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Oxymag is a controlled volume, pressure and time cycled emergency and transport ventilator. It is intended for use with infant, child, and adult patients with a tidal volume from 50 ml upwards who are in respiratory and/or cardiac arrest or respiratory distress and who require the ventilatory support.

It is intended for pre-hospital and hospital use including intra-hospital, inter-hospital and transport settings.

Device Description

Oxymag provides a mixture of ambient air and oxygen at concentrations adjusted by the operator using the accurate oxygen concentration system using the venturi principle. O2 concentration is obtained through a galvanic cell by passing gas through the sensor. In addition, it performs the control of flows and pressures in the respiratory circuit to provide the ventilation modalities appropriate to the patient's condition.

The associated accessories include:

Power outlet 12V/3,34A
AC cable
Disposable respiratory circuit
02 extension
Environment filters

AI/ML Overview

The provided document is a 510(k) summary for the Oxymag - Transport and Emergency Ventilator. It focuses on demonstrating substantial equivalence to a predicate device (O-two e700, K141595) rather than establishing novel performance acceptance criteria or conducting a comprehensive study to prove these criteria.

Therefore, the document does not contain the specific information requested in most of your numbered points, as it's not a study designed to establish and prove acceptance criteria for a new device's performance in a clinical setting with human subjects. Instead, it describes bench testing, software verification, electrical safety, and biocompatibility to confirm the device operates as intended and is comparable to an already cleared device.

Here's what can be extracted and what is missing:

Acceptance Criteria and Device Performance (Based on Comparison to Predicate):

The submission demonstrates substantial equivalence by comparing the Oxymag's parameters and features to those of the predicate device, e700. The "acceptance criteria" are implicitly that the Oxymag's performance is equivalent or does not raise new safety or effectiveness concerns compared to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) summary, formal "acceptance criteria" for a study are not explicitly stated in the way one might find in a clinical trial protocol. Instead, the performance is demonstrated by comparison with a predicate device and through various forms of engineering and non-clinical testing.

The provided "Table 1. Comparison table between the subject and predicate devices" serves as the primary evidence for this. Instead of a 'reported device performance' against a strict new acceptance criterion, it shows 'equivalence' or 'similarity' to the predicate.

