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To help prevent Deep Vein Thrombosis (DVT)

The Flowtron ACS800 pump is a pneumatic pump that supplies compressed air to inflate compression garments that are attached to patient's limbs.
It is designed to work with the ArjoHuntleigh ranges of DVT calf/thigh compression garments, Foot compression garments and Tri Pulse calf/thigh compression garments.
The pump automatically senses the type of compression garment connected and adjusts the pressure/time cycle accordingly.
Each garment is compressed alternately, applying pressure to the patient's limb. to help prevent deep vein thrombosis.

This device, the Flowtron ACS800 Pump and Tri Pulse Garments, is a pneumatic pump system designed to help prevent Deep Vein Thrombosis (DVT). Its clearance is based on demonstrating substantial equivalence to predicate devices: the Flowtron Universal AC600 (K010744) for the pump and the STS garments (K012008) for the Tri Pulse garments.

The provided document describes various tests performed to demonstrate this equivalence, primarily focusing on bench testing of the device's functionality and performance rather than clinical studies with human subjects.

Here's an analysis of the available information against your requested points:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating "substantial equivalence" to predicate devices through various tests. The reported performance refers to the satisfactory outcomes of these tests.

Study Details:

Based on the provided document, the regulatory submission relies heavily on bench testing and comparison to predicates rather than a primary clinical study with a test set of patient data.

1. Sample size used for the test set and the data provenance:

   • Test set sample size: Not applicable in the context of human subjects or patient data. The "test set" here refers to physical prototypes of the device components (pump, Tri Pulse garments, DVT garments, Foot garments) undergoing various engineering and performance tests.
   • Data provenance: Not applicable. The data is generated from laboratory bench tests.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for bench testing is defined by engineering specifications, international standards (e.g., IEC, EN, ISO), and performance of predicate devices. This type of evaluation does not typically involve human expert consensus for "ground truth" as it would for image interpretation or diagnosis.

3. Adjudication method for the test set: Not applicable. Adjudication methods (like 2+1 or 3+1) are used in clinical studies with human evaluations (e.g., blinded reading of medical images). For bench testing, results are typically determined by instrument readings against predefined pass/fail criteria or direct comparison to predicate device performance.

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 device is a mechanical pump and garment system, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself "stands alone" in its automated function (pump delivering compression to garments). The tests described (functionality, performance, life testing) assess this standalone performance against specified criteria and predicate devices. There is no "algorithm only" component in the sense of a software-based diagnostic or AI tool being evaluated separately from a human operator.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" is established through:

   • Engineering specifications: Predefined performance parameters (e.g., pressure, timing, durability).
   • International standards: Compliance with recognized safety and performance standards (IEC 60601-1, EN 60601-1-2, ISO 10993 series).
   • Predicate device performance: Directly comparing the new device's performance to that of previously cleared devices to establish equivalence in function and safety.

7. The sample size for the training set: Not applicable. This submission does not involve machine learning or AI models that require training sets.

8. How the ground truth for the training set was established: Not applicable, as there is no training set for an AI/ML model.

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The Restep DVT System is a prescriptive device that helps stimulate blood flow in the deep veins of the legs and is intended for use in :- . Preventing Deep Vein Thrombosis due to the presence of risk factors for thrombus formation during orthopedic, trauma, neurology, urologic, critical care, general medicine obstetrics and general surgery.

The Restep DVT System consists of the Restep pump and compatible leg and foot compression garments. The system is a lightweight, portable, prescriptive pneumatic compression device that helps to stimulate blood flow in the deep veins of the legs through the use of pneumatically controlled single chamber pressure cuffs, actuated by an electronically controlled pump unit and solenoid valves.

The Restep DVT System is an intermittent pneumatic compression device intended to prevent Deep Vein Thrombosis (DVT). The 510(k) submission (K090308) indicates that no separate acceptance criteria or a dedicated study proving device performance against such criteria were performed for this device in the same way a diagnostic AI device might be evaluated. This device was deemed substantially equivalent to predicate devices based on technological characteristics and similar performance in pressure/cycle profile and blood flow augmentation.

Here's an analysis of the provided information based on your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

• Sensitization: Material does not elicit a sensitization response (ISO10993-10).
• Irritation: Material is a non-irritant (ISO10993-10). | - Cytotoxicity testing (ISO10993-5) results indicate the material is non-cytotoxic.
• Sensitization testing (ISO10993-10) results indicate the material does not elicit a sensitization response.
• Primary skin Irritation testing (ISO10993-10) results indicate the material is a non-irritant.
  Overall: "results indicate that the material used will have negligible effects on the patient." |
  | Clinical Performance (Blood Flow Augmentation) | Produce a similar pressure/cycle profile and similar level of blood flow velocity augmentation in the femoral vein compared to predicate devices (specific quantitative acceptance criteria are not provided for "similar," but implied to be within an acceptable range for therapeutic equivalence). | Test results of the Restep DVT System and predicate devices have shown that the Restep DVT System produces a similar pressure and time profile whilst squeezing a patient's limb and this results in similar level of blood flow velocity augmentation, as measured in the femoral vein. |

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

The documentation does not explicitly state a specific "test set" sample size or its provenance (country of origin, retrospective/prospective) for a study intended to "prove the device meets acceptance criteria" in the way a diagnostic algorithm would.

