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The Armory Motion is a prescription device that combines cold and compression therapy and is intended to treat postsurgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated.

Armory Motion is intended to be used by a licensed health care professional in rehabilitation facilities, athletic training settings, and home settings.

Armory Motion is a multimodality software-controlled device designed to provide both a muscle massage and a circulatory thermal therapy.

The Armory Motion is an AC Rechargeable Battery powered device designed to provide cold and intermittent Pneumatic Compression to a treatment site on the user. The device includes a lid with LCD panel, pump and electronics, a reservoir, tubing and a single-patient use, non-sterile, pneumatic air compression joint wrap that can also circulate water (dual bladder), to provide cold thermal therapy in addition to the compression. The Joint wrap can be used to treat the back, elbow, shoulder, foot, ankle, and knee.

The Armory Motion device contains several key parts: A cold-compression pad with a connector hose, an insulated container to hold ice and water, and a lid that contains a water pump and air pump, electronics to control the pumps, tubing, and an intuitive keypad to operate the device.

The cold-compression pads are connected to the lid tubing and are applied to the body to deliver cold and intermittent compression therapy. The cold compression pads are made of flexible materials that form two bladders. The dual bladder design allows cold water to continuously flow through one of the bladders to provide cold therapy, and air to be cyclically pumped into and released from a second bladder to provide intermittent pneumatic compression therapy.

The insulated container is filled with ice and water by the user. The water circulates through the cold compression pad to deliver cold therapy to the application site.

The lid which houses the electronics, water pump, and air pump, is sealed and not accessible by the user. The lid also houses the keypad, which controls the device and allows the user to select the therapies as directed by a healthcare professional.

This document, K213097, is a 510(k) premarket notification for a medical device called Armory Motion, which provides cold and compression therapy. The core of the submission is to demonstrate substantial equivalence to a legally marketed predicate device (Breg Polar Care Wave, K183702).

The provided text does not contain detailed acceptance criteria for a study demonstrating detailed device performance against specific metrics using a test set of data with established ground truth. Instead, the "study" demonstrating the device meets acceptance criteria is primarily a comparison with a predicate device and adherence to recognized consensus standards.

The document states:

• "No formal clinical testing was performed on the Armory Motion. The clinical testing is not applicable in this submission."
• "Test results, Risk Analysis, and FMEA analysis show that the new device Armory Motion is safe with no hazard."
• "The new device Armory Motion is designed to comply with relevant safety applicable recognized consensus standards."
• "The output characteristics of Armory Motion are similar to those of predicated device, see Table below."

Given this information, it's clear that a typical "study" proving performance against quantitative acceptance criteria for parameters like sensitivity, specificity, accuracy, or reader agreement for an AI/diagnostic device (as implied by the detailed questions) was not conducted or presented in this 510(k). The device is a therapeutic device, not a diagnostic one.

However, I can extract the information provided to address your points as best as the document allows, interpreting "acceptance criteria" as the criteria for demonstrating substantial equivalence based on technical specifications and safety standards, rather than direct performance metrics against a clinical outcome or diagnostic accuracy.

Here's a breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document establishes "acceptance criteria" through comparison to the predicate device and compliance with recognized standards. Performance is reported through a comparative table.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable as no formal clinical or performance study with a "test set" of data for diagnostic evaluation was performed. The "test set" in this context is the device itself being compared to the predicate device's specifications and standards.
• Data Provenance: Not applicable. The "study" is a technical comparison and demonstration of compliance with standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth as typically understood for diagnostic AI (e.g., expert reads, pathology) was not established because no such study was conducted. The "ground truth" here is the established safety and effectiveness profile of the predicate device and the relevant consensus standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. No expert adjudication process for a test set was performed.

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 not an AI/diagnostic assistant for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a physical therapeutic device, not a standalone algorithm. Its performance is inherent in its design and operation.

