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The reprocessed vessel sealer/dividers are bipolar electrosurgical instruments intended for use with the ForceTriad™ Energy Platform in general, minimally invasive and open surgical procedures where ligation and division of vessels and lymphatics is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymphatics) interposed between the iaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue.

Indications for use include general open and minimally invasive procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures where ligation and division of the vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy, etc. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The reprocessed vessel sealer/dividers can be used on vessels and lymphatics up to and including 7 mm, and tissue bundles.

The reprocessed vessel sealer is a sterile, hand-held bipolar RF electrosurgical instrument designed exclusively for use with the ForceTriad™ energy platform (generator) to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics clamped between the jaws, grasping tissue, and blunt dissection during general surgical procedures (as indicated), laparoscopic or open, using radio frequency (RF) energy. A hand actuated lever allows the user to open and close the instrument jaws without having to latch the lever, which includes a clicking mechanism that indicates to the user that the jaws are in the grasping zone, a button (switch) to activate the LigaSureTM mode by closing the handle against the button (switch) for vessel sealing, and a trigger to actuate an independent cutting blade.

This document describes the regulatory clearance for reprocessed vessel sealers (device name: Reprocessed Vessel Sealers, models LF1737 and LF1723) which are electrosurgical instruments. The submission aims to demonstrate substantial equivalence to predicate devices (Covidien LigaSure™ 5 mm, Maryland Jaw Sealer/Dividers, K133338).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance values in the way one might expect for an AI/CADe device. Instead, the acceptance criteria are implicitly defined by a series of non-clinical tests designed to demonstrate that the reprocessed devices perform as intended and are safe and effective, similar to the original predicate devices. The reported device performance is generally stated as achieving compliance with these tests.

However, based on the "Summary of Non-Clinical Tests Conducted" section, we can infer the following:

Overall Conclusion: "Performance testing shows the reprocessed vessel sealers to perform as originally intended." and "Sterilmed concludes that the reprocessed vessel sealers are safe, effective, and substantially equivalent to the predicate devices..."

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

The document mentions that "Representative samples of reprocessed devices were tested" for various functional and safety characteristics. However, specific sample sizes (e.g., number of devices, number of seals, number of tests for each parameter) for each test are not provided.

The data provenance is not explicitly stated in terms of country of origin. The study appears to be bench and laboratory testing performed by the manufacturer/reprocessor (Sterilmed, Inc., located in Minnesota, USA). The nature of these tests (cleaning, sterilization, packaging, functional performance, biocompatibility) indicates they are prospective tests performed on manufactured devices, not retrospective data analysis from clinical cases.

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 section is not applicable as the device is a reprocessed surgical instrument, not an AI/CADe device or diagnostic tool that requires expert human interpretation to establish ground truth for a test set. The "ground truth" for this device's performance is established by objective engineering and safety standards (e.g., burst pressure thresholds, sterility levels, biocompatibility profiles) and comparison to the performance of the original device.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies involving human readers or AI outputs. The tests described are objective engineering and laboratory tests where the outcome is determined by adherence to a predefined standard or measurement, not by expert consensus or adjudication.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic performance, especially for AI-assisted image interpretation. The device in question is a reprocessed surgical instrument, and its performance is evaluated through bench testing and safety assessments, not through human reader interpretation.

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

This section is not applicable. The device is not an algorithm or AI system. It is a physical medical instrument. Therefore, the concept of "standalone (algorithm only)" performance does not apply.

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

The "ground truth" for this device's performance is based on objective engineering standards, validated laboratory testing protocols, and comparison to the established performance of the original, new device. For example:

• Sterility: Absence of microorganisms, verified by sterilization indicators and microbial testing.
• Ethylene Oxide Residuals: Concentrations below a specified limit (ISO 10993-7).
• Mechanical Functionality: Ability to open, close, grasp, seal, and cut within specified force ranges and dimensions, often compared to the original device's specifications.
• Vessel Seal Burst Strength: Ability to withstand a certain pressure without leaking (e.g., specified kPa or mmHg).
• Electrical Safety: Compliance with electrical safety standards (e.g., leakage current, insulation).
• Biocompatibility: Absence of adverse biological reactions (cytotoxicity, irritation, etc.) validated through in vitro and in vivo tests.

Essentially, the ground truth is established by meeting predefined scientific and engineering thresholds that demonstrate the device is safe and performs identically or equivalently to the original device.

8. The sample size for the training set

This section is not applicable. The device is a physical reprocessed medical instrument, not an AI model. Therefore, there is no "training set" in the context of machine learning. The "training" for the reprocessing procedures involves process validation and adherence to established protocols for cleaning, sterilization, and functional testing.

