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The PHAKOS Disposable Retinal Cryo Probe and Accessories is for use in ophthalmic surgery in cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, and cryo destruction of lash follicles for trichiasis.

The cryoprobe ADAPTER is a mechanical accessory used to adapt the PHAKOS Disposable Retinal Cryo Probe to different cryosurgery generators found on the market; it is connected to the cryoprobe connector on the generator. The rear end piece receiving the cryoprobe is the same for all ADAPTERs; the body varies according to the generator used. The ADAPTER is fitted on the generator in the place of the original cryoprobe, and remains in position, while the PHAKOS Disposable Retinal Cryo Probe is plugged into the universal rear end piece.

The provided text describes a 510(k) premarket notification for the MIRA Adapter, a mechanical accessory used to adapt the PHAKOS Disposable Retinal Cryo Probe to different cryosurgery generators. The submission claims substantial equivalence to predicate devices based on non-clinical testing.

Here's an analysis of the acceptance criteria and the study information as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA letter and the 510(k) summary do not specify numerical performance acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity thresholds) because this is a mechanical adapter, not an AI or diagnostic device with such quantifiable performance metrics. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence in terms of intended use, design, materials, mechanical safety, and performance as compared to predicate devices.

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

The provided documentation does not detail a "test set" in the context of clinical data or AI algorithm evaluation. The non-clinical testing involved "creation of the ice ball." The sample size for this specific test, and the number of repetitions or conditions tested, are not specified.

Data Provenance: This is a mechanical device, and the testing described is non-clinical performance (e.g., mechanical functionality and ice ball creation). Thus, there is no "country of origin of the data" or "retrospective/prospective" label applicable in the usual sense for clinical or AI studies. The tests would have been performed in a laboratory setting.

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

Not applicable. This is a non-clinical evaluation of a mechanical adapter. There is no "ground truth" established by human experts in the context of diagnostic accuracy or AI performance. The ground truth for mechanical performance would be objective measurements of physical properties or functional outcomes (e.g., ice ball size, secure connection).

4. Adjudication Method for the Test Set

Not applicable, as there is no expert-based ground truth or test set requiring adjudication in this context.

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 versus without AI assistance

No. This device is a mechanical adapter, not an AI or diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.

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

No. This is a mechanical device, not an algorithm.

7. The type of ground truth used

For the non-clinical tests (e.g., "creation of the ice ball"), the ground truth would be based on objective physical measurements and engineering specifications, demonstrating that the adapter allows the cryo probe to function as intended (i.e., reliably create an ice ball). This is not "expert consensus, pathology, or outcomes data" in the typical sense.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI/machine learning model, 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.

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The ENDOCULAR VIEWING LENSES AND SILICONE RING family allows visualizations of the retina, the vireous humor, the lens, the iris, the anterior chamber, as well as other ocular structures during surgical procedures or consultation.

The endocular viewing lens is a passive device that is used to view the fundus of the eye by placing it on the cornea.

The "ENDOCULAR VIEWING LENSES AND SILICONE RING" family includes devices comprised of an endocular viewing lens and/or of a cornea support that allows for stabilization of this lens on the eye. This range allows one to view the retina, the vitreous humor, the lens, the iris, the angle of the anterior chamber, as well as other ocular structures during surgical procedures or consultation.

This document is a 510(k) Premarket Notification summary for the "ENDOCULAR VIEWING LENSES AND SILICONE RING" device. Based on the provided text, the device is not an AI/ML medical device and therefore the concepts of acceptance criteria for an AI model, training/test sets, ground truth establishment by experts, adjudication, or MRMC studies, do not apply.

The device is a passive ophthalmic viewing lens classified as a Class II medical device. The 510(k) submission establishes substantial equivalence to legally marketed predicate devices, primarily based on the following:

• Intended Use: The device is used to view ocular structures during surgical procedures or consultation, which is similar to the predicate devices.
• Design: The device includes various types of viewing lenses and a silicone ring, comparable to the predicate devices.
• Materials: The materials used (PMMA, OKP4 Polyester Optical Plastic, silicone) are similar to those used in predicate devices.
• Mechanical Safety and Performance: No specific details are provided on performance metrics, but the claim of substantial equivalence implies comparable safety and performance.

Non-clinical tests performed:

• ISO 10993-5 In vitro cytotoxicity
• ISO 10993-10 Irritation
• ISO 10993-10 Sensitization

Clinical tests:

• No clinical studies were performed. The submission states: "No clinical studies were performed."

Therefore, the request for acceptance criteria and study details related to AI/ML performance is not applicable to this 510(k) submission.

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The PHAKOS Disposable Retinal Cryo Probe and Accessories is for use in ophthalmic surgery in cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, and cryo destruction of lash follicles for trichiasis.

