(29 days)
The PeerScope System is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The PeerScope System is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients. The PeerScope System consists of PeerMedical camera heads, endoscopes, video system, light source and other ancillary equipment.
The PeerScope system Model H is a GI platform for diagnostic visualization and therapeutic intervention of the lower digestive tract. The PeerScope system Model H is a modification of the legally marketed (K 120289) PeerScope system Model B (the predicate device). The system consists of endoscopic Main Control Unit (MCU H) and of the PeerScope CS colonoscope, enabling physicians to view a high resolution wide field of view of up to 300°. The system is labeled for use in healthcare facilities / hospitals for adult patients.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Risk Analysis | Conducted in accordance with ISO 14971; tests performed and met criteria. |
| Software Validation | Carried out in accordance with FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005)". |
| Reprocessing Validation | Carried out in accordance with FDA Guidance Document "Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Draft Guidance (May 2011)". |
| Device Safety & Performance | Verified by PeerMedical and accredited third-party laboratories. |
| Usability | Tested in a clinical environment by seven experienced GI physicians; device meets specifications; "at least as safe and effective for its intended use as the predicate device." |
| Technological Differences Impact | Impact of differences between Model H and Model B (video resolution, user interface, I/O ports, video signal output/input, monitor display options) deemed "insignificant in terms of the device safety and effectiveness for the device intended use" based on verification and performance testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Usability Study: 7 experienced GI physicians.
- Bench Data (Verification Tests): Not explicitly stated, but implies sufficient tests were run to meet ISO 14971 risk analysis, software validation, and reprocessing validation criteria.
- Data Provenance: Clinical environment in a US medical center (for usability testing). Other bench data provenance is not specified beyond "PeerMedical and accredited third party laboratories." The study is prospective in nature for the usability and verification testing of the new Model H.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: 7
- Qualifications of Experts: Experienced GI physicians. No further details (e.g., years of experience, specific board certifications) are provided.
4. Adjudication Method (for the test set)
The document does not explicitly state an adjudication method (such as 2+1 or 3+1) for the usability testing. It mentions "Device Usability was carried out by means of testing within a clinical environment in a US medical center by seven experienced GI physicians," and that "The conclusions drawn... demonstrate that the device meets its specifications." This suggests a consensus or individual assessment by the physicians during the usability testing, rather than a formal adjudication process comparing their findings against a pre-established ground truth for diagnostic accuracy.
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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a device modification (PeerScope System Model H) and focuses on demonstrating substantial equivalence to its predicate device (PeerScope System Model B). The "improvements" are in technological features (e.g., HD video, digital output) and usability, not in AI-assisted diagnostic performance or human reader improvement with AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. The device is a colonoscope system, an endoscopic tool for visualization and intervention, not an AI algorithm intended to perform standalone diagnostic functions.
7. The Type of Ground Truth Used
- Usability: User satisfaction and observed performance against device specifications in a clinical setting.
- Bench Data: Compliance with established engineering standards (e.g., ISO 14971, IEC 60601 series, ISO 10993 series, ASTM E 1837-96), software validation guidance, and reprocessing validation guidance.
- The "ground truth" here is adherence to regulatory and performance standards and user satisfaction, rather than a diagnostic 'truth' (like pathology or clinical outcomes for disease detection) because the device's primary function is visualization and access for intervention, not autonomous diagnostic interpretation.
8. The Sample Size for the Training Set
No training set is mentioned or applicable here. This device is a hardware system (colonoscope and accessories) for visualization and therapeutic intervention, not a machine learning or AI model that requires a training set.
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.