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Veinoflow SCD, LBTK-M-I 5006 is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. LBTK-M-I 5006 is indicated for Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema -Acute, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery, Leg ulcers, Venous Stasis / Venous Insufficiency.

Veinoflow SCD, Model LBTK-M-I 5006, is a pneumatic pump system that supplies compressed air to inflate garments that are attached to a patent's lower limbs. It consists of a pump controller, specially designed inflation and deflation garments for feet and legs, air supply tubes, and power line. The inflation and deflation garments have 3 types: ① leg garments, ② calf garments, ③ foot cuffs. The system offers sequential inflation and propels the vein blood from limb to heart, therefore enhancing the blood circulation. The controller can automatically detect the external garment type, and provides pressure correspondingly. The pressure value is preset and adjustable. The controller has a self test system, when there is any error, it will alarm both in visual and audio.

This document does not describe acceptance criteria for the performance of an AI/ML device in terms of diagnostic accuracy or clinical outcomes. Instead, it is a 510(k) summary for a medical device called "Veinoflow SCD" (Model: LBTK-M-I 5006), which is an intermittent pneumatic compression device.

The study described is focused on demonstrating substantial equivalence to a predicate device (Veinoflow SCD, Model: LBTK-M-I 5001, K123830), primarily through non-clinical testing of safety and performance characteristics. This type of regulatory submission does not typically involve the kinds of studies (e.g., multi-reader multi-case studies, standalone algorithm performance) that would be conducted for AI/ML-driven diagnostic or prognostic devices seeking to establish clinical performance.

Here's an analysis based on the provided text, addressing your questions where applicable and noting where the information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on compliance with established international standards for medical devices and demonstration that differences from the predicate device do not raise new safety or effectiveness concerns.

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

This document does not describe a "test set" in the context of AI/ML evaluation (i.e., a dataset used to evaluate diagnostic performance). The testing mentioned is for device safety and electrical performance (e.g., electrical safety, EMC, biocompatibility, battery safety) according to international standards. Therefore, information on sample size and data provenance in this context is not applicable or not provided. The provenance of the device manufacturer is China.

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

Not applicable. As noted above, this device is not an AI/ML diagnostic device requiring an expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is not an AI-assisted device.

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

Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" in this context is compliance with established engineering and safety standards (e.g., IEC 60601-1 for electrical safety, ISO 10993 for biocompatibility) and the functional specifications of the device as tested against these standards. It's not a clinical ground truth for a diagnostic outcome.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the AI/ML sense.

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

Not applicable.

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Veinoflow SCD system, Model LBTK-M-1 5001 is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. LBTK-M-I 5001 is indicated for Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema -Acute, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery, Leg ulcers, Venous Stasis / Venous Insufficiency.

Veinoflow SCD, Model LBTK-M-I 5001, is a pneumatic pump system that supplies compressed air to inflate garments that are attached to a patent's lower limbs. It consists of a pump controller, specially designed inflation and deflation garments for feet and legs, air supply tubes, and power line. The inflation and deflation garments have 3 types: ① thigh-calf garments, ② calf garments, and ③ foot cuffs. The system offers sequential inflation and propels the vein blood from limb to heart, therefore enhance the blood circulation. The controller can automatically detect the external garment type, and provides pressure correspondingly. The pressure value and inflatable interval time are preset and adjustable. The controller has a self test system, when there is any error, it will alarm both in visual and audio.

This document describes the Veinoflow SCD, Model LBTK-M-I 5001, an intermittent pneumatic compression device intended to prevent Deep Vein Thrombosis (DVT) by improving blood velocity. The submission is a 510(k) for a new device, seeking substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define 'acceptance criteria' in terms of success/failure rates for clinical outcomes but focuses on demonstrating substantial equivalence to a predicate device through functional and safety testing. The "reported device performance" is essentially a comparison of its technical specifications and tested safety features against recognized standards and the predicate device.

