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The GloCyte Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories to provide quantitation of fluorescence labeled total nucleated cells and erythrocytes in cerebrospinal fluid collected from adult and pediatric patients.

The GloCyte Low and High Level Controls are assayed hematology controls designed to monitor the performance of the GloCyte Automated Cell Counter System. Assayed parameters include total nucleated cells and erythrocytes.

The GloCyte® Automated Cell Counter System is an automated cell counter that concentrates and enumerates total nucleated cells (TNCs) and red blood cells (RBCs) using fluorescent microscopy and digital image analysis principles. The test method uses one of two reagents to stain TNCs (propidium iodide with detergent) or RBCs (fluorochrome labeled anti- human RBC antibody in buffer with stabilizers), and a digital imaging system to count the cells. The image is captured by a digital CCD camera, and the fluorescent stained cells are counted via digital image processing.

The GloCyte® Automated Cell Counter System includes the Instrument, Computer (hardware & software), Vacuum Station, Sample Preparation Tray, Barcode Reader, Pipettes (10 and 30 µL), Test Cartridge, TNC and RBC Reagents, Low and High Level Controls.

Here's an analysis of the provided text regarding the GloCyte® Automated Cell