Instead, the performance evaluation relies on bench testing (for pump and software) and biocompatibility testing (for garments) against established standards and in-house protocols. For clinical performance, it refers to:

• "test results of the predicate devices"
• "the Restep DVT System have been done for pressure/cycle profile, and blood flow augmentation on test subjects."

The number of "test subjects" for the blood flow augmentation comparison is not provided. The data provenance is also not specified.

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

Not applicable in the context of this device. The "ground truth" for electrical safety, EMC, software validation, pump output, and biocompatibility is based on adherence to published international standards and in-house testing protocols, not expert consensus on clinical cases.
For blood flow augmentation, the "ground truth" would be the measured femoral vein velocity, but this is a physiological measurement, not an expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

Not applicable. This is not an AI diagnostic device that requires expert adjudication of cases. The performance is assessed through objective measurements against technical specifications and physiological responses in test subjects.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret images or data, and their performance is compared with and without AI assistance. The Restep DVT System is a therapeutic device (intermittent pneumatic compression).

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

Yes, in a sense, a standalone evaluation of the device's functional performance was central to its submission. The "algorithm" here would be the pump's control software and the pneumatic mechanism.

• Software verification and validation was performed.
• Performance testing of the output parameters and profiles of the pump was done to ensure it met its specifications (e.g., pressure, cycle times).
• The comparison for blood flow augmentation was described as "test results... on test subjects" measuring a physiological response directly, implying an "algorithm only" (device only) assessment of its effect.

7. The Type of Ground Truth Used

The "ground truth" for the various tests performed can be characterized as:

• Technical Specifications/Standards: For electrical safety, EMC, software validation, and pump output performance, the ground truth is defined by the requirements of the cited industry standards (e.g., UL, CSA, IEC, EN) and the device's design specifications (e.g., 40mmHg pressure, 12s inflate/48s deflate cycle).
• Biological/Chemical Assays: For biocompatibility (cytotoxicity, sensitization, irritation), the ground truth is derived from laboratory tests adhering to ISO10993 standards.
• Physiological Measurements: For blood flow velocity augmentation, the ground truth is the direct measurement of femoral vein velocity in test subjects.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI that would require a "training set." Its operation is based on fixed algorithms and pneumatic principles.

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

Not applicable as there is no training set for this device.

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The STS system is designed to help prevent Deep Vein Thrombosis (DVT), by increasing venous blood flow.

The STS range of sleeves, are three chamber graduated, sequential compression sleeves, to be used in conjunction with the Huntleigh AC600 Flowtron Universal pump (K010744). The STS range of compression sleeves consist of two sheets of PVC laminate materials welded together to form three chambers. The size and shape of these chambers are similar to the predicate device, as is the method of fitting to the patient's limb. On the proposed device, a single tube into the lower chamber inflates the complete sleeve. proposed devices and gradient inflation of the middle and upper chambers is achieved by a series of bleed channels between chambers and bleed orifices to atmosphere. On the predicate device, the material in contact with the patient's skin is non-woven fibre. The STS has a layer of polyester foam against the patient's skin, identical in composition to other approved Huntleigh sleeves. The systems have similar fault alarms, i.e. low pressure, blocked/kinked tubes, and system faults.

The provided text describes a 510(k) premarket notification for STS Compression Sleeves, focusing on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance metrics as would be found for an AI/ML-based device.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, ground truth, and training sets is not applicable in this context. The document describes a non-clinical equivalence testing rather than a clinical study or a study validating an AI/ML algorithm.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly defined with quantitative acceptance criteria and performance statistics as would be for an AI/ML device.

The determination of substantial equivalence for this device is based on non-clinical, inflation performance testing. The acceptance criterion implicitly is that the Huntleigh STS compression sleeves demonstrate similar inflation performance (pressure/time cycle) to the predicate device.

• Pressures in each chamber are similar.
• Compresses a similar area of the patient's limb.
• Made from similar materials. |

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

• Sample Size: Not specified quantitatively. The text states "The sleeves are tested by fitting to a subject's limbs," implying at least one subject, but no specific number is given.
• Data Provenance: The testing appears to be internal to Huntleigh Healthcare, Inc. The country of origin of the data is not specified, but the company is based in the USA (New Jersey). The testing is prospective for the purpose of this 510(k) submission, as it was performed to support the new device.

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

Not applicable. There is no "ground truth" in the sense of expert medical diagnosis or labeling for this type of device. The assessment is based on physical performance comparisons to a predicate device.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication process is described for this non-clinical performance test. The comparison is objective (inflation metrics) against a predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is not an AI/ML device, nor a diagnostic device that would typically involve human readers. Therefore, an MRMC study is not relevant to this submission.

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

Not applicable. This is a physical medical device (compression sleeves), not an algorithm or AI/ML product.

7. The Type of Ground Truth Used

Predicate Device Performance Data. The "ground truth" (or more accurately, the comparator) for determining equivalence is the established performance characteristics (inflation pressure/time cycles) of the legally marketed predicate device, the Kendall SCD Therapeutic System (K890938).

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is not an AI/ML 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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