(29 days)
The ArterioFlow 7500 is intended as an adjunctive therapy for patients with ischemic disease of the lower extremities, due to one or more of the following causes:
- Amputations (minor) .
- Angioplasty/stent failure .
- Arteriopathic wounds .
- Graft failure .
- Intermittent claudication .
- Ischemia .
- Night Pain .
- Rest Pain .
- Small vessel disease .
- Ulcers .
The device is intended for home and hospital use.
The ArterioFlow 7500 is intended for the improvement of blood circulation in the lower extremities to help prevent and reduce complication of poor circulation, by increasing arterial blood flow through the application of bilateral or unilateral intermittent compression to the foot and calf.
The device for consists of a pump, inflatable garments, and tubing. In operation, the device is attached via tubing to garments containing inflatable chambers applied externally and bilaterally over the feet and calves. Maximum pressure and treatment times are digitally programmable. Quick connector fitting on the tubing prevent accidental and incorrect orientations. Garments are available in anatomical designs including a single inflation chamber for the foot and a single inflation chamber for the calf. Garments are non-sterile, intended for single patient use and are intended to be applied over bandages or clean hosiery. Hook-and-loop fasteners allow for easy application and adopting a variety of sizes.
The provided document describes a 510(k) premarket notification for the "ArterioFlow 7500 Sequential Compression Device." This device is a sequential compression device used to improve blood circulation in the lower extremities. The document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria for an AI/ML device or a new type of therapeutic device.
Therefore, many of the requested points from the prompt (related to AI performance, ground truth, expert adjudication, MRMC studies, sample sizes for training/test sets, etc.) are not applicable to this type of medical device submission. The device is a physical medical device (pump, garments, tubing) and its performance is assessed through bench and laboratory testing against specifications, not through an AI model's predictive accuracy.
Here's the information that can be extracted relevant to the prompt, with explanations for why other points are not present:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Specification) | Reported Device Performance (Conformity) |
|---|---|
| Pressure Calibration for Pressure Sensor | Meets specifications (Implied by "assures that the product meets its specifications") |
| Cycle Time Performance | Meets specifications (Implied by "assures that the product meets its specifications") |
| Treatment Time Performance | Meets specifications (Implied by "assures that the product meets its specifications") |
| Pressure Performance of Arterial Garment | Meets specifications (Implied by "assures that the product meets its specifications") |
| Tensile Strength of Arterial Garment | Meets specifications (Implied by "assures that the product meets its specifications") |
| Conformance to UL 60601-1-2 | Conforms |
| Conformance to ISO 14971 | Conforms |
Study Proving Acceptance Criteria:
The document states, "Bench and laboratory testing was performed and assures that the product meets its specifications." This indicates that the performance tests listed (PQ-03 to PQ-07) were conducted as part of this bench and laboratory testing.
Non-Applicable or Unknown Information (based on the provided text)
Since this is not an AI/ML device or a diagnostic device requiring clinical accuracy studies, the following information is not present or relevant in this 510(k) summary:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. "Test set" refers to data for evaluating an algorithm, which is not relevant here. The testing involved physical device performance. The sample size for bench/laboratory tests of physical parts is not specified, but it would typically be a limited number of devices or components tested to engineering specifications.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not relevant here. Device specifications (e.g., pressure, cycle time, tensile strength) are engineering parameters.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudication of expert opinions is relevant as there's no clinical "ground truth" being established by experts for algorithmic performance.
- 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 does not involve human readers interpreting data with or without AI assistance. It is a therapeutic physical device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm or AI device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a physical device like this is its engineering specifications and its ability to meet those during manufacturing and operation, confirmed by bench testing.
- The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no "training set."
- How the ground truth for the training set was established: Not applicable. No training set is involved.
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).