Search Results

Therm-X (Therm-X Home and Therm-X AT) combines cold, heat contrast, and compression therapy. Therm-X (Therm-X Home and Therm-X AT) is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surqical conditions for which localized thermal therapy (hot or cold) are indicated. The Therm-X (Therm-X Home and Therm-X AT) is also intended for treatment of disorders associated with vascular or lymphatic insufficiency, such as lymphedema and chronic venous insufficiency (CVI).

Therm-X Home systems also provide DVT therapy. Therm-X Home systems with DVT therapy are intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.

Therm-X (Therm-X Home and Therm-X AT) is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings.

Therm-X is an AC powered, software-controlled multimodality device, designed to be used in a clinical or home-use setting, and under the direction, prescription, or supervision of a licensed healthcare professional. The device is available in two configurations: Therm-X Home and Therm-X AT.

Therm-X (Therm-X Home and Therm-X AT) features iceless cold therapy, heat therapy, and contrast (alternating heat and cold) therapy. The Therm-X Home system also provides DVT prophylaxis therapy and continuous therapy for users who wish to receive treatment over an extended period of time.

Therm-X (Therm-X Home and Therm-X AT) consists of various reusable inflatable wraps for thermal treatment of the back, elbow, hand/wrist, shoulder, ankle, hip, lower leg, or knee and DVT prophylactic treatment applied to the foot or calf. Multi-patient use garments are available for all anatomical areas that can be cleaned and disinfected in between uses to be reused for different patients. Single-patient use garments are available for thermal treatment of the back, hand/wrist, shoulder, neck, ankle, hip, and knee and can be disposed of after patient treatment is concluded. The thermal garments are flexible coolant circulating garments that apply to the body to deliver cold, heat, or contrast therapy in combination with or without pneumatic compression. The foot and calf DVT prophylactic garments apply pneumatic compression alone and are intended for use by the Therm-X Home system only.

Therm-X (Therm-X Home and Therm-X AT) is controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust and monitor treatment times, temperature, and compression settings. Therm-X AT and Therm-X Home models provide an optional password protection feature that allows for a user to use only stored cycles, giving health care providers an ability to ensure compliance to a chosen cycle. The device also provides functionality to allow the health care provider to assign a date at which the user will be able to access a second stored cycle instead of the first. The Therm-X device also allows users to chanqe treatment pressure and temperatures to less extreme therapies (e.g. changing a warm cycle to a lower warm temperature or changing a cold cycle to a higher cold temperature).

Therm-X (Therm-X Home and Therm-X AT) is approximately 15 lbs. when filled with coolant and has a handle placed on the top of the device. It has a centralized coolant reservoir accessible through a cap located at the back of the device that supplies its coolant and radiator systems. The reservoir, pumps, fans, circuit board, and other components of the Therm-X are located inside a covered enclosure made out of plastic and metal components, accessible only using a specialized tool.

The provided text describes the 510(k) premarket notification for the Therm-X device, which is a therapeutic device combining cold, heat, contrast, and compression therapies. The document focuses on demonstrating that the Therm-X device is substantially equivalent to legally marketed predicate devices, particularly the previous Therm-X (K231912) and the VascuTherm™ (K061866).

The context of the document is a regulatory submission for a medical device seeking FDA clearance, not a study proving a device meets specific acceptance criteria in the context of an AI/ML product where the acceptance criteria would be metrics like accuracy, sensitivity, specificity, etc., with corresponding ground truth and expert adjudication. The "acceptance criteria" discussed in this document refer to the regulatory requirements for demonstrating substantial equivalence to a predicate device, which largely involves comparing design, intended use, technological characteristics, and safety/performance data.

Therefore, many of the specific questions about "acceptance criteria" and "study that proves the device meets acceptance criteria" as they relate to AI/ML performance metrics (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance) are not directly applicable to this type of device and submission.

However, I can extract the relevant information regarding the device's performance claims and the testing undertaken to support its substantial equivalence, particularly concerning the newly added indications for use.

