(35 days)
The Juniper 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 Juniper 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 relief of minor muscle aches, pain, and spasm and for the improvement in local circulation and temporary reduction in the appearance of cellulite.
The Juniper Medical Coupling Gels 400 and 600 facilitate thermal contact of Juniper Dermal Cooling Devices with a patient's skin by mitigating minor variances in device-toskin contact.
The Juniper 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 massage.
The provided text describes the Juniper CLN1 Dermal Cooling Device and its associated coupling gels. However, it does not contain specific acceptance criteria, detailed study results with performance metrics, or information about sample sizes for test/training sets, expert qualifications, or adjudication methods.
The document is a 510(k) summary for premarket notification, which primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailed performance studies with hard acceptance criteria.
Therefore, I cannot fully answer your request based on the provided input. I will extract the information that is available.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The general principle is "functional equivalence" to predicate devices. | Functionality: "Testing confirms that the Juniper CLN1 Dermal Cooling Device system can be used in an equivalent manner to the predicate devices." |
| Safety (Gels): "The Juniper Medical Coupling Gels 400 and 600 can be safely applied to the skin prior to use with Juniper Dermal Cooling Devices." |
The study essentially aimed to prove that the device is "functionally equivalent" and can be "safely applied" to skin, rather than meeting specific quantifiable performance metrics like sensitivity, specificity, or temperature ranges.
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified. The document states "bench testing" was conducted but provides no details on sample size for the device or the gels.
- Data Provenance: Not specified. The testing is referred to as "bench testing." No information is given about the origin of any data (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This type of device (skin cooling/heating, massage) does not typically involve expert-established ground truth in the way medical imaging or diagnostic AI devices do. The testing described is "bench testing" for functional equivalence and safety.
4. Adjudication method for the test set
- Not applicable. There is no mention of expert review or adjudication for the testing 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. An MRMC comparative effectiveness study is not applicable to this type of device. This device is a physical cooling/heating/massage device, not an AI diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated, but the "ground truth" or reference standard for "functional equivalence" and "safety" would likely come from established engineering specifications for heating/cooling and materials safety for the gels, referenced against the predicate devices. This would involve physicochemical testing and perhaps some basic human factors/skin irritation testing for the gels, rather than medical ground truth like pathology or expert consensus.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" as it is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. This device does not involve a "training set" or its associated ground truth establishment.
Summary of what the document does say about the study:
- The study performed was "bench testing."
- The purpose of the testing was to demonstrate "functional equivalence" to predicate devices.
- Testing confirmed the device system "can be used in an equivalent manner" to predicate devices.
- Testing confirmed the coupling gels "can be safely applied to the skin."
- The basis for substantial equivalence determination included "A technological comparison and bench testing."
§ 890.5720 Water circulating hot or cold pack.
(a)
Identification. A water circulating hot or cold pack is a device intended for medical purposes that operates by pumping heated or chilled water through a plastic bag and that provides hot or cold therapy for body surfaces.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.