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Aerosure is indicated for use as a Positive Expiratory Pressure (PEP) Device.

• · The use of Aerosure improves clearance of secretions
• · The use of Aerosure may reduce the need for postural drainage
• Aerosure facilitates opening of airways in patients with Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems
• · Aerosure may be used to prevent or reverse atelectasis
  · Aerosure may also be useful in the removal of mucus from the lungs of patients who have chronic bronchitis or bronchiectasis

Aerosure is intended for patients age 21 and above with Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems, and patients with atelectasis. All patients must be capable of following instructions for Positive Expiratory Pressure Therapy.

Aerosure may be used in hospital as well as the home after a period of training.

Aerosure is a small, battery powered device. It produces a rapidly alternating occlusion of airflow as a user breathes through the replaceable valve head (containing the powered rotating vane mechanism) which creates a general increase in resistance to breathing and a vibration of the respiratory tree and the associated structures, including the musculature. Frequency is adjusted by switching modes.

The provided document is a 510(k) summary for the Aerosure Medic device. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for clinical performance.

Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and ground truth establishment cannot be directly extracted from this document.

However, I can provide the available information based on what is presented:

Acceptance Criteria and Reported Device Performance

The document states that a variety of performance tests were conducted, and the device "functioned as intended" and "met its specifications." It also notes that performance bench test data demonstrated the Aerosure Medic is "substantially equivalent" to predicate devices and has "directly comparable basic characteristics and substantially similar output specifications." Crucially, it highlights that human factors and usability testing concluded the device is "reasonably safe and effective for the intended users, uses and use environments."

General Acceptance Criteria (Implied / Stated):

Missing Information (Not Present in the Document):

Due to the nature of this 510(k) summary, the following specific details are not provided:

1. Sample size used for the test set and the data provenance: The document mentions "performance data," "functional testing," "bench testing," and "usability testing," but it does not specify sample sizes for any of these tests or the data provenance (e.g., country of origin, retrospective/prospective).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as detailed clinical performance results and ground truth establishment involving human experts are not described in this regulatory submission for substantial equivalence.
3. Adjudication method for the test set: Not applicable for the type of testing described (which is primarily bench, safety, and usability).
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance: Not applicable, as this is not an AI-assisted diagnostic device, and no MRMC study or AI components are mentioned.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm-only device; it's a physical medical device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the tests described would be objective measures against engineering specifications, safety standards, and usability criteria. There is no mention of clinical ground truth (like pathology or outcomes) as a basis for device performance in this submission.
7. The sample size for the training set: Not applicable, as this is not a machine learned AI device.
8. How the ground truth for the training set was established: Not applicable.

Summary of Study Information (Based on Document):

• Type of Studies: Biocompatibility, Electromagnetic Compatibility, Medical Device Safety, Cleaning & Ingress Protection, Functional Testing, Bench Testing (comparison to predicates), and Usability/Human Factors Testing.
• Purpose of Studies: To demonstrate that the Aerosure Medic "functioned as intended," "met its specifications," is "substantially equivalent" to predicate devices, and is "reasonably safe and effective" for its intended users and uses.
• Methodology for Usability Testing: Followed FDA's human factors draft guidance for industry entitled, "Applying Human Factors and Usability Engineering to Optimize Medical Device Design (June 22, 2011)."

The document primarily serves to demonstrate that the Aerosure Medic's technological characteristics and performance are substantially equivalent to existing, legally marketed predicate devices, thereby supporting its 510(k) clearance for marketing.

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The Revitive IX is indicated for:

• Relaxation of muscle spasms; .
• Prevention or retardation of disuse atrophy; ●
• Increasing local blood circulation; .
• Muscle re-education; .
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and .
• Maintaining or increasing range of motion. .

The Revitive IX consists of foot pads and/or electrode pads that deliver electrical stimulation to the muscles; an optional feature that allows for ankle movement during stimulation (IsoRocker); a remote control; and a user interface.

Here's an analysis of the provided 510(k) summary regarding acceptance criteria and the supporting study:

The provided 510(k) summary for the Actegy's Revitive IX does not contain specific acceptance criteria or a dedicated study explicitly designed to prove the device meets pre-defined performance acceptance criteria in the way typically found for novel diagnostic algorithms or complex medical devices requiring clinical efficacy studies.

Instead, the submission relies on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics, intended uses, and safety standards. The performance data mentioned refer to general safety and functional testing, not to specific clinical performance metrics with pre-defined acceptance thresholds.

Therefore, many of the requested fields cannot be directly answered from the provided text. I will address what information is available and indicate where information is absent.

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this 510(k) is primarily centered around safety, electromagnetic compatibility, biocompatibility, and functional equivalence to the predicate device. There are no specific quantitative clinical performance metrics (like sensitivity, specificity, accuracy, etc.) provided in relation to the stated indications for use.

Study Details (Based on the provided text)

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not applicable/Not specified. This was not a study involving a "test set" of patients or data in the context of diagnostic or clinical performance. The "performance data" refers to engineering and safety verification.
   • Data Provenance: Not applicable/Not specified.

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

   • Not applicable. There was no "ground truth" to establish for a test set in a clinical performance context. The assessment was against engineering specifications and regulatory standards.

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

   • Not applicable. No test set for clinical performance was evaluated this way.

4. 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 muscle stimulator, not an AI-powered diagnostic or assistive tool for human readers.

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

   • Not applicable as this is a physical medical device for muscle stimulation, not an AI algorithm. Its performance is measured directly by its electrical output and safety, not as an algorithm's classification accuracy.

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

   • Not applicable in the clinical sense. The "ground truth" for the performance data mentioned would be the relevant engineering standards (e.g., EN60601-1-2 for EMC) and the device's design specifications for electrical output and safety characteristics.

7. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

   • Not applicable.

Summary of the Study:

The "study" or "performance data" referred to in the 510(k) submission for the Revitive IX comprises standard engineering and regulatory compliance testing. This includes:

• Biocompatibility testing: To ensure the materials in contact with the patient are safe.
• Electromagnetic compatibility (EMC) testing (EN60601-1-2:2007): To ensure the device operates correctly in its electromagnetic environment and does not interfere with other devices.
• Electrical Safety testing (EMDD (93/42EEC), UL 60601-1, CSA C22.2 No.601-1-M90): This covers aspects like patient leakage current, enclosure leakage current, and insulation.
• Functional performance verification: Confirming that the device's electrical output parameters (frequency, pulse type, voltage range) and operational features (channels, modes, controls) align with its design specifications and are comparable to the predicate device.

The overarching goal of these tests was to demonstrate that the Revitive IX is as safe and effective as its predicate devices and that its minor technological differences do not raise new issues of safety or effectiveness, thus justifying a finding of substantial equivalence. There was no clinical trial or algorithm performance study described in the provided document.

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