Search Results

The Cryo 7 is indicated to be used to: Minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.

The Cryo 7 is a non-invasive Therapeutic device. The cold air therapy device cools and dehumidifies the air, which can be used to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections. The cold air therapy device is intended to cool the patient's skin locally and is intended to be used contactless. The subject Cryo 7 device is the same as the currently-cleared Cryo 6 (K060395), except for branding and state-of-the-art updates. Both the subject device and predicate device are manufactured by Zimmer MedizinSysteme GmbH. The mechanical assembling consists of a housing, a chassis with 4 rotating rollers and a shelf plate. The chassis includes all technical components, like compressor, evaporator, condenser, fans and all electrical power components. On the upper front cover, the user interface control it operated via touchscreen. The software controls the device initialization, the hardware components for the cooling circuit as well as the user interface. The user interface can be controlled via capacitive touch display. The software controls the device initialization, the hardware components for the cooling circuit as well as the user interface.

The provided text describes the Zimmer MedizinSysteme Cryo 7 device, its intended use, and its comparison to a predicate device (Cryo V6.0, K060395). It also details the performance data and testing conducted to support its substantial equivalence.

Here's an analysis of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a quantitative table format with corresponding device performance values as typically found in a clinical study report comparing a device against specific thresholds for accuracy, sensitivity, or specificity.

Instead, the performance characteristics are described in comparison to the predicate device in a qualitative manner, and compliance with various standards is listed. The key performance comparison is for the air temperature and speed.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical study with a "test set" of patient data in the conventional sense for evaluating diagnostic accuracy or treatment effectiveness using AI. The Cryo 7 is a non-invasive therapeutic device for cooling, and the evaluation focuses on its physical and functional performance, safety, and substantial equivalence to a predicate device.

Therefore, there is no sample size for a test set of patient data mentioned, nor is there information on data provenance (country of origin, retrospective/prospective). The study described is primarily a bench testing and engineering verification study rather than a clinical trial.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Since there is no "test set" of patient data requiring clinical ground truth established by experts, this information is not applicable and not provided in the document.

4. Adjudication Method

As there is no clinical test set requiring ground truth establishment, no adjudication method (e.g., 2+1, 3+1) is mentioned or relevant.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size

No MRMC study was conducted. The device is not an AI-assisted diagnostic or therapeutic aid for human readers. Its function is to provide cold air. Therefore, evaluating human reader improvement with AI assistance is not applicable to this device.

6. Standalone (Algorithm Only) Performance Study

The Cryo 7 is a physical medical device, not an algorithm, so a standalone algorithm-only performance study is not applicable. The software integral to the device was verified, but this is different from an "algorithm only" study for AI.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily based on engineering specifications, compliance with recognized standards (e.g., electrical safety, EMC, software lifecycle, usability), and physical performance measurements (e.g., air temperature and speed) compared to its predicate and its own design requirements. It's not a clinical ground truth like pathology or outcome data.

8. Sample Size for the Training Set

There is no "training set" in the context of machine learning or AI algorithms mentioned for this device. The development process would involve standard engineering design, testing, and verification.

9. How the Ground Truth for the Training Set Was Established

As there is no training set as understood in AI/ML, this question is not applicable. The device's design and performance are based on established engineering principles and regulatory standards, not on learning from a dataset.

In summary: The provided document describes a 510(k) premarket notification for the Cryo 7 device, which is a physical cold air therapy device. The evaluation presented is focused on demonstrating substantial equivalence to a predicate device through engineering and performance comparisons, safety testing, and compliance with general medical device standards. It does not involve AI/ML components or clinical studies that would require the establishment of complex ground truth for patient data by experts.

Ask a specific question about this device