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The intended use of the ABI Vest Airway Clearance System is to promote airway clearance or improve bronchial drainage by enhancing mobilization of bronchial secretions where external manipulation of the thorax is the physician's choice of treatment. The indications typically follow the Clinical Practice Guideline published by the American Association for Respiratory Care (AARC) 1991. In addition, the device is also indicated for the purpose of collecting mucus for diagnostic evaluation.

The intended use of the ABIVest™ Airway Clearance System is the same as the predicate device, which is to provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. Indications for this form of therapy are described by the American Association for Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy (1991). According to AARC guidelines, specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, the ABIVest™ Airway Clearance System is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for purposes of collecting mucus for diagnostic evaluation.

The ABI Vest Airway Clearance System is a high-frequency chest wall oscillator designed to be used in a wide variety of settings for enhancing the mobilization of bronchial secretions. The primary components of the ABI Vest Airway Clearance System include an air-pulse generator and an inflatable vest. Oscillating positive pressure air pulses are applied to the vest by the air-pulse generator. The resulting pressure pulses cause the vest to inflate and deflate against the chest of the patient creating high-frequency chest wall oscillation and mobilization of bronchial secretions. The frequency of the air pulse is operator controlled and adjustable from 5 to 25 Hz.

This document is a 510(k) premarket notification for the ABI Vest Airway Clearance System. It explicitly states that no performance testing was required for this submission. The purpose of this 510(k) was solely to expand the indicated use of an already cleared device to include collecting mucus for diagnostic evaluation, making it substantially equivalent to its predicate device (ThAIRapy® Vest System K965192) in all other aspects.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth, and MRMC studies cannot be extracted from this document, as no such studies were conducted or presented for this specific submission.

The document indicates:

• Comparison of Technological Characteristics: "The ABI Vest System is identical to the previously cleared ABI Vest™ Airway Clearance System (a.k.a. ThAIRapy® Vest System) (K965192)... The only reason for this submission is to include in the device's indication for use that the device can be used for the mobilization of bronchial secretions to promote bronchial drainage for purposes of collecting mucus for diagnostic evaluation."
• Performance Testing: "None required."

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The intended use of the modified ThAIRapy® Vest is the same as the predicate device, which is to provide airway clearance therapy when external manipulation of thorax is the physician's choice of treatment. Indications for this form of therapy are described by the American Association for Respiratory Care (AARC) in the Clinical Practice Guidelines for Postural Drainage Therapy. According to AARC guidelines, the goals of airway clearance therapy are to improve mobilization of bronchial secretions, match ventilation and perfusion, and normalize functional residual capacity. Specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with secretion clearance, or presence of atelectasis caused by mucus plugging.

The ThAIRapy® System is a high-frequency chest wall oscillator designed be used in a wide variety of settings for enhancing the mobilization of bronchial secretions. The primary components of the ThAIRapy® System include an air oscillator and an inflatable vest. Oscillating positive pressure air pulses are applied to the vest by the air oscillator. The resulting pressure pulses cause the vest to inflate and deflate against the chest of the patient creating high-frequency chest wall oscillation and mobilization of bronchial secretions. Frequency of the pulse air is operator controlled and adjustable from 5 to 25 Hz.

The provided document is a 510(k) summary for the ThAIRapy® System, a medical device. It describes the device, its intended use, and a comparison to a predicate device, focusing on technological characteristics and performance testing related to safety and effectiveness.

However, the document does not contain the level of detail asked for in the request regarding acceptance criteria and study particulars for a typical AI/ML device submission.

This document predates widespread AI/ML medical device submissions and focuses on demonstrating substantial equivalence to a predicate device, not on specific performance metrics against a defined ground truth using statistical methods relevant to AI/ML.

Here's a breakdown of why and what information is available:

This document does not contain the following information typically found in an AI/ML device submission:

• Detailed acceptance criteria with target metrics (e.g., sensitivity, specificity, AUC).
• Reported device performance against such metrics.
• Sample sizes for test sets where ground truth is established for diagnostic accuracy.
• Data provenance (country of origin, retrospective/prospective) for a test set.
• Number of experts or their qualifications used to establish ground truth for a test set.
• Adjudication method for a test set.
• MRMC comparative effectiveness study results or effect sizes.
• Standalone algorithm performance results.
• Type of ground truth (e.g., pathology, outcomes data) for a diagnostic output.
• Sample size for a training set.
• How ground truth for a training set was established.

What is available and can be inferred from the document:

The submission focuses on demonstrating substantial equivalence to a predicate device (ThAIRapy® System, K884098) primarily through comparison of technological characteristics and performance testing related to the physical operation of the device, rather than diagnostic or analytical performance.

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

• Acceptance Criteria: The implicit acceptance criterion is that the modified device's performance should be "consistent with the predicate" device.
• Reported Device Performance:

  Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
  Pressures in inflatable vests	Consistent with predicate device	"Results depict pressures that are consistent with the predicate."

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

• Sample Size: Not specified. The performance testing mentions "Pressures obtained in the inflatable vests" but does not give a number of vests or tests conducted.
• Data Provenance: Not specified, but likely obtained through internal testing by American Biosystems, Inc. There is no mention of external data or patient data in this context.

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

• Not applicable. The performance testing here involves physical measurements (pressures) of the device, not expert interpretation of diagnostic outputs.

4. Adjudication method 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/ML diagnostic interpretation tool; it's a therapeutic physical device.

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

• Not applicable.

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

• The "ground truth" for the performance testing cited is the measured pressures obtained from the predicate device, against which the modified device's pressures were compared.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device.

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

• Not applicable.

In summary, this 510(k) submission relates to a physical medical device (chest wall oscillator), not an AI/ML-driven diagnostic or treatment planning system. Therefore, the detailed requirements for AI/ML study data are not present in this document. The "study" mentioned is a direct comparison of physical performance (pressure generation) between the modified device and its predicate.

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