(148 days)
The ActiveCare+SFT®and ActiveCare+DTx® Systems are portable, ambulatory, sequential, intermittent pneumatic compression devices (IPCDs) prescribed by health care professionals. The systems include a rechargeable battery powered option allowing patient mobility and ease of use. These devices simulate muscle contractions in order to treat or enhance blood flow velocity in individuals experiencing venous impairment or reduced pulsatility (dysfunction of the muscle pump) when blood flow may become challenged or compromised, such as during and after major orthopaedic surgery procedures e.g. total joint (hip and knee) arthroplasty. They are in the clinical setting or home environment and can be provided directly to the patient for home use.
These devices are indicated for use in:
- · Preventing Deep Vein Thrombosis (DVT)
- · Diminishing post-operative pain and swelling
- Reducing wound healing time
· Patients at risk for Deep Vein Thrombosis (DVT) and related Pulmonary Embolism (PE) (Venous Thromboembolism (VTE))
- · Treatment of venous stasis
- · Treatment and assistance in healing: Stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers
- · Enhancing blood circulation
- · Treatment of chronic venous insufficiency
- · Reducing edema
The ActiveCare+SFT® and ActiveCare+DTx® Systems are intended to provide external compression in synchrony with the specific patient's natural venous blood flow return profile in order to achieve a high pulsatile venous blood flow. In addition, the ActiveCare+DTx® System can detect hemodynamic changes in venous blood flow.
The ActiveCare Systems are portable, ambulatory, sequential, intermittent pneumatic compression devices (IPCDs) prescribed by healthcare professionals. The systems include a rechargeable battery powered option allowing patient mobility and ease of use. These devices simulate muscle contractions in order to treat or enhance blood flow velocity in individuals experiencing venous impairment or reduced pulsatility (dysfunction of the muscle pump) when blood flow may become challenged or compromised such as during and after major orthopedic surgery procedures e.g. total joint(hip and knee) arthroplasty. They are intended for use in the clinical setting or home environment, and can be provided directly to the patient for home use.
The modified ActiveCare@Home is different from the cleared device in the following:
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- The modified ActiveCare@Home was equipped with hardware Bluetooth Module.
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- Two new Software Blocks were added to its original Software, which were designed to:
- · Establish a communication between the ActiveCare main processor and the Bluetooth module (Bluetooth Communication)
- · Collect and reprocess data already being measured by the device in order to detect the number of the patient's steps generated during the treatment period (hereinafter referred to in this document as "Patient's Activity Index").
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- Three minor modifications were added to the ActiveCare@Home device GUI:
- · Reduction of the battery icon size in order to generate space for displaying the Activity Index graph mentioned above.
- · Displaying under the battery icon an estimation of the remained battery life time (appears only when the ActiveCare@Home device is powered by the internal battery).
- · Adding a 2D barcode icon to the Archives screen, this will include digital information, in addition to the same data which is displayed on the LCD screen verbally - for logistic.
This document is a 510(k) premarket notification for the ActiveCare@Home device. While it describes the device, its intended use, and a comparison to a predicate device, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving the device meets those criteria.
Specifically, the document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (K151377) and the minor modifications made to the device in this submission (K160431). The "Performance Data" section lists general categories of testing (Risk analysis, Software validation, EMC, Performance Testing) but does not provide specific acceptance criteria or detailed results from a study that would quantify device performance against those criteria.
Therefore, I cannot populate the table or answer several of your questions directly from the provided text.
Here's what I can extract and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated with quantifiable thresholds in the document.
- Reported Device Performance: Not provided with specific measurements or metrics. The document generally states "Performance data demonstrates that the modified ActiveCare@Home is as safe and effective as the cleared ActiveCare@Home" and "Performance data and software validation has been provided, establishing that the ActiveCare@Home device performs as intended and in a manner that is substantially equivalent to the predicate." However, no raw data, statistical analysis, or specific performance metrics are given.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "Performance testing simulated use for the patient activity index, and monitoring functionalities," which suggests laboratory testing rather than clinical data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable as the primary focus seems to be on engineering performance testing (e.g., software, EMC, simulated use) rather than a clinical study requiring expert ground truth for interpretation of medical images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as it's not a study involving human reader interpretation.
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
- No, this device is a medical compression system, not an AI-assisted diagnostic imaging device. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of a "standalone algorithm" as this is a physical device with embedded software. The software verification and validation are noted, but not as a "standalone algorithm performance" study in the sense of an AI model's performance on a dataset.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Given the nature of the device (pneumatic compression) and the tests mentioned (software, EMC, simulated use), the "ground truth" would likely be engineering specifications, functional requirements, and perhaps physiological measurements in simulated environments or healthy volunteers, rather than clinical outcomes or expert consensus on medical images. No specific details are provided.
8. The sample size for the training set
- Not applicable. This is a device modification submission, not a deep learning model development where a "training set" would be used in the traditional sense for AI.
9. How the ground truth for the training set was established
- Not applicable for the reason above.
Summary of what can be gleaned from the document regarding the study:
- Study Purpose: To demonstrate substantial equivalence of the modified ActiveCare@Home device to its predicate device (K151377) and to show that the minor modifications (Bluetooth, Patient Activity Index software, GUI changes) do not raise new questions of safety or effectiveness.
- Tests Performed (Types):
- Risk analysis per ISO 14971:2012
- Software validation and verification (software considered "Moderate" level of concern per FDA guidance)
- Electromagnetic compatibility (EMC) per IEC 60601-1-2
- "Performance Testing simulated use for the patient activity index, and monitoring functionalities"
- Device Context: The device is a portable, ambulatory, sequential, intermittent pneumatic compression device (IPCD) used for preventing DVT, reducing pain/swelling, enhancing blood circulation, etc. The modifications allowed for Bluetooth communication and sensing of "Patient's Activity Index" (number of steps).
To get the detailed information you are requesting, one would typically need access to the full 510(k) submission, which includes the detailed test reports and validation data. The publicly available K summary document is a high-level overview.
§ 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).