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

The document describes bench testing for the device, including:

• Pressure testing
• Inflation/deflation time
• Anti-stretch test of garment materials
• Anti-stretch test of air chamber welding point
• Air leakage test
• Burst testing of garment
• Bladder fatiguing test
• Velcro adhesion evaluation test
• Biological compatibility test
• Electromagnetic compatibility test
• Electrical Safety test

The sample size for these tests is not specified in the provided text. The data provenance is also not explicitly stated as retrospective or prospective clinical data, as the study focuses on bench testing and technical comparison, not patient outcomes. The manufacturer is Dalian Labtek Science & Development Co., Ltd. from Dalian, China, so the testing likely occurred there.

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

This information is not provided. The study relies on objective technical measurements and comparisons to recognized standards and the predicate device's specifications, rather than expert consensus on a test set.

4. Adjudication Method for the Test Set:

This information is not provided. Given the nature of the bench testing, an adjudication method for a test set (e.g., 2+1, 3+1) is not applicable or 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. This device is a physical medical device (intermittent pneumatic compression system), not an AI-assisted diagnostic tool, so such a study would not be relevant.

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

This question is not applicable. The device is a physical system, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is established through:

• Compliance with recognized international standards: ISO 10993 (biocompatibility) and IEC 60601 (electrical safety, EMC).
• Comparison against the predicate device's specifications and performance: The predicate device is "The Venous Assist System DVT-2600" (K112677). The new device is deemed substantially equivalent based on matching or exceeding the predicate's technical characteristics and safety features.
• Bench testing results: Demonstrating that the device meets functional and safety requirements through objective measurements (e.g., pressure, timing, material integrity).

8. The Sample Size for the Training Set:

This question is not applicable. This device is not an AI/machine learning algorithm requiring a training set.

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

This question is not applicable, as there is no training set mentioned for this device.

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A-V Hand & Foot Pump, Model LBTK-M-I 1000, is intended for use to enhance blood circulation in the arteries and veins in patents. The indications vary depending on whether pump is used with the foot pad or hand pad.
A. Foot use

• Acute Edema
• Chronic Edema
• Circulation Enhancement
• Deep Vein Thrombosis and Pulmonary Embolism Prophylaxis
• Leg Pain Incident to Trauma or Surgery
• Leg Ulcers
• Venous Stasis/Venous Insufficiency
  B. Hand use
• Acute Edema
• Chronic Edema
• Circulation Enhancement
• Pain Incident to Trauma or Surgery

A-V Hand & Foot Pump, Model LBTK-M-I 1000, consists of a pump controller connected by air supply hoses to specially designed inflation pads. The pump controller is microprocessor controlled, with a liquid crystal display, power switch, two air output sockets, function keys of "Left impulse run/pause", "Pressure adjustment", "Left preset settings", "Increase key-press", "Decrease key-press", "Right preset settings", "Impulse interval control", "Right Impulse run/pause", and so on. The pulse pressure, pulse duration, and pulse interval can be displayed by the screen. The inflation pads include foot pad, hand pad and undercast foot pad. The pads have one air chamber, through which the air energy is transferred to the body. The pads are non-sterile and for single patient use only. The inflation pad is rapidly inflated by a controlled impulse of air from the controller. After each impulse the controller automatically allows the inflation pad to deflate. To deliver the impulse pressure effectively to the extremity, the inflation pad must be retained in the correct position. The system has built-in alarms and displays to alert attention to adjustment requirements and to assist with rapid troubleshooting.

The provided document is a 510(k) summary for a medical device called the "A-V Hand & Foot Pump, Model LBTK-M-I 1000." This document describes the device, its intended use, and its substantial equivalence to a predicate device.

It does not contain information related to an AI-based device, nor does it present any clinical study data comparing the device's performance against acceptance criteria in the context of diagnostic accuracy or reader improvement.

The "Performance data" section only lists engineering and biocompatibility tests, not clinical performance for diagnosis or treatment. The "Effectiveness" section claims similarity to a predicate device in intended use and operation, but again, no specific performance criteria or studies are presented.

Therefore, I cannot fulfill the request for information regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance. This document pertains to a physical medical device and its safety/effectiveness based on engineering and biocompatibility testing, not an AI/algorithm-driven device with clinical performance metrics.

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