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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:

• 1. The modified ActiveCare@Home was equipped with hardware Bluetooth Module.
• 2. 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").
• 3. 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.

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The ActiveCare DVT, ActiveCare+SFT and ActiveCare+DTx Systems are prescriptive devices that induce Continuous Enhanced Circulation Therapy of the lower limbs. The Systems are intended for use in: Preventing Deep Vein Thrombosis (DVT). Enhancing blood circulation. Diminishing post-operative pain and swelling. Reducing wound-healing time. Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers. Treatment of chronic venous insufficiency. Reducing edema.

The ActiveCare+DTx, ActiveCare+SFT and ActiveCare DVT Systems are prescriptive, pneumatic compression Systems designed to apply sequential compression to the lower limb. The control units of the Systems provide the user with several treatment options: compression of the foot - single or double, compression of the calf - single or double, compression of the thigh - single or double, and combined compression of any combination of two sleeves. The foot compression program is an intermittent pressure pulse application to a single celled foot sleeve. The calf and thigh compression program is a sequential intermittent application of a pressure to a three-celled cuff sleeve.

This 510(k) summary describes modifications to an existing device, the ActiveCare DVT, ActiveCare+SFT, and ActiveCare+DTx Systems. The submission is a Special 510(k), which is used for modifications to a manufacturer's own legally marketed device where the modifications do not require scientific review of clinical data to determine substantial equivalence. Therefore, the information provided below will reflect the nature of a Special 510(k) rather than a de novo submission requiring extensive new performance data.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a Special 510(k) for minor modifications to an already cleared device, detailed performance metrics (like sensitivity, specificity, accuracy) and corresponding acceptance criteria are not typically presented in the same way as for a novel device. The acceptance criteria here are implicitly that the modified device performs demonstrably equal to or better than the predicate device and does not raise new questions of safety or efficacy.

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

No external test set with human subjects or real-world data is described for this Special 510(k). The "testing" mentioned is primarily internal verification and validation against design specifications and safety standards for the modified components. This type of submission relies on demonstrating that the minor changes do not alter fundamental performance.

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

Not applicable. As described above, no external test set requiring expert-established ground truth was part of this particular submission. The "ground truth" for a Special 510(k) is the performance of the legally marketed predicate device, and the evaluation focuses on whether the modifications deviate from that established performance.

4. Adjudication Method for the Test Set

Not applicable for the same reasons as #3.

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 system, not an imaging or diagnostic AI-assisted device. Therefore, MRMC studies and AI assistance comparisons are not relevant.

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

Not applicable. This is not an algorithmic diagnostic device. The "standalone" performance here refers to the device's ability to mechanically deliver compression according to its design specifications.

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

The "ground truth" for this Special 510(k) is the established performance and safety of the legally marketed predicate devices (K113525, K110159). The submission aims to demonstrate that the modifications maintain this existing ground truth. The "Performance Data" section explicitly states that "Medical Compression Systems (DBN) Ltd. believes that the modified ActiveCare DVT, ActiveCare+SFT and ActiveCare+DTx Systems are substantially equivalent to the previously cleared ActiveCare DVT, ActiveCare+SFT and ActiveCare+DTx Systems without raising new safety and/or effectiveness issues."

8. The Sample Size for the Training Set

Not applicable. This device does not employ machine learning or AI that would require a "training set" in the conventional sense.

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

Not applicable, as there is no training set for an AI/ML algorithm.

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The ActiveCare+SFT® System is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs.

The ActiveCare+SFT® System is intended for use in:

• Preventing Deep Vein Thrombosis (DVT).
• Enhancing blood circulation.
• Diminishing post-operative pain and swelling.
• Reducing wound-healing time.
• Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers.
• Treatment of chronic venous insufficiency.
• Reducing edema.

The ActiveCare+SFT® is a prescriptive, pneumatic compression system designed to apply sequential compression to the lower limb. The control unit of the ActiveCare+SFT® is light and compact, thus making it a portable ambulant system. The ActiveCare+SFT® provide the user with an option of battery operation in addition to the operation from the mains option. The ActiveCare+SFT® is easy to use and provides the user with several treatment options: compression of the foot - single or double, compression of the calf - single or double, compression of the Thigh - single or double, and combined compression of any combination of two sleeves.

