(30 days)
The medi pneumatic compression system (pcs) genius is a compression device based on sequential neumatic compression technique which is intended for the treatment of the following conditions:
-Lymphedema
-Venous stasis ulcers
-Venous insufficiency
-Peripheral edema
The device is intended for home, and hospital use.
The medi pneumatic compression system (pcs) genius (Model 652) system consists of a medi pcs pump device a medi pcs air inflatable sleeve with air hose and connectors. The pump device, air hose, and sleeves are all non-sterile and single patient use.
The medi pcs genius (Model 652) device is an intermittent mechanical gradient compression pump that includes a pressure control unit (PCU) with two connection points for air inflatable sleeves with air hose and connectors, a power switch, and a wall power connection for standard 125v AC Power. The PCU provides compression in cycles of pneumatic pressure applied in short, steady cycles. The air compressor distributes calibrated gradient pressure through a series of regulators to original compression sleeves containing either 6, 8, or 10 inflatable chambers to be externally applied over the affected extremity of the patient. The medi pcs genius (Model 652) is adjustable and limits the different treatment pressures and treatment times according to clinician prescription.
The medi pcs genius (Model 652) is used exclusively with air hose and medi pcs compression sleeves to fit both the upper and lower extremities. The medi pcs genius (Model 652) device, air hoses and air inflatable sleeves together may only be distributed, sold, and operated as a prescribed device. The device must be operated only with a new, original manufacturer limb sleeve(s) that are non-sterile and single patient use.
The provided text describes a 510(k) submission for the "medi pneumatic compression system (pcs)-genius (Model 652)". This document is a premarket notification for a medical device and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a comparative effectiveness study involving AI or human readers.
Therefore, many of the requested details, particularly those related to AI algorithm performance, human reader studies, and large-scale data provenance and ground truth establishment, are not applicable or not available in this type of regulatory submission for this specific device.
The "acceptance criteria" for a 510(k) submission predominantly revolve around demonstrating substantial equivalence to a legally marketed predicate device in terms of intended use, technological characteristics, and safety and effectiveness. The reported device performance is primarily through non-clinical bench testing to ensure the device meets its design specifications and relevant safety standards.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Reported Device Performance
The document does not present "acceptance criteria" in the format of a clinical trial's pre-defined endpoints for an AI algorithm or human reader performance. Instead, acceptance is based on demonstrating substantial equivalence and conformity to relevant safety and performance standards. The "reported device performance" refers to the results of non-clinical testing validating the device's functional integrity and safety.
| Acceptance Criteria (Implied by 510(k) process) | Reported Device Performance (Non-Clinical Testing) |
|---|---|
| Intended Use Equivalence: Same indications for use as predicate. | Device intended for Lymphedema, Venous stasis ulcers, Venous insufficiency, Peripheral edema (Same as predicate). |
| Technological Equivalence: Similar principles of operation, design, materials. | Similar pump, sleeve design, materials; electrically generated compressed air, tubing, cyclical pressure application. |
| Safety - Electrical Safety & EMC: Conformance to relevant standards. | Conforms to ANSI/AAMI 60601-1, ANSI/AAMI 60601-1-11, IEC 60601-1-2. |
| Safety - Biocompatibility: Conformance to relevant standards for patient contact. | Conforms to ISO 10993-1, ISO 10993-5, ISO 10993-10 for cytotoxicity, sensitization, and irritation. |
| Safety - Software Verification & Validation: Conformance to relevant standards based on concern level. | Conforms to IEC 62304:2006 (moderate level of concern). |
| Performance - Functional Specifications: Device operates as designed (e.g., pressure, cycle times, inflation/deflation). | Bench testing assures meeting specifications: Inflation and Deflation Time, Treatment Time, Pressure (including Burst Pressure & Gradient), Software Integration (GUI & Pressure Calibration), Safety Errors & Alarm, Packaging, Use Life. |
| Usability: Manual is appropriate for users. | Usability testing confirmed user manual appropriateness for professional and non-medical operators. |
| Shelf-Life: Device maintains functionality over time. | Accelerated aging studies demonstrated 5-year shelf-life stability for PCU, sleeves, and connectors. |
| Sterilization: Device provided non-sterile. | Device is non-sterile. |
Details Not Applicable or Not Available from this Document:
- Sample sizes used for the test set and the data provenance: This information is not relevant to a 510(k) for a physical medical device like a compression system. "Test set" in the context of AI models does not apply here. The document mentions "non-clinical testing" and "bench performance" which would involve testing individual devices or components, not a "test set" from a large image dataset. No human patient data is discussed for performance validation in this context.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a compression device is based on engineering specifications, physical measurements, and safety standards, not expert medical opinion on, for example, image interpretation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 pneumatic compression system, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this device, "ground truth" for performance is established by engineering specifications, physical measurements (e.g., pressure, time), adherence to recognized electrical and biocompatibility standards, and software validation against requirements.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires training data.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory clearance for a physical medical device (pneumatic compression system) and not for an AI/ML-based diagnostic or assistive device. Therefore, the questions related to AI algorithm performance, training/test sets, human reader studies, and intricate ground truth establishment for such applications are not addressed in this document.
§ 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).