Search Results

The MD300M122/MD300M222/MD300M322 handheld pulse oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of single adult and pediatric patients in hospitals and home care.

The applicant device MD300M122 Handheld Pulse Oximeter is integrated with Bluetooth® technology allowing the user to transfer measurement data any time and anywhere. The oximeter is designed with the measurement, storage, review, visible and audible alarms and data transmission function. The MD300M122 Handheld Pulse Oximeter works by applying a external sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660nm, which is red light; the other is 940nm, which is infrared light. The applicant device of MD300M122 Handheld Pulse Oximeter is the handheld equipment, which mainly function are measurement, display, alarm, data storage & replay etc.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The provided document, K111494, focuses on the substantial equivalence of the Handheld Pulse Oximeter Model: MD300M122, MD300M222, MD300M322 to a predicate device, rather than explicitly stating acceptance criteria in a table format with specific performance metrics. However, it does imply acceptance criteria through its adherence to standards and the results of its clinical testing.

The primary acceptance criteria are derived from the applicable standard, ISO 9919:2005 Annex EE, which specifically addresses pulse oximeter accuracy. The study aimed to demonstrate compliance with the "specification claimed by the manufacturer compared with 'Golden Standard' Co-Oximeter."

Here's a table based on the implicit criteria and the reported outcome:

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated. The document indicates that "The Clinical Tests following ISO 9919:2005, Annex EE.2 are conducted," and that "Procedures of testing required in EE.2 are adopted." ISO 9919:2005 Annex EE.2 typically outlines methodologies for clinical evaluation of pulse oximeter accuracy, which involves human subject testing over a range of oxygen saturation levels. The specific number of subjects and measurements within that framework is not detailed in this submission.
   • Data Provenance: The study was conducted in a clinical lab in Beijing, China, specifically at the "Beijing Military General Hospital." The study is prospective in nature, as it is clinical testing for the purpose of demonstrating device performance and gaining regulatory clearance.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document refers to a "Golden Standard" Co-Oximeter for ground truth. This implies a gold standard instrument rather than expert consensus on subjective data. Therefore, the concept of "experts establishing ground truth" in the traditional sense of image interpretation or diagnosis is not directly applicable here. The accuracy of the Co-Oximeter itself is assumed to be established and validated. The individuals operating the Co-Oximeter and conducting the study would be trained clinical professionals, but their specific number and qualifications as "experts establishing ground truth" are not detailed.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • As the ground truth is established by an objective "Golden Standard" Co-Oximeter measurement, an adjudication method for reconciling differing human expert interpretations is not relevant or described. The comparison is between the device's SpO2 and PR readings and the Co-Oximeter's readings.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not conducted. This device is a standalone pulse oximeter for measuring SpO2 and pulse rate. It does not involve human "readers" interpreting data or an AI component designed to assist human interpretation.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Yes, the performance evaluation described, which compares the device's measurements directly against a "Golden Standard" Co-Oximeter, represents a standalone performance assessment of the oximeter's algorithm and sensing capabilities. There is no human-in-the-loop component in the accuracy validation described.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth used was continuous physiological measurement from a "Golden Standard" Co-Oximeter. This is an objective, instrumental measurement considered highly accurate for blood oxygen saturation.

7. The sample size for the training set:

   • The document does not provide information on a training set. Pulse oximeters typically rely on established physiological principles and sensor technology rather than machine learning algorithms that require extensive training data. If any internal algorithm optimization occurred during development, details about its data would not typically be included in a 510(k) summary focused on validation.

8. How the ground truth for the training set was established:

   • As no training set is described for an algorithm in the machine learning sense, this question is not applicable based on the provided text. The device's design is based on established scientific principles of light absorption by oxygenated and deoxygenated hemoglobin.

Ask a specific question about this device

M800 Handheld Pulse Oximeter is indicated for spot checking of functional arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in hospital, hospital type facilities as well as in the home care environment.

The proposed device is a handheld device, which can display %SpO2, waveform, pulse rate value, pulse amplitude bar indication. It consists of detector and emitter LED, OLED display module, CPU, driving circuit, power supply circuit and battery. In addition, it has alarming function including physical parameter alarming and technical alarming. The physical alarming limit can be set by user. The modifications to M700 Handheld Pulse Oximeter are presented in Table 3-1 Modifications List on the next page.

The provided document is a 510(k) summary for the M800 Handheld Pulse Oximeter, which is a modification of the M700 Handheld Pulse Oximeter. The document focuses on demonstrating substantial equivalence to the predicate device and does not contain detailed information about a study to prove acceptance criteria for a new AI or diagnostic device.

Pulse oximeters are typically evaluated based on specific performance criteria related to the accuracy of SpO2 and pulse rate measurements. However, the provided text does not contain the detailed results of such a study. It only states: "Per the risk management during the design change control, the verification tests performed demonstrated that risks of each hazard are reduced to acceptable region."

Therefore, based on the provided text, I cannot complete the requested tables and sections as they pertain to a detailed study proving device meets acceptance criteria related to performance metrics like sensitivity, specificity, or reader improvement with AI. The document primarily highlights design modifications and claims substantial equivalence.

Information NOT present in the provided text:

• A table of specific acceptance criteria for SpO2 and pulse rate accuracy (e.g., A_rms values, bias, precision) and the reported device performance against these criteria.
• Sample size used for a test set to evaluate accuracy.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size for human reader improvement with AI.
• If a standalone (algorithm only) performance study was done.
• Type of ground truth used (e.g., arterial blood gas analysis for SpO2 accuracy).
• Sample size for a training set (as this is not an AI/ML device in the context of typical training sets).
• How ground truth for a training set was established.

The document is a 510(k) summary for a pulse oximeter, and these types of devices traditionally undergo verification and validation testing to ensure accuracy and compliance with standards (e.g., ISO 80601-2-61 for pulse oximeter basic safety and essential performance). However, the specific details of these tests and their results against quantitative acceptance criteria are not presented in this summary.

Ask a specific question about this device

The MD300A/MD300K2/MD300M handheld pulse oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of single adult and pediatric patients in hospitals and home care.

Handheld Pulse Oximeter Model MD300A/ MD300K2/ MD300M

This document is a 510(k) premarket notification letter for a Handheld Pulse Oximeter and does not contain the detailed study information required to fill out the table and answer all the questions. The letter confirms that the device is substantially equivalent to legally marketed predicate devices but does not include the actual performance data, acceptance criteria, or study design details.

Therefore, I cannot provide the requested information from the given text. The relevant sections like "Acceptance criteria and the study that proves the device meets the acceptance criteria" are not present.

The document only states the "Regulation Number: 21 CFR 870.2700" and "Regulation Name: Oscillometer" which would generally dictate the standards and required performance for such a device, but the specific acceptance criteria and study proving compliance are not detailed here.

Ask a specific question about this device