(29 days)
The AMR Insufflation Needle is a disposable device indicated for use for insufflating the peritoneum prior to laparoscopic surgery.
The design consists of a 14 gauge stainless steel needle attached to a plastic handle. The Insufflation Needle features a spring loaded safety stylet. The position of the safety stylet may be determined external to the patient by a color coded indicator on the handle. The needle will be made in two lengths, 120 and 150mm and contains a stopcock with a luer port for connection to an insufflation pump.
This 510(k) summary for the K963359 Applied Medical Insufflation Needle does not contain any information about acceptance criteria or a study proving device performance in the context of an AI/ML-driven device.
The document describes a medical device, an insufflation needle, which is a physical instrument, not a software algorithm. Therefore, the questions you've posed, which are specifically tailored for AI/ML device validation, are not applicable to the provided text.
Here's why each of your requested points cannot be answered from the provided input:
- A table of acceptance criteria and the reported device performance: Not applicable. The document mentions "Mechanical testing was conducted to verify the safety and functional performance," but it does not specify quantitative acceptance criteria (e.g., minimum tensile strength, maximum leakage rate) or report specific performance values against them.
- Sample size used for the test set and the data provenance: Not applicable. This refers to data used for AI/ML model validation. The insufflation needle uses mechanical testing, not data sets in this context.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI/ML model. Mechanical testing of a physical device doesn't involve "experts establishing ground truth" in this sense.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is for expert consensus in AI/ML.
- 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 relates specifically to the impact of AI on human performance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical needle, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" in this context would likely be engineering specifications or measurements (e.g., burst pressure, flow rate), not expert consensus or pathology.
- The sample size for the training set: Not applicable. There is no AI/ML model being trained.
- How the ground truth for the training set was established: Not applicable. No AI/ML model.
In summary, the provided document describes a traditional medical device and its predicate comparison, not an AI/ML device. Therefore, the questions are misaligned with the content.
§ 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.