(117 days)
AlphaXenon Light 300W and 180W light source is used with an endoscope to provide illumination during endoscopic procedures.
AlphaXenon Light is a light generating device that when used with in conjunction with endoscopes to illuminate surgical site during Endoscopic procedures.
The provided text is a 510(k) summary for the AlphaXenon Light, a medical device. This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to existing devices, not on presenting novel clinical study data with acceptance criteria for device performance as would be expected for a new technology or diagnostic AI.
Therefore, the document does not contain information on:
- Acceptance criteria for device performance (beyond substantial equivalence to predicates).
- A "study that proves the device meets the acceptance criteria" in the sense of clinical performance or accuracy study.
- Sample sizes for test sets.
- Data provenance.
- Number of experts, their qualifications, or adjudication methods for ground truth.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for training sets.
- How ground truth for training sets was established.
The document primarily focuses on demonstrating that the AlphaXenon Light is substantially equivalent to legally marketed predicate devices.
Here's what the document does state regarding its compliance and equivalence:
1. Acceptance Criteria and Reported Device Performance:
The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to predicate devices already on the market. The reported "performance" is that the device is "similar in design, technology and intended use" and raises "no new questions of safety and effectiveness."
| Acceptance Criteria (Implied by 510(k) process for this device type) | Reported Device Performance |
|---|---|
| Substantial Equivalence in Design, Technology, and Intended Use | "similar in design, technology and intended use to [predicate devices]" |
| No new questions of safety and effectiveness | "The differences... are minor and raise no new questions of safety and effectiveness." |
2. Sample size used for the test set and the data provenance:
Not applicable. This is a light source, not a diagnostic AI or imaging device requiring a test set for performance evaluation in the usual sense. The submission likely relies on engineering and bench testing to demonstrate functionality and safety, but these details are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable for this type of device and submission.
4. Adjudication method for the test set:
Not applicable.
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:
Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. This is a light source, its "ground truth" relates to functional specifications and safety, not diagnostic accuracy.
8. The sample size for the training set:
Not applicable. This is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
Not applicable.
In summary, this 510(k) summary is for a basic medical device (light source) where the primary regulatory hurdle is demonstrating substantial equivalence to existing, legally marketed devices. It does not involve complex clinical performance studies or AI evaluation metrics as outlined in your request.
§ 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.