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The LD Q-IPC III is a system to prevent DVT(Deep Vein Thrombosis) by improving the blood velocity of patients.

Leg Compression
The use of the product with Calf Cuff and Thigh Cuff is indicated for:

1. Deep vein thrombosis and pulmonary embolism prophylaxis.

Foot Compression
The use of the product with Foot Cuff is indicated for:

1. Circulation enhancement.
2. Deep vein thrombosis prophylaxis.
3. Edema-Acute.
4. Edema-Chronic.
5. Extremity pain incident to trauma or surgery.
6. Leg Ulcers.
7. Venous stasis /Venous insufficiency.

The LD Q-IPC III Intermittent pneumatic compression device is a pneumatic compression device that noninvasively helps reduce the incidence of deep vein thrombosis, a potentially life threatening condition.

The LD Q-IPC III Intermittent pneumatic compression device consists of the controller, the Tubing Sets and single-patient used cuff. The cuff includes calf cuffs, thigh cuffs and foot cuffs.

The controller will deliver air to the cuffs and sequentially pressurize them. Cuffs will be pressurized from the distal air chamber to the proximal air chamber. After the compression, the controller will allow an interval time for vein refilling, before the controller starts to pressurize the cuffs again. The cycles will be repeated throughout the time the unit is in use or for the duration of the default operating time.

The provided document is a 510(k) premarket notification for an intermittent pneumatic compression device (LD Q-IPC III) and primarily focuses on establishing substantial equivalence to a predicate device (Veinoflow SCD, LBTK-M-I 5001).

Based on the information provided in the document, here's an analysis of the acceptance criteria and study details:

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

The document does not explicitly state "acceptance criteria" in terms of specific performance metrics with numerical thresholds (e.g., a certain percentage of DVT reduction). Instead, the submission focuses on demonstrating substantial equivalence to a predicate device. The performance is assessed by comparing the device's technical specifications and intended use against the predicate device.

Table: Acceptance Criteria (Implied by Substantial Equivalence) and 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)

The document does not describe a clinical study with a "test set" of patients or data in the way one would for a diagnostic algorithm or a comparative clinical trial. This submission is for a physical medical device (intermittent pneumatic compression device), not an AI/ML-based diagnostic or prognostic tool.

The "testing" performed was non-clinical (bench testing, standards compliance) rather than patient-based data collection.

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. There was no clinical "test set" and thus no ground truth established by experts in this context.

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

Not applicable, as there was no clinical "test set" requiring adjudication.

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 device, and no MRMC study was performed or described.

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

Not applicable. This is a physical device, not an algorithm, and the concept of "standalone performance" for an algorithm does not apply. The device's performance is inherently "standalone" in its function as a compression device.

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

Not applicable in the context of a clinical test set. The "ground truth" for this submission are the established safety and performance standards (IEC, ISO) and the specifications of the legally marketed predicate device. The device is shown to meet these standards and be substantially equivalent to the predicate.

8. The sample size for the training set

Not applicable. This is a physical device submission and does not involve AI/ML models requiring a "training set."

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

Not applicable. No training set was used.

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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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