The foot compression program is intermittent pressure pulse application to a single celled foot sleeve. The calf and thigh compression program is a sequential intermittent application of a pressure to a three-celled cuff sleeve.

Acceptance Criteria and Device Performance Study for ActiveCare+SFT® System (K110159)

The submission for the ActiveCare+SFT® System (K110159) focuses on demonstrating substantial equivalence to a previously cleared device (K060146) with an added software module. Therefore, the acceptance criteria and performance data specifically address the new "Venous Obstruction Detection software module" rather than the core functionality of the compression system itself. As a result, the information provided in the document is limited for a detailed breakdown of acceptance criteria and a comprehensive study that proves all aspects of device performance.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the submission (modifying an already cleared device with a new software module), the "acceptance criteria" appear to be focused on ensuring the new software module does not raise new questions of safety and efficacy and performs as intended. Specific quantitative acceptance criteria are not explicitly stated in the provided text, but rather implied by the overall goal of demonstrating substantial equivalence.

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

• Sample Size: The document mentions "clinical comparison in healthy volunteers." However, it does not specify the sample size for this clinical comparison or the "Lab 003" validation study.
• Data Provenance: The document does not explicitly state the country of origin of the data. It mentions "healthy volunteers," implying the study was prospective in nature.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth related to the "Venous Obstruction Detection software module." The nature of the device (a pneumatic compression system) and the added software's function (detecting potential obstruction) suggest that objective physiological measurements might have been used as ground truth rather than expert consensus on image interpretation.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set.

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

No. The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device is a physical compression system with an added software module for detection, not an imaging AI diagnostic aid that would typically involve multiple readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

Yes, a standalone performance evaluation of the algorithm was conducted. The "Lab 003 - Validation of the ActiveCare+SFT®'s Venous Obstruction Detection software module" explicitly refers to validating the software module itself, implying an evaluation of the algorithm's performance.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the "Venous Obstruction Detection software module." Given the nature of detecting "venous flow obstruction," it is likely that objective physiological measurements (e.g., Doppler ultrasound, plethysmography, or other forms of vascular assessment) were used to establish the presence or absence of venous obstruction as ground truth in the healthy volunteers, rather than expert consensus on visual assessment or pathology.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set for the "Venous Obstruction Detection software module."

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

The document does not provide information on how the ground truth for the training set was established. Given the validation study involved "healthy volunteers," it's possible that the initial development (training) of the software module might have used data from a different cohort or internally generated data, or a portion of the "healthy volunteers" data was used for development and another for validation.

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The ActiveCare®++ System is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs. The ActiveCare®++ System is intended for use in:

• Preventing Deep Vein Thrombosis (DVT). .
• Enhancing blood circulation. .
• Diminishing post-operative pain and swelling. .
• Reducing wound-healing time. .
• Treatment and assistance in healing: stasis dermatitis; . venous stasis ulcers; arterial and diabetic leg ulcers.
• Treatment of chronic venous insufficiency. .
• Reducing edema. .

The ActiveCare®++ is a prescriptive, pneumatic compression device designed to apply sequential compression to the lower limb. The control unit of the ActiveCare®++ is light and compact, thus making it a portable ambulant system. The ActiveCare®++ provides the user with an option of battery operation in addition to the operation from the mains option. The ActiveCare®++ is easy to use and provides the user with several treatment options: compression of the foot - single or double (either regular foot or foot booster), compression of the calf - single or double, compression of the Thigh - single or double, and combined compression of any combination of two sleeves.
The foot compression program is sequential intermittent pressure pulse application to a single celled foot sleeve. The calf and thigh compression program is a sequential intermittent gradient application of a pressure (s) a three-celled calf sleeve.

The provided text describes the Medical Compression Systems (DBN) Ltd ActiveCare®++ System, but it does not contain a table of acceptance criteria or a detailed study proving the device meets specific acceptance criteria in the manner requested.

Instead, the submission for K060146, filed in 2006, focuses on demonstrating substantial equivalence to previously cleared predicate devices. The changes made to the ActiveCare®++ system compared to its predecessors (ActiveCare® System, Wizair Compression System, Wizair DVT, or ProAir 3000) are primarily software updates, a new user interface, a compliance indicator, and a new calf sleeve.

