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The Tenacore Oxygen Blender, is intended for non-invasive mixing and delivery of a ratio of therapeutic oxygen and medical grade air as a stand-alone unit or as a component of a respiratory support apparatus.

The Tenacore Oxygen Blender is typically a wall-mounted unit that provides inlets for medical grade air and therapeutic oxygen. The percentage of oxygen to air can be adjusted from 21-100%.

The Tenacore Oxygen Blender is intended for non-invasive mixing and delivery of a ratio of therapeutic oxygen and medical grade air as a stand-alone unit or as a component of a respiratory support apparatus.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective).

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

This information is not applicable as the study described is a performance test for a medical device's physical specifications (accuracy) and not an evaluation based on expert interpretation of data like medical images.

4. Adjudication Method for the Test Set

This information is not applicable for the type of performance testing described. Adjudication typically refers to resolving discrepancies between multiple expert interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The study focuses on the device's technical performance, not on human-in-the-loop improvements with AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was performed. The "Performance Data & Conclusions" section indicates that "Performance testing was conducted as required by standards," which refers to the device itself meeting specified technical standards like accuracy.

7. Type of Ground Truth Used

The ground truth used was based on established engineering and medical device standards for oxygen blenders. Specifically, the device was tested against standards such as EN ISO 15001:2004, 60601-1, 9703-3:1998, 601-1:1988, and IEC 79-4:1975 to verify its accuracy and other performance parameters.

8. Sample Size for the Training Set

This information is not applicable. The device is a mechanical oxygen blender, not an AI/machine learning model that requires a training set.

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

This information is not applicable as there is no training set for this type of device.

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Accessory to pulse oximeter for the purpose of continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring.

SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The optical components are housed in soft pad with a clear window. The sensor cable is terminated in a connector that couples with the corresponding monitor.

Here's a breakdown of the acceptance criteria and study information for the Tenacore Holdings, Inc. SpO2 Sensor:

1. Table of Acceptance Criteria and Reported Device Performance

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

The exact sample size for the clinical hypoxia studies is not explicitly stated in the provided text.

• Data Provenance: Clinical hypoxia studies were conducted in an independent research lab. The data is prospective as it involved conducting new studies. The country of origin is not specified, but given the submission to the FDA, it is likely the studies were conducted in the US or in a manner compliant with US regulatory standards.

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

• The document does not specify the number of experts used to establish ground truth or their qualifications.
• The ground truth for SpO2 accuracy was established by comparing the subject sensors to arterial blood samples analyzed on a laboratory co-oximeter. This implies the co-oximeter itself provides the "ground truth," rather than human experts interpreting results.

4. Adjudication Method for the Test Set

• The document does not mention any adjudication method for the test set. The comparison was directly against objective measurements from a laboratory co-oximeter for SpO2 and likely a reference standard for pulse rate.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret images. For an SpO2 sensor, the performance is measured against objective physiological parameters.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, a standalone performance assessment was done. The performance data explicitly states, "Subject sensors were compared to arterial blood samples analyzed on a laboratory co-oximeter and found to be equivalent to predicate device accuracy claims." This indicates the device's accuracy was assessed directly without human interpretation influencing the measurement.

7. The Type of Ground Truth Used

• SpO2 Accuracy Ground Truth: Achieved by arterial blood samples analyzed on a laboratory co-oximeter. This is an objective, gold-standard physiological measurement.
• Pulse Rate Accuracy Ground Truth: The text states, "Bench testing was performed to verify pulse rate accuracy." While not explicitly stated, this would typically involve comparing the device's pulse rate reading against a known, highly accurate reference standard (e.g., an ECG or a precision pulse generator).

8. The Sample Size for the Training Set

• The provided document does not mention a training set or its sample size. This is typical for a medical device like an SpO2 sensor where performance is based on physical principles and calibration, not a machine learning algorithm that requires extensive data for training.

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

• As no training set is mentioned (or generally applicable to this type of device), this question is not applicable.

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These transducers are intended to be used as replacement accessories for Hewlett Packard and Corometrics fetal monitors. These transducers measure fetal heart rate or uterine contractions in the gravid patient.

Tenacore Holdings, Inc. Transducers for Fetal Ultrasound and Tokodynamometer Monitoring are direct replacements for similar transducers manufactured by GE Marquette Medical Systems and Epic Medical Equipment Services. A Transducer employing ultrasound Doppler Shift Technology is used for the detection of Fetal Heart Rate during labor and a Tokodynamometer Transducer, which actually is a strain gauge, is used to evaluate and measure the duration, frequency, and relative pressure of uterine contractions during labor.

I am sorry, but the provided text does not contain the detailed information needed to answer your request about acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary and FDA clearance letter for a medical device (transducers for fetal monitoring), which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against specific acceptance criteria.

The document mentions:

• Intended Use: As direct replacement accessories for appropriate Perinatal Monitoring Systems that display the graphical relationship between labor and fetal heart rate.
• Performance Standards: "Tenacore Holdings, Inc has declared to conform to consensus performance standards concerning Electrical Electromagnetic Compatibility / Mechanical / Efficacy / Safety and Biocompatibility aspects of the product."

However, it does not provide:

• A table of specific acceptance criteria and reported device performance.
• Details about a specific study (e.g., sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC study, standalone performance).
• Information on training set sample size or how its ground truth was established.

Therefore, I cannot generate the requested table and answer the study-related questions based on the provided text.

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Indicated in the compression of the femoral artery or vein after catherization.

Not Found

This document is an FDA 510(k) clearance letter for a medical device called "The Hammer, Model H100," a vascular clamp. This type of document is a regulatory approval notice and typically does not contain the kind of detailed study information requested in your prompt (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, etc.).

The letter confirms that the FDA reviewed the premarket notification and found the device substantially equivalent to legally marketed predicate devices for its stated indications for use: "Indicated in the compression of the femoral artery or vein after catheterization."

Therefore, I cannot provide the requested information from the provided text. The document is solely an approval letter based on a substantial equivalence finding, not a clinical study report.

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