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Endotracheal Tubes are indicated for use in providing airway management by oral intubation of the trachea during anesthesia and during ventilator support of respiration. Wire Reinforced Endotracheal Tubes are indicated for use in procedures requiring flexing of the neck or movement of the patient (lateral or prone position).

Arcadia Medical® Silicone Wire Reinforced Endotracheal Tubes are available in Cuffless or Air Cuff styles. All tubes consist of a radiopaque biocompatible wire reinforced silicone shaft and have a standard 15mm connector, depth marks in centimeters and two ring marks behind the cuff for reference in determining the position of the cuff or distal tip in the trachea.

Air Cuff Endotracheal Tubes have a radiopaque hooded tip to ease insertion through the vocal cords. Air Cuff Tubes also have an Above the Cuff Access Port (ACAP)® for removing secretions above the cuff to help prevent aspiration.

Air Cuff Endotracheal Tubes have an inflatable air cuff to seal the trachea. When properly inflated, the air cuff conforms to the shape of the trachea providing an effective seal. The tube has an inflation line with a luer valve and blue pilot balloon to indicate cuff inflation.

The provided 510(k) summary for K060094 describes a medical device, the Arcadia Medical® Silicone Wire Reinforced Endotracheal Tubes. It focuses on demonstrating substantial equivalence to pre-existing devices rather than outlining distinct acceptance criteria and a detailed study proving the device meets those criteria.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth establishment, as typically found in studies for AI/software devices, is not present in this document because this is not an AI/software device. This is a traditional medical device submission (endotracheal tube).

Here's an analysis based on the information provided, highlighting what is available and what is not:

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

This document does not specify quantitative acceptance criteria or a detailed performance table with numerical results as one would expect for a study evaluating an AI/software device. Instead, it states that "Performance Data for the device is shown in Section 11: Performance Standards" and "Performance Data indicates that the device is substantially equivalent in performance to the predicate device."

Without access to Section 11, specific criteria and performance values cannot be extracted. However, for traditional devices like endotracheal tubes, typical performance aspects relate to:

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 refers generally to "Performance Data" without detailing a specific test set, its size, or provenance. For a physical device, testing often involves bench testing (material properties, strength, leak rates), animal studies, or human cadaveric studies, but none of these specifics are mentioned.

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 is not applicable and not provided. The device is a physical endotracheal tube, not an AI/software requiring expert-established ground truth for a diagnostic task. Its performance is typically assessed through engineering tests and clinical equivalence to predicate devices, not through interpretation of outputs by experts.

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

Not applicable and not provided. Adjudication methods are relevant for cases where multiple experts interpret data (e.g., medical images) to establish a consensus ground truth, which is not the context for this physical device submission.

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 and not provided. An MRMC study is relevant for evaluating the clinical utility and impact of AI on human reader performance, typically in diagnostic imaging. This submission concerns a physical medical device (an endotracheal tube), not an AI algorithm.

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

Not applicable and not provided. This question pertains to AI algorithm performance evaluation, which is not relevant for this physical device.

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

Not applicable and not provided in the sense of a reference standard for diagnostic accuracy. "Ground truth" for a physical device like an endotracheal tube would likely be defined by established engineering and medical standards for material properties, dimensions, integrity, and functional performance (e.g., cuff sealing pressure, flow rates, radiopacity). The document only generally refers to "Performance Standards."

8. The sample size for the training set

Not applicable and not provided. This device is not an AI/machine learning model, so there is no "training set."

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

Not applicable and not provided. As established in point 8, there is no training set for this physical device.

In summary:

This 510(k) submission for an endotracheal tube primarily relies on demonstrating substantial equivalence to legally marketed predicate devices. The performance data mentioned (in Section 11, which is not provided here) would have focused on showing that the new device performs as safely and effectively as its predicates, likely through engineering bench tests, material characterization, and potentially pre-clinical (animal) or limited human use data, but not in the format of an AI/software performance study with distinct acceptance criteria, test sets, and reader studies.

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Tracheostomy tubes are intended for use in providing direct tracheal access for airway management.

