Search Results

The Nicel combines cold and compression therapies. It 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 a healthcare professional in hospital, outpatient clinics, athletic training settings, or home settings.

Nice1 is a cold and compression therapy device used to aid recovery and reduce pain associated with soft tissue injuries. The device works by circulating cooled water and air through a therapy wrap that is placed on the injured body part. The cooled water circulates through the therapy wrap and provides cold therapy; the air inflates the therapy wrap causing it to compress around the injured body part.

The Nice1 uses thermoelectric technology to chill the water. The Nice1 consists of 3 key components:

1. The control unit which chills the water and contains the pneumatic system for inflating and deflating the therapy wraps.
2. The hose assembly which connects to the control unit to the therapy wrap and provides conduits for the flow of water and air to and from the therapy wrap.
3. The therapy wrap which is placed on the patient and wraps around the injured body part to deliver cold and compression therapy.

The control unit is an electromechanical, software-controlled device housed in a plastic enclosure. The device is approximately 8 x 7.64 x 8" and weighs 10 lbs. Inside the control unit are a thermoelectric heat exchange for cooling the water, a pneumatic system to control the flow of air to/from the therapy wrap to regulate compression, and electronics to control the therapy. Integrated into the plastic enclosure is graphical touch screen that displays outputs and receives inputs from the user. Temperature, compression levels and therapy duration are selected by the user via the graphical touch screen interface and controlled by a microprocessor.

The control unit contains a 300ml reservoir that is filled with water by the user. Water from the reservoir is cooled by passing through the thermoelectric heat exchange; it is then pumped from the control unit through the hose assembly, through the therapy wrap and then returns to the control unit to be re-chilled. Temperature is controlled in five (5) levels ranging in temperature from 59°F to 43°F.

Compression can be set at low, medium and high settings ranging from 0 mmHg to 75 mmHg. The compression cycles from high to low on 2 – 5 minute intervals to achieve Intermittent Pneumatic Compression.

The hose assembly is 6 feet long and consists of a foam rubber outer sheath to provide insulation and 3 urethane tubes that carry water and air to/from the control unit and therapy wrap.

The therapy wraps are comprised of 3 layers of urethane coated nylon that are welded together to make 2 separate air and liquid tight layers for the air and water. The therapy wraps are tailored to fit specific body parts. At the current time the company is only marketing a knee wrap. Therapy wraps use a Velcro closure to allow for customized fitting for different patients.

The provided text describes the Nice1 device, a cold and compression therapy system, and its substantial equivalence to a predicate device, the Game Ready System, as reviewed by the FDA. However, the document does not contain acceptance criteria for the device in the sense of performance thresholds (e.g., minimum accuracy, sensitivity, or specificity values) that need to be met by a medical device.

Instead, the "acceptance criteria" presented are implicitly defined by the demonstration of substantial equivalence to the predicate device through non-clinical performance testing. The study performed is a non-clinical comparative performance testing study.

Here's an analysis based on the information provided, addressing your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, there are no explicit "acceptance criteria" with numerical thresholds in the provided document. The criteria are derived from the comparison to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified. The study involved non-clinical performance testing of the device itself, not human subjects. It likely involved a single or small number of Nice1 units and predicate units for direct comparison.
• Data Provenance: The data is from non-clinical performance testing conducted on the devices, presumably by Nice Recovery Systems LLC or a contracted lab. There is no mention of country of origin for test data or whether it was retrospective or prospective in the context of human data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Experts: Not applicable. For this type of non-clinical device performance testing, "ground truth" is established through engineering and scientific measurements and specifications, not expert consensus (e.g., radiologists, pathologists). The comparison is against objective performance metrics of a legally marketed predicate device.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There was no need for expert adjudication, as the "ground truth" was based on direct physical measurements and comparison to the predicate device's documented performance.

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

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a physical therapy device that does not involve image interpretation or AI assistance for human readers/users.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• Standalone Performance: Not applicable in the context of an "algorithm." This device is a physical therapy machine. Its performance was assessed in a standalone manner as a device (e.g., its ability to cool water and generate pressure), but this phrasing typically refers to AI/software performance.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for the non-clinical testing was established by the engineering specifications and measured performance of both the Nice1 device and the predicate device (Game Ready System). This includes objective measurements of temperature ranges, compression levels, flow rates, and adherence to electrical safety standards. The predicate device's established safety and effectiveness served as the benchmark.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This document describes the premarket notification (510(k)) for a physical medical device, not a machine learning or AI-based diagnostic/therapeutic algorithm. There is no "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device submission.

Ask a specific question about this device