(172 days)
For laparoscopic minimally invasive surgery to provide sight access for use with operative and diagnostic instrumentation.
The VerreScope is intended for use during laparoscopic minimally invasive surgery to provide access for use of operative and diagnostic instrumentation. It is made of Stainless Steel and uses Fiber Optics.
The provided document is a 510(k) summary for the Cooper VerreScope, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical study with specific acceptance criteria and detailed performance reporting. Therefore, much of the requested information regarding acceptance criteria, study details, and ground truth establishment is not present in this document.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Device must be comparable in intended use and technological characteristics to a legally marketed predicate device. | The VerreScope's intended use and technological characteristics are stated to "not vary significantly" from the Gynescope Laparoscopes. |
| Material | Material should be Stainless Steel | VerreScope: Stainless Steel |
| Optics | Optics should be a recognized type for medical visualization (e.g., Rod Lens as in predicate). | VerreScope: Fiber Optics |
| Safety and Effectiveness | Safety and effectiveness must be comparable to the predicate. | The safety and effectiveness of the CooperSurgical's VerreScope are stated to be "comparable to that of the Gynescope Laparoscope." |
Explanation: The "acceptance criteria" here are implicitly defined by the FDA's 510(k) pathway, which requires demonstrating substantial equivalence to a predicate device already on the market. The reported performance is a direct comparison of the VerreScope's characteristics against the Gynescope Laparoscopes using a comparison table. There are no quantitative performance metrics (e.g., accuracy, sensitivity, specificity) reported in this document.
2. Sample Size Used for the Test Set and the Data Provenance
This document does not describe a test set or any specific testing involving human subjects or data. The comparison is based on the design and material specifications of the device itself and its predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. No test set requiring ground truth established by experts is mentioned.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication is mentioned.
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 surgical instrument (laparoscope), not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No ground truth is established as there is no specific clinical study data presented in this 510(k) summary. The "truth" in this context is the comparison of device specifications to a legally marketed predicate.
8. The Sample Size for the Training Set
Not applicable. No training set is mentioned as this is not an AI/machine learning device. The design and manufacturing processes implicitly involve experience and data, but not in the context of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set or ground truth establishment for a training set is mentioned.
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.