(116 days)
The intended use of the device is to illuminate the eye during anterior and posterior vitreoretinal surgery.
The PHOTON EX is a table-top, xenon lamp lightsource used for intraocular illumination during vitreoretinal surgery. The lightsource employs two channels from a single lamp. The channels terminate with entry ports on the unit's front panel. Each channel has a dedicated filter wheel; the filter wheels include the following band pass filters with an upper cut-off at 650 nm and lower cut-offs at 435nm, 475nm, 475nm, and 515nm respectively. The user inputs are controlled by membrane switches on the front panel.
The provided text describes a 510(k) premarket notification for a medical device called PHOTON EX, an ophthalmic light source. The document focuses on establishing substantial equivalence to a predicate device (Synerlight) rather than providing detailed acceptance criteria and a comprehensive study for de novo approval.
Therefore, the requested information for acceptance criteria and a study proving the device meets them, especially with specific details like ground truth establishment, expert qualifications, adjudication methods, and MRMC studies, cannot be found in this document.
This type of submission (510(k)) primarily demonstrates that a new device is as safe and effective as a legally marketed predicate device. The information provided is generally a comparison of technological characteristics and a summary of non-clinical tests to show equivalence.
However, I can extract the information that is present in the document which relates to performance and testing:
Device: Synergetics PHOTON EX
Predicate Device: Synergetics Synerlight FiberOptic Lightsource, K032598
Intended Use: The intended use of the device is to illuminate the eye during anterior and posterior vitreoretinal surgery.
Here's an attempt to answer the questions based on the available information, noting where information is explicitly not present in the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative manner for specific performance metrics (e.g., "illumination intensity must be > X lumens with a tolerance of Y%"). Instead, it focuses on demonstrating equivalence to the predicate device.
| Acceptance Criteria (Implied by equivalence) | Reported Device Performance (Summary of Non-clinical Tests) |
|---|---|
| Safety: Complies with applicable requirements of safety standards. | The PHOTON EX has undergone testing and complies with the applicable requirements of safety standards. |
| Effectiveness: Similar performance profile to the predicate device. | The subject device performed equivalently to the predicate device in a comparative bench test. The device is as safe and effective as the predicate device. |
| Technological Characteristics: Similar to or improved upon predicate. | Many characteristics are directly compared and are either identical or represent an improvement (e.g., digital control vs. analog, more filter options). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document mentions "comparative bench test" but does not detail the sample size (e.g., number of units tested, number of test cycles), data provenance, or study design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. For a physical device like an ophthalmic light source, "ground truth" as it applies to diagnostic interpretation or clinical outcomes (which would involve experts) is not typically the focus of a 510(k) submission. Performance is usually assessed through engineering benchmarks and comparative tests against the predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
An MRMC study is relevant for diagnostic devices that involve human interpretation, often assisted by AI. The PHOTON EX is an ophthalmic light source, a non-diagnostic device used for illumination during surgery. Therefore, an MRMC study is not applicable and was not performed for this device in the context of this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A "standalone" performance evaluation typically refers to the performance of an algorithm or an automated system without human intervention, again common in AI-driven diagnostic devices. Since the PHOTON EX is a surgical light source, this concept is not applicable and was not performed. Its performance is assessed through its physical characteristics and functionality.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a physical light source, "ground truth" would relate to measurable physical parameters (e.g., light output intensity, spectral purity, color temperature, beam uniformity, operational safety). The document states "The PHOTON EX has undergone testing and complies with the applicable requirements of safety standards." and "The subject device performed equivalently to the predicate device in a comparative bench test." This implies that the ground truth for performance was established through engineering specifications, safety standards, and direct comparative measurements against the predicate device's measured performance. Details of these specific ground truths (e.g., the exact safety standards, detailed performance metrics) are not provided.
8. The sample size for the training set
This information is not provided in the document. The concept of a "training set" is typically associated with machine learning or AI models, which are not described as part of this device.
9. How the ground truth for the training set was established
As the concept of a "training set" is not applicable or discussed for this device, information on how its ground truth was established is not provided.
§ 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.