(90 days)
The Scope Guard protective sheath is intended for use during the transport, storage and sterilization of certain ACMI scopes for protection of these delicate instruments. It is not intended to be used alone for terminal sterilization but can be used in conjunction with an approved sterilization wrap to maintain sterility until the device is required for use. The ACMI scopes with Scope Guard can be wrapped, or placed into an approved sterilization tray for sterilization processing.
The Scope Guard Protective Sheath is a polymer tube in various widths and lengths with evenly distributed holes along the length of the shaft. It is designed to snap onto ACMI telescopes for protection during storage and sterilization.
Here's an analysis of the provided text regarding the Scope Guard™ Protective Sheath, focusing on acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it broadly states that "ACMI Scope Guards have been bench tested for durability, sterile efficacy and material compatibility with several sterilization methods." It then concludes that "The Scope Guard is substantially equivalent to the predicate described for the parameters tested."
To extract conceptual acceptance criteria and reported performance from the provided text, we can infer the following:
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Durability | Bench tested and found to be "substantially equivalent" to predicate device. |
| Sterile Efficacy | Bench tested and found to be "substantially equivalent" to predicate device. |
| Material Compatibility | Bench tested and found to be "substantially equivalent" to predicate device for "several sterilization methods." |
2. Sample size used for the test set and the data provenance
The document does not provide specific sample sizes for any test sets.
The document does not specify the data provenance (e.g., country of origin, retrospective or prospective) for any of the testing mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish ground truth for a test set. The testing described appears to be bench testing for physical and sterilization properties, not involving interpretative assessments by human experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not mention any adjudication method for a test set. This is consistent with the type of bench testing described, which typically involves objective measurements rather than expert consensus on subjective interpretations.
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
The document does not describe a multi-reader, multi-case (MRMC) comparative effectiveness study. This device is a protective sheath, not an AI-powered diagnostic tool, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not describe a standalone algorithm performance study. As mentioned, this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench testing described (durability, sterile efficacy, material compatibility), the "ground truth" would be established by:
- Durability: Objective physical measurements against engineering specifications or established industry standards.
- Sterile Efficacy: Microbiological testing results (e.g., sterility testing after sterilization cycles) against accepted sterility assurance levels.
- Material Compatibility: Visual inspection or material analysis after exposure to sterilization methods to detect degradation or incompatibility issues.
The document does not provide details on the specific methods used to establish these ground truths, but they would be based on objective scientific/engineering principles rather than expert consensus on medical images or pathology.
8. The sample size for the training set
The document does not mention any training set. As this is not an AI/machine learning device, the concept of a "training set" is not applicable.
9. How the ground truth for the training set was established
Not applicable, as 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.