(78 days)
The MicroLap ™ and MicroLap Gold Laparoscopes are used to permit viewing of the abdominal cavity for the purpose of performing diagnostic and surgical procedures.
The MicroLap ™ and MicroLap Gold Laparoscopes are small diameter, rigid, fiberoptic laparoscopes without through lumens. The devices consist of an outer stainless steel shaft, inner illumination fibers, and an imaging fiber bundle. At one end of the imaging bundle is the distal lens and at the other is the rotatable eyepiece. An endoscopic light source is connected to the light post of the laparoscopes through compatible light cables. If desired, the eyepiece can be connected through a focusing optical coupler to a camera head which carries the image by cable to the camera.
Here's a breakdown of the information requested, based on the provided 510(k) summary for the Iriágyn MicroLap™ and MicroLap Gold Laparoscopes:
This 510(k) summary describes a medical device (laparoscopes), not an AI/ML-based device. Therefore, many of the requested categories related to AI performance, ground truth, expert consensus, and comparative effectiveness studies are not applicable as they relate to AI/ML systems. I will indicate "Not Applicable (N/A)" for those sections.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Optical Characteristics | Performed according to description; evaluated and tested. |
| Mechanical Characteristics | Performed according to description; evaluated and tested. |
| Effect of Simulated Reuses | Evaluated with respect to optical and mechanical characteristics. |
| Thermal Characteristics | Evaluated. |
| Biocompatibility | Evaluated. |
2. Sample size 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 specified. The summary mentions "Non-clinical tests were performed," but does not detail the number of devices or components tested.
- Data Provenance: Not specified, but implied to be internal laboratory testing ("Non-clinical tests were performed").
- Retrospective or Prospective: Not applicable, as this refers to non-clinical laboratory testing of a device, not a study involving 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 (N/A). This device is a physical medical instrument (laparoscope), not an AI/ML system requiring expert-established ground truth for its performance evaluation in the context of diagnostic interpretation. Its performance is evaluated based on engineering and material science metrics.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical image interpretation studies, particularly for AI/ML systems. This device's performance is assessed through non-clinical testing of its physical properties.
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 (N/A). This is a physical device, not an AI system. MRMC studies are used to evaluate diagnostic imaging systems or AI software performance, not the performance of a laparoscope itself.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable (N/A). This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not Applicable (N/A). The "ground truth" for this device's performance would be established engineering specifications, material standards, and industry benchmarks for optical, mechanical, thermal, and biocompatibility properties. It's not about diagnostic accuracy derived from clinical data.
8. The sample size for the training set
Not Applicable (N/A). This is a physical device, not an AI/ML system that requires a "training set."
9. How the ground truth for the training set was established
Not Applicable (N/A). As there is no training set for a physical device, there is no ground truth to establish for it in 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.