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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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For use to perform endo-ocular laser photocoaguation treatments, with illumination, aspiration and back-wash during surgical interventions. The operating wavelength is 500 nm to 1,100 nm.

This device consists of the following parts already connected to each other: Handpiece with a 20G extension that holds the tip of the fibers and tubes, and guides it inside the eye. 8 ft fiber. A special connector that attaches the laser fiberoptic end to the laser source. A special connector that attaches the illumination fiberoptic end to the illumination source Luer lock that attaches the aspiration/ back-wash tube to the vitrectomy machine A flexible plastic jacket covers the length of the fiberoptics and tubes. Laser fiberoptic provides the function of laser photocoagulation treatment. Illumination fiberoptic (by providing illumination) provides the physician with the view at the surgical site, while aspiration/backwash tube allows suction of intraocular fluids at the surgical site to facilitate the laser photocoagulation.

The provided document is a 510(k) summary for a medical device (OphthalMed 20g SMA Laser/Illumination/Aspiration/Back-wash probes, Model LF100). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed studies with acceptance criteria and precise performance metrics in the way one might expect for a novel device requiring a full premarket approval (PMA) or de novo classification.

Therefore, the study described does not include typical acceptance criteria, a test set with ground truth, or an MRMC study. Instead, it relies on a comparative analysis against existing predicate devices to assert safety and effectiveness.

Here’s a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" defined in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy thresholds) of the new device itself. Instead, the "acceptance criteria" are implicitly that the new device's technological characteristics and performance are "similar" or "identical" to those of the predicate devices.

The "reported device performance" is not quantified with specific numerical values for the new device. Instead, its performance is deemed similar to that of the predicate devices. The safety and effectiveness are "better expressed in the tabulated comparison" by showing these similarities.

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

Not applicable. This type of 510(k) submission does not typically involve a "test set" in the sense of a dataset used to evaluate a diagnostic algorithm. It relies on a comparison of design, materials, and intended use to existing devices. There is no mention of clinical data or studies involving human subjects in this summary for the purpose of demonstrating device performance.

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

Not applicable. No test set or ground truth in this context.

4. Adjudication Method for the Test Set

Not applicable. No test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document does not describe an MRMC study. The comparison is against predicate devices' characteristics, not a study involving human readers with and without AI assistance. The device itself is a surgical tool, not an AI diagnostic algorithm.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Not applicable. The device is a surgical probe, not an algorithm.

7. The Type of Ground Truth Used

Not applicable. There is no mention of a ground truth in the context of device performance data. The "truth" in this submission is the established safety and effectiveness of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a training set for an algorithm.

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

Not applicable. There is no mention of a training set or its ground truth.

Summary of the Study and Acceptance Criteria:

The "study" presented is a comparative analysis demonstrating substantial equivalence to legally marketed predicate devices. The acceptance criteria are that the new device's technological characteristics (indications, target population, design, materials, performance, safety features, etc.) are similar or identical to those of the predicate devices. The document tables these characteristics and directly states "Identical" or "Similar" for each, effectively demonstrating that these criteria are met. This approach avoids the need for new, extensive clinical trials to prove safety and effectiveness, as it leverages the established safety and effectiveness of the predicate devices.

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THIS DEVICE IS INDICATED FOR USE TO PERFER 1 PHOTOCo.9 GULATION TREATHENTS INSUDE THE EYE LASER ાં. ૮ . PANKETINAL PHOTOCOAGULATION, MACULAR TREATHENTS, ENDO PHOTO COLLIATION TO CILIARY PROCESSES, LASER TRABECUPLASTY ) , DURING SURGEAL INTERVENTIONS e g .: TRANS PARS PLANA VITRECTOry Si4 To 532 nm THE OPERATING WAVELENGTH IS

This device consists of the following parts already connected to each other: - Handpiece with either a 20G or a 25G extension that holds the tip of the fiber and guides it inside the eye. - 6 ft fiber. - A special connector that attaches the fiber end to the laser source. - A flexible plastic jacket covers the length of the fiber.

The provided text is a 510(k) summary for the "20g and 25g SMA Laser Fibers". It does not describe an AI/ML device or a study involving acceptance criteria for such a device. Instead, it demonstrates substantial equivalence to a predicate device based on technological characteristics.

Therefore, most of the requested information regarding acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth for training sets is not applicable to this document.

However, I can extract the relevant information from the provided text to demonstrate the comparison made for substantial equivalence.

Device: 20g and 25g SMA Laser Fibers (K021696)
Predicate Device: LightLas 532 Ophthalmic Photocoagulator Laser from Light med Corporation (K010372)

Acceptance Criteria and Reported Device Performance (Comparison for Substantial Equivalence):

The submission demonstrates substantial equivalence by comparing technological characteristics to a predicate device. The "acceptance criteria" here is met if the new device is shown to be "identical" or "similar" to the predicate in key areas, as summarized below.

Since this is a 510(k) for a medical device (laser fiber) and not an AI/ML device, the following points are not applicable and cannot be extracted from the provided text:

2. Sample sizes used for the test set and the data provenance: Not applicable. This is a comparison of engineering characteristics, not a clinical study on a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no concept of "ground truth" established by experts in this type of submission.
4. Adjudication method 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: Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable. This is not an AI/ML device with a training set.
9. How the ground truth for the training set was established: Not applicable.

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