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

• The "ground truth" for this 510(k) submission is the established safety and performance of the predicate device (Breg Polar Care Wave, K183702) and compliance with recognized consensus standards (listed in the document, e.g., ANSI AAMI ES60601-1, IEC 60601-1-2, ISO 14971, etc.).

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device requiring a training set.

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

• Not applicable. No training set was used.

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This device is intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief of injections.

COOLSKIN is a 14" by 16" by 2 ¾ ft, 66 lb thermo-cooling mobile device that applies controlled cooling in the range of 3 degrees F to 50 degrees F (-16 degrees C to 10 degrees C) at skin surface in order to decrease skin temperature via a probe which is in direct contact with the skin surface. The device operates by semiconductor using Peltier principle. While the proximal side (towards the skin surface) gets cold, the distal side gets hot. The hot side is cooled by a water cooling system, which runs to the probe tip via a water circulating tube, and cools it. The warm/hot water is channeled away to the main unit where it is cooled via a fan. The probe is available in small and large versions.

This document does not contain the information required to fulfill the request. The provided text is a 510(k) summary for a skin cooling device (COOLSKIN), which primarily focuses on establishing substantial equivalence to a predicate device. It does not include details about acceptance criteria, a specific study proving those criteria were met, sample sizes, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

The document states:

• "COOLSKIN is safe and effective as the predicate device cited above."
• "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...".

This indicates the device's clearance was based on demonstrating equivalence, not necessarily on a detailed performance study with defined acceptance criteria as described in the prompt's requirements.

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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.

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The Juniper CLN1 Dermal Cooling Device is intended for use as a skin cooling device to minimize pain and thermal injury during laser and dermatological treatments. Alternative uses include skin cooling as a local anesthetic for procedures that induce minor local discomfort. The Juniper CLN1 Dermal Cooling Device can also provide localized thermal therapy (hot or cold) to minimize pain for post traumatic and / or post surgical pain and to temporarily relieve minor aches and pains and muscle spasms. The optional massage function can also be used for the relief of minor muscle aches, pain, and spasm and for the improvement in local circulation and temporary reduction in the appearance of cellulite.

The Juniper Medical Coupling Gels 400 and 600 facilitate thermal contact of Juniper Dermal Cooling Devices with a patient's skin by mitigating minor variances in device-toskin contact.

The Juniper CLN1 Dermal Cooling Device is a thermoelectric cooling and heating device that applies controlled cooling or heating to a treatment site. The device also includes the option of electrically powered massage.

The provided text describes the Juniper CLN1 Dermal Cooling Device and its associated coupling gels. However, it does not contain specific acceptance criteria, detailed study results with performance metrics, or information about sample sizes for test/training sets, expert qualifications, or adjudication methods.

The document is a 510(k) summary for premarket notification, which primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailed performance studies with hard acceptance criteria.

Therefore, I cannot fully answer your request based on the provided input. I will extract the information that is available.

1. Table of Acceptance Criteria and Reported Device Performance

The study essentially aimed to prove that the device is "functionally equivalent" and can be "safely applied" to skin, rather than meeting specific quantifiable performance metrics like sensitivity, specificity, or temperature ranges.

2. Sample size used for the test set and the data provenance

• Sample Size (Test Set): Not specified. The document states "bench testing" was conducted but provides no details on sample size for the device or the gels.
• Data Provenance: Not specified. The testing is referred to as "bench testing." No information is given about the origin of any data (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This type of device (skin cooling/heating, massage) does not typically involve expert-established ground truth in the way medical imaging or diagnostic AI devices do. The testing described is "bench testing" for functional equivalence and safety.

4. Adjudication method for the test set

• Not applicable. There is no mention of expert review or adjudication for the testing described.

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

• No. An MRMC comparative effectiveness study is not applicable to this type of device. This device is a physical cooling/heating/massage device, not an AI diagnostic or assistance tool.

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

• Not applicable. This is not an algorithm-based device.