Here's an interpretation based on the provided document:

Acceptance Criteria and Device Performance (in the context of a 510(k) submission)

The primary "acceptance criteria" for this 510(k) submission is to demonstrate substantial equivalence to predicate devices for the specified indications for use, and to show the device is safe and effective. This is not about meeting specific numerical performance targets for an AI algorithm's diagnostic accuracy, but rather demonstrating that the device functions as intended and does not raise new questions of safety or effectiveness compared to existing devices.

The "device performance" reported is largely in the form of conformance to established standards and the outcome of testing, rather than specific quantitative metrics of clinical efficacy.

Table of "Acceptance Criteria" (Regulatory Requirements for Substantial Equivalence) and Reported Device Performance:

Study Details (as applicable to this type of device submission):

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

   • Test Set (for clinical testing): The document mentions "healthy volunteer human subjects" for the skin temperature measurement. The exact sample size is not specified in the provided text.
   • Data Provenance: Not explicitly stated, but clinical testing typically occurs in supervised settings. The nature of the device (physical therapy equipment) suggests this is likely prospective data collection for specific safety parameters. There is no indication of retrospective data from any specific country.

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

   • This is not applicable in the context of this device and submission. "Ground truth" in AI/ML typically refers to expert labels for diagnostic tasks. For Therm-X, "ground truth" for physical characteristics would be instrument measurements (e.g., temperature gauges, pressure sensors) or established clinical endpoints (e.g., absence of skin damage). The experts involved would be medical and engineering professionals conducting the tests, not labeling data for an algorithm.

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

   • Not applicable. This is a method used for resolving discrepancies in expert labeling of data for AI/ML validation. The testing described for Therm-X is direct physical performance validation and human factors assessment.

4. 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 framework for evaluating the diagnostic performance of AI-assisted human readers. Therm-X is a physical therapy device, not an AI for diagnosis or interpretation.

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

   • Not applicable, as Therm-X is not an AI/ML algorithm. However, the device itself has "software validation" which assesses its performance independently of direct human control over its internal functions, ensuring it meets its "performance requirements and specifications."

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

   • For the skin temperature testing: The ground truth was direct physiological measurement (skin temperature) obtained from human subjects under controlled, worst-case conditions. The "ground truth" for other tests (e.g., electrical safety, biocompatibility, cleaning validation) would be adherence to scientific standards and specifications, confirmed through various laboratory and bench tests.

7. The sample size for the training set:

   • Not applicable. Therm-X is not an AI/ML device that requires a "training set" in the machine learning sense. The device's operation is based on pre-programmed parameters and physical principles, not learned from data.

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

   • Not applicable, as there is no "training set."

Important Note: The document explicitly states: "No additional testing has been performed for the additional indications for use." This means the demonstration of substantial equivalence for the new indications (lymphedema and CVI) relies primarily on the comparison to the predicate device (VascuTherm™ K061866) which already has these indications, and on the existing testing data for the Therm-X device from its previous 510(k) clearance (K231912) and general safety and performance testing.

Ask a specific question about this device

Therm-X (Therm-X Home and Therm-X AT) combines cold, heat, contrast, and compression therapy. Therm-X is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.

Therm-X Home systems also provide DVT therapy. Therm-X Home systems with DVT therapy are intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.

Therm-X (Therm-X Home and Therm-X AT) is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, athletic training settings.

Therm-X is an AC powered, software-controlled multimodality device, designed to be used in a clinical or home-use setting, and under the direction, prescription, or supervision of a licensed healthcare professional. The device is available in two configurations: Therm-X Home and Therm-X AT.

Therm-X (Therm-X Home and Therm-X AT) features iceless cold therapy, heat therapy, and contrast (alternating heat and cold) therapy. The Therm-X Home system also provides DVT prophylaxis therapy and continuous therapy for users who wish to receive treatment over an extended period of time.

