(20 days)
The ClearCam System is indicated to provide lens clearing during laparoscopic procedures.
The ClearCam System is a laparoscopic accessory lens clearing device consisting of a sheath and handle that slides over the laparoscope. The handle contains a wire connected to a wiper at the distal end of the sheath that provides lens clearing when activated. The device is intended to clear the intra-operative view of the surgical site during minimally invasive surgery by physically removing debris, blood, and bodily fluids from the laparoscope lens.
The provided text is a 510(k) premarket notification for the ClearCam System and describes its substantial equivalence to a predicate device, ClickClean (K170103). The document primarily focuses on demonstrating that the ClearCam System is as safe and effective as existing legally marketed devices, rather than presenting a performance study with acceptance criteria in the context of an AI/algorithm-driven medical device.
Therefore, the information required to answer many of the specific points about acceptance criteria and a study proving performance (especially in the context of AI and human readers) is not present in the provided document. The ClearCam System is a physical medical device (a laparoscopic accessory lens clearing device) and not an AI-based diagnostic or assistive system.
However, I can extract the information that is present and indicate where information is missing.
Here's the breakdown of what is available and what is not:
Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for the ClearCam System
Based on the provided 510(k) summary, the ClearCam System is a physical medical device designed to clear laparoscopic lenses during surgery. The "acceptance criteria" and "study" described in the document are primarily focused on demonstrating substantial equivalence to a predicate device (ClickClean) through mechanical, functional, pre-clinical, and biocompatibility testing, rather than statistical performance metrics of an algorithm or human-in-the-loop study typical for AI/diagnostic devices.
1. Table of Acceptance Criteria and Reported Device Performance
For a physical device, "acceptance criteria" are typically defined by engineering design specifications and regulatory standards. The document reports "Pass" for all tested criteria, indicating that the device met these predefined specifications.
| Test Description | Method | Acceptance Criteria (Implicit: Pass) | Reported Device Performance |
|---|---|---|---|
| Mechanical Testing | |||
| Sterilization | ISO 14937:2009 Sterilization of healthcare products | Pass | Pass |
| Performance - Mechanical | In accordance with device performance specifications | Pass | Pass |
| Performance - Functional | In accordance with device performance specifications | Pass | Pass |
| Performance - Pre-Clinical | Functional testing set by the standard ISO 8600-1:1997 | Pass | Pass |
| Biocompatibility Testing | |||
| Cytotoxicity | ISO 10993-5 (in vitro cytotoxicity) | Pass | Pass |
| Hemocompatibility | ISO 10993-4 (selection of tests for interactions with blood) | Pass | Pass |
| Sensitization | ISO 10993-10 (irritation and skin sensitization) | Pass | Pass |
| Intracutaneous Reactivity | ISO 10993-10 (irritation and skin sensitization) | Pass | Pass |
| Systemic Toxicity (acute) | ISO 10993-11 (tests for systemic toxicity) | Pass | Pass |
| Pyrogenicity | ISO 10993-11 (tests for systemic toxicity) | Pass | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not specify the sample size for the mechanical and biocompatibility testing. It only states that "devices were tested." For these types of tests, sample sizes are typically determined by relevant ISO standards or internal quality procedures, but the specific number is not disclosed here.
- Data Provenance: Not applicable in the context of patient data for an AI/algorithm. The data provenance refers to materials and samples used for mechanical and biocompatibility testing of the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This question is not applicable as the device is a physical tool for clearing lenses, not an AI or diagnostic device requiring expert interpretation of images/data to establish ground truth. The "ground truth" for this device's function is its ability to physically clean the lens and its biological compatibility.
4. Adjudication Method for the Test Set:
- Not applicable for this type of device and testing. Adjudication is relevant for subjective assessments, primarily in diagnostic accuracy studies involving multiple readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC study was not done. This type of study is specifically for evaluating the impact of an AI system on human reader performance, which doesn't apply to a physical lens-clearing device.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Not applicable. The ClearCam System is a physical accessory, not an algorithm.
7. The Type of Ground Truth Used:
- The "ground truth" for this device's performance is established by compliance with engineering design specifications, international standards (ISO), and successful completion of predefined functional and biocompatibility tests. For instance, "pass" for sterilization means it meets the defined sterility assurance level, and "pass" for functional testing means it performs its intended lens-clearing action as specified.
8. The Sample Size for the Training Set:
- Not applicable. This device is not an AI/machine learning algorithm, so there is no "training set."
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.