(133 days)
The Anchorage™ Scope is a flexible fiber optic endoscope intended for the visualization of body cavities, organs, canals, and tissues. The Anchorage Scope is designed to be introduced through natural body cavities or surgical incisions through introducers, needles or trocars, catheters, sheaths or other devices with lumens having an inside diameter larger than the outside diameter of the endoscope. The Anchorage Scope is indicated for the following applications:
Ureteroscopy Bronchoscopy Thoracoscopy Nasopharyngoscopy/Sinuscopy General laparascopy Urology Gynecology
The Anchorage™ Scope is a flexible fiber optic endoscope provided as a sterile single use device. The endoscope is used to visualize body cavities, organs, canals, and tissues. The Anchorage Scope is introduced through natural body cavities or surgical incisions through introducers or trocars, catheters, sheaths or other devices of with lumens having an inside diameter greater than the outside diameter of the endoscope.
Here's an analysis of the provided text regarding the Epitek Anchorage™ Scope, focusing on the acceptance criteria and supporting study data:
The provided 510(k) summary for the Epitek Anchorage™ Scope does not contain the specific acceptance criteria or a detailed study description that proves the device meets those criteria, as one would typically find for a medical imaging AI device.
Instead, this document describes a traditional medical device (an endoscope) and focuses on demonstrating substantial equivalence to a predicate device based on in-vitro testing, biocompatibility testing, and conformance to consensus and voluntary standards.
Therefore, I cannot populate the requested table or provide answers to most of the specific questions about AI/software performance studies. The information provided is for a hardware device, not an AI or software-based medical device.
However, I can extract the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Expected/Implied) | Reported Device Performance |
|---|---|
| Functional/Performance | |
| Visualization of body cavities, organs, canals, and tissues (Implied by Indications for Use) | Addressed by overall device design and testing, deemed substantially equivalent to predicate. |
| Introduction through natural body cavities or surgical incisions via introducers/trocars/catheters (Implied by Indications for Use) | Addressed by overall device design and testing, deemed substantially equivalent to predicate. |
| Safety | |
| Biocompatibility | Biocompatibility testing conducted. |
| Sterility (Implied, as it's a sterile single-use device) | Manufacturing processes and testing would address this. |
| Regulatory Conformance | |
| Conformance to consensus and voluntary standards | Conformance demonstrated. |
| Substantial Equivalence to predicate device | Achieved through testing and comparison. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document refers to "in-vitro testing" but does not give specific sample sizes for particular tests.
- Data Provenance: Not applicable in the context of clinical data for AI. The testing appears to be laboratory-based (in-vitro) and compliance-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not a study requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is not a clinical study involving adjudication of 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:
- No. This is not an AI device, and therefore no MRMC study with human readers and AI assistance was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the context of clinical ground truth. For the hardware device, the "ground truth" for its performance would be its adherence to engineering specifications, safety standards (e.g., biocompatibility standards), and functional requirements observed during in-vitro testing.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.