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The NBM-200 is a portable Hemoglobin and oximetry monitor. It non-invasively spot checks and displays Hemoglobin (Hb), estimated Hematocrit (Hct) values, functional saturation of arterial oxygen hemoglobin (SpO2), and pulse rate (PR). These parameters can be displayed periodically for patient monitoring.

The monitor estimates Hct via a calculation based on the Hb measurement for normal hemoglobin values (11 to 17 g/dl) only and abnormal values will not be displayed. It is intended for use by trained medical personnel, with adult individuals, in non-critical clinical and non-clinical settings (e.g. non-critical settings in hospitals, hospital-type facilities, mobile environments, clinics, physician offices and ambulatory surgery centers). In this context, non-critical means patient examination settings where continuous monitoring is unnecessary. Non-critical environments exclude, for example, intensive care units.

The NBM-200 is a portable Hemoglobin and oximetry monitor, based on occlusion spectroscopy technology, for non-invasive spot checking of hemoglobin (Hb), estimated Hematocrit (Hct), SpO2 and pulse rate.

The NBM-200 includes a reusable ring-shaped sensor probe that fits on the patient's finger, and a portable desktop monitor that calculates and displays the measurement result.

The sensor probe consists of a multi-wavelength optical measuring system and inflatable cuff employing pneumatic tissue manipulation. Blood flow in the finger can be briefly occluded and the resulting changes in its optical behavior are analyzed to provide accurate measurements of Hb.

The provided text is a 510(k) summary for the NBM-200 Pulse Oximeter and Hemoglobin Monitor. It describes the device, its intended use, and its substantial equivalence to a predicate device (NBM 200MP). However, it explicitly states, "Clinical data for the predicate NBM 200-MP were submitted for the K124041 clearance and no clinical data were generated for the modified device."

This means that the document does not contain the acceptance criteria or the study details for the NBM-200 itself. It relies on the clinical data and acceptance criteria established for the predicate device (NBM 200MP) from its K124041 submission.

Therefore, I cannot extract the requested information from the provided text for the NBM-200. The document states that no clinical data was generated specifically for the NBM-200 device.

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The NBM-200MP is a portable Hemoglobin and oximetry monitor. It non-invasively monitors and displays Hemoglobin (Hb), estimated Hematocrit (Hct), functional saturation of arterial oxygen hemoglobin (SpO2), temporary occluded blood oxygen saturation (SoO2), pulse rate (PR) and plethysmogram waveform.

For oximetry (SpO2/SoO2), the NBM-200MP permits continuous patient monitoring with adjustable alarm limits, as well as visible and audible alarm signals. SoO2 is intended for use in low perfusion conditions and under any conditions that will cause poor signal quality.

The NBM-200MP periodically displays Hemoglobin (Hb) and estimated Hematocrit (Hct) values and it can also be used for spot measurements. The monitor estimates Hct via a calculation based on the Hb measurement for normal hemoglobin values (i.e. 11 to 17 g/dl) only and abnormal values will not be displayed. It is intended for use by trained medical personnel, with adult individuals, in clinical and non-clinical settings (e.g. hospitals, hospital-type facilities, mobile environments, clinics, physician offices and ambulatory surgery centers).

OrSense NBM-200MP device is a pulse oximetry and hemoglobin monitoring device, measuring SpO2, pulse rate, hemoglobin and estimated Hematocrit. In addition to a regular operating mode, it also includes an "occlusion spectroscopy" mode, which is activated during low-perfusion conditions for oximetry (SoO2) and for Hb measurements. The sensor probe pneumatic cuff is placed around a finger and briefly inflates and deflates; the resulting changes in blood optical behavior within the finger are measured and analyzed to provide accurate measurements of SoO2 during low-perfusion conditions and Hemoglobin values at predetermined time intervals. The monitor should not be used under any circumstances as a substitute for an approved lab blood analyzer.

