Search Results

The Frequencer™ V2 or V2x provides airway clearance therapy and promotes bronchial drainage by inducing vibration in the chest walls. This device is intended to be a component of chest physiotherapy by providing a convenient method of external thorax manipulation. It is indicated for patients having respiratory ailments which involve defective mucociliary clearance, as is typical in patients suffering from cystic fibrosis as well as chronic bronchitis, bronchiectasis, ciliary dyskinesia syndromes, asthma, muscular dystrophy, neuromuscular degenerative disorders, postoperative atelectasis and thoracic wall defects. Indications for this form of therapy are described in the Clinical Practice Guidelines for Postural Drainage Therapy of the American Association for Respiratory Care (AARC) published in 1991. This particular device provides a gentler, less painful form of therapy than the traditional "clapping" method of postural drainage therapy, allowing it to be used on patients who cannot be treated by clapping.

The Frequencer™ V2 or V2x provides airway clearance therapy and promotes bronchial drainage by inducing vibration in the chest walls. It induces oscillatory sound waves in the chest by means of an electroacoustical power head (hereafter referred to as the "transducer") which is " placed externally on the patient's chest. The transducer is connected to a frequency generator which is capable of producing frequencies between 20 and 65 Hz. The transducer induces sound waves in the patient's chest which are effective in loosening mucus deposits. The model V2x uses disposable adapters with filters and is intended for use in multi-patient settings. The model V2 uses a permanent non-filtering adapter and is intended for single patient use.

The Dymedso Frequencer V2™ and Frequencer V2x™ Airway Clearance Device is not an AI/ML device. The provided text describes a medical device for airway clearance therapy that induces vibrations in the chest walls. The performance testing conducted includes electrical safety, electromagnetic radiation, biocompatibility, and bench testing to compare applied force with a predicate device and conventional chest physiotherapy (CCPT). There is no mention of an algorithm, AI, or machine learning in the device's description or performance testing. Therefore, the specific criteria requested for AI/ML device evaluations (such as sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance) are not applicable to this submission.

Here's a summary of the performance testing and acceptance criteria as described in the document, which pertains to the physical and electrical characteristics of the device, and its safety:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document references "Clinical testing conducted on the original Frequencer™" for sputum weights and "In vitro flow rate measurements," but does not specify sample sizes or data provenance for these studies. The primary testing for the V2 and V2x models focuses on electrical safety, EMC, biocompatibility, and a bench test for applied force, which do not typically involve patient "test sets" in the AI/ML context.

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. The device is not an AI/ML device that generates outputs requiring expert ground truth for evaluation.

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

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

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/ML device.

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

Not applicable. This is not an AI/ML device. The "standalone" performance here refers to the device's physical and electrical operation, and its ability to induce vibrations.

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

For the performance assessment, the "ground truth" or reference points were:

• Safety and EMC Standards: IEC 60601-1 and IEC 60601-1-2.
• Biocompatibility Standards: ISO 10993-5 and ISO 10993-10.
• Predicate Device Performance: Comparison of applied force to the Frequencer™ v2x (K100749).
• Conventional Chest Physiotherapy (CCPT): Used as a clinical benchmark for sputum weights and a comparison for applied force.
• No Treatment: Used as a benchmark for in vitro mucus flow rates.

8. The sample size for the training set

Not applicable. This is not an AI/ML device and does not have a "training set."

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

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

Ask a specific question about this device

The Frequencer™ v2x provides airway clearance therapy and promotes bronchial drainage by inducing vibration in the chest walls. This device is intended to be a component of chest physiotherapy by providing a convenient method of external thorax manipulation.

