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The SafeT T-Piece Resuscitator is a gas-powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10 kg (22 lb).

The SafeT T-Piece Resuscitator is a single-use, non-sterile, manually operated, gas-powered resuscitator for use with patients less than 10 kg (22 lb). It is a simple T-Piece resuscitator with a manometer and the ability to adjust Peak Inspiratory Pressure (PIP) and Positive End-Expiratory Pressure (PEEP). It incorporates a pressure relief valve to protect against excessive pressure. The T-Piece resuscitator can be connected to the patient via a face mask or tube. The subject device consists of several components: T-Piece patient valve with variable PEEP dial and integrated manometer, Adjustable inspiratory pressure controller, 40 cm H2O pressure relief valve, 7' Oxygen tubing with a red universal (Fits-all) connector, 20" x 10 mm circuit tubing, Face mask.

The provided text is a 510(k) summary for the Ventlab, LLC SafeT T-Piece Resuscitator, a medical device for emergency respiratory support. It details the device's characteristics and its comparison to predicate devices to establish substantial equivalence for FDA clearance.

Crucially, this document does not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) study. It focuses on the substantial equivalence of a physical medical device (a resuscitator) based on its technological characteristics and performance testing against established standards, not on an algorithm's performance in interpreting medical images or data.

Therefore, many of the requested points, such as acceptance criteria for AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment for AI, are not applicable to the context of this document.

However, I can extract the closest analogous information regarding "acceptance criteria" and "study proving the device meets the acceptance criteria" in the context of this physical medical device:

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

The document doesn't present a specific "acceptance criteria" table in the way one might for an AI device (e.g., sensitivity, specificity thresholds). Instead, "acceptance criteria" are implied by the compliance with applicable performance standards and the comparative data to predicate devices. The "reported device performance" is demonstrated by stating that the subject device "met all quantitative and qualitative requirements" of these standards and by the head-to-head comparison data presented in the "Substantial Equivalence Comparison Table" and subsequent discussion.

The most direct representation of "acceptance criteria" and "reported device performance" is found within the "Substantial Equivalence Comparison Table" itself, where critical performance metrics of the SafeT T-Piece Resuscitator are compared against those of the predicate device (Mercury Medical Neo-Tee) and a reference device (Fisher & Paykel NeoPuff).

Here is a partial table, extracted and reformatted from the "Substantial Equivalence Comparison Table" that acts as the primary evidence of meeting "acceptance criteria" (i.e., being substantially equivalent to the predicate device):

The study that proves the device meets the acceptance criteria is primarily the "Bench Performance Testing" described on page 12-13, assessed against the "Applicable Standards" listed on page 11-12.

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

• Sample Size: Not applicable. This is a bench performance test for a physical device, not an AI model. The "tests" refer to evaluations of the manufacturing design and performance characteristics, often involving one or a few units under controlled conditions (e.g., measuring pressure, flow, resistance). The phrase "head-to-head testing" is mentioned for resuscitator dead space but does not specify a "sample size" in the statistical sense for a data set.
• Data Provenance: Not applicable. The "data" comes from the physical testing of the device itself by the manufacturer (Ventlab, LLC/SunMed) to demonstrate compliance with standards. There's no country of origin of patient data, nor is it retrospective or prospective in the context of clinical data.

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. This is not an AI/ML device that requires expert-established ground truth from medical images or clinical observations. The "ground truth" for this device's performance is objective measurement against established engineering and safety standards (e.g., ISO 10651-5 for lung ventilators). The experts involved would be engineers and quality control personnel performing the bench testing.

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

• Not applicable. No human interpretation or adjudication of outputs is described, as this is a physical device subject to objective performance measurements.

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

• No. This is explicitly stated as not being an AI device.

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

• Not applicable. This device is a mechanical resuscitator.

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

• The "ground truth" for this device's performance is established by engineering standards and specifications (e.g., ISO 10651-5, ISO 5356-1) which define acceptable ranges for physical parameters (pressure, flow, dead space, etc.). Compliance is determined by direct physical measurement during bench testing.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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