(104 days)
The 8X-10-XXXX Camera System is indicated for use in diagnostic and operative endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The 8X-10-XXXX Camera System is indicated for use with a compatible 8X-10-XXXX Camera Head and other accessory devices including an endoscope, optical coupler, and light cable.
The 8X-10-XXXX Camera System is a high-definition camera used to capture still and video images of endoscopic or general surgications. The system also incorporates an optional internal light source featuring a Turret Light Guide Adapter which accepts various light guides. The 8X-10-XXXX Camera System consists of a console and a compatible 8X-10-XXXX camera head.
The document provided describes the 8X-10-XXXX Camera System, an endoscopic camera system.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for performance; instead, it relies on demonstrating compliance with recognized safety standards and bench testing showing that the device "met all requirements" and is "substantially equivalent" to the predicate device.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Safety | Compliance with recognized safety standards: |
- IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-2-18: Medical Electrical Equipment, Particular Requirements for Endoscopic Equipment | The 8X-10-XXXX Camera System "demonstrates substantial equivalence in safety by tested compliance with" IEC 60601-1 and IEC 60601-1-2.
It "has been tested and found to comply with the relevant international Medical Device Standards for Safety" including IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-18. |
| Performance | Bench testing specifications for functionality, visualization, illumination, image/video capture, and other primary/secondary device functions. (Implicit: Must perform comparably to the predicate device). | "Bench testing of performance specifications were completed and demonstrate that the device met all requirements."
"Bench comparison testing between the predicate device and the 8X-10-XXXX Camera System demonstrated that the devices are substantially equivalent." |
| Intended Use/Indications | Device is indicated for use in diagnostic and operative endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening, with compatible camera head and accessories. (Implicit: Performance must support this use.) | The Indications for Use for the 8X-10-XXXX Camera System are "Same" as the predicate device. The Intended Use is "Substantially Equivalent" to the predicate device. |
| Biocompatibility | (Implicit: Materials in contact with the body must be biocompatible) | "Biocompatibility" is "Same" for the subject device and the predicate device, implying it meets the necessary standards. |
| Sterility | (Implicit: Sterilization methods for reusable components must be effective and validated.) | "Sterility" is "Same" for the subject device and the predicate device, implying it meets the necessary standards. The endoscopic camera head "may be sterilized by steam autoclave or other prescribed sterilization methods." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as this was a non-clinical study. The evaluation appears to involve testing of physical devices and components (bench testing).
- Data Provenance: The study described is non-clinical bench testing. It is not based on patient data (e.g., country of origin, retrospective/prospective) but on lab-based performance and safety evaluations of the medical device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided. Given that the listed tests are primarily engineering and compliance tests (IEC standards, bench testing of specifications), the "ground truth" would be established by adherence to these standards and the device's measured performance against its own specifications and the predicate device's performance. Experts would likely be engineers, test technicians, and regulatory compliance specialists, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
- This information is not provided. As mentioned above, the "ground truth" and "adjudication" for this type of testing typically rely on objective measurements against engineering specifications and international standards, rather than expert consensus on diagnostic outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No comparison of clinical performance data was used for demonstration of substantial equivalence." This device is an endoscopic camera system, which provides visual output, but the submission focuses on its performance as a device (safety, image quality, functionality) rather than its impact on human reader diagnostic accuracy in a clinical setting. There is no mention of AI assistance in this document.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, this is not applicable. The device is a camera system, not an AI algorithm. Its performance is measured as a standalone physical device.
7. The Type of Ground Truth Used
- The ground truth used for this submission is based on:
- Compliance with recognized international safety and performance standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18).
- Engineering specifications and objective measurements from bench testing.
- Comparison to the performance and characteristics of a legally marketed predicate device (OVS I Video System K123359) to demonstrate "substantial equivalence."
8. The Sample Size for the Training Set
- Not applicable. This submission describes the evaluation of a physical medical device (an endoscopic camera system) through non-clinical bench testing and comparison to a predicate device. It does not involve a "training set" in the context of machine learning or AI algorithms.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, there is no "training set" in this context.
§ 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.