(84 days)
The KARL STORZ H1 camera head, in combination with an appropriately indicated camera control unit (CCU), light source, and monitor, and with an appropriately indicated endoscope, or microscope, is used for real-time visualization in diagnostic and surgical procedures.
The camera head consists of an anodized aluminum, stainless steel enclosure containing a CMOS (Complementary metal-oxide-semiconductor) NTSC image sensor that converts light into electrons, the transistors in each pixel then amplify and move the charge using the more traditional wires forming conventional output signals. The camera head is intended to be attached to the proximal end of the endoscopes and is connected via cable to the compatible CCU for power and operational functions. The camera head is designed to be compatible for use with all standard KARL STORZ Endoscopes, Fiberscopes and Microscope for endoscopic observation in general endoscopic procedures.
The provided text describes a 510(k) submission for the KARL STORZ H1 Camera Head, which is an endoscope camera. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
1. A table of acceptance criteria and the reported device performance
The document lists several performance tests conducted for the subject device to ensure it meets its design specifications and is substantially equivalent to the predicate device. However, it does not explicitly state numerical acceptance criteria for each test or a direct comparison of the subject device's performance against those criteria in a table format. It generally states that the device "met all its design specification" and "performs as well as the predicate device."
Implied Acceptance Criteria Categories (from "Performance Testing" section):
- Color Reproduction and Color Contrast Enhancement
- Illumination
- Detection Uniformity
- Depth of field
- Spatial Resolution
- Dynamic Range & Detection Linearity
- Distortion
- Latency
- Signal-to-Noise Ratio (SNR) & Sensitivity
- Field of View
Reported Device Performance:
The document states, "The bench testing performed verified and validated that the H1 Camera Head has met all its design specification and is substantially equivalent to its predicate devices." It also concludes, "The conclusions drawn from the nonclinical tests demonstrate that the subject devices, the H1 Camera Head performs as well as the predicate device."
Without specific numerical acceptance criteria and performance data, a detailed table cannot be created.
2. Sample size used for the test set and the data provenance
The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications."
Therefore, there was no clinical test set in terms of human subjects or medical images. The testing was entirely non-clinical bench testing. The sample size for this non-clinical testing is not specified. The data provenance is also not applicable in the sense of country of origin for retrospective or prospective data, as it was bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
As no clinical testing was performed and the ground truth was established through non-clinical bench testing against design specifications, no human experts were used to establish ground truth in the traditional sense of medical image interpretation.
4. Adjudication method for the test set
Since no clinical test set involving human experts was used for ground truth establishment, no adjudication method (like 2+1 or 3+1) was employed.
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
No MRMC study was done. The device is a camera head, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not directly applicable. The device is a camera head, not an algorithm. The "standalone" performance was essentially the non-clinical bench testing of the device itself (hardware performance), which was done without human-in-the-loop in a clinical diagnostic context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the non-clinical testing was based on design specifications and objective physical measurements during bench testing, ensuring the camera met its intended performance characteristics (e.g., spatial resolution measurements, color accuracy, brightness control functionality). This is not expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This question is not applicable as the H1 Camera Head is a hardware device and not an AI/machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established
This question is not applicable as the H1 Camera Head is a hardware device and not an AI/machine learning algorithm requiring a training set.
§ 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.