(23 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).
This document is a 510(k) Summary for the AutoPulse® Resuscitation System Model 100, which is an external cardiac compressor. The summary primarily focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria, performance metrics, or study designs typically found in clinical validation studies.
Therefore, I cannot provide the requested information such as a table of acceptance criteria and reported device performance, sample sizes for test or training sets, data provenance, details on expert opinion for ground truth, or adjudication methods, as these details are not present in the provided text.
The document states that "Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to the predicate device. Testing of the device modifications demonstrates the device meets and improves upon the predicate device." However, no specific performance metrics or the results of these tests are provided.
The provided text focuses on the regulatory submission process and the determination of substantial equivalence, rather than a clinical study evaluating defined performance criteria.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)