(13 days)
The proposed SpyGlass Direct Visualization Probe is intended to provide direct visualization for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.
The proposed SpyGlass Direct Visualization Probe a fiberoptic endoscope. The proposed device is used through the SpyScope Access and Delivery Catheter (K051504) which provides stability for steering the device. The delivery catheter/probe is inserted into the working channel of a duodenoscope for entry into the duodenum for access to the indicated site.
The provided document is a 510(k) summary for the Boston Scientific SpyGlass™ Direct Visualization Probe. It details a submission for substantial equivalence to a predicate device, not a study performing comparative effectiveness or standalone performance with specific acceptance criteria in the typical sense of a novel algorithm or AI device.
Therefore, many of the requested elements (like sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance with acceptance criteria, ground truth types for training) are not applicable or cannot be extracted from this type of FDA submission.
Here's a breakdown of what can be extracted based on the document:
1. A table of acceptance criteria and the reported device performance:
The document states: "A comparison of the optical performance and image quality specifications was made between the proposed and predicate SpyGlass™ Direct Visualization Probe." It also mentions "Electrical safety testing was performed in accordance with industry standards."
This indicates that the acceptance criteria were based on:
- Equivalence in optical performance and image quality to the predicate device (K050403). Specific quantitative metrics for these "specifications" are not provided in this summary.
- Compliance with industry standards for electrical safety. The specific standards are not listed.
Since this is a submission for substantial equivalence to an existing device, the "reported device performance" is essentially that it met these equivalence and safety benchmarks, making it like the predicate. No specific performance metrics (e.g., sensitivity, specificity, accuracy) are reported because it's not a new performance claim but an equivalence claim.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Optical Performance & Image Quality | Found to be comparable to the predicate SpyGlass Direct Visualization Probe. |
| Electrical Safety | Performed in accordance with industry standards. |
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. This 510(k) does not describe a clinical study with a test set of data (e.g., patient cases) to evaluate an algorithm's performance. Instead, it describes a technical comparison of the physical device and its components to a predicate device.
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. No ground truth establishment by experts for a test set of data is described in this submission. The comparison is technical.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or associated adjudication method is described.
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. This document describes a traditional medical device (a mini-endoscope), not an AI or imaging diagnostic algorithm requiring an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm, but a physical medical device. Standalone performance as described (algorithm only) is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. No "ground truth" in the context of diagnostic accuracy against a reference standard is used or described. The "ground truth" for this submission would be the verifiable specifications and performance of the predicate device and relevant industry safety standards.
8. The sample size for the training set:
- Not Applicable. No training set, as would be relevant for an AI/ML model, is described.
9. How the ground truth for the training set was established:
- Not Applicable. No training set or associated ground truth establishment is 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.