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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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The proposed device is to be used to improve the return circulation of body fluid that has pooled in one or more of a patient's extremities. This treatment reduces debilitating pain, swelling, ulceration, and risk of dermatological impact, infection, and amputation.

This is an electromechanical pneumatic device that employs a compressor and precision timer, regulator, and gage to sequentially inflate a sleeve appliance that fits over the patient's extremity. The device is approximately 8"W x 6.75"H x 5.5"D and weighs less than 15 lbs.

The prompt asks to describe the acceptance criteria and the study that proves the device meets them, based on the provided text. However, the provided text describes a "Wright Linear Pump" which is a sequential compression pump, not an AI/ML powered medical device. Therefore, many of the requested fields are not applicable to the given text.

Here's an analysis based on the provided information, noting where sections are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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The proposed device is to be used to improve the return circulation of body fluid that has pooled in one or more of a patient's extremities. This treatment reduces debilitating pain, swelling, ulceration, and risk of dermatological impact, infection, and amputation. Compression pumps of various kinds are in wide use in hospitals, clinics, patient homes, and elsewhere for treating acute and chronic fluid accumulation disorders. Complies with physician-prescribed treatment pressures.

This is an electromechanical pneumatic device that employs a compressor and precision timers, regulators, and gages to sequentially inflate a sleeve appliance that fits over the patient's extremity. This unit delivers a calibrated gradient pressure. The device is approximately 10"W x 6.75"H x 5.6"D and weighs less than 15 Ibs.

The provided text describes a medical device, the WLP Pro Lite gradient sequential compression pump, and its comparison to an existing device (K830577B) for the purpose of a 510(k) submission. This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, not typically a detailed study proving novel acceptance criteria for a new device's performance.

Based on the provided information, I can extract the acceptance criteria related to its functional equivalence and performance characteristics from the "non-clinical test data" section. However, the document explicitly states "clinical test data: not applicable," which means a clinical study to prove efficacy or safety against defined acceptance criteria was not conducted or provided in this summary.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated for the "prototype device" measurements. The measurements were taken on a "prototype device," implying a single or very limited number of units.
• Data Provenance: Not specified, but likely from internal testing by Wright Linear Pump, Inc. It is a retrospective assessment against established design parameters, not a prospective study. There is no mention of country of origin for the data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable. The "ground truth" for the non-clinical tests was established by comparison to a "calibrated Hg manometer," which is a standard measurement device, not expert consensus.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The test involved direct measurement against a calibrated standard, not a subjective assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No. The document explicitly states "clinical test data: not applicable." This device is a sequential compression pump, not an imaging or diagnostic device that would typically involve human readers interpreting output.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Standalone Performance: A form of standalone non-clinical performance was done, as described in Section 5.8.1. The device's pressure delivery and timing characteristics were measured and compared against specifications using a calibrated manometer. This is the device operating on its own, without a human in the loop for interpreting output (as might be the case for AI).

7. The Type of Ground Truth Used

• Ground Truth Type:
  • For pressure accuracy: Comparison to a calibrated Hg manometer (a physical gold standard measurement tool).
  • For timing (cell activation and sustained pressure): Intrinsic design specifications and observed performance.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is an electromechanical pump, not a machine learning or AI-driven system that requires a "training set" in the conventional sense. Its "design parameters" are likely derived from engineering principles and prior device models.

9. How the Ground Truth for the Training Set was Established

• Ground Truth for Training Set: Not applicable, as there is no "training set." The device's operational parameters and design would have been established through engineering design, previous product iterations (as it's similar to K830577B), and adherence to general medical device standards for mechanical and pneumatic systems.

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The proposed device is to be used to improve the return circulation of body fluid that has pooled in one or more of a patient's extremities. This treatment reduces debilitating pain, swelling, ulceration, and risk of dermatological impact, infection, and amputation.

This is an electromechanical pneumatic device that employs a compressor and precision timer, regulator, and gage to inflate a sleeve appliance that fits over the patient's extremity. The device is approximately 8"W x 6.75"H x 5.5"D and weighs less than 13 Ibs.

The provided text describes a 510(k) summary for a medical device (WLP Solo VII, a single-pressure pump for lymphedema). However, it does not contain information about acceptance criteria or a specific study proving the device meets those criteria, as typically understood in a regulatory submission for clinical performance.

Here's an analysis based on the provided text, highlighting the absence of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

• Pressure in appliance reaches the prescribed setting 10 or more seconds before the end of the cycle. |

Explanation: The document mentions "similar pressure ranges, degrees of accuracy, cycle times," to predicate devices, and that the "Cell pressure of prototype device was measured comparing on-board gauge reading to calibrated Hg manometer." However, it does not define specific quantitative acceptance criteria for these parameters (e.g., "pressure accuracy must be within +/- 5 mmHg"). The reported performance elements are descriptive rather than criteria-meeting statements.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not applicable as a "test set" for clinical performance is not mentioned. The non-clinical test involves measuring "Cell pressure of prototype device" but the number of devices or measurements is not specified.
• Data Provenance: Not applicable. The non-clinical tests are presumed to be conducted internally by the manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not Applicable. The document explicitly states "clinical test data: not applicable." No ground truth was established by experts for clinical performance.

4. Adjudication Method for the Test Set:

• Not Applicable. No clinical test set or related adjudication is mentioned.

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 compressed limb sleeve pump; it is not an AI-powered diagnostic or assistive technology for human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This device is a physical electromechanical pump, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not Applicable for clinical ground truth. For the non-clinical pressure measurement, the "calibrated Hg manometer" served as the reference for accuracy, acting as the ground truth for pressure readings.

8. The sample size for the training set:

• Not Applicable. This device uses electromechanical principles and does not involve machine learning or a "training set."

9. How the ground truth for the training set was established:

• Not Applicable. As there is no training set.

Summary of Device Evaluation in the Provided Text:

The document describes a 510(k) submission where the manufacturer is claiming substantial equivalence to predicate devices. The "study that proves the device meets the acceptance criteria" in this context is primarily focused on non-clinical performance and similarity to existing devices, rather than a clinical trial demonstrating efficacy against pre-defined acceptance criteria.

The non-clinical tests included:

• Measuring cell pressure of a prototype device comparing the on-board gauge reading to a calibrated Hg manometer (no specific acceptance criteria or results beyond "measured" are provided).
• Verifying that pressure in the appliance reached the prescribed setting 10 or more seconds before the end of the cycle (again, no specific acceptance criteria or number of tests are provided).

The submission explicitly states "clinical test data: not applicable," indicating that a clinical study with a test set, ground truth established by experts, or MRMC studies was not performed or deemed necessary for this 510(k) submission based on its classification and comparison to predicate devices.

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