(99 days)
The HEMORPEX SYSTEM (HPS) is intended for physician use to examine the anal sphincter and anus and to perform several diagnostic and therapeutic procedures, such as surgical treatment for hemorrhoidal disease.
HEMORPEX SYSTEM (HPS) is a diagnostic and operating anoscope, which is mainly intended for the surgical treatment of the hemorrhodal disease through dearterializing hemorrhoidopexy. HemorPex System (HPS) is a device made by a fixed part which remains in contact with the anoderma and the sensible mucosa of the anal canal, and by a rotating operative part which includes the window through which the suture stitches are posed. The instrument has 6 preset positions of the operative window. In these positions there are the 6 terminal branches of the superior hemorrhoidal artery.
The provided text is a 510(k) Summary for the HEMORPEX SYSTEM (HPS), a disposable anoscope. This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance studies with acceptance criteria for a novel AI or diagnostic device. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics is not available in this document.
Here's a breakdown of what can be inferred and what is explicitly not mentioned:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a diagnostic or AI device. The acceptance criteria for a 510(k) submission generally revolve around demonstrating substantial equivalence in terms of intended use, technological characteristics, safety, and effectiveness to a legally marketed predicate device.
- Reported Device Performance: No quantitative performance data (e.g., sensitivity, specificity, accuracy, precision) is reported for the HEMORPEX SYSTEM (HPS) in the context of an AI or diagnostic study. The document focuses on comparing its characteristics to a predicate device.
| Metric (if applicable) | Acceptance Criteria (Not stated) | Reported Device Performance (Not stated) |
|---|---|---|
| (No AI/Diagnostic metrics are provided in this document) | (No AI/Diagnostic metrics are provided in this document) | (No AI/Diagnostic metrics are provided in this document) |
The comparison table in the document (under "Comparison to predicate devices") highlights characteristics such as intended use, material, single use, and packaging, showing alignment with the predicate device, which serves as the "performance" in a substantial equivalence context for this type of device.
2. Sample size used for the test set and the data provenance:
- Not applicable. This is a medical device clearance document, not a study evaluating an AI/diagnostic algorithm on a test set. There is no mention of a test set, data provenance, or patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no mention of a test set, ground truth, or experts establishing it.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable.
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:
- Not applicable. This document does not describe a study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (anoscope), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. There is no AI or diagnostic algorithm being evaluated that would require ground truth.
8. The sample size for the training set:
- Not applicable. This is a physical medical device.
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.