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UNIPOLAR IPG GROUND CABLE, Model 5473
The provided document describes performance testing for medical device, likely a component of a larger system. However, the information requested about a study proving a device meets acceptance criteria, particularly in the context of an AI-powered device or a study involving human readers/experts, is not present in the provided text.
The document details device integrity testing for the UNIPOLAR IPG GROUND CABLE, Model 5473, focusing on its physical and functional integrity. It does not describe an AI medical device, diagnostic performance, or a comparative effectiveness study involving human readers.
Here's an analysis of the provided text against your requested points:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (Test Requirement) | Reported Performance |
|---|---|---|
| Autoclave Sterilization | Devices shall remain within specification following flash autoclave sterilization. | Pass |
| Grounding Clip Life Cycling | Devices shall be capable of grasping and holding a minimum of 2 ounce weight in the vertical direction, and shall have acceptable contact resistance. | Pass |
| Rotational Flex | Devices shall be reusable | Pass |
Missing Information (Not present in the provided text):
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample sizes for device integrity testing are provided:
- Autoclave Sterilization: 10 cable assemblies
- Grounding Clip Life Cycling: 20 cable assemblies
- Rotational Flex: 8 cable assemblies
- Data provenance (country of origin, retrospective/prospective) is not mentioned. This type of information is typically irrelevant for device integrity testing of physical 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. This document describes physical device integrity testing, not a diagnostic study requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This describes physical device testing, not a diagnostic study requiring adjudication.
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
- No, an MRMC study was not done. This document describes physical device integrity testing, not an AI-powered diagnostic study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document describes physical device integrity testing, not an algorithm's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the device integrity testing, the "ground truth" is defined by the test requirements/specifications. For example, "remaining within specification," "grasping and holding a minimum of 2 ounce weight," and "acceptable contact resistance." These are engineering-defined metrics, not clinical ground truth.
8. The sample size for the training set
- Not applicable. No training set is mentioned as this is physical device testing, not an AI model.
9. How the ground truth for the training set was established
- Not applicable. No training set or ground truth in the context of machine learning is mentioned.
In summary, the provided text details engineering-focused device integrity testing for a physical medical device component. It does not contain any information related to AI devices, diagnostic studies, human reader performance, or typical ground truth establishment methods for such studies.
§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.
(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.