(73 days)
The trocar sleeves and trocars serve to gain access to body cavities. The dilation set is used for enlarging the access; trocar sleeves of smaller diameters can be replaced with trocar sleeves of larger diameters. For examination, diagnosis, and/or therapy when used in conjunction with endoscopic accessories in the various medical specialties such as surgery, urology and, gynecology when used by suitably trained and qualified specialists.
The trocar sleeves are part of the MICRO and MINI instrument set for laparoscopic microsurgery, particularily suitable for diagnostics, smaller interventions, outpatient, and pediatric laparoscopy. The instruments smaller diameter allows better cosmetic effects than the larger diameters because they are less invasive. The trocar sleeves and trocars have comparable biocompatible device materials as previous R. Wolf devices. The dimensions are smaller to perform minimally invasive laparoscopy. Partly the trocar sleeves are without automatic valves as a result of minimizing the sealing housing.
This document describes a 510(k) premarket notification for "Trocar sleeves and trocars, Dilatation sleeve and guide rod" manufactured by Richard Wolf Medical Instruments Corp. This submission focuses on establishing substantial equivalence to previously marketed devices rather than presenting new performance data against specific acceptance criteria for a novel device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating the performance of an AI/ML powered device, is largely not applicable to this type of regulatory submission. This 510(k) is for a physical medical instrument, not a software or AI-driven diagnostic tool.
Here's an attempt to address your points based on the provided document, highlighting where the information is not available or not relevant for this type of device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | "The trocar sleeves and trocars have comparable biocompatible device materials as previous R. Wolf devices." |
| Sterilization | "The steam sterilization tests performed by Richard Wolf show that the steam sterilization has no influence on the functional performance of the submitted devices when using the fractional method." |
| Functional Performance | "These devices are designed and tested to guarantee the safety and effectiveness when used according to the instruction manual." (This is a general statement, no specific functional metrics are provided as acceptance criteria). |
| Dimensions/Minimally Invasive Design | "The dimensions are smaller to perform minimally invasive laparoscopy. Partly the trocar sleeves are without automatic valves as a result of minimizing the sealing housing." (This describes a design feature, not an explicit performance criterion with a quantifiable target.) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. No clinical or performance data involving a "test set" in the context of an AI/ML device is presented. This device underwent sterilization testing as a physical product.
- Data Provenance: Not applicable. The steam sterilization tests were performed by Richard Wolf. The country of origin for the data is implicitly the USA, where Richard Wolf Medical Instruments Corp. is located. The testing is likely prospective for this specific device, but it's not "data" in the sense of patient data.
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. This device is a physical instrument, not an AI/ML algorithm requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical or performance data requiring adjudication for a test set is presented.
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, not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm; it is a physical surgical instrument.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable in the context of AI/ML ground truth. The "ground truth" for this device's performance would be engineering and material science standards (e.g., successful sterilization, material compatibility, structural integrity, functional operation as intended).
8. The sample size for the training set
- Not applicable. This device does not involve a training set for an AI/ML model.
9. How the ground truth for the training set was established
- Not applicable. This device does not involve a training set for an AI/ML model.
Summary of the document's relevance to your questions:
The provided document is a 510(k) summary for a set of surgical instruments (trocar sleeves and trocars). The primary purpose of this submission is to demonstrate substantial equivalence to existing legally marketed predicate devices, not to validate the performance of a novel AI/ML powered device against specific, quantifiable acceptance criteria using clinical study data.
The "performance data" mentioned in the document refers to steam sterilization tests showing no adverse influence on functional performance. There were no clinical tests performed for this 510(k) submission. Therefore, many of your questions, which are highly relevant for AI/ML device validation, do not apply to this context.
§ 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.