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The PnueAira device and garments for legs and core are intended for use by medical professionals and patients who are under medical supervision to increase lymphatic flow in the treatment of many conditions such as:

• Lymphedema
• Primary lymphedema
• Post mastectomy edema
• Edema following trauma and sports issues
• Post immobilization edema
• Venous insufficiency
• Reducing wound healing time
• Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, arterial ulcers, and diabetic leg ulcers
• Lipedema

The PnueAira (PNCU-01) is a pneumatic compression device that uses air to systematically compress a patient's limbs affected by lymphedema and/or similar conditions. The control unit is placed on a table near the user and plugged into a power outlet. The patient wears the desired garment (i.e., core or full leg) and attaches it to the control unit via the connectors located on the garment. The patient uses the control unit to select the appropriate prescribed treatment profile, as shown on the device display, to begin their therapy profile. The device supports Peristaltic (i.e., a chamber is inflated and deflated before moving to the next chamber in a particular sequence) and Non-Peristaltic, sometimes known as sequential (i.e., all chambers are inflated in order, then all chambers are deflated simultaneously) compression modes.

The PnueAira device is designed for at-home treatment of lower extremity lymphedema. It assists in reducing lymphedema-related swelling by directing excess fluid from an impaired lymphatic area to healthier parts of the body.

The PnueAira system consists of the following components:

• Control unit
• Power Adapter
• Garments - Core and Full-leg
• Y-Connector Accessory

The provided FDA 510(k) clearance letter for PnueAira (PNCU-01) does not include information about a clinical study or human reader performance. This device is a Class II Compressible Limb Sleeve, and the clearance is based on substantial equivalence to predicate devices, primarily the AIROS 6P Sequential Compression Device.

The submission relies on non-clinical testing to demonstrate safety and effectiveness, rather than clinical trials or studies involving human readers and AI assistance. The information presented specifically details the acceptance criteria regarding the device's functional performance and compliance with relevant electrical safety, usability, home use, and biocompatibility standards.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from human reader studies, or details regarding sample sizes, expert adjudication, MRMC studies, or standalone algorithm performance, as these were not part of the documented submission for this particular device.

Here's a breakdown of the information that can be extracted based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

The document outlines functional and performance testing conducted to ensure the device meets its design specifications and complies with relevant standards. These serve as the "acceptance criteria" for non-clinical performance characteristics.

Information Not Applicable/Provided in the Document:

The following points are typically associated with AI/ML-based medical devices or devices requiring clinical effectiveness studies. This 510(k) submission for the PnueAira (PNCU-01) does not describe such studies.

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for this device's non-clinical testing. The submission does not mention clinical test sets or 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" in the context of clinical expert review is not mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 or interpretive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical pneumatic compression system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to the non-clinical testing described. For device performance, the "ground truth" would be established by validated measurement equipment and adherence to standard specifications.
8. The sample size for the training set: Not applicable. This device does not use an AI/ML model trained on data.
9. How the ground truth for the training set was established: Not applicable.

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The Coretech Compression System RHB3003 is a sequential compression device which is intended for treatment of patients with the following conditions:

• Lymphedema
• Venous stasis ulcers
• Venous insufficiency
• Peripheral edema

The device is safe for both home and hospital use.

The Coretech Compression System RHB3003 (Coretech RHB3003) is a compression device that delivers sequential compression to the affected upper and lower extremity of patients with lymphedema, chronic edema, peripheral edema, venous insufficiency and venous stasis ulcers.

This device helps direct and move excess fluid from an impaired lymphatic region to healthy regions, where fluid can be absorbed and processed naturally by the body. The Coretech RHB3003 controller is used to inflate the connected garment chambers. The air chambers inflate and deflate repeatedly and orderly to create circular pressure on the affected limb. The air inflates from the distal end to the proximal end of the patient. This helps to promote the flow of blood and lymph and improves microcirculation. The pressure can be adjusted to avoid discomfort to the patient and deflates as one cycle.

