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The ActiveCare DVT and ActiveCare+SFT Systems are prescription 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 DVT and ActiveCare+SFT Systems are prescription, pneumatic compression Systems designed to apply sequential compression to the lower limb. The control units of the ActiveCare DVT and ActiveCare+SFT Systems provide the user with several treatment options: compression of the foot - single or double, compression of the call - 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.

The provided text describes a 510(k) submission for minor modifications to the ActiveCare DVT and ActiveCare+SFT Systems. This is a premarket notification for a medical device seeking to demonstrate substantial equivalence to a legally marketed predicate device.

Here's an analysis of the provided information regarding acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify the sample size for a "test set" in the context of clinical or performance data for the modified device. The testing described focuses on demonstrating that the modifications themselves do not raise new safety or efficacy concerns, rather than re-proving the device's original clinical effectiveness.

The document indicates "field testing" was performed, but no details on sample size, data provenance (country of origin, retrospective/prospective), or type of data are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This submission is for modifications to an existing device, and the testing described does not involve establishing ground truth for a diagnostic or predictive algorithm. There's no mention of experts being used in this capacity.

4. Adjudication method for the test set

Not applicable. As noted above, this type of testing is not described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or described in this document. The submission focuses on demonstrating the safety and equivalence of minor hardware and software modifications.

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

Not applicable. The device is a pneumatic compression system, not an AI or algorithm-based diagnostic tool. The "software updates" mentioned are likely related to the control unit's operational logic, not a standalone diagnostic algorithm.

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

Not applicable. The testing described involves performance, electrical safety, risk analysis, and software validation for the device's functionality, not a diagnostic accuracy assessment against a ground truth.

8. The sample size for the training set

Not applicable. This document pertains to modifications of an existing physical medical device, not a machine learning model that would require a training set.

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

Not applicable, as there is no mention of a training set for a machine learning model.

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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 DVT™ 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 (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 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 sequential intermittent gradient application of a pressure to a three-celled calf cuff.

The provided text describes the WizAir DVT™ device and its substantial equivalence to a predicate device, focusing on the addition of a "Foot Booster cuff." However, it does not contain detailed information about acceptance criteria or a comprehensive study proving the device meets specific acceptance criteria in the way typically required for AI/algorithm performance. The document is a 510(k) summary for a medical device and primarily addresses substantial equivalence for a hardware modification.

Based on the provided text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: "clinical analysis that was performed on healthy volunteers." The specific number of volunteers is not specified.
• Data Provenance: The study was a "clinical analysis" performed on "healthy volunteers." The country of origin is implicitly Israel, given the applicant's address, but this is not explicitly stated for the study data. The study appears to be prospective as it involved performing clinical analysis.

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

This information is not provided in the document. The study described is a clinical analysis on healthy volunteers to verify the performance of a pneumatic compression device, not an AI or diagnostic device that typically relies on expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable to the type of device and study described.

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

No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices involving human interpretation (e.g., radiologists interpreting images), which is not the case for this pneumatic compression device.

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

This concept is not applicable to the WizAir DVT™. It is a hardware medical device with a software component to control pneumatic compression, not an "algorithm" in the sense of an AI model for diagnosis or prediction. The "performance" refers to the mechanical and physiological effects of the device.

7. The Type of Ground Truth Used

For the clinical analysis, the "ground truth" would likely involve physiological measurements related to blood circulation, pressure, or other relevant health indicators in healthy volunteers, comparing the device's performance to expected physiological responses or the predicate device. However, the specific type of ground truth used (e.g., specific physiological measurements) is not detailed in the document.

8. The Sample Size for the Training Set

This information is not provided and is not applicable as this is not an AI/machine learning device that requires a distinct "training set" in the conventional sense. The "software modification" was verified and validated, but no mention of a training set for an algorithm is made.

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

This information is not provided and is not applicable for the reasons mentioned above.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence for a physical device (pneumatic compression) with a minor modification (Foot Booster cuff). The "study" mentioned is a "clinical analysis...performed on healthy volunteers" and "bench testing" to ensure the new cuff performs "according to its specifications in safe and effective manner" and has a "similar" pressure profile to the predicate. The document doesn't provide the detailed methodological rigor, acceptance criteria, sample sizes, and ground truth establishment typically associated with the evaluation of AI/ML-based diagnostic algorithms.

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The ProAir 3000 is a prescriptive device that induces controlled compression of the calf, the foot or combined compression of both. The ProAir 3000 is intended for use by patients and medical professionals in treating many conditions, such as: prevention of deep vein thrombosis (DVT), enhancement of blood circulation, reduction of post-operative pain and swelling, reduction of wound-healing time, stasis dermatitis, treatment and assist healing of cutaneous ulceration, venous stasis ulcers, leg ulcers, chronic venous insufficiencies, reduction of edema.

