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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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Prevention of Deep Vein Thrombosis (DVT)
Enhancement of venous & arterial circulation
Prevention of venous stasis
Assist healing of cutaneous ulcers
Reduction of acute or chronic edema
Reduction of lower limb pain due to surgery or trauma
Reduction of compartmental pressures

The Flowtron Foot Garment is a wrap around foot garment comprising of a bladder and surrounding material intended to apply cyclic compression to the foot to improve return venous blood flow to prevent and reduce the risk of Deep Vein Thrombosis (DVT).

The Flowtron Foot Garment is connected to an ArjoHuntleigh Flowtron pneumatic pump. The pump controls and generated the delivery of air to inflate and deflate the Foot Garment in a cyclic manner.

Flowtron Foot Garments are configured with a custom design connector that means that they are only compatible with ArjoHuntleigh Flowtron pneumatic pumps.

The provided text describes a 510(k) premarket notification for "Flowtron Foot Garments – Sterile" (K122330). The core of the submission is to demonstrate substantial equivalence to a predicate device (K965153, Huntleigh FP5000 System, Model FP5000), with the primary difference being the sterility of the new device.

Therefore, the acceptance criteria and the study that proves the device meets them are focused on demonstrating that the sterility process makes the sterile garments safe and effective, and that they perform identically to the non-sterile predicate.

Here's an analysis based on the provided document:

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

The document does not explicitly state quantitative "acceptance criteria" in a table format for performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device. The performance is deemed acceptable if it is identical to the predicate except for the sterility aspect, and the sterility process itself is validated.

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 specify a "test set" in the context of clinical performance data for the device's therapeutic function (e.g., DVT prevention efficacy). The performance is established by direct comparison and equivalence to the predicate.

For the sterility validation, which is the primary novelty of this submission, the document states: "Full details of the validation of sterility processing and shelf life stability have been submitted for sterile garments." However, it does not provide the sample size, data provenance, or whether the study was retrospective or prospective. Given it's a validation of a manufacturing process (sterilization and shelf life), it would typically be a prospective, controlled study performed by the manufacturer, ArjoHuntleigh AB, located in Sweden.

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 submission relies on substantial equivalence to a previously cleared device and validation of a manufacturing process (sterilization). There is no "ground truth" derived from expert consensus on clinical images or patient outcomes for this particular submission.

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

Not applicable. There's no clinical "test set" requiring expert adjudication mentioned in the document.

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 medical garment for compression therapy, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device is a physical medical device, not an algorithm.

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

The "ground truth" here is primarily established by:

• Predicate Device Performance: The established safety and effectiveness of the existing non-sterile Flowtron Foot Garments (K965153).
• Sterilization Standards: Adherence to recognized international standards for sterilization (ISO 11135) and subsequent validation of that process.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" in the context of this device submission, as it's not a machine learning or AI device.

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

Not applicable, as there is no training set.

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