(206 days)
Parker tracheal tubes are designed for oral intubation and are indicated for airway management.
The Parker tracheal tubes are sterile, single use devices, for use in anesthesia and emergent and respiratory care where mechanical ventilation is required. The tube will be made in four sizes: 6.5, 7.0, 7.5, and 8.0 mm ID. It is identical to the predicate device in material composition, biocompatibility, packaging, sterilization, and in all structural respects, except for the following features:
- (1) Instead of a semi-rigid, side-beveled distal tip, the Parker tube has a flexible, slightly rounded, rear-beveled distal tip which tapers centrally toward the midline of the lesser curvature of the tube.
- (2) Instead of a single, lateral Murphy eye opposite the bevel, the Parker tube has two, facing Murphy eyes flanking the bevel.
- (3) Instead of a radiopaque stripe on the greater curvature of the tube and a cuff inflation circuit on the lesser curvature of the tube, the positions of these two features are reversed on the Parker tube.
Here's a breakdown of the acceptance criteria and study information based on the provided text for the Parker Flex-Tip Endotracheal Tube:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device and safety/efficacy through non-clinical and clinical data, rather than explicit, quantifiable acceptance criteria with pass/fail thresholds. However, based on the text detailing compliance and deviations from the ASTM standard, and the outcomes of the clinical study, we can infer the following as the implicit acceptance criteria and the device's performance against them:
| Acceptance Criteria (Inferred from ASTM F1242-96 and study goals) | Reported Device Performance |
|---|---|
| Material Composition, Biocompatibility, Packaging, Sterilization: Identical to predicate device. | Identified as identical to predicate device. |
| Mechanical Design - Distal Tip: Semi-rigid, side-beveled tip (ASTM 6.4.1). | Deviation: Flexible, slightly rounded, rear-beveled distal tip tapering centrally. |
| Mechanical Design - Murphy Eye: Single, lateral Murphy eye opposite the bevel (ASTM 6.5). | Deviation: Two, facing Murphy eyes flanking the bevel. |
| Mechanical Design - Radiopaque Stripe/Cuff Inflation Circuit Position: Radiopaque stripe on greater curvature, cuff inflation circuit on lesser curvature. | Deviation: Positions reversed on Parker tube. |
| Mechanical Design - Patient End: Rounded without sharp points or rough edges (ASTM 4.2.1). | Compliance: Although tapered, its point is rounded (not sharp) and edges are rounded (not rough). |
| Clinical Safety & Efficacy (compared to standard tracheal tubes): |
- Not adversely affect safety or efficacy.
- Be at least as safe and efficacious for orotracheal intubation.
- (Implicit) Reduce trauma during intubation. | Clinical safety/efficacy found to be at least as safe and efficacious as standard tracheal tubes.
Appeared clearly and consistently less traumatic to the nose, larynx, and trachea during intubation (cadaver study). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Comparative Study): 66 adult patients (31 intubated with standard tracheal tube, 35 with Parker tracheal tube).
- Data Provenance: The text does not explicitly state the country of origin. It mentions an "IRB approval and informed consent," suggesting a prospective clinical study in human subjects. Given the manufacturer's location in the US (Cincinnati, Ohio), it's highly probable the study was conducted in the US. The study appears to be prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not detail the specific "ground truth" establishment for the clinical study beyond the outcomes observed during intubation and patient follow-up. It doesn't mention expert readers or adjudicators for "ground truth" in the traditional sense of image analysis. The "ground truth" here is the observed clinical outcome during intubation and subsequent patient status, as assessed by the medical professionals performing the procedures and patient care. No specific number or qualification of experts establishing a separate ground truth is mentioned.
4. Adjudication Method for the Test Set
No explicit adjudication method (like 2+1 or 3+1) is mentioned. The clinical study describes intubations being "watched through a videoscope, and some were recorded," and conclusions drawn from this direct observation and patient outcomes. It implies direct assessment by the medical staff involved in the study rather than a separate adjudication panel.
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 device is a physical medical device (endotracheal tube), not an AI/software device. Therefore, an MRMC comparative effectiveness study involving human readers with or without AI assistance is not applicable and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
As this is a physical medical device, not an algorithm, a standalone performance study in the context of AI is not applicable and was not done.
7. The Type of Ground Truth Used
- Cadaver Study: Direct visual observation via videoscope of the intubation process and its immediate effects on the nose, larynx, and trachea. The ground truth was the observed trauma.
- Clinical Study: The ground truth was the observed safety and efficacy during and after orotracheal intubation in adult patients for surgery. This would typically involve assessments of intubation success, ease of intubation, presence of complications (e.g., vocal cord damage, airway trauma), and adequacy of ventilation. This is essentially outcomes data from a clinical setting.
8. The Sample Size for the Training Set
No training set is mentioned as this is a physical medical device. The "training" or development would have been through engineering, materials testing, and iterative design, not through a data-driven machine learning approach.
9. How the Ground Truth for the Training Set Was Established
As no training set (in the AI/machine learning sense) was used, this question is not applicable. The "ground truth" for the device's design and non-clinical development would have been established through engineering specifications, material performance standards, and manufacturing quality control.
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).