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The Syntec, Inc. True Light End Irrigating Endoilluminator is used to illuminate with visible spectrum light the intraocular portion of the eye for improved visualization and to provide irrigation during vitreo-retinal surgery.

The End Irrigating Endoilluminator comprises of five basic components. The handpiece tube. The fiberoptic handle. The fiber optic cable sheath and the cable connector.

The provided text is a 510(k) premarket notification for the Syntec, Inc., True Light End Irrigating Endoilluminator. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a study with performance metrics in the way a novel AI algorithm might.

Therefore, the requested information elements (1-9) which are typically associated with testing and validation of AI/ML-based devices or novel devices with performance claims, are not applicable in this context.

Here's why and what information is available in the document:

• Type of Submission: This is a 510(k) for a medical device (an ophthalmic endoilluminator) that is seeking to demonstrate substantial equivalence to a legally marketed predicate device (Grieshaber Disposable End Irrigating Light Pipe).
• Focus of 510(k): The core of a 510(k) is to show that the new device has the same intended use, technological characteristics, and safety and effectiveness as a predicate device. It does not typically involve proving new performance thresholds or conducting extensive clinical trials with acceptance criteria in the manner requested for AI or highly novel devices.
• "Acceptance Criteria" in this context: For this device, "acceptance" is primarily based on demonstrating substantial equivalence, meaning the device performs similarly to or no worse than the predicate device. The "criteria" are therefore the similarities in intended use, design, materials, and lack of new safety/effectiveness questions.

Information applicable from the document (but not directly answering the AI-centric questions):

• Device Name: Syntec, Inc., True Light End Irrigating Endoilluminator
• Predicate Device: Grieshaber Disposable End Irrigating Light Pipe (K884043)
• Intended Use (for both new and predicate device): To illuminate with visible spectrum light the intraocular portion of the eye for improved visualization and to provide irrigation during vitreo-retinal surgery.
• Similarities noted: Same clinical purpose, similar design, same materials (except for a zinc connector on the Syntec design), materials meet US Pharmacopoeia Class VI criteria and are widely used, device is biocompatible, sterilized using ethylene oxide (validated by overkill method), and the light output intensity and spot size are the same as the predicate device.
• Differences noted: "The only device differences are cosmetic." (This strongly supports substantial equivalence).

In summary, none of the specific questions regarding acceptance criteria tables, sample sizes, ground truth, expert adjudication, or MRMC studies are addressed or relevant to this 510(k) submission document. The document aims to demonstrate equivalence, not to establish new performance criteria through a study.

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The Syntec, Inc. True Light Endoilluminator with Pick is used to illuminate with visible spectrum light the intra ocular portion of the eye for improved visualization and manipulation during vitreo-retinal surgery.

The Endoilluminator with Pick is comprised of five basic components: the handpiece handle, the handpiece tube, the fiberoptic cable, the fiber optic cable sheath and the connector.

The provided text describes the Syntec, Inc. True Light Endoilluminator with Pick, a device cleared through the 510(k) pathway. This pathway relies on demonstrating "substantial equivalence" to a predicate device already legally marketed, rather than extensive clinical studies proving new safety and effectiveness. Therefore, the information requested about acceptance criteria, detailed performance metrics, sample sizes for testing and training, expert ground truth, adjudication methods, MRMC studies, and standalone performance studies is largely not applicable or not provided within this type of submission.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable / Not provided. The 510(k) submission for this device does not involve a "test set" in the sense of a clinical performance study with human subjects or a defined dataset. Substantial equivalence is demonstrated through comparison of technical characteristics and intended use to a legally marketed predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

• Not applicable / Not provided. Ground truth, in this context, refers to a consensus or gold standard used to evaluate a diagnostic or AI device's performance. Since this is a surgical illumination/manipulation tool cleared via substantial equivalence, such a "ground truth" and expert panel for a test set is not part of the submission described.

4. Adjudication Method for the Test Set:

• Not applicable / Not provided. No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• No. An MRMC study is typically performed for diagnostic devices to assess the impact of AI assistance on human reader performance. This device is an illumination and manipulation tool, not a diagnostic AI system, and no such study is mentioned.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:

• No. This device is a physical surgical tool and does not employ an algorithm that would have a "standalone" performance.

7. The Type of Ground Truth Used:

• Not applicable / Not provided in the traditional sense. The "ground truth" for this 510(k) submission relies on the established safety and effectiveness of the predicate devices:

  • Grieshaber Disposable Standard Micro Lite Pipe with Pic (K875004)
  • Gamp & Associates Disposable Fiberoptic Endoilluminator with Pick

  The Syntec device demonstrates substantial equivalence by showing that its materials, design (functionally), intended use, and key performance characteristics (like light output) are the same or very similar to these legally marketed predicates.

8. The Sample Size for the Training Set:

• Not applicable / Not provided. As this is not an AI/ML device, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable / Not provided. (See point 8).

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