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The Endolink™ True Movement System™ is intended for grasping, mobilization, dissection and transaction of tissue under direct and endoscopic visualization.

The Endolink™ True Movement System™ (Endolink Instruments) are single use, sterile instruments that consist of a handle, jaws, and a shaft which includes distal and proximal articulating sections. The Endolink Instruments are similar in size to other instruments and are designed for use through an incision or appropriately sized surgical trocars/ports. The instrument jaws (or scissors blades) are opened and closed by compressing and releasing the handle. The handle can include a ratchet and ratchet release which allow the instrument jaws to be locked in place.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Product testing" and "Testing comparing the Endolink Instruments to a commercially available predicate product."

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The comparative testing appears to be primarily performance-based (grasping, manipulating, cutting, suturing) against a predicate device, rather than requiring expert-annotated ground truth in the traditional sense.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method. The study described is a comparison against a predicate device, not a human reader study requiring adjudication.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The study described focuses on direct device equivalence to a predicate, not on how human readers improve with AI assistance.

6. Standalone Performance Study

Yes, a form of standalone performance study was conducted. The document states:

• "Product testing was conducted to evaluate conformance to product specifications."
• "Testing comparing the Endolink Instruments to a commercially available predicate product was conducted."
• "results showed the Endolink Instruments were equivalent to the predicate device."

While not a typical "AI standalone performance study," these statements indicate the device's functional performance was evaluated independently and in comparison to a benchmark.

7. Type of Ground Truth Used

The "ground truth" in this context appears to be the performance and characteristics of the predicate device. The Endolink True Movement System™ was evaluated for its ability to match the functional capabilities and material properties of existing, legally marketed devices. This is a form of comparative ground truth rather than a clinical ground truth like pathology or expert consensus on a diagnosis.

8. Sample Size for the Training Set

The document does not mention any training set. This is not an AI/ML device in the modern sense; it's a surgical instrument. Therefore, there's no "training set" as would be relevant for machine learning models.

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

Not applicable, as there is no training set mentioned for this device.

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