This document is a 510(k) clearance letter for the Vive Health Coretech Compression System (model RHB3003). It confirms that the device is substantially equivalent to a predicate device for its indicated uses. However, the provided document does not contain the detailed acceptance criteria and study information requested.

The letter mentions that various types of testing were completed to support the substantial equivalence determination, including:

• Electrical safety and electromagnetic compatibility (EMC) testing
• Software verification and validation testing
• Mechanical bench testing (covering start/stop, inflation/deflation, cycle time, operating modes, pressure calibration, operating/treatment time, pressure accuracy, burst pressure/garment integrity, firmware/software integration, and noise performance)
• Packaging Validation

Crucially, the document states: "The technological comparison and performance testing together demonstrate that Coretech RHB3003 has a similar safety and effectiveness profile as the predicate device." It does not, however, numerically report acceptance criteria or the specific device performance against these criteria. It only lists the types of tests conducted.

Therefore, I cannot populate the table or provide specific answers to the detailed questions regarding sample sizes, ground truth establishment, expert qualifications, or MRMC studies for this device based on the provided text. The document is an FDA clearance letter, not a detailed technical report of the studies themselves.

In summary, the requested information (acceptance criteria, reported performance, sample sizes, ground truth details, expert involvement, and MRMC studies) is NOT present in the provided FDA 510(k) Clearance Letter.

If you have a different document (e.g., the actual test reports or a summary of the performance data submitted to the FDA), I would be able to extract that information.

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The Venera 608 Series system is a prescription device intended to be used preventatively to increase venous blood flow in patients at risk of deep vein thrombosis due to the associated risk factors for thrombus formation during: trauma, critical care, general medicine, general surgery, as well as neurological, orthopedic, urologic, obstetric conditions and treatments.

The Venera™ 608 Series deep vein thrombosis prevention system is a pneumatic compression device that noninvasively helps reduce the incidence of deep vein thrombosis, a potentially life-threatening condition. The Venera™ 608 Series system consists of a device and a pair of soft compression cuff(s) (sleeves) and the extension tubing set for the calf, calf-thigh, and foot. The device will alternatively inflate the two cuffs and mimic the natural walking pace in order to enhance circulation. The device-supplied compression provides a 60-second automatically timed cycle consisting of an approximately 12-second inflation period followed by a 48-second period of relaxation. A pressure of 40mmHg is used for the calf, calf-thigh, and 120mmHg for foot treatments. This pressurization enhances venous flow and fibrinolytic activity in order to ultimately prevent early blood clotting.

This document is a 510(k) summary for the Venera 608 Deep Vein Thrombosis (DVT) Prevention System. This device is an intermittent pneumatic compression device.

Here's an analysis of the acceptance criteria and the study data provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for the functional and performance tests (e.g., Pressure Accuracy Test, Cycle Time Test). It generically states "samples of the device underwent function and mechanical testing."

The data provenance is from tests conducted by the manufacturer, Suzhou Minhua Medical Apparatus Supplies Co. Ltd. (China). The document does not specify if the testing was performed retrospectively or prospectively, but standard device verification and validation testing is typically prospective.

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

This information is not provided in the document. The device performance tests are primarily engineering and technical validations against defined specifications, not expert-adjudicated clinical outcomes.

4. Adjudication method for the test set

This information is not applicable/not provided as the performance tests listed are objective engineering and technical validations, not clinical studies requiring adjudication of results by experts.

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 MRMC study was conducted. The document explicitly states: "No animal study or clinical study was conducted." This device is a mechanical DVT prevention system, not an AI diagnostic tool that would typically involve human readers.

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

This question is not applicable in the context of this device. The Venera 608 is a physical medical device (intermittent pneumatic compression device) with embedded software for control, not a standalone algorithm used for diagnostic or predictive purposes without human intervention as implied by the question. The software verification and validation section confirms the software's performance, but not in a "standalone algorithm" context for clinical decision-making.

