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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 D.O.R.C. Harmony Total Vitrectomy System is a surgical system for ophthalmic surgery intended for use in surgery of the posterior segment (vitrectomy).

The D.O.R.C. Harmony Total Vitrectomy System is an integrated system for posterior segment eye surgery. It provides the majority of functions required by the ophthalmic surgeon for performing a vitrectomy including vitreous cutting and aspiration, phacofragmentation, illumination, diathermy, air system and viscous fluid injection/extraction. The system is operated from one multifunction footswitch which gives the surgeon control over all of the surgical functions. The D.O.R.C. Harmony Total Vitrectomy System which includes the system, multifunction footswitch, trolley, automatic infusion pole and various sterile and non-sterile accessories provides the majority of functions needed to complete a posterior segment vitrectomy. The system is ac powered and also requires a source of medical grade compressed air to provide for some of the system functions.

The provided text is a 510(k) premarket notification for the D.O.R.C. Harmony Total Vitrectomy System. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics in the way one might for a novel diagnostic or AI-powered medical device.

Therefore, many of the requested elements (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this type of regulatory submission.

The "study" in this context is the comparison of technological characteristics of the D.O.R.C. Harmony Total Vitrectomy System to its predicate devices. The acceptance criteria are implicit in the FDA's "substantial equivalence" determination, meaning the new device must be as safe and effective as a legally marketed predicate device.

Here's an breakdown based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission like this, there isn't a formally stated "acceptance criteria" in terms of specific performance metrics with PASS/FAIL thresholds for a novel diagnostic. Instead, the acceptance criteria are satisfied by demonstrating that the new device's technological characteristics are substantially equivalent to legally marketed predicate devices. The "reported device performance" is essentially the listed specifications of the D.O.R.C. Harmony Total Vitrectomy System, as compared to the predicate devices.

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

• Not Applicable. This is a comparison of device specifications to predicate devices, not a study involving patient data or a "test set" in the context of diagnostic accuracy. The provenance of the data is the device's own specifications and publicly available information about predicate devices.

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" derived from expert assessment of a test set is mentioned or required for this type of submission. The "ground truth" is the demonstrated functionality and specifications of the device itself and its predicates.

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

• Not Applicable. No adjudication process is described for a test set.

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 or diagnostic device that involves human readers.

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

• Not Applicable. This is a surgical system, not an algorithm.

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

• The "ground truth" for this submission is the functional specifications and intended use of the D.O.R.C. Harmony Total Vitrectomy System and its predicate devices. Substantial equivalence is established by demonstrating that these characteristics are similar enough to ensure equivalent safety and effectiveness.

8. The sample size for the training set

• Not Applicable. This is a hardware surgical system, not a machine learning model requiring a training set.

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

• Not Applicable. See point 8.

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The Fiber Optic Endoillumination Probe is indicated for intraocular illumination in vitreoretinal surgery.

The Fiber Optic Endoillumination Probe provides intraocular illumination. The light is transmitted from the source to the inside of the eye through a flexible optical fiber, which has been threaded through an illumination probe.

This 510(k) summary (K980636) for the Fiber Optic Endoillumination Probe does not describe a study with acceptance criteria and reported device performance. Instead, it demonstrates substantial equivalence to a predicate device (Infinitech, Inc. Fiber Optic Probe, K870942) based on operational and technological characteristics.

Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics is not available in the provided text.

Here's a breakdown of what can be extracted and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided.

The submission relies on a comparison table to establish substantial equivalence, not to report performance against specific acceptance criteria. The "Comparison Criteria" act as attributes that are matched for equivalence rather than performance metrics with thresholds.

Note: The predicate device details for "Sterilization Method" and "Packaging" are "Not Known," indicating that Dutch Ophthalmic's methods were assessed for safety and effectiveness on their own merits and found acceptable, rather than directly comparing to a known predicate value.

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

Not applicable/Not provided. This submission does not detail an experimental test set with sample sizes. It's a regulatory submission for substantial equivalence based on descriptive and technological characteristics.

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

Not applicable/Not provided. No test set or ground truth established by experts is described.

4. Adjudication method for the test set

Not applicable/Not provided. No test set or adjudication method is described.

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

No. This is not an AI-enabled device. It's a fiber optic endoillumination probe. Therefore, no MRMC study or AI-related effectiveness is discussed.

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

No. This is not an algorithm-only device.

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

Not applicable/Not provided. No ground truth is described as the device is for illumination, not diagnosis or measurement requiring ground truthful comparison.

