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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 Gas Delivery System is a gas supply and humidification system mounted on a medical stand. Components include an oxygen blender, a flow meter, pressure relief valve, humidifier, and pressure monitor. A blended source of compressed air and oxygen allow choosing flow rate and FiO2 of the mixture. Flows are delivered at 6-15 LPM. Oxygen concentrations are available from 21% to 77%.

The provided text describes a 510(k) submission for the CS Medical TTCF Gas Delivery System. This is a medical device, not an AI/ML software. Therefore, the questions regarding acceptance criteria, study details, ground truth, and expert evaluation are not applicable in the context of AI/ML performance.

The document primarily focuses on establishing "substantial equivalence" of the new device to a legally marketed predicate device (Transtracheal Systems, Inc., TTHF-1000, K981078). This involves demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.

Here's a breakdown of the information provided, re-contextualized to the device clearance process:

1. Acceptance Criteria and Reported Device Performance:

The concept of "acceptance criteria" for an AI/ML model's performance (e.g., sensitivity, specificity thresholds) is not relevant here. Instead, the "acceptance criteria" for device clearance are focused on demonstrating:

• Hazard Analysis: Acceptable and mitigated potential hazards (following ISO 14971).
• Electrical Safety: Demonstrated for individual components.
• Effectiveness: Demonstrated for individual components by previous 510(k) clearance (i.e., the components themselves are already proven safe and effective).
• Biocompatibility: Plastic materials meet ISO 10993.
• Substantial Equivalence: The device is designed, labeled, and verified for performance and safety in a manner that makes it substantially equivalent to the predicate device.

Reported Device Performance (against the concept of substantial equivalence):

• Indications for Use: Same as predicate device (treatment of hypoxemia with delivery of transtracheal high flows of heated and humidified air/oxygen mixture to self-breathing adult patients with a cuff deflated fenestrated tracheostomy tube).
• High Flow Oxygenation: Same as predicate (high flow oxygenation for treatment of hypoxemia in self-breathing adult patient populations).
• Heated/Humidified Air-Oxygen Mixtures: Same as predicate.
• Open System Support: Both devices support an open system.
• Flow Rates: Same as predicate (6-15 LPM delivering oxygen mixture up to 77%).

Differences noted but deemed not to impact substantial equivalence:

• Intended Use Environment: TTHF-1000 for home use, TTCF for hospital use.
• System Delivery Pressure: Substantially lower for the TTCF system at the catheter.
• Oxygen Supply: TTCF uses facility piped oxygen, predicate uses an air compressor.

2. Sample Size for Test Set and Data Provenance:

This section is not applicable to traditional medical device clearance. No "test set" in the AI/ML sense (e.g., a dataset of images with ground truth labels) was used. The evaluation involves engineering testing and comparison to an existing device.

3. Number of Experts and their Qualifications:

This is not applicable. The evaluation does not involve clinical experts establishing ground truth for a dataset. The clearance process relies on regulatory experts at the FDA reviewing the manufacturer's provided documentation.

4. Adjudication Method:

This is not applicable. No adjudication of expert opinions on a dataset was performed.

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

This is not applicable. The device is a gas delivery system, not an AI diagnostic or assistive tool for human readers.

6. Standalone Performance Study:

This is not applicable in the AI/ML sense. The "effectiveness" of individual components was "demonstrated... by previous 510(k) clearance," meaning the sub-components had their own standalone performance verified previously. The current submission demonstrates the system's integration and safety.

7. Type of Ground Truth Used:

This concept is not applicable. There's no "ground truth" derived from expert consensus, pathology, or outcomes data in the context of validating an AI/ML algorithm's performance. The "truth" in this context is adherence to safety standards, engineering specifications, and functional equivalence to a predicate device.

8. Sample Size for Training Set:

This is not applicable. The device is not an AI/ML algorithm, so there is no training set.

9. How Ground Truth for Training Set was Established:

This is not applicable for the same reason as above.

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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.

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:
  1. Materials meet ISO 10993 for biocompatibility.
  2. Flow rates are comparable to the predicate and accurate (6-15 LPM for CS Medical device vs. 6-12 LPM for predicate).
  3. Potential hazards are identified and mitigated.
  4. 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.

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