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The Caremed Supply Inc. VesoFlow Lite Deep Vein Thrombosis (DVT) Compression Device is intended to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.

The VesoFlow Lite DVT Compression Device is an Intermittent Pneumatic Compression System that counteracts blood stasis and coagulation changes; two of the three major factors that promote deep vein thrombosis (DVT) a potentially life threatening condition which can lead to pulmonary embolism.

The VesoFlow Lite is a non-invasive mechanical prophylactic system that massages the feet or legs in a wavelike, milking motion that promotes blood flow and deters thrombosis, helping to empty pooled or static blood from the valve cusps of the femoral vein. Fibrinolytic activity is increased, stimulating the release of a plasminogen activator. This therapy typically complements other prophylactic measures, such as antiembolic stockings and anticoagulants.

Some exciting features include:

• o User friendly master control unit that is designed so that its functions are self-explanatory
• Power micro switch (ON/OFF)
• . An alarm light displays a fault status with an audio alarm and LED display
• . LED display that can monitor errors, sleeves statuses the device
• User friendly hanging bracket that provides easy attachment

The system consists of an air pump and single-patient-use compression sleeve one for the foot, one for the calf and one for the thigh. The air pump and compression sleeve may be used on one lower extremity. If the air pump is used simultaneously on both lower extremities, it is important that the identical sleeve type be used on both legs (i.e. foot sleeve with foot sleeve, calf sleeve with calf sleeve, or thigh sleeve with thigh sleeve). The inflation pressure settings are pre-set by the manufacturer and cannot be changed. The compression level for the foot sleeve is 120mmHg (16kPa). The compression level for the calf and thigh sleeve is 40mmHg. The sleeve inflates and maintains compression for 12 seconds. Then, the sleeve deflates for a period of 48 seconds. As the sleeve inflates, it compresses the foot, calf or thigh which augments venous blood flow, thereby reducing stasis. This process also stimulates fibrinolysis: thus, reducing the risk of early clot formation. Regularly check the system while in use, assuring pump operation and sleeve fit.

The provided text describes a 510(k) premarket notification for the VesoFlow Lite DVT Compression Device, asserting its substantial equivalence to a predicate device. However, the document does not contain a study that proves the device meets specific acceptance criteria in the format you requested.

Instead, the document details a comparative performance test against a predicate device (VESOFLOW PLUS DVT Compression Devices Model Name: IPCS) and references another device (VesoPress DVT System, Pump Model VP500D) to establish "substantial equivalence" for market clearance.

Here's an analysis based on the information provided, highlighting what is present and what is missing concerning your request:

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

• Acceptance Criteria: Not explicitly defined or provided in a table. Instead, the "acceptance criteria" are implied to be that the VesoFlow Lite DVT Compression Device's performance, physical characteristics, and safety aspects are sufficiently similar or superior to the predicate device and comply with relevant standards.

• Reported Device Performance:
  The document provides a comparison table (Section 5.11) outlining various specifications of the subject device (VesoFlow Lite DVT Compression Device) against the predicate device (VESOFLOW PLUS DVT Compression Devices Model Name: IPCS) and, for certain parameters, the reference device (VesoPress DVT System, Pump Model VP500D).

