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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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