(146 days)
The Bloom2 is intended for use in the electrophysiology laboratory during electrophysiology testing, under the direction of qualified personnel trained to administer electrophysiology procedures. The Bloom2 Cardiac Stimulator System is a programmable, electrical, pulse generator intended to provide diagnostic, electrical, cardiac stimulation. It is not intended for use, nor should it be used, as an external pacemaker for long-term support of the pacemaker dependent patient.
The Bloom2™ Cardiac Stimulator System (Bloom²) is a programmable pulse generator used for electrophysiological testing of the human heart. The Bloom² has three main components, the Bloom2 Console, the Bloom2 Stimulator Unit and the Bloom2 Increment / Decrement Floater. The Console and the Floater contain the main user controls of the system. The Console consists of a touch screen and will allow the operator to setup the functions and parameters of the system. The user interface of the Console is based on the proven and familiar interface of the Bloom DTU-215B. The Floater provides additional user controls and will provide the operator with tactile feedback on those functions that the user is expected to use while going through their protocols. The Stimulator is the heart and brains of the system. The Stimulator has four, independent output channels that have a direct connection to the patient through third party catheters.
The provided text is a 510(k) summary for the Bloom2 Cardiac Stimulator System. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in terms of diagnostic accuracy or clinical outcomes. Instead, it focuses on non-clinical performance and safety testing.
Therefore, most of the requested information cannot be extracted from this document, particularly regarding studies related to AI performance, expert adjudication, or ground truth establishment relevant to an AI/diagnostic device.
However, I can provide what is discussed regarding non-clinical performance:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| IEC/EN 60601-1 3.1 Edition Safety Test Report | Bloom2 device fulfills the referenced standard |
| IEC 60601-1-1-2 Fourth Edition EMC Test Report | Bloom2 device fulfills the referenced standard |
| Software Life Cycle Processes Test Report | Not specified if it fulfills a named standard, but implicitly indicates software safety/functionality. |
| FCC CFR 47, Part 15, subpart EMC Test Report | Bloom2 device fulfills the referenced standard |
| ICES-001 for Class A Digital EMC Test Report | Bloom2 device fulfills the referenced standard |
| Canada Differences to IEC 60601-1 Test Report | Bloom2 device fulfills the referenced standard |
| Withstand normal shipping and storage environments and meet labeling standards (21 CFR 801, EN 1041, ISO 15223) | The packaged device will withstand normal shipping and storage and labeling shall meet the specified standards. (This is a statement of intent/design, not a report of specific test results within this summary). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No information about sample size, test sets, or data provenance in the context of clinical or diagnostic performance is provided, as no such study was conducted. The non-clinical tests relate to the device itself and its components.
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, as no expert-adjudicated test set is detailed. The device is a stimulator, not an AI diagnostic tool requiring ground truth from medical experts in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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 cardiac stimulator, not an AI system for diagnostic image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the non-clinical tests, the "ground truth" would be the specifications and requirements of the safety and EMC standards (e.g., IEC 60601-1). The tests demonstrated that the device met these engineering and safety standards.
8. The sample size for the training set:
Not applicable, as no training set for an AI algorithm is mentioned.
9. How the ground truth for the training set was established:
Not applicable.
§ 870.1750 External programmable pacemaker pulse generator.
(a)
Identification. An external programmable pacemaker pulse generators is a device that can be programmed to produce one or more pulses at preselected intervals; this device is used in electrophysiological studies.(b)
Classification. Class II (performance standards).