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510(k) Data Aggregation
(113 days)
The Metron QA-IDS Infusion Pump Tester is designed for use by trained service technicians, for testing all types of infusion purips. Tests include volumetric tests, and occlusion tests. The Metron-QA-IDS Infusion:Putmp;Tester is designed to be used by trained service technicians.
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This document is a 510(k) clearance letter from the FDA for a device called "Metron QA-IDS I.V. Pump Tester." It does not contain the kind of detailed study information (acceptance criteria, performance data, sample sizes, ground truth, etc.) that you are asking for. It's a regulatory approval document confirming that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot extract the requested information from the provided text. The document is for a medical device that tests infusion pumps, not an AI or diagnostic device that would typically have the kind of performance metrics you've listed.
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(87 days)
The Metron U.S. QA-510 SpO2 Analyzer is a precision instrument designed to perform tests on Pulse Oximeters. It also performs important measurements, such as the quality of the infrared LED and Red LED.
The Metron U.S. QA-510 SpO2 Analyzer is a precision instrument designed to perform tests on Pulse Oximeters. It also performs important measurements, such as the quality of the infrared LED and Red LED.
This document is a 510(k) Pre-market Notification from the FDA regarding the Metron U.S. QA-510 SpO2 Analyzer. It is a regulatory approval letter and an indications for use statement. Therefore, it does not contain the detailed technical study information requested about acceptance criteria and device performance.
The document discusses:
- Device Name: Metron U.S. QA-510 SpO2 Analyzer
- Regulatory Class: II (two)
- Product Code: 74 DQA
- Indications for Use: "The Metron U.S. QA-510 SpO2 Analyzer is a precision instrument designed to perform tests on Pulse Oximeters. It also performs important measurements, such as the quality of the infrared LED and Red LED. The QA-510 is designed to be used by trained service technicians."
- Substantial Equivalence: The FDA has determined the device is substantially equivalent to devices marketed prior to May 28, 1976.
Therefore, I cannot provide the requested information about acceptance criteria and study details because this type of information is typically found in the 510(k) submission itself (which includes engineering reports, test data, and performance specifications), not in the FDA's clearance letter.
The letter confirms the device's clearance for marketing, but it does not disclose the specific performance metrics, study designs, sample sizes, or ground truth methodologies that were part of the underlying submission that led to this clearance.
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(320 days)
The Metron U.S. OA-40M Defibrillator Analyzer is a precision instrument for testing defibrillators, and for ensuring that defibrillators comply with the specified requirements.
The QA-40M tester is a device that is connected to the output of a defibrillator and is used to measure the energy delivered by the defibrillator into a standard resistive load and can also provide waveform information. The OA-40M test for ANSI/AAMI DF39 standards.
The QA-40M Defibrillator Analyzer's main function is to measure the energy output of a defibrillator. The instrument has a built-in load resistance of 50 ohm, which roughly corresponds to the impedance of the human body. The defibrillator pads are placed on the OA-40M contact plates. Thus, the defibrillator is connected through load resistance, When the defibrillator is discharged. OA-40M will calculate and display the energy delivered.
The OA-40M Defibrillator Analyzer performs the following tests and features (1) energy and cardioversion measurement, (2) peak voltage and current reading, (3) storage and playback of output waveform. (4) 12 lead ECG simulation. (5) ECG, performance and arrhythmia simulation, (6) transcutaneous cardiac pacemaker testing ( module is optional), (7) integrated pacemaker loads selectable from 50 ohm to 2500 ohm, (8) automatic defibrillator test procedures, (9) large graphic display and (10) RS-232C and Centronic printer interface.
The QA-40M tester is a device that is connected to the output of a defibrillator and is used to measure the energy delivered by the defibrillator into a standard resistive load and can also provide waveform information. The OA-40M test for ANSI/AAMI DF39 standards.
The QA-40M Defibrillator Analyzer's main function is to measure the energy output of a defibrillator. The instrument has a built-in load resistance of 50 ohm, which roughly corresponds to the impedance of the human body. The defibrillator pads are placed on the OA-40M contact plates. Thus, the defibrillator is connected through load resistance, When the defibrillator is discharged. OA-40M will calculate and display the energy delivered.
The OA-40M Defibrillator Analyzer performs the following tests and features (1) energy and cardioversion measurement, (2) peak voltage and current reading, (3) storage and playback of output waveform. (4) 12 lead ECG simulation. (5) ECG, performance and arrhythmia simulation, (6) transcutaneous cardiac pacemaker testing ( module is optional), (7) integrated pacemaker loads selectable from 50 ohm to 2500 ohm, (8) automatic defibrillator test procedures, (9) large graphic display and (10) RS-232C and Centronic printer interface.
The provided text is a 510(k) premarket notification approval letter for a medical device called the "Metron U.S. QA-40M Defibrillator Analyzer." However, this document does not contain the detailed information necessary to complete the requested table and study description.
Specifically, it is an approval letter stating that the device is "substantially equivalent" to previously marketed devices. It describes the device's indications for use and functions, but it does not include any acceptance criteria, performance data, or details of a study that proves the device meets specific criteria.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study based on the provided text. The document itself is the FDA's response to a submission, not the submission or study report itself.
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(202 days)
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