(265 days)
Comparison of Indications for Lower Extremity:
Reduces acute edema, such as elevated compartment pressures, edema secondary to trauma and/or surgical procedures, post-bypass graft edema, post-operative edema secondary to venous ligation or venous stripping and edema secondary to sprains, strains and sports related injuries of the lower extremity.
Reduces chronic edema.
Assists in treating patients at risk for deep vein thrombosis (DVT) and pulmonary embolism (PE), including providing pre-, intra, and post-operative prophylaxis for DVT and PE.
Relieves circulatory disorders secondary to diminished blood flow, such as ischemia secondary to peripheral vascular disease.
Assists healing of cutaneous ulcers.
Relieves pain, increases range of motion and limb mobility, and expedites return of function following trauma or surgery.
Treats venous stasis, venous insufficiency and varicose veins.
Reduces lymphedema, including lymphedema secondary to trauma and/or surgery and reduces or controls chronic lymphedema, including post-paralytic lymphedema due to stroke or spinal cord injury.
Comparison of Indications for Upper Extremity:
Reduces acute edema, such as elevated compartment pressures, edema secondary to trauma and/or surgical procedures, and edema secondary to sprains, strains and other sports related injuries of the upper extremity.
Reduces chronic edema.
Relieves circulatory disorders secondary to diminished blood flow, such as ischemia secondary to peripheral vascular disease.
Relieves pain, increases range of motion and limb mobility, and expedites return of function following trauma or surgery.
Reduces lymphedema, including lymphedema secondary to trauma and/or surgery, post-mastectomy lymphedema, and reduces or controls chronic lymphedema including post-paralytic lymphedema due to stroke or spinal cord injury.
The A-V Impulse System Model 6060 (AVIS 6060) is designed to stimulate the natural pumping action of a patient's venous plexus system located in the sole of the foot. During the normal weightbearing phase of ambulation, blood is forcibly emptied from a plexus of veins in the sole of the foot into the deep and high pressure veins of the calf and thigh. This internal pump propels the blood up the leg and back to the heart. The A VIS 6060 foot pump mimics this natural physiological process for patients who are confined to the bed or are otherwise unable to walk normally due to trauma, surgery or pathology.
A similar pumping mechanism exists within the palm of the hand. There is a system of looping veins located near the metacarpo-phalangeal joints of the hand. Flexion of these joints triggers an internal pumping process that propels the blood into the deep and/or superficial veins of the arm and back to the heart. Besides flexing the fingers, increasing the tissue tension on the dorsum of the hand can trigger this pumping action. Either way, activation of the internal pump is followed by post-compression hyperaemia during which the venous plexus refills with blood.
The provided text is a 510(k) summary for the A-V Impulse System Model 6060. It discusses the device's mechanism, safety features, and claims of effectiveness, referencing numerous clinical studies. However, it does not contain the specific information required to complete the requested table and answer all questions, particularly regarding detailed acceptance criteria, specific performance metrics of the device as a standalone entity, sample sizes for test sets, data provenance, expert qualifications for ground truth, adjudication methods, or MRMC studies.
The document primarily focuses on presenting a summary of clinical literature to support expanded indications for use. It lists various conditions for which the device is claimed to be effective by citing existing studies. It does not present a single, structured study designed to establish acceptance criteria and demonstrate the device's performance against them in a systematic way that would allow direct population of the requested table.
Therefore, I can only extract limited information and point out what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the provided text does not define explicit "acceptance criteria" in a quantitative, measurable way that would typically be found in a study designed to demonstrate performance against pre-defined thresholds. Instead, it summarizes findings from various clinical studies, often stating "reduces swelling," "prevents need for surgery," "significantly decreases," "increases blood flow," etc. These are outcomes, but not framed as acceptance criteria with specific numerical targets.
