(190 days)
Wright Gradient 52 - Torso and Wright 51 - Torso are for treatment of lymphedema, venous insufficiencies, and other edematous conditions.
The Wright Gradient 52 - Torso and Wright 51 - Torso consists of a pneumatic compression pump, a hose assembly, and associated inflatable appliances. It is typically used to compress upper and lower body extremities and portions of the torso.
The pump consists of an enclosure that contains a small air compressor, solenoid valves, printed circuit board including a programmable microprocessor, graphic display, and associated electronic circuits and pneumatic connections. Software controls the sequential. opening and closing of the solenoid valves, which are connected to five (5) external pressure ports.
The appliance assembly is made of fabric and consists of one or two limb appliances (for an arm or a leg) and a torso appliance (for abdomen or chest area). Each limb appliance comprises four cells, with the dimensions of the appliance dependent upon the physician's order and the patient's limb measurements. There are two basic variations of the torso appliance: (1) a vest-like appliance for compression of the upper torso; and (2) a girdle-like appliance for compression of the lower torso. In each case the dimensions of the appliance dependent upon the physician's order and the patient's anatomical measurements.
In operation, the pump fills the inflatable appliance(s) with air to compress the prescribed limb(s) and torso area with the prescribed pressures in a preset therapy program. The therapy program is based on manual fymph drainage massage principles and intended to improve ymphatic and venous return circulation for the patient.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Wright Gradient 52 - Torso and Wright 51 - Torso device.
Key Observation: The provided documentation is a 510(k) summary for a medical device that does not involve AI or imaging. It is a pneumatic compression pump. Therefore, many standard questions related to AI/imaging device studies (such as MRMC studies, ground truth establishment by experts for image interpretation, training/test set provenance, etc.) are not applicable to this device. The summary indicates that the device's performance was evaluated through bench testing.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of specific numerical acceptance criteria and corresponding reported device performance values. Instead, it states a general adherence to performance specifications through bench testing.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Performance Verification | Conformity to performance specifications | "All tests were verified to meet acceptance criteria." |
| Sequences, Timing, Pressure | Measurements of sequences, timing, and pressure of therapy delivery | "Bench performance testing consisted of measurements of the sequences, timing, and pressure of therapy delivery... All tests were verified to meet acceptance criteria." |
| Operator Interface Functionality | Verification of functionality of the operator interface | "...along with verification of the functionality of the operator interface. All tests were verified to meet acceptance criteria." |
| Safety | As safe as the predicate devices | "Evaluation of the device consisted of risk analysis to confirm that the device is as safe as the predicate devices." |
| Equivalence | Equivalent performance to predicate | "Bench performance testing was performed to verify equivalent performance." |
| Maximum Torso Pressure | Reduced to 30 mmHg (compared to predicate) | This is a design change, implicitly met through testing. The document doesn't state it failed this, so it implies it was met. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable in the traditional sense of a clinical trial or AI model testing with patient data. The testing described is bench testing of the device hardware and software. The document does not specify a "sample size" of devices or test cycles for the bench tests.
- Data Provenance: Not applicable. The "data" comes from bench tests conducted on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of expert consensus, is typically for evaluating diagnostic accuracy or image interpretation. This device is a pneumatic pump, and its "ground truth" performance is a measure of its physical outputs (pressure, timing, sequences) against engineering specifications. Expert judgment for device functionality verification would be part of the quality assurance process, but not in the sense of establishing "ground truth" for a test set.
4. Adjudication method for the test set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve discrepancies in expert interpretations, primarily in diagnostic studies or when establishing ground truth from multiple human readers. This is a bench test on a physical device.
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
Not applicable. This device is a pneumatic compression pump, not an AI-powered diagnostic or imaging device that aids human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a sense. The "standalone" performance here refers to the device's ability to operate according to its specifications without human intervention during its operation. The bench testing evaluated the pump's performance (pressure, timing, sequences, operator interface functionality) in a "standalone" capacity against its design specifications and compared to the predicate device. However, this is not an "algorithm only" study in the context of AI.
7. The type of ground truth used
The "ground truth" for this device's evaluation is its engineering specifications and design requirements. The device is expected to deliver specific pressures, follow specific timing sequences, and have a functional operator interface. These predefined parameters are the "ground truth" against which its performance was measured during bench testing.
8. The sample size for the training set
Not applicable. This device does not use machine learning algorithms that require a "training set" of data.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a machine learning model, there is no ground truth establishment for a training set.
§ 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).