Search Results

For wide angle illumination of the posterior segment during ophthalmic surgery

The Peregrine Tapered 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 provided text is a 510(k) Premarket Notification summary for the Peregrine Tapered Diffusion Probe. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through clinical studies in the way a new, high-risk device might.

Therefore, the document does not contain the information requested regarding:

• A table of acceptance criteria and reported device performance: The submission focuses on comparing physical characteristics and indications for use with predicate devices.
• Sample size and data provenance for a test set: No test set for performance evaluation is described.
• Number and qualifications of experts for ground truth, adjudication methods: These are relevant for studies establishing clinical performance, which this document does not detail.
• Multi-reader multi-case (MRMC) comparative effectiveness study: This is not mentioned as part of the 510(k) submission process for this device.
• Standalone algorithm performance: This is a manual device, not an algorithm.
• Type of ground truth used: Not applicable in this context.
• Sample size for the training set, how training set ground truth was established: Not applicable, as this is not an AI/ML device or a study involving training data.

The relevant information from the document is related to sterilization validation, which is the only aspect where "acceptance criteria" and a "study" (validation method) are explicitly mentioned:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document states a "method used to validate the sterilization cycle is AAMI Overkill Method", but does not provide details on sample size for this validation or its provenance.

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)
Not applicable. This is not a study requiring expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
No, an MRMC study was not done. This is a medical device, not an AI/ML diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a manual surgical instrument.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For sterility, the 'ground truth' is successful sterilization as defined by the AAMI Overkill Method, which is a recognized standard for sterilization validation.

8. The sample size for the training set
Not applicable. This is not an AI/ML device or a study involving a training set.

9. How the ground truth for the training set was established
Not applicable.

Ask a specific question about this device