FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

Summary

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).