The ProAir 3000 is a prescriptive, pneumatic compression device designed to apply sequential compression to the lower limb. The device is composed of four components: Portable pneumatic control unit, Pair of cuffs (calf and/or foot-ware), Pneumatic connecting tubes, Electrical transformer. During the compression cycle the solenoid valves are activated to insert air into one cuff and then other valves are activated for the other cuff. After inflating the cells in one cuff, the solenoid valves are deactivated and, simultaneously, the second cuff is inflated. Following a complete cycle for both legs there is a relaxation period. A software-based protection limits the pressure in all cuff cells using pressure sensors. In addition, a mechanical valve has been included in the air system for releasing air in case of over pressure in one of the cells. The ProAir 3000 has three operation modes: calf cuff mode, foot cuff mode and combined mode.

The provided text describes a 510(k) submission for the ProAir 3000 Compression System. While it mentions safety and performance testing, it does not provide specific acceptance criteria or the details of a study that proves the device meets them.

The documentation focuses on demonstrating substantial equivalence to predicate devices based on a series of safety and performance testing, but the specifics of what was tested to what standard, and the results, are not included in this document.

Therefore, for your request, I can only state that the detailed information you are asking for is not present in the provided text.

Specifically, the following sections cannot be answered:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific test set requiring expert ground truth is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not described. This type of study would not typically apply to a compression system anyway; it's more relevant for diagnostic imaging AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an algorithm in the traditional AI sense.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable as no AI/algorithm training is described.
9. How the ground truth for the training set was established: Not applicable.

The document states: "Based on a series of safety and performance testing including a comparative study, Medical Compression Systems (DBN) Ltd. believes that the ProAir 3000 is substantially equivalent to its predicate devices cited above without raising new safety and/or effectiveness issues." This statement indicates that testing occurred, but the specifics of that testing are omitted from this particular 510(k) summary.

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The SlendAir 4000 is a prescriptive device that induces controlled compression of the leg or the arm. The SlendAir 4000 is intended for use by medical professionals and patients at home in treating many conditions, such as: Primary lymphoedema, Post mastectomy edema, Leg ulcers, Edema following trauma and sport injuries, Post immobilization edema, Venous insufficiencies, Lymphoedema.

The SlendAir 4000 is a prescriptive, pneumatic compression device designed to apply peristaltic compression to a limb. The device is composed of four components: Light and portable pneumatic control unit, Calf, foot, full leg, or full arm cuff composes of 1-12 cells, Pneumatic connecting tubes, Electrical transformer. The SlendAir enables different treatment pressures (30-90mmHg) and treatment times (15-60 minutes) that should be used according to physician discretion. When activated, air flows into the cuff cells in a continues, predetermined peristaltic waveform. A mechanical valve has been included in the air system for releasing air in case of over pressure in one of the compartments.

Based on the provided text, the SlendAir 4000 Compression System is a medical device, and the information is from a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results with specific acceptance criteria and performance metrics for the device itself. Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this document.

Here's what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit acceptance criteria or reported device performance in terms of clinical outcomes (e.g., reduction in edema, healing of leg ulcers) are provided. The "performance" described refers to compliance with voluntary engineering standards and a comparative safety and performance study for substantial equivalence determination.

2. Sample size used for the test set and the data provenance

Not available. The document mentions "a series of safety and performance testing including a comparative study," but it does not specify the sample size, the type of data (e.g., patient data, engineering data), or the provenance (country of origin, retrospective/prospective nature) of this test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not available. The document does not describe the establishment of a "ground truth" in the context of a clinical test set, as its focus is on substantial equivalence through engineering and comparative performance.

4. Adjudication method for the test set

Not available.

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 AI-assisted diagnostic or imaging device used by human readers. Therefore, an MRMC study and AI improvement effect size are irrelevant.

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

Not applicable. This is not an algorithmic device.

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

Not available. The concept of "ground truth" in a clinical diagnostic sense is not discussed. The "ground truth" for demonstrating equivalence would likely be meeting the performance specifications of the predicate devices or relevant engineering standards.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

Summary of available information regarding the study:

The document states:

• "Based on a series of safety and performance testing including a comparative. study, Medical Compression Systems (DBN) Ltd. believes that the SlendAir 4000 is substantially equivalent to its predicate devices cited above without raising new safety and/or effectiveness issues."

This indicates that a comparative study was performed to demonstrate substantial equivalence to predicate devices (Talley TM300, TM500, and Multipulse Sequential Compression Systems) in terms of safety and performance. However, specific details about the methodology, sample sizes, or results of this study are not provided in this 510(k) summary. The summary focuses on regulatory compliance and the device's basic operational description rather than detailed clinical trial data.

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