The document states:
"A series of safety and performance testing, including bench testing and clinical comparison in healthy volunteers, were performed to demonstrate that the modified ActiveCare®++ System does not raise any new questions of safety and efficacy. These tests include:

• Electrical and electromagnetic testing
• Software verification and validation
• Performance testing of the output parameters and pressure profile"

However, it does not provide the specific acceptance criteria for these tests nor the detailed results or methodologies of the studies performed (e.g., sample sizes, expert involvement, particular metrics used for "performance testing of output parameters and pressure profile").

Therefore, I cannot fulfill all parts of your request based on the provided text.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The document states that "No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act." While it mentions compliance with voluntary standards (IEC 60601-1, IEC 60601-2, AAMI / ISO 14971-1), these are general safety and risk management standards and not specific performance criteria for the device's therapeutic effect. The "performance testing of the output parameters and pressure profile" is mentioned, but no specific criteria or results 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)

• The document mentions "clinical comparison in healthy volunteers" as part of the safety and performance testing.
• Sample Size: Not specified.
• Data Provenance: The applicant is based in Israel (Medical Compression Systems (DBN) Ltd. and Biomedical Strategy (2004) Ltd.), suggesting the studies likely occurred there, but this is not explicitly stated for the "clinical comparison."
• Retrospective or Prospective: The "clinical comparison in healthy volunteers" implies a prospective study.

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/Not specified. The nature of the device (pneumatic compression for DVT prevention, circulation enhancement, etc.) does not typically involve image interpretation or diagnosis that would require expert "ground truth" establishment in the cognitive sense. The "performance testing" would likely involve objective biomechanical or physiological measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not specified. Adjudication methods are typically used when there is subjective interpretation or a need to resolve discrepancies in expert opinions, which does not appear to be the case for the described tests on a pneumatic compression 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

• No. This device is not an AI-powered diagnostic tool, so an MRMC study is irrelevant.

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

• Not applicable. This device is a physical medical device, not an algorithm, so "standalone performance" in that context is not relevant. The "software verification and validation" would assess the algorithm's correct functioning within the device.

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

• For the "performance testing of output parameters and pressure profile" in healthy volunteers, the ground truth would likely be objective physiological measurements (e.g., blood flow velocity, pressure readings, temperature changes) and device output parameters measured by calibrated equipment. The document does not elaborate on these specifics.

8. The sample size for the training set

• Not applicable. This device does not use machine learning in a way that would require a "training set" for an AI model. "Software verification and validation" would be based on established software engineering principles, not statistical training data.

9. How the ground truth for the training set was established
* Not applicable. See point 8.

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The WizAir DVT™ is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs. The WizAir DVT™ is intended for use in: Preventing Deep Vein Thrombosis (DVT). Enhancing blood circulation. Diminishing post-operative pain and swelling. Reducing wound-healing time. Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers. Treatment of chronic venous insufficiency. Reducing edema.

The WizAir DVT™ is a prescriptive, pneumatic compression device designed to apply sequential compression to the lower limb. The control unit of the WizAir DVT™ is light and compact, thus making it a portable ambulant system. The WizAir DVTTM provides the user with an option of battery operation in addition to the operation from the mains option. The WizAir DVT™ is easy to use and provides the user with several treatment options: compression of the foot - single or double, compression of the calf - single or double, compression of the Thigh - single or double, and combined compression of any combination of two cuffs. The foot compression program is sequential intermittent pressure pulse application to a single celled foot cuff. The calf and thigh compression program is a a sequential intermittent gradient application of a pressure to a three-celled calf cuff.

This document describes a 510(k) submission for the WizAir DVT™, a pneumatic compression device. The provided text, however, does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.

The document primarily focuses on:

• Device Description: What the WizAir DVT™ is and how it works.
• Indications for Use: The medical conditions the device is intended to prevent or treat.
• Contraindications: Situations where the device should not be used.
• Regulatory Information: Classification, product code, applicant details, and the FDA's decision regarding substantial equivalence.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is a regulatory clearance letter, not a clinical study report or a detailed performance validation document.

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