This document describes the NBM-200MP Pulse Oximetry and Hemoglobin Monitor. Here's an analysis of the acceptance criteria and study data:

Acceptance Criteria and Device Performance

• Low bias (mean difference)
• Small standard deviation of the difference
• Acceptable Root Mean Square Error (RMSE)
• Narrow 95% Limits of Agreement (LoA) | Overall results in the Hb study:
• Mean difference (bias) of -0.13 g/dl
• Standard deviation of the difference: 0.96 g/dl
• Root mean square error (RMSE): 0.97 g/dL
• 95% limits of agreement: [-2.01, 1.76 g/dl]
• Reproducibility SD of the NBM is 0.5 g/dl; the CV is 4.2%.
  Measurement range: The device demonstrated accuracy over the range of 6.5 to 17.1 g/dl, and the specified measurement range of the device is 7 to 17 g/dl. |
  | SpO2 Accuracy (Pulse Mode) | Conformance to ISO9919:(2005) Standard for Medical Electrical Equipment-Particular Requirements for the Basic Safety and Essential Performance of Pulse Oximeter Equipment for Medical Use.
  Implied (from regulatory expectations and previous submission K091564):
• Acceptable error (rms)
• High correlation with reference
• Low bias | Results (K091564 study):
• Based on 388 pairs of data points
• Error (rms) obtained was 2.5%
• 0.95 correlation
• 0.2% bias |
  | SoO2 Accuracy (Occlusion Mode) | Conformance to ISO9919:(2005) Standard for Medical Electrical Equipment-Particular Requirements for the Basic Safety and Essential Performance of Pulse Oximeter Equipment for Medical Use.
  Implied (from regulatory expectations and previous submission K091564):
• Acceptable error (rms)
• High correlation with reference
• Low bias | Results (K091564 study):
• Based on 438 data pairs
• Error (rms) was 2.2%
• 0.96 correlation
• 0.05% bias |
  | Repeatability and Reproducibility (Hb) | Implied: Low variability (SD and CV) to ensure consistent measurements over time and across different operators/devices. | Reproducibility SD of the NBM is 0.5 g/dl; the CV is 4.2%. |
  | Safety (Cuff inflation/deflation) | Compliance with IEC 60601-2-30 (1999) standard for automatic non-invasive blood pressure monitoring equipment and demonstration of safe device duty cycle.
  Implied: No adverse events related to cuff use. | Analyzed by comparison of device duty cycle to predicate, compliance with IEC 60601-2-30, and clinical testing.
  No adverse events or subject discontinuation related to the use of the NBM-200MP were reported during the multi-center studies (which included cuff use). |
  | General Safety and Performance Standards | Compliance with:
• ISO9919:(2005)
• IEC/EN-60601-1 (1990 + amendments)
• IEC/EN 60601-1-2 (2001)
• IEC/EN 32604:2006 (Software)
• ISO14971:2007 (Risk Management)
• Extensive safety, performance testing, and validation.
  Implied: Device meets all functional specifications. | All tests passed and demonstrated substantial equivalence with predicates and compliance with the relevant standards.
  Final testing included various performance tests and software validation tests, Biocompatibility, Bench Performance Testing (Simulator testing), Safety testing, Environmental testing, and Clinical testing. |
  | Adverse Events | Implied: No significant adverse events related to the device. | No adverse events or subject discontinuation related to the use of the NBM-200MP were reported during the multi-center studies for Hb.
  No adverse events were reported for the oximetry study. |

Study Information

The document describes clinical studies supporting the NBM-200MP device, particularly for Hemoglobin (Hb) accuracy and reproducibility, and refers to a previous submission (K091564) for SpO2/SoO2 accuracy.