| Acceptance Criteria (Not explicitly stated as criteria, but inferred from indications and study outcomes) | Reported Device Performance (Summary of outcomes from cited literature) |
|---|---|
| Lower Extremities | |
| Reduction of acute edema | "Reduces dangerously high compartment pressures" (Gardner et al., MacEachern et al.); "Statistically significant decrease in limb swelling" (Gardner et al., Stranks et al., Myerson & Henderson, Stockle et al., Beuker & Johnson, England & Simms) |
| Prevention/reduction of need for surgical intervention (e.g., fasciotomy) | "Prevented the need for surgical intervention in four patients" (Gardner et al.); "Prevented the need for fasciotomy" (MacEachern et al.) |
| Reduction of post-bypass graft edema | "Significant decrease in swelling" (England & Simms, White & Zarge); "Significantly diminished postoperative edema" (White & Zarge) |
| Reduction of post-operative edema secondary to venous ligation/stripping | "Well-suited for use in patients with post-operative edema and diminished venous capacity" |
| Reduction of edema secondary to sprains, strains, sports-related injuries | "Reduce edema following limb trauma in multiple studies" (including hip, knee injuries, ruptured ligaments, ankle sprains, various fractures) |
| Prophylaxis for DVT and PE | "Reduced the rate of fatal pulmonary embolisms (PE) from 9.1% to 0% and the six-month mortality from 18.2% to 6.3%" (randomized, prospective study, 92 patients); "No PEs occurred in the group treated with the AVIS 6060" vs. "six PEs occurring in the control group" (randomized prospective study, 74 patients); "Reduces the incidence of proximal DVTs" |
| Relief of ischemia secondary to peripheral vascular disease | "Significant relief" in ischemic rest pain (Gardner & Fox); "Successfully increased exercise tolerance" (Delis et al.); "Increases popliteal artery flow by 40-50%" (Nicolaides & Delis); "70% increases in waking distances" (3 months therapy, 10 patients); "Relieved ischemic rest pain significantly" (Morgan et al.); "Increase blood flow and relieve rest pain" (Morgan) |
| Improvement in Raynaud's Syndrome symptoms | "Increases arterial flow" in affected extremities; described as similar to medications for the disorder. |
| Improvement in Range of Motion and Limb Mobility | "Significant improvements in subtalar range of movement at three months, as well as an earlier return to work" (Erdmann et al. 23 patients); "Faster attainment of motion goals" (Beuker & Johnson) |
| Reduction of Reflex Sympathetic Dystrophy symptoms | "Reduced swelling and facilitated physiotherapy" (Gardner & Fox case studies) |
| Treatment of Varicose Veins / Venous Insufficiency | "Increased venous return" (McMullin et al.); "Effective in all types of venous insufficiency" (McMullin et al.); "Used successfully to treat varicose veins" (Beuker & Johnson) |
| Reduction of Lymphedema | "Effective in reducing accumulations of lymphedema" (Gardner & Fox); "Reduced the post-operative swelling" |
| Upper Extremities | |
| Reduction of Compartment Syndrome | "Reduce compartmental pressure levels"; "Reduce both post-trauma edema and consequent venous congestion" |
| Reduction of acute edema secondary to trauma/surgery | "Swelling was reduced dramatically" (Reflex Sympathetic Dystrophy patients); "Significant reduction of swelling occurred within the first twenty-four hours in over fifty percent of the patients" (20 patients); "Significant decreases in post-traumatic edema" (7-10 days, 2 patients with radius fractures); "Dramatic reductions in swelling" (hand and arm injuries); "Average 52% reduction in swelling in four patients" (soft tissue injury) |
| Reduction of edema secondary to sprains, strains, sports-related injuries | "Effective in reducing post-traumatic edema"; "Reduce compartmental pressures" (e.g., frozen shoulder, tendinitis) |
| Relief of ischemia secondary to peripheral vascular disease | "Increase arterial blood flow" by impulse pumping; supported by lower extremity findings |
| Improvement in Raynaud's Syndrome symptoms | "Increases arterial blood flow" in hands and fingers; seen as consistent with medication effects |
| Improvement in Range of Motion and Limb Mobility | "Improved range of motion" (Stockle); "Faster attainment of motion goals"; "Average 52% reduction in swelling" (Kohrs); "Facilitated early use of the extremity" |
| Reduction of Reflex Sympathetic Dystrophy symptoms | "Useful to reduce swelling and facilitate physiotherapy" (Gardner & Fox case studies); "Reported success in treating" (Liedke, Stockle) |
| Reduction of Lymphedema | "Reduces lymphedema"; "Reduce lymphedema in patients following mastectomy" |
2. Sample Size for Test Set and Data Provenance
- Test Set Sample Sizes: Not explicitly defined as a single "test set." The device's effectiveness is supported by a collection of independent clinical studies, each with its own sample size. Examples mentioned:
- Compartment Syndrome: 11 patients (Gardner et al.), 1 case study (MacEachern et al.)
