(90 days)
The Meditec Link is intended to be attached to slit lamps to allow green laser energy light to be delivered to the slit lamp via fiber optic.
Once the Meditec Link is attached to a slit lamp the user should refer to the User's Manual or Operator's Manual provided with the laser for clinical use information regarding the laser and for additional use instructions or information.
The Meditec Link is presently designed for attachment to Zeiss Slit Lamps or to Haag Streit 900 BQ and 900 BM Slit Lamps.
The Meditec Link is an adapter which attaches to slit lamps, e.g., Zeiss Slit Lamps and Haag Streit 900 BQ and 900 BM Slit Lamps, to allow green laser light, to be delivered to the slit lamps. The laser light (532 nm) can then be directed to selected sites within the eye by an ophthalmologist.
Here's an analysis of the provided text regarding the Meditec Link device, addressing your specific questions.
Based on the provided documentation, the Meditec Link is an adapter for ophthalmic slit lamps, designed to deliver green laser light (532 nm) via fiber optic for use by an ophthalmologist.
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for Substantial Equivalence:
The documentation states that the Meditec Link is considered substantially equivalent to its predicate device, the Infinitech Multi-Spot Slit Lamp laser Adapter. This means the acceptance criteria are primarily based on demonstrating:
- Same Intended Use: The device must have the same fundamental purpose as the predicate.
- Same Technological Characteristics: The device's design and operating principles must be similar to the predicate.
- No new questions of safety and effectiveness: The device should not introduce new risks or effectiveness concerns compared to the predicate.
Given these overarching criteria, the specific performance aspects are implicitly tied to the predicate device's established performance. The submission explicitly states: "The specifications and intended uses of the Meditec Link are the same or very similar to those of the claimed predicate devices. There are no significant differences between the Meditec Link in design or intended use and the claimed predicates under conditions of intended use of these accessories to ophthalmic lasers."
Reported Device Performance:
| Acceptance Criteria Category | Specific Criterion | Reported Meditec Link Performance |
|---|---|---|
| Intended Use Equivalence | Intended to be attached to slit lamps (e.g., Zeiss, Haag Streit 900 BQ/BM) to allow green laser energy light (532 nm) to be delivered to the slit lamp via fiber optic for directing to selected sites within the eye by an ophthalmologist. | The Meditec Link's intended use is stated to be the same or very similar to the predicate: "The Meditec Link is intended to be attached to slit lamps to allow green laser energy light to be delivered to the slit lamp via fiber optic... to be directed to selected sites within the eye by an ophthalmologist." |
| Technological Characteristics Equivalence | Design and fundamental operating principles of the adapter for integrating a green laser with slit lamps. | The Meditec Link's specifications and design are stated to be the same or very similar to the predicate. No significant differences in design were identified. |
| Safety and Effectiveness Equivalence (Risk) | No new questions of safety or effectiveness are raised. This implies that the device does not introduce new failure modes, optical hazards, or mechanical instability that would make it less safe or effective than the predicate. | The submission concludes: "Aesculap-Meditec believes that the Meditec Link is substantially equivalent to legally marketed predicate devices." This implies that no new questions of safety and effectiveness were raised. |
| Clinical Performance (if applicable) | The predicate device has demonstrated clinical utility in ophthalmic laser procedures. | The document explicitly states: "Because of this, performance data were not required." The substantial equivalence claim is based on similarity to the predicate, not new clinical trials. |
Study that Proves the Device Meets Acceptance Criteria:
The documentation does not describe a detailed study with specific acceptance criteria beyond the substantial equivalence comparison. The conclusion is based on a comparative analysis of the device's design, specifications, and intended use against a legally marketed predicate device (Infinitech Multi-Spot Slit Lamp laser Adapter).
The key statement is from the "Performance Data" section: "The specifications and intended uses of the Meditec Link are the same or very similar to those of the claimed predicate devices. There are no significant differences between the Meditec Link in design or intended use and the claimed predicates under conditions of intended use of these accessories to ophthalmic lasers. Because of this, performance data were not required."
This indicates that a formal efficacy or safety study with acceptance criteria, as one might expect for a novel device, was not conducted or submitted because the device was deemed sufficiently similar to an already approved device. The "study" here is essentially the 510(k) substantial equivalence determination process itself, where the manufacturer provides evidence (in the form of descriptions and comparisons) to establish similarity to a predicate.
Additional Requested Information:
Given that the submission asserts "performance data were not required" due to substantial equivalence, most of the following questions cannot be answered as no specific performance study was conducted.
- Sample size used for the test set and the data provenance: Not applicable. No test set or performance study was conducted.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set was performed.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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. The device is a physical adapter for a laser system, not an AI or imaging diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical accessory, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for the submission is the regulatory acceptance and established performance of the legally marketed predicate device.
- The sample size for the training set: Not applicable. The device is not a machine learning model, so there is no "training set."
- How the ground truth for the training set was established: Not applicable.
§ 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.