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For Illumination, coagulation, irrigation/aspiration, and tissue manipulation during ophthalmic surgery.

For wide angle illumination of the posterior segment during ophthalmic surgery

The Peregrine Shielded Diffusion Probe is a single use light guide approximately 6' in length consisting of the following: A Universal Aluminum connector at the proximal end to fit into a surgical light source. A polyethylene jacket through which an Acrylic fiber runs. A Delrin Handpiece with a 20 GA Stainless Steel Needle at the distal end. The acrylic fiber, which is polished and affixed at both ends, is tapered and extends past the tip to achieve the diffusion of light. The Stainless Steel Needle is ground at an angle so as to "shield" a portion of the exposed fiber in order to reduce light emitted in the surgeon's eyes. (glare)

The provided text is a 510(k) summary for the Peregrine Shielded Diffusion Probe, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive de novo clinical study data to define acceptance criteria and prove device performance in the way a new drug or novel high-risk device might.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a specific study proving the device meets those criteria in terms of performance metrics like sensitivity, specificity, or reader improvement.

Here's a breakdown of why the information isn't present and what is available:

1. A table of acceptance criteria and the reported device performance:

• Information not available: The document does not define specific "acceptance criteria" for performance metrics in terms of clinical outcomes or diagnostic accuracy. It focuses on demonstrating equivalence to predicate devices (Peregrine Diffusion Light Pipe and Peregrine Wide Angle Light Pipe) in terms of design and intended use.
• Available in document: The "Substantial Equivalence Comparison" table lists design features of the proposed device against two predicate devices. This implies that the 'acceptance criteria' for this type of submission are essentially that the device's characteristics and intended use are similar enough to existing, legally marketed devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Information not available: No test set sample size or data provenance is mentioned because a clinical performance study with such a test set was not presented in this 510(k) summary.

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):

• Information not available: Not applicable, as there is no mention of a test set requiring ground truth established by experts.

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

• Information not available: Not applicable.

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:

• Information not available: This device is a fiber optic light pipe for surgical illumination, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is not relevant or included.

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

• Information not available: Not applicable, as this is a surgical illumination device, not an algorithm.

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

• Information not available: Not applicable, as no clinical performance study requiring ground truth is presented.

8. The sample size for the training set:

• Information not available: Not applicable, as there is no machine learning or AI component to this device that would involve a training set.

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

• Information not available: Not applicable.

What the document does address regarding "acceptance criteria" and "proof":

For a 510(k) submission like this, "acceptance criteria" primarily relate to:

• Substantial Equivalence: The primary "acceptance criterion" is whether the device is substantially equivalent to a predicate device already legally marketed. This is "proven" by providing a comparison of features, materials, and intended use as seen in the "Substantial Equivalence Comparison" table.
• Sterility: The document explicitly states:
  • Acceptance Criteria (Implied): The device must be sterile.
  • Study/Method of Proof: "The method used to validate the sterilization cycle is AAMI Overkill Method." This is the standard method for validating sterilization.
• Intended Use Compatibility: The device's "Indications for Use" (For wide angle illumination of the posterior segment during ophthalmic surgery) are reviewed and deemed acceptable by the FDA (indicated by the FDA's concurrence signature on the "STATEMENT OF INDICATIONS FOR USE" form).

In summary, this 510(k) document demonstrates the device meets the regulatory requirements for market clearance by showing substantial equivalence and addressing basic safety aspects like sterilization, but it does not present a clinical performance study with quantifiable acceptance criteria for typical performance metrics (e.g., sensitivity, specificity) as would be the case for a diagnostic device.

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