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

• Not explicitly stated, but the "ground truth" or reference standard for "functional equivalence" and "safety" would likely come from established engineering specifications for heating/cooling and materials safety for the gels, referenced against the predicate devices. This would involve physicochemical testing and perhaps some basic human factors/skin irritation testing for the gels, rather than medical ground truth like pathology or expert consensus.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" as it is not an AI/machine learning device.

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

• Not applicable. This device does not involve a "training set" or its associated ground truth establishment.

Summary of what the document does say about the study:

• The study performed was "bench testing."
• The purpose of the testing was to demonstrate "functional equivalence" to predicate devices.
• Testing confirmed the device system "can be used in an equivalent manner" to predicate devices.
• Testing confirmed the coupling gels "can be safely applied to the skin."
• The basis for substantial equivalence determination included "A technological comparison and bench testing."

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• Local anesthetic effect which significantly reduces pain . following an injury, surgery or rehabilitative therapy
• Early use of cold therapy following an injury or surgery will ● reduce primary bleeding and swelling
• Temporary decrease in blood circulation, where applied, . reduces pain and swelling.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding the BREG, Inc. Polar Care 500 device. This document primarily focuses on regulatory approval and does not contain the detailed technical study information required to answer your specific questions about acceptance criteria and device performance studies.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
6. Whether a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This document confirms the device's substantial equivalence to a predicate device and lists its indications for use, but it does not detail the specific performance studies that led to this determination.

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1. To be used for cooling therapy when applied to the affected body surface during a migraine headache and for the reduction of pain from muscle spasms associated with migraine headaches.

IVC™ device

This is a 510(k) clearance letter for the IVC™ device, a water circulating hot or cold pack. The document states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it does not require a new study to prove its safety and effectiveness.

Therefore, the provided document does not contain the acceptance criteria or a study proving the device meets those criteria because it's a substantial equivalence determination.

Here's why and what information would typically be needed if it were a de novo submission or required clinical data:

Why the requested information isn't in this document:

• Substantial Equivalence (510(k)): The FDA's 510(k) pathway determines if a new device is "substantially equivalent" to a legally marketed predicate device. This means the new device has the same intended use and technological characteristics as the predicate, or if it has different technological characteristics, those differences do not raise different questions of safety and effectiveness.
• No New Clinical Data Required: For most 510(k) clearances, clinical studies demonstrating specific device performance against acceptance criteria are not required. Manufacturers typically provide information comparing their device to a predicate, often using bench testing, non-clinical data, or existing clinical literature on the predicate.

If this were a document for a device requiring clinical performance data, the following would be required:

• Acceptance Criteria Table: This would define specific thresholds (e.g., sensitivity, specificity, accuracy, precision, error rates, pain reduction scores, temperature control ranges) that the new device must meet to be considered safe and effective for its indicated use.
• Study Design and Results: Details of a clinical trial or performance study would be presented.

Let's address the specific points you asked for, even though they are not applicable to the provided document:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method for the test set: Not provided.
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 not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) clearance letter for an IVC™ device based on substantial equivalence, not a document detailing a performance study with acceptance criteria.

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The InCare HOT/ICE Cold Therapy Foot/Ankle Blanket is intended to provide hot/cold therapy for body surfaces.

The proposed devices consist of a connector/tubing that is an integral part of the plastic blanket where warm or cold water is circulated through and is intended to be used for the delivery of hot or cold therapy to the Foot/Ankle surface of the body. Detachable hook and loop securing straps allow for more flexibility in positioning the blanket onto the Foot/Ankle. The proposed HOT/ICE System Foot/Ankle Blanket can be used with all of the circulating pumps within the InCare HOT/ICE System and is available as a sterile product.

The provided document is a 510(k) summary for the InCare HOT/ICE Cold Therapy Foot/Ankle Blanket. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through a clinical trial or performance study comparing it against predefined metrics.

Instead, the submission focuses on demonstrating substantial equivalence to a previously marketed device (K931843). This is a common pathway for medical device clearance in the US, where the company argues that its new device is as safe and effective as a legally marketed predicate device, rather than conducting new clinical performance studies to meet new acceptance criteria.