7. The type of ground truth used

For the functional and performance tests (e.g., pressure accuracy, cycle time, alarm function), the "ground truth" would be the established engineering specifications and regulatory standards for the device's operational parameters. For biocompatibility, the ground truth is established by the specified ISO standards. For electrical safety and EMC, the ground truth is established by the specified IEC standards.

8. The sample size for the training set

Not applicable. This document describes a physical medical device (pneumatic compression system), not an AI/ML-based system that requires a "training set" in the conventional sense. The "software verification and validation" mentioned refers to traditional software testing, not machine learning model training.

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

Not applicable for the same reasons as #8.

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The ARTAIRA Arterial Compression Device's is an intermittent pneumatic compression device intended for treatment of patients with the following conditions:

• · Intermittent claudication
• · Rest pain
• Diabetic Foot
• · Ischemic neuritis
• · Arterial ulcers
• · Gangrene
• Poor runoff.

The AIROS ARTAIRA Arterial Compression Device is an intermittent pneumatic compression device intended to increase blood flow and increase circulation in the lower extremities by providing timed compression to the foot/ankle and calf. The device consists of a hard casing with an air pump, a set of air valves, an air reservoir controlled by the device software to deliver a rapid burst of pneumatic pressure to the treatment area. The device connects through air tubing to a pair of compression garments (left and right leg), each with two air chambers: one on the underfoot (Foot/Ankle chamber) and one on the calf area (Calf Chamber). The device can either be used with one garment or two garments. The system is intended to be used primarily at home settings according to a physician-prescribed therapy.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the ARTAIRA Arterial Compression Device. This document does not contain information about the acceptance criteria and study proving device performance as typically understood for AI/ML-driven medical devices.

The listed device, the "ARTAIRA Arterial Compression Device (AACD01)", is an intermittent pneumatic compression device. The document primarily focuses on demonstrating substantial equivalence to a predicate device (ArtAssist Device) based on technological characteristics, functional performance testing of the device hardware (e.g., pressure accuracy, timing accuracy, integrity testing), and adherence to various medical device standards (e.g., ISO, IEC).

There is no mention of an AI/ML component in the device description or the testing conducted. Therefore, the specific questions regarding acceptance criteria for AI/ML performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable to the information provided in this FDA clearance letter.

The functional performance testing described in the document (User Interface & Error Indicator Testing, Noise Testing, Compression Sequence Timing Accuracy Testing, Pressure Accuracy Testing, Therapy Time Accuracy Testing, Garment Integrity Testing, Air Leakage Testing) relates to the mechanical and software control aspects of a traditional medical device, not an AI/ML algorithm's diagnostic or predictive capabilities.

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The UMED REPROCESSED CTC VP 520 FOOT CUFF is used in the same manner as intended by the original device manufacturer (OEM) to increase venous blood flow in patients at risk of developing Deep Vein Thrombosis (DVT) and pulmonary embolism (PE). The device is a prescription device for the use in a clinical setting or in the home.

The UMED REPROCESSED CTC VP 501 CALF CUFF is used in the same manner as intended by the original device manufacturer (OEM) to increase venous blood flow in patients at risk of developing Deep Vein Thrombosis (DVT) and pulmonary embolism (PE). The device is a prescription device for the use in a clinical setting or in the home.

The UMED REPROCESSED AIRCAST ELITE CALF CUFF 3040 / 3050 is used in the same manner as intended by the original device manufacturer (OEM) to increase venous blood flow in at-risk patients in order to prevent deep vein thrombosis (DVT) and. The device is a prescription device for the use in a clinical setting or in the home.

The UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE is used in the same manner as intended by the original device manufacturer (OEM) to increase venous blood flow in patients at risk of developing Deep Vein Thrombosis (DVT) and pulmonary embolism (PE). The device is a prescription device for the use in a clinical setting or in the home.

The UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF is used in the same manner as intended by the original device manufacturer (OEM) to increase venous blood flow in at- risk patients in order to prevent deep vein thrombosis (DVT). The device is a prescription device for the use in a clinical setting or in the home.

Not Found

The provided document is an FDA 510(k) clearance letter for reprocessed medical devices, specifically compressible limb sleeves used to prevent Deep Vein Thrombosis (DVT) and pulmonary embolism (PE).

It is important to note that this document DOES NOT contain information about acceptance criteria or a study proving that a device meets such criteria. The letter is a regulatory approval, stating that the reprocessed devices are substantially equivalent to legally marketed predicate devices. It discusses general controls, regulations, and reporting requirements, but not the specific performance testing data, acceptance criteria, or study methodologies that would be used to demonstrate a device's performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided input. The document does not contain the information required to populate the table or answer the other questions about study design, ground truth, or expert involvement.

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The Venowave VW5 series of devices are prescriptive and induce improved vascular and lymphatic flow of the lower limbs. Venowave device are intended to treat the following:
Indications for Use:

• Management of the symptoms of post thrombolytic syndrome (PTS)
• Prevention of deep vein thrombosis (DVT)
• Prevention of primary thrombosis
• Treatment of lymphedema
• Diminishing post-operative pain and swelling
• Treatment of leg swelling due to vascular insufficiency
• Treatment of varicose veins
• Treatment of chronic venous insufficiency
• Enhancing blood circulation
• Treatment of intermittent claudication

The Venowave VW5 is a series of compact, battery-operated peristaltic pumps that generate a wave-form motion, and when worn below the knee strapped firmly to the calf, result in compression of the calf and consequently, an increased upward volumetric displacement of venous and lymph fluid. Each of the models within the family (VW5-6;VW5-10; VW5-20; and VW5-30) is distinguished by the maximum number of times the wave plate cycles each minute (6, 10, 20 and 30 cycles/minute respectively). Clinical preference to choose a specific frequency of motion for each specific patient based upon that patient's clinical symptoms, severity of disease, and perceived compliance with treatment has been the motivation for creating each model within the series.

The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria. The document is a 510(k) premarket notification decision letter from the FDA for the Venowave VW5 device.

It primarily focuses on:

• Substantial Equivalence: The FDA's determination that the Venowave VW5 is substantially equivalent to a legally marketed predicate device (K073028).
• Device Description and Intended Use: Details about the device's function as a peristaltic pump to improve vascular and lymphatic flow in lower limbs, and its intended uses (e.g., prevention of DVT, treatment of lymphedema).
• Comparison to Predicate: A table outlining updates and changes made to the device compared to the predicate, such as specified contraindications, design changes, and battery type.
• Summary of Testing: A brief list of performance testing conducted (Software Verification, EMC, Electrical Safety Drop Test, Battery Testing) with "Pass" results.

The document does not provide:

1. A table of specific acceptance criteria (e.g., "Device must achieve 90% accuracy in detecting X") and reported performance metrics against those criteria.
2. Details on sample size, data provenance, expert ground truth establishment, or adjudication methods for any clinical study.
3. Information on multi-reader multi-case studies or standalone algorithm performance.
4. Details on the type of ground truth used or the sample size/establishment of ground truth for a training set.

The "Summary of Testing" section lists general performance tests (Software, EMC, Safety, Battery) which are typically engineering or non-clinical tests, not clinical performance studies with acceptance criteria relevant to medical diagnosis or treatment effectiveness.

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The Nimbl system is intended for use by medical professionals and patients who are under medical supervision, for the treatment of the following conditions: - Chronic edema - Lymphedema - Venous insufficiency - Wound healing

The Nimbl system is a pneumatic compression device that delivers intermittent sequential compression treatment to affected extremities for lymphedema, chronic edema, venous insufficiency, and wound healing. This device helps direct and move excess fluid from an impaired lymphatic region to healthy regions, where fluid can be absorbed and processed naturally by the body. The Nimbl controller is used to inflate the connected garment chambers in a pre-programmed sequence from the distal end to the proximal end of the patient. The pressure gradient provides higher distal pressures. This creates a dynamic wave of therapy that directs fluid into the lymphatic capillaries while maintaining distal prevent distal backflow. The patient's healthcare provider determines what pressure setting is appropriate for the patient.

