(230 days)
This instrument has been designed to be used with an Olympus endoscope to deliver injectable materials into the urinary bladder wall during the transurethral endoscopic procedures.
This instrument has been designed to be used with an Olympus endoscope to deliver injectable materials into the urinary bladder wall during the transurethral endoscopic procedures. The subject device is sterilized and packaged in a sterilization package.
The provided document is a 510(k) premarket notification for a medical device called the "Single Use Injector NM-221C-0427." This is a device used in conjunction with an endoscope to deliver injectable materials into the urinary bladder wall.
Based on the content, specifically Section 7 "PERFORMANCE DATA," it is clear that this submission focuses on bench testing, sterilization/shelf-life testing, and biocompatibility testing to demonstrate substantial equivalence to a predicate device. There is no mention of a study involving AI, human readers, or image analysis.
Therefore, many of the requested details about acceptance criteria and studies related to AI performance, such as MRMC studies, expert ground truth establishment, training sets, and data provenance, are not applicable to this specific device submission as described in the provided text.
However, I can extract the acceptance criteria and performance data that were provided for this traditional medical device.
1. Table of Acceptance Criteria and Reported Device Performance
For this device, the "acceptance criteria" are implied by the successful completion of the specified performance tests. The document states that the tests were conducted "to ensure that the subject device performs as intended and meet design specifications."
| Acceptance Criteria Category | Specific Tests Conducted | Stated Performance (Implicit Acceptance) |
|---|---|---|
| Sterilization/Shelf-life | Sterilization in accordance with FDA Guidance | Conducted in accordance with FDA Guidance. Accelerated aging test done (ASTM F1980-16). Real-time aging (3 years) ongoing. |
| Biocompatibility | Cytotoxicity, ISO Intracutaneous, ISO Guinea Pig Maximization Sensitization, ISO Acute Systemic Toxicity, USP Rabbit Pyrogen Study | Conducted in accordance with FDA Guidance (ISO 10993-1). Device considered externally communicating, limited exposure (up to 24 hrs). |
| Performance (Bench) | Endoscope compatibility | Conducted to ensure device performs as intended and meets design specifications. |
| Needle slidability | Conducted to ensure device performs as intended and meets design specifications. | |
| Puncture performance | Conducted to ensure device performs as intended and meets design specifications. | |
| Liquid leakage | Conducted to ensure device performs as intended and meets design specifications. | |
| Durability | Conducted to ensure device performs as intended and meets design specifications. | |
| Flow rate (BS EN 1618: 1997) | Conducted. | |
| Corrosion Testing (ISO 9626: 2016) | Conducted. | |
| Risk Analysis | Conducted in accordance with ISO 14971:2007 | Design verification tests and their acceptance criteria identified and performed as a result. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for each test, but standard engineering practices for medical devices (e.g., ISO, ASTM standards) imply sufficient samples were tested to demonstrate performance and meet statistical confidence. This is not a data-driven AI model, so "test set" in the context of images or AI performance isn't applicable.
- Data Provenance: Not applicable in the context of image data. The testing was conducted by Olympus Medical Systems Corp. and Aomori Olympus Co., Ltd. (Japan) to support their 510(k) submission to the FDA (USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a physical instrument, not an AI or image analysis system. Ground truth is established through adherence to engineering specifications and performance standards (e.g., "Needle slidability" is assessed against a defined mechanical threshold, not expert consensus on an image).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
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. The document explicitly states: "No clinical study was performed to demonstrate substantial equivalence." and "No animal study was performed to demonstrate substantial equivalence." This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For physical performance characteristics (e.g., flow rate, durability, puncture performance), engineering specifications and validated testing methods serve as the "ground truth." For biocompatibility and sterilization, the "ground truth" is adherence to established international standards (e.g., ISO, ASTM, USP) and FDA guidance.
8. The sample size for the training set
- Not applicable. No training set was used as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
In summary, the provided document describes the regulatory submission for a physical medical device (a single-use injector) that demonstrates substantial equivalence through bench testing, biocompatibility testing, and sterilization validation, rather than studies focused on AI performance or human reader interaction with an AI system.
§ 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.