(132 days)
The T-Pump Localized Temperature Therapy Pump is intended for use in supplying warm or cold water at controlled temperatures via water circulating pad for the application of localized therapy in situations where a physician determines that temperature therapy is necessary or desirable.
Localized temperature therapy is of particular benefit in treating the following; orthopedic conditions such as acute injuries, chronic pain, lower back pain, muscle spasm and strains; skin trauma such as abscesses, boils, bruises, burns and contusions; other medical conditions such as chronic arthritis, neuritis, phlebitis, tendonitis and I.V. infiltration: and symptoms such as infection and localized pain.
The T-Pump Localized Temperature Therapy Pump is a small electronically controlled water heater that supplies warm or cold water at controlled temperatures to a water circulating pad for the application of localized temperature therapy. The control unit is an cloctrical device that uses a heating element to increase the temperature of water to controlled temperature set points, which the user selects from the digital display face. The temperature is controlled by a dual microprocessor control circuit and a thermostat to prevent overheating. To utilize the cold therapy option, the user adds ice water to the device, which will heat the water to a set point of 50 degrees Fahrenheit. The temperature range of the device ranges from 50 degrees Fahrenheit (for the cooling option) to 107 degrees Fahrenheit (the highest heating set point).
The T-Pump Localized Temperature Therapy Purnp attaches to a connector hose that connects to the water-circulating pad; the temperature-controlled water flows from the pump to the pad. The pads are applied to the part of the body requiring temperature therapy, thereby providing the interface for the therapy.
The T-Pump Localized Temperature Therapy Pump measures, in inches, 11.5 x 8 x 8. The device weighs under 10 pounds with the unit filled with water reservoir has a maximum capacity of 2750ml. The housing is composed of ABS Plastic and Polycarbonate.
The leakage current is 100 microamperes maximum, and the flow rate is 9 gph (34 lph) minimum, with the water circulating pad attached.
The provided text describes the T-Pump Localized Temperature Therapy Pump (K073675) and its regulatory submission, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.
The document is a 510(k) summary and approval letter from the FDA. Its primary purpose is to demonstrate "substantial equivalence" to previously cleared predicate devices, not to present a detailed performance study with acceptance criteria.
The information sought in your request (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth, training set size and ground truth establishment) is typically found in design validation reports or clinical study reports, which are part of the detailed submission to the FDA but are not usually included in the publicly available 510(k) summary.
Therefore, I cannot provide the requested table and details based solely on the provided text.
Here's a breakdown of why the information is not present and what is mentioned:
- Acceptance Criteria & Reported Performance: Not explicitly stated. The document focuses on comparing the new device's features and intended use to predicate devices to establish equivalence.
- Sample Size (Test Set) & Data Provenance: Not mentioned for any specific performance test.
- Number of Experts, Qualifications, Adjudication Method: Not applicable as no specific test set or ground truth establishment process is described beyond the general device description.
- MRMC Comparative Effectiveness Study: Not mentioned. The 510(k) pathway for this device typically relies on demonstrating equivalence rather than conducting a full comparative effectiveness study with human readers/users.
- Standalone Performance Study: Not mentioned in terms of quantitative performance metrics, sensitivity, specificity, accuracy, etc. The document describes the device's technical specifications and intended function.
- Type of Ground Truth: Not mentioned.
- Sample Size (Training Set): Not applicable, as this is a physical medical device, not an AI/ML algorithm that requires training data in the same way.
- How Ground Truth for Training Set was Established: Not applicable.
What the document does provide in relation to product performance and characteristics:
- Temperature Range: "From 50 degrees Fahrenheit (for the cooling option) to 107 degrees Fahrenheit (the highest heating set point)."
- Physical Dimensions: "11.5 x 8 x 8 inches."
- Weight: "Under 10 pounds with the unit filled with water."
- Reservoir Capacity: "Maximum capacity of 2750ml."
- Leakage Current: "100 microamperes maximum."
- Flow Rate: "9 gph (34 lph) minimum, with the water circulating pad attached."
These are specifications, not "acceptance criteria" against which a clinical or performance study's results are measured and reported for the purpose of demonstrating efficacy or safety in the way an AI algorithm's performance would be.
§ 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.