(232 days)
Cryo-Thermo Compression Device combines cold, heat and compression therapies.
It is intended to treat post-surgical and acute injuries to reduce edema, swelling and pain for which cold and compression are indicated. It is intended to treat post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.
It is intended to be used by, or on the order of, licensed healthcare professionals in rehabilitation facilities, outpatient clinics and athletic training settings.
Cryo-Thermo Compression Device. Model Number: FGK002. is an AC powered. software-controlled device, designed to be used in rehabilitation facilities, outpatient clinics and athletic training settings and under the direction, prescription, or supervision of a licensed healthcare professional.
Cryo-Thermo Compression Device features iceless cold therapy, heat therapy and intermittent pneumatic compression therapy.
Cryo-Thermo Compression Device provides various inflatable wraps for thermal treatment (heat or cold) of the elbow, shoulder, ankle, hand-wrist or knee. The wraps are reusable for a single patient and can be cleaned if necessary.
Cryo-Thermo Compression Device is controlled by a touch screen interface, allowing the user to manage in the therapy modalities as well as easily adjust treatment temperature, compression level and time settings.
Cryo-Thermo Compression Device consists of a main equipment, wraps and accessories. The main equipment includes a control unit, a hose and a power cable. The drainpipe and the ice stick are accessories which can be ordered upon request. It is approximately 17.641bs (8kg) when reservoir is full of coolant. And, it is recommended to use 10% ethanol with 90% distilled water as the coolant.
The provided document is a 510(k) Pre-Market Notification for a medical device called the "Cryo-Thermo Compression Device." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving effectiveness through clinical trials with strict acceptance criteria and comparative effectiveness studies as might be found for a PMA (Pre-Market Approval) device or a novel high-risk device.
Therefore, the document does not contain the kind of detailed information typically found in studies designed to prove acceptance criteria for AI/ML-driven diagnostic devices, such as sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or training set details.
The performance data summarized in this document are primarily related to bench testing, electrical safety, software verification, biocompatibility, and skin temperature testing of a physical device. It is not a study proving an algorithm's diagnostic performance against a clinical ground truth.
Given this, I will describe the "acceptance criteria" and "study" as presented in the document for this specific type of device and submission.
Device Name: Cryo-Thermo Compression Device
Device Type: Powered Inflatable Tube Massager (Class II)
This device combines cold, heat, and compression therapies for post-surgical and acute injuries to reduce edema, swelling, and pain.
Acceptance Criteria and Study Details (as per FDA 510(k) Submission)
The "acceptance criteria" in this context are primarily conformance to established performance criteria and safety standards, demonstrating that the device is as safe and effective as its predicate devices, rather than a diagnostic accuracy threshold. The "study" refers to the verification and validation activities conducted.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter / Test Category | Acceptance Criteria (Implicit from testing purpose) | Reported Device Performance / Outcome |
|---|---|---|
| Biocompatibility | Conformance to ISO 10993 standards for intended use (surface medical device with prolonged intact skin contact). | Overall biological safety conclusion: acceptable based on evaluation per ISO 10993-1, 10993-5 (cytotoxicity), and 10993-10 (irritation and skin sensitization). |
| Electrical Safety | Conformance to IEC 60601-1:2005+AMD1:2012+AMD2:2020 and US National Differences. | Testing results indicated that the device is safe. |
| EMC (Electromagnetic Compatibility) | Conformance to IEC 60601-1-2:2014. | Testing results indicated that the device is safe. |
| Software Verification & Validation | Conformance to FDA guidance "Content of Premarket Submissions for Software Contained in Medical Devices" and IEC 62304. Software concern level "Moderate" for no new safety/effectiveness issues compared to predicates. | Testing demonstrated that the Cryo-Thermo Compression Device does not raise any new issues of safety and effectiveness as compared to the predicate devices. |
| Bench Performance Testing: | ||
| - Temperature accuracy | Tolerance between wrap temperature and target value. | Conforms to predetermined specifications. |
| - Time to reach target temp. | Time spent to achieve target temperature. | Conforms to predetermined specifications. |
| - Pressure accuracy | Tolerance between wrap pressure and target value. | Conforms to predetermined specifications. |
| - Timing accuracy | Tolerance between duration of treatment/rest and target value. | Conforms to predetermined specifications. |
| - Water flow rate | Flow rate of water circulation under working condition. | Conforms to predetermined specifications. |
| - Water pressure | Pressure of water circulation under working condition. | Conforms to predetermined specifications. |
| - Wrap seam strength | Wrap does not burst or deform when pressure exceeds maximum pressure. | Conforms to predetermined specifications. |
| - Hose function | Hose does not leak under maximum pressure for maximum duration. | Conforms to predetermined specifications. |
| - Failure mode test | Device can release pressure if there is a software failure. | Conforms to predetermined specifications. Overall: "Testing results indicated that Cryo-Thermo Compression Device conforms to its predetermined specifications and operates within safety limits." |
| Skin Temperature Testing | No thermal damage or cold injury to the skin in worst-case use scenario. | Minimum skin temperature: 7.0°C (44.6°F); Maximum skin temperature: 44.2°C (111.6°F). Concluded "didn't cause any thermal damage or cold injury to the skin." These values are included in the Instruction for Use. |
| Cleaning & Expected Life Testing | Validation of cleaning instructions for single-patient reusable wraps. Continued functional performance throughout service life for main equipment (5 years) and wraps (1 year). | Cleaning instructions validated per FDA guidance. Accelerated life test performed for main equipment; fatigue test performed for wraps, accounting for repeated cleaning. Confirmed safe use for expected duration. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable in the context of diagnostic performance testing for an AI/ML device. For physical product testing, the "samples" are the device units and their components. The document does not specify the number of units tested for each bench performance test, but it implies a sufficient number were tested to demonstrate conformance to specifications.
- Data Provenance: Not applicable for clinical data in this type of submission. The performance data provenance is from internal lab testing conducted by the manufacturer (Suzhou MicroPort RehabTech (Group) Co., Ltd.) and external accredited testing facilities for safety standards. The skin temperature testing was conducted on "healthy volunteers who provided informed consents" but the number of volunteers or their country of origin is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is not a diagnostic device where expert ground truth is established for a test set of clinical images/data. The "ground truth" for this device's performance relates to established engineering and medical device safety standards and the device's ability to maintain specific physical parameters (temperature, pressure, timing).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study involving human readers or interpretation of clinical data requiring adjudication.
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 is not an AI/ML-driven diagnostic device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML-driven diagnostic device. Software testing was done, but it was for controlling the physical device's functions and ensuring proper operation, not for diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance verification is based on:
- Established international and national standards for medical device safety and essential performance (e.g., IEC 60601 series, ISO 10993 series).
- Predetermined functional specifications for the device's operational parameters (temperature, pressure, timing, flow rate, seam strength, etc.).
- Physiological safety limits for human tissue regarding temperature exposure, as assessed through skin temperature testing on healthy volunteers.
8. The sample size for the training set
- Not applicable. This device does not use an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning for diagnostic tasks. The software development follows traditional software engineering principles outlined in IEC 62304.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" for an AI/ML algorithm in this context.
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).