The document describes several types of Silicone Tracheostomy Tubes: Silicone Foam Cuff Tracheostomy Tubes, Silicone Cuffless Neonatal and Pediatric Tracheostomy Tubes, Silicone Cuffless Adult Tracheostomy Tubes, and Silicone Air Cuff and Air Cuff Adjustable Neck Flange Tracheostomy Tubes. These devices are made of silicone, are radiopaque, and are white or clear in color. They include a 15mm connector and an obturator. The packaging is a PETG Tray with Tyvek Lid or a Tyvek Pouch, and they are packaged with accessories including Twill Tape and a Disconnect Wedge. Sterilization is by ETO. Labels contain product information such as name, style, size, part number, ID, OD, length, lot number, manufacturer's name, quantity, sterilization method, and expiration date. The devices comply with ASTM F 1666-95 and ASTM F 1627-95 standards.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Arcadia Medical Tracheostomy Tubes.

Important Note: The provided text is a 510(k) Summary, which is a premarket notification to the FDA. It demonstrates substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a full-fledged clinical study in the way a new, high-risk device might. The "study" here is primarily a comparison to the predicate device and adherence to industry standards, along with standard manufacturing quality controls.

Acceptance Criteria and Device Performance

The acceptance criteria for the Arcadia Medical Tracheostomy Tubes are implicitly defined by their substantial equivalence to the Bivona Medical Technologies predicate devices and compliance with relevant ASTM standards. The "reported device performance" is essentially the device's characteristics matching or being comparable to the predicate and meeting standard specifications.

Table of Acceptance Criteria and Reported Device Performance

Study Details to Prove Acceptance Criteria

The provided text is a 510(k) summary, which focuses on demonstrating "substantial equivalence" of the new device to a predicate device already on the market. It does not describe a clinical study in the traditional sense with a "test set" of patients, ground truth experts, or an AI algorithm. Instead, the "study" is a comparison of technical characteristics and compliance with recognized standards.

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

   • Test Set Sample Size: Not applicable in the context of a 510(k) substantial equivalence comparison based on technical characteristics. The "test" is a comparison to the predicate device's specifications and ASTM standards.
   • Data Provenance: The data is a comparison of specifications of the Arcadia Medical device against the Bivona Medical Technologies predicate device and relevant ASTM standards. This is a technical comparison, not patient data. It is inherently "prospective" in the sense that the new device's specifications are established. Country of origin for data is not explicitly stated beyond Arcadia Medical being in Schaumburg, IL, USA.

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

   • Number of Experts: Not applicable. Ground truth for a device's technical specifications is established through engineering design, testing, and compliance with industry standards, not typically by expert consensus in the way clinical images would be. The "experts" are the engineers and quality assurance personnel at Arcadia Medical and the standards bodies (ASTM) who defined the specifications.

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

   • Adjudication Method: Not applicable. This is a comparison of technical specifications to a predicate device and industry standards, not a judgment of clinical data.

4. 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:

   • MRMC Study: No, an MRMC study was not done. This device is a physical medical device (tracheostomy tube), not an AI algorithm for diagnostic imaging.

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

   • Standalone Study: No, this device is a physical medical device, not an AI algorithm.

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

   • Type of Ground Truth: The "ground truth" for this submission are the established technical specifications of the predicate device (Bivona Medical Technologies tracheostomy tubes) and the requirements outlined in relevant ASTM International standards (ASTM F 1666-95 for Adult Tracheostomy Tubes and ASTM F 1627-95 for Pediatric Tracheostomy Tubes). This is a specification-based ground truth or standard compliance ground truth.

7. The sample size for the training set:

   • Training Set Sample Size: Not applicable. This is not an AI algorithm that requires a training set. The development of the device would involve engineering design, prototyping, and testing, but these are not referred to as "training sets" in this context.

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

   • Ground Truth for Training Set: Not applicable, as there is no "training set" for physical device development in the AI sense. The design and manufacturing processes are guided by the "ground truth" of the predicate device's successful performance and adherence to established industry standards for safety and efficacy.

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