Therm-X consists of various reusable inflatable wraps for thermal treatment of the back, elbow, hand/wrist, shoulder, ankle, hip, lower leg, or knee and DVT prophylactic treatment applied to the foot or calf. Multi-patient use garments are available for all anatomical areas that can be cleaned and disinfected in between uses to be reused for different patients. Single-patient use garments are available for thermal treatment of the back, hand/wrist, shoulder, neck, ankle, hip, and knee and can be disposed of after patient treatment is concluded. The thermal garments are flexible coolant circulating garments that apply to the body to deliver cold, heat, or contrast therapy in combination with or without pneumatic compression. The foot and calf DVT prophylactic garments apply pneumatic compression alone and are intended for use by the Therm-X Home system only.

Therm-X is controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust and monitor treatment times, temperature, and compression settings. Therm-X AT and Therm-X Home models provide an optional password protection feature that allows for a user to use only stored cycles, giving health care providers an ability to ensure compliance to a chosen cycle. The device also provides functionality to allow the health care provider to assign a date at which the user will be able to access a second stored cycle instead of the first. The Therm-X device also allows users to change treatment pressure and temperatures to less extreme therapies (e.g. changing a warm cycle to a lower warm temperature or changing a cold cycle to a higher cold temperature).

The Therm-X is approximately 15 lbs. when filled with coolant and has a handle placed on the top of the device. It has a centralized coolant reservoir accessible through a cap located at the back of the device that supplies its coolant and radiator systems. The reservoir, pumps, fans, circuit board, and other components of the Therm-X are located inside a covered enclosure made out of plastic and metal components, accessible only using a specialized tool.

The Therm-X device, a powered inflatable tube massager combining cold, heat, contrast, and compression therapy, has demonstrated substantial equivalence to its predicate device (Therm-X, K193550) through a series of verification and validation tests. The modifications in the current submission include the addition of four new anatomical garment types and one XL version of an existing garment, and an expanded range of operating temperatures for the device, and a slight difference in continuous edema pressure levels.

Here is a summary of the acceptance criteria and performance, along with details of the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes modifications to the Therm-X device as compared to its predicate (Therm-X, K193550). The acceptance criteria are implicit in the "Comparison" column, where the new device is either "identical" or the differences are deemed to "not affect the intended use or raise different questions of safety and effectiveness". For the purpose of this table, the predicate device's characteristics serve as the acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to a clinical testing study that was "IRB approved" and conducted "on healthy volunteer human subjects who provided informed consent." This indicates a prospective study design.

• Sample Size: The exact number of human subjects is not specified in the provided text. It mentions "healthy volunteer human subjects."
• Data Provenance: The country of origin of the data is not specified. The mention of "IRB approved studies" implies a research institution setting.

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)

For the clinical testing for skin temperature, the "ground truth" was established by direct measurement of the skin temperature using the device on human subjects. This is not a situation where a human expert consensus is used to establish ground truth for a diagnostic interpretation. The study was to measure the lowest skin temperature the device could generate.

• Number of experts: Not applicable in the context of diagnostic "ground truth" establishment, as it was a direct physical measurement.
• Qualifications of those experts: Not applicable.

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

Not applicable. The clinical study described was to measure skin temperature directly, not to adjudicate results from interpretive tasks.

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. The Therm-X device is a physical therapy device (powered inflatable tube massager) and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC comparative effectiveness study regarding "human readers improve with AI vs without AI assistance" is not relevant to this device.

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

Not applicable. The Therm-X device is a physical therapy device and does not inherently involve an algorithm for diagnostic interpretation in a standalone fashion. Its software controls the physical modalities (temperature, compression, cycles). Software validation ensures the software operates as intended, but this is not "standalone algorithm performance" in the context of diagnostic AI.

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

For the human clinical study mentioned:

• Type of Ground Truth: The ground truth for the performance related to skin temperature was direct physical measurement ("lowest skin temperature ... measured") on human subjects under "worst case conditions."

