(108 days)
To be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following:
- Keeping the suitable depth of endoscope's view field
- Helping the endoscope with being inserted into the gastrointestinal tract
The subject device is a sterile, single use, disposable medical device. It is designed to be placed on the distal end of an endoscope during endoscopic procedures to improve the physician's ability to visualize and examine the mucosa. AmplifEYE is made of injection molded polymer and consists of a main body tube with flexible wings arranged in a single row around one end of the main body tube. In a standard colonoscopy procedure, the endoscope is intubated through the rectum and advanced forward through the length of the colon. The endoscope is then retracted while the physician visually examines the colon mucosa for polyps or other abnormalities. The AmplifEYE wings fold down during intubation and movements that advance the endoscope forward so that forward movement is not hindered. During endoscope withdrawal, the wings open and fold outward to keep the depth of the endoscope's view field by manipulating the colonic folds and stabilizing the position of the endoscope within the intestinal lumen, thus aiding in the physician's ability to visualize and examine the mucosa.
The Medivators AmplifEYE device, an endoscope accessory, does not present Acceptance Criteria in the provided text. Instead, the document focuses on demonstrating substantial equivalence to predicate devices (Arc EndoCuff and Arc Endocuff Vision) rather than defining specific performance thresholds as acceptance criteria for a new clinical indication or outcome.
The study presented is a non-clinical performance evaluation comparing the AmplifEYE with its predicate devices.
Here's an analysis based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance:
As no explicit acceptance criteria are provided in the document for the AmplifEYE's primary function of "keeping the suitable depth of endoscope's view field" or "helping the endoscope with being inserted into the gastrointestinal tract," a table of acceptance criteria and reported device performance cannot be created as requested. The document primarily focuses on demonstrating equivalence through design and non-clinical testing.
The document highlights:
| Parameter | Acceptance Criteria (Not explicitly stated, but implied by equivalence) | Reported Device Performance (AmplifEYE) |
|---|---|---|
| Intended Use | Equivalent to predicate devices (facilitate endoscopic therapy, maintain suitable depth of view, aid insertion). | Claimed equivalent by Medivators. |
| Principle of Operation | Equivalent to predicate devices. | Claimed equivalent by Medivators. |
| Scientific Technology | Equivalent to predicate devices. | Claimed equivalent by Medivators. |
| Sterilization Method | Demonstrate equivalent sterility assurance to predicate devices' irradiation method, even if different. | Ethylene Oxide sterilization validated to provide equivalent sterility assurance. |
| Open Wings Diameter | Equivalent performance, no questions of safety or efficacy despite slight size difference. | Slight greater open wings diameter than predicates, but bench testing and animal testing demonstrated equivalent performance and no safety/efficacy concerns. |
| Force to Remove | (Implied to be within acceptable limits for safe use and equivalent to predicates) | Tested as part of Design Verification. Specific values not reported. |
| Force to Deflect | (Implied to be within acceptable limits for safe use and equivalent to predicates) | Tested as part of Design Verification. Specific values not reported. |
| Shelf-life | (Implied to meet required duration and maintain functionality/sterility) | Validated (Functional Testing, Sterile Barrier Integrity Testing). Specific duration not reported. |
| Biocompatibility | Conformance to ISO 10993-1. | Polymer conforming to ISO 10993-1. |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated for specific tests.
- Bench Testing: Indicated for "open wing diameter difference" and "Design Verification (Force to Remove Testing, Force to Deflect Testing)". The exact number of units or repetitions used for these tests is not provided.
- Animal Testing: Performed. The number and type of animals used are not specified.
- Data Provenance: Not specified, but likely internal company testing (Medivators Inc.). The document does not indicate external or multi-center trial data. The data is non-clinical, related to device characteristics and animal studies, not human patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This study is a non-clinical evaluation for substantial equivalence, primarily focusing on engineering and material performance, and animal testing. It does not involve human subjects or the establishment of a medical 'ground truth' by experts in a diagnostic or clinical efficacy context.
4. Adjudication Method for the Test Set:
- Not Applicable. As no 'ground truth' from human data or expert consensus is established for a diagnostic or efficacy claim, no adjudication method would be relevant or discussed in this context.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. An MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI or other tools on human reader performance with medical images, which is not the scope of this device or its evaluation. The AmplifEYE is a physical accessory to an endoscope, not a diagnostic AI tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Yes, in spirit, as a non-clinical standalone device evaluation. The testing performed (Design Verification, Shelf-life, Sterilization Validation, Animal Testing) evaluates the device's inherent characteristics and performance without human interaction in a diagnostic or interpretive loop. However, it's important to note this is not an "algorithm-only" performance as the device is mechanical/physical, not software. The performance demonstrated in these tests is for the device itself.
7. The Type of Ground Truth Used:
- Engineering specifications, industry standards, and biological response.
- For Design Verification (Force to Remove, Force to Deflect): Ground truth would be defined by engineering design requirements and acceptable ranges for mechanical properties.
- For Sterilization Validation: Ground truth involves demonstrating a Sterility Assurance Level (SAL), often 10^-6, through established microbiological testing methods.
- For Biocompatibility: Ground truth is adherence to standards like ISO 10993-1.
- For Animal Testing: Ground truth would be observed physiological responses, safety, and functionality in a living system.
8. The Sample Size for the Training Set:
- Not Applicable. As described, this is not an AI/machine learning device; therefore, there is no "training set." The device is a physical medical accessory.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. See point 8.
§ 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.