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The Wright 51 and 52 Sequential Compression System is for treatment of lymphedema, venous insufficiencies, and other edematous conditions.

The Wright 51 and 52 Sequential Compression System consists of a sequential, segmental, intermittent, pneumatic compression pump and appropriate limb appliances. It is typically used to compress an upper or lower body extremity.

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 pressure ports are connected to the limb appliance through a hose assembly.

The inflatable limb appliance is made of fabric and may comprise from one to five cells, with the length of the appliance dependent upon the physician's order or patients limb length. In operation, the pump fills the inflatable limb appliance with air, to prescribed, preset pressures -- each cell in sequence. This simple repetition of the sequence of compression and exhaust improves return blood circulation for the patient.

The Wright 51 and 52 Sequential Compression System is a medical device intended for the treatment of lymphedema, venous insufficiencies, and other edematous conditions. The acceptance criteria and the study proving the device meets these criteria are detailed below, based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Sample Size: Not explicitly stated. The document indicates "bench tests" were performed, implying a test set of the device itself (likely one or more units) rather than a human subject sample.
• Data Provenance: The testing was conducted by or on behalf of the manufacturer, Wright Therapy Products, located in Oakdale, PA, USA. This suggests the data is prospective, generated specifically for this 510(k) submission.

3. Number and Qualifications of Experts for Ground Truth (Test Set)

• Experts: Not applicable for this type of submission. The evaluation was based on non-clinical testing (risk analysis and bench tests) against engineering specifications and consensus standards, not on expert interpretations of clinical data.

4. Adjudication Method (Test Set)

• Adjudication Method: Not applicable. The evaluation involved objective measurements and comparisons against predetermined performance specifications and safety criteria in a non-clinical setting.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No. The document explicitly states "Clinical Testing: None." The submission relies on substantial equivalence to legally marketed predicate devices through comparison of technical characteristics and non-clinical testing.

6. Standalone Performance Study

• Standalone Performance Study: Yes, in a non-clinical context. The "Nonclinical Testing" section describes a standalone evaluation of the device's performance through risk analysis, bench tests (sequence, timing, pressure, operator interface functionality), and electrical safety/EMC testing. This represents the algorithm/device-only performance in a simulated or controlled environment.

7. Type of Ground Truth Used

• Ground Truth: The ground truth for the non-clinical testing was based on:
  • Engineering Specifications: Predetermined parameters for sequence, timing, and pressure of therapy delivery, as well as operator interface functionality.
  • Consensus Standards: Standards for electrical safety and electromagnetic compatibility.
  • Predicate Device Characteristics: The safety profile of the legally marketed predicate devices served as a benchmark for the risk analysis.

8. Sample Size for Training Set

• Sample Size for Training Set: Not applicable. The document describes a medical device, not an AI/ML algorithm that employs a training set in the conventional sense. The device's control system uses a programmable microprocessor with software, which would have been developed and verified through standard software engineering practices, not through a 'training set' of data.

9. How Ground Truth for Training Set Was Established

• Ground Truth for Training Set: Not applicable for this device. The software controlling the pump would have been developed and verified against functional requirements and design specifications, which serve as the "ground truth" for its operation, established through engineering design processes rather than data labeling.

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