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510(k) Data Aggregation
(90 days)
Cryopush Cold Compression Device
A02-P-001:
The Cryopush Cold Compression Device is indicated for the temporary relief of minor muscle aches and pains. The device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneading and stroking of tissues using by an inflatable wrap.
The cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.
A02-P-002:
The Cryopush A02-P-002 is indicated for the temporary relief of minor muscle aches and pains.
The device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneading and stroking of tissues using by an inflatable wrap.
Cryopush Cold Compression Device consists of a main unit and wraps which simulates kneading and stroking of tissue with the hands by use of inflatable pressure wraps. It is for temporary increase in circulation of the treated areas and temporary relief of minor muscle aches and pains. By inflating the air chambers and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The device includes two models A02- P-001 and A02- P-002. The A02- P-001 has one chamber, and A02- P-002 has 2 chambers. The A02- P-001 contains cold pack, and the cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.
When the A02- P-001 is used for 30 minutes (Default time) at the operating temperature (5°C~ 40°C) specified in the user manual, the temperature of the cold pack is (-18℃~-4℃) (±2℃).
The provided document is a 510(k) summary for the "Cryopush Cold Compression Device" (K222669). It details the device's characteristics and its substantial equivalence to a predicate device. However, it does not contain information about a study proving the device meets specific acceptance criteria in the sense of clinical performance or diagnostic accuracy.
Instead, the document focuses on demonstrating substantial equivalence through non-clinical testing and comparison of technological characteristics. The "acceptance criteria" discussed are related to manufacturing standards, electrical safety, electromagnetic compatibility, and basic functional performance, not clinical efficacy or diagnostic accuracy.
Therefore, many of the requested points about "acceptance criteria" for performance, sample size, ground truth, experts, and comparative effectiveness studies are not applicable or cannot be extracted from this document, as it outlines a regulatory submission based on substantial equivalence to a predicate device rather than a de novo clinical trial demonstrating novel performance against defined criteria.
Here's the information that can be extracted based on the provided text, with notes for items not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Internal Standards based on Predicate) | Reported Device Performance/Characteristics |
|---|---|
| Electrical Safety, EMC | Device complies with IEC 60601-1:2005, AMDI:2012, IEC 60601-1-11:2015, IEC 60601-1-2:2014 |
| Software Validation | Software document determined according to FDA guidance (May 11, 2005) for software in medical devices |
| Pressure Range | A02-P-001: 0-100mmHg; A02-P-002: 0-215mmHg (Predicate: 0-240 mmHg) |
| Pressure Levels | A02-P-001: 20, 40, 60, 80, 100 mmHg; A02-P-002: 100, 160, 215 mmHg (Predicate: 150, 185, 215 mmHg) |
| Pressure Error Range | A02-P-001: ±15mmHg; A02-P-002: ±20mmHg (Predicate: ±25mmHg) |
| Cold Pack Temperature (A02-P-001) | -18℃ to -4℃ (±2℃) within 30 minutes of operation at 5°C-40°C operating temperature |
| Noise Level | ≤ 55dB (Predicate: ≤ 65dB) |
| Working Time | A02-P-001: 10-120 min (default 30 min); A02-P-002: 10-60 min (default 30 min) (Predicate: 20 minutes) |
| Keep time (Pressure hold time) | 10s (Predicate: 1-5s) |
| Deflation time | 20s (Predicate: 1-5s) |
| Product Appearance and Size, Wrap Performance, Function Test (Internal Standards) | Tested according to internal standards; specific metrics or results are not provided in this summary. |
| No adverse impact on safety and effectiveness compared to predicate despite differences | Concluded that differences in cold pack (A02-P-001) and treatment time do not raise adverse impact on safety and effectiveness. |
| Overall substantial equivalence to predicate device (K193354) | Concluded based on comparison of intended use, technological characteristics, and performances. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable. The document describes non-clinical engineering and performance testing against standards, not a clinical test set with human subjects for performance evaluation.
- Data provenance: Not applicable. The testing is described as internal testing by the manufacturer ("Chengdu Cryo-Push Medical Technology Co., Ltd") to conform to engineering standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth, in the context of expert consensus, is not relevant for the type of engineering and performance testing described. The "ground truth" here is adherence to specified engineering standards and internal performance metrics.
4. Adjudication method for the test set
- Not applicable. No expert adjudication process is described for this type of non-clinical testing.
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
- Not applicable. This device is a physical medical device (cold compression device), not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies and "human readers improving with AI" are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithm or AI-based device.
7. The type of ground truth used
- For engineering and performance tests: The ground truth implicitly refers to the specifications defined by relevant standards (e.g., IEC 60601 series for electrical safety, internal product specifications for pressure, noise, temperature) and the characteristics of the predicate device for comparison of substantial equivalence. There is no "expert consensus," "pathology," or "outcomes data" ground truth established for this type of submission.
8. The sample size for the training set
- Not applicable. There is no software or algorithm that would require a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable. No training set is mentioned or implied.
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