(135 days)
The device is intended to use in urologic endoscopic procedures to facilitate the passage of endoscopes.
The Single Use Ureteral Access Sheath is a single use sterile device, provides ureteral dilation and a continuous working channel for the introduction of endoscopes and instruments during ureteral access procedures. The Ureteral Access Sheath is comprised of five components: outer sheath base, outer sheath, dilator tube, locking clip and joint. The outer surface of the sheath has a hydrophilic coating. When activated, the hydrophilic feature allows for easier insertion and removal of the sheath. The sheath is offered in three French sizes: 10Fr, 12Fr and 14Fr, and range in effective length of sheath from 10.0cm (shortest) to 55cm (longest). The device is packaged in a peel-open pouch with a two-year shelf life.
The request is to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided FDA 510(k) summary.
However, the provided document does not contain information related to an AI/ML device or its performance criteria, expert review, MRMC studies, or training/test set details. The product described is a "Single Use Ureteral Access Sheath," which is a physical medical device. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through bench testing, material biocompatibility, and sterilization validation, not AI/ML model performance.
Therefore, I cannot fulfill the request as it pertains to AI/ML device performance and related study details, as these are not present in the provided text.
Based on the document, here's what can be inferred about the criteria for this specific device:
Device: Single Use Ureteral Access Sheath (A physical medical device, not an AI/ML diagnostic tool)
1. A table of acceptance criteria and the reported device performance:
The document describes the performance data through bench testing and compliance with various standards. It does not present specific quantitative acceptance criteria in a table format with corresponding performance results for each criterion, but rather states that tests were "passing" and standards were "met."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Bench Tests (Physical Properties) | "The results of all testing were passing." (Details of specific physical properties tested are not provided, only general categories: Appearance, Dimension, Physical properties) |
| EO Residuals | "Measured after sterilization of the device to meet the criteria defined in ISO 11135... and ISO 10993-7..." |
| Shelf-Life (2 years) | "Validated in accelerated testing according to ASTM F1980-16... and the requirements on packaging for terminally sterilized medical device per ISO 11607-1... and ISO 11607-2 are also met. The testing successfully demonstrated essential performance is achieved before and after the shelf life test." |
| Biocompatibility | "All patient contacting materials meet applicable biocompatibility standards per ISO 10993-1:2009 and the FDA guidance... The cytotoxicity, sensitization and intracutaneous reactivity were performed to ensure the biocompatibility of the subject device set." |
Sections that cannot be addressed due to the nature of the device and information in the document:
- 2. Sample sizes used for the test set and the data provenance: Not applicable to a physical device evaluated by bench testing; no "test set" of patient data is mentioned.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; ground truth in the context of AI/ML diagnostics is not relevant for this physical device.
- 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: Not applicable, as this is not an AI/ML device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable; the "truth" is based on material properties, mechanical performance, and compliance with recognized standards.
- 8. The sample size for the training set: Not applicable; no AI/ML model training is described.
- 9. How the ground truth for the training set was established: Not applicable.
In conclusion, the provided document describes a 510(k) submission for a physical medical device. The "acceptance criteria" discussed relate to engineering, material, and sterilization standards for medical devices, rather than the performance of an AI/ML algorithm.
§ 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.