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TECHNOSANAT KRYO TSK 2005 is intended for use in conjunction with a laser to provide surface cooling during cutaneous laser treatment and is a cooling device indicated for:

1. The reduction of pain associated with laser treatment,
2. Less discomfort.
3. Cooling of the skin just before laser impulse treatment.

TECHNOSANAT KRYO TSK 2005 is a skin-cooling device designed for support of laser treatment. The device consists of a control device and the treatment applicator which are connected via hose lines. Cold is generated in the applicator by means of Peltierelement, and directed to the patient via a metallic finger transfer medium. A piece of cooled metal comes in contact with skin and performs skin cooling. The treatment temperature is recorded by means of one temperature sensor in the applicator and is then displayed on the device's temporatur controllar

The provided document is a 510(k) summary for the TECHNOSANAT KRYO TSK 2005 cooling device. It describes the device and its intended use, and states that it is substantially equivalent to predicate devices. However, it explicitly states that "performance data were not required" because "The specifications and intended uses of TECHNOSANT KRYO TSK 2005 are the same or very similar to those of claimed predicate devices."

Therefore, based solely on the provided text, there is no study described that proves the device meets specific acceptance criteria. The acceptance of the device for market clearance was based on its substantial equivalence to existing predicate devices, not on new performance data demonstrating it meets specific criteria through a study.

As such, many of the requested details about a study, acceptance criteria, sample sizes, expert involvement, and ground truth cannot be extracted from this document as no such study is presented.

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

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

• Acceptance Criteria: Not explicitly stated as new performance criteria for this device. The criteria for acceptance for market clearance was "substantial equivalence" to predicate devices.
• Reported Device Performance: "None. Performance data were not required."

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

• Not applicable as no performance study was conducted for this device.

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

• Not applicable as no performance study was conducted for this device.

4. Adjudication method for the test set

• Not applicable as no performance study was conducted for this device.

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 a cooling device for laser treatment, not an AI diagnostic tool. No MRMC study was conducted.

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

• Not applicable as this is a physical cooling device, not an algorithm.

7. The type of ground truth used

• Not applicable as no performance study was conducted for this device. Its approval was based on substantial equivalence to predicate devices, implying that the established safety and effectiveness of those predicates served as the basis for evaluation.

8. The sample size for the training set

• Not applicable as no performance study or machine learning model training was conducted for this physical device.

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

• Not applicable as no performance study or machine learning model training was conducted for this physical device.

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