1. Sample Size Used for the Test Set and Data Provenance:

   • Hb Accuracy Studies (NBM-200MP):
     • Total Subjects: 359 (Site 1) + 212 (Site 2) + 100 (Site 3) = 671 subjects
     • Provenance: Retrospective comparison to routine Hb measurements. The studies were conducted at three sites in Israel (Assaf Harofeh Medical Center, Rabin Medical Center, Chaim Sheba Medical Center).
   • Hb Reproducibility Study:
     • Total Subjects: 33 subjects
     • Provenance: Retrospective data from Site 3 (Sheba MC) in Israel.
   • Hb Continuous Trending / Hemodilution Study:
     • Total Subjects: 27 volunteers for variability; 12 of these for hemodilution.
     • Provenance: Supplemental study performed at one site in the U.S. (Zabloki Veterans Affairs Medical Center).
   • SpO2 and SoO2 Accuracy Studies (K091564 submission):
     • Total Subjects: 10 healthy individuals.
     • Provenance: Clinical study of induced hypoxia. Country of origin not explicitly stated in this document for the K091564 study, but given the company is Israeli, it's likely Israel or a comparable medical research environment.

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

   • The ground truth for Hb measurements was established using automated blood analyzers (Coulter LH750 or Radiometer OSM3). These are laboratory instruments, not human experts. Therefore, the concept of "number of experts" is not directly applicable here.
   • The ground truth for SpO2 and SoO2 was established by reference measurements of blood SaO2 by a cooximeter. Again, this is an instrument, not human experts.

3. Adjudication Method for the Test Set:

   • The document does not describe any human expert adjudication process for the clinical study results. The ground truth was based on objective laboratory measurements from automated analyzers and cooximeters.

4. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is an automated measurement tool, not an AI-assisted diagnostic imaging or interpretation system that would typically involve human readers.

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

   • Yes, the clinical studies presented for the NBM-200MP are standalone performance studies (algorithm only). The device directly measures and displays Hb, Hct, SpO2, SoO2, and pulse rate. Its performance is compared against established reference methods, not against human interpretation or with human-in-the-loop assistance for its core function.

6. Type of Ground Truth Used:

   • Hemoglobin (Hb): Laboratory reference standard from automated blood analyzers.
     • For Israeli sites: Coulter LH750 using venous whole blood samples.
     • For U.S. site (supplemental study): Radiometer OSM3.
   • SpO2 and SoO2: Reference measurements of blood SaO2 by a cooximeter (for the K091564 study).

7. Sample Size for the Training Set:

   • The document does not explicitly state the sample size for a training set. This is common for devices using established biophysical principles and algorithms, where detailed "training set" information, as understood in machine learning, might not be separately presented in a 510(k) summary. The development and internal validation would have been performed on various datasets before the final clinical validation studies.

8. How the Ground Truth for the Training Set Was Established:

   • As the training set size is not provided, the method for establishing its ground truth is also not described in this 510(k) summary. However, implicitly, any internal development and validation would have used similar reference standards (laboratory measurements for Hb and cooximetry for SaO2) to establish ground truth for algorithm development.

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The NMB-200MP is a portable Oximetry monitor which may be used in low perfusion conditions. It non-invasively and continuously monitors and displays arterial blood oxygen saturation (SpO2), temporary occluded arterial blood oxygen saturation (SoO2), pulse rate (P.R.) and plethysmogram waveform.

Temporary occluded arterial blood oxygen saturation (SoO2) is intended for use under any conditions that will cause poor signal quality. It is not intended for use under motion conditions.

It may be used on adult patients in the hospital or clinical environments.

The NBM-200MP permits continuous patient monitoring with adjustable alarm limits for oximetry, as well as visible and audible alarm signals.

The NBM-200MP is NOT intended for home use.

OrSense NBM-200MP device is a pulse oximetry device, measuring SpO2 and Pulse Rate. In addition to a regular operating mode, it also includes an "occlusion spectroscopy" mode, which is activated during low-perfusion conditions. A pneumatic cuff placed around a finger temporarily inflates and deflates; the resulting changes in blood behavior within the occluded finger are measured and analyzed to provide accurate measurements of blood oxygen saturation during low-perfusion conditions.

