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The B&J DVT Calf/Thigh Garments, Models 801/830 Series are designed to increase venous blood flow in at risk patients in order to help lower the risk of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).

The 801/830 series of DVT calf/thigh garments are compression devices. When the devices are attached to a pump system, they provide intermittent, sequentially gradient pressure to a patient calf/thigh for the prevention of deep vein thrombosis (DVT). When the compression sleeve is inflated, the veins collapse which forces blood to move upward toward the heart. After compression is complete, the sleeves deflate which allows the veins to reopen and bring oxygenated blood to the calf or thigh.

The provided document is a 510(k) Premarket Notification for a medical device (B&J DVT Calf/Thigh Garments, Models 801/830 Series). It's important to understand that a 510(k) submission generally aims to demonstrate substantial equivalence to a previously cleared predicate device, rather than proving safety and efficacy from scratch through extensive clinical trials as would be required for a PMA (Premarket Approval).

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this 510(k) submission refer to the non-clinical tests performed to demonstrate that the new device performs at least as well as the predicate device regarding specific physical and functional characteristics.

Here's an analysis based on the provided text for the B&J DVT Calf/Thigh Garments:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "predefined acceptance criteria" but does not explicitly list them in a table format with corresponding performance metrics. Instead, it states that "All the test results demonstrate 801 series and 830 series garments meet the requirements of its predefined acceptance criteria and intended use."

The non-clinical tests conducted are listed as:

Note on Acceptance Criteria: The document implies that the acceptance criteria for these non-clinical tests were based on established standards for similar devices or performance equivalent to the predicate devices. Specific quantitative criteria (e.g., "bladder burst pressure > X mmHg", "leakage

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The B&J DVT Foot Garments, Models 820 Series are external pneumatic compression devices intended to lower the risk of deep vein thrombosis (DVT) and resulting pulmonary embolism (PE) in patients who may be at risk for thrombosis formation.

The 820 series of DVT foot garments are compression devices. When the devices are attached to a pump system, they provide sequentially gradient pressure to a patient foot for the prevention of deep vein thrombosis (DVT). When the compression sleeve is inflated, the veins collapse which forces blood to move upward toward the heart. After compression is complete, the sleeves deflate which allows the veins to reopen and bring oxygenated blood to the foot.

820 series includes 820M, 820L, 820MSQ, 820LSQ. Model variations are distinguished by characters. 820 means foot. M means medium size; L means large size. No SQ means intermittent devices; SQ means sequential devices. For example, 820MSQ means the foot garment is with medium size, and used for a sequential pump.

The provided text is a 510(k) submission for a medical device (B&J DVT Foot Garments, Models 820 Series), which is a type of premarket notification to the FDA. It does not describe a study involving an AI/Machine Learning algorithm, human readers, or image analysis. Instead, it focuses on demonstrating the substantial equivalence of the DVT garments to previously cleared predicate devices through non-clinical performance and safety testing.

Therefore, many of the requested criteria for describing an acceptance study for an AI/ML device cannot be extracted from this document, such as:

• Table of acceptance criteria and reported device performance for an AI/ML device: The document discusses performance tests for the physical DVT garments (bladder burst, leak, pressure cyclic test), not AI/ML performance metrics like sensitivity, specificity, or AUC.
• Sample size for test set and data provenance (e.g., country of origin, retrospective/prospective): Not applicable for a physical device.
• Number of experts and their qualifications for ground truth: Not applicable for a physical device.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable, as there's no AI involved.
• Standalone (algorithm-only) performance: Not applicable.
• Type of ground truth used (expert consensus, pathology, outcomes data): Not applicable. The "ground truth" here is physical performance specifications.
• Sample size for training set/How ground truth for training set was established: Not applicable, as this is not an AI/ML device.

However, I can extract the acceptance criteria and study information relevant to this specific medical device (DVT Garments), even though it doesn't pertain to an AI/ML system as your prompt implies:

Device Description and Purpose:
The B&J DVT Foot Garments, Models 820 Series, are external pneumatic compression devices. They are designed to lower the risk of deep vein thrombosis (DVT) and resulting pulmonary embolism (PE) in patients at risk for thrombosis formation. When attached to a pump system, they provide sequentially gradient pressure to a patient's foot.

Study Type:
This is a non-clinical testing study to assess the safety and performance of the physical device and demonstrate substantial equivalence to predicate devices, not an AI/ML performance study.

1. Table of acceptance criteria and the reported device performance

The document states: "All the test results demonstrate 820 series of foot garments meet the requirements of its predefined acceptance criteria and intended use."

However, the specific "predefined acceptance criteria" values are not explicitly detailed in the provided text for each test. We know the types of tests performed:

Note: The document only lists the types of tests performed and broadly states that the acceptance criteria were met. It does not provide the specific numerical acceptance thresholds (e.g., "bladder must withstand X mmHg," "leakage rate must be less than Y mL/min," "must withstand Z cycles").

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

• Sample Size: Not specified in the provided text. The document refers to "the following safety and performance tests were conducted," implying a sample of prototypes or production units were tested, but exact numbers are not given.
• Data Provenance: Not explicitly stated, however, the DVT garments are manufactured by B&J Manufacturing Ltd. in Shenzhen, China. Tests would likely have been conducted in a validation or manufacturing setting. The data is non-clinical/engineering test data.

