(29 days)
The EleGARD™ Patient Positioning System (EleGARD) is a 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 System or ARM XR Automated Chest Compressor; and patient transport. EleGARD is indicated for adults only when used with the LUCAS Chest Compression System or the ARM XR Automated Chest Compressor. When not used with an automated compression system, EleGARD can be used for adults and children, not including infants and neonates.
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.
There are several different CPR methods which use a back board, stretcher or bed, e.g., manual CPR, manual CPR Adjuncts, and with the Defibtech Chest Compression System and ARM XR backplate or with the LUCAS Chest Compression System as previously cleared under K191689.
The provided text is a 510(k) Summary for the EleGARD™ Patient Positioning System, detailing its substantial equivalence to a predicate device. However, it does not contain the specific information requested about acceptance criteria and the comprehensive study that proves the device meets those criteria.
The document discusses performance in a general sense within the "Non-clinical Testing Summary" but refers to tests performed for the predicate device (K191689) and a bench test for the proposed device's compatibility. It does not present acceptance criteria or detailed results in a table format, nor does it describe a study specifically designed to prove its performance against such criteria.
Here's an breakdown of the absence of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not provided. The text states "K191689 included testing per ANSI/AAMI/ES 60601-1 and IEC 60601-1-2, and the device performed as intended and met the requirements," and that a bench test "was found to meet its performance requirements." However, specific acceptance criteria (e.g., "device must elevate to X degrees within Y seconds, with a load capacity of Z lbs") and corresponding reported performance values are not tabulated or detailed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The "Bench testing" section mentions testing to evaluate connection ability but gives no sample size for the test set or details on data provenance.
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/Not provided. The type of testing described (bench testing for mechanical compatibility, electrical safety for the predicate) does not involve expert-established ground truth in the manner of diagnostic AI or image analysis. No experts are mentioned in the context of establishing ground truth for the performance tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Similar to point 3, the described tests do not involve an adjudication process.
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/Not provided. This is a hardware device (cardiopulmonary board) and not an AI/diagnostic software. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/Not provided. This is a hardware device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. The document refers to "performance requirements" but does not define a "ground truth" in the context of its testing for this type of device. Performance is typically assessed against engineering specifications and safety standards.
8. The sample size for the training set
- Not applicable/Not provided. This is a hardware device, not an AI or machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As above, no training set is relevant.
In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence of a medical device (a cardiopulmonary board) to a legally marketed predicate device. It highlights similarities in indications for use, technology, and environments of use, and references non-clinical testing (electrical safety, biocompatibility from the predicate, and bench testing for compatibility with a new automated compression system). However, it does not detail a study with specific acceptance criteria and detailed performance results as would be expected for a diagnostic or AI-driven device.
§ 880.6080 Cardiopulmonary resuscitation board.
(a)
Identification. A cardiopulmonary resuscitation board is a device consisting of a rigid board which is placed under a patient to act as a support during cardiopulmonary resuscitation.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.