- Edema (Lower Extremities): 38 patients (Gardner et al.), 40 patients (Stockle et al.), 20 patients (England & Simms)
- DVT/PE: 92 patients (randomized, prospective, hip fractures), 74 patients (randomized, prospective, total hip replacement)
- Ischemia: 12 patients (Gardner & Fox), 10 patients (claudication), 10 patients (PVD), 22 patients (PVD)
- Range of Motion: 23 patients (Erdmann et al.)
- Edema (Upper Extremities): 20 patients, 2 patients (radius fractures), 4 patients (soft tissue injury)
- Data Provenance: The studies cited are primarily clinical literature, implying real-world patient data. Given the context of a 510(k) submission, these would be retrospective summaries of previously published or conducted studies. The text does not specify the country of origin for each study, but the authors' names suggest a Western (likely UK/US) context. The studies are by nature prospective clinical studies conducted by various investigators, but the 510(k) itself is a retrospective compilation of their findings.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. The text refers to "clinical investigators," "clinicians," and "authors" of medical literature. These would be expert physicians, but their specific qualifications for establishing 'ground truth' in the context of a defined test set (e.g., a consensus panel for image review) are not described. Each study would have its own methodology for diagnosis and outcome assessment, forming its "ground truth."
4. Adjudication Method for the Test Set
This information is not provided. As the content summarizes various independent clinical studies, there isn't a single, unified "adjudication method" for a single test set. Adjudication methods would have been specific to each cited study, but these details are not aggregated here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable: The device (AVIS 6060) is a physical medical device (an impulse pump), not an AI algorithm for diagnostic reading. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device. The studies described compare device use versus non-use (control groups or baseline conditions) or report outcomes in device-treated patients.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Applicable, but definition differs: The AVIS 6060 is a standalone physical device designed to work independently after being applied to the patient. Its performance is entirely "standalone" in the sense that it mechanically performs its function without a human-in-the-loop directly influencing its immediate operation other than setup and monitoring. The effectiveness studies summarize its performance in this standalone capacity.
7. The type of ground truth used
The ground truth used in the various cited studies generally falls into these categories:
- Clinical Outcomes/Measurements: Direct measurements of physiological parameters (e.g., compartment pressures, limb swelling/edema reduction, blood flow velocity/volume, popliteal artery flow, walking distances), incidence of medical events (PEs, DVTs), and subjective patient reports (pain relief, exercise tolerance, range of motion).
- Pathology/Diagnosis: Implied by the conditions being treated (e.g., DVT, PE, various fractures, Raynaud's, PVD). The diagnosis of these conditions would also form part of the "ground truth" for patient inclusion in studies.
- Expert Consensus (Implied): Clinical diagnosis and assessment of improvement by medical professionals (physicians, nurses, physiotherapists) involved in each study would constitute expert assessment/consensus on the patient's condition and treatment efficacy.
8. The Sample Size for the Training Set
- Not Applicable: The AVIS 6060 is an electro-mechanical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data for model development. Its design is based on physiological principles, and its effectiveness validated through clinical studies on a "test set" (or multiple test sets, as seen here).
9. How the Ground Truth for the Training Set was Established
- Not Applicable: As there is no "training set" for an AI algorithm, this question does not apply to the AVIS 6060 device.
§ 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).