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The PnueAira device and garments for legs and core are intended for use by medical professionals and patients who are under medical supervision to increase lymphatic flow in the treatment of many conditions such as:

• Lymphedema
• Primary lymphedema
• Post mastectomy edema
• Edema following trauma and sports issues
• Post immobilization edema
• Venous insufficiency
• Reducing wound healing time
• Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, arterial ulcers, and diabetic leg ulcers
• Lipedema

The PnueAira (PNCU-01) is a pneumatic compression device that uses air to systematically compress a patient's limbs affected by lymphedema and/or similar conditions. The control unit is placed on a table near the user and plugged into a power outlet. The patient wears the desired garment (i.e., core or full leg) and attaches it to the control unit via the connectors located on the garment. The patient uses the control unit to select the appropriate prescribed treatment profile, as shown on the device display, to begin their therapy profile. The device supports Peristaltic (i.e., a chamber is inflated and deflated before moving to the next chamber in a particular sequence) and Non-Peristaltic, sometimes known as sequential (i.e., all chambers are inflated in order, then all chambers are deflated simultaneously) compression modes.

The PnueAira device is designed for at-home treatment of lower extremity lymphedema. It assists in reducing lymphedema-related swelling by directing excess fluid from an impaired lymphatic area to healthier parts of the body.

The PnueAira system consists of the following components:

• Control unit
• Power Adapter
• Garments - Core and Full-leg
• Y-Connector Accessory

The provided FDA 510(k) clearance letter for PnueAira (PNCU-01) does not include information about a clinical study or human reader performance. This device is a Class II Compressible Limb Sleeve, and the clearance is based on substantial equivalence to predicate devices, primarily the AIROS 6P Sequential Compression Device.

The submission relies on non-clinical testing to demonstrate safety and effectiveness, rather than clinical trials or studies involving human readers and AI assistance. The information presented specifically details the acceptance criteria regarding the device's functional performance and compliance with relevant electrical safety, usability, home use, and biocompatibility standards.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from human reader studies, or details regarding sample sizes, expert adjudication, MRMC studies, or standalone algorithm performance, as these were not part of the documented submission for this particular device.

Here's a breakdown of the information that can be extracted based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

The document outlines functional and performance testing conducted to ensure the device meets its design specifications and complies with relevant standards. These serve as the "acceptance criteria" for non-clinical performance characteristics.

Information Not Applicable/Provided in the Document:

The following points are typically associated with AI/ML-based medical devices or devices requiring clinical effectiveness studies. This 510(k) submission for the PnueAira (PNCU-01) does not describe such studies.

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for this device's non-clinical testing. The submission does not mention clinical test sets or patient data.
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. "Ground truth" in the context of clinical expert review is not mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI-assisted diagnostic or interpretive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical pneumatic compression system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to the non-clinical testing described. For device performance, the "ground truth" would be established by validated measurement equipment and adherence to standard specifications.
8. The sample size for the training set: Not applicable. This device does not use an AI/ML model trained on data.
9. How the ground truth for the training set was established: Not applicable.

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The AIROS 6P Sequential Compression Device utilizes gradient pneumatic compression, which is intended for treatment of patients with the following conditions:

• Lymphedema
• Venous stasis ulcers
• Venous insufficiency
• Peripheral edema
  The device is safe for both home and hospital use.

AIROS 6P Sequential Compression Device is a pneumatic compression device used for treatment and management of venous or lymphatic disorders. The application of compression is effective by increasing blood flow and encouraging extracellular fluid clearance. The device consists of the mechanical device that is used to set the treatment options and supplies cycles of air to the compression garments. There are two primary treatment modes, Gradient Mode and Peristaltic Mode. The air is supplied at adjustable pressures and sequences and inflates the compression garments from the distal to proximal areas of the body. The compression garments are supplied in various sizes for the upper and lower extremity areas of the body.

The AIROS 6P Sequential Compression Device is a pneumatic compression device used for the treatment and management of venous or lymphatic disorders. The study provided in the 510(k) summary focuses on functional performance testing to demonstrate substantial equivalence to predicate devices, rather than a clinical study involving human patients or complex AI algorithms requiring expert adjudication of ground truth.

Here's an breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" with numerical targets and "reported device performance" in a comparative table for specific clinical outcomes. Instead, it lists functional performance tests conducted to ensure the device meets its specifications and is substantially equivalent to predicate devices.

