(280 days)
The pyramidal trocars with spring-return protective sleeve are designed for establishing access by piercing a vessel or chamber to facilitate insertion of the trocar sleeve (cannula) to carry out diagnostic and therapeutic measures.
Trocars are made of medical grade stainless steel and brass (satin chromeplated).
The provided text describes a 510(k) Summary of Safety and Effectiveness for a medical device: "Pyramidal Trocar with spring-return protective sleeve" manufactured by Richard Wolf Medical Instruments Corporation.
Based on the provided information, the following answers can be given:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state specific acceptance criteria (e.g., numerical thresholds for performance metrics). Instead, it makes a general statement about performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Efficacy | Trocars have been tested and found to be safe when used in accordance with the intended use as outlined in the Instruction for Use Manual. |
| Substantial Equivalence | The device is equivalent to existing Richard Wolf Pre-enactment Devices and substantially equivalent to existing competitor devices on the market today. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states under "9.0 Clinical Tests: No clinical tests performed." This implies that there was no test set of patient data, and therefore no information on sample size or data provenance in that context. The "testing" mentioned under "8.0 Performance Data" likely refers to in-house engineering and bench testing, not clinical studies.
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, as no clinical tests were performed, and thus no expert-established ground truth for a clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical tests were performed.
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 (trocar), not an AI-powered diagnostic or assistive tool. No MRMC study was mentioned or would be relevant.
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, as no clinical tests were performed. The "ground truth" for the device's safety and performance would have been established through engineering design specifications, material testing, and functional bench testing against internal standards for surgical instruments.
8. The sample size for the training set
Not applicable, as this device does not involve a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as this device does not involve a machine learning model requiring a training set.
§ 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.