For other tests:

• Performance - Bench: Predetermined specifications/performance criteria.
• Electromagnetic Compatibility / Electrical Safety: Conformance to international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11).
• Biocompatibility: Conformance to international standards (ISO 10993-1, ISO 10993-5, ISO 10993-10).
• Cleaning, Disinfection & Shelf Life Testing: Validation of instructions and accelerated aging tests against expected performance and absence of deterioration.
• Software Validation: Conformance to performance requirements and specifications, and FDA Guidance documents (e.g., General Principles of Software Validation, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices/Device Software Functions).
• Human Factors / Usability: Adequacy for safe and effective use by intended users in intended environments.

8. The sample size for the training set

Not applicable. The Therm-X device does not appear to involve machine learning or AI that would require a "training set" in the typical sense for diagnostic algorithms. The software validation ensures its functionality based on established design specifications.

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

Not applicable, as there is no mention or indication of an AI model requiring a training set in the document.

Ask a specific question about this device

Therm-X (Therm-X Home and Therm-X AT) combines cold, heat, contrast, and compression therapy. Therm-X is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.

Therm-X Home systems also provide DVT therapy. Therm-X Home systems with DVT therapy are intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.

Therm-X (Therm-X Home and Therm-X AT) is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, athletic training settings.

Therm-X is an AC powered, software-controlled multimodality device, designed to be used in a clinical or home-use setting, and under the direction, prescription, or supervision of a licensed healthcare professional. The device is available in two configurations: Therm-X Home and Therm-X AT.

Therm-X (Therm-X Home and Therm-X AT) features iceless cold therapy, heat therapy, and contrast (alternating heat and cold) therapy. The Therm-X Home system also provides DVT prophylaxis therapy and continuous therapy for users who wish to receive treatment over an extended period of time.

Therm-X consists of various reusable inflatable wraps for thermal treatment of the back, elbow, shoulder, ankle, hip, or knee and DVT prophylactic treatment applied to the foot or calf. Multipatient use garments are available for all anatomical areas that can be cleaned and disinfected in between uses to be reused for different patients. Single-patient use garments are available for thermal treatment of the shoulder, ankle, hip, and knee and can be disposed of after patient treatment is concluded. The thermal garments are flexible coolant circulating garments that apply to the body to deliver cold, heat, or contrast therapy in combination with pneumatic compression. The Foot and calf DVT prophylactic garments apply pneumatic compression alone and are intended for use by the Therm-X Home system only.

Therm-X is controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust and monitor treatment times, temperature, and compression settings.

Therm-X is approximately 15 lbs. when filled with coolant and has a handle placed on the top of the device. It has a centralized coolant reservoir accessible through a cap located at the back of the device that supplies its coolant and radiator systems. The reservoir, pumps, fans, circuit board, and other components of the Therm-X are located inside a covered enclosure made out of plastic and metal components, accessible only using a specialized tool.

Here's an analysis of the provided text to extract information related to acceptance criteria and the study proving the device meets them, presented in the requested format.

It's important to note that the provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device's performance against specific, quantitative clinical acceptance criteria. Therefore, some of the requested information (like specific target performance metrics for a novel technology or a detailed MRMC study with effect sizes) is not present because this type of submission is not designed to provide that. The "acceptance criteria" here are primarily about meeting safety and performance standards equivalent to existing devices and fulfilling regulatory requirements.

Device Name: Therm-X

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are primarily defined by the performance characteristics of the predicate devices and general safety/performance standards for medical devices. The performance data presented isn't against pre-defined numerical thresholds for novel claims, but rather to show the new device operates similarly to cleared predicates.

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

• Sample Size:
  • Clinical Testing (Skin Temperature): Not explicitly stated how many healthy volunteer human subjects were included, only "healthy volunteer human subjects who provided informed consent."
  • Biocompatibility, EMC/Electrical, Software, Bench, Cleaning/Disinfection, Human Factors: These involve device-specific testing or material testing, not human subject sample sizes in the clinical sense.
• Data Provenance:
  • Clinical Testing: Stated as "healthy volunteer human subjects who provided informed consent." No country of origin is specified.
  • Retrospective/Prospective: The clinical testing for skin temperature measurement appears to be prospective ("IRB approved studies have been performed to measure the lowest skin temperature... Therm-X was tested for worst case conditions on healthy volunteer human subjects"). Other testing (bench, software, etc.) are standard verification and validation activities.

