging device or an AI human-in-the-loop study.

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

• Not applicable. This relates to AI algorithms. The device here is a physical surgical instrument.

7. The Type of Ground Truth Used:

• The "ground truth" for these tests is based on a combination of:
  • Validated Engineering and Regulatory Standards: e.g., ISO and ASTM standards for sterilization, biocompatibility, packaging, and shelf life; USP for sterility.
  • Predicate Device Performance: The reprocessed device's performance is compared to the known and established performance characteristics of the original (new) predicate device (Covidien LigaSure Impact™ Hand Activated Sealer/Divider). The implicit "ground truth" is that the reprocessed device must meet or exceed the performance parameters of the new device.
  • Objective Measurements and Bench Testing Results: Data from simulated use on beef tissue, visual inspections, fatigue testing, and direct functional testing against design specifications.

8. The Sample Size for the Training Set:

• Not applicable. A "training set" refers to data used to train machine learning models. This submission is for a physical medical device, not an AI algorithm. The manufacturing process and validation activities for a reprocessed device do not involve a "training set" in this context.

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

• Not applicable. (See point 8).

In summary, the document provides evidence of rigorous non-clinical testing and validation to demonstrate that the reprocessed surgical electric instrument performs identically to and is as safe as its predicate device. This evidence forms the basis for the FDA's "substantial equivalence" determination, rather than a clinical study against specific disease-detection acceptance criteria commonly seen for diagnostic devices.

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