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

The document does not mention a "test set" in the context of patient data or clinical outcomes. The testing described is functional performance testing of the device itself. Therefore, concepts like sample size of patients, data provenance (country of origin), or retrospective/prospective data collection are not applicable to the tests reported.

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

There is no mention of experts being used to establish a "ground truth" for a test set in the provided text. The testing described is engineering/functional testing.

4. Adjudication Method for the Test Set

Not applicable, as no test set requiring adjudication by experts is described.

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. The AIROS 6P is a pneumatic compression device, not an AI-assisted diagnostic or therapeutic tool that would involve "human readers" or "AI assistance" in the sense of image interpretation or similar cognitive tasks.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. The AIROS 6P is a physical medical device, not a standalone algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the functional performance testing would be the device's design specifications and established engineering standards. For example, "cycle time accuracy" would be compared against the designed cycle times. There is no biological or clinical "ground truth" like pathology or outcomes data involved in the described testing.

8. The Sample Size for the Training Set

Not applicable. The AIROS 6P 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, as there is no training set for this device.

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The AIROS 8P Sequential Compression Device utilizes gradient pneumatic compression, which is intended for treatment of patients with the following conditions:

• Lymphedema
• Venous stasis ulcers
• Venous insufficiency
• Peripheral edema

The device is safe for both home and hospital use.

AIROS 8P Sequential Compression Device is a pneumatic compression device used for treatment and management of venous or lymphatic disorders. The application of compression is effective by increasing blood flow and encouraging extracellular fluid clearance. The device consists of the mechanical device that is used to set the treatment options and supplies cycles of air to the compression garments. There are three primary treatment modes, Gradient Mode, Pressure Mode, and Peristaltic Mode. The air is supplied at adjustable pressures and sequences and inflates the compression garments from the distal to proximal areas of the body. The compression garments are supplied in various sizes for the upper and lower extremity areas of the body.

The provided text is a 510(k) premarket notification for the AIROS 8P Sequential Compression Device. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving that a device meets specific performance acceptance criteria for a novel AI/ML algorithm.

Therefore, the requested information regarding acceptance criteria for an AI/ML device, its performance, sample sizes for test and training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be found in this document.

This document describes a medical device (a pneumatic compression device) and its functional performance testing (e.g., Error Indicator Testing, Noise Testing, Cycle Time Accuracy, Pressure Time Accuracy, Therapeutic Performance, Therapy Time Accuracy, Garment Integrity). These tests ensure the hardware and software functionality, and compliance with electrical and safety standards, but do not involve an AI/ML algorithm that requires a dedicated clinical or imaging study with a ground truth established by experts.

Here's why the specific questions cannot be answered from the provided text:

• No AI/ML Component: The AIROS 8P Sequential Compression Device is a physical medical device that applies pneumatic compression. The "AIROS" in the name refers to the company, not Artificial Intelligence. The description of the device's operation ("digitally controlled device consists of an electrically generated source of compressed air, tubing to convey the pressurized air to the sleeve") confirms it's a mechanical device with digital controls, not an AI/ML algorithm that interprets data or images.
• Substantial Equivalence Focus: The entire premise of this 510(k) submission is to demonstrate that the AIROS 8P is "substantially equivalent" to already legally marketed predicate devices (AIROS 8 Sequential Compression Device and Mego Afek Lympha Press Optimal). This type of submission does not typically involve clinical trials or performance studies that would establish acceptance criteria for a novel AI/ML algorithm's accuracy, sensitivity, or specificity.
• Functional Performance Testing: The "Functional Performance Testing" listed (Error Indicator Testing, Noise Testing, Cycle Time Accuracy, etc.) pertains to the engineering and operational parameters of the physical device, not an AI algorithm's diagnostic or predictive performance.

In summary, the provided document does not contain information about acceptance criteria or a study for an AI/ML device because the AIROS 8P Sequential Compression Device is not described as an AI/ML device.

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The Bio Compression Systems' Sequential, pneumatic compression devices intended for either primary or adjunctive treatment of lymphedema, peripheral edema, venous insufficiency, and venous stasis ulcers. Sequential Circulators are also intended for the prophylaxis of deep vein thrombosis (DVT). Intended for use in a home or healthcare setting.

