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The EleGARD™ Patient Positioning System is cardiopulmonary board which may elevate a patient's head and thorax including during airway management; during manual CPR, manual CPR adjuncts, CPR with the LUCAS Chest Compression Systems; and patient transport.

Device Description

The EleGARD™ patient positioning system is an electrically powered device on which a patient is placed. It can be used to elevate a patient's head and thorax during a number of different procedures, e.g., airway management and different CPR techniques.

The EleGARD™ acts as a back board for airway management and for performing CPR. It allows the user to position the patient in supine or with the head and thorax elevated. The EleGARD™ is a cardiopulmonary back board which is placed under the patient.

It may be used with the patient lying flat or may elevate the patient's thorax and head. The device would be used in emergency conditions when healthcare professionals need to: provide airway management, perform CPR with manual / hand compressions, adjunctive manual CPR devices, and a LUCAS mechanical compression device, perform manual bag / mask ventilation, and transport a patient.

AI/ML Overview

The provided document describes the EleGARD™ Patient Positioning System, a cardiopulmonary board, and its 510(k) submission for FDA clearance. The document focuses on establishing substantial equivalence to a predicate device and outlines various performance tests conducted.

Here's an analysis of the acceptance criteria and study information based on the provided text:

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

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance	Comments
Biocompatibility	ISO 10993-1	Evaluated via Cytotoxicity, Sensitization, and Irritation testing.	The document states "Testing included by Cytotoxicity, Sensitization and Irritation" and implies successful evaluation.
Electrical Safety	ANSI/AAMI/ES 60601-1	Proposed device met the requirements of the standards.	"ES160601-1" is mentioned in the bench testing section as covered.
Electromagnetic Compatibility (EMC)	IEC 60601-1-2	Proposed device met the requirements of the standards.
Safety for EMS Environments	IEC 60601-1-12	Proposed device met the requirements of the standards.
Functional Performance	Raising and lowering the device to specified positions.	"The proposed device was tested for functional performance of raising and lowering the device to the specified positions."	Implies successful performance, though no specific metrics are given.
Software Verification	Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices	Software verification was completed.	Implies successful verification.
System Verification	(Implied as part of overall system functionality)	System verification was completed.	Implies successful verification.
Compatibility of Lucas Backplate Connection	Not explicitly stated, but implies proper mechanical and functional compatibility.	Testing was completed for "compatibility of the backplate connection."	Implies successful compatibility.

2. Sample sized used for the test set and the data provenance

The document does not specify sample sizes for any of the tests. The studies conducted are primarily bench testing and evaluations against recognized standards (e.g., ISO, IEC). There is no mention of patient data (retrospective or prospective) being used in these performance tests. The provenance of any data beyond the specific test standards and internal evaluations is not detailed.

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

This information is not provided in the document. The performance data described relates to engineering and material testing standards, not clinical evaluation requiring expert consensus on ground truth.

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

This information is not provided in the document. Adjudication methods are typically relevant for clinical studies where expert consensus is needed to establish ground truth, which is not the type of study detailed here.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is focused on evaluating the performance of diagnostic algorithms, often with AI assistance, in a clinical setting involving human readers and interpretation of images/data. The EleGARD™ is a patient positioning system, and its evaluation focuses on mechanical, electrical, and material safety and functionality, not diagnostic accuracy or AI assistance for human readers.

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

This is not applicable as the EleGARD™ Patient Positioning System is a physical medical device, not an algorithm that performs a diagnostic or analytical function. Therefore, a standalone algorithm performance study was not conducted.

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

For the engineering and material safety tests described, the "ground truth" is established by adherence to the specified international and national standards (e.g., ISO 10993-1, ANSI/AAMI/ES 60601-1, IEC 60601-1-2, IEC 60601-1-12). Compliance with these standards serves as the benchmark for acceptable performance. There is no mention of clinical outcomes data, expert consensus, or pathological findings being used as ground truth for these studies.

8. The sample size for the training set

This is not applicable. The EleGARD™ is a physical medical device, not a machine learning or AI algorithm that requires a training set.

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

This is not applicable for the same reasons above; there is no training set for this type of device.

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