(85 days)
For wide angle illumination of the posterior segment during ophthalmic surgery
The Peregrine Tapered Diffusion Probe is a single use light guide approximately 6' in length consisting of the following: A Universal Aluminum connector at the proximal end to fit into a surgical light source. A polyethylene jacket through which an Acrylic fiber runs. A Delrin Handpiece with a 20 GA Stainless Steel Needle at the distal end. The acrylic fiber, which is polished and affixed at both ends, is tapered and extends past the tip to achieve the diffusion of light.
The provided text is a 510(k) Premarket Notification summary for the Peregrine Tapered Diffusion Probe. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through clinical studies in the way a new, high-risk device might.
Therefore, the document does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance: The submission focuses on comparing physical characteristics and indications for use with predicate devices.
- Sample size and data provenance for a test set: No test set for performance evaluation is described.
- Number and qualifications of experts for ground truth, adjudication methods: These are relevant for studies establishing clinical performance, which this document does not detail.
- Multi-reader multi-case (MRMC) comparative effectiveness study: This is not mentioned as part of the 510(k) submission process for this device.
- Standalone algorithm performance: This is a manual device, not an algorithm.
- Type of ground truth used: Not applicable in this context.
- Sample size for the training set, how training set ground truth was established: Not applicable, as this is not an AI/ML device or a study involving training data.
The relevant information from the document is related to sterilization validation, which is the only aspect where "acceptance criteria" and a "study" (validation method) are explicitly mentioned:
1. A table of acceptance criteria and the reported device performance
| Aspect | Acceptance Criteria (Implied) | Reported Device Performance / Method |
|---|---|---|
| Sterility | Sterilized product | ETO sterilized, validated using AAMI Overkill Method |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document states a "method used to validate the sterilization cycle is AAMI Overkill Method", but does not provide details on sample size for this validation or its provenance.
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 is not a study requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
No, an MRMC study was not done. This is a medical device, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a manual surgical instrument.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For sterility, the 'ground truth' is successful sterilization as defined by the AAMI Overkill Method, which is a recognized standard for sterilization validation.
8. The sample size for the training set
Not applicable. This is not an AI/ML device or a study involving a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.