(18 days)
The CryoMini Cold Air Device is intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.
The CryoMini consists of a refrigeration unit that creates cold air. The cold air is blown onto the skin using an air hose.
This document is a 510(k) summary for the CryoMini device, which is a skin refrigerant. The provided information focuses on demonstrating substantial equivalence to a predicate device (Cryo V6.0), rather than outlining explicit acceptance criteria and a dedicated study to prove unique performance.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate) | Reported Device Performance (CryoMini) | Outcome |
|---|---|---|---|
| Mechanical Dimensions | Equivalent or "well tested and proofed" | Changed (smaller device size) | Met (Claimed as "well tested and proofed by reasonable people") |
| Electronic Board Placement | Equivalent or "well tested and proofed" | Changed | Met (Claimed as "well tested and proofed by reasonable people") |
| Electronic Safety | Meet UL60601-1 and IEC60601-1-2 standards | Tested and verified | Met |
| Electronic Functionality | Tested and verified | Tested and verified | Met |
| Air Flow Output (Maximum) | Equivalent to Cryo V6.0 or acceptable improvement | Higher than Cryo V6.0 | Met (Considered an improvement) |
| Air Temperature (Minimum) | Equivalent to Cryo V6.0 or acceptable | Higher than Cryo V6.0 | Met (Implied as acceptable, alongside other efficacy tests) |
| Therapy Skin Temperature | Reach necessary therapy skin temperature | Reached necessary therapy skin temperature | Met (Similar to Cryo V6.0) |
| Operating Principles | Similar to predicate (Cryo V6.0) | Similar | Met |
| Intended Use | Similar to predicate (Cryo V6.0) | Similar | Met |
| Functional Performance | Similar to predicate (Cryo V6.0) | Similar | Met |
Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is not a single, comprehensive clinical trial with defined endpoints but rather a series of internal tests and comparative analysis against the predicate device (Cryo V6.0) to demonstrate "substantial equivalence."
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document describes "an air flow measurement" and "Some more tests," implying laboratory testing on the device itself, not human subjects.
- Data Provenance: The data originates from Zimmer Medizinsysteme GmbH (the manufacturer). It is retrospective in the sense that it relies on comparisons to an already cleared device, and the testing was conducted internally by the manufacturer. The country of origin is Germany.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. The "ground truth" for the performance claims (e.g., air flow, temperature, therapy skin temperature) was established through direct physical measurements of the device's output, not through expert opinion on clinical outcomes or diagnostics. The statement "well tested and proofed by reasonable people" is vague and does not refer to qualified experts in a clinical context.
- Qualifications of Experts: Not applicable, as no external experts were used for ground truth establishment.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. There was no clinical endpoint or diagnostic assessment requiring adjudication. The tests were direct physical measurements of the device's performance characteristics.
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
- MRMC Study: No. This device is a physical medical device (skin refrigerant), not an AI diagnostic or assistance system. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Not applicable. This device is a physical instrument, not an algorithm, and does not operate in a standalone algorithmic fashion. Its performance is inherent to its mechanical and electrical function. The "study" mentioned (air flow measurement, temperature checks) would be considered standalone in the sense that it only measured the device's output without human intervention as a variable in the outcome.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The ground truth for the performance claims was based on physical measurements (air flow, air temperature) and the established performance characteristics of the predicate device (Cryo V6.0) regarding reaching "necessary therapy skin temperature." It's a technical demonstration of equivalence rather than clinical ground truth like pathology or patient outcomes.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this device.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.