(123 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, a 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 purnp, 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. Leakage current for the device shall not exceed 100uA.
This document describes an ice therapy device. The provided text is a summary of safety and effectiveness, but it does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically understood in the context of AI/ML devices or diagnostic tools.
The document discusses:
- The general concept of cold therapy after surgery/injury.
- The device's components (tank, pump, console, pad).
- A safety specification: "Leakage current for the device shall not exceed 100uA." This is a single electrical safety standard, not a set of performance acceptance criteria.
- References to existing literature on the benefits of cold therapy, implying its well-established nature, rather than a specific study conducted for this device's performance.
- A comparison to other similar devices on the market, noting they are "more convenient and safer means to apply ice."
Therefore, I cannot fulfill the request as the essential information is missing from the provided text. To answer your questions, I would need a description of:
- Specific performance metrics (e.g., cooling rate, temperature accuracy, duration of cooling, comfort metrics, etc.)
- Target values or ranges for these metrics (acceptance criteria).
- Details of a study that measured these metrics for the device.
Without this information, I cannot complete the table or answer the specific questions about sample sizes, ground truth, expert involvement, or AI-related aspects, as these pertain to a different type of device evaluation than what is presented here.
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L. SUMMARY OF SAFETY AND EFFECTIVENESS
The application of ice after surgery or injury to reduce swelling and pain is a well established treatment with well know indications and contraindications. Devices approved for market, such as the Breg Inc. Polar Care 500, the Burke/Nutech Inc. Sports Therapy 1000, and the Smith & Nephew DonJoy, Inc. Model 1100 device, are essentially more convenient and safer means to apply ice. More convenient because of less bulk for example, and safer because the treatment temperature can be set above the melting temperature of ice, 32F (0C), allowing extended safe treatment. A bag of ice in contrast, will necessarily be at 32F (0C) without option.
The device consists of a tank containing ice and water, a 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 purnp, 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. Leakage current for the device shall not exceed 100uA.
To our knowledge, no new safety issues regarding the use of these and like devices approved for market, have been raised. To the contrary, the literature continues to study the benefits of cold therapy. Some recent publications follow:
Bert, Stark, Maschka, Chock. The Effect of Cold Therapy on Morbidity Subsequent to Arthroscopic Lateral Retinacular Release, Orthopaedic Review, Vol. XX, No. 9, September 1991
Ho, Coel, Kagawa, Richardson. The Effect of Ice on Blood Flow and Bone Metabolism in Knees, The American Journal of Sports Medicine, Vol. 22, No. 4, 1994
Ho, Illgen, Meyer, Comparison of Various Icing Times in Decreasing Bone Metabolism and Blood Flow in the Knee, The American Journal of Sports Medicine, Vol. 23, 1995
Grana WA, Cold Modalities (Chapter 7) in: Orthopedic Sports Medicine, Ed. Delee, Drez Vol 1, 1994
Smith & Nephew DonJoy Inc.
Dan W. Miller 11-3-95
Dan W. Miller Director of Regulatory Affairs and Quality Assurance
Smith & Nephew DonJoy 510K Premarket Submission Page 18
§ 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.