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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 EVA Ophthalmic Surgical System is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery.

In addition, the optional laser is indicated for the following:

The EVA Ophthalmic Surgical System (EVA) is a combined anterior and posterior procedure ophthalmic system that is modular in design and serves as an enhanced version of the currently cleared Associate (K081877). The EVA is designed for use in anterior and posterior procedures that require infusion, vitreous cutting, aspiration, illumination, irrigation, lens emulsification and fragmentation, cautery, diathermy as well as photocoagulation.

The provided text describes the "EVA Ophthalmic Surgical System." It discusses various performance data, including biocompatibility, electrical safety, electromagnetic compatibility (EMC), and software verification and validation. However, the document does not contain information about specific clinical performance studies where the device's efficacy is measured against defined acceptance criteria using patient data. Instead, it focuses on demonstrating the device's safety and equivalence to predicate devices through engineering and laboratory tests.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) cannot be sourced from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document does not explicitly state acceptance criteria in a quantitative format for device performance in clinical use, nor does it report patient-centric performance in such a table. It states that "animal and clinical performance testing was not required for the EVA to demonstrate efficacy, safety and substantial equivalence to predicate devices."

Instead, it lists various engineering and laboratory tests and states that the device "complies" or "will not fail."

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

• Sample size for test set: Not applicable. The document states that "animal and clinical performance testing was not required." The performance data provided are from laboratory/bench testing on device components and the system itself, not from a clinical test set with patient data.
• Data provenance: Not explicitly stated, but the testing appears to be internal lab/bench testing for device compliance.

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, as no clinical test set with human-established ground truth was used for performance evaluation.

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

• Not applicable, as no clinical test set requiring adjudication was used.

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 surgical system, not an AI-assisted diagnostic or imaging device that would typically involve human readers or MRMC studies.

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

• Not applicable. The device is a surgical system, not an algorithm. The software verification and validation are for the embedded software controlling the surgical system, not for a standalone diagnostic algorithm.

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

• Not applicable. The ground truth for the "performance testing" described is based on engineering specifications, physical properties, and compliance with recognized standards (e.g., whether a pump is durable, if a tip melts, if a waste bag ruptures, if a cutter generates particulates, compliance with electrical safety standards).

8. The sample size for the training set

• Not applicable. There is no mention of a training set as this is not an AI/machine learning product for performance evaluation.

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

• Not applicable.

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The ASSOCIATE is intended for ophthalmic anterior and posterior segment surgery. It provides capabilities for phacoemulsification, phacofragmentation, diathermy coagulation, irrigation/aspiration, vitrectomy, illumination, air/fluid exchange and silicone oil injection & extraction.

The Associate is medical electrical equipment to be used during eye surgery. The Associate is intended for ophthalmic anterior and posterior segment surgery. It provides capabilities for phacoemulsification, phacofragmentation, diathermy coagulation, irrigation/ aspiration, vitrectorny, illumination, air/fluid exchange, silicone oil injection and extraction. The equipment has a display with touch screen for selecting and activating the functions. With the equipment a footswitch and a remote control are delivered for control by the surgeon. The equipment can be installed on a trolley and is able to control an automated infusion pole.

This document is a 510(k) summary for the ASSOCIATE Phacoemulsification/vitrectomy System. It primarily focuses on demonstrating substantial equivalence to existing predicate devices based on device description, intended use, and compliance with non-clinical safety standards. This particular submission does not contain information about acceptance criteria or a study proving the device meets those criteria from an AI/algorithm performance perspective.

The provided text describes a medical device, the "ASSOCIATE Phacoemulsification/vitrectomy System," and its intended use in ophthalmic surgery. It lists predicate devices and compliance with various safety standards (IEC, ISO). The FDA's 510(k) clearance letter confirms substantial equivalence to predicate devices.

Therefore, based on the provided text, I cannot extract the information required for your request.

The request specifically asks for information related to:

• A table of acceptance criteria and reported device performance.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size and ground truth establishment for the training set.

These details are characteristic of studies evaluating the performance of an AI/algorithmic diagnostic or prognostic device, often involving classification, detection, or measurement tasks. The ASSOCIATE device described here is a surgical instrument (hardware) used during eye surgery. Its performance is typically evaluated through different means, such as:

• Engineering specifications and tests: Flow rates, vacuum levels, ultrasonic power output, precision of controls, sterility, durability, etc. These would be detailed in technical specification documents and test reports, not typically in a 510(k) summary focused on substantial equivalence to predicates.
• Safety and biocompatibility testing: As indicated by the listed IEC and ISO standards.
• Usability studies: Ensuring the device is safe and effective for surgeons to operate.

Since the submission is for a surgical system and not an AI/algorithm, the concepts of "acceptance criteria," "test set," "training set," "ground truth," and "reader studies" in the context you've outlined for AI performance are not applicable to this document.

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The Xenon BrightStar Illumination System is intended to provide intraocular illumination in vitreoretinal surgery.

The Xenon BrightStar Illumination System consists of the Illumination Unit and accessories. The Illumination Unit uses a Xenon Short Arc Lamp and utilizes two internal focusing systems to focus the light into the end of an optical fiber of two individually controlled ports. Both ports can be individually controlled by choice of an UV cut-off filter and a light intensity setting. Accessories trother system include single use and reusable fiber optic probes, fibers and micro instruments which are delivered sterile or require sterilization prior to use.

This 510(k) summary describes a traditional medical device (an ophthalmic light source), not an AI/ML-driven device. As such, it does not contain the information requested in your prompt regarding acceptance criteria, study details, expert involvement, or AI performance metrics.

The document primarily focuses on establishing substantial equivalence to a predicate device based on technological characteristics and intended use. There is no mention of a study to "prove the device meets acceptance criteria" in terms of algorithmic performance, as this device does not involve an algorithm.

Therefore, I cannot provide the requested information for acceptance criteria and study details for an AI/ML device based on the provided text.

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