(88 days)
The PERIscope Optical Dissector is intended for dissection of connective tissue and the creation of an operative cavity in the extraperitoneal spaces and subcutaneous areas. The instrument has application in various general surgical procedures, such as laparoscopic hernia repair.
The PERIscope Optical Dissector consists of a handle, a scope retainer clip, a cannula and a dissecting tip. The dissecting tip dissects tissue and creates a cavity that allows instrument passage. The dissecting tip allows visualization during insertion, tunneling, and dissection. The device is designed to be used with a trocar. The instrument is compatible with a 0° rigid endoscope that has a maximum diameter of 5.5 mm and is 290 mm to 300 mm in length.
This document provides limited information regarding acceptance criteria and studies. Based on the provided text, here’s a breakdown of the available information:
- No specific acceptance criteria: The document does not explicitly state quantitative acceptance criteria for device performance (e.g., minimum dissection depth, maximum tissue damage).
- No detailed study results: The document mentions "Preclinical testing" and "Animal testing" but does not provide specific performance data, statistical results, or a comparison table against any predefined criteria.
However, I can extract information related to the general performance assessment:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No explicit criteria mentioned in the document. | Animal testing demonstrated satisfactory performance according to the requirements for an Optical Dissector during laparoscopic surgical procedures. |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified. The document only mentions "Animal testing."
- Data provenance: Not specified beyond "Animal testing." It does not mention country of origin, nor whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The document does not describe a process for establishing ground truth using experts.
4. Adjudication method for the test set
- This information is not provided. There is no mention of an adjudication method.
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
- This information is not provided. The PERIscope Optical Dissector is a surgical instrument, not an AI-assisted diagnostic device, so an MRMC study with human readers improving with AI assistance would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not provided. The PERIscope Optical Dissector is a physical surgical instrument, not an algorithm. Standalone algorithm performance is not applicable.
7. The type of ground truth used
- The document implies that the ground truth for performance was established by observing "satisfactory performance according to the requirements for an Optical Dissector during laparoscopic surgical procedures" in animal models. This suggests a functional/procedural ground truth based on the successful execution of intended surgical tasks. It is not explicitly stated if this involved pathology, expert consensus on outcomes, or other specific metrics.
8. The sample size for the training set
- This information is not provided, and the concept of a "training set" typically applies to machine learning algorithms, which is not relevant for this device.
9. How the ground truth for the training set was established
- This information is not provided, as it is not applicable to the type of device described.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.