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Intended Use: Localized cold therapy for post-traumatic and post-surgical medical and or surgical conditions.
Indications For Use:

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 Artrocool® - S is a typical cold liquid recirculating cryotherapy device. The Artrocool® -S is an insulated ice chest-like box with a closed loop liquid recirculating pump and tubing. The tubing connects to a variety of cuffs designed to be placed on or around injured or post surgical body structures, limbs or joints. The device operates by the use of a water filled cartridge and an insulated chest. The water filled bottle is frozen solid prior to first use. When the bottle is frozen, it is placed within the insulated chamber of the Artrocool. A 4:1 mixture of water and alcohol is poured into the fluid reservoir (balancing container) until full. The pump is circulated with the connecting tubing and cuff attached. Once both are filled and all air bubbles have been purged from the system the unit is ready for service.

Here's an analysis of the provided text regarding the Artrocool®-S Water Circulating Cold Pack, focusing on acceptance criteria and the study that proves its effectiveness, as per your requested format:

Important Note: The provided document is a 510(k) Premarket Notification for a medical device (Artrocool®-S Water Circulating Cold Pack). It establishes "substantial equivalence" to legally marketed predicate devices, rather than directly demonstrating novel performance through a clinical trial with specific acceptance criteria. Therefore, some of your requested points, such as "effect size of how much human readers improve with AI vs without AI assistance" or "sample size for the training set," are not applicable to this type of submission, as it doesn't involve AI or a traditional clinical study to prove efficacy in the same way a new drug or diagnostic might.

The "study" in this context is the comparison of the device's features and performance parameters to those of existing, legally marketed predicate devices to establish substantial equivalence.

1. Table of Acceptance Criteria and the Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence, there aren't explicit "acceptance criteria" in the traditional sense of a clinical trial's primary endpoint. Instead, the acceptance criteria are implicitly defined by the characteristics and performance of the predicate devices that the Artrocool®-S is compared against. The "reported device performance" is essentially how the Artrocool®-S aligns with or performs similarly to these predicate devices.

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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.

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