(17 days)
The AutoPulse Resuscitation System Model 100 is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.
AutoPulse Resuscitation System Model 100 ("Device") is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR. The Device consists of a single use chest compression assembly (CCA) that includes a patient liner, and a reusable platform that contains a user control panel, a drive mechanism, a control system, and a power system (rechargeable battery).
The provided text describes the AutoPulse™ Resuscitation System Model 100, an automatic mechanical chest compressor. However, the document does not contain specific acceptance criteria or study details in the format requested. It states that "Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to the predicate device" and that "Testing of the device modifications demonstrates the device meets and improves upon the predicate device." This indicates that internal testing was performed, but no details about the methodology, results, or specific criteria are provided.
Therefore, many of the requested fields cannot be populated based on the given information.
Here's an analysis of what can be inferred or what is explicitly missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document | "meets and improves upon the predicate device" |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only mentions "product testing was conducted."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable; the testing described is for device conformance and substantial equivalence, not a ground truth establishment by experts for diagnostic or interpretative performance.
4. Adjudication method for the test set
- Not applicable; the testing described is for device conformance and substantial equivalence.
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. This device is a mechanical chest compressor, not an AI diagnostic imaging device that would involve human reader interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The device operates as a standalone mechanical chest compressor, but this question typically refers to the "standalone performance" of an AI algorithm's diagnostic accuracy. The document does not describe such a study for this device.
7. The type of ground truth used
- The document implies that the "ground truth" for its performance would be its ability to perform mechanical chest compressions according to its specifications and "substantially equivalent" to (or improved upon) its predicate device. No external "ground truth" like pathology or outcomes data is mentioned in relation to specific performance metrics for the device itself in this summary.
8. The sample size for the training set
- Not applicable. This device is a mechanical system, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable.
Conclusion:
The provided 510(k) summary focuses on general device description, intended use, predicate device comparison, and regulatory status. It states that testing was conducted to demonstrate conformance and substantial equivalence but does not provide details about the specific acceptance criteria, study design, sample sizes, or performance metrics that would answer the posed questions. The questions are largely tailored to AI/diagnostic devices, which this medical device (a mechanical chest compressor) is not.
§ 870.5200 External cardiac compressor.
(a)
Identification. An external cardiac compressor is an externally applied prescription device that is electrically, pneumatically, or manually powered and is used to compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest. External cardiac compressor devices are used as an adjunct to manual cardiopulmonary resuscitation (CPR) when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR).(b)
Classification. Class II (special controls). The special controls for this device are:(1) Nonclinical performance testing under simulated physiological conditions must demonstrate the reliability of the delivery of specific compression depth and rate over the intended duration of use.
(2) Labeling must include the following:
(i) The clinical training necessary for the safe use of this device;
(ii) Adjunctive use only indication prominently displayed on labels physically placed on the device and in any device manuals or other labeling;
(iii) Information on the patient population for which the device has been demonstrated to be effective (including patient size and/or age limitations,
e.g., adult, pediatric and/or infant); and(iv) Information on the time necessary to deploy the device as demonstrated in the performance testing.
(3) For devices that incorporate electrical components, appropriate analysis and testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.
(4) Human factors testing and analysis must validate that the device design and labeling are sufficient for effective use by the intended user, including an evaluation for the time necessary to deploy the device.
(5) For devices containing software, software verification, validation, and hazard analysis must be performed.
(6) Components of the device that come into human contact must be demonstrated to be biocompatible.