Characteristic	Acceptance Criteria (Implied: Equivalent/Similar to Predicate)	Reported Device Performance (Oxymag)	Discussion/Proof of Equivalence
Indications for Use	Equivalent to e700	Controlled volume, pressure and time cycled emergency and transport ventilator for infant, child, and adult patients (tidal volume 50ml upwards) in respiratory/cardiac arrest or distress requiring ventilatory support. For pre-hospital and hospital use (intra-hospital, inter-hospital, transport settings).	The indications for use are equivalent to e700.
Patient Population	Equivalent to e700	Infant, child, and adult patients	The patient population is equivalent to e700.
Environment of Use	Equivalent to e700	Pre-hospital and hospital use including intra-hospital, inter-hospital and transport settings.	The environment of use is equivalent to e700.
Product Code	Equivalent to e700	BTL	The product code is equivalent to e700.
Ventilation Modes	Similar to e700	VCV, PCV, V-SIMV, P-SIMV, CPAP/PS	Similar to e700. Except for CPR (not in Oxymag), other modes have different nomenclature but are equivalent (e.g., ACV = VCV/PCV, SIMV = V-SIMV, BiLVL = P-SIMV, CPAP is same).
Breathing Circuit	Performance similar to e700	Dual limb, unique for all patient types	Different from e700 (which is single limb). "Despite the difference, the performance of both devices is similar as demonstrated in bench test."
Exhalation Valve	Performance similar to e700	Connected to the equipment in the exhalation connector. Electronically controlled.	Different from e700 (which has pneumatic control, valve in circuit). "Despite this difference, the exhalation for both devices is similar."
Waveforms	Equivalent to e700	Volume-time, pressure-time and flow-time	Waveforms are equivalent to e700 as demonstrated in bench test.
Flow Sensor	Equivalent to e700	Pneumotachograph	Flow sensor is equivalent to e700.
Flow Control	Performance similar to e700	Proportional valves controlled by microprocessor	Similar to e700 (solenoid valves). "Despite the difference, the performance of both devices is similar as demonstrated in bench test."
Trigger Sensitivity	Parameter range equivalent to e700	OFF; 1 to 15 L/min	Parameter range is equivalent to e700.
Input Pressure	Performance not affected by difference from e700	39 to 87 psi	Different to e700 (45-87 PSI). "The lower limit of Oxymag's input pressure is lower than e700, but the difference does not affect the performance of Oxymag. Oxymag delivers all ventilation parameters between 39 and 87 psi."
PSV (Pressure Support Ventilation)	Parameter range equivalent to e700	OFF; 4 to 35 cmH2O (± 10% or ± 2 cmH2O)	Parameter range is equivalent to e700.
Ventilation Frequency	Parameter range equivalent to e700	5 to 60 breath/min (± 10% or ± 1 bpm)	Parameter range is equivalent to e700.
Tidal Volume (L)	Parameter range equivalent to e700	50 to 2000 mL (±20ml or ±15%)	Parameter range is equivalent to e700.
Manual Ventilation/Inspiration Hold	Equivalent to e700	Yes	Parameter range is equivalent to e700.
Inspiration time to expiration time ratio	Parameter range equivalent to e700	1:4 to 3:1 (± 20%)	Parameter range is equivalent to e700.
Inspiration time Ti (sec.)	Parameter range equivalent to e700	0.2 to 9 s (± 20%)	Parameter range is equivalent to e700.
PEEP/CPAP (cm H2O)	Parameter range equivalent to e700	OFF; 4 to 20 (± 10% or ± 2 cmH2O)	Parameter range is equivalent to e700.
FiO2 (%)	Parameter range equivalent to e700	60 or 100 (± 15%)	Parameter range is equivalent to e700.
Pmax	Does not raise safety questions	10 to 60 (± 10% or ± 2 cmH2O)	Different to e700 (10-80 cmH2O). Oxymag has a more restricted upper limit, which generally implies enhanced safety.
Safety relief valve	Equivalent to e700	Yes	Safety valve is equivalent to e700.
Inhalation pressure (cmH2O)	Parameter range equivalent to e700	OFF; 4 to 50 cmH2O (± 10% or ± 2 cmH2O)	Parameter range is equivalent to e700.
Apnea Backup time	Parameter range equivalent to e700	10 to 60 sec	Parameter range is equivalent to e700.
Monitoring	Similar to e700, does not affect performance	Minute Volume, Volume Measured, Instant pressure measured, maximum inspiratory pressure, Respiratory Rate, Plateau pressure, PEEP, Flow, inspiratory time, expiratory time, Ratio I:E, Airway resistance, Dynamic compliance, Static compliance, FiO2, O2 consumption	Oxymag has monitored parameters that e700 has and additional others, but the difference does not affect the performance of Oxymag.
Waveform Displayed	Equivalent to e700	Pressure and flow	Waves are equivalent to e700.
Alarms Audible/Visual & Indications	Significant alarms similar to e700; differences do not raise safety questions	Disconnection, Low airway pressure, High airway pressure, Low minute volume, High minute volume, Obstruction, Low supply pressure, Apnea, Low battery, High PEEP, Low PEEP, AC input fail, High volume and Low volume, High r. rate, Low r. rate, Low internal temperature, High internal temperature, Flow sensor off, HW:High O2 int.	Significant alarms are similar to e700. Differences like additional ISO-required alarms or different alarm trigger mechanisms are stated not to raise safety questions.
Accessories	Significant accessories equivalent to e700	AC/DC power supply, Patient ventilation circuit, Oxygen supply hose, Environment filter	Significant accessories are equivalent to e700.
Reprocessing of Patient Circuit	Equivalent to e700	Single use	Patient circuit reprocessing is equivalent to e700.

Regarding the Study (Performance Data provided for Substantial Equivalence):

The document explicitly states: "There were no animal or clinical studies done for the subject device." This means that most of the specific questions about sample sizes, human experts, adjudication, and MRMC studies are not applicable to the data presented for this 510(k) submission.

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable. No human test subjects were used. Performance data was derived from bench testing.
Data Provenance: Not applicable for human data. Bench testing was performed on the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No human test set requiring expert ground truth was used.

4. Adjudication method for the test set:

Not applicable. No human test set was used for adjudication.

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. No MRMC study was done, as this is a ventilator and not an AI-assisted diagnostic device, and no human studies were conducted.

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

Not applicable in the context of an algorithm's diagnostic performance. However, "Performance testing was conducted on the Oxymag to determine its specifications regarding ventilatory parameters" and "verification of technical data, comparison between Oxymag and the predicate e700, human factors evaluation, validation of ventilatory modes, alarm system, monitored parameters, auto test, hardware and mechanical specifications" serve as standalone device performance evaluations in a non-clinical setting.

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

For Biocompatibility: International standard ISO 10993-1 and FDA Guidance as recognized by FDA.
For Electrical Safety and EMC: IEC 60601-1, IEC 60601-1-8, IEC 60601-1-12, IEC 80601-2-12, IEC 80601-2-55 for safety; IEC 60601-1-2 for EMC; AIM 7351732 for RFID.
For Software: FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
For Mechanical Testing: Device specifications based on engineering design and comparison to the predicate device's established performance. The "ground truth" here is the established and expected performance curves and parameter ranges for ventilators, often derived from industry standards and the predicate device's known capabilities.

8. The sample size for the training set:

Not applicable. There is no mention of a training set as this is not an AI/machine learning device requiring such.

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

Not applicable. No training set was used.

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