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The AeroDVx™ Arm System is comprised of a gradient compression sleeve, portable intermittent pneumatic pump and hand pump designed to provide static or intermittent pneumatic compression to the bicep and forearm, in both a clinical and outpatient setting. It is intended to provide treatment for:

• . Enhancement of blood circulation
• Reduction of post-operative pain and swelling .
• Reduction of edema
• Lymphedema .
• Post immobilization edema .
• Post mastectomy edema
• Edema following trauma and sports injuries
• Reducing wound healing time ●
• . Lipedema

The AeroDVx ™ Arm System is compression sleeve, electronic intermittent pneumatic pump for intermittent pneumatic compression therapy or DVT Prophylaxis. The AeroDVx™ Arm compression sleeves are composed of a family of non-sterile single patient use medical devices. The AeroDVx ™ Arm compression sleeves contain a single bladder with a built-in gradient profile and inelastic Velcro straps to affix it to the patient's arm. The AeroDVx ™ Compression Sleeve for the Arms are available in three sizes, small, medium and large. The sleeves are composed of two polyurethane laminates that are sealed together creating an internal bladder system. The Arm Sleeves were developed on a technology platform that allows the sleeves to be wearable, which is designed to provide mobility for patients during use. The bladder system contains circular and bar welds that were engineered with their spacing and location to provide a gradient compression profile when worn and inflated. An inflation source is attached to the inflation valve on the sleeve. The insertion of the inflation source into the check valve, opens the luer valve so that the bladder can be inflated or deflated based on the direction of airflow. There is an inflation source provided: a portable, battery-operated intermittent pneumatic pump, the AeroDVx™ Pump (cleared under K183349), to provide intermittent pneumatic compression and a hand pump for static inflation. The system is intended for clinical and outpatient use. The AeroDVx Arm system is developed on a wearable compression technology platform, which is designed to provide mobility for patients.

The provided text is a 510(k) summary for the AeroDVx™ Arm System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific quantitative performance acceptance criteria through the kind of studies you're asking about (e.g., MRMC studies, specific sensitivity/specificity targets for an AI algorithm).

The AeroDVx™ Arm System is a medical device for pneumatic compression, not an AI/ML powered diagnostic device that would typically have the detailed AI performance criteria and studies you've outlined. Therefore, many of the requested points are not applicable or cannot be extracted from this document.

However, I can extract the information relevant to the device's "acceptance criteria" and "proof" within the context of a 510(k) submission, heavily focusing on non-clinical performance and substantial equivalence.

Here's how the document addresses the concept of acceptance criteria and validation, adapted to the context of a physical medical device submission:

Acceptance Criteria and Reported Device Performance

Here's an attempt to answer the remaining points, noting where the information is not applicable (N/A) for this type of medical device submission.

2. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated as a "test set" in the context of an AI algorithm; rather, testing was conducted on samples of the device and its components. For "Performance Pressure testing," "The sample size determination is identical for all protocols" (referring to prior K183349 protocols), but the number is not given. For "Mobility" testing (TR-0058), the sample size is also not stated.
   • Data Provenance: Not specified (e.g., country of origin). The studies appear to be bench testing and internal verification/validation, not patient data trials. The submission is retrospective in the sense that it relies on previously cleared device data (K183349).

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

   • N/A. This device does not use an AI algorithm that requires expert "ground truth" establishment for diagnostic accuracy evaluation. The "ground truth" for this device refers to meeting established engineering and safety standards, and functional equivalence, typically verified by internal engineers and quality control personnel.

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

   • N/A. No expert adjudication process for image interpretation or similar tasks is involved.

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:

   • N/A. This is not an AI-assisted diagnostic device, so an MRMC study is not relevant.

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

   • N/A. Not an AI algorithm. Its "standalone" performance refers to its physical and electrical functioning, which was assessed via bench testing protocols (e.g., pressure output, electrical safety).

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

   • N/A (in the AI context). For this device, "ground truth" is established by adherence to engineering specifications, validated test protocols, and recognized standards (e.g., ISO 10993 for biocompatibility, IEC 60601-1 for electrical safety). Functional equivalence to the legally marketed predicate device also serves as a "ground truth" for performance.

8. The sample size for the training set:

   • N/A. This is not a machine learning/AI device, so there is no training set.

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

   • N/A. As there is no training set, this question is not applicable.

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The AeroDVx ™ System is comprised of a gradient compression sleeve, portable intermittent pneumatic pump, and hand pump designed to provide static or intermittent pneumatic compression to the calf and foot, in both the hospital and outpatient setting. It is intended to provide treatment for:

1. DVT Prophylaxis
2. Enhancement of blood circulation
3. Reduction of post-operative pain and swelling
4. Reduction of wound-healing time
5. Stasis dermatitis
6. Treatment and assistance of healing cutaneous ulceration
7. Venous stasis ulcers
8. Leg ulcers
9. Chronic venous insufficiency
10. Reduction of edema
11. Lymphedema

The AeroDVx ™ System is comprised of a gradient compression sleeve, electronic intermittent pneumatic pump and hand pump to provide static and/or intermittent pneumatic compression for compression therapy or DVT Prophylaxis. The AeroDVx™ gradient compression sleeve is composed of a family of non-sterile single patient use medical devices.

The AeroDVx ™ Gradient Compression Sleeve contains a single bladder with a built-in gradient profile and inelastic straps to affix it to the patient's leg. The AeroDVx TM Gradient Compression Sleeve is available in four sizes and two different lengths (standard and short). The wrap is composed of two polyurethane laminates that are sealed together creating an internal bladder system. The bladder system contains circular and bar welds that were engineered with their spacing and location to provide gradient compression profile when worn and inflated.

An inflation source is attached to the inflation valve on the sleeve. The insertion of the inflation source onto the check valve of pressure opens the leur valve so that the bladder can be inflated or deflated based on the direction of airflow.

There will be two inflation sources provided: a portable, battery-operated intermittent pneumatic pump, the AeroDVx™ Pump, to provide intermittent pneumatic compression and a hand pump to provide static compression.

The system is intended for hospital and outpatient use.

The provided text is a 510(k) premarket notification for the AeroDVx System. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. However, it does not contain specific details about acceptance criteria, a study proving the device meets those criteria, or the methodology of such a study.

The "Performance Data" section merely states: "The critical functions of the device have been tested for verification and have met the design inputs." without providing any quantitative data, study design, or results.

Therefore,Based on the provided text, I cannot complete a table of acceptance criteria and reported device performance or describe a study that proves the device meets the acceptance criteria. The document states:

"Performance Data [21 CFR 807.92(b) (1)]: The critical functions of the device have been tested for verification and have met the design inputs."

This statement confirms that testing was done and that design inputs were met, but it does not provide:

• A table of specific acceptance criteria.
• The reported device performance metrics against those criteria.
• Details of the study (sample size, data provenance, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set details) that yielded these results.

Without this specific information, the requested table and study description cannot be generated from the given document.

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