The provided text describes the 510(k) premarket notification for the Nimbl (model PD08-N1) pneumatic compression device. It establishes substantial equivalence to a predicate device (Entre, model PD08-U). The focus of this document is on the comparison of technological characteristics and performance testing to demonstrate similar safety and effectiveness.

Here's an analysis of the acceptance criteria and study data based on the provided text:

Important Note: The provided document is a 510(k) clearance letter and summary, not a detailed clinical study report for an AI/ML medical device. Therefore, many of the requested details regarding AI/ML-specific study design (e.g., number of experts for ground truth, MRMC studies, training set details) are not applicable or not present in this type of submission for a pneumatic compression device. Wearable/Pneumatic Compression devices typically rely on bench testing, electrical safety, software V&V, and usability testing to demonstrate equivalence, rather than large-scale clinical studies with AI components that require expert consensus on image interpretation or similar.

Key Findings from the Document:

The Nimbl device is a pneumatic compression device, not an AI/ML-driven diagnostic or interpretative system. The "Performance Data" section lists types of testing completed, which are typical for hardware devices:

• Electrical safety and electromagnetic compatibility (EMC) testing
• Software verification and validation (including cybersecurity)
• Mechanical bench testing (pressure verification, port strength, component life testing)
• Usability testing
• Environment and distribution testing

The document repeatedly emphasizes that the subject and predicate devices utilize "the same fundamental technology, mode of action, and principles of operation." The "Software-Concern Level" is listed as "Basic Documentation Level" for the Nimbl, although it notes "Moderate Level of Concern" for the predicate with "Minor software updates have been made." This suggests the software functionality is not for complex interpretation or diagnosis.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this device (pneumatic compression) and the document provided, "acceptance criteria" is typically defined by adherence to relevant standards and demonstration of comparable performance to the predicate through bench and usability testing. Specific quantitative "device performance" metrics in the context of diagnostic accuracy (like sensitivity, specificity, AUC) are not relevant or provided here.

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

As this is a hardware device clearance, rather than an AI/ML diagnostic algorithm, there isn't a "test set" in the context of diagnostic accuracy. The testing performed involves bench testing (e.g., pressure verification, component life testing, port strength), electrical safety/EMC testing, software verification and validation, and usability testing. The sample sizes for these tests would typically be defined by engineering standards (e.g., number of units tested for durability, number of cycles, number of users for usability). These specific details (e.g., 'N' for specific bench tests) are not provided in this summary document, as they would be in the detailed testing reports submitted to the FDA.

Data Provenance: Not applicable in the context of clinical data for an AI/ML algorithm. The data provenance here refers to the origin of the device and testing, which is Tactile Medical. The testing is assumed to be conducted in a controlled lab/test environment. It is not listed as retrospective or prospective clinical data.

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

Not Applicable. This device does not generate medical diagnoses or interpretations that require expert human adjudication for "ground truth" establishment in the way AI/ML diagnostic devices do. The "performance" is mechanical and electrical, governed by engineering specifications and standards.

4. Adjudication Method for the Test Set

Not Applicable. See point 3 above.

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 not an AI-assisted diagnostic tool for human readers.

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

Not Applicable. This is a hardware pneumatic compression device. While it has software, it does not perform standalone diagnostic interpretation.

7. The Type of Ground Truth Used

Device Ground Truth: The "ground truth" for this device's performance relies on engineering principles, validated test methods against specifications (e.g., pressure accuracy against a manometer, force against a load cell), compliance with international standards (IEC 60601-1, IEC 62304), and comparability to the predicate device’s established safe and effective performance. Clinical outcomes data for efficacy (treating edema, lymphedema, etc.) are established for the class of devices and the predicate, not newly proven by this 510(k) submission, which focuses on substantial equivalence.

