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To filter a patient's inspiratory and expiratory respiratory gasses to remove bacteria and viruses.

For non-mechanically ventilated tracheostomy patients who are awake and alert or monitored by a trained healthcare provider or caregiver, where filtration of inspired and/or expired gases is desired. Use up to 24 hours.

Environment of use - clinical settings including hospital, sub-acute, pre-hospital, and home. For adults with Tidal Volumes >300 ml and pediatrics with Tidal Volumes >80 ml. Do not use on neonate or infant patients.

The Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) is a non-sterile, lightweight, single-patient use device for non-mechanically ventilated tracheostomy patients to filter viral, bacterial, and other particulate matter. The filter is intended to fit onto the 15mm hub of a tracheostomy tube. The filter is easy to apply and remove with a gentle twist motion.

The provided document is a 510(k) summary for the Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15). It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. Here is a breakdown of the requested information based on the provided text:

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

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

The document does not specify the exact sample sizes (N per test) for each performance test. It only states the acceptance criteria and results. The data provenance is non-clinical, likely laboratory testing, and no geographic origin is specified for these tests. All tests appear to be prospective, laboratory-based evaluations of the device's physical and filtration properties.

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. The study described is non-clinical performance testing of a physical filter device, not a study involving human or image interpretation by experts. Ground truth is established by measurable physical and chemical properties according to recognized standards (e.g., ISO, ASTM).

4. Adjudication method for the test set

Not applicable, as this is non-clinical performance testing, not a study requiring adjudication of expert opinions.

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 a passive filtration device, not an AI-assisted diagnostic tool. Therefore, no MRMC study or AI-related effectiveness was assessed.

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

Not applicable. This device does not involve an algorithm.

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

The ground truth for the non-clinical tests is based on pre-defined physical and chemical standards and objective measurements. For example:

• Conical Connector Compliance: Measured against ISO 5356-1 standard.
• Filtration Efficiency (BFE/VFE/PFE): Measured objectively against ASTM F2101 and ASTM F2299 standards.
• Leakage/Dead Space/Flow Resistance: Directly measured physical properties.
• Biocompatibility (Cytotoxicity, Sensitization, Irritation): Assessed according to ISO 10993 series standards, which involve laboratory assays and observations against established biological safety criteria.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

Not applicable. No training set for an algorithm is involved.

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The PMV 2020 (Clear) JIT is designed to be used in conjunction with the Passy-Muir Adapter PMA-S JIT 4-6 for use on the Pilling Weck metal Jackson Improved tracheostomy tubes sizes #4, #5 and #6 or equivalent in providing vocalization without finger occlusion for both short-term and long-term tracheostomized patients. It is appropriate for neonatal, pediatric and adult patients and is ideal for use in decannulation as an assessment device for physicians, as well as providing the patient comfort and confidence in upper airway usage. The PMV 2020 (Clear) JIT Valve is also designed to be used without an adapter on the Bivona (Non-Foam Filled Cuffed) tracheostomy tubes currently on the market.

Indications for Use - Including but not limited to the following:

• For Sleep Apnea patients who are tracheostomized as an alternative to plugging when awake
• Bilateral Vocal Cord Paralysis without significant airway obstruction
• Tracheomalacia
• Mild Tracheal and Laryngeal Stenosis
• Non-Obstructive Laryngeal Tumors (can include patients who have intact vocal cords following surgical resection of the tumor)
• Neuromuscular Disease
• Chronic Obstructive Pulmonary Disease
• Brain Injury
• Non-Ventilator Dependent Quadriplegics
• Patients who emotionally or physically are unable to tolerate plugging

Passy-Muir Low-Profile Tracheostomy Speaking Valve PMV 2020 (Clear) JIT to be used in conjunction with the Passy-Muir Adapter PMA 2020-S JIT 4-6 for use on Pilling Weck metal Jackson Improved tracheostomy tubes sizes #4. #5 and #6 or equivalent, and also for use without an adapter on the Bivona (Non-Foam Filled Cuffed) tracheostomy tubes currently on the market.

I am sorry, but based on the provided document, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a medical device and does not contain information about acceptance criteria or a specific study designed to prove the device meets such criteria.

The document primarily focuses on:

• The FDA's determination of substantial equivalence to a predicate device.
• The device's classification and regulatory controls.
• The intended use and indications for use of the device.

There is no mention of specific performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment that would allow me to answer your request.

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The P-M O2 Adapter is designed for use with the companion PMV 2000 (clear) and PMV 2001 (purple) Low Profile Tracheostomy and Ventilator Speaking Valves. The P-M O2 Adapter allows for improved mobility of those patients requiring a tracheostomy tube, speaking valve, and low flow supplemental oxygen.

The Passy-Muir O2 Adapter is a one-piece, injection-molded plastic device designed to attach to the outer surface of either one of the Passy-Muir Low-Profile Tracheostomy and Ventilator Speaking Valves (PMV 2000 or PMV 2001) and provide a means for connecting a supplemental oxygen supply tube

This 510(k) summary describes a device that is an accessory to an existing medical device, rather than a standalone diagnostic or therapeutic device. As such, it does not involve the typical clinical study or performance metrics that would require the detailed breakdown of acceptance criteria, sample sizes, and ground truth establishment you've requested.

The submission focuses on demonstrating substantial equivalence to existing devices, primarily by showing that it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.

Here's an analysis based on the provided text, addressing your points where applicable and explaining why others are not present:

Description of the Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria

This submission is for a Class II medical device accessory, the Passy-Muir Oxygen (O2) Adapter. The acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices, focusing on safety and functional characteristics typical for O2 delivery accessories. No specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) for device performance are explicitly stated in the document, nor would they be expected for this type of device. The "study" proving the device meets criteria is primarily a comparison to predicate devices and an assessment of its operational principles.

1. Table of Acceptance Criteria and the Reported Device Performance

As mentioned, explicit quantitative acceptance criteria are not provided for this type of accessory. The "reported device performance" is described through its functional design and how it operates similarly to existing devices.

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

• Sample Size for the Test Set: Not applicable. No clinical "test set" of patients or data was used in the assessment of this device, given its nature as an accessory relying on the established safety and effectiveness of its predicate devices and its simple mechanical function.
• Data Provenance: Not applicable. The submission relies on a comparison to existing, legally marketed devices and general knowledge about oxygen delivery systems. No specific patient data or clinical trial data is presented.

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

• Number of Experts & Qualifications: Not applicable. There was no "test set" requiring ground truth establishment by experts in a clinical context. The assessment is based on engineering principles and comparison to predicate devices, evaluated by the FDA's reviewers.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No test set requiring clinical adjudication was involved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No. Such a study is completely irrelevant for an oxygen adapter. This type of study is typically used for diagnostic imaging devices to assess how AI impacts the performance of human interpreters.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: No. This device is a mechanical accessory, not an algorithm or an AI system.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable in the clinical sense. The "ground truth" for this submission revolves around the known functional principles of oxygen delivery accessories and the established safety and effectiveness profiles of predicate devices. The truth is established through engineering design, material compatibility, and comparison to existing products.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a mechanical accessory, not an AI or machine learning algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable. As there is no training set for an algorithm, there is no ground truth to establish for it.

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Ask a specific question about this device