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This document is a 510(k) summary from 1997 for a device relating to "Protected Design Leadwires," which are typically components of medical electrical equipment, likely for patient monitoring. The summary is very brief and refers to meeting regulatory requirements and voluntary standards, rather than describing a clinical performance study with AI.
Therefore, most of the requested information regarding acceptance criteria specific to AI performance, study design (sample size, data provenance, experts for ground truth, adjudication, MRMC, standalone performance), and training set details cannot be provided because the document does not describe such a study.
Here's what can be extracted based on the provided text, and where information is missing:
Acceptance Criteria and Device Performance (Based on the document's content):
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Compliance with 21 CFR Parts 895 & 897 (Proposed Rule) | "The submitted device meets the requirements of the Proposed Rule from 21 CFR Parts 895 and 897 regarding Protected Design Leadwires." |
| Compliance with ANSI/AAMI EC53-1995 | "samples of the submitted device passed all applicable sections of the voluntary standard ANSVAAMI EC53-1995." |
| "Additional testing" (not part of any standard) | "samples of the submitted device passed additional testing, not a part of any standard." |
| Safety & Effectiveness (Substantial Equivalence) | "it is concluded that the submitted device raises no new concerns of safety or effectiveness, and should be considered Substantially Equivalent to the predicate devices listed in this submission." |
Missing Information (Due to the nature of the provided document):
- Sample size used for the test set and the data provenance: This document describes compliance with regulatory requirements and voluntary standards, and "additional testing." It does not specify the sample size or provenance of data for these tests. It is highly unlikely to involve a "test set" in the context of AI performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no ground truth for AI performance is mentioned.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This document predates widespread AI in medical devices and describes a different type of compliance testing.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as there's no mention of a performance study requiring ground truth for clinical outcomes or diagnostic accuracy. The "ground truth" for the tests described would be the specifications and requirements of the standards themselves (e.g., electrical integrity, mechanical strength, biocompatibility if applicable to the leadwire).
- The sample size for the training set: Not applicable, as this device does not appear to involve AI/machine learning requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of Document Context:
This 510(k) summary focuses on demonstrating that a device (Protected Design Leadwires) meets pre-established regulatory requirements (21 CFR Parts 895 and 897) and voluntary industry standards (ANSI/AAMI EC53-1995). The "testing" mentioned refers to engineering and safety tests to ensure the physical and electrical integrity of the leadwires, not a clinical performance study involving diagnostic accuracy, expert review, or AI algorithms. The conclusion of "substantial equivalence" is based on these compliance tests and comparison to existing predicate devices.
§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.