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The MEDISIZE GOLD Heater and Booster T-Piece is intended to feed additional heat and moisture into the system, through the T-Piece or via the Medisize Gold, during anaesthesia and respiratory care, specifically, when the use of an HME alone is no longer adequate due to the patients moisture deficit.

The reusable MEDISIZE GOLD Heater in combination with the disposable single use Medisize Gold Booster T-Piece (or Medisize Gold, 510k number K052615) combines the simplicity of a Heat and Moisture Exchanger (HME) with the features of active humidification. Use of the MEDISIZE GOLD Heater in combination with a HME increases the number of options for humidifying and heating respiratory gases, greatly expanding the field of application for HMEs. When used in combination with a HME, the MEDISIZE GOLD Heater improves the absolute humidity, the relative humidity and the temperature of the respiratory gases. Use of the MEDISIZE GOLD Heater makes it possible to administer additional moisture and heat in a simple way, which is self-regulating. As a result, use of the MEDISIZE GOLD Heater is not particularly labor or knowledge intensive. The ease of use makes it a reliable, stable and effective method to administer additional moisture and heat to patients when required.

Here's a breakdown of the acceptance criteria and the study information for the Medisize Gold Heater and Booster T-Piece, based on the provided text:

Important Note: This submission is a 510(k) for a modified device, showing substantial equivalence to a predicate device. This often means extensive new clinical trials are not performed if the changes are minor and do not raise new safety or effectiveness concerns. The focus here is on demonstrating compliance with safety standards and similar performance to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in terms of a "test set" for human subjects or a dataset. The testing described is primarily non-clinical device testing. For the electrical safety and performance tests, it implies a sample size of at least one device, or a small number of devices sufficient to carry out the specified standard tests.
• Data Provenance: Not applicable in the context of human data. The tests are laboratory-based and conducted on the device itself.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Not applicable. The "ground truth" for this device's evaluation is based on compliance with established international standards for medical electrical equipment and respiratory humidifiers (IEC 60601-1, IEC 60601-1-2, ISO 8185). The assessment relies on engineering and testing experts performing and interpreting these standardized tests, rather than clinical experts establishing a ground truth from patient data.

4. Adjudication Method for the Test Set

• Not applicable. There is no clinical test set requiring adjudication by human experts. The evaluation is based on whether the device passed specific, objective engineering and performance tests from recognized standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study was not done. This type of study is typically performed for diagnostic imaging devices or other devices where human interpretation of medical data is a critical component of efficacy. This submission is for a respiratory gas humidifier, where the evaluation focuses on physical performance and safety characteristics.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

• The "ground truth" for demonstrating the device's acceptable performance and safety is its compliance with recognized international standards:
  • IEC 60601-1: For general requirements for basic safety and essential performance of medical electrical equipment.
  • IEC 60601-1-2: For electromagnetic compatibility (EMC) requirements.
  • ISO 8185: For particular requirements for respiratory humidification systems.
• Additionally, the ground truth for biocompatibility is established by stating that "the materials are identical to the Medisize Gold Heater and Booster (with T-Piece) cleared under the previous 510(k) clearances K070714 and K052615," meaning previous regulatory approvals serve as the basis.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to this device submission.

Ask a specific question about this device

1. The MEDISIZE GOLD Heater and Booster makes it possible to feed additional heat and moisture into the system, through a T-Piece or via the Medisize Gold, during anaesthesia and respiratory care, specifically, when the use of an HME alone is no longer adequate due to the patients moisture deficit.

Not Found

The provided text is a 510(k) premarket notification acceptance letter from the FDA for a medical device called the "MEDISIZE GOLD Heater and Booster." This document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The letter states that the FDA has reviewed the Section 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This means the device's safety and effectiveness are deemed comparable to already approved devices.

Therefore, I cannot provide the requested information based on the given input. The document focuses on regulatory approval based on substantial equivalence, not on specific performance acceptance criteria or a detailed study report.

Ask a specific question about this device

• 1. The Heat and Moisture Exchanger (HME) of the Medisize Gold is intended for passive humidification during anaesthesia and respiratory care.
• 2. The integrated booster ability makes it possible to feed additional heat and moisture into the system during respiratory care, specifically, when the use of an HME alone is no longer adequate due to the patients moisture deficit.

Not Found

This is a Medical Device 510(k) Premarket Notification from the FDA to Medisize BV regarding their "Medisize Gold" Respiratory Gas Humidifier. It confirms that the device is substantially equivalent to legally marketed predicate devices and is thus cleared for marketing.

While the document refers to product performance and regulatory compliance, it does not contain the acceptance criteria or the study data proving the device meets those criteria. This type of information would typically be found in the manufacturer's submission package to the FDA, not in the FDA's clearance letter itself.

Therefore, I cannot provide the requested information from the provided text. The document is an approval letter, not a technical report on device performance.

Ask a specific question about this device