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

• Clinical Testing (Skin Temperature): The "ground truth" here is the measured skin temperature. This is a direct physical measurement from the device's application. Experts would be involved in designing and overseeing the study, but the "ground truth" itself is objective physical data rather than expert consensus on, say, an image interpretation. No specific number or qualifications of experts establishing ground truth are mentioned beyond the implication of an "IRB approved study."
• Other Testing (Bench, Software, etc.): Ground truth for these studies is typically defined by engineering specifications, regulatory standards, and established test protocols. The "experts" would be the engineers and quality assurance personnel conducting and reviewing the tests, but not in the sense of independent clinical experts adjudicating medical findings.

4. Adjudication Method for the Test Set

• Clinical Testing (Skin Temperature): Not applicable. The "ground truth" is a direct measurement of skin temperature. This is not an interpretive task requiring an adjudication process.
• Other Testing: Not applicable. These are engineering and performance compliance tests.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done.
  • This type of study is typically used for diagnostic devices (e.g., AI for image interpretation) to compare the performance of human readers with and without AI assistance.
  • The Therm-X is a therapeutic device (powered inflatable tube massager). The clinical testing focused on physical performance metrics (skin temperature) and safety, not on human interpretive tasks.
• Effect size of how human readers improve with AI vs without AI assistance: Not applicable, as no MRMC study was conducted.

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

• No, not directly applicable in the typical sense for AI/diagnostic algorithms.
  • The Therm-X does contain software, and "Software Validation" was performed, which is akin to testing the "algorithm" or software functionality in isolation from human interaction, to ensure it meets its specifications. This is a component of the device's overall performance.
  • However, the term "standalone" performance usually refers to an AI's diagnostic accuracy without human input for tasks like image classification. As this is not an AI diagnostic device, this concept doesn't directly apply in that context. The device's primary function is physical therapy, controlled by software.

7. The Type of Ground Truth Used

• Clinical Testing (Skin Temperature): Objective physical measurements (measured skin temperature).
• Biocompatibility: Laboratory test results against recognized standards (ISO 10993).
• Electrical Safety & EMC: Laboratory test results against recognized standards (IEC 60601 series).
• Software Validation: Conformance to pre-defined software requirements and specifications, and compliance with FDA guidance documents.
• Bench Performance: Conformance to engineering specifications for proper system operation and safety limits.
• Human Factors/Usability: Data from simulated use environments to assess safe and effective operation by intended users, typically observed directly or through surveys/interviews.
• Cleaning, Disinfection & Shelf Life: Laboratory validation of cleaning protocols and durability testing.

8. The Sample Size for the Training Set

• Not applicable. The Therm-X is presented as a physical therapy device with software control, not a machine learning/AI device that undergoes a "training" phase on a dataset of patient information (e.g., images for diagnostic AI). The software validation process ensures its functionality, but it's not "trained" on a dataset in the AI sense.

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

• Not applicable, as there is no "training set" in the context of an AI/machine learning model for this device.

Ask a specific question about this device

Therm-X (Therm-X Pro, Therm-X Pro Athlete, and Therm-X AT) combines cold, heat, contrast, and compression therapy. Therm-X is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.

Therm-X Pro and Therm-X Pro Athlete systems also provide DVT therapy. Therm-X Pro Athlete are intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow beart via lower extremity limb compression.

Therm-X (Therm-X Pro Athlete and Therm-X AT) is intended to be used by, or on the order of, licensed health care professionals in rehabilities, outpatient clinics, athletic training settings, and home settings.

Therm-X is an AC powered, software-controlled multimodality device, designed to be used in a clinical or home-use setting, and under the direction, prescription or supervision of a licensed healthcare professional. The device is available in three configurations: Therm-X Pro Athlete and Therm-X AT.