The cryoprobe adapter is a mechanical accessory used to adapt the PHAKOS Disposable Retinal Cryo Probe to different cryosurgery generators found on the market; it is connected to the cryoprobe connector on the generator. The rear end piece receiving the cryoprobe is the same for all adapters; the body varies according to the generator used. The adapter is fitted on the generator in the place of the original cryoprobe, and remains in position, while the PHAKOS Disposable Retinal Cryo Probe is plugged into the universal rear end piece.

This document is a 510(k) premarket notification for a medical device called the "Frigitronics Adapter." It describes the device, its intended use, and demonstrates its substantial equivalence to previously marketed predicate devices.

Based on the provided text, there is no information about a study proving the device meets acceptance criteria related to AI/algorithm performance.

The document states: "No clinical studies were performed" and the "Non-clinical Test Summary" only mentions "creation of the ice ball" and that "The results of these evaluations indicate that the Frigitronics Adapter is equivalent to predicate devices."

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-powered device, as this document pertains to a mechanical adapter and not an AI/algorithm-driven device.

To directly answer your prompt based on the provided text, the following points are relevant:

• 1. A table of acceptance criteria and the reported device performance: Not applicable. The document assesses substantial equivalence based on intended use, design, materials, mechanical safety, and performance (evidenced by ice ball creation), not specific performance metrics against pre-defined quantitative acceptance criteria in the context of an AI/algorithmic output.
• 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. No test set for an AI/algorithm is described.
• 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. No ground truth for an AI/algorithm test set is described.
• 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: Not applicable. No multi-reader study or AI assistance is mentioned.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 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.
• 9. How the ground truth for the training set was established: Not applicable.

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The PHAKOS Disposable Retinal Cryo Probe is for use in ophthalmic surgery in cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataraction, and cryo destruction of lash follicles for trichiasis.

The PHAKOS Disposable Retinal Cryo Probe is a single use item used with cryopexy equipment. It produces an ice ball at the tip of the pencil allowing you to treat the detachment of the retina by welding the tissues together. The ice ball is the result of a specific gas released at a high pressure, N2O or CO2, allowing the welding of the tissues by burn.

The provided text describes a 510(k) premarket notification for the PHAKOS Disposable Retinal Cryo Probe. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on its own performance metrics. Therefore, many of the requested categories for a study proving device performance are not applicable or cannot be extracted from this document directly.

Here's a breakdown of the information that can be extracted and a clear statement where information is not available within the provided text:

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

The document does not explicitly define acceptance criteria as a quantitative benchmark for the PHAKOS Disposable Retinal Cryo Probe's own performance (e.g., a specific ice ball size or temperature achieved in a defined time). Instead, it focuses on demonstrating that its characteristics are identical to a legally marketed predicate device.

Therefore, the "acceptance criteria" are implied to be "being identical to the predicate device in terms of intended use, design, materials used, mechanical safety, and performances." The "reported device performance" is then its similarity to the predicate.

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

This document describes non-clinical bench testing, not a human-subject study with a "test set" in the context of clinical data. The non-clinical tests performed were:

• Operation of adapters for single-use cryodes on different equipment.
• EO residual measurement.
• Pyrogenicity evaluation using the Limulus amebocyte lysate (LAL) assay.

The sample sizes for these bench tests are not specified in the document. The data provenance is also not specified, though the manufacturer (PHAKOS) is based in France.

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 was a non-clinical bench study, not a study involving expert-established ground truth for diagnostic or interpretative performance.

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

Not applicable, as this was not a study requiring adjudication of expert opinions.

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-assisted device, nor was an MRMC study performed.

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

Not applicable. This is a physical medical device (cryo probe), not an algorithm or AI system.

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

For the non-clinical tests, the "ground truth" would be established by standardized laboratory methods and specifications (e.g., maximum allowable endotoxin levels for pyrogenicity, acceptable ranges for EO residuals, functional integrity during operation). The document states the device "meets the recommended maximum endotoxin level," which implies comparison against an established standard.

8. The sample size for the training set

Not applicable, as this is a physical medical device and not a machine learning model.

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

Not applicable, as this is a physical medical device and not a machine learning model.

Summary of Key Findings from the Document:

The PHAKOS Disposable Retinal Cryo Probe underwent non-clinical bench testing to demonstrate its substantial equivalence to its predicate device, the Keeler Cryomaster Probes. The "acceptance criteria" were primarily focused on demonstrating identical characteristics and performance to the predicate device in aspects like indications for use, disposable nature, cryogen type, freeze system, control mechanisms, construction materials, dimensions, and sterilization method.

Specific non-clinical tests included evaluating the operation of adapters, measuring EO residuals, and assessing pyrogenicity using the LAL assay, with the device reportedly meeting recommended maximum endotoxin levels. No clinical studies were performed for this 510(k) submission, and therefore, there are no details on clinical efficacy, human reader performance, or AI-related metrics.

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