(281 days)
The AIROS 8 Sequential Compression Device utilizes gradient pneumatic compression, which is intended for treatment of patients with the following conditions:
- · Lymphedema
- Venous stasis ulcers
- · Venous insufficiency
- · Peripheral edema
The device is safe for both home and hospital use,
The AIROS 8 Sequential Compression Device is a gradient pneumatic compression device. The device is used for treatment and management of venous or lymphatic disorders. The application of gradient sequential compression increases blood flow and encourages extracellular fluid clearance.
The AIROS 8 system consists of the device and 8-chambered garments. The device provides cycles of compressed air at certain adjustable pressures, and sequentially inflates the garments from distal to proximal. The pressure at each chamber can be individually adjusted to accommodate different therapy needs.
Here's an analysis of the provided text regarding the AIROS 8 Sequential Compression Device, focusing on acceptance criteria and study data:
Based on the provided 510(k) summary for the AIROS 8 Sequential Compression Device, the document does not contain the detailed information typically found in an AI/ML-based medical device submission regarding acceptance criteria, performance metrics, and study details (like sample size for test/training sets, expert qualifications, ground truth establishment, or clinical outcome studies).
The AIROS 8 device is a physical medical device (a sequential compression device) and its 510(k) submission focuses on demonstrating substantial equivalence to a predicate device (CircuFlow 5208) based on technological characteristics and functional performance testing, rather than AI/ML algorithm performance.
Therefore, I cannot populate the requested table and answer many of the specific questions as they are designed for AI/ML device assessment. The provided text describes a traditional medical device submission.
However, I can extract the acceptance criteria and performance testing described for this type of physical device:
Acceptance Criteria and Reported Device Performance (for a physical medical device)
1. A table of acceptance criteria and the reported device performance
The document does not present quantitative acceptance criteria or specific numerical performance results in a table format. Instead, it states that "Testing was performed and to ensure that the system meets its specifications" and lists the types of functional performance tests conducted. The conclusion is that the device is "substantially equivalent" to the predicate.
Interpretation for a physical device: The acceptance criteria for these tests would likely be "passes" or "meets specification" for each functional test, implying the device performed as intended and comparably to the predicate. Specific numerical targets for pressure accuracy, cycle time, noise, etc., would be in the full submission, but are not in this summary.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Alarm Testing: Alarms function correctly. | Testing performed; system meets specifications. |
| LED/LCD Testing: Displays function correctly. | Testing performed; system meets specifications. |
| Cycle Time Testing: Cycles occur within specified times. | Testing performed; system meets specifications. |
| Pressure Accuracy Testing: Pressure output is accurate within specified tolerances. | Testing performed; system meets specifications. |
| Therapy Time Testing: Therapy duration is accurate. | Testing performed; system meets specifications. |
| Therapeutic Performance Testing: Device delivers intended therapy. | Testing performed; system meets specifications. |
| Garment Integrity Testing: Garments maintain integrity under use. | Testing performed; system meets specifications. |
| Pull Testing: Components withstand specified pull forces. | Testing performed; system meets specifications. |
| Transportation Testing: Device withstands transport conditions. | Testing performed; system meets specifications. |
| Garment Printing Testing: Printing is durable and legible. | Testing performed; system meets specifications. |
| Button Life Testing: Buttons endure specified number of actuations. | Testing performed; system meets specifications. |
| Noise Testing: Operating noise is within specified limits. | Testing performed; system meets specifications. |
| Visual Appearance Testing: Device meets aesthetic and manufacturing standards. | Testing performed; system meets specifications. |
Study Details (as inferable for a physical medical device)
The following points are mostly not applicable (N/A) in the context of this 510(k) summary for a physical compression device, as they are typically relevant to AI/ML or diagnostic device studies. The "study" here is primarily functional performance and electrical safety testing.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. For functional testing of a physical device, this would typically involve testing a representative sample of manufactured units (e.g., a few devices from a production batch).
- Data Provenance: Not specified, but generally refers to in-house laboratory testing of the manufactured device.
- Retrospective/Prospective: N/A. This is functional testing, not a clinical data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. Ground truth as understood in AI/ML (e.g., disease presence/absence determined by experts) is not relevant for the functional testing of a pneumatic compression device. Testing relies on engineering specifications and measurement equipment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication is not applicable for functional engineering tests.
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
- N/A. This device is not an AI/ML diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This device does not have an AI algorithm. Its "performance" is its mechanical and electrical function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- N/A. The "ground truth" for the listed functional tests would be engineering specifications, direct measurements, and established quality control protocols for pressure, time, electrical safety, etc.
8. The sample size for the training set
- N/A. This concept is for AI/ML models. No training set is mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established
- N/A. Not applicable, as there is no training set for an AI/ML model for this 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).