(62 days)
The application of ice after surgery or injury to reduce swelling and pain is a well established treatment with well know indications and contraindications.
The device consists of a tank containing ice and water pump to circulate cold water, a console containing a means to control and indicate temperature and a pad through which the cold water circulates. The pump, contained in a waterproof case, is submerged in the ice water bath and connected to the console via insulated tubing through which the chilled water flows to and from the pad. The console is located along this tubing about halfway between the pad and the water bath for easy access by the patient.
It seems there might be a misunderstanding or a missing part of the input. The provided text describes a cold therapy device and references safety and effectiveness, but it does not contain information related to acceptance criteria, device performance metrics (like accuracy, sensitivity, specificity), sample sizes for testing, expert qualifications, or ground truth establishment relevant to the typical application of such questions in the context of AI/ML or medical imaging device approvals.
The provided text discusses:
- The general concept of cold therapy.
- Existing similar devices (Breg Inc. Polar Care 500, Burke/Nutech Inc. Sports Therapy 1000, Smith & Nephew DonJoy, Inc. Model 1100).
- The basic components and function of the device in question (tank, pump, console, pad).
- A safety parameter (leakage current not exceeding 100uA).
- References to literature supporting cold therapy benefits.
Therefore,Based on the provided text, I cannot extract the information required to answer your questions. The text describes a physical cold therapy device and its general safety and effectiveness in broad terms, but it does not detail performance criteria or clinical study methodologies typically associated with establishing the performance of diagnostic or AI-assisted devices as implied by your questions.
Here's why and what's missing:
- Acceptance Criteria & Reported Performance: The text only mentions one specific technical safety criterion: "Leakage current for the device shall not exceed 100uA." It does not provide any other performance metrics (e.g., cooling efficiency, temperature stability over time, patient comfort scores, or specific clinical outcomes like reduction in swelling percentage) or their corresponding acceptance thresholds.
- Sample Size & Data Provenance: There is no mention of any clinical study involving a test set, sample sizes, or data provenance (e.g., country, retrospective/prospective).
- Experts for Ground Truth & Qualifications: No information regarding expert involvement for ground truth establishment.
- Adjudication Method: Not applicable as there's no mention of a test set requiring adjudication.
- Multi-Reader Multi-Case (MRMC) Study: Not mentioned as this is a physical therapy device, not typically an imaging interpretation or AI-assisted device that would undergo such studies.
- Standalone Performance: Not applicable in the context of this device description.
- Type of Ground Truth: Not specified, as there's no clinical study described.
- Training Set Sample Size & Ground Truth Establishment: Not applicable, as this device does not appear to involve AI/ML that would require a training set.
To answer your questions accurately, I would need a different type of input document, such as a clinical study report, a regulatory submission for a diagnostic AI device, or a performance testing protocol that specifies detailed performance metrics and study designs.
If you have such a document, please provide it, and I would be happy to help extract the requested information.
§ 890.5720 Water circulating hot or cold pack.
(a)
Identification. A water circulating hot or cold pack is a device intended for medical purposes that operates by pumping heated or chilled water through a plastic bag and that provides hot or cold therapy for body surfaces.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.