Bio Compression Systems' Sequential Circulators are sequential pneumatic compression device which consists of a segmented pneumatic compression sleeve ("qarment") connected to a pneumatic compression pump ("pump"). The pump cyclically inflates the garment's segments ("chambers") in sequence from the distal end toward the trunk of the body. The inflation of the garment compresses the limb on which it is worn, stimulating the movement of interstitial fluid and blood flow.

The core components of the pump are the motor, air compressor, disc valves, and micro switch. The air compressor generates air flow into a stationary disc valve. The motor moves a rotating disc valve. The geometry of the disc valve directs air flow and cyclically triggers the micro switch.

The pump is controlled by softkeys and an LED display (models SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL) or by a touch screen LCD (models SC-4004-DL, SC-4008-DL).

The device uses the Predicate Device's garments.

The provided document is a 510(k) premarket notification for a medical device (Sequential Circulators) and does not describe a study that establishes acceptance criteria for a device based on expert performance or to prove a device meets acceptance criteria through a comparison with human readers or a standalone algorithm study.

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device, as required for 510(k) submissions to the FDA. The "acceptance criteria" discussed are primarily related to general performance, electrical safety, electromagnetic compatibility, and software verification/validation, rather than clinical performance based on ground truth established by experts.

Therefore, many of the requested points related to acceptance criteria and performance studies in the context of AI/ML or expert adjudication in a clinical setting cannot be directly extracted from this document.

However, I can provide the information that is present:

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

The document doesn't present "acceptance criteria" in a typical table format with quantitative performance metrics for a diagnostic or AI device (e.g., sensitivity, specificity). Instead, it lists various tests and validations performed to ensure the device performs as intended and is safe. The "reported device performance" is implied by the satisfactory completion of these tests, leading to the substantial equivalence determination.

Here's an interpretation based on the document's content:

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

The document does not specify sample sizes in terms of a "test set" for clinical evaluation in the way an AI/ML device submission would. The testing described (electrical safety, functional verification, comparative pressure) refers to engineering and bench testing of the devices themselves, not a dataset of patient cases.

• Sample Size: Not applicable in the context of clinical "test sets" for diagnostic performance. The sample size would refer to the number of device units tested.
• Data Provenance: Not applicable. The testing is described as being conducted on the subject device and reference devices, not on patient data.

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

This information is not applicable to this 510(k) submission. The device is a pneumatic compression device, not a diagnostic imaging device or an AI/ML algorithm requiring expert ground truth for clinical performance evaluation. The "ground truth" for this device's performance is its direct physical output (e.g., pressure, cycle time) verified through engineering tests against specifications.

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

Not applicable. There is no expert adjudication mentioned as this is not a diagnostic or AI/ML device relying on interpretation of clinical data.

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 is not an AI-assisted device, and no MRMC study was conducted.

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

Not applicable. This is not an AI algorithm.

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

For this device, the "ground truth" used for testing would be the engineering specifications and established standards for medical devices (e.g., pressure accuracy, cycle time, electrical safety parameters). It is not clinical ground truth derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. This device does not involve training of an AI/ML model.

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

Not applicable. No training set for an AI/ML model.

Summary of the Study Proving Device Meets Acceptance Criteria (as described in the 510(k)):

The study to prove the device meets its "acceptance criteria" (understood here as performance specifications and safety standards) consisted of a series of bench testing, engineering verification, and validation activities. These included:

• Electrical Safety and Electromagnetic Compatibility (EMC) Testing: Adherence to recognized national and international standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, etc.).
• Predicate Device Routine Acceptance Tests Conducted on Subject Device: This implies the new device underwent the same internal quality control and performance tests as the predicate, including continuous and timed operation observation, pressure testing, and HiPot testing.
• Functional Verification and Validation Testing: Specific tests were conducted to verify and validate cycle time, treatment time, pressure setting endpoints, and overall functionality of all modes and settings.
• Comparative Pressure Testing: Specific tests were done to compare the pressure performance of the Subject Device and Predicate Device, particularly regarding individual chamber adjustment and pressure gradients. This was crucial for demonstrating substantial equivalence for critical performance parameters.
• Software Verification and Validation Testing: Conducted in accordance with FDA guidance for medical device software, confirming its functionality and safety (classified as "minor" level of concern).

The conclusion states: "The data included in this submission demonstrates that the Subject Device is substantially equivalent to the legally marketed Predicate Device and performs comparably to the Predicate Device that is currently marketed for the same intended use." This statement serves as the justification that the device meets the implied "acceptance criteria" for demonstrating substantial equivalence.

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