8. The sample size for the training set

Not applicable/Not provided. This is not an AI/machine learning device, so there is no training set mentioned.

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

Not applicable/Not provided. As there's no training set, there's no ground truth established for one.

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The D.O.R.C. HEXON Illumination System is indicated for intraocular illumination in vitreoretinal surgery.

The D.O.R.C. HEXON Illumination System consists of the Illumination Unit and accessories. The Illumination Unit uses a metal halide discharge lamp and utilizes an internal focusing system to focus the light into the end of the optical fiber. Accessories to the Illumination Unit include adapters and color filters. Accessories to the system include single use and reusable fiberoptic probes, fibers, and microinstruments which require storilization prior to use.

The provided text is a 510(k) premarket notification summary for the D.O.R.C. HEXON Illumination System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study to prove novel performance or efficacy. Therefore, much of the requested information regarding acceptance criteria, specific study design, expert involvement, and detailed performance metrics as would be found in a clinical trial for a new therapeutic or diagnostic device is not applicable or not provided in this document.

Here's a breakdown based on the available information:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study with specific thresholds. Instead, it demonstrates performance by comparing the device's characteristics to those of predicate devices to establish substantial equivalence.

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

• Sample Size: Not applicable. This is not a study assessing device performance on patient samples. The "test set" here refers to the characteristics of the device itself and its comparison to predicate devices, not data from patients.
• Data Provenance: Not applicable in the context of clinical data. The data provenance relates to the specifications and characteristics of the D.O.R.C. HEXON Illumination System and the predicate devices (Grieshaber Light Source and Escalon VitLite I), derived from engineering specifications and existing market information.

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

• Not applicable. Ground truth in a clinical or diagnostic sense is not being established. The "truth" here is the stated technical specifications of the devices being compared.

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

• Not applicable. There is no expert adjudication of clinical findings in this type of submission. The comparison is based on documented device specifications.

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 an ophthalmic illumination system, not an AI or diagnostic tool that would involve "human readers" or AI assistance.

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

• Not applicable. This device is a medical instrument, not an algorithm.

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

• The "ground truth" for this 510(k) submission is the technical specifications and intended use of the legally marketed predicate devices. The D.O.R.C. HEXON Illumination System demonstrates substantial equivalence by showing that it has similar technological characteristics and the same intended use as these predicates.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of device development for a 510(k) involving an illumination system.

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

• Not applicable. See point 8.

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The D.O.R.C. SOLUX Light Source is indicated for intraocular illumination in vitreoretinal surgery.

The D.O.R.C. SOLUX Light Source uses a halogen lamp and an internal focusing system to focus the light into the end of the optical fiber. Accessories to the Illumination Unit include adapters and color filters.

This 510(k) summary (K973757) describes the D.O.R.C. SOLUX Light Source, an ophthalmic light source intended for intraocular illumination in vitreoretinal surgery. The submission establishes substantial equivalence to existing predicate devices (Grieshaber Light Source and Escalon VitLite I) primarily based on operational and technological characteristics, rather than clinical performance studies with acceptance criteria in the typical sense of AI/software devices.

Here's an analysis based on the provided document, addressing your specific points:

Summary of the Study and Acceptance Criteria:

The "study" in this context is a 510(k) premarket notification which aims to demonstrate substantial equivalence to legally marketed predicate devices. The primary method is a comparison of technological and operational characteristics.

• Acceptance Criteria (Implied): The D.O.R.C. SOLUX Light Source is accepted if its technical specifications and intended use are similar enough to the predicate devices (Grieshaber Light Source and Escalon VitLite I) that it can be considered equally safe and effective. The comparison table (page 1) serves as the core of this demonstration. For instance, having "YES" for "Indication: Endoillumination for vitreoretinal surgery" for all devices shows alignment in intended use. The fact that its lamp type is Halogen, like the Grieshaber, and its wavelength range (400-800 nm) encompasses that of the Escalon VitLite (450-700 nm), along with features like UV and color filtration, contribute to this claim of equivalence.

• Proof of Meeting Criteria: The provided table titled "Comparison of SOLUX Light Source to Predicate Devices" directly shows how the D.O.R.C. SOLUX Light Source's characteristics align with or are similar to the predicate devices across various attributes like lamp type, variable intensity, filtration, and intended use. The FDA's letter (page 2-3) confirming "substantial equivalence" is the official recognition that the device meets these implied acceptance criteria based on the information provided in the 510(k) submission.

This 510(k) is characteristic of traditional medical device clearances based on engineering comparisons rather than clinical performance data typical of AI/ML-powered diagnostic devices.

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