(147 days)
TTCF is indicated for the treatment of hypoxemia with delivery of transtracheal high flows of a heated and humidified air/oxygen mixture to self-breathing patients with a cuff deflated fenestrated tracheostomy tube. TTCF is indicated for hospital use in adult patients.
The TTCF Catheter is constructed of clear, latex-free plastics with a radiopaque stripe for identification by x-ray. A rounded tip facilitates insertion and minimizes potential mucous irritation or injury. The catheter is 4 mm O.D. used within an adult Portex Blue Line Fenestrated Tracheostomy Tube. Inner diameter is 3.1 mm in 11.5, 13.5 and 15.5 cm lengths. The distal end is an 11 mm connector capable of attaching to the CS Medical Mid-section Hose. The catheter is supplied sterile and designed as single patient use.
The provided text describes a medical device, the CS Medical Adult TTCF Catheter and Mid Section Hose, and its 510(k) submission. However, it does not contain information about acceptance criteria and a study proving the device meets those criteria in the format requested.
The document is a 510(k) summary and FDA clearance letter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed performance study against predefined acceptance criteria.
Here's what can be inferred and what is missing relative to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
- Missing. The document explicitly states "Non-Clinical Data" but presents findings as general statements of equivalence or mitigation, not as specific acceptance criteria with corresponding quantified performance results.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Missing | Missing |
2. Sample size used for the test set and the data provenance:
- Missing. No information on a "test set" or specific study subjects (sample size) is provided. The non-clinical data points refer to material testing and flow rate comparisons, which typically wouldn't involve a "test set" in the context of human subject data. The data provenance is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Missing. This information is relevant for studies involving expert review (e.g., imaging studies). No such study or expert involvement is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Missing. As no test set with expert adjudicated ground truth is mentioned, an adjudication method is not applicable.
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:
- Missing. This type of study (MRMC, AI assistance) is not mentioned and is typically associated with AI/software-as-a-medical-device (SaMD) rather than a physical catheter.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Missing. This is also relevant for SaMD and does not apply to this physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Missing. For the "Non-Clinical Data" mentioned, the "ground truth" would be engineering specifications and standards (e.g., ISO 10993 for biocompatibility, measured flow rates) rather than clinical ground truth types like pathology or expert consensus.
8. The sample size for the training set:
- Missing. No training set is applicable or mentioned for this type of device submission.
9. How the ground truth for the training set was established:
- Missing. As no training set is mentioned, this information is not applicable.
Summary of available information related to performance/safety (Non-Clinical Data):
The document only provides general statements about non-clinical data:
- Non-Clinical Data:
- Materials meet ISO 10993 for biocompatibility.
- Flow rates are comparable to the predicate and accurate (6-15 LPM for CS Medical device vs. 6-12 LPM for predicate).
- Potential hazards are identified and mitigated.
- The catheter is designed, labeled, and verified for performance and safety.
This information indicates that engineering and biocompatibility testing was performed, and the performance (flow rates) was compared to the predicate device to establish substantial equivalence. However, it does not detail specific acceptance criteria, study methodologies, or quantitative results in the manner requested for a detailed performance study.
§ 868.5800 Tracheostomy tube and tube cuff.
(a)
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.(b)
Classification. Class II.