Search Results

The FlowMedic™ FM220 System is intended for the improvement of blood circulation in the lower extremities to help prevent and reduce complications of poor circulation.

The FlowMedic™ FM220 System is a small, battery operated, microprocessor controlled, portable and simple mechanical system, intended for the improvement of blood circulation in the lower extremities through the application of intermittent compression to the calf.

The FlowMedic™ FM220 System consists of the following basic components:

1. FlowMedic™ FM220 System Control Unit and Straps
2. FlowMedic™ FM220 System Disposable Sleeve
3. Charger

The anatomical concave-convex shaped Control Unit is directly mounted on a pre-positioned Sleeve on the calf. Upon Control Unit activation, the straps are periodically pulled into the Control Unit base and subsequently pull the underneath sleeve, generating an intermittent compressive pressure on the patient's limb.

The FlowMedic™ FM220 System is a mechanical system intended to improve blood circulation in the lower extremities. The provided text, a 510(k) summary, outlines its substantial equivalence to predicate devices and testing performed. However, it does not contain specific acceptance criteria, performance metrics, or details of a clinical study with human subjects, making it impossible to complete the table or answer many of the subsequent questions.

Here's an analysis of what can be gleaned from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document mentions "a set of in vitro (bench) performance testing and side by side comparison to the predicate devices." No sample size for a test set (e.g., number of patients, limbs, or cases) is provided, nor is the data provenance (e.g., country of origin, retrospective/prospective). This indicates that the primary testing for this 510(k) submission was likely bench testing, not human clinical trials.

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

This information is not provided. Given the nature of the testing described (in vitro bench testing), it's unlikely that experts were used to establish "ground truth" in the way they would be for image interpretation or diagnosis.

4. Adjudication method for the test set

This information is not provided.

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 MRMC study was described or performed. The device is a mechanical system, not an AI-powered diagnostic tool, so this type of study would not be applicable.

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

This information is not explicitly stated in terms of a "standalone" study for an algorithm. However, the "in vitro (bench) performance testing" is essentially standalone testing of the device's mechanical and operational characteristics.

7. The type of ground truth used

For the in vitro (bench) testing, the "ground truth" would be the actual physical measurements of parameters like pressure output, pressure duration, and frequency, as measured by calibrated instruments. This is not explicitly detailed but inferred from the type of testing described for a mechanical device.

8. The sample size for the training set

No information about a training set is provided, as the testing described is primarily bench testing for substantial equivalence, not a machine learning model.

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

Not applicable, as no training set for a machine learning model is mentioned.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The 510(k) summary for the FlowMedic™ FM220 System (K042217) focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving specific clinical efficacy with new, quantitative acceptance criteria via a clinical trial for this specific product.

The study described to support the device's performance and safety involved:

• Electrical safety and electromagnetic compatibility testing according to IEC 60601-1 (and amendments), and IEC 60601-1-2 standards.
• Software verification and validation testing.
• A set of in vitro (bench) performance testing and side-by-side comparison to the predicate devices.
• Hazard analysis including risk level and solutions performed in compliance with EN 1441 (1997) and AAMI/ISO 14971-1, 2000 for the entire system and for the software.

The results of this testing "indicated that the FlowMedic™ FM220 System performs according to its specifications and share very similar operational characteristics, including applied pressure output, pressure duration and frequency, with its predicate devices."

The acceptance criteria implicitly used in this submission are that the FlowMedic™ FM220 System demonstrates similar safety and operational characteristics to its predicate devices, as demonstrated through the listed engineering and bench tests, without raising new safety or effectiveness concerns. The specific quantitative acceptance criteria or detailed methodologies for these tests are not provided in this summary.

Ask a specific question about this device