Therm-X (Therm-X Pro, Therm-X Pro Athlete and Therm-X AT) features iceless cold therapy, heat therapy, and contrast (alternating heat and cold) therapy. Therm-X Pro and Therm-X Pro Athlete systems also provide DVT prophylaxis therapy.

Therm-X consists of various reusable inflatable wraps for thermal treatment of the back, elbow, shoulder, ankle, or knee and DVT prophylactic treatment applied to the foot or calf. The thermal garments are flexible coolant circulating garments that apply to the body to deliver cold, heat, or contrast therapy in combination with pneumatic compression. The Foot and calf DVT prophylactic garments apply pneumatic compression alone and are intended for use by Therm-X Pro and Therm-X Pro Athlete systems only.

Therm-X is controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust and monitor treatment times, temperature and compression settings. Therm-X AT and Therm-X Pro models provide an optional password protection feature that allows for a home user to use a stored cycle without being able to change it, giving health care providers an ability to ensure compliance to a chosen cycle. The device also provides functionality to allow the health care provider to assign a date at which the user will be able to access a second stored cycle instead of the first.

Therm-X is approximately 15 lbs. when filled with coolant and has a handle placed on the top of the device. It has a centralized coolant reservoir accessible through a cap located at the back of the device that supplies its coolant and radiator systems. The reservoir, pumps, fans, circuit board, and other components of the Therm-X system are located inside a covered enclosure made out of plastic and metal components, accessible only using a specialized tool.

Therm-X is a class II medical device per FDA classification and has been previously cleared by the FDA under K181149. The Therm-X single-patient use garments under K181149 have been changed to multi-patient use garments through the use of a low-level disinfection process. Based on the guidance "Guidance for Industry and Food and Drug Administration Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2015), the Therm-X garments are considered reusable medical devices initially supplied as non-sterile to the user and requiring the user to process (i.e., disinfect) the device for initial use, as well as to reprocess the device after each use. The qarments are considered non-critical devices in that they contact only intact skin and do no penetrate it. Therm-X garments may become contaminated with microorganisms and organic soil during patient care and such contamination may not be visible. To account for this contamination and to prevent patient harm when used with multiple patients, Zenith uses a low-level disinfection process for the Therm-X garments.

The provided text describes a 510(k) premarket notification for a medical device called Therm-X. This document aims to demonstrate that the Therm-X device (K190854) is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document doesn't present a formal table of explicit acceptance criteria with specific quantitative thresholds and corresponding reported device performance values. Instead, it relies on demonstrating substantial equivalence to predicate devices across various characteristics. The "Comparisons" column in the detailed comparison table (pages 6-7) serves as the primary mechanism for showing how Therm-X aligns with or justifies differences from the predicate devices. The acceptance criteria are implicitly that the device is "as safe and effective" as the predicate devices, and this is shown through direct comparisons and safety/performance testing.

However, we can infer some criteria and the device's performance based on the comparative table:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily focuses on demonstrating substantial equivalence to existing predicate devices through a comparison of technical characteristics and existing test data from a previous clearance (K181149) and new testing for features not present in the primary predicate (like reusable garments).

• Sample Size for Test Set: Specific sample sizes for quantitative "test sets" for performance are not explicitly detailed for most aspects.
  • For Performance Bench Testing (cleaning and disinfection validation): A "cleaning validation study was performed" and a "low-level disinfection validation study was performed." The exact number of units or cycles tested is not provided.
  • For Durability accelerated aging test: "A durability accelerated aging test was performed." The number of garments or test conditions is not specified.
  • For Human Factors / Usability testing: "The Human Factors Validation study demonstrated..." The number of participants in this study is not provided.
• Data Provenance: Not explicitly stated in terms of country of origin or whether it's retrospective or prospective for the new studies (cleaning, disinfection, human factors). However, the predicate devices are legally marketed in interstate commerce, implying US market relevance for the comparison. The human factors study explicitly mentions "intended clinical users in the US market."

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)

This information is not provided in the document. The studies mentioned are focused on technical performance and user interaction with cleaning instructions rather than diagnostic accuracy or clinical outcomes requiring expert interpretation.

