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The Bi-Flow D/R is designed to provide manual mechanical ventilation triggered by the operator to a nonbreathing patient. This is accomplished by providing the patient a source of oxygen from the Bi-Flow D/R through a device such as a facemask or endotracheal tube. Between the oxygen source and the patient interface is the Bi-Flow valve, which allows for the release of oxygen from its source when triggered by the operator thus providing emergency respiratory support. For the spontaneous breathing patient, the Bi-Flow D/R may be used as an Inhalator. This is accomplished by the patient triggering the valve with his her negative inspiratory force and the source gas being delivered to the patient through a face mask.

Additionally, there is a non-rebreathing valve (reusable version or single patient use version) attached to the Bi-Flow D/R which directs the patient's exhalation back to atmosphere. The combination of the Bi-Flow D/R and the non-rebreathing valve as a single device is commonly referred to as a Demand Valve.

The power for the device is provided by the compressed oxygen source. There is no additional source of power for this device.

The Bi-Flow D/R will be sold by Spiracle Technology only by or on the order of a physician and is intended to be used exclusively by trained health care professionals. The Bi-Flow D/R will be sold as a component of a respiratory support system to be configured by the health care provider. As such, it will be compatible with all commonly available oxygen source and face mask connections.

Device Description

The Bi-Flow D/R is designed to provide manual mechanical ventilation triggered by the operator to a nonbreathing patient. The small portable device is primarily constructed of aluminum components and utilizes a plastic and silicone rubber inhalation valve. The device is gas powered and has no electronic components or software. The device is pilot actuated.

AI/ML Overview

The provided text is a 510(k) summary for the Spiracle Technology Bi-Flow D/R, a medical device (Demand Valve) intended to provide manual mechanical ventilation. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than a detailed performance study with acceptance criteria and statistical analysis typical of AI/software devices.

Therefore, many of the requested categories for AI/software device evaluation cannot be fully addressed from this document.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format with specific performance metrics and target values (e.g., accuracy > 95%, sensitivity > 90%). Instead, it refers to general functional and environmental testing.

Acceptance Criteria (Implied)	Reported Device Performance
Meets performance objectives	"demonstrated that the device meets its performance objectives"
Complies with applicable standards and FDA guidelines	"complies with applicable standards and FDA guidelines"
Withstands various environmental conditions (impact/drop, vomitus, immersion, storage temperature, operating temperature)	"testing of the device has been performed under various environmental conditions, including impact/drop testing, vomitus testing, immersion testing, storage temperature testing and operating temperature testing."
Provides manual mechanical ventilation and acts as an Inhalator (functional)	"The Bi-Flow D/R is designed to provide manual mechanical ventilation..." and "For the spontaneous breathing patient, the Bi-Flow D/R may be used as an Inhalator."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of data used for an algorithm. It discusses "functional and environmental testing" on the physical device. Therefore, no information is provided regarding data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. This device is a mechanical ventilator, not an AI/software diagnostic tool that requires expert-established ground truth for performance evaluation.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of adjudication, as this is a hardware device assessment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a mechanical hardware device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance would be engineering specifications and functional requirements (e.g., proper oxygen flow, valve actuation, pressure limits, environmental resilience). The document indicates performance was assessed against "performance objectives" and "applicable standards and FDA guidelines."

8. The Sample Size for the Training Set

Not applicable. This device does not use a training set as it is a mechanical device, not an AI algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set is used.

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K Number

K973347

Device Name

TSX PRM PULMONARY RESUSCITATION MONITOR

Manufacturer

SPIRACLE TECHNOLOGY

Date Cleared

1998-07-23

(321 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K812140,K814608

Intended Use

The TDx PRM is intended to be used as an accessory to emergency resuscitators to monitor vontilatory functions including peak inspiratory pressure, respiratory rate, positive end expiratory pressure, and inspiratory/expiratory time ratio.