  Item	Subject device (VesoFlow Lite DVT Comp. Device)	Predicate device (VESOFLOW PLUS DVT Comp. Devices IPCS)	Reference Device (K061814) (where applicable)	Substantial equivalence determination (Comment)
  Intended Use	Same as predicate	Intended to increase venous blood flow in at-risk patients to prevent DVT	-	Same
  Type of use	Prescription Use	Prescription Use	-	Same
  Size	9.83" x 4.37" x 8.28"	7.54" x 5.12" x 7.95"	-	Different but does not raise new issue of substantial equivalence
  Weight	2.4 Kg	2.8 Kg	-	Different but does not raise new issue of substantial equivalence
  Pressure (mmHg)	Calf/Thigh: 40; Foot: 120	Calf/Thigh: 40; Foot: 130	Calf/Thigh: 40; Foot: 80-120	Different but Same as Reference Device K061814
  Input Rating	AC 100-240V, 50/60Hz	AC 100-240V, 50/60Hz	-	Same
  Fuse Rating	T2AL 250V	1A/250V	-	Different but does not raise new issue of substantial equivalence
  IEC Classification	Class II, Type BF Not AP or AGP type	Class II, Type BF Not AP or AGP type	-	Same
  Ingress of Water Protection	IP21	IP22	-	Different but does not raise new issue of substantial equivalence (likely due to other safety measures)
  Operation Humidity	30% to 75%	30 - 75%	-	Same
  Operation Temperature	15°C - 40°C	15°C - 35°C	-	Different but does not raise new issue of substantial equivalence
  Operation Atmospheric Pressure Range	700 hPa to 1060 hPa	700 hPa to 1060 hPa	-	Same
  Mode of Operation	Continuous	Continuous	-	Same
  Applied Part	Sleeve and Air Hose	Garment and Air Hose	-	Same
  Applied Mode of Pressure	Intermittent	Intermittent	-	Same
  Inflation time per chamber	12 seconds	12 seconds for Calf/Thigh, 3 seconds for Foot	All 12 seconds	Different but Same as Reference Device K061814
  Deflation time per chamber	48 seconds	48 seconds for Calf/Thigh, 30 seconds for Foot	All 48 seconds	Different but Same as Reference Device K061814
  Application	Non-invasive / external	Non-invasive / external	-	Same
  Battery Pack	No	Yes	-	Different but does not raise new issue of substantial equivalence (implies AC power is sufficient or design choice)
  Software / Control panel complexity	w/o Pressure and Timer display, w/o Mute, Caution, and Battery symbols display, w/o Timer Reset function, w/o Alarm mute button, w/o Maintenance alarm light	w/ Pressure and Timer display, w/ Mute, Caution, and Battery symbols display, w/ Timer Reset function, w/ Alarm mute button, w/ Maintenance alarm light	-	Different but does not raise new issue of substantial equivalence (simpler UI, likely cost-related)
  Sleeve Sizes (Calf, Thigh, Foot)	Equivalent ranges and types	Equivalent ranges and types	-	Same
  Air Hose	extension of 60" (pair), standard; extension of 118" (pair)	extension of 60" (pair), standard; extension of 118" (pair); extension of 177" (pair)	-	Same (for the available types)

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 states "A series of safety and performance tests were conducted on the subject device..." (Section 5.9). These typically involve engineering design verification tests and compliance with recognized standards.
• No sample size for a clinical test set is provided because "No clinical test data was used to support the decision of substantial equivalence" (Section 5.10).
• Data Provenance: The tests mentioned (Biocompatibility, Software Validation, EMC/Electrical Safety, Reliability, Performance, Usability) are non-clinical (laboratory/bench testing). The country of origin of the data is not explicitly stated but is implicitly Taiwan, given the submitter's address. The data is prospective as it was generated specifically for this submission.

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. Since no clinical test data was used and the evaluation was based on non-clinical comparative performance, there was no "ground truth" established by medical experts in the context of patient outcomes. The "ground truth" for non-clinical tests is established by engineering specifications, recognized standards, and the performance of the predicate device.

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

• Not applicable. This refers to methods for resolving discrepancies among expert readers in clinical studies. No clinical studies were conducted for this submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a mechanical DVT compression device, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.

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

• Not applicable. This is a physical medical device, not an algorithm or software-only device.

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

• For the non-clinical performance tests, the "ground truth" was based on:
  • Engineering specifications and design requirements: The device had to perform within specified parameters (e.g., pressure, inflation/deflation times).
  • Compliance with recognized standards: (e.g., biocompatibility standards, electrical safety standards IEC 60601-1, EMC standards IEC 60601-1-2).
  • Performance of the predicate device: The subject device's performance was compared to that of the legally marketed predicate device to demonstrate substantial equivalence.

8. The sample size for the training set

• Not applicable. As the submission did not involve AI/machine learning, there is no concept of a "training set."

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

• Not applicable. As the submission did not involve AI/machine learning, there is no "training set" or corresponding ground truth establishment.

In summary: The FDA clearance for the VesoFlow Lite DVT Compression Device was based on demonstration of substantial equivalence through comprehensive non-clinical testing (bench testing, safety, and performance evaluations) against a legally marketed predicate device, rather than new clinical trials or studies with explicit acceptance criteria for human performance or diagnostic accuracy. The key "study" was the comparative performance testing and verification of compliance with various safety and performance standards.

