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To conserve oxygen by delivering flow during the inspiration cycle

DOC-3000 Demand Oxygen Controller

The provided text is a 510(k) clearance letter from the FDA for the "DOC-3000 Demand Oxygen Controller." This type of document primarily confirms substantial equivalence to a predicate device and outlines regulatory conditions. It does not contain information about acceptance criteria, specific device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot provide the information requested in your prompt based on the input document. The document focuses on regulatory approval rather than detailed study results.

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High flow oxygenation for patients requiring supplemental oxygen for the treatment of hypoxemia

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called "Transtracheal High Flow 1000" (TTHF 1000). It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria or the study that proves the device meets acceptance criteria.

The 510(k) process is primarily a premarket notification to demonstrate substantial equivalence to a predicate device, not necessarily to establish detailed performance metrics or conduct extensive clinical studies with specific acceptance criteria as you would see for a PMA (Premarket Approval) device, or in more recent AI/ML device submissions.

Therefore, I cannot provide the requested information based solely on the provided text. To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data, a design control document, or a clinical study report for the TTHF 1000, which are typically more detailed than a 510(k) clearance letter.

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Transtracheal catheter for patients requiring high flow supplemental oxygen for the treatment of hypoxemia

SCOOP I, Transtracheal Catheter

The provided document is a 510(k) premarket notification approval letter for the SCOOP I Transtracheal Catheter. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.

The letter from the FDA primarily focuses on the regulatory approval process, stating that the device is substantially equivalent to pre-amendment devices and can proceed to market. It mentions general controls provisions, potential additional controls for Class II/III devices, and compliance with Good Manufacturing Practice.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, study details, expert qualifications, etc.) from the provided text. This information would typically be found in the 510(k) submission itself or a separate clinical/performance study report, neither of which is included in this document.

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• 1. Conserve the flow of oxygen
• 2. Deliver oxygen during the inspiration cycle
• 3. Maintain adequate oxygen saturation of a patient
• 4. Adjustable time for delayed inspiration alarm
• 5. Adjustable inspiration time

Not Found

This FDA letter is a 510(k) clearance for the Transtracheal Systems, Inc. DOC 2000 Demand Oxygen Controller. It does not describe a study with acceptance criteria and device performance in the way a clinical trial or AI/ML study would.

Instead, the letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar intended use and technological characteristics and raises no new questions of safety or effectiveness. For a device like a demand oxygen controller, substantial equivalence is typically demonstrated through bench testing and potentially limited human factors testing, rather than large-scale clinical performance studies as seen in drug approvals or advanced diagnostic devices.

Therefore, many of the requested points are not applicable in this context. However, I can extract the relevant information where possible and explain why other points are not present.

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

This document does not contain a table of acceptance criteria or reported device performance in the format typical for AI/ML or clinical efficacy studies. The FDA 510(k) clearance process for devices like this typically relies on demonstration of compliance with recognized standards and comparison to predicate devices, rather than establishing new, specific performance metrics for the approval itself. Performance metrics would have been evaluated during the design and testing phases by the manufacturer (Transtracheal Systems, Inc.) to ensure the device met its functional specifications and standards for oxygen delivery and conservation, which the FDA reviewed as part of the 510(k) submission.

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

Not applicable. This is a 510(k) clearance letter confirming substantial equivalence to a predicate device. It does not involve a "test set" of patient data for performance evaluation in the context of diagnostic accuracy or clinical outcomes. The "testing" involved would have been engineering and bench tests, possibly human factors testing, to ensure the device met its specifications and performed as intended in a controlled environment.

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)

Not applicable. There is no mention of "ground truth" established by experts in this context. Device safety and efficacy for a demand oxygen controller are evaluated based on engineering specifications, adherence to standards, and comparison to existing, already approved devices.

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

Not applicable. As there is no "test set" requiring expert review for ground truth establishment, no adjudication method is mentioned.

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. The DOC 2000 is a demand oxygen controller, a medical device for oxygen delivery, not a diagnostic imaging device utilizing AI. Therefore, an MRMC study and AI assistance are irrelevant to this product's clearance.

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

Not applicable. The DOC 2000 is a hardware device for oxygen delivery, not an algorithm.

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

Not applicable in the conventional sense of diagnostic or clinical outcome studies. For this type of device, "ground truth" would relate to its functional performance (e.g., accurate oxygen delivery, oxygen conservation rate, proper trigger sensitivity) measured against engineering specifications and industry standards, perhaps through bench testing or simulated use.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Summary of what can be inferred from the document:

• Device: Transtracheal Systems, Inc. DOC 2000 Demand Oxygen Controller
• Purpose of clearance: Substantial Equivalence (510(k)) to a predicate device.
• Indications for Use (from Enclosure):
  • Conserve the flow of oxygen
  • Deliver oxygen during the inspiration cycle
  • Maintain adequate oxygen saturation of a patient
  • Adjustable time for delayed inspiration alarm
  • Adjustable inspiration time
• Regulatory Class: II (two)
• Product Code: 73 NFB
• Regulation Number: 868.5905 (Noncontinuous Ventilator)

The FDA's finding of "substantial equivalence" means they reviewed the manufacturer's submission which would have included:

• A description of the device and its intended use.
• Comparison to a predicate device already legally on the market.
• Data from non-clinical (bench) testing to demonstrate that the device performs as intended and is as safe and effective as the predicate device. This would include testing related to oxygen delivery accuracy, conservation efficiency, alarm functions, and biocompatibility if applicable.
• Verification that the device meets relevant recognized standards.

The acceptance criteria for such a device are typically defined by these standards and the performance of the predicate device, which the manufacturer would have provided data to demonstrate compliance with. The FDA clearance letter itself does not detail these specific criteria or the exact performance data.

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