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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.

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

This document does not describe a "test set" in the sense of a clinical or analytical study with a specific sample size of patients or data. The "test" is the comparison itself against the specifications and performance of legally marketed predicate devices.

• Sample Size: Not applicable. The "test" is a regulatory comparison.
• Data Provenance: The data comes from the specifications and characteristics of the existing predicate devices (Theracool™, Polar Care™, Dr. Kool™, Cryo Cuff™) and the engineering specifications of the Artrocool®-S. This is retrospective in the sense that it relies on previously established devices and the design of the new device. The country of origin for the predicate devices isn't specified in detail, but the Artrocool®-S is from Germany (ORMED, GMBH).

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

Not applicable. The "ground truth" for a 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices. There wouldn't be a panel of experts specifically establishing "ground truth" for a test set in this context. The FDA's review process itself relies on regulatory experts.

4. Adjudication Method for the Test Set

Not applicable. There's no "adjudication method" in the context of human interpretation of a device's output for establishing ground truth, as would be seen in an imaging study. The comparison is based on objective device specifications and intended use.

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 device (cold pack), not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study or AI-related performance metrics are irrelevant.

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

Not applicable, for the same reasons as point 5.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" is the regulatory precedent of the predicate devices. The FDA assesses whether the new device is "substantially equivalent" in terms of its intended use, technological characteristics, and safety/effectiveness profile to devices already on the market. There's no specific pathology, outcomes data, or expert consensus (beyond the regulatory review) invoked for a new clinical determination.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. There is no training set for this device.

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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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