(9 days)
The Cryo V6.0 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 Cryo V6.0 consists of a refrigeration unit that creates cold air. The cold air is blown onto the skin using an air hose.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Cryo V6.0 device, structured to answer your questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical safety tested against UL2601/UL60601-1 standard | Cryo V6.0's mechanical safety tested against UL2601/UL60601-1 and found equal to Cryo5 |
| Electrical safety tested against UL2601/UL60601-1 and IEC60601-1-2 standards | Cryo V6.0's electrical safety tested against UL2601/UL60601-1 and IEC60601-1-2 and found equal to Cryo5 |
| Effectiveness measured by air flow, specifically maximum output air flow, to be equivalent to the predicate device Cryo5. | The measurement shows that the maximum output air flow of Cryo V6.0 is equal to Cryo5. |
Summary of Device Performance: The Cryo V6.0 device met all specified acceptance criteria by demonstrating equivalent mechanical safety, electrical safety, and maximum output air flow to its predicate device, Cryo5.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a "test set" in the traditional sense of human or device performance data. The "effectiveness" was tested by an air flow measurement, suggesting a physical test on the device itself.
- Sample Size for Test Set: Not applicable or not specified for a clinical or comparative effectiveness study. The test involved measurements on the Cryo V6.0 and comparison to Cryo5.
- Data Provenance: The air flow measurement was conducted at "Zimmer Medizinsysteme" (the manufacturer). This indicates a retrospective comparison against the predicate device's established performance, or possibly a direct comparison of a Cryo V6.0 unit against a Cryo5 unit. The country of origin is Germany (where Zimmer Medizinsysteme GmbH is located).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided and is likely not applicable to the type of testing described. The "ground truth" for the declared acceptance criteria (mechanical safety, electrical safety, air flow) would be established by validated testing methodologies and compliance with international standards, not expert consensus in a clinical context.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable to the technical testing (safety standards, air flow measurement) performed. Adjudication methods are typically used in clinical studies involving interpretation of results by multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The submission is for a 510(k) premarket notification, which relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving improved effectiveness or conducting a comparative effectiveness study involving human readers.
- Effect size of human readers improvement: Not applicable, as no such study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a manner of speaking, a "standalone" evaluation was done in the sense that the device's technical performance (safety and air flow) was assessed directly without human interaction performing its intended clinical function for an outcome evaluation. The assessment was of the device's compliance with safety standards and its physical air flow output, independent of a human operator's performance or clinical outcomes.
7. The Type of Ground Truth Used
The "ground truth" for this submission relies on:
- Technical Standards Compliance: For mechanical and electrical safety, the ground truth is adherence to established international and national safety standards (UL2601/UL60601-1 and IEC60601-1-2).
- Predicate Device Performance: For effectiveness (maximum output air flow), the ground truth is the established performance of the legally marketed predicate device, Cryo5. The new device must match or exceed this performance.
It does not involve expert consensus, pathology, or outcomes data in a clinical trial setting.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The Cryo V6.0 is a physical medical device (a refrigeration unit), not an algorithm or AI system that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, as there is no training set for this type of 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.