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K Number
K970879
Device Name
CARDIOVIT CS-200
Manufacturer
SCHILLER AMERICA, INC.
Date Cleared
1997-06-25

(107 days)

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

The Cardiovit CS-200 device maybe used to record and store standard 12 lead Electrocardiograms (ECG) at patients resting or exercising. Resting ECG's are automatically measured and interpreted by the optionally available Schiller ECG interpretation program.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a device called "Cardiovit CS-200". It states that the device can record and store standard 12-lead Electrocardiograms (ECG) at rest or during exercise. It also mentions that "Resting ECG's are automatically measured and interpreted by the optionally available Schiller ECG interpretation program."

However, the document does not include the detailed information required to fill out a table of acceptance criteria and a study that proves the device meets those criteria. Specifically, the document is a regulatory clearance letter, not a study report or a detailed technical specification.

Therefore, I cannot provide the requested information from the given text.

Here's a breakdown of why this information is missing:

  • Acceptance Criteria and Reported Device Performance: While the document states the device's function (ECG recording, storage, and interpretation), it does not specify any performance metrics (e.g., sensitivity, specificity, accuracy for specific ECG interpretations) or the quantifiable acceptance criteria for these metrics.
  • Sample size and data provenance: No details about a test set, its size, or origin are provided.
  • Number and qualifications of experts for ground truth: This information is not present.
  • Adjudication method: Not mentioned.
  • MRMC comparative effectiveness study: There's no indication of any study comparing human readers with and without AI assistance.
  • Standalone performance: While it mentions "automatically measured and interpreted," it doesn't provide performance data for this standalone function.
  • Type of ground truth: Not specified.
  • Sample size for training set: Not mentioned.
  • How ground truth for training set was established: Not mentioned.

To answer your request, a more detailed technical submission, clinical study report, or a publication describing the validation of the Schiller ECG interpretation program would be needed.

N/A