Device Description

The TDx PRM is intended to be used as an accessory to emergency resuscitators to monitor ventilatory functions. It is a small, portable battery operated device that attaches to bag mask resuscitators, oxygen powered demand valve resuscitators or automatic transport ventilators, which may not be equipped with pressure gauges for the purpose of patient airway monitoring. The TDx PRM monitors the following patient parameters: peak inspiratory pressure, breath frequency, inspiratory and expiratory times, positive end expiratory pressure ("PEEP"). The TDx PRM also offers a cardiopulmonary resuscitation metronome to assist in the pacing of cardiopulmonary resuscitation efforts. The TDx PRM performs no diagnostic or therapeutic functions; it functions solely as a patient monitor and does not provide any patient alarms. Moreover, the TDx PRM has no direct patient contact; transmission of airborne pathogens is prevented by means of standard bacterial filters such as are routinely used with emergency resuscitation equipment. The TDx PRM is a microprocessor-controlled device that utilizes a electronic pressure transducer.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Spiracle Technology TDx PRM Pulmonary Resuscitation Monitor, based on the provided text:

Device: Spiracle Technology TDx PRM Pulmonary Resuscitation Monitor

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific numerical acceptance criteria for the device's performance parameters (e.g., peak inspiratory pressure accuracy within X mmHg, respiratory rate accuracy within Y breaths/min).

Instead, it broadly states that the device "meets its performance objectives." Without explicit criteria, the "reported device performance" can only be a confirmation that the device functions as intended.

Performance Characteristic	Acceptance Criteria (Explicitly Stated)	Reported Device Performance
Ventilatory function monitoring	Not explicitly stated	"demonstrated that it meets its performance objectives"
Peak inspiratory pressure	Not explicitly stated	Functions as intended, part of "performance objectives"
Respiratory rate	Not explicitly stated	Functions as intended, part of "performance objectives"
Positive end expiratory pressure	Not explicitly stated	Functions as intended, part of "performance objectives"
Inspiratory/expiratory time ratio	Not explicitly stated	Functions as intended, part of "performance objectives"
Cardiopulmonary resuscitation metronome accuracy	Not explicitly stated	Functions to "assist in the pacing of cardiopulmonary resuscitation efforts"
Environmental conditions (impact/drop, storage temp, EMI, ESD, spill resistance, surface temp)	Not explicitly stated	"demonstrated that it meets its performance objectives and complies with applicable FDA guidelines"
Power supply (battery life, low power icon)	Not explicitly stated	"demonstrated that it meets its performance objectives"

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for any of the performance tests. It refers to "Extensive functional testing" and "testing... performed under various environmental conditions."

The data provenance is not explicitly stated, but given the context of a 510(k) submission, it would be internal company testing conducted for regulatory approval.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of external experts to establish ground truth for the device's performance. The testing described appears to be internal validation by the manufacturer.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for establishing ground truth, as no external experts or consensus process is mentioned. The testing relies on the device itself and its ability to monitor specified parameters.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a monitor, not a diagnostic imaging tool that would typically involve human readers interpreting results. Its function is to display physiological parameters.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device itself is a standalone monitor. Its performance evaluation would inherently be a standalone assessment of its accuracy in measuring the ventilatory functions it's designed to monitor. The phrase "standalone performance" isn't explicitly used, but the testing described (functional, environmental, power supply) is an evaluation of the device's inherent capabilities without human intervention for its primary function of measurement.

7. The Type of Ground Truth Used

The type of ground truth used would be measurement standards or reference devices/methods. For example, to verify the accuracy of peak inspiratory pressure, the TDx PRM's readings would be compared against a calibrated, highly accurate pressure gauge. Similarly, respiratory rate would be validated against precise timing mechanisms. The document doesn't explicitly state what reference methods were used, but rather that the device "meets its performance objectives."

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. The TDx PRM is a hardware-based monitor with a microprocessor calculating parameters from transducer inputs. It does not use machine learning or AI algorithms that require a training set to learn patterns or make predictions. Its "logic" is programmed, not learned.