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Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.

Trocars are devices inserted into a patient in order to maintain a clear pathway to facilitate the insertion of various surgical tools. Trocars are designed in both bladed and non-bladed configurations, however this submission is for non-bladed B5LTs. Non-bladed trocars require an incision be made before insertion into the patient's cavity. Trocars have a luer stopcock port for insufflation and desufflation of the patient's cavity. NES Reprocessed Endoscopic Trocars are sent from a user facility to be cleaned, sterilized and repackaged by NES. NES Reprocessed Endoscopic Trocars have the same intended use and performance characteristics equivalent to Endoscopic Trocars provided by Original Equipment Manufacturers (OEM).

The provided text describes the regulatory submission for a reprocessed medical device, the "NES Reprocessed Endoscopic Trocar." The focus of the submission is to demonstrate that the reprocessed device is substantially equivalent to legally marketed predicate devices. This type of submission relies on demonstrating that the reprocessed device meets the same performance characteristics as the original, rather than establishing acceptance criteria for a novel algorithm or AI system.

Therefore, the information requested regarding acceptance criteria and a study proving a device meets those criteria in the context of an algorithm's performance is largely not applicable to this document. The document focuses on showing that the reprocessed physical device has equivalent performance, safety, and effectiveness to its original, non-reprocessed counterpart.

Here's an analysis of the provided text in relation to your questions, highlighting why most are not directly addressed:

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

• Not applicable in the typical sense for an algorithm. For a reprocessed physical device like a trocar, the "acceptance criteria" are generally that it functions identically and safely to the original device. This is demonstrated through various physical, chemical, and biological tests, not statistical performance metrics of an algorithm.
• The document states: "NES Reprocessed Endoscopic Trocars have the same intended use and performance characteristics equivalent to Endoscopic Trocars provided by Original Equipment Manufacturers (OEM)." and "NES Reprocessed Endoscopic Trocars operate as originally intended and are safe, effective and sterile as demonstrated by cleaning, packaging, performance, sterilization and biocompatibility testing."
• Implied Acceptance Criteria (based on the text):
  • Functionality: Operates "as originally intended" and has "performance characteristics equivalent" to OEM. This would be assessed through mechanical testing (e.g., insertion force, structural integrity, insufflation seal).
  • Safety: Demonstrated by "biocompatibility testing."
  • Effectiveness: Functions as intended for its "intended use" (establishing a port of entry). This is a broad claim supported by the functionality.
  • Sterility: Demonstrated by "sterilization testing."
  • Cleaning/Reprocessing Efficacy: Demonstrated by "cleaning, packaging" assessments.

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

• Not explicitly mentioned. The document refers to "testing" but does not provide specific sample sizes for each type of test conducted (e.g., how many reprocessed trocars were tested for strength, sterility, or biocompatibility).
• Data Provenance: Not specified. It's implied that the testing was performed by Northeast Scientific, Inc., likely in the USA given their address.

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)

• Not applicable. There is no "ground truth" in the algorithmic sense. The "ground truth" for a physical device's performance is typically established by engineering specifications, material science standards, and established medical device performance criteria, often determined by industry standards and regulatory guidance for reprocessed devices. The testing is objective against these standards, not against expert human interpretations.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in expert interpretations, typically in diagnostic imaging or clinical trials involving subjective assessments. The tests for a medical device like a trocar are objective (e.g., tensile strength, leak rate, sterility tests), so adjudication by human experts is not relevant.

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 device is a physical medical instrument (trocar), not an AI algorithm. Therefore, an MRMC study or AI assistance is irrelevant.

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

• Not applicable. This is a physical device, not an algorithm.

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

• Objective testing against predetermined physical, chemical, and biological standards. For a reprocessed device, the "ground truth" for showing substantial equivalence relies on proving that the reprocessed device performs identically to the original OEM device under various conditions (e.g., mechanical strength, sterility, biocompatibility). These are derived from established engineering and biological standards, not from expert consensus or pathology on a specific case.

8. The sample size for the training set

• Not applicable. This device is a reprocessed physical instrument, not an AI algorithm that requires a training set.

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

• Not applicable. As above, no training set for an AI algorithm.

Summary regarding the provided text (K060676):

The document is a 510(k) summary for a reprocessed medical device. The "study" referenced is a series of tests to demonstrate that the reprocessed device meets the performance and safety characteristics of its original, non-reprocessed counterpart. These tests (cleaning, packaging, performance, sterilization, and biocompatibility) are designed to show substantial equivalence, not to prove the statistical performance of an AI algorithm against specific acceptance criteria in the manner you've outlined in your questions. Therefore, most of your specific questions are not directly answerable or applicable from this regulatory submission.

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