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Pilling™ Tracheostomy Tubes are intended to provide tracheal access for airway management of tracheostomized patients.

Pilling™ Tracheostomy Tubes are stainless-steel tracheostomy tubes that are intended to provide tracheal access for airway management of tracheostomized patients. The tracheostomy tubes are reusable, single-patient devices that are provided non-sterile, and intended to be cleaned prior to initial use. Each tube consists of an outer cannula, inner cannula, and pilot/obturator. The inner and outer tubes fit closely to provide maximum airway. The distal edge of the inner tube is flush with, and fits very closely to, that of the outer tube to allow for complete cleaning. Variations in diameter, shape of the inner and outer tubes (radius of curvature), locking mechanism, and neck plate configurations are the basis of the various styles available.

The tubes are available in sizes ranging from 00 (4.5mm outside diameter, 2.4mm inside diameter) to 12 (16.3mm outside diameter. 12.7mm inside diameter) based on individual style. Insertable lengths range from 33mm (size 00) to 85mm (size 9 Extra Long) based on individual style. Shape of the device and specific design of the neck plate and locking feature is based on style (Jackson, Jackson Improved, and Mayo).

Some Pilling™ Tracheostomy Tubes are fenestrated to facilitate speech and all tubes can be fenestrated upon request. Certain inner tubes are compatible with the Shikani-French Speaking Valve (Product Code JOH, 510(k) K982128). Pilling™ Tracheostomy Tubes are available in models with or without permanently attached 15mm adapters.

Here's a breakdown of the acceptance criteria and study information for the Pilling™ Tracheostomy Tubes, based on the provided FDA 510(k) summary:

It's important to note that this document is a 510(k) summary for a medical device, not an AI or software device. Therefore, many of the typical questions related to AI acceptance criteria, ground truth, and reader studies are not applicable. The focus here is on demonstrating equivalence to a predicate conventional medical device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify exact sample sizes for each test (e.g., number of tubes tested for biocompatibility, locking mechanism, or separation). This is common for traditional medical device bench testing where the focus is on design verification against established standards and predicate characteristics, rather than statistical significance across a large patient dataset as seen in AI/Clinical studies.
• Data Provenance: Not applicable in the context of clinical data. The tests described are non-clinical performance testing (bench testing and biocompatibility analysis) of the manufactured device. These tests are inherently prospective, conducted by the manufacturer. There is no mention of country of origin for "data" in a patient/clinical sense.

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

• This question is not applicable for this type of medical device submission. Ground truth, in the AI/clinical sense, typically refers to expert annotations or diagnoses on medical images/data. For a physical device like a tracheostomy tube, "ground truth" is established by adherence to engineering specifications, recognized international standards (like ISO 10993 and ISO 5366), and direct physical measurements or functional tests of the device itself. Experts involved would be engineers, materials scientists, and quality control professionals, ensuring the device meets its design requirements and regulatory standards.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies or expert review processes, particularly for AI, to resolve discrepancies in expert opinions on ground truth. For the described non-clinical bench testing, results are typically objective (e.g., does it lock, does it separate at a certain force, are materials biocompatible). Any discrepancies would be handled through standard engineering and quality control procedures (e.g., re-testing, root cause analysis), not through expert adjudication in the medical sense.

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

• No. An MRMC study is designed to evaluate the performance of human readers (e.g., radiologists) with and without the assistance of an AI tool on a set of cases. This submission is for a physical medical device (tracheostomy tube), not an AI system. Therefore, no MRMC study was performed.

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

• No. This question is specific to AI algorithms. The Pilling™ Tracheostomy Tube is a physical medical device. There is no algorithm involved to perform a standalone study.

7. The Type of Ground Truth Used

• Engineering Specifications and International Standards: For this device, the "ground truth" is primarily based on:
  • Biocompatibility: Confirmation by laboratory testing that materials meet the requirements of ISO 10993-1:2018.
  • Functional Performance: Verification through bench tests that the device components (locking mechanism, connector fit, obturator) operate as designed according to internal engineering specifications.
  • Security of Attachment: Demonstration of compliance with ISO 5366:2016 related to the physical integrity and attachment strength of specific components.
  • Comparison to Predicate: The ultimate "ground truth" for a 510(k) is demonstrating that the device is substantially equivalent to a legally marketed predicate device in terms of safety and effectiveness, based on its characteristics and performance.

8. The Sample Size for the Training Set

• Not applicable. This question refers to the training data for an AI algorithm. As established, this is a physical medical device, not an AI product.

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

• Not applicable. This question pertains to AI algorithm development.

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To allow airflow over the vocal cords for speaking function. To be used with a standard 15 mm connection on tracheostomy tubes.

The Shikani speaking valve consists of a plastic housing with a captured ball that acts as a check valve. Once attached to the tracheostomy tube connector the speaking valve allows the patient to inhale through the tracheostomy tube and exhale across the vocal cords which facilitates speech or phonation.

Acceptance Criteria and Device Performance for Shikani Speaking Valve

This report details the acceptance criteria and the study (or, in this case, comparison to a predicate device) that demonstrates the Shikani Speaking Valve meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for a device that is essentially identical to a previously cleared predicate and is considered a line extension, the "acceptance criteria" are primarily established by the performance of the predicate device. The study performed is a demonstration of substantial equivalence based on identical design and performance parameters.

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

This submission is for a device explicitly stated to be "the same device" as the legally marketed predicate (Shikani-French 15, which was a line extension of K982128). Therefore, there isn't a new "test set" in the traditional sense for evaluating AI/algorithm performance. The "test" is an assertion of identicality to the predicate device, which itself had performance testing.

• Sample Size for Test Set: Not applicable as a distinct new test set for the "proposed device" was not used. The performance claims rely on the predicate device's testing.
• Data Provenance: The original performance data for the predicate device (K982128) would have been generated during its initial clearance, likely from laboratory testing. Specific details on the country of origin or whether it was retrospective/prospective are not provided for the original K982128 submission in this document.

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

Not applicable. This device is a mechanical speaking valve, not an AI/imaging device requiring expert interpretation for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. This device is a mechanical speaking valve, not an AI/imaging device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a mechanical device, not an AI algorithm assisting human readers.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a mechanical device, not an algorithm.

7. Type of Ground Truth Used

For the original predicate device (K982128), and by extension for this identical device, the "ground truth" for performance was based on physical measurements such as:

• Resistance to flow (pressure drop)
• Weight
• Material composition
• Biocompatibility test results (laboratory assays)

These are objective, quantifiable physical properties rather than expert consensus, pathology, or outcomes data typically associated with diagnostic or AI devices.

8. Sample Size for the Training Set

Not applicable. This is a mechanical device, not an AI algorithm requiring a training set.

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

Not applicable. This is a mechanical device, not an AI algorithm.

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