(165 days)
The Movement and Compressions System is intended to be a portable system, prescribed by healtheare professionals, to treat the following conditions by stimulating blood flow in the legs:
- · Aid in the prevention of DVT (deep vein thrombosis) by enhancing blood circulation; and,
- · As a prophylaxis for DVT by persons expecting to be stationary for long periods of time.
During use, the system also monitors patient orientation and movement. It allows healthcare providers and users to implement individualized patient management plans for DVT prophylaxis and patient mobility protocols by utilizing data accumulated by the patient on the previous day as a benchmark. The data displayed on the device allows providers to monitor the patient's orientation and activity, which can be used to identify risk factors for hospital-acquired events linked to immobility such as: deep vein thrombosis, pressure ulcers, pneumonia, atrophic muscles, and delirium.
The device can be used in the home or clinical setting. The device is intended for use in an adult patient population.
The Movement and Compressions System (The MACTM System) is a prescriptive, portable, rechargeable-battery powered, intermittent compression device designed to stimulate blood flow in the lower limb. The MAC System consists of the MAC Strap, MAC Charging Hub, and MAC Controller. The MAC Strap is a disposable single patient use strap that is wrapped around the patient's calf muscle. The MAC Controller houses a rechargeable battery, DC motor, gyroscope sensor, and microprocessor that is attached to the strap during use. The battery is removed from the controller for charging in the supplied MAC Charging Hub when not in use.
Compression is applied to the calf, immediately below the knee, by intermittent application of mechanical force by the device strap. When the strap is contracted, compression is applied to the patient's calf muscle. When the strap is retracted, compression force is released from the patient's calf muscle. Since mechanical force is used to provide intermittent compression, the system does not require a powered air supply, so the risk of aerosolization of potential contaminants or germs is mitigated as there is no blowing air. There are no air connections or pneumatic pumps to clean between patients.
The MAC system also monitors and displays patient orientation and movement information. This data is stored in a RFID tag in the MAC Strap. When the MAC Controller is connected to the MAC Strap, and functioning, all DVT prophylaxis compliance data, orientation and movement data is synced between the controller and the strap using Radio Frequency Identification (RFID) communication and stored between them.
The provided document, a 510(k) Premarket Notification for the "Movement and Compressions System (the MAC System)," primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance. While it outlines various performance tests, it does not contain the level of detail typically required to fully describe acceptance criteria for specific device performance metrics (beyond safety and electrical compliance) and a rigorous study proving the device meets these criteria in the context of clinical efficacy or deep learning model validation.
Specifically, for the "data accumulated by the patient on the previous day as a benchmark" and "monitor the patient's orientation and activity" functionalities, the document mentions "Performance testing also evaluated accuracy of mobility data and strap slippage." However, it does not provide quantitative acceptance criteria or detailed results for this "accuracy of mobility data" evaluation. It also does not elaborate on a study that would demonstrate how this data is "utilized" or its "effect size" regarding "how much human readers improve with AI vs without AI assistance" as it is related to a patient monitoring feature, not an AI-assisted diagnostic or interpretive system for human readers.
Therefore, many of the requested items related to deep learning model validation (such as sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, and ground truth establishment) are not present in this regulatory submission document as it pertains to a mechanical medical device with a monitoring feature, not an AI/ML-driven diagnostic or prognostic device requiring such extensive validation.
Below is an attempt to address the request based only on the information available in the provided text. Many fields will be marked as "Not provided/Not applicable" due to the nature of the device and the document.
Device Description and Functionality Summary:
The Movement and Compressions System (The MAC System) is a portable, rechargeable, intermittent compression device aimed at stimulating blood flow in the lower limb to aid in DVT prevention and prophylaxis. A key feature is its ability to monitor patient orientation and movement using a 6-axis gyroscope sensor and microprocessor, with data stored in an RFID tag in the MAC Strap. This mobility data is intended to help healthcare providers implement individualized patient management plans and identify risk factors for immobility-linked hospital-acquired events.
Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating substantial equivalence through safety, electrical, biocompatibility, and software testing, and general functionality. Specific quantitative acceptance criteria and performance data for the accuracy of mobility data are not detailed in a table format in the provided text. The document states that "Performance testing also evaluated accuracy of mobility data and strap slippage" and that the "device met all performance requirements," suggesting these evaluations were conducted and passed internal criteria, but the specific metrics and results are omitted from this public summary.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly detailed in source for performance, only for safety/compliance) | Reported Device Performance (Summary from text) |
|---|---|---|
| Biocompatibility | Adherence to ISO 10993-1 for cytotoxicity, sensitization, and irritation. | Non-cytotoxic, non-sensitizer, and produces no dermal irritation. |
| Electrical Safety & EMC | Compliance with IEC 60601-1-2:2014, IEC 60601-1:2005 (3rd Ed), IEC 60601-1-11:2015, IEC 60601-1-6:2013 | Testing successfully performed according to all applicable portions of the listed standards. |
| Software Verification & Validation | As recommended by FDA's Guidance for Software, for "minor" level of concern. | Verification and validation conducted; documentation provided. Software considered "minor" level of concern. |
| Mechanical Performance | Not explicitly detailed (e.g., specific thresholds for elasticity, shear strength). | Verification of strap elasticity and shear strength successful. |
| Electrical Components Performance | Not explicitly detailed (e.g., specific thresholds for controller/charging hub, battery). | MAC Controller and Charging Hub electrical verification successful. Verification of battery pack safety and performance successful according to applicable standards. |
| Radiofrequency & Radiated Emissions | Compliance with established requirements. | Compliance with established requirements applicable to radiofrequency and radiated emissions testing successful. |
| Overall Functionality & Reliability | Not explicitly detailed. | Functionality and reliability testing successful. |
| Blood Flow Increase (Compression) | Not explicitly detailed (e.g., specific percentage increase over baseline). | Performance testing of the subject device and predicate device to evaluate blood flow increase over baseline was conducted and successful, demonstrating "similar performance characteristics as the predicate devices." |
| Accuracy of Mobility Data | Not explicitly detailed (e.g., specific accuracy/precision metrics for orientation or steps). | Performance testing also evaluated accuracy of mobility data. The document states "device met all performance requirements," implying accuracy criteria were met, but quantitative results are not provided. This feature is compared to the DynaSense System, which also monitors orientation and activity (K130752). |
| Strap Slippage | Not explicitly detailed. | Performance testing also evaluated strap slippage. The document states "device met all performance requirements," implying criteria were met. |
| Usability Testing | Not explicitly detailed. | Usability testing successful. |
Study Details for Performance Evaluation (Specifically for Mobility Data/Other Performance)
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Sample size used for the test set and the data provenance:
- Test set sample size: Not provided. The document states "Performance testing" was done, but does not specify the number of subjects or data points used for evaluating mobility data accuracy or other performance aspects.
- Data provenance: Not provided (e.g., country of origin, retrospective or prospective nature).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a sensor-based measurement device, not an AI/ML system requiring expert interpretation for ground truth. It's likely that a physical standard or reference measurement was used for "accuracy of mobility data."
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Ground truth for sensor data accuracy would be established by comparison to a calibrated reference system or direct physical measurement, not human adjudication.
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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:
- No MRMC study was done, and it is not applicable for this device. The device's mobility monitoring feature is for providing data to healthcare providers, not for assisting human readers in interpreting complex medical images or data from an AI-driven component where performance enhancement would be measured.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- A standalone performance evaluation of the "accuracy of mobility data" was indicated as part of "Performance Testing." However, specific quantitative results or methodologies are not provided beyond the statement that it was "evaluated" and the device "met all performance requirements." This would have involved comparing the device's sensor output to a known, true value of orientation and movement (e.g., from a more precise measurement system). The "algorithm" here refers to the device's internal processing of sensor data.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For "accuracy of mobility data," the ground truth would likely be based on a physical reference standard or a highly accurate, calibrated measurement system for orientation and movement tracking, not expert consensus or pathology.
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The sample size for the training set:
- Not applicable. This document describes a traditional medical device with embedded sensor capabilities, not a deep learning model that requires a "training set" in the machine learning sense.
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How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for a deep learning model. The device's internal algorithms for processing sensor data would typically be developed and validated against engineering specifications and reference measurements.
§ 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).