(222 days)
The Cardiotron EKG Multi-Phase Information Analysis System is intended to be used as an aid to diagnosis by means of analysis of the EKG waveform in the frequency domain (power spectral estimate).
The Cardiotron EKG Multi-Phase Information Analysis System will be available in two models, the basic model system and the remote model system. The basic model system consists of two standard EKG amplifiers and an off-the-shelf analog-to-digital ("A/D") converter, EKG lead wires, a computer, a monitor, and a printer. The remote model system additionally includes a dummy terminal or computer. The EKG amplifiers are supplied by the Fortune, Co. The additional components, which are off-the-shelf products, are unmodified. The computer is programmed with the Company's multi-phase information analysis software.
Here's an analysis of the provided 510(k) summary, focusing on acceptance criteria and the study used to demonstrate device performance.
Important Note: The provided document is a 510(k) summary, which is a high-level overview. It generally lacks the detailed methodology, raw data, and specific statistical analyses found in a full study report. Therefore, some information will be inferred or noted as missing based on the summary's content.
Acceptance Criteria and Device Performance
The provided 510(k) summary doesn't explicitly state "acceptance criteria" in a table format with specific thresholds for sensitivity and specificity. Instead, it leverages the performance of its predicate device, the New York Heart Instrument Inc.'s EKG Multi-Phase Information Diagnosis System, Model FFF-IA, to establish substantial equivalence.
The summary states: "Both systems also contain the same approximately 78 questions that are asked of the patient, and the answers stored in a database... In addition, both systems provide the same ischemia indexes in the form of a positive or negative index. They also have the same sensitivities (i.e., approximately 90%) and specificities (i.e., approximately 85%)."
From this, we can infer the implied acceptance criteria are to demonstrate performance comparable to or better than the predicate's reported 90% sensitivity and 85% specificity. The study described in the 510(k) is implicitly aimed at showing the Cardiotron system achieves these values.
Table 1: Implied Acceptance Criteria and Reported Device Performance
| Performance Metric | Implied Acceptance Criterion (from Predicate Device) | Reported Device Performance (Cardiotron EKG Multi-Phase Information Analysis System) |
|---|---|---|
| Sensitivity | Approximately 90% | Approximately 90% |
| Specificity | Approximately 85% | Approximately 85% |
Study Proving Device Meets Acceptance Criteria
The 510(k) summary describes the Cardiotron system's performance by directly stating it has "the same sensitivities (i.e., approximately 90%) and specificities (i.e., approximately 85%)" as the predicate device. This implies that testing was conducted to confirm these metrics for the Cardiotron system, likely as part of comparing it to the predicate. The summary also explicitly mentions: "the Company has validated the software to demonstrate that the software functions as intended."
Here's an breakdown of the study information based on the provided text:
-
Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the document.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The summary focuses on technological equivalence and software validation rather than a clinical trial detailed with patient demographics.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not detail how the ground truth for measuring sensitivity and specificity was established. Given the context of EKG analysis for ischemia, "diagnosis" by a physician (e.g., cardiologist) or a more definitive test would typically serve as ground truth, but this is not mentioned.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
-
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. The document makes no mention of an MRMC study or of evaluating human reader performance with or without AI assistance. The device is intended "as an aid to diagnosis," implying it provides output for a physician to interpret, but its impact on reader performance is not studied here.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The stated sensitivities (90%) and specificities (85%) refer to the performance of the system (algorithm only) in providing "ischemia indexes in the form of a positive or negative index." This is a direct measurement of the algorithm's diagnostic capability without human interpretation factored into the reported metrics.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified. For EKG interpretation related to ischemia, common ground truths include:
- Coronary angiography results
- Stress test findings (e.g., nuclear imaging, echocardiography)
- Clinical diagnosis by a cardiologist
- Follow-up for cardiac events.
The summary does not clarify which of these (or other methods) were used to establish the ground truth against which the EKG system's performance was measured.
- Not specified. For EKG interpretation related to ischemia, common ground truths include:
-
The sample size for the training set:
- Not specified. Given the system uses "the same algorithms" as the predicate device, it's possible that the training was done on a dataset used for the predicate, or that the algorithms are pre-established and primarily validated on a test set. This detail is absent.
-
How the ground truth for the training set was established:
- Not specified, as the training set details are not provided.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).