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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

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.

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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

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.

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The Cryo 5 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 5 consists of a refrigeration unit that creates cold air. The cold air is blown onto the skin using an air hose.

The provided text is a 510(k) summary for the Zimmer Cryo 5 device, which is a skin refrigerant. This document is a premarket notification to the FDA for market clearance and not a study report detailing acceptance criteria and performance against those criteria. As such, the input does not contain the information requested regarding acceptance criteria and a study proving the device meets them.

Specifically, the document states:

• "Performance Standards: None established (as a medical device) under section 514." This indicates that there are no specific performance standards or acceptance criteria defined by a regulatory body for this type of device.
• "Summary of Substantial Equivalence: The Zimmer Cryo 5 is substantially equivalent to the compared devices on the basis of similarities in operating principles, intended use and functional performance." The 510(k) process relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, I cannot extract the following information because it is not present in the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device