The key points from the document regarding substantial equivalence are:

• Technological Characteristics: The proposed device is "identical in intended use, size/shape and flow design to the predicate device, with the following exception, the proposed device is available with detachable hook and loop securing straps that hold the blanket in place and allow for more flexibility in positioning the blanket." This indicates minor design changes rather than fundamental operational differences.
• Biocompatibility Assessment: The document states that "Issues of biomaterial safety or biocompatibility have been addressed based upon the biomaterial history or in separate in-vitro or in-vivo evaluations using licensed commercial reference laboratories." It concludes that "The materials used to construct the InCare HOT/ICE Cold Therapy Foot/Ankle Blanket are considered biocompatible and appropriate for their intended use." This is about material safety, not performance.
• Conclusion: "Based upon the information presented above it is concluded that the proposed InCare HOT/ICE Cold Therapy Foot/Ankle Blanket is safe and effective for it's intended use and is substantially equivalent to the predicate device."

Therefore, I cannot provide the requested information because the document does not describe acceptance criteria, a performance study, sample sizes, ground truth establishment, or expert involvement in the way a clinical study or AI/algorithm performance validation would. The device's approval is based on its similarity to an already approved device.

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The HTP-1500 Localized Heat Therapy Pump is intended for use in those situations where a physician determines that heat therapy is necessary or desirable.

The HTP-1500 Localized Heat Therapy Pump is a small electronically controlled electric water heater containing a water reservoir, an electric resistance heater, a heat exchanger, an integral electric pump and associated tubing, hoses and fittings that allow it to be connected to a separate external pad. In use, the pump circulates water from the reservoir through the heat exchanger, associated tubing, hoses and fittings into and through the external pad. The operator, using a membrane switch keypad, selects the desired water temperature as observed and confirmed on a digital display. The electronic controller selectively turns on and off the electric resistance heater to heat the heat exchanger, thereby heating the water to the desired temperature. The actual water temperature is monitored and displayed on a digital display.

The provided document is a 510(k) summary for the HTP-1500 Localized Heat Therapy Pump, submitted to the FDA in 1997. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing new clinical study data with specific acceptance criteria, performance metrics, or ground truth establishment relevant to AI/ML device evaluations.

Therefore, many of the requested details regarding acceptance criteria, study design for performance evaluation, sample sizes, expert qualifications, and ground truth establishment methods (which are standard for modern AI/ML device submissions) are not present in this document because they were not required for this type of submission at that time.

Here's an attempt to extract and interpret the information based on the prompt, acknowledging the limitations of the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the way it would for a performance study. Instead, it presents a "SPECIFICATION COMPARISON" table to demonstrate substantial equivalence to predicate devices (Seabrook SMS-2000 and SMS-1000). The implicit acceptance criteria are that the HTP-1500's specifications are comparable or superior to the predicate devices.

SPECIFICATION COMPARISON (Directly from document)

2. Sample size used for the test set and the data provenance

The document explicitly states: "This section is not required for this submission because substantial equivalence is based on intended use and device characteristics and specifications, and not on an assessment of performance data." (b, page 2).
Therefore, no separate "test set" or performance data (in the sense of a clinical or analytical study with a defined sample size and provenance) was provided or required for this 510(k) submission. The comparison is based on published specifications of existing devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As noted above, no performance evaluation requiring expert ground truth for a test set was conducted or submitted.

4. Adjudication method for the test set

Not applicable. No test set requiring adjudication was used.

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 is a submission for a hardware medical device (heat therapy pump), not an AI/ML device. Therefore, no MRMC study or assessment of AI assistance was performed.

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

Not applicable. This is not an algorithm-based device.

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

Not applicable. No ground truth was established for "performance data" as no such data was submitted. The "ground truth" for the comparison is the published specifications of the predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires ground truth for a training set.

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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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