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

Adjudication methods are not applicable nor mentioned, as the studies are focused on technical validation (bench testing, human factors for cleaning) rather than expert consensus on diagnostic ground truth.

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

Such a study was not done. The device is a physical therapy device (cold, heat, contrast, compression, DVT therapy), not an AI-based diagnostic tool. Therefore, MRMC studies and AI effect sizes are not relevant to this submission.

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

A standalone algorithm performance study was not done, as this device does not involve an AI algorithm for diagnosis or interpretation in the way "standalone" usually refers to in regulatory contexts for AI/ML devices. The "software-controlled" aspect refers to control logic for the physical therapies, not a diagnostic algorithm.

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

The concept of "ground truth" (in the medical diagnostic sense) is not directly applicable here. The "ground truth" for the various new tests performed would be:

• Cleaning Validation: The measured reduction in soil/contaminants to an acceptable level.
• Disinfection Validation: The measured reduction/destruction of microorganisms to an acceptable level, as per relevant standards for low-level disinfection.
• Durability Testing: The continued functional performance of the garment after accelerated aging/reprocessing cycles.
• Human Factors Validation: The successful demonstration by users of understanding and correctly performing the cleaning/disinfection procedures as outlined in the IFU.

These are established against pre-defined engineering and microbiological standards, rather than expert clinical consensus on a disease state.

8. The sample size for the training set

This information is not applicable/not provided. The device is not an AI/ML device that requires a training set in the typical sense. Any internal calibration or control system development would use functional testing data, not a "training set" of patient data.

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

This information is not applicable/not provided for the reasons stated above (not an AI/ML device with a training set).

Ask a specific question about this device

Therm-X (Therm-X Pro, Therm-X Pro Athlete, and Therm-X AT) combines cold, heat, contrast, and compression therapy. Therm-X is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.

Therm-X Pro and Therm-X Pro Athlete systems also provide DVT therapy. Therm-X Pro and Therm-X Pro Athlete are intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.

Therm-X (Therm-X Pro, Therm-X Pro Athlete and Therm-X AT) is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings.

Therm-X is an AC powered, software-controlled multimodality device, designed to be used in a clinical or home-use setting, and under the direction, prescription of a licensed healthcare professional. The device is available in three configurations: Therm-X Pro, Therm-X Pro Athlete and Therm-X AT.

Therm-X (Therm-X Pro, Therm-X Pro Athlete and Therm-X AT) features iceless cold therapy, heat therapy, and contrast (alternating heat and cold) therapy. Therm-X Pro and Therm-X Pro Athlete systems also provide DVT prophylaxis therapy.

Therm-X consists of various single-patient use inflatable wraps for thermal treatment of the back, elbow, shoulder, ankle, or knee and DVT prophylactic treatment applied to the foot or calf. The thermal garments are flexible coolant circulating garments that apply to the body to deliver cold, heat, or contrast therapy in combination with pneumatic compression. The Foot and calf DVT prophylactic garments apply pneumatic compression alone and are intended for use by Therm-X Pro and Therm-X Pro Athlete systems only.

Therm-X is controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust and monitor treatment times, temperature and compression settings. Therm-X AT and Therm-X Pro models provide an optional password protection feature that allows for a home user to use a stored cvcle without being able to change it, giving health care providers an ability to ensure compliance to a chosen cycle. The device also provides functionality to allow the health care provider to assign a date at which the user will be able to access a second stored cycle instead of the first.

The Therm-X is approximately 15 lbs. when filled with coolant and has a handle placed on the top of the device. It has a centralized coolant reservoir accessible through a cap located at the back of the device that supplies its coolant and radiator systems. The reservoir, pumps, fans, circuit board, and other components of the Therm-X are located inside a covered enclosure made out of plastic and metal components, accessible only using a specialized tool.

The provided document describes the Therm-X device, which combines cold, heat, contrast, and compression therapy. It includes a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria or detailing a clinical study to prove device performance against specific, quantifiable metrics.