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

This section is not applicable as there is no "training set" in the machine learning sense. However, if one were to loosely interpret "training set" as the data that informed the reprocessing procedures and quality checks, then the "ground truth" for establishing these procedures would be derived from:

• Regulatory standards: Follow FDA guidelines and relevant international standards (e.g., ISO for sterilization, biocompatibility).
• Manufacturer's specifications: Understanding the original device's design, materials, and performance requirements.
• Scientific and engineering principles: Applying established methods for cleaning, disinfection, sterilization, and material compatibility.
• Validation studies: Performing rigorous studies to prove that the reprocessing methods consistently achieve the desired outcomes (e.g., sterility, functionality).

The "ground truth" in this context is the successful demonstration that the reprocessed device can consistently meet the same safety and performance characteristics as the new, original device.

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The reprocessed vessel sealers are indicated for use in general and gynecological, laparoscopic surgical prooedures where ligation of vasculature is desired. The reprocessed vessel sealers can be used to seal to seal to seal to seal and including 7 imm, lymphatics, and tissue bundles. The reprocessed vessel scalers can also be used to seal pulmonary vasculature when used with the ForceTriad™ energy platform.

The vessel sealers are electrosurgical instruments for use with the ForceTriad™ energy platform when performing laparoscopic procedures. The vessel sealers are capable of sealing vessels and lymphatics, grasping tissue and dissection. The vessel sealers have a 5 mm shaft diameter, 37 cm shaft length and a shaft rotation of 159 degrees. The distal end mechanism may have a blunt or dolphin nose tip.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Reprocessed Vessel Sealers:

Based on the provided information, this submission focuses on the substantial equivalence of a reprocessed medical device to its original predicate devices, rather than a novel device requiring a typical clinical study with acceptance criteria for efficacy. The "acceptance criteria" here therefore refers to demonstrating that the reprocessed device performs identically to the predicate device and meets established safety and functional standards.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not explicitly state specific sample sizes for each non-clinical test (e.g., how many reprocessed devices were tested for cleaning validation). It refers to "Representative samples" for functional testing.

• Test Set Sample Size: Not explicitly stated for specific tests, but general reference to "representative samples."
• Data Provenance: The studies are described as internal non-clinical tests performed by Sterilmed, Inc. (submitter). The country of origin for the data is implicitly the USA, where Sterilmed is located and where the submission was made to the FDA. The data is prospective in the sense that these tests were conducted by Sterilmed for the purpose of this 510(k) submission to demonstrate equivalence.

3. Number of Experts and Qualifications for Ground Truth

This type of submission (reprocessed device) primarily relies on engineering and laboratory test standards rather than expert interpretation of clinical data or images. Therefore, the concept of "ground truth established by experts" as seen in diagnostic AI is not directly applicable here. The "experts" would be the engineers, microbiologists, and other technical specialists who conducted and validated the non-clinical tests according to established international and national standards (e.g., ISO, ASTM, USP). Their qualifications would be expertise in those particular testing methodologies and standards.

4. Adjudication Method

Not applicable. This is not a study involving human reader interpretation or clinical outcomes requiring adjudication.

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

No. This is a submission for a reprocessed medical device demonstrating equivalence through non-clinical testing. It does not involve AI, human reader performance, or clinical comparative effectiveness studies in the traditional sense of a novel diagnostic or therapeutic device.

6. Standalone Performance Study

Yes, in a sense. The "standalone performance" is demonstrated through the various non-clinical tests (cleaning, sterilization, biocompatibility, functional performance, etc.) where the reprocessed device is tested in isolation against defined criteria and regulatory standards. The purpose is to show the device performs on its own, as originally intended, after reprocessing.

7. Type of Ground Truth Used

The ground truth used in this context is predominantly:

• Engineering/Performance Standards: Adherence to established performance specifications (e.g., sealing capability, fatigue resistance, visual inspection criteria, shaft rotation).
• Regulatory/Industry Standards: Compliance with international and national standards for sterility (ISO 11135, USP ), biocompatibility (ISO 10993), packaging (ASTM D.4169, ASTM F 88, ASTM F 2096), shelf life (ASTM 1980-07), and residual chemicals (ISO 10993-7).
• Predicate Device Performance: The original functional specifications and performance of the predicate Covidien LigaSure™ Laparoscopic Instruments serve as the benchmark for "as originally intended" performance.

8. Sample Size for the Training Set

Not applicable. This is a reprocessed device submission based on non-clinical testing, not an AI model that requires a training set.

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

Not applicable, as there is no training set for an AI model in this submission.

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