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510(k) Data Aggregation
(262 days)
Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube
Rusch tracheal tubes are indicated for airway management by oral or nasal intubation of the trachea.
The proposed Teleflex Medical Rusch Safety Silk Pediatric Tracheal Tube Series tracheal tubes are sterile, single use devices that are made from Polyvinyl chloride (PVC) resin that is formulated without DEHP ("Non-DEHP" =
The document provided describes a 510(k) premarket notification for the Teleflex Medical Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube. It does not contain information about a study proving the device meets acceptance criteria in the context of AI/ML performance, but rather outlines performance testing for a medical device.
Therefore, many of the requested categories related to AI/ML studies are not applicable. However, I can extract the acceptance criteria and a summary of the performance studies mentioned for the medical device itself.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cuff Bonding Leak Evaluation | No leak around the welding area | Not explicitly stated "met," but implied by "Performance test results demonstrate that the proposed device meets its intended use." |
| Tube Curvature Test | Must meet the product requirement of 140mm ± 20mm | Not explicitly stated "met," but implied by "Performance test results demonstrate that the proposed device meets its intended use." |
| Tube Collapse | The steel ball (OD = 75% of the stated ID) must pass through the lumen freely. | Not explicitly stated "met," but implied by "Performance test results demonstrate that the proposed device meets its intended use." |
| Cuff Resting Diameter | The cuff resting diameter shall be within ± 15% of specification for each individual size | Not explicitly stated "met," but implied by "Performance test results demonstrate that the proposed device meets its intended use." |
| Cuff Herniation | No abnormality or defect on the cuff (any part of the inflated cuff reaches beyond the nearest edge of the bevel will be considered as defect). No abnormality on the configuration of the cuff during deflating the cuff over a period of not less than 10s (any abnormality will be considered as defect). | Not explicitly stated "met," but implied by "Performance test results demonstrate that the proposed device meets its intended use." |
| Tube Compression Evaluation | Must be within the range of current data | Not explicitly stated "met," but implied by "Performance test results demonstrate that the proposed device meets its intended use." |
| Cuff Unrestrained Burst Evaluation | Must be within the range of current data | Not explicitly stated "met," but implied by "Performance test results demonstrate that the proposed device meets its intended use." |
| Cuff Restrained Burst Evaluation | Must be within the range of current data | Not explicitly stated "met," but implied by "Performance test results demonstrate that the proposed device meets its intended use." |
| Cuff Sealing Pressure Evaluation | Must be within the range of current data | Not explicitly stated "met," but implied by "Performance test results demonstrate that the proposed device meets its intended use." |
| Biocompatibility | Materials have been tested per ISO 10993 | "All patient contacting materials are in compliance with ISO 10993-1. Testing included Cytotoxicity, sensitization, intracutaneous activity, implantation and genotoxicity testing, and Extractables/Leachables Testing." |
Study Proving Device Meets Acceptance Criteria:
The document states, "Performance test results demonstrate that the proposed device meets its intended use." This is a general statement rather than a detailed report of specific study outcomes for each acceptance criterion. The tests conducted were primarily engineering and material characterization tests to ensure the physical and functional aspects of the tracheal tube met specifications, often by comparing them to existing "current data" or "specifications." The overall conclusion drawn is that the device is substantially equivalent to its predicates.
The following information is not present in the provided document, as it pertains to a different type of medical device assessment (AI/ML performance studies) than what is described for this tracheal tube:
- Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a physical medical device, not an AI/ML system.
- 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): Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as there is no "ground truth" in the AI/ML sense for a physical tracheal tube's performance tests. The "ground truth" for these tests would be the established engineering specifications and material properties.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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