8. The Sample Size for the Training Set

Not Applicable. This device does not have a "training set" in the context of machine learning.

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

Not Applicable. See point 8 above.

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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.

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DVT Motion Pneumatic Compression Device is a prescription device intended for prophylaxis of Deep Vein Thrombosis (DVT), stimulating venous and arterial circulation, aiding in the prevention of venous stasis ulcers, aiding in the healing of cutaneous ulcers, reducing acute/chronic edema and compartmental pressures. For use in home or hospital setting.

The DVT Motion Pneumatic Compression Device is a portable, rechargeable battery-powered device intended for prescribed home use or hospital use to help prevent Deep Vein Thrombosis (DVT) in patients by stimulating blood flow. This is accomplished using an electronically controlled pump delivering a set amount of air to the leg garment that compresses the calf and aids blood flow through the lower extremities. The pump will inflate to a preset pressure of 50mmHg and deflate once this pressure is reached. The cycle continues until the unit is turned off. The tube free solution comes complete with a fully integrated lithium ion battery that supplies over 18 hours of treatment on a single charge, assuring that patients can be transported easily from the hospital to their homes without interruptions in treatment.

The provided text describes the 510(k) premarket notification for the "DVT Motion Pneumatic Compression Device." This device is a medical device and not an AI/ML-driven diagnostic or treatment system. Therefore, the questions related to AI/ML specific concepts like "acceptance criteria for AI models," "training set," "ground truth establishment," "experts for ground truth," "adjudication methods," and "MRMC comparative effectiveness studies" are not applicable to this document.

The document focuses on demonstrating substantial equivalence to a predicate device (VascuEase IC-1200-WH) through non-clinical performance and safety testing, not on the performance of a predictive algorithm.

However, I can extract information related to the device's performance based on the non-clinical testing mentioned.

Here's what can be extracted:

Device Performance and Proof of Meeting Acceptance Criteria

The document states that the "DVT Motion Pneumatic Compression Device meets the requirements of its pre-defined acceptance criteria and intended use" based on a series of non-clinical safety and performance studies. The specific acceptance criteria themselves are not detailed in the provided text, only the tests performed to demonstrate compliance.

1. Table of Acceptance Criteria and Reported Device Performance

As the specific numerical acceptance criteria are not explicitly detailed for each test within the document, I can only provide the types of tests performed and the general statement of compliance.

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

• Sample Size: Not specified for individual non-clinical tests. The tests were performed on the device itself.
• Data Provenance: The tests were conducted on the "subject device" (DVT Motion Pneumatic Compression Device) by Koge Micro Tech Co., Ltd. The document does not specify the country of origin of the labs, but Koge Micro Tech Co., Ltd. is located in Taiwan. These were prospective tests performed on the device to demonstrate its performance.

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

• Not Applicable: This is a physical medical device clearance, not an AI/ML system requiring expert-established ground truth for a test set. The "ground truth" for these tests comes from engineering standards and measurements, not human interpretation of data.

4. Adjudication Method for the Test Set

• Not Applicable: As above, this does not involve human adjudication for a test set in the context of an AI/ML model.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, Not Applicable: No MRMC study was performed as this is not an AI/ML diagnostic or image analysis device. The study type was non-clinical testing against engineering standards and comparison to a predicate device.

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

• Not Applicable: This is not an algorithm. The "software validation" mentioned refers to the software controlling the pneumatic compression device, ensuring its proper functioning, not a standalone diagnostic algorithm.

7. The Type of Ground Truth Used

• "Ground truth" was established by predefined engineering standards and test methodology. For example, pressure measurements are compared against a specified mmHg range, and cycle times against a target duration. The document states that "All the test results demonstrate DVT Motion Pneumatic Compression Device meets the requirements of its pre-defined acceptance criteria and intended use."

