(57 days)
The OpClear® Platform consists of a reusable control unit and a range of disposable sterile single-use accessories intended to remove visual obstructions on the distal window of laparoscopes, such as condensation, blood and other tissue particulates, therefore maintaining a clear image of the surgical site.
The OpClear ®Platform is indicated for use in abdominal laparoscopy.
OpClear® Platform is a laparoscopic lens cleaning device which is intended to be used during any laparoscopic surgical procedure where there is a potential for contamination of the distal lens. Consisting of a reusable control unit and a range of sterile, invasive, single use disposables, it is intended to maintain surgical vision by removing contaminants such as condensation, blood, peritoneal fluid, smoke, fat and tissue smears that have contaminated the distal lens of the laparoscope during surgical procedures.
OpClear® Platform is composed of a control unit and a range of disposable accessories as shown below.
| Description | Part Number |
|---|---|
| OpClear Control Unit with footswitch | CS-CU33 |
OpClear® Disposables
| OpClear Part # | Diameter | Angle | Working
Length |
|----------------|----------|-----------|-------------------|
| CS-10-00-300 | 10 mm | 0° | 300 mm |
| CS-10-30-300 | 10 mm | 30° / 45° | 300 mm |
| CS-10-00-315 | 10 mm | 0° | 315 mm |
| CS-10-30-315 | 10 mm | 30° / 45° | 315 mm |
| CS-10-00-330 | 10 mm | 0° | 330 mm |
| CS-10-30-330 | 10 mm | 30° / 45° | 330 mm |
| CS-05-00-290 | 5 mm | 0° | 290mm |
| CS-05-30-290 | 5 mm | 30° / 45° | 290mm |
| CS-05-00-300 | 5 mm | 0° | 300mm |
| CS-05-30-300 | 5 mm | 30° / 45° | 300mm |
| CS-05-00-315 | 5 mm | 0° | 315mm |
| CS-05-30-315 | 5 mm | 30° / 45° | 315mm |
This document describes the OpClear® Platform, a laparoscopic lens cleaning device. The submission is a 510(k) for substantial equivalence to an existing predicate device (OpClear® System, K171637). The information provided focuses on the device's technical specifications and comparison to the predicate, rather than a clinical study evaluating its performance against specific acceptance criteria.
Therefore, I cannot fully address all aspects of your request, particularly those related to a clinical study and its acceptance criteria, as such a study is not detailed in the provided text. However, I can extract information related to non-clinical testing and the comparison between the device and its predicate.
Here's a breakdown of what can and cannot be answered based on the provided text:
What can be extracted:
- Acceptance Criteria (Implied Non-Clinical): The document implies that the "suitability" and "performance" of the OpClear® Platform in a simulated abdominal cavity environment were validated by comparing them to the predicate device. However, specific numerical acceptance criteria for performance (e.g., minimum clarity achieved, cleaning time) are not explicitly stated.
- Reported Device Performance (Non-Clinical): The document states that "The performance of the predicate device, OpClear® System and the subject device, OpClear® Platform, have been validated using the same bench model." It then concludes that "The proposed device has the same principles of operation and technological characteristics as the predicate device" and "does not adversely affect safety or effectiveness." This indicates that its performance in the simulated environment was considered comparable or equivalent to the predicate. Specific metrics are not provided.
- Sample Size for Test Set: For non-clinical testing, it mentions "a simulated human abdominal cavity environment." The "sample size" for this bench model is not quantifiable in terms of patient numbers.
- Data Provenance: The "test" (non-clinical validation) was conducted in a "laboratory." No country of origin for the "data" (results of the bench testing) is specified, nor is whether it was retrospective or prospective.
- Adjudication Method: Not applicable for non-clinical bench testing.
- MRMC Comparative Effectiveness Study: Not described. The document focuses on non-clinical bench testing and a comparison to a predicate device for substantial equivalence, not a clinical MRMC study.
- Standalone Performance: The non-clinical testing appears to evaluate the device's functional performance in a simulated environment, which could be considered a form of standalone testing, but no specific metrics are given.
- Type of Ground Truth (Non-Clinical): The ground truth for the non-clinical testing was based on the performance of the predicate device in the same simulated environment, implying that the predicate's performance was the established baseline for "clearness" or "effectiveness" in that setting.
- Sample Size for Training Set: Not applicable. This device is hardware for cleaning, not an AI/ML algorithm that requires a training set in the typical sense.
- How Ground Truth for Training Set was Established: Not applicable.
What cannot be extracted (due to lack of information in the document):
- Explicit numerical acceptance criteria for clinical performance.
- Detailed clinical performance metrics (e.g., success rates, cleaning duration in vivo).
- Sample size for a clinical test set (as no clinical study is described).
- Number of experts, qualifications of experts, or adjudication methods for establishing ground truth in a clinical context.
- Effect size of human readers improving with AI vs. without AI assistance (as no AI component or human reader study is discussed).
Based on the provided text, here is the information that can be extracted, primarily pertaining to the non-clinical validation:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Type (Implicit Non-Clinical) | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Functional Performance | Device maintains clear vision by removing visual obstructions (condensation, blood, tissue particulates) in a simulated abdominal cavity environment, comparably to the predicate device. | "The performance of the predicate device, OpClear® System and the subject device, OpClear® Platform, have been validated using the same bench model." "The proposed device has the same principles of operation and technological characteristics as the predicate device." "OpClear® Platform does not adversely affect safety or effectiveness." |
| Safety & Biocompatibility | No adverse safety or effectiveness issues, with materials comparable to predicate. | "There are no significant changes to the materials, dimensions (except for the diameter) or to the assembly process of the disposables. No new biocompatibility testing is deemed to be required as compared to the predicate device." |
| Electrical Safety | Compliance with IEC 60601-1:2005. | "Independently tested to IEC 60601-1:2005." |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2-2014. | "Independently tested to IEC 60601-1-2-2014." |
| Software Control | Developed, tested, and verified to IEC 62304-2015. | "Developed, tested and verified to IEC 62304-2015." |
| Sterility | Single-use disposables sterilized with Ethylene Oxide in accordance with ISO 11135-2014. | "Single use disposables - Ethylene Oxide sterilisation validated in accordance with ISO 11135-2014." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: Non-clinical bench testing was performed using "a simulated human abdominal cavity environment."
- Sample Size: Not quantifiable in terms of patient samples; it's a simulated environment. The number of tests performed within this simulation is not specified.
- Data Provenance: The testing was conducted in a "laboratory." The country of origin is not specified, nor is whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable for this non-clinical bench testing. The "ground truth" for comparison was the performance of the predicate device in the same simulated environment.
4. Adjudication Method for the Test Set
- Not applicable for this non-clinical bench testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not described or presented in this document. The submission focuses on substantial equivalence based on technical characteristics and non-clinical bench testing.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The non-clinical "Summary of Non Clinical Testing" describes the device's functional performance in a simulated environment. This can be considered a form of standalone performance evaluation for the device's physical function (cleaning capability), but it's not "algorithm only" and doesn't involve "human-in-the-loop" as in AI-assisted diagnosis.
7. The Type of Ground Truth Used
- For the non-clinical testing, the "ground truth" was established by comparing the performance of the new OpClear® Platform to the legally marketed predicate device (OpClear® System) within the simulated abdominal cavity environment. The predicate's validated performance implicitly served as the acceptable standard.
8. The Sample Size for the Training Set
- Not applicable. The OpClear® Platform is a hardware device for laparoscopic lens cleaning; it does not involve AI/ML algorithms that require a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for an AI/ML algorithm.
§ 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.