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The Ophthalmed Bending Laser Probes (Models A207000, and A307000) are indicated for performing laser endophotocoagulation in the posterior segment of the eye during vitreoretinal surgery at an operating wavelength range from 500 to 1100 nm.

This laser probe is made out of 8ft fiberoptic, terminated on one end with Alcon compatible (SMA905) laser connector, and on another side with a handpiece for holding and manipulation during surgery. For protection against damages, a flexible plastic jacket covers the length of the fiber. The handpiece is terminated by a proximal stainless steel tubing that is 20, 23 or 25 gauge in size, and ending with a distal pre-curved PEEK memory tube that can change angle when activated by the sliding button on the handle side. When the sliding button on the handle is advanced, an internal straightening tube advances into the distal pre-curved PEEK memory tube, thus causing a reduction of the angle of the pre-curved PEEK memory tube, down to zero degrees at the maximum sliding position, allowing the selection of the desired angle during surgery. The maximum angle is 55 degrees for 20g and 23g, and 40 degrees for 25g. This device allows to transmit laser energy from the laser source to the surgical site, facilitated by the aiming beam that is provided by the laser source. This device does not provide illumination and should not be used to illuminate the surgical site.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Ophthalmed Bending Laser Probes.

Based on the provided 510(k) Summary for the Ophthalmed Bending Laser Probes (K142830), the device is a laser probe designed for endophotocoagulation in the posterior segment of the eye. The study supporting its substantial equivalence is primarily focused on bench testing rather than clinical or AI-centric performance. Therefore, many of the requested elements for AI/clinical studies (like sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, and standalone performance) are not applicable to this type of device and submission.

The acceptance criteria are established through comparison with predicate devices and demonstrated through various physical and performance tests.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly derived from its equivalence to predicate devices, particularly K021696 and K113857, in terms of various physical and performance characteristics. The device is expected to perform comparably in key metrics.

Study Information (as applicable to a non-AI/clinical device)

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

   • Test Set Sample Size: For mechanical and acoustic testing, three 20g, three 23g, and three 25g sterile probes (a total of 9 devices) of the Ophthalmed Bending Laser Probes (K142830) were used. The document also refers to testing "same laser probes (K021696, K113857 and K142830)" for spot size and energy distribution tests, implying predicate devices were tested alongside the proposed device for comparison.
   • Data Provenance: The studies were conducted internally or by external labs, as indicated by "internal and external" tests and references to GLP studies for biocompatibility. The data is thus prospective, proprietary to Ophthalmed LLC, and not tied to specific countries beyond the manufacturer's location (USA).

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

   • Not Applicable. This is a bench test and performance verification study for a physical device, not an AI or diagnostic tool needing expert ground truth. The "ground truth" is defined by established engineering parameters, standards (e.g., ISO 10993), and measurements from laboratory equipment.

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

   • None. Adjudication methods are relevant for subjective assessments, particularly in clinical or image-based diagnostic studies. These tests involve objective physical measurements and comparisons to defined performance targets or predicate device performance.

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 surgical instrument (laser probe), not an AI-assisted diagnostic or decision-making tool that involves human readers/interpreters.

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

   • Not Applicable. This is not an algorithm or AI device. Its performance is inherent to its physical and functional characteristics.

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

   • The "ground truth" for this submission consists of objective physical measurements and standard compliance. For example, laser transmission rates are measured directly, bending angles are measured in degrees, and biocompatibility is confirmed through standardized laboratory tests (Cytotoxicity, Irritation, Sensitization) following ISO 10993. The performance of predicate devices also serves as a comparative "ground truth" to establish substantial equivalence.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/machine learning device; there is no training set.

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

   • Not Applicable. As there is no training set for an AI model, this question is not relevant.

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Revolver Laser Probes, Revolver Illuminated Laser Probes & Revolver Illuminated Probes are intended for use in vitreoretinal surgery to perform endo-ocular laser photocoagulation treatments.

The Revolver Laser Probes can only be used with a medical laser at operating wavelengths of 500nm to 900mm. The Revolver assemblies containing illumination should only be used with the light wavelength range of 425nm to 700nm.