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

• Not applicable in the context of an AI/ML device. This refers to engineering and material testing, where "ground truth" is established by manufacturing specifications, international standards, and test methodologies.

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

• Not applicable. This is for an AI/ML device where human readers adjudicate discrepancies. For physical device testing, results are typically objective measurements against predefined engineering specifications.

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. This is not an AI/ML device, so an MRMC study comparing human reader performance with and without AI assistance was not performed.

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

• No. This is not an AI/ML algorithm. The performance tests are on the physical device itself.

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

• Engineering Specifications and Standards: For physical devices like these DVT garments, the "ground truth" for performance is established through predefined engineering specifications, material properties, and relevant international or industry standards (e.g., for bursting strength, leak rates, cyclic fatigue). It's objective measurement against a benchmark.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no "training set."

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

• Not applicable. As above, no training set for an AI/ML algorithm is involved.

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The B&J Manufacturing Ltd. MHH800 and MHH800SQ 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 Deep Vein Thrombosis (DVT) Pumps MHH800 and MHH800SQ are external pneumatic compression (EPC) devices that aid in the prevention of DVT from a potentially life threatening condition which can lead to pulmonary embolism. MHH800 and MHH800SQ are non-invasive mechanical prophylactic devices. The devices function as secondary pumps to propel venous blood for patients whose deep veins thrombosis must be prevented after surgeries in Orthopaedics etc. Additionally, the devices are reusable and can be used for more than one patient within its lifecycle.

Model variations are distinguished by characters. MHH800 is without SQ, so the device means an intermittent pneumatic compression pump. MHH800SQ is with SQ, so the device means a sequential pneumatic compression pump.

The two devices separately consist of an air pump and a soft pliable compression garment(s) for the foot, calf or thigh. For MHH800, the controller supplies compression on a preset timing cycle (12 seconds inflation and maintenance followed by 48 seconds of deflation) at a suggested pressure setting of 40 mmHg for the Leg and 120mmHg for the Foot. For MHH800SQ, the controller supplies compression on a preset timing cycle (12 seconds inflation followed by 48 seconds of deflation) at a suggested pressure setting, 45mmHg in the 1st chamber, 40 mmHg in the 2nd chamber and 30mmHg in the 3rd chamber for the Leg and 120mmHg for the Foot. The pressure in the garments is transferred to the extremity, augmenting venous blood flow when the leg is compressed, reducing stasis. This process also stimulates fibrinolysis; thus, reducing the risk of early clot formation.

The DVT pumps produce automatically timed cycles of compressed air. This compressed air forces blood out of the deep veins, helping to prevent slowed or stopped blood flow. Bursts of air are delivered to the specially designed garments wrapped around extremities. This air helps to move blood out of the deep veins and reduce the risk of developing DVT. Garments are lined with tricot fabric to help reduce heat and perspiration.

The provided text describes the 510(k) premarket notification for the B&J DVT Compression Devices MHH800/MHH800SQ. This document focuses on demonstrating substantial equivalence to a predicate device, rather than a de novo approval requiring extensive clinical efficacy studies with specific acceptance criteria for AI performance. As such, the information typically requested in questions related to AI-driven medical devices (e.g., sample sizes for test and training sets, number of experts for ground truth, MRMC studies, standalone performance with effect sizes) are not relevant to this submission.

However, based on the non-clinical testing section, we can infer some general "acceptance criteria" related to the device's functional and safety performance, and the "study" that proves these criteria were met is the non-clinical testing itself.

Here's a breakdown of the requested information, adapted to the context of this 510(k) submission:

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

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: Not specified. For non-clinical, bench testing, this would typically refer to the number of units or components tested. This information is not provided in the summary.
• Data Provenance: Not specified. This is non-clinical testing, likely performed in a lab setting, possibly at the manufacturer's facility in China, or at a contracted testing lab. The data would be prospective as the tests are conducted specifically for the 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. This device is a DVT compression pump, a hardware device, not an AI or imaging diagnostic tool. "Ground truth" in the context of expert review for medical image analysis is not relevant here. The ground truth for performance tests is established by calibrated measuring equipment and established test protocols.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical studies, particularly for AI evaluations. This is a non-clinical, bench testing scenario.

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

• No. An MRMC study is not applicable to this device. This device is a physical therapy device and does not involve human "readers" or AI assistance in the interpretation of medical data.

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

• Not applicable. This is not an algorithm-only device. Its performance is evaluated through direct physical measurements (pressure, cycle time) and material/electrical safety tests.

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

• The "ground truth" for the non-clinical tests would be established by:
  • Calibrated Measurement Standards: For pressure accuracy, cycle time, etc., the "truth" is determined by measurements against known, calibrated equipment.
  • Industry Standards & Regulations: For biocompatibility, EMC, and electrical safety, the "truth" is adherence to established national and international standards (e.g., ISO, IEC).

8. The sample size for the training set

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

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

• Not applicable. (See #8)

In summary, the provided document is a 510(k) premarket notification for a Class II medical device, a DVT compression pump. The "acceptance criteria" and "study" proving they are met refer to a series of non-clinical, bench-top performance and safety tests conducted on the device, rather than clinical trials or AI performance evaluations commonly associated with the detailed questions on ground truth, expert review, and training/test sets. The conclusion states that these tests demonstrate the device meets predefined acceptance criteria and is substantially equivalent to a predicate device.

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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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