(90 days)
Advanced UroScience InnerSheath is indicated for use to help position an injection needle within the center of an endoscope.
Advanced UroScience InnerSheath consists of a cannula and a cap. The cannula is designed to fit easily within an endoscope and to permit easy alignment of an injection needle within to in easily within an endosope and to provide adequate gripping of the cannula and endoscope, and an adequate seal with the injection needle. Advanced UroScience InnerSheath is provided sterile and is intended for single use only.
Here's an analysis based on the provided document, addressing the various points about acceptance criteria and device study.
It's important to note that this document is a 510(k) summary for a medical device (Advanced UroScience InnerSheath) submitted to the FDA for market clearance. 510(k) submissions typically rely on demonstrating "substantial equivalence" to a predicate device rather than presenting full-blown clinical trials with detailed acceptance criteria and statistical performance metrics in the same way a PMA (Pre-Market Approval) study would. Therefore, some of the requested information (especially around specific performance metrics, sample sizes for specific tests, and AI-related details) is unlikely to be found in this type of document because it wasn't required for this device's regulatory pathway.
Device Name: Advanced UroScience InnerSheath
Intended Use: To help position an injection needle within the center of an endoscope.
1. A table of acceptance criteria and the reported device performance
Based on the provided document, specific quantitative acceptance criteria and detailed performance metrics are not explicitly stated as they would be in a full clinical study report. The submission relies on "technological characteristics and performance" being "similar to or equivalent to the predicate device" and demonstrating safety and effectiveness through "Biocompatibility and bench testing."
| Acceptance Criteria Category (Inferred) | Reported Device Performance |
|---|---|
| Material Biocompatibility | Demonstrated to be safe (via "Biocompatibility testing") |
| Functional Equivalence to Predicate | "Technological characteristics are similar to or equivalent to the predicate device." "performance is substantially equivalent to the predicate device." |
| Ease of Fit within Endoscope | "designed to fit easily within an endoscope" |
| Ease of Alignment of Injection Needle | "permit easy alignment of an injection needle" |
| Adequate Gripping (Cannula & Endoscope) | "provide adequate gripping of the cannula and endoscope" |
| Adequate Seal with Injection Needle | "an adequate seal with the injection needle" |
| Sterility | "provided sterile" (Implies meeting sterility standards) |
| Single Use | "intended for single use only" |
Note: The acceptance criteria listed above are inferred from the device description and the claim of "safety and effectiveness" and "substantial equivalence." The document does not provide pass/fail thresholds or specific quantitative results from these tests.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in this 510(k) summary. The document mentions "bench testing" but does not provide details on the number of devices or iterations tested.
- Data Provenance: The document does not specify the country of origin of the data. Given it's an FDA submission, the testing would typically be conducted according to US or international standards accepted by the FDA. It would generally be prospective for bench testing and biocompatibility, but the exact study design details are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not specified. For a device like an endoscope accessory, "ground truth" (in the sense of expert radiological or pathological labels) is not typically established. The testing would focus on engineering and functional performance, and possibly biocompatibility by qualified lab personnel.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable / Not specified. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints. For bench testing of a device's physical and functional properties, a formal adjudication process as described (e.g., 2+1 reader consensus) is not typically used.
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. This device (Advanced UroScience InnerSheath) is a physical medical device (an endoscope accessory) and does not involve AI or human "readers" in the context of interpretation. Therefore, an MRMC study or AI assistance effect size is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical, non-AI medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the conventional sense. For this device, "ground truth" would relate to the successful and safe mechanical/functional performance (e.g., proper fit, seal, alignment) as evaluated by engineering standards, and biological compatibility as evaluated by established lab tests. It's not about diagnosing or classifying medical conditions, so expert consensus, pathology, or outcomes data in a diagnostic context are not relevant.
8. The sample size for the training set
- Not applicable / Not specified. This device does not use machine learning, so there is no "training set." The engineering and biocompatibility testing would not be described in terms of training data.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI/ML model, this question is not relevant.
Summary of Limitations due to 510(k) Regulatory Pathway:
This document is a 510(k) summary, which aims to demonstrate "substantial equivalence" to a predicate device rather than proving de novo safety and effectiveness through extensive, detailed clinical trials with explicit acceptance criteria and statistical endpoints in the way a PMA submission or an AI/software as a medical device (SaMD) study would. The focus is on showing that the new device is as safe and effective as a legally marketed predicate device through similar technological characteristics and performance. Therefore, many of the detailed quantitative and methodological questions provided in the prompt are not addressed in this type of regulatory filing.
§ 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.