(52 days)
The Mentor Skin Protection Pad is used to protect the patient's skin from abrasion, frictional heat, or other minor damage that may be encountered during a surgical procedure. It is intended to adhere to the patient's skin around the incision site.
The Skin Protection Pad will be available in two shapes: rectangular and semicircular. It will consist of a pad substrate of rayon and polypropylene, a pad lining of polyethylene, a double-coated pressure sensitive adhesive, and a peel-away backing material with a release system. Three pads will be sealed in a TYVEK pouch. Twelve TYVEK pouches will be packaged in a shelf carton. The Skin Protection Pad is sterile and single-use only.
The provided document describes a 510(k) submission for the Mentor Skin Protection Pad. This submission focuses on establishing substantial equivalence to a predicate device and includes biocompatibility testing. It does not involve an AI or software-as-a-medical-device (SaMD) component. Therefore, many of the requested categories related to AI/algorithm performance and ground truth establishment are not applicable.
Here's the information that can be extracted and a clear indication of what is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No evidence of delayed dermal contact sensitization in guinea pigs | No evidence of causing delayed dermal contact sensitization in the guinea pig. |
| No irritation on rabbit skin | No irritation was observed on the skin of the rabbits. |
| No cell lysis or toxicity greater than USP grade of 2 (mild reactivity) | Showed no evidence of causing cell lysis or toxicity greater than a USP grade of 2 (mild reactivity). |
2. Sample Size Used for the Test Set and Data Provenance
- Sensitization Study (Guinea Pig):
- Sample Size: Not specified (refers to "the guinea pig" generally, implying a standard number used for such tests, but not explicitly stated).
- Data Provenance: Prospective (experiments were performed for this submission). Country of origin is not specified, but the submission is to the U.S. FDA.
- Skin Irritation Study (Rabbit):
- Sample Size: Not specified (refers to "the rabbits" generally, implying a standard number used, but not explicitly stated).
- Data Provenance: Prospective. Country of origin not specified.
- Cytotoxicity Test (L-929 Mouse Fibroblast Cell Line):
- Sample Size: Not specified (refers to "the L-929 mouse fibroblast cell line"). This usually involves multiple plates/wells in a lab setting.
- Data Provenance: Prospective. Country of origin not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This device is a physical product (skin protection pad), and the testing performed is biocompatibility testing (sensitization, irritation, cytotoxicity). Ground truth for these types of tests is established by laboratory protocols and scientific observation, not by expert consensus interpreting images or clinical data. No "experts" in the sense of clinicians establishing ground truth are involved.
4. Adjudication Method for the Test Set
- Not Applicable. As per point 3, there is no "adjudication" in the context of clinical interpretation. The results of the biocompatibility tests are objective measurements and observations from the laboratory.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This device is not an AI/SaMD product. No human readers or AI assistance are involved in its primary function or testing as described.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is not an AI algorithm.
7. The Type of Ground Truth Used
- Experimental Results/Laboratory Observation:
- For sensitization: Observation of dermal reactions in guinea pigs.
- For irritation: Observation of dermal reactions in rabbits.
- For cytotoxicity: Measurement of cell lysis/toxicity level in a cell line.
8. The Sample Size for the Training Set
- Not Applicable. This device is not an AI/machine learning model and therefore does not have a "training set."
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As per point 8, there is no training set for this device.
§ 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.