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HemoNIR is intended for in vitro diagnostic use by healthcare professionals in quantitative testing of whole blood for total hemoglobin, methernoglobin and carboxyhemoglobin.

HemoNIR is a small, portable, battery-powered system using rechargeable batteries to measure total hemoglobin, methemoglobin and carboxyhemoglobin using spectroscopic technology. The system uses inexpensive disposable sample tabs and requires no sample preparation or reagents. Samples are introduced into the HemoNIR, JM by using sample tabs. The sample tab well is filled with approximately 10uL of sample and is then inserted into the sample slot of the HemoNIR, "10 unit. The unit automatically starts-up and runs its built-in self-test before performing the measurements. After less than 30 seconds from sample insertion, results will be displayed on the built-in LCD.

Here's an analysis of the provided text regarding the HemoNIRLab™ device, focusing on acceptance criteria and supporting studies:

It's important to note that the provided text is a 510(k) summary from 2005, which typically focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and exhaustive study results in the same way a modern medical device submission or academic paper might. Therefore, some information requested will not be explicitly present.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state numerical acceptance criteria for performance metrics like accuracy, precision, or linearity. Instead, it broadly states that "These studies demonstrated that the HemoNIRLab™ performs in accordance with its specifications." It does, however, mention the types of studies conducted and implies that the performance was found to be acceptable relative to a predicate device.

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

• Sample Size for Test Set: The document does not specify the sample size for any of the performance studies (method comparison, linearity, precision, interference).
• Data Provenance: Not specified within the provided text. It's unclear if the data was retrospective or prospective, or the country of origin of the samples.

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

This information is not applicable and not present in the document. The HemoNIRLab™ is an in vitro diagnostic device measuring objective biochemical parameters (hemoglobin, methemoglobin, carboxyhemoglobin). Its ground truth would be established by reference methods or instruments, not by expert human interpretation.

4. Adjudication Method for the Test Set

Not applicable for a device measuring objective biochemical parameters. The "ground truth" would be the result from a reference laboratory method or a predicate device. There is no mention of adjudication in the context of human reviewers.

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

No. This type of study (MRMC) is typically relevant for interpretative diagnostic devices where human readers provide diagnoses (e.g., radiology AI). The HemoNIRLab™ is an analytical device that provides quantitative measurements.

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

Yes, effectively. The performance testing described (method comparison, linearity, precision, interference) inherently evaluates the device (including its "algorithm" if it uses one for spectroscopic analysis) in a standalone manner, comparing its output directly to a reference or predicate method. The device is intended to provide quantitative measurements and does not involve human interpretation as part of its primary function where AI assistance would be relevant for "human-in-the-loop" scenarios.

7. The Type of Ground Truth Used

The ground truth for the performance studies was implicitly established by:

• Reference Devices/Methods: The "commercially available system" used in the method comparison study served as the reference for accuracy. For linearity, precision, and interference studies, the ground truth would typically be established using carefully prepared samples with known concentrations or by comparison to established laboratory reference methods. The predicate devices (OSM3 Hemoximeter, AVOXimeter 4000) also served as benchmarks for substantial equivalence.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI models. Given that this submission is from 2005 and describes a spectroscopic device, it's highly likely that any internal calibration or "learning" parameters would be determined through a combination of physics-based models, empirical calibration using physical standards, and possibly statistical regression on specific sample sets, rather than a "training set" in the modern AI sense. The size of any such calibration set is not specified.

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

Not applicable in the modern AI sense of "training set ground truth." If internal calibration or model development involved empirical data, the "ground truth" for those samples would be established by highly accurate laboratory reference methods (e.g., hemoximetry, spectrophotometry) using carefully prepared samples with known characteristics. However, the document does not provide details on this.

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The Stat Profile pHOx CO-Oximeter Analyzer is intended for in vitro diagnostic use by health care professionals in the quantitative determination of oxyhemoglobin, carboxyhemoglobin, methemoglobin, and deoxyhemoglobin in human blood.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Stat Profile pHOx CO-Oximeter Analyzer". This document primarily focuses on the regulatory clearance and does not contain the detailed information necessary to answer the questions about acceptance criteria and the specifics of a device study.

Specifically, the document does not include:

1. A table of acceptance criteria or reported device performance.
2. Information on sample sizes, data provenance, or details about test sets.
3. Details about expert involvement, qualifications, or ground truth establishment.
4. Adjudication methods.
5. Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
6. Results of a standalone algorithm performance study.
7. The type of ground truth used.
8. Training set sample size or how its ground truth was established.

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

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device