(60 days)
The Polar Care Wave System is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. It is intended to be used by or on the order of licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings.
The Polar Care Wave system is an AC powered, software controlled, multimodality system. The device is intended for application of external cold therapy and intermittent pneumatic compression therapy to be used by, or on the order of, licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings. The device features a multi-setting cold therapy module and multi-setting compression therapy module which can be run simultaneously or independently. The device contains three key parts: A cold-compression pad with connector, an insulated container to hold ice and water, and a lid that contains a water pump and air pump, electronics to control the pumps, tubing, and an intuitive keypad to operate the device. The device is intended to be used with Breg Cold-Compression pads only, which are designed for specific application sites. The cold-compression pads are connected to the lid tubing and are applied to the body to deliver cold and intermittent compression therapy. The cold compression pads are made of flexible materials that form two bladders. The dual-bladder design allows cold water to continuously flow through one of the bladders to provide cold therapy, and air to be cyclically pumped into and released from a second bladder to provide intermittent pneumatic compression therapy. The insulated container is filled with ice and water by the user. The water circulates through the cold-compression pad to deliver cold therapy to the application site. The lid which houses the electronics, water pump, and air pump, is sealed and not accessible by the user. The lid also houses the keypad, which controls the device and allows the user to select the therapies as directed by a healthcare professional.
The provided text is a 510(k) Summary for the Breg Polar Care Wave system. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study with specific acceptance criteria and performance metrics as would be typical for a novel device or a device requiring de novo classification.
The document discusses performance testing in a general sense, stating:
- "The Polar Care Wave System has been subjected to design verification and validation testing. These tests verified and validated the proper operation of the system."
- "The Polar Care Wave device has been found to be adequately safe and effective for the intended users, its intended uses, and use environment."
- "The labeling materials have been found to be easy to use and understandable to the intended users."
- "The software in the Polar Care Wave system has been validated and demonstrated to be safe and effective for its intended use."
However, it does not provide a table of specific acceptance criteria, reported device performance (quantitative metrics like sensitivity, specificity, accuracy, etc.), or details of a clinical study in the way medical AI or diagnostic devices typically require. Instead, the focus is on engineering and safety standards compliance (e.g., IEC 60601) and comparison of features to predicate devices.
Therefore, for the information requested regarding acceptance criteria and a study proving performance, this document does not contain the specific details you've asked for, such as:
- A table of acceptance criteria and reported device performance.
- Sample size used for a clinical test set or data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication method for a test set.
- MRMC comparative effectiveness study or human reader improvement data.
- Standalone algorithm performance.
- Type of ground truth used (clinical outcomes, pathology, expert consensus).
- Sample size for training set or how ground truth was established for it.
The primary study detailed here is a comparison to predicate devices, focusing on demonstrating similarities in intended use, technology, and compliance with general safety standards, leading to a conclusion of substantial equivalence.
Based on the provided text, here is what can be inferred or explicitly stated regarding performance, albeit without the detailed clinical study metrics you requested:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria (Implied, not explicitly quantified as typically done for AI/diagnostic devices): The device functions as intended, providing cold and compression therapy safely and effectively within specified ranges, and meets relevant electrical safety and EMC standards. It is "adequately safe and effective" and its labeling is "easy to use and understandable."
- Reported Device Performance (Qualitative, not quantitative clinical metrics from the document):
- "The Polar Care Wave System has been subjected to design verification and validation testing. These tests verified and validated the proper operation of the system."
- "The Polar Care Wave device has been found to be adequately safe and effective for the intended users, its intended uses, and use environment."
- "The software in the Polar Care Wave system has been validated and demonstrated to be safe and effective for its intended use."
- Therapy Temperature Range: 45°F-60°F (falls within the range of predicate devices).
- Compression Setting: Low (0-25 mm Hg), Regular (0-50 mm Hg). The high pressure is within the predicate device range, and low pressure being lower is noted as having no safety/effectiveness issues as it represents minimum pressure.
- Compliance: Certified to IEC 60601-3rd edition (medical electrical safety) including ANSI/AAMI/ES60601-1-11, and IEC 60601-1-2 4th edition (EMC).
2. Sample size used for the test set and the data provenance:
- Not provided. This document does not describe a clinical test set with a specific sample size of patients or images. The "testing" mentioned refers to design verification and validation, likely internal engineering tests, not a clinical trial on a patient cohort specified by sample size.
- Data Provenance: Not applicable in the context of a clinical test set for performance evaluation in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The submission does not detail a clinical study where human experts established ground truth for a test set. The validation is based on engineering and safety standards, and functional verification.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set and associated ground truth adjudication described.
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:
- No. This is a physical therapy device (cold and compression), not an AI/diagnostic imaging device. Therefore, MRMC studies and concepts of "human readers improving with AI assistance" are not relevant 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 device. Its performance is inherent to its mechanical and electrical function.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable in the clinical sense. For a device like this, "ground truth" would be the engineering specifications and clinical indications for which cold and compression are generally accepted therapies (e.g., reduction of edema, swelling, and pain). Performance is established by meeting design specifications and safety standards, rather than direct comparison to a "ground truth" diagnosis.
8. The sample size for the training set:
- Not applicable. This is not a machine learning/AI device, so there is no training set in that context.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
In summary: The provided FDA 510(k) summary focuses on demonstrating substantial equivalence of a physical therapy device (Polar Care Wave) to existing predicate devices. It relies on engineering verification and validation, compliance with recognized safety and electrical standards (IEC 60601 series), and a comparison of functional features to establish that the device is "adequately safe and effective" for its intended use, rather than presenting a clinical study with quantitative performance metrics (like sensitivity/specificity) against a clinically established ground truth, which would be typical for AI-driven or diagnostic technologies.
§ 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).