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K Number
K043520
Device Name
EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR
Manufacturer
EMG TECHNOLOGY CO., LTD.
Date Cleared
2005-10-21

(305 days)

Product Code
CAW
Regulation Number
868.5440
Type
Abbreviated
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The EMG CTX01-XXX Series Oxygen Concentrator is designed to provide 1 to 5 liters per minute oxygen for the patient who has been prescribed oxygen therapy by a physician. This device is used in home type environments, nursing homes, patient care facilities, etc.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding an oxygen concentrator (EMG CTX01-XXX Series Oxygen Concentrator). It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the request.

The request asks for specific details about a study proving the device meets acceptance criteria, including:

  1. Table of acceptance criteria and reported device performance: This information is not present.
  2. Sample size, test set, and data provenance: Not mentioned.
  3. Number of experts and qualifications: Not mentioned.
  4. Adjudication method: Not mentioned.
  5. MRMC comparative effectiveness study: Not mentioned.
  6. Standalone performance study: Not mentioned.
  7. Type of ground truth: Not mentioned.
  8. Training set sample size: Not mentioned.
  9. Ground truth for training set: Not mentioned.

The document primarily focuses on regulatory approval based on "substantial equivalence" to a predicate device, as opposed to a detailed performance study with specific acceptance criteria that might be found in a clinical trial report or a more technical submission for a novel device or AI/ML-based device.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The document is a regulatory clearance letter, not a technical performance report.

§ 868.5440 Portable oxygen generator.

(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).