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The MTEK-40 hand held pulse oximeter is used to measure the percent arterial oxygen saturation by using a completely non-invasive finger sensor. The oxygen saturation sensor contains LEDs which emit two specific wavelengths of light through a pulsating vascular bed. The MTEK-40 can also measure pulse rate and pulse strength. Continuous arterial oxygen saturation monitoring is valuable in any situation where oxygen administration is indicated. Real time information allows for earlier detection of hypoxia or hyperoxia tan arterial sampling. Federal Law restricts the use of this device by or on the order of a qualified physician only.

Hand Held Pulse Oximeter, Device Model: MTEK-40. The oxygen saturation sensor contains LEDs which emit two specific wavelengths of light through a pulsating vascular bed.

This document is a 510(k) clearance letter for the MAGNATEK 40 Hand Held Pulse Oximeter (model MTEK-40). It primarily concerns the regulatory approval of the device and does not contain detailed information about specific acceptance criteria, study methodologies, or performance statistics typically found in a clinical study report.

Therefore, I cannot provide the requested information. The document focuses on confirming that the device is "substantially equivalent" to legally marketed predicate devices, allowing its market entry, rather than detailing its performance against specific acceptance criteria.

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The MagnaTek 80 hand held CO2 Monitor (Capnometer) is intended to be used as a transportable capnometer, providing End-Tidal CO2, respiration rate, and real-time breath indications for use in clinical settings including patient transport, ICU, CCU, ER, OR, and recovery room. The Capnometer can be used for patient checking (spot checking) and data logging of End Tidal CO2 and respiration rate.

Hand Held CO2 Monitor (Capnometer) Model: MTEK-80

This document is a 510(k) premarket notification decision letter from the FDA for a Hand-Held CO2 Monitor (Capnometer), Model 80. It approves the device for marketing.

Unfortunately, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

The letter is a regulatory approval document and focuses on the substantial equivalence of the device to a predicate device, the regulatory class, and the general controls that apply. It outlines the indications for use of the device, which are:

• As a transportable capnometer.
• Providing End-Tidal CO2, respiration rate, and real-time breath indications.
• For use in clinical settings including patient transport, ICU, CCU, ER, OR, and recovery room.
• For patient checking (spot checking) and data logging of End Tidal CO2 and respiration rate.

To answer your request, I would need a different document, specifically a study report or a summary of performance data that would typically be included in the 510(k) submission itself, but is not present in this decision letter.

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The MTEK-1400 unit is to be used to in order to measure CO2 concentration using the principles of infrared absorption spectrometry. This unit provides continuous non-invasive information used to aid the clinician in assessing a patient's cardiopulmonary function and metabolic state. It is extremely effective in determining the efficacy of various respiratory treatments. Capnography can aid in detecting esophageal intubations, disconnections, apnea, malignant hyperthermia and air emboli. The MTEK-1400 can also measure respiration rate and capnography. The MTEX-1400 Plus model is capable of measuring percent arterial oxygen saturation and pulse rate.

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This document is a 510(k) clearance letter from the FDA for a device called "MTEK-1400". It does not contain information about acceptance criteria, study details, or performance data as requested. The letter confirms substantial equivalence to a predicate device but does not provide the supporting study data.

Therefore, I cannot answer your request based on the provided text.

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The MTEK-1000 unit is to be used to measure percent of arterial oxygen saturation and pulse rate by using a completely non-invasive sensor. The oxygen saturation sensor contains LEDs which emit two specific wavelengths of light through a pulsating vascular bed. The MTEK-1000-US oximeters are equipped to monitor ECG waveforms and can be used to measure cardiac activity.

The MTEK-1000 unit is a pulse oximeter. The oxygen saturation sensor contains LEDs which emit two specific wavelengths of light through a pulsating vascular bed. The MTEK-1000-US oximeters are equipped to monitor ECG waveforms.

This is a submission for a 510(k) premarket notification for the MTEK-1000 Pulse Oximeter, which was cleared by the FDA in 1998. The document provided does not contain the detailed study information typically required to answer your questions about acceptance criteria and device performance in the format you've requested.

