(78 days)
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
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence to predicate devices in grasping, manipulating, cutting, and suturing of tissue. | "results showed the Endolink Instruments were equivalent to the predicate device." |
| Conformance to product specifications. | "Product testing was conducted to evaluate conformance to product specifications." |
| Equivalence in general use, basic overall function, manufacturing methods, and materials. | "The Endolink Instruments are equivalent to the predicate products. The general use, basic overall function, methods of manufacturing, and materials used are substantially equivalent." |
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.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.