8. The Sample Size for the Training Set

• Not Applicable: There is no "training set" in the AI/ML sense for this device.

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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The Lymphedema Compression is comprised of a gradient compression sleeve and a portable intermittent pump to provide graduated compression in both sustained and intermittent settings for use in both the hospital and outpatient setting. It is pre-set to the default setting of 50 mmHg that cannot be adjusted or can be adjusted by the physician to a pressure within the specified range. It is intended for use in:

• Treatment of lymphedema
• Treatment of chronic venous insufficiency
• Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers
• Reducing venous leg ulcer healing time
• Reducing edema due to venous stasis
• Enhancing venous return
  The device is intended for home, and hospital use.

As a portable and rechargeable prescriptive device, the Lymphedema Compression is intended to be used in the home or clinical/hospital setting by or under the direction of a medical professional. It applies pressure to treat lymphedema and other edematous conditions.
Supplied clean and non-sterile, the Lymphedema Compression utilizes the pneumatically controlled cuff and is actuated by an electronically controlled air pump unit. All pump, battery and control components are protectively housed in a plastic case of the control unit, which is attached to an inflatable cuff/sleeve. The Lymphedema Compression contains an ON/OFF button, a SET button, and a display for user interface. In addition, there is also a port on the control unit for connecting the battery charger/AC adapter plug. The cuff component consists of multiple air chambers/bladders encased inside a soft nylon fabric or equivalent biocompatible fabric for increased patient comfort and biocompatibility compliance.
In operation, the user simply press the ON/OFF button to turn on the control unit, to which a cuff containing air chambers/bladders is connected. And the control unit then inflates the cuff to the default pre-determined pressure (50 mmHg) that cannot be adjusted to a pressure within the specified range via the SET button. Once the cuff pressure of the multiple air chambers/bladders reaches the pre-determined or adjusted level, the pump is turned off, and the cuff deflates to the ambient pressure through a valve inside the control unit. After the rest period, the cycle of inflation and deflation repeats until the device is turned off automatically or manually.

The provided FDA 510(k) summary (K240011) describes the "Lymphedema Compression" device and its substantial equivalence to a predicate device, ManaFlow (K200353).

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

The provided document doesn't explicitly list "acceptance criteria" in the typical sense of numerical thresholds for performance metrics. Instead, the substantial equivalence relies on demonstrating that the subject device's characteristics and performance are identical to or similar to the predicate device. The primary "acceptance criterion" is functional and technical equivalence to the predicate.

Here's a table based on the comparison provided in the 510(k) summary:

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

The document explicitly states: "Clinical testing was not needed in support of this 510(k) application."

Therefore, there was no clinical test set of patient data, no sample size of patients, and no data provenance relevant to clinical performance evaluation. The "test set" for the device's technical specifications consists of the individual components and the assembled device that underwent non-clinical bench testing.

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

Not applicable. Since no clinical testing was performed, there was no ground truth established by experts on patient cases. The evaluation of electrical safety, EMC, and physical/performance requirements relies on adherence to published voluntary standards and internal company specifications, not expert consensus on clinical outcomes.

4. Adjudication method for the test set

Not applicable. As no clinical testing or human reader study was conducted, there was no need for an adjudication method.

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 MRMC study was conducted. This device is a pneumatic compression device, not an AI-powered diagnostic or assistive tool 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 medical device (pneumatic compression) and does not involve an algorithm with standalone performance in the context of diagnostic interpretation. Its "performance" is based on mechanical and electrical parameters (e.g., pressure output, cycle time, safety features).

7. The type of ground truth used

The "ground truth" for this submission is adherence to recognized voluntary standards for medical device safety and performance (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2) and the technical specifications and functional characteristics of the legally marketed predicate device. Bench tests validated that the subject device met its own design specifications, which were shown to be identical or very similar to the predicate.

8. The sample size for the training set

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

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

Not applicable. (See #8)

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