The Katalyst Revolver Laser Probes are cables made out of one fiber optic (Single-Use), one laser adapter(Reusable), and one handle (Reusable) for surgeon manipulation, metal tubing extending from the handle which penetrates into the surgical site and protective sheath over the fiber.

The fiber for laser transmission is made out of glass, and is restricted for use within the wavelength range of 500nm to 900nm.

The fiber for illumination transmission is made out of either glass or plastic.

The illumination fiber (glass or plastic) is between 100 and 750 microns in size (measure based on the core diameter). The laser fiber (glass) is between 150 and 300 microns in size (measure based on the core diameter).

The tubing is provided in four different variations are referred to as straight, Curved, Flex-Curved, Steerable and Articulating. The configuration is chosen based on the surgeon requirements. The total length of the device is 8-10 feet.

In case of laser and illumination functionalities provided by the same probe, the common protective sheath runs for 1-2 feet, while both branches run for the remainder of the 8-10 feet with each branch having its own protective sheath and each branch ending with its own adapter. The same tubing will then hold within its internal diameter the laser fiber and the illumination fiber.

The Revolver Laser Probes can only be used with a medical laser at an operating wavelength range of 500nm to 900nm. The Revolver Illumination Probes can only be used with the light wavelength range of 425nm to 700nm.

This document is a 510(k) summary for the Katalyst Revolver Laser Probes, Revolver Illuminated Laser Probes, and Revolver Illuminated Probes. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a comprehensive clinical study with detailed acceptance criteria and performance data as might be found in a PMA.

Therefore, the information required to fully answer your request regarding acceptance criteria and a study proving the device meets those criteria is not explicitly present in the provided text in the typical format of a clinical trial report. The document describes bench testing and biocompatibility testing to support substantial equivalence, but not a study designed to meet specific performance "acceptance criteria" as you've requested for an AI/device performance.

However, I can extract the relevant information and present it in a way that aligns with your request as much as possible, interpreting "acceptance criteria" as the performance specifications and "study" as the testing performed for substantial equivalence.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance for Katalyst Revolver Laser Probes, Revolver Illuminated Laser Probes & Revolver Illuminated Probes

The provided document describes substantial equivalence testing for a medical device rather than a standalone performance study with explicit acceptance criteria for diagnostic accuracy, sensitivity, or specificity. The "acceptance criteria" are implicitly met by demonstrating that the new device performs comparably to the predicate device and adheres to relevant standards. The "study" mentioned is primarily a series of bench tests and biocompatibility assessments designed to support this substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

As explicit acceptance criteria with numerical targets (e.g., minimum sensitivity, maximum false positive rate) are not stated for a diagnostic or AI device, I will use the performance specifications and comparison to the predicate device as the "acceptance criteria" and "reported device performance," respectively.

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

• Sample Size: Not explicitly stated as a number of distinct devices tested for each performance characteristic. The testing appears to have been done on representative samples of the Katalyst Revolver Probes and predicate devices for comparison.
• Data Provenance: The data comes from bench testing performed by the manufacturer (Katalyst Surgical, LLC) and specialized labs (e.g., Toxikon, Inc. for biocompatibility). The testing is prospective in the sense that it was conducted specifically to support this 510(k) submission. No information about country of origin of the data beyond the name of the testing labs is provided.

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

• This device is a surgical instrument (laser probe/illuminated probe), not a diagnostic AI device requiring expert-established ground truth. Therefore, this information is not applicable to this 510(k) submission. The performance testing focuses on physical and operational characteristics and comparison to a predicate, not diagnostic accuracy.

4. Adjudication method for the test set

• Not applicable as this is not a diagnostic device requiring expert adjudication of results. Performance is measured against physical specifications and direct comparison.

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, not an AI-assisted diagnostic or interpretative system.

6. 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.

7. The type of ground truth used

• The "ground truth" for this type of device is primarily defined by engineering specifications, established industry standards (e.g., ISO, ASTM), and the performance characteristics of the legally marketed predicate devices. For biocompatibility, the ground truth is defined by the requirements of ISO 10993.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

• Not applicable. This is a physical medical device, not an AI model that requires a training set.

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