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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 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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The D.O.R.C. Disposable Cryo Probe is intended for use in combination with the Cryostar Cryosurgical System to perform ophthalmic surgery of the posterior segments including cryopexy for retinal detachment, glaucoma, cataract extraction, trichiasis, and retionopathy of prematurity.

The D.O.R.C. Disposable Cryo Probe is a single-use, handheld medical device intended for use in combination with the Cryostar Cryosurgical System to perform ophthalmic surgery. When the foot pedal of the CryoStar Console is pressed, high pressure gas (CO2 or N2O) is supplied via a small aperture to target tissue.

Here's a breakdown of the acceptance criteria and the study information for the D.O.R.C. Disposable Cryo Probe, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample size (number of probes tested) for the freeze and defrost performance tests. It refers to the "Disposable Cryo Probe (1540.D)" and "Reusable Cryoprobe (1540)" generically, indicating these were the devices tested.

Data Provenance: The studies were laboratory (bench) performance tests, conducted internally by the manufacturer (D.O.R.C. Dutch Ophthalmic Research Center International B.V.). There is no indication of country of origin of the data beyond the manufacturer's location in The Netherlands. The studies are prospective in the sense that they were conducted for the purpose of this 510(k) submission.

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

Not applicable. This device is a surgical instrument. The performance testing (freeze/defrost rate) involved objective measurements (ice ball diameter, time to release) rather than subjective assessment requiring expert interpretation or "ground truth" to be established by experts.

4. Adjudication Method for the Test Set

Not applicable. As the performance tests involved objective measurements, there was no need for adjudication involving human experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is typically relevant for interpretative devices (e.g., AI for image diagnosis) where human readers' performance with and without AI assistance is compared. The D.O.R.C. Disposable Cryo Probe is a surgical tool, and its performance is evaluated through objective physical parameters.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done in the sense that the performance of the device itself (the D.O.R.C. Disposable Cryo Probe) was evaluated objectively through laboratory (bench) tests without human intervention as part of the primary measurements (freeze and defrost rates). The study directly measured the physical output (ice ball size, defrost time) of the probe when operated with the Cryostar system.

7. Type of Ground Truth Used

The "ground truth" for the performance tests was based on objective physical measurements rather than clinical outcomes, pathology, or expert consensus.

• Freeze Performance: The ground truth was the measured diameter of the ice ball (in mm).
• Defrost Performance: The ground truth was the measured time (in seconds) for the ice ball to release.

8. Sample Size for the Training Set

Not applicable. This device is a physical surgical tool and does not employ a machine learning algorithm or AI that requires a "training set" of data.

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

Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth to be established for it.

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The Keeler Cryomatic System and probes are for use in ophthalmic surgery such as cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, cryo destruction of lash follicles for trichiasis and treatment of retinopathy of prematurity (ROP).

The Cryomatic MKII console is a self-contained system. The console consists of a rigid PU enclosure, housing the principle subsystems, switch mode power supply, controller PCB and pneumatic control module. On the front of the console is an LCD screen and membrane key panel. The console provides the connection point for the range of probe (reusable and disposable), footswitch, mains electricity, gas supply and scavenging system.

There is a variety of Keeler Re-usable Cryomatic Probes whose stainless tips are shaped depending on surgical application. The plastic handle is permanently connected to flexible pressure hose and integral connector, which connects to Cryomatic MKII Console.

The Keeler Disposable Cryo Probe comprises a stainless steel stem with a metal handle connected to a 2m long bi-lumen high-pressure plastic hose contained within a protective outer tube and terminated with a customdesigned plastic connector for insertion into the Cryomatic MKII console.

Here's a breakdown of the acceptance criteria and study information for the Keeler Cryomatic MKII System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state specific sample sizes for each verification test. It refers to "verification tests" and "all tests," implying a comprehensive evaluation.

• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given that Keeler Instruments Inc. is based in Broomall, PA, USA, and the 510(k) is submitted to the FDA, it is highly probable that the testing was conducted in a manner consistent with US regulatory requirements for medical devices. The nature of the modifications (simplification of a coupling mechanism) suggests bench testing and internal validation rather than clinical trials with patient data.

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

The document does not mention the use of experts to establish "ground truth" in the context of diagnostic accuracy. This submission is for a modification to an existing surgical system, not a diagnostic imaging device that requires expert interpretation. The "ground truth" for this device's performance would be established through engineering and performance testing against predefined specifications and recognized standards.

4. Adjudication Method for the Test Set

Not applicable. As described in point 3, this is a modification to a surgical device, not a diagnostic AI system requiring adjudication of expert interpretations.

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

No. An MRMC comparative effectiveness study is not mentioned and would not be relevant for this type of device modification. This device is a surgical instrument, not an assistive technology for diagnostic interpretation.

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

Not explicitly applicable in the context of a "standalone algorithm." The device itself functions as a "standalone" surgical tool in that it performs its intended function without requiring human input beyond operating it. The "verification tests" described are essentially standalone performance evaluations of the modified hardware and associated software.