The document primarily states that the MTEK-1000 is substantially equivalent to legally marketed predicate devices. For 510(k) submissions, manufacturers typically compare their device to existing devices rather than conducting extensive clinical trials with detailed acceptance criteria and standalone performance studies as might be done for a PMA (Premarket Approval).

Therefore, based solely on the provided text, I cannot provide the specific details regarding:

• 1. A table of acceptance criteria and the reported device performance: This information is not present in the letter. A 510(k) summary (which is a separate document) or the full 510(k) submission would contain performance data used to demonstrate substantial equivalence, but it's not in this clearance letter.
• 2. Sample size used for the test set and the data provenance: Not available in this document.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
• 4. Adjudication method for the test set: Not available.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: MRMC studies are generally not required for 510(k) clearances, especially for devices like pulse oximeters, and are not mentioned here.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a pulse oximeter in this context. While the device itself is a "standalone" measurement tool, the concept of "algorithm only" performance or "human-in-the-loop" is typically associated with AI/ML diagnostic software, which this device is not.
• 7. The type of ground truth used: Not available.
• 8. The sample size for the training set: Not applicable as this device is not an AI/ML algorithm that requires a "training set" in the modern sense.
• 9. How the ground truth for the training set was established: Not applicable.

What the document does tell us:

• Device: MTEK-1000 Pulse Oximeter
• Indications for Use: To measure percent of arterial oxygen saturation and pulse rate by using a completely non-invasive sensor. Also, "MTEK-1000-US oximeters are equipped to monitor ECG waveforms and can be used to measure cardiac activity."
• Regulatory Class: II
• Product Code: 74 DQA (Pulse Oximeter)
• Regulatory Pathway: 510(k) Premarket Notification
• Outcome: Substantial Equivalence to legally marketed predicate devices, allowing the device to be marketed.

To get the specific data you're looking for, one would typically need to review the 510(k) Summary (often publicly available) or the full 510(k) submission itself, which would contain the performance data and comparisons to predicate devices that led to the FDA's substantial equivalence determination. This letter is the official notification of clearance, not the detailed technical review.

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C-300 Coagulator is used in small surgical procedures in The dermatology, plastic surgery and general surgery in order to only coagulate (burn) an open wound or skin lesions. This device does not cut the skin, it only closes open wounds or lesions by coagulating (burning) the skin in any of the small surgical procedures mentioned above.

Coagulator Device Name: C-300

This document is a 510(k) clearance letter from the FDA for a device called "MagnaTek C-300 Coagulator". It does not contain information about acceptance criteria or a study proving the device meets them. This type of information is typically found in the 510(k) submission itself, not in the clearance letter.

Therefore, I cannot provide the requested information based on the given text.

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The ESU-10 / ESU-15 units is to be used in order to cut and coagulate (burn) the skin in surgical procedures.

Electrosurgical Units, Device Model: ESU-10 / ESU-15

This document is a 510(k) clearance letter from the FDA for an electrosurgical unit. It confirms that the device is substantially equivalent to a previously marketed device. However, it does not contain the detailed information needed to answer your request about acceptance criteria and study data.

Here's a breakdown of why and what kind of information is missing:

Why the requested information is not present in this document:

• This is a clearance letter, not a study report. The FDA 510(k) clearance letter primarily states that a device is substantially equivalent to a predicate device and can be marketed. It does not typically include the specifics of performance studies, acceptance criteria, or detailed ground truth methodologies.
• The device is an Electrosurgical Unit. For this type of device, the "performance" is often related to electrical safety, power output accuracy, tissue effect (cutting/coagulation effectiveness), and biocompatibility, rather than diagnostic accuracy metrics like sensitivity, specificity, or AUC, which are common for AI/ML-driven diagnostic devices.
• The clearance date is June 24, 1998. AI/ML-driven medical device evaluations, with their specific metrics and study designs, were not common or required in 1998 in the way they are today.

Therefore, I cannot provide the requested information from this document. It does not describe a study involving algorithms, test sets, experts, or ground truth for diagnostic performance.

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