It is indicated for patients having respiratory ailments which involve defective mucociliary clearance, as is typical in patients suffering from cystic fibrosis as well as chronic bronchitis, bronchiectasis, ciliary dyskinesia syndromes, asthma, muscular dystrophy, neuromuscular degenerative disorders, postoperative atelectasis and thoracic wall defects. Indications for this form of therapy are described in the Clinical Practice Guidelines for Postural Drainage Therapy of the American Association for Respiratory Care (AARC) published in 1991. This particular device provides a gentler, less painful form of therapy than the traditional "clapping" method of postural drainage therapy, allowing it to be used on patients who cannot be treated by clapping.

The Frequencer™ v2x is only intended for use in hospitals and clinics.

The Frequencer™ v2x provides airway clearance therapy and promotes bronchial drainage by inducing vibration in the chest walls. It induces oscillatory sound waves in the chest by means of an electro-acoustical transducer (hereafter referred to as the "Power Head") which is placed externally on the patient's chest. The Power Head is connected to a frequency generator which is capable of producing frequencies between 20 and 65 Hz. The Power Head induces sound waves in the patient's chest which are effective in loosening mucus deposits. This model is intended for use in hospital and clinic settings only and disposable filters are available for multi-patient use.

The provided text describes the Dymedso Frequencer™ v2x, an airway clearance device, and its performance testing to demonstrate substantial equivalence to a predicate device. However, the document does NOT contain details about acceptance criteria directly in a clear, tabulated format with specific performance metrics and their corresponding reported values for the Frequencer™ v2x itself.

Instead, the document focuses on:

• Comparison to a predicate device: Frequencer™ 1001.
• Bench testing results: demonstrating "similar, though slightly lower maximum applied force" compared to the predicate. This comparison is not a direct measure against specific acceptance criteria for the Frequencer™ v2x's therapeutic effect.
• Reference to prior clinical testing on the original Frequencer: which showed "comparable sputum weights" and "higher flow rates of mucus in vitro." These are findings from the predicate device's studies, not new studies for the v2x.
• Compliance with safety and electromagnetic standards: IEC 60601-1 and IEC 60601-1-2. These are general safety standards, not performance criteria for its therapeutic indication.

Therefore, many of the requested items (sample sizes, expert qualifications, adjudication methods, MRMC studies, ground truth details for training/test sets) for the Frequencer™ v2x are not explicitly stated in this 510(k) summary. The summary focuses on showing that the Frequencer™ v2x is substantially equivalent to the Frequencer™ 1001 due to identical indications, operating principles, electronics, and similar basic performance (force applied).

Given the limitations of the provided text, here's an attempt to answer the questions based only on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

As specific therapeutic acceptance criteria for the Frequencer™ v2x (e.g., minimum sputum weight, minimum mucus flow rate) are not explicitly stated or quantified in this 510(k) summary, and the performance testing primarily focused on comparison to a predicate device and compliance with general safety standards, a direct table of acceptance criteria vs. specific reported values for the v2x's therapeutic efficacy cannot be fully constructed from the provided text.

The closest we can infer for "acceptance" is substantial equivalence to the predicate device.

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

The document does not specify a separate "test set" with a defined sample size for the Frequencer™ v2x. The clinical data referenced pertains to the original Frequencer™ (the predicate device). The performance testing for the v2x appears to be bench testing for mechanical force comparison and compliance testing for safety standards.

• Sample Size for Frequencer™ v2x performance testing: Not specified. It refers to "Performance bench testing" but not specific numbers of tests or devices.
• Data Provenance for Frequencer™ v2x: Not explicitly stated, implied to be laboratory bench testing undertaken by the manufacturer (DYMEDSO, Inc.) in Canada.
• Clinical data provenance (for predicate device results): Not detailed (e.g., country of origin, retrospective/prospective). It only mentions "Clinical testing conducted on the original Frequencer™."

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

Not applicable. The document does not describe a clinical "test set" and ground truth establishment involving human experts for the Frequencer™ v2x performance evaluation. The clinical claims for efficacy are based on the predicate device's studies, for which expert involvement is not described in this summary.

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

Not applicable. No clinical test set requiring adjudication by experts is described for the Frequencer™ v2x.

