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K Number
K042849
Device Name
CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD)
Manufacturer
CARDIOBIOMEDICAL CORPORATION
Date Cleared
2005-01-13

(90 days)

Product Code
DQK
Regulation Number
870.1425
Type
Traditional
Panel
Cardiovascular
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Cardio Spectrum Diagnostic System intended to be used as an aid to diagnosis by means of analysis of the ECG waveform in the frequency domain (power spectral estimate).

Device Description

Not Found

AI/ML Overview

This FDA 510(k) clearance letter for the Cardio Spectrum Diagnostic System (K042849) does not contain the detailed information required to answer your questions about acceptance criteria, study design, and performance metrics.

The document primarily focuses on:

  • Confirming the device's substantial equivalence to a predicate device.
  • Stating its classification and regulation number.
  • Listing general regulatory requirements for the manufacturer.
  • Defining the intended use (Indications For Use).

Therefore, I cannot extract the following information from the provided text:

  1. A table of acceptance criteria and the reported device performance: This document does not include specific performance metrics or acceptance criteria.
  2. Sample size used for the test set and the data provenance: No information on test sets or data sources (country, retrospective/prospective) is provided.
  3. Number of experts used to establish the ground truth for the test set and their qualifications: The text does not mention experts, ground truth establishment, or their qualifications.
  4. Adjudication method: No adjudication method is described.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: There is no mention of an MRMC study or any comparison of human readers with and without AI assistance.
  6. If a standalone performance study was done: The document does not describe any standalone algorithm performance studies.
  7. The type of ground truth used: No ground truth type (expert consensus, pathology, outcomes data) is specified.
  8. The sample size for the training set: There is no information about a training set or its size.
  9. How the ground truth for the training set was established: This is not discussed.

To obtain this information, you would typically need to refer to the original 510(k) submission document itself, which contains the detailed technical and clinical performance data submitted by the manufacturer to the FDA. The clearance letter is a summary of the FDA's decision, not the full submission.

§ 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).