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The Zeltiq CLN1 Dermal Cooling Device is intended for use as a skin cooling device to minimize pain and thermal injury during laser and dermatological treatments. Alternative uses include skin cooling as a local anesthetic for procedures that induce minor local discomfort. The Zeltiq CLN1 Dermal Cooling Device can also provide localized thermal therapy (hot or cold) to minimize pain for post traumatic and/or post surgical pain and to temporarily relieve minor aches and pains and muscle spasms. The optional massage function can also be used for the temporary relief of minor muscle aches, pain, and spasm, for temporary improvement in local circulation and temporary reduction in the appearance of cellulite.

The Zeltig Coupling Gels facilitate thermal contact of the Zeltiq CLN1 Dermal Cooling Device with a patient's skin by mitigating minor variances in device-to-skin contact.

The Zeltiq CLN1 Dermal Cooling Device is a thermoelectric cooling and heating device that applies controlled cooling or heating to a treatment site. The device also includes the option of electrically powered or pulsatile vacuum massage.

The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria. The document is a 510(k) summary for the "Zeltiq CLN1 Dermal Cooling Device," primarily focused on establishing substantial equivalence to predicate devices.

Here's what the document does provide:

• Device Description: The Zeltiq CLN1 Dermal Cooling Device is a thermoelectric cooling and heating device that applies controlled cooling or heating to a treatment site, with an optional electrically powered or pulsatile vacuum massage feature.
• Intended Use/Indications for Use:
  • Skin cooling to minimize pain and thermal injury during laser and dermatological treatments.
  • Skin cooling as a local anesthetic for procedures inducing minor local discomfort.
  • Localized thermal therapy (hot or cold) to minimize pain for post-traumatic and/or post-surgical pain and to temporarily relieve minor aches, pains, and muscle spasms.
  • Optional massage function for temporary relief of minor muscle aches, pain, and spasm, temporary improvement in local circulation, and temporary reduction in the appearance of cellulite.
• Predicate Devices: The Zeltiq CLN1 Dermal Cooling Device is deemed substantially equivalent to the Juniper CLN1 Dermal Cooling Device (K072152) and the Cynosure Triactive Therapeutic massager (K030876).
• Performance Data (General Statement): "Testing confirms that the Zeltig CLN1 Dermal Cooling Device can be used in an equivalent manner to the predicate devices."
• Basis for Substantial Equivalence: The indications for use are the same as the predicate devices, and a "technological comparison and bench testing" demonstrate functional equivalence.

Missing Information:

The document lacks all the specific details requested in the prompt regarding acceptance criteria and a study to prove they are met. Specifically:

1. Table of Acceptance Criteria and Reported Device Performance: Not provided.
2. Sample size used for the test set and data provenance: No information on a specific test set or its sample size or provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no clinical study with a ground truth is described.
4. Adjudication method for the test set: Not applicable.
5. MRMC comparative effectiveness study: Not mentioned.
6. Standalone (algorithm only) performance study: Not applicable, as this is a physical device, not an AI algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

The 510(k) submission primarily relies on demonstrating equivalence to already cleared devices through technological comparison and general "bench testing," rather than presenting a detailed clinical performance study against specific acceptance criteria.

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