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The PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula is indicated for use in providing percutaneous temporary tracheal access for airway management.

The PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula is designed to permit percutaneous insertion of a specifically designed tracheostomy tube. This single cannula Percutaneous Tracheostomy Tube has a radiopaque blue line and is constructed of biocompatible polyvinylchloride material and incorporates a tapered and beveled distal tube tip to facilitate insertion through the percutaneously dilated stoma site. The tracheostomy tube has a neck flange, an integral 15 mm connector, and a cuff which deflates to a low profile on the tube for a smooth transition during insertion. The cuff inflation line has a self sealing Luer valve. The tracheostomy tube is supplied with a disposable inner cannula of the appropriate size. The Percutaneous Tracheostomy Kit comes with the necessary components for percutaneous tracheostomy tube insertion into a stoma created by serial dilation.

The manufacturer, Portex, Inc., submitted a 510(k) premarket notification (K031057) for their PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula. The submission includes a summary of nonclinical and clinical tests that support the device's substantial equivalence to predicate devices and its safety and effectiveness.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The clinical user evaluation involved 28 subjects in the control group and 26 subjects in the two study groups. This totals 54 subjects for the clinical test set.
• Data Provenance: The study was a prospective clinical user evaluation conducted at St. John's Mercy Medical Center. The country of origin is not explicitly stated but can be inferred as the United States (given the submission to the FDA and the U.S. location of the manufacturer and study site).

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

The document does not specify the number of experts used to establish the ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). It refers to a "clinical user evaluation," which implies participation from medical professionals. The study was conducted at "St. John's Mercy Medical Center," suggesting that the evaluation was carried out by healthcare professionals at that institution who are experienced in performing tracheostomies and managing tracheostomy patients.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical user evaluation. It presents the findings as conclusions from the evaluation without detailing the consensus or disagreement resolution process.

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 conducted, nor is this device an AI-assisted device. The study was a clinical user evaluation comparing a new medical device to existing (predicate) devices, focusing on clinical outcomes directly related to the device itself, not AI interpretation or human reader performance with or without AI.

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

No, a standalone algorithm performance study was not done. This device is a physical medical device (tracheostomy kit), not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used in this study would be based on clinical observation and assessment of patient outcomes. This would include:

• Clinical Assessment: Direct observation by healthcare professionals during tube insertion for "trauma or difficulty."
• Patient Outcomes/Monitoring: Data collected on the "incidence of occlusion of the tracheostomy tube" over time for the study subjects.
• Expert Clinical Judgement: The expertise of the clinicians performing the procedures and evaluating the patients would form the basis of the "ground truth" for success or failure regarding safety and effectiveness.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of this device. As a physical medical device, there isn't a "training set" in the sense of data used to train a machine learning model. Instead, the design and development of the device would have involved internal testing and refinement (e.g., engineering tests, bench testing, animal studies, or earlier human factors analysis) which are not detailed as a "training set" in this summary.

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

Since there is no "training set" in the context of an algorithm or machine learning for this device, the concept of establishing ground truth for a training set does not apply. The development process for the physical device would have involved standard medical device design control procedures, where design inputs are translated into design outputs, and verification/validation activities ensure the device meets its requirements. Any "ground truth" during development would stem from engineering specifications, material testing standards, and preclinical (e.g., animal, bench) study results.

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The PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula is indicated for use in providing percutaneous temporary tracheal access for airway management.

The PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula is designed to permit percutaneous insertion of a specifically designed tracheostomy tube. This single cannula Percutaneous Tracheostomy Tube has a radiopaque blue line and is constructed of biocompatible polyvinylchloride material and incorporates a tapered and beveled distal tube tip to facilitate insertion through the percutaneously dilated stoma site. The tracheostomy tube has a neck flange, an integral 15 mm connector, and a cuff which deflates to a low profile on the tube for a smooth transition during insertion. The cuff inflation line has a self sealing luer valve. The tracheostomy tube is supplied with a disposable inner cannula of the appropriate size. The Percutaneous Tracheostomy Kit comes with the necessary components for percutaneous tracheostomy tube insertion into a stoma created by serial dilation.

The provided text describes a 510(k) summary for the PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria and proving performance through a detailed clinical study with performance metrics.

Based on the provided information, I can answer some of your questions and explain why others cannot be answered from this text:

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

This information is not available in the provided text. The document is a 510(k) summary, which aims to demonstrate "substantial equivalence" to a predicate device rather than setting or meeting specific performance acceptance criteria with detailed metrics like sensitivity, specificity, or inter-reader agreement. The "Conclusion" section states: "The testing performed and comparison to the predicate devices demonstrate that the proposed device is safe and effective and is substantially equivalent to the predicate devices." This implies that the device meets the safety and effectiveness standards derived from the predicate, but it doesn't quantify specific performance metrics or acceptance criteria as you would find in a clinical trial report.

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 available in the provided text. The document refers to "testing performed and comparison to the predicate devices" but does not detail any specific human subject test sets, their sample sizes, or data provenance. It's highly probable that the testing referred to was primarily bench testing and material compatibility assessments, rather than a clinical study requiring human subject data provenance.

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)

This information is not available in the provided text. Since there's no mention of a clinical test set with human data requiring ground truth establishment by experts, this detail is not relevant to the content provided.

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

This information is not available in the provided text. Again, without a clinical test set for human readers, adjudication methods are not discussed.

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

This information is not available in the provided text. The device described is a medical instrument (tracheostomy kit) and not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be applicable or expected for this type of device.

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

This information is not available and not applicable to the device described. This question typically relates to the performance of artificial intelligence algorithms. The PER-FIT™ Percutaneous Dilational Tracheostomy Kit is a physical medical device.

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

This information is not available in the provided text. As explained above, the submission claims substantial equivalence through testing and comparison to predicates, which likely involved engineering and material testing rather than clinical ground truth establishment in the traditional sense for diagnostic tools.

8. The sample size for the training set

This information is not available in the provided text. This question is typically relevant for machine learning algorithms, which is not what this device is.

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

This information is not available in the provided text and is not applicable to this device.

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