Therefore, the information required to fully answer the request, particularly regarding specific acceptance criteria values and a dedicated study proving these criteria are met, is not present in the provided text. The document refers to "established performance criteria" and "predetermined specifications" but does not explicitly list them.

Based on the available text, here's what can be extracted and what is missing:

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

The document does not provide a table with specific, quantifiable acceptance criteria and directly reported device performance values against those criteria. Instead, it makes general statements about compliance with standards and equivalence to predicate devices.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified for any performance testing.
• Data Provenance: Not specified. Retrospective or prospective nature is not mentioned for any testing.

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)

This information is not provided. The document details various tests (EMC/Electrical Safety, Biocompatibility, Software Validation, Bench Performance, Skin Temperature Testing, Human Factors/Usability) but does not mention the use of experts to establish a "ground truth" in the context of diagnostic accuracy, which is what "ground truth" typically refers to in medical device validation studies.

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

This information is not provided. This concept typically applies to studies where multiple readers assess cases and their disagreements need to be resolved, which isn't described for the Therm-X validation.

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

There is no mention of an MRMC comparative effectiveness study, human readers, AI assistance, or effect size related to AI improvement. The Therm-X is a physical therapy device, not an AI-assisted diagnostic tool.

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

This concept is not applicable to the Therm-X device. It is a physical therapy device, not an algorithm, and its performance inherently involves human interaction during application and use.

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

The concept of "ground truth" as typically understood in diagnostic studies (e.g., expert consensus, pathology) is not applicable here. The device's validation relies on demonstrating compliance with safety standards, proper operation, and equivalence to predicate devices, rather than a diagnostic accuracy evaluation against a reference standard. For the "Clinical Testing" (skin temperature testing), the "ground truth" would implicitly be the actual skin temperature measurements and the absence of thermal damage, but the methodology for establishing this is not detailed as a "ground truth" process.

8. The sample size for the training set

This information is not provided. The term "training set" typically refers to data used to train machine learning algorithms, which is not relevant for this device.

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

This information is not provided and is not applicable to this device as it does not involve machine learning.

Summary of available information regarding acceptance and studies:

The document focuses on demonstrating substantial equivalence to predicate devices through various verification and validation activities.

• Acceptance Criteria (Implicit/General):

  • Conformance with established performance criteria/predetermined specifications.
  • Compliance with Electromagnetic Compatibility / Electrical Safety standards (IEC 60601-1, IEC 60601-1-2).
  • Biocompatibility of patient contact materials per ISO 10993 series (ISO 10993-1, ISO 10993-5, ISO 10993-10).
  • Software meeting performance requirements and specifications, and complying with FDA Guidance documents and Industry Standards for Moderate Level of Concern software.
  • Proper operation of the system (bench performance).
  • Temperature limits not causing thermal damage to the skin (clinical testing).
  • Safe and effective operation by users (human factors/usability).
  • Overall safety and effectiveness equivalent to predicate devices.

• Study/Testing Information:

  • Electromagnetic Compatibility / Electrical Safety: Performed in accordance with IEC 60601-1 and IEC 60601-1-2.
  • Biocompatibility: Testing of patient contact materials per ISO 10993-1, ISO 10993-5, ISO 10993-10.
  • Software Validation: Completed according to an established Validation procedure and FDA Guidance documents ("General Principles of Software Validation," "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"). Software is classified as a Moderate Level of Concern.
  • Performance (Bench): Tested for proper operation against predetermined specifications.
  • Clinical Testing (Skin Temperature): Performed for maximum time limits at highest/lowest temperature settings and for contrast therapy at default settings. Concluded no thermal damage and device is safe and effective as predicate devices. The type of study and sample size are not specified.
  • Human Factors / Usability: Assessments performed in a simulated use environment.

In conclusion, the document aims to assert substantial equivalence through demonstrating compliance with relevant standards and successful completion of various tests, rather than detailing a specific clinical study with quantifiable acceptance criteria against which the device's performance is precisely measured and reported.

Ask a specific question about this device