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Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and or surgical conditions.

1. Treatment of pain and swelling of acute periarticular processes. 2) Treatment of pain and swelling following mobilization of shoulder stiffness under anesthesia. 3) Treatment of pain and swelling postoperatively for bones, joints and soft tissue. 4) Treatment of pain and swelling caused by musculoskeletal contusions and athletic injury.

The ARTROTHERM™ CRYOTHERAPY AND THERMOTHERAPY unit utilizes a small portable heating and cooling unit, a length of dual lumen connecting tubing and assorted thermal therapy cuffs/pads. The various cuff/pads of the ARTROTHERM™ are shaped to better contour to different body surfaces. Therapy pads designed to accommodate the ankle, foot, wrist, hand, back, shoulder, hip, neck and knee are offered at present. The pads are held in place with straps and/or wraps. The unit requires 110 -115 or 220-230 VAC 50/50Hz current for operation. The unit is fully electrically isolated and meets UL-544 requirements. The ground leakage current value for the water circulating electric pump is less than 55 micro-amps. Minimum and maximum cooling and heating temperatures are affected by available environmental conditions, size of pad selected and patient temperature. Under typical conditions, best low temperature is +4 °C. Best low temperature is achieved after approximately 30 minutes of operation. Maximum high temperature is +50 °C and the unit requires about 15 minutes to reach this level. A high temperature alarm is utilized to warn of temperatures in excess of the +50 °C.

The provided document is a 510(k) Premarket Notification for the ORMED, GMBH - ARTROTHERM CRYOTHERAPY AND THERMOTHERAPY UNIT. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through a dedicated study with acceptance criteria and detailed performance metrics as would be found in a clinical trial report for an innovative device.

Therefore, the document does not contain the requested information regarding specific acceptance criteria for a study, the detailed results of such a study, sample sizes for test or training sets, data provenance, expert qualifications for ground truth establishment, adjudication methods, or MRMC comparative effectiveness study results.

Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices (TTU-100 by Danninger Medical Technology, Inc. and Hot/Ice® HE500/A by ThermoTemp, Inc.) based on device features, intended use, and technical specifications.

Here's a breakdown of what the document does provide, addressing the spirit of your request within the context of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance:

The document includes a "Comparison Table" (Section 13) which serves a similar purpose to an acceptance criteria table in a 510(k) by demonstrating that the new device's features and performance are "substantially equivalent" to predicate devices. It doesn't present "acceptance criteria" in the sense of predefined thresholds for a study outcome, but rather compares the ARTROTHERM's specifications to those of its predicates.

Summary of How Device Meets Criteria:
The table explicitly states "Yes" under the "SE?" (Substantially Equivalent) column for all features, indicating the applicant's claim that the ARTROTHERM™ meets the equivalence standard against the predicate devices based on these performance and design characteristics. For example, the temperature ranges are compared, and while not identical, they are deemed equivalently suitable for the intended therapeutic use. Similarly, electrical safety standards (UL-544 requirements, ground leakage current) are noted as equivalent.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) submission for a medical device that achieves substantial equivalence through comparison of design and performance specifications to predicate devices, not through a clinical "test set" in the sense of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth as typically understood for clinical studies involving expert review is not relevant here. The "ground truth" for this submission are the established specifications, intended uses, and safety profiles of the predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a test set is discussed.

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
Not applicable. This device is a physical therapy unit, not an AI-assisted diagnostic or imaging system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm, it's a physical device. Its "standalone" performance is implicitly covered by the technical specifications and safety features described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this 510(k) submission is the established regulatory acceptance and performance of the identified predicate devices (TTU-100 and Hot/Ice® HE500/A). Substantial equivalence is determined by comparing the new device's features, intended use, and technical specifications against these legally marketed devices.

8. The sample size for the training set
Not applicable. No "training set" in the context of machine learning or complex statistical modeling is mentioned or relevant for this type of device and submission.

9. How the ground truth for the training set was established
Not applicable.

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