(39 days)
The Expandacell™ Anti-Fog Instrument Wipe is identical to an existing medical device, K923843/A and K791736. These Anti-Fog Instrument Wipes, marketed by Xomed/ Merocel and Dixide, Inc. have a proven track record that establishes this product line as safe and effective for use in surgery. There is no modification in the proposed device and the predicate devices that alters safety and effectiveness. The proposed product is identical in intended use, materials, anatomical sites, target population, physical safety, biocompatibility and performance to the predicate device stated.
Here's an analysis of the provided text regarding acceptance criteria and a hypothetical study, followed by detailed answers to your questions based on the actual information in the K964334 document:
Analysis of the Provided Text (K964334):
The provided text for K964334 is a 510(k) summary for a device called "Expandacell™ Anti-Fog Instrument Wipe." Crucially, this document does not describe a study involving specific acceptance criteria or performance metrics for the device itself. Instead, it relies on the concept of substantial equivalence to predicate devices.
The core argument is that the Expandacell™ Anti-Fog Instrument Wipe is identical to previously cleared devices (K923843/A and K791736) in terms of:
- Intended use
- Materials
- Anatomical sites
- Target population
- Physical safety
- Biocompatibility
- Performance
Because the device is claimed to be identical to predicate devices that already have a "proven track record that establishes this product line as safe and effective," the submission asserts that no new safety and effectiveness concerns are raised, and therefore, no new performance study is needed to demonstrate new acceptance criteria are met.
Therefore, for many of your questions, the answer will be that this information is not applicable or not provided in this type of 510(k) submission, as it's not a performance study report but a substantial equivalence claim.
Detailed Answers to Your Questions (Based on K964334):
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as performance metrics in this document. The implicit acceptance criterion is that the device is "identical" to predicate devices that are already deemed safe and effective.
- Reported Device Performance: No specific performance metrics (e.g., fogging duration, clarity improvement percentage) are reported for the Expandacell™ Anti-Fog Instrument Wipe itself in this document. Its performance is assumed to be equivalent to the predicate devices due to its identical nature.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. No new test set or performance study was conducted or reported in this 510(k) summary for the Expandacell™ Anti-Fog Instrument Wipe.
- Data Provenance: Not applicable.
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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 new ground truth validation was performed as no new performance study was conducted.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No new performance study was conducted.
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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 is an anti-fog instrument wipe, not an AI-assisted diagnostic device. An MRMC study is not relevant to this type of product.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This product is an instrument wipe, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for the Expandacell™ Anti-Fog Instrument Wipe's safety and effectiveness relies on the historical "proven track record" and regulatory clearances of the predicate devices.
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The sample size for the training set
- Not applicable. This is not an AI/algorithm-based device and does not involve a training set.
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How the ground truth for the training set was established
- Not applicable. No training set was used.
§ 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.