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 Frequencer™ v2x is an airway clearance device, not an AI-assisted diagnostic tool involving human readers.

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

Not applicable. The Frequencer™ v2x is a physical medical device, not an algorithm.

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

For the Frequencer™ v2x performance, the "ground truth" was its mechanical performance measured against the predicate device and compliance with safety standards. For the predicate device's efficacy data, the "ground truth" appears to be:

• "comparable sputum weights produced after treatment" (clinical outcome).
• "higher flow rates of mucus through a capillary tube" (in vitro laboratory measurement).

8. 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.

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

Not applicable. This device does not involve a "training set."

Ask a specific question about this device

The Frequencer™ provides airway clearance therapy and promotes bronchial drainage by inducing vibration in the chest walls. This device is intended to be a component of postural drainage therapy by providing a convenient method of external thorax manipulation.

It is indicated for patients having respiratory ailments which involve defective mucociliary clearance, as is typical in patients suffering from cystic fibrosis as well as chronic bronchitis, bronchiectasis, ciliary dyskinesia syndromes, asthma. muscular dystrophy, neuromuscular degenerative disorders, post-operative atelectasis and thoracic wall defects. Indications for this form of therapy are described in the Clinical Practice Guidelines for Postural Drainage Therapy of the American Association for Respiratory Care (AARC) published in 1991. This particular device provides a gentler, less painful form of therapy than the traditional "clapping" method of postural drainage therapy, allowing it to be used on patients who cannot be treated by clapping.

The Frequencer™ provides airway clearance therapy and promotes bronchial drainage by inducing vibration in the chest walls. It induces oscillatory sound waves in the chest by means of an electro-acoustical transducer (hereafter referred to as the "Power Head") which is placed externally on the patient's chest. The Power Head is connected to a frequency generator which is capable of producing frequencies between 20 and 100 Hz. The Power Head induces sound waves in the patient's chest which are effective in loosening mucus deposits.

Here's a breakdown of the acceptance criteria and study information for the Dymedso Frequencer™ Powered Percussor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Information:

The document describes one clinical trial to assess the efficacy of the Frequencer™ compared to Conventional Chest Physiotherapy (CCPT).

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

• Sample Size (Test Set): 20 adult patients
• Data Provenance: The document does not explicitly state the country of origin. Given the submitter's address in Quebec, Canada, and the FDA submission, it's likely the study was conducted in Canada or the US, but this is not confirmed. The study was a prospective clinical trial.

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 "ground truth" here is the amount of expelled sputum, which is a quantitative measurement, not something requiring expert consensus for its establishment in this context.

4. Adjudication Method for the Test Set

• This information is not applicable/not provided. The primary outcome measure (expelled sputum quantity) is a direct measurement, not an assessment requiring adjudication by experts.

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

• No, an MRMC comparative effectiveness study was not done. This device is a powered percussor for airway clearance, not an AI-powered diagnostic tool requiring human reader interpretation. Therefore, the concept of "human readers improve with AI vs without AI" is not relevant here.

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

• Yes, in spirit, a standalone performance was assessed. The clinical trial directly evaluated the Frequencer™ device's effectiveness (as a standalone therapy or component of therapy) in terms of sputum clearance against a traditional method (CCPT). There is no "algorithm" in the AI sense, but the device's inherent function was tested on its own.

7. The Type of Ground Truth Used

• The ground truth used was outcomes data, specifically the quantity of expelled sputum (in grams).

8. The Sample Size for the Training Set

• This information is not applicable/not provided. The Frequencer™ is a physical medical device, not an AI or machine learning algorithm that requires a "training set" in the computational sense. The device's design and operating parameters would have been developed through engineering and physiological understanding, not data-driven machine learning.

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

• This information is not applicable/not provided for the same reason as point 8. The "training" for such a device involves engineering design, prototyping, and testing, not establishing ground truth for a dataset.

Ask a specific question about this device