Search Results

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