(90 days)
The OptoMedic Laparoscopes are intended to be used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The OptoMedic Laparoscopes are intended to be used by trained healthcare professional in diagnostic and therapeutic procedures.
The OptoMedic laparoscopes are rigid endoscopes that are used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. An endoscope is a slender, tubular optical instrument used as a viewing system for examining an inner part of the body. The inside of the endoscope contains a series of lenses that transmit the endoscopic image, which is illuminated by an external light source. The Laparoscope has 8 models which are available in two insertion widths (5.6 mm and 10.1mm), two working lengths (320mm and 310mm) and two different directions of view (0° and 30°).
This document is a 510(k) Premarket Notification for the OptoMedic Laparoscope, signifying its clearance by the FDA based on substantial equivalence to predicate devices. The information provided is primarily focused on the device's technical specifications and comparisons, rather than a clinical study demonstrating performance against specific acceptance criteria in the context of AI/ML.
Therefore, for the request regarding acceptance criteria and a study proving the device meets them, it's important to understand that this submission is for a medical device (a laparoscope), not an AI/ML diagnostic tool. As such, the typical metrics and study designs for AI/ML performance (like those related to sensitivity, specificity, reader studies, etc.) are not directly applicable or provided in this document.
However, I can extract the information related to the device's performance testing as described for regulatory clearance, which serves a similar purpose to demonstrating that the device meets its design specifications and is safe and effective for its intended use.
Here's a breakdown based on the provided document, addressing the closest analogues to your request:
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device, "acceptance criteria" are generally derived from recognized industry standards and regulatory requirements for safety, performance, and functionality. The "reported device performance" is the demonstration that the device complies with these standards.
| Acceptance Criteria Category (Derived from Standards) | Reported Device Performance (Compliance Statement) |
|---|---|
| Electrical Safety | Complies with ANSI/AAMI ES 60601-1: 2005+A2 (R2012) +A1 (General requirements for basic safety and essential performance). |
| Endoscopic Equipment Safety | Complies with IEC 60601-2-18:2009 (Particular requirements for the basic safety and essential performance of endoscopic equipment). |
| General Endoscope Requirements | Complies with ISO 8600-1-2015 (General requirements for endoscopes). |
| Optical Characteristics (Field of View & Direction) | Complies with ISO 8600-3-2019 (Determination of field of view and direction of view of endoscopes with optics). |
| Physical Characteristics (Maximum Width) | Complies with ISO 8600-4-2014 (Determination of maximum width of insertion portion). |
| Optical Characteristics (Resolution) | Complies with ISO 8600-5-2020 (Determination of optical resolution of rigid endoscopes with optics). |
| Biocompatibility (Cytotoxicity) | Complies with ISO 10993-5:2009 (Tests for in vitro cytotoxicity). |
| Biocompatibility (Sensitization) | Complies with ISO 10993-10:2021 (Tests for skin sensitization). |
| Biocompatibility (Systemic Toxicity) | Complies with ISO 10993-11:2017 (Tests for systemic toxicity). |
| Biocompatibility (Irritation) | Complies with ISO 10993-23:2021 (Tests for irritation). |
| Reprocessing (Cleaning) | Complies with AAMI TIR 30:2016 (Cleaning reusable medical devices) and AAMI TIR 12:2020 (Designing, testing, and labeling). |
| Overall Performance & Intended Functionality | "Performance testing were also conducted on the subject device and demonstrate that the proposed system performs according to specifications and functions as intended." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail specific "sample sizes" in the context of clinical or AI/ML test sets. The performance evaluation primarily involved non-clinical tests conducted to verify compliance with national and international standards. These tests typically involve physical and functional evaluations of the device itself rather than patient data.
- Sample Size: Not applicable in the context of AI/ML test sets. For device testing, it would involve a representative number of device units.
- Data Provenance: Not applicable in the context of clinical data. The testing involves the physical device and its components, complying with engineering and safety standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of device clearance. Ground truth, in the context of image analysis or diagnostic performance, is not established for a rigid laparoscope in this document. The "ground truth" for this device's performance is its adherence to the technical specifications defined by the relevant standards (e.g., whether its field of view is indeed 68°, its resolution meets the specified criteria, or its materials are biocompatible). These are verified through engineering and laboratory testing.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert reviews of data (often medical images) to establish a consensus ground truth. This document describes non-clinical engineering and bench testing, not clinical data review.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This document does not mention any MRMC comparative effectiveness study. These studies are typically conducted for AI/ML diagnostic tools to evaluate how AI assistance impacts human reader performance. The OptoMedic Laparoscope is a physical medical instrument, not an AI system.
6. If a Standalone (Algorithm Only) Performance Study was Done
No. This is not an AI/ML algorithm. Therefore, a standalone algorithm performance study was not conducted or reported.
7. Type of Ground Truth Used
The "ground truth" used for this device's regulatory clearance is compliance with established engineering, safety, and performance standards (e.g., ISO, IEC, AAMI standards) as verified through non-clinical laboratory testing. This is distinct from clinical ground truth based on pathology, expert consensus, or outcomes data, which would be relevant for diagnostic devices or AI algorithms.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no AI/ML 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.