(285 days)
The Endophotocoagulation Delivery Unit (for sterilized endophoto probe) is intended to be used in ophthalmic surgical procedures for retinal photocoagulation. Spot size can be varied by altering the distance between the tissue and the probe tip.
The Endophotocoagulation Delivery Unit (for sterilized endophoto probe) is connectable to Nidek laser photocoagulators such as NIDEK Multicolor Laser Photocoagulator System MC-500 or Green Laser Photocoagulator Model GYC-1000 and to the additional following surgical microscopes:. The delivery unit, which consists of a sterilized endophoto probe (available in 3 different sizes and 2 different shapes), protective filter unit, and carrying case, is used for endophotocoagulation. The photocoagulation system can be easily assembled by connecting the sterilized endophoto probe to the main laser device and connecting the protective filter to the laser device and surgical microscope. This photocoagulation system enables laser endophotocoagulation while observing the affected area through the surgical microscope.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Endophotocoagulation Delivery Unit.
Based on the provided text, the device in question is the "Endophotocoagulation Delivery Unit (for sterilized endophoto probe)". This document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive study report with detailed performance metrics against specific acceptance criteria. Therefore, much of the requested information about device performance, ground truth, and specific study details is not explicitly stated in this type of regulatory submission.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with explicit numerical acceptance criteria (e.g., minimum accuracy, maximum error) or specific quantitative device performance reports in terms of clinical outcomes. Instead, the acceptance criteria are framed in terms of meeting functional specifications, performance requirements, and compliance with international standards, particularly for safety and sterility.
| Acceptance Criterion Type | Description from Document | Reported Device Performance |
|---|---|---|
| Functional Specifications & Performance Requirements | "We have verified and validated that the Endophotocoagulation Delivery Unit (for sterilized endophoto probe) meets its functional specifications and performance requirements..." | The document states that the device "meets its functional specifications and performance requirements." Specific quantitative performance metrics (e.g., laser spot size accuracy, energy delivery precision, success rate of photocoagulation) are not provided. The device's intended use is for "retinal photocoagulation" and the "Spot size can be varied by altering the distance between the tissue and the probe tip," implying functionality in delivering laser energy for this purpose. |
| Biocompatibility/Sterility | Compliance with ISO 10993-1. For sterility, EO and ECH residual testing following ANSI/AAMI/ISO 10993-7:2008 (R2012) for a simulated extraction, ensuring residue levels are below limits for intraocular lenses (not exceeding 1.25 micrograms EO and 5 micrograms ECH), for the endophoto probe tip. Shelf life of 3 years based on seal integrity and product sterility tests at 3 accelerated or real years. | "The results demonstrate that the subject device complies with applicable international standards (ISO10993-1)." EO and ECH residual levels after sterilization of the endophoto probe were "below the current limits for intraocular lenses, it means not exceed 1.25 micrograms and 5 micrograms (respectively), testing just the endophoto probe tip." A shelf life of 3 years was "claimed" based on testing. |
| Electrical Safety | Testing according to IEC 60601-1. | "The electrical safety test report according to IEC 60601-1...were provided." The implication is that the device met these standards, though specific test results or pass/fail outcomes are not detailed. |
| Electromagnetic Compatibility (EMC) | Testing according to IEC 60601-1-2. | "The Electromagnetic Compatibility test report according IEC 60601-1-2 were provided." Similar to electrical safety, the implication is compliance. |
| Mechanical Properties | Testing of endophoto probes according to ISO 9626. | "The mechanical properties of all the endophoto probes were tested according to ISO 9626 and the results confirmed the ability of the device to withstand the forces it will be subjected during normal use." Again, specific quantitative data is absent, but compliance is asserted. |
| Substantial Equivalence | The device must be "substantially equivalent to the predicate devices with regard to design, function, technological characteristics, intended use and performance characteristics." Differences (maximum laser output/wavelength, endophoto probe length, fixed protective filter, cable length of protective filters) must not "affect the intended use or the indication for use or alter the fundamental scientific technology." | The document asserts: "The proposed Endophotocoagulation Delivery Unit shares the substantially equivalent indications for use, the substantially equivalent technological characteristics and substantially equivalent principle of operation as the predicate devices." The document implies that the non-clinical tests (sterility, electrical safety, EMC, mechanical) serve to support this claim by demonstrating that despite minor differences, the new device performs acceptably and safely, similar to the predicate. Specific comparative performance data showing equivalence is not detailed in the summary. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a sample size for a "test set" in the context of clinical validation or performance measurement against a ground truth. The testing described is primarily bench testing for safety, sterility, and mechanical properties.
- Data Provenance: The testing described is non-clinical bench testing. There is no mention of human subject data, and thus no country of origin or retrospective/prospective designation applies in this context, beyond the device manufacturer being Nidek Co. Ltd, Japan, and the official correspondent being Nidek Technologies srl, Italy.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable and not provided in the document. The studies mentioned are non-clinical engineering and materials tests (sterility, electrical safety, mechanical endurance). There is no "test set" requiring expert ground truth or assessment for clinical performance.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. As there's no clinical "test set" with expert assessment, no adjudication method would be needed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not reported in this 510(k) summary. This document focuses on establishing substantial equivalence through non-clinical testing. It does not evaluate human reader performance with or without the AI assistance, as this is not an AI-based device, nor a diagnostic device that requires interpretation by readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone performance study was not done as this is not an AI algorithm but a medical device delivery unit. The testing reported focuses on the physical and functional aspects of the device components.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically understood in diagnostic or AI performance studies (e.g., pathology, expert consensus, outcomes data) is not applicable to the non-clinical testing described. The "ground truth" in this context would be the compliance with quantitative thresholds defined by international standards (e.g., acceptable levels of EO/ECH, mechanical strength thresholds, electrical safety limits).
8. The Sample Size for the Training Set
This information is not applicable and not provided. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. As there is no training set mentioned.
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.