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 describes the NBM-200MP Pulse Oximetry device, focusing on its accuracy for blood oxygen saturation (SpO2) and temporary occluded arterial blood oxygen saturation (SoO2).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for pulse oximeters are typically defined by regulatory standards, such as ISO9919:(2005), which specifies accuracy requirements. While the document states that the study was performed in compliance with ISO9919:(2005), it doesn't explicitly list the numerical acceptance criteria from the standard. However, it does provide the measured performance in terms of Root Mean Square (RMS) accuracy, correlation, and bias.

Study Proving Device Meets Acceptance Criteria:

The document describes two clinical studies:

1. Hypoxia Study: This study validated SpO2 and SoO2 accuracy against a reference co-oximeter.
2. Safety Study: This study evaluated the safety of the inflation/deflation mechanism in an Intensive Care Unit (ICU) environment.

2. Sample Size and Data Provenance for the Test Set

• Hypoxia Study (Accuracy Validation):

  • Sample Size: 10 healthy individuals.
  • Data Points: 388 pairs of data points for pulse mode, 438 data pairs for occlusion mode.
  • Data Provenance: Not explicitly stated, but the study was performed to validate accuracy, implying it served as the primary test set for performance. The use of "consenting healthy individuals" suggests a prospective controlled study. Country of origin is not specified.

• Safety Study (Cuff Mechanism):

  • Sample Size: 32 patients.
  • Data Provenance: Conducted in an Intensive Care Unit (ICU) environment. The patient profiles (pneumonia, pancreatitis, GI Bleeding, etc.) indicate a prospective clinical observation in a hospital setting. Country of origin not specified.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• Hypoxia Study: The "reference measurements of blood SaO2 by a cooximeter" are considered the ground truth. A co-oximeter is a laboratory device, and its operation and results are typically interpreted by trained medical laboratory professionals, but the exact number and qualifications of experts interpreting the co-oximeter data are not specified in the document.
• Safety Study: The ground truth for safety was established by "investigators observ[ing] the fingers" for changes. The number and specific qualifications of these investigators are not specified, beyond being based in an ICU environment, implying medical professionals.

4. Adjudication Method for the Test Set

• Hypoxia Study: No explicit adjudication method (e.g., 2+1, 3+1) is mentioned for the co-oximeter readings or the comparison. The co-oximeter is likely considered the gold standard, so its readings would be directly used.
• Safety Study: The investigators "observed the fingers." The method for ensuring consistent evaluation among multiple observers (if there were more than one) or an explicit adjudication process is not described.

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

No multi-reader multi-case (MRMC) comparative effectiveness study evaluating how much human readers improve with AI vs. without AI assistance was reported. This device is a measurement device (a pulse oximeter) rather than an image interpretation or diagnostic aid that would typically involve human readers.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance study was done for the NBM-200MP device. The reported accuracy, correlation, and bias for both pulse mode and occlusion mode (SpO2 and SoO2) represent the algorithm's performance independent of human intervention in the measurement process, aside from initial sensor placement.

7. Type of Ground Truth Used

• Hypoxia Study: The ground truth for SpO2 and SoO2 accuracy was established using reference measurements of blood SaO2 by a co-oximeter. This is considered a highly accurate, objective, and quantitative physiological measurement.
• Safety Study: The ground truth for safety was based on clinical observation of patient outcomes (skin integrity) by investigators.

8. Sample Size for the Training Set

The document does not specify the sample size for any training set. As this is a 510(k) submission for a non-AI device relying primarily on established physiological principles and signal processing, the concept of a "training set" in the machine learning sense might not be explicitly relevant or documented in the same way. The device's algorithms were likely developed and validated using engineering principles, bench testing, and pilot studies, but specific "training set" sizes are not mentioned.

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

Since no specific "training set" is mentioned in the context of machine learning, the method for establishing its ground truth is not provided. Device development typically involves a variety of engineering and pre-clinical testing, where ground truth would be established through calibrated instruments, known physiological models, or expert evaluation to refine the device's algorithms and hardware before formal clinical validation.

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