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The Caremed Supply Inc. VESOFLOW®PLUS SQS and IPCS Deep Vein Thrombosis (DVT) Compression Devices are intended to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.

VESOFLOW®PLUS that counteracts blood stasis and coagulation changes - two of the three major factors that promote deep vein thrombosis (DVT). VESOFLOW® PLUS is a non-invasive mechanical prophylactic system that massages the feet or legs in a wavelike, milking motion that promotes blood flow and deters thrombosis, helping to empty pooled or static blood from the valve cusps of the femoral vein. Fibrinolytic activity is increased, stimulating the release of a plasminogen activator. This therapy typically complements other prophylactic measures, such as antiembolic stockings and anticoagulants.

VESOFLOW®PLUS is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb. Therefore, VESOFLOW®PLUS is identified as a compressible limb sleeve.

The provided text is a 510(k) premarket notification for a medical device (VESOFLOW®PLUS DVT Compression Devices). It outlines the device's purpose, non-clinical testing, and a comparison to a predicate device to claim substantial equivalence.

However, the document does not describe a study involving an AI/Machine Learning device that requires a test set, training set, or human expert adjudication. The device in question is a mechanical deep vein thrombosis (DVT) compression device, and the evaluation focuses on standard medical device safety and performance testing (biocompatibility, software, electromagnetic compatibility, electrical safety, performance, and risk management) as well as substantial equivalence to a previously marketed device.

Therefore, the requested information regarding acceptance criteria and a study proving an AI/ML device meets them, including sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details, cannot be extracted from the given text.

The document explicitly states in "5.9 Clinical Testing": "No clinical test data was used to support the decision of safety and effectiveness." This further confirms that there was no study of the type you are asking about for this particular device submission.

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The Caremed Supply Inc. VASOPOUSE® SQS and IPCS Decp Vein Thrombosis (DVT) Compression Devices are intended to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.

VASOPOUSE® that counteracts blood stasis and coagulation changes - two of the three major factors that promote deep vein thrombosis (DVT) - a potentially life threatening condition which can lead to pulmonary embolism. VASOPOUSE® is a non-invasive mechanical prophylactic system that massages the legs in a wavelike, milking motion that promotes blood flow and deters thrombosis, helping to empty pooled or static blood from the valve cusps of the femoral vein. Fibrinolytic activity is increased, stimulating the release of a plasminogen activator. This therapy typically complements other prophylactic measures, such as ant embolic stockings and anticoagulants.

VASOPOUSE® is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb. Therefore, VASOPOUSE® is identified as a compressible limb sleve.

This document describes the 510(k) notification for the VASOPOUSE® DVT Compression Device Model: IPCS/SQS by Caremed Supply Inc. The submission aims to demonstrate substantial equivalence to a predicate device, the VESOFLOW (K110977), also manufactured by Caremed Supply Inc.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Reported Device Performance

The document states that "All the test results demonstrate VASOPOUSE® meets the requirements of its pre-defined acceptance criteria and intended uses." However, the specific quantitative or qualitative acceptance criteria for each test performed are not explicitly provided in the document. The reported device performance is generally stated as meeting these unspecified requirements.

The non-clinical testing performed includes:

• Function Test
• Vibration Test
• Shock Test
• Free Fall Drop
• Life Test

Additionally, the device was tested in accordance with several safety and biocompatibility standards:

• EN/IEC60601-1-2:2007 (Electromagnetic compatibility for medical electrical equipment)
• ISO10993-1:2009 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process)
• ISO10993-5:2009 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity)
• ISO10993-10:2002/AMD.1:2006(E) (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)
• IEC60068-2-06 (Environmental testing - Part 2-6: Tests - Test Fc: Vibration, sinusoidal)
• IEC60068-2-27 (Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock)
• ISO14971:2007 (Medical devices - Application of risk management to medical devices)

The document asserts that these non-clinical tests confirmed the device's safety and effectiveness and its substantial equivalence to the predicate device.