7. The Type of Ground Truth Used

The "ground truth" for this device modification is based on:

• Engineering Specifications: The device's performance (probe temperature, iceball growth, defrost, tractive power) was measured against established specifications for the predicate device and the new design.
• Safety Standards: Compliance with recognized international standards (IEC 60601-1 for electrical safety, IEC 60601-1-2 for electromagnetic compatibility).
• Sterilization Validation: Specific protocols and measurements to ensure the re-usable probes could be adequately sterilized according to defined parameters.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for this device would be its design, engineering tolerances, and manufacturing processes.

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

Not applicable for the same reasons as point 8.

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The Keeler Cryomatic System and probes are for use in ophthalmic surgery in cryopexy procedures in refractory glaucoma, for retinal detachment, cryo destruction, cataract extraction, cryo destruction of lash follicles, extraction of fragments within the eye, and treatment of retinopathy of prematurity (ROP).

Cryomatic System and Probes comprising of: a) Cryomatic Console b) Cryomatic Probes

This looks like a 510(k) premarket notification for a medical device. Based on the provided text, there's no information about a study with acceptance criteria and device performance as typically understood for AI/ML or diagnostic devices.

The submission is for the Cryomatic System and Probes, which is an ophthalmic cryo system. This device is classified as a Class II cryogenic surgical device.

The core of this 510(k) submission is to demonstrate substantial equivalence to legally marketed predicate devices, which are identified as:

• K992954 Keeler Cryomaster and Probes
• K874555 Keeler ACU 22 XT Ophthalmic Cryo unit.

The substantial equivalence is based on "similarity of the subject device to the predicate devices in intended use, materials, design and principles of operation."

Therefore, there isn't a "study" in the sense of a clinical trial or performance evaluation with specific acceptance criteria as you've outlined for diagnostic or AI/ML devices. Instead, the "proof" the device meets acceptance criteria (i.e., being safe and effective for its indicated use) is established by its similarity to already approved devices.

To directly answer your questions based only on the provided text:

1. Table of acceptance criteria and the reported device performance: Not applicable. The submission focuses on substantial equivalence to predicate devices, not performance against specific numerical acceptance criteria.
2. Sample sized used for the test set and the data provenance: Not applicable. There's no test set described for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is mentioned.
4. Adjudication method: 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-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
7. The type of ground truth used: 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.

In summary, the provided document is a 510(k) submission for a surgical instrument (an ophthalmic cryo system) seeking clearance based on substantial equivalence to existing devices, not unique performance data from a new clinical study.

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The D.O.R.C. Harmony CryoStar Cryosurgical System is a surgical system for ophthalmic surgery intended for use in surgery of the posterior segment or anterior segment including cryopexy for retinal detachment, glaucoma, cataract extraction, trichiasis, and retinopathy of prematurity.

The D.O.R.C. CryoStar Cryosurgical System consists of a cryogen gas bottle, a console, an ophthalmic probe, a footswitch and necessary interconnections. The console controls delivery of the gas to the probe. It also processes signals from the footswitch, enabling the probe to freeze and defrost.

This is a 510(k) premarket notification for a medical device called the D.O.R.C. CryoStar Cryosurgical System. It claims substantial equivalence to predicate devices, and therefore no clinical study was performed.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The provided document is a 510(k) submission, not a study report. The "study" that proves the device meets the acceptance criteria is a demonstration of substantial equivalence to predicate devices. This means the manufacturer presented evidence that the D.O.R.C. CryoStar Cryosurgical System has the same intended use and similar technological characteristics to previously cleared devices (D.O.R.C. Cryo 1500 and Keeler Cryo Master) and that any differences do not raise new questions of safety or effectiveness.

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

• Sample Size for Test Set: Not applicable. This is not a clinical study involving a test set of data. The submission relies on a comparison of technical specifications and intended use.
• Data Provenance: Not applicable. The data is descriptive information about the device itself and a comparison to predicate devices, not data collected from a clinical setting.

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

Not applicable. No ground truth was established by experts for a test set in this context. The determination of substantial equivalence is made by the FDA based on the provided technical information and comparison to predicate devices.

4. Adjudication Method for the Test Set:

Not applicable. There was no test set or adjudication process as part of a clinical study.

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 cryosurgical system, not an AI-powered diagnostic tool engaging human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

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

Not applicable. This device is a surgical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used:

Not applicable in the typical sense of a clinical study. The "ground truth" in this 510(k) submission is the established safety and effectiveness of the predicate devices (D.O.R.C. Cryo 1500 and Keeler Cryo Master) based on their prior FDA clearance. The new device is deemed substantially equivalent if it can demonstrate it performs safely and effectively like these predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning study requiring a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable.

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The Keeler CryoMaster & Probes are 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, cryo destruction of lash follicles for trichiasis, and treatment of retinopathy of prematurity (ROP).

Not Found

The provided text is a 510(k) clearance letter from the FDA for a medical device called "Keeler CryoMaster & Probes." This document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria and performance studies.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or their data provenance.
• Information on the number or qualifications of experts used to establish ground truth.
• Adjudication methods.
• Results of any Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Results of any standalone algorithm performance studies.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample size for training sets.
• How ground truth for training sets was established.

This document merely states that the FDA has reviewed the 510(k) notification and determined that the device is "substantially equivalent" to legally marketed predicate devices for the stated indications for use. Substantial equivalence is a regulatory standard, not a performance metric defined by a specific study with acceptance criteria.

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