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For photocoagulation and illumination during ophthalmic surgery. This device delivers illumination as well as laser energy to target tissue, causing coagulation. Spot size can be varied by altering the distance between the tissue and the probe tip.

Peregrine's 25ga Curved Illuminating Laser Probe is an ophthalmic light and laser delivery device. It consists of glass fiber with PVC jacket, an SMA connector, a Delrin handpiece and a needle set consisting of 304 stainless steel and nitinol. There is also an actylic fiber with PVC jacket and an aluminum illumination connector. Both connectors plug into existing laser and light sources.

The Laser Probe can only be used in combination with a medical laser in the Vis-NIR transmission range of 532nm to 810mm with a maximum power output of 2.5 Watts and that is appropriate for photocoagulation. The light portion of the device is designed for use with the Alcon Constellation Vision System. The Constellation uses a 50 Watt Xenon arc lamp that emits light with an output of 30 lumens within the wavelength range of 400nm to 700mm.

The outer dimension of the glass fiber to be used in the proposed device is 98 microns or about .004 inches, which is about 25% of the size of the glass fiber in Peregrine's predicate device.

The acrylic fiber that will be used has an outer dimension of 254 microns or .01 inches, which is 25% of the size of the acrylic fiber used in the predicate device. The decrease in size of both fibers has created an acceptable device.

Here's a breakdown of the acceptance criteria and study information for the Peregrine 25ga Curved Illuminating Laser Probe, based on the provided text:

Device: Peregrine 25ga Curved Illuminating Laser Probe (PD725.37SA)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly derived from the comparison to the predicate device and the successful completion of performance tests. The goal was to demonstrate substantial equivalence, meaning the new device performs at least as safely and effectively as the predicate.

2. Sample size used for the test set and the data provenance

The document does not explicitly state a "test set" in the context of human data or a specific number of devices tested for each performance characteristic. Instead, it refers to:

• "3 performance tests" to evaluate light output, laser power output, and laser field clarity. The sample size for these tests is not specified.
• "Bend testing" performed on both the existing and proposed designs. The number of samples for bend testing is not specified.
• Biocompatibility testing. The number of material samples tested is not specified.
• Sterilization and shelf-life validation. This would involve a specific number of packages/devices, but the exact count is not given.

The data provenance is Peregrine Surgical Ltd. internal testing. The document does not specify country of origin for test data, nor does it explicitly state if it was retrospective or prospective, though performance and material testing are typically prospective.

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

Not applicable. The document describes engineering and material performance testing rather than studies involving expert human review of medical images or diagnoses. The "ground truth" here is based on measurable physical properties and compliance with established material and manufacturing standards.

4. Adjudication method for the test set

Not applicable. This type of adjudication (e.g., 2+1, 3+1) is relevant for studies where human experts interpret data (like images) and resolve discrepancies. The provided document details technical performance and material testing.

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

Not applicable. This device is a surgical tool (laser probe), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI assistance are not relevant to its evaluation.

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

Yes, in essence, standalone performance tests were done. The "3 performance tests" (light output, laser power output, laser field clarity), "bend testing," and biocompatibility testing represent the standalone performance evaluation of the device itself, without human interpretation in a diagnostic context. The device's function is to transmit laser and light energy, and these tests evaluate that function directly.

7. The type of ground truth used

The ground truth used for this device's evaluation is primarily based on:

• Physical measurements and engineering specifications: Metrics like laser power efficiency, spot size, fiber dimensions, length, weight, etc., are directly measured and compared against the predicate device's established performance parameters.
• Material standards: Biocompatibility is assessed against established biological safety standards. Nitinol's use is justified by its existing approval in other ophthalmic devices and by specific bend testing.
• Sterilization and shelf-life validation standards: Compliance with AAMI Overkill Method according to ISO 11135-1 and residual testing.

8. The sample size for the training set

Not applicable. This device's development and evaluation do not involve machine learning or AI, so there is no "training set."

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

Not applicable. As there is no training set, this question is not relevant.

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For photocoagulation and illumination during ophthalmic surgery. This device delivers illumination as well as laser energy to target tissue, causing coagulation. Spot size can be varied by altering the distance between the tissue and the probe tip.

The 23ga Curved Illuminating Laser Probe is an ophthalmic light and laser delivery device. It consists of glass fiber with PVC jacket, an SMA connector, an acetal handpiece and a needle set consisting of 304 stainless steel and nitinol. There is also an acrylic fiber with PVC jacket and an acetal connector. Both connectors plug into existing laser and light sources.

The device is designed to be an accessory for an Iridex medical laser (cleared under K071687) in the Vis-NIR transmission range of 532 nm to 810 nm with a maximum power output of 2.5 Watts and that is appropriate for photocoagulation. The device can be used with other lasers but they must be FDA approved and also meet the above specifications. The light portion of the device was designed for use with the Bausch & Lomb Stellaris PC light source which is a component of the Bausch & Lomb Stellaris PC Vision Enhancement System (cleared under K101325). The Stellaris PC uses a 75 Watt Xenon arc lamp that emits light with an output of 30 lumens within the wavelength range of 441nm to 665nm (photocoagulation is not applicable to the illumination aspect of the probe).

Here's an analysis of the provided text regarding the acceptance criteria and study for the 23ga Curved Illuminating Laser Probe (K122997).

It's important to note that this 510(k) summary is for a substantially equivalent device, meaning much of the performance evaluation relies on demonstrating equivalence to an already cleared predicate device (Peregrine's Illuminated Laser Probe, K031023) rather than proving de novo safety and effectiveness through extensive clinical trials. Therefore, the information provided isn't as detailed as what might be found for a novel device.

Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for substantial equivalence, the "acceptance criteria" are primarily defined by the performance characteristics of the predicate device. The goal is to show that the new device either meets or performs similarly to the predicate in key areas, or that any differences do not raise new questions of safety or effectiveness.

Study Details

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

   • Test Set Sample Size: Not explicitly stated as a number of "samples" in a traditional clinical study sense. The testing involved comparing parameters of one new device (23ga Curved Illuminating Laser Probe) against one predicate device (PD600.10).
   • Data Provenance: The testing was conducted by the manufacturer, Peregrine Surgical. No information on the country of origin or whether it was retrospective/prospective is provided, but it would have been prospective testing specifically for this 510(k) submission.

2. 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 in the context of this device. This is a comparison of physical and functional characteristics of medical instruments, not an evaluation requiring expert consensus on images or diagnoses. The "ground truth" for performance is established by direct measurement and comparison to the predicate's known performance or accepted engineering standards.
   • The document mentions that "Surgeons understand that light outputs are compromised due to the use of smaller needle/tube gauges," implying a general expert consensus or understanding within the ophthalmic surgical community, but no specific experts were involved in a formal ground truth establishment process for the test set.

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

   • Not applicable. This is not a study requiring adjudication of findings. Performance measurements were objective.

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 is a physical ophthalmic instrument, not an AI-powered diagnostic device, so no MRMC study was performed.

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

   • Not applicable. This is a physical medical device, not an algorithm. Performance tests were done on the device itself.

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

   • The "ground truth" for demonstrating substantial equivalence was the measured performance of the legally marketed predicate device (PD600.10) and established engineering/biocompatibility standards. For biocompatibility, testing results demonstrating 100% biocompatibility according to recognized standards served as the ground truth. For sterility, the specified SAL and validation method (AAMI Overkill, ISO 11135-1) serve as the ground truth.

7. The sample size for the training set

   • Not applicable. This is a physical device, not an AI-based system requiring a training set.

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

   • Not applicable given that no training set was used.

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