(61 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 a 510(k) submission for the AutoPulse™ Resuscitation System Model 100, which is an automated chest compression device. However, it does not contain the detailed information required to answer the specific questions about acceptance criteria and a study proving device performance as requested.
The document states:
- "Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices." (Page 1, "Testing" section)
- "The AutoPulse Resuscitation System Model 100 is equivalent to the predicate products. The indications for use, basic overall function, and materials used are substantially equivalent." (Page 1, "Summary of Substantial Equivalence" section)
This indicates that some testing was performed to demonstrate substantial equivalence to predicate devices (Thumper™ Model 1005, K011046, and K022345), but the specifics of what those tests were, what the acceptance criteria were, and what the reported performance was are not included in this document.
Therefore, I cannot populate the table or answer most of the follow-up questions from the provided text.
Here's what I can extract and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. The document only states that "appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence." No specific performance metrics, thresholds, or results are detailed. | Not provided in the document. |
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).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
4. Adjudication method for the test set
- Adjudication method: Not specified.
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
- MRMC study: Not specified. This device is an automated chest compressor, not an AI-assisted diagnostic tool, so an MRMC study in the context of "human readers" is unlikely to be relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is inherently "standalone" in its operation as an automated chest compressor, but no specific study reporting its standalone performance metrics are provided in this document. The term "algorithm only" might not directly apply in the same way it would to a diagnostic AI, but the device's mechanical performance would be its standalone metric.
7. The type of ground truth used
- Type of ground truth: Not specified. For a resuscitation system, ground truth would typically relate to physiological parameters (e.g., blood flow, chest compression depth/rate) or clinical outcomes, but this is not detailed.
8. The sample size for the training set
- Sample size: Not specified.
9. How the ground truth for the training set was established
- Ground truth establishment: Not specified.
§ 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.