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The intended use of the device is to illuminate the eye during anterior and posterior vitreoretinal surgery and to provide photocoagulation when used with the appropriate commercially available laser light source and probe.

The intended use of the device is to illuminate the eye during anterior and posterior vitreoretinal surgery and to provide photocoagulation when used with the appropriate commercially available laser light source and probe.

Acceptance Criteria and Study Details for Synergetics Synerlight FiberOptic Lightsource

The provided document describes the 510(k) summary and FDA clearance letter for the Synergetics Synerlight FiberOptic Lightsource. This submission is for substantial equivalence to a predicate device, K964005.

Based on the provided information, there are no explicit acceptance criteria or detailed study results demonstrating device performance against such criteria in the manner typically expected for AI/ML-based medical devices.

Instead, the submission relies on the concept of substantial equivalence to a predicate device already on the market. This means the device is considered safe and effective because it is as safe and effective as a legally marketed device, and does not raise different questions of safety and effectiveness.

Here’s a breakdown of the information that is available and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document does not provide specific, measurable acceptance criteria in terms of clinical or technical performance parameters for the device itself (e.g., minimum lumen output, color temperature range, specific photocoagulation effectiveness). The primary "acceptance criterion" from an FDA 510(k) perspective is demonstrated substantial equivalence to a legally marketed predicate device. The "reported device performance" is a general statement of meeting this substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable/not provided. This type of information is typically associated with studies involving data analysis, such as image analysis for AI devices. The submission for a fiberoptic light source would not involve a "test set" of patient data in this manner.
• Data Provenance: Not applicable/not provided. The submission focuses on the performance characteristics of the hardware device itself, likely through engineering and functional testing, rather than analysis of patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable/not provided. Ground truth establishment with experts is relevant for diagnostic devices that interpret clinical data. For a fiberoptic light source, the "ground truth" would be objective measurement of its physical properties and functionality.

4. Adjudication Method for the Test Set

• Not applicable/not provided. This typically refers to resolving discrepancies in expert interpretations, which is not relevant for a hardware device like a light source.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. MRMC studies are used to assess the impact of a diagnostic tool (often AI-assisted) on human reader performance, usually in interpreting medical images or data. This is not relevant for a light source.
• Effect Size of Human Readers with vs. without AI assistance: Not applicable.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a hardware component and does not operate as a standalone algorithm. Its function is to illuminate, and potentially provide photocoagulation when used with a laser.

7. The Type of Ground Truth Used

• Implicit Ground Truth: For a fiberoptic light source, the "ground truth" would implicitly be based on established engineering standards for light output, spectral characteristics, safety (e.g., heat generation, electrical safety), and compatibility with other surgical equipment. These would be objectively measured and compared to the predicate device.
• The document does not specify the exact technical parameters or standards used for comparison, but states unequivocally that "Testing demonstrated that the subject device is substantially equivalent to the predicate device."

8. The Sample Size for the Training Set

• Not applicable. This device is a hardware product, not an AI/ML algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set was Established

• Not applicable. As there is no training set, there is no ground truth for it to be established.

Summary of Approach for This Device:

The Synergetics Synerlight FiberOptic Lightsource gained FDA clearance through the 510(k) pathway by demonstrating substantial equivalence to an existing predicate device (K964005). The "study" mentioned, "Testing demonstrated that the subject device is substantially equivalent to the predicate device," refers to internal engineering and functional testing. This testing would have assessed that the new device has similar technological characteristics (e.g., light output, spectral range, safety features, intended use, materials) or, if different, that those differences do not raise new questions of safety and effectiveness.

The documentation does not contain the detailed performance metrics, clinical study designs, or expert review processes that would be typical for more complex diagnostic or AI-driven devices.

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The Synergetics Fiber Optic light Source is indicated for use during anterior and posterior vitreoretinal surgery to illuminate the eye.

The Synergetics lightsource is a stand alone arc-lamp based lightsource that incorporates a standard connector mount used by most endoilluminators. It has a brightness control, accessory filter control and lamp life timer display.

Here's an analysis of the provided text regarding the Synergetics, Inc. Synerlight Fiber Optic Lightsource, focusing on acceptance criteria and the study proving its performance.

It's important to note that this document is a 510(k) submission, which primarily aims to demonstrate substantial equivalence to a predicate device, rather than a clinical study establishing novel safety and effectiveness. Therefore, some of the requested information, particularly regarding formal acceptance criteria with specific thresholds, detailed study designs, and human reader performance comparisons, is not explicitly present in the provided text. The "study" described herein is a comparison between the new device and a predicate device.

Acceptance Criteria and Device Performance

The acceptance criteria for the Synergetics Synerlight Fiber Optic Lightsource are implicitly derived from its comparison to the predicate device, the Dutch Ophthalmic, USA Xenon Illumination System (D.O.R.C.). The core acceptance criterion is substantial equivalence in intended use, safety, and effectiveness. The reported device performance is measured against that of the predicate device across various parameters.

Table of Acceptance Criteria and Reported Device Performance

Study Details (Substantial Equivalence Comparison)

The "study" presented here is a comparison against a predicate device to establish substantial equivalence under the 510(k) pathway, not a traditional clinical trial or performance study with acceptance criteria in the sense of predefined statistical thresholds for device accuracy or efficacy.

1. Sample Size used for the test set and the data provenance:

   • Test Set: No explicit "test set" in the sense of patient data is used. The comparison is between the Synergetics Synerlight Fiber Optic Lightsource (new device) and the D.O.R.C. Xenon Illumination System (predicate device).
   • Data Provenance: The data appears to be a mix of manufacturer specifications (for both devices) and internal testing conducted by Tayman Medical (for D.O.R.C.'s visible light output) and Synergetics (for its own device's power output and IR output). It is a retrospective analysis and comparison of device specifications and internal lab measurements. The country of origin of the data is not specified beyond the manufacturers' locations (USA for Tayman Medical/Synergetics, and USA for D.O.R.C.).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This type of expert evaluation is not mentioned or relevant for a 510(k) substantial equivalence submission, which relies on objective device specifications and comparative measurements rather than expert clinical judgment on individual cases.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. There is no expert adjudication of imaging or clinical findings. The comparison is based on technical specifications and measured output.

4. 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 device is a light source for surgery, not an AI or imaging diagnostic tool. An MRMC study is not relevant here.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is not an AI algorithm. The device's "standalone" performance is described through its technical specifications and measured outputs as compared to the predicate.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this submission is the technical specifications and measured performance of the predicate device, as stated in its own documentation or measured by the applicant, and established industry standards for medical device safety (e.g., phototoxicity concerns regarding UV and IR light). The goal is to show the new device is as safe and effective, or safer/more effective where justified and controlled (e.g., reduced UV/IR output, higher controlled visible light).

7. The sample size for the training set:

   • Not applicable. This device is not developed using machine learning, so there is no concept of a "training set."

8. How the ground truth for the training set was established:

   • Not applicable for the same reason as above.

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