(56 days)
This instrument has been designed to be used with an Olympus endoscope to perform endoscopic vascular or submucosal injection in the GI tract.
This instrument has been designed to be used with an Olympus endoscope to perform endoscopic vascular or submucosal injection in the GI tract.
The subject device consists of a handle section, needle section, and sheath section. The subject device is used to puncture the target tissue where guided by the endoscope. The fluid is injected to the target through the subject device by an injector which is connected the subject device.
The provided text describes a medical device, the "Single Use Injector NM600/610," and its 510(k) summary for FDA submission. However, it does not include the detailed information required to fill out a table of acceptance criteria, reported device performance, or details about a study proving the device meets those criteria in the way typically associated with AI/ML-based medical devices.
The document focuses on the substantial equivalence of the new device to existing predicate devices based on technological characteristics and non-clinical performance testing for a physical medical instrument (an injector for endoscopes). It does not describe a study involving data provenance, ground truth establishment by experts, or AI/ML performance metrics.
Therefore, I cannot provide a response that directly answers your request in the format you provided because the document is not about an AI/ML device and does not contain the type of study data you are asking for.
The information primarily available is related to non-clinical performance testing to demonstrate the basic functionality of a physical injector.
Here's an analysis of what is recoverable from the text, highlighting why it doesn't fit the requested format:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria Mentioned: The document vaguely states "Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment." However, it does not list specific numerical or qualitative acceptance criteria for the performance tests.
- Reported Device Performance: Similarly, it states "The following performance testing was conducted to demonstrate the basic performance of the subject device and confirmed that the subject device performs as intended." It lists categories of tests but provides no quantitative or qualitative results for "performance as intended."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not present. The tests mentioned are for a physical device, likely involving engineering and mechanical tests, not data sets in the typical AI/ML sense.
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/Not present. Ground truth is not established in the context of expert review of images or data for this physical medical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not present.
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/Not present. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/Not present. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not present. The "ground truth" for a physical device's performance would be engineering specifications and functional benchmarks, not clinical outcomes data in the usual sense for AI/ML.
8. The sample size for the training set
- Not applicable/Not present. There's no "training set" for this type of device.
9. How the ground truth for the training set was established
- Not applicable/Not present.
Summary of available information relevant to "studies" for the Single Use Injector NM600/610:
- Type of Study: Non-clinical (bench/engineering) performance testing.
- Purpose: To demonstrate basic performance and confirm the device performs as intended.
- Tests Performed (Categories):
- Inserting into endoscope
- Withdrawing from endoscope
- Advance of tube
- Retraction of tube
- Needle extension length
- Smooth puncturing of the needle
- Normal reaction force to needle puncturing
- Amount of injected fluid
- Needle retraction propriety
- Performance after repeated device operation
- Visual inspection of the package
- Peel strength of the package
- Endurance to splitting of the package
- Integrity of the package
- Risk Analysis: Performed in accordance with ISO 14971:2007 using in-house acceptance criteria.
- Biocompatibility Testing: Performed in accordance with FDA Guidance (Blue Book Memo, G95-1) and ISO 10993 standards (10993-1, 10993-5, 10993-10, 10993-11).
- Other Standards Applied: ASTM F756-13, ISO 11135, ISO 14971, ASTM F1980-07.
The document is a 510(k) summary for a fairly standard, non-AI medical instrument. The questions you've posed are highly specific to AI/ML medical devices and predictive algorithms, which is not what this document describes.
§ 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.