Table of Acceptance Criteria and Reported Device Performance:

Additional Requested Information:

Since this 510(k) pertains to a DVT compression device (mechanical, non-diagnostic), many of the detailed aspects typically associated with AI/software-as-a-medical-device (SaMD) validations (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not relevant or provided in this type of submission. This document focuses on demonstrating physical and functional equivalence to a predicate device, primarily through non-clinical bench testing.

Therefore, for the remaining points, the answer is "Not Applicable" based on the provided document, as the submission does not involve an AI/software component that would require such studies.

2. Sample size used for the test set and the data provenance: Not Applicable (Bench testing of physical device, not data-driven software).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not Applicable (Bench testing, not expert-adjudicated data).
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 (No AI component).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not Applicable (No algorithm/AI).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not Applicable (Performance evaluated against engineering specifications and industry standards for physical device functioning, not clinical ground truth in the context of diagnoses or outcomes).
8. The sample size for the training set: Not Applicable (No training set as it's not a machine learning device).
9. How the ground truth for the training set was established: Not Applicable.

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The Caremed Supply Inc. Vesoflow SQS and IPCS Deep Vein Thrombosis (DVT) Compression Devices are intended to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.

The Caremed Vesoflow® SQS and IPCS Deep Vein Thrombosis (DVT) Compression Systems are electrically powered, non-invasive mechanical compression devices designed for use by patients for whom external compression therapy is indicated. Their intended function and use is to increase venous blood flow and help prevent Deep Vein Thrombosis (DVT), by applying intermittent, controlled pressure to the calf, thigh or foot.

The Vesoflow product will be available in two (2) models. These are the Vesoflow SQS and the Vesoflow IPCS. They differ in that the SQS delivers sequential compression therapy while the Vesoflow IPCS delivers intermittent compression therapy.

The provided 510(k) summary for the Caremed Supply Vesoflow SQS and IPCS Deep Vein Thrombosis Device does not contain detailed information about acceptance criteria and a specific study proving the device meets those criteria in the way typically seen for AI/ML-based medical devices.

Instead, the submission focuses on:

• Substantial Equivalence: The primary method for FDA clearance for this type of device (compression therapy) is by demonstrating substantial equivalence to predicate devices (Huntleigh Healthcare Universal Flowtron (K010744) and Tyco/Kendall SCD Express (K040511)). This means demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.
• Performance Data (Safety Standards): The only "performance data" mentioned is compliance with the IEC 60601-1 Standard for Medical electrical equipment, Part 1: General requirements for safety. This is a general electrical safety standard, not a clinical performance or diagnostic accuracy study.
• Internal Garment Testing: It states that "Garments were tested internally by Caremed and met their specified requirements." This is vague and does not provide details of the requirements, test methods, or results.

Therefore, many of the requested sections below cannot be populated from the provided text because a clinical performance study with acceptance criteria, ground truth, expert readers, and statistical analysis (as typically done for diagnostic AI/ML products) was not included or required for this type of device submission.

Here is an attempt to address your request based only on the provided text, with many N/A or "Not Provided" entries due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable (N/A) – No clinical performance test set or study detailed for efficacy. The primary "test" was for electrical safety (IEC 60601-1) and internal garment testing, for which sample sizes are not specified.
• Data Provenance: Not applicable (N/A) – No clinical data is described. The IEC 60601-1 testing is a laboratory-based safety standard, not a clinical study with patient data. Internal garment testing details are not provided.

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

• Not applicable (N/A) – No clinical performance study requiring expert ground truth for a test set is described.

4. Adjudication Method for the Test Set

• Not applicable (N/A) – No clinical performance study requiring adjudication is described.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described. This type of study focuses on diagnostic performance compared to human readers, which is not relevant for this mechanical compression therapy device.

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

• Not applicable (N/A) – This is a mechanical compression device, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

• Not applicable (N/A) – No clinical performance study requiring a specific type of ground truth (like expert consensus, pathology, or outcomes data) is described. The "ground truth" for the device's substantial equivalence relates to its functional characteristics and safety compliance compared to existing devices and standards.

8. The Sample Size for the Training Set

• Not applicable (N/A) – This is not an AI/ML device; therefore, there is no "training set."

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

• Not applicable (N/A) – This is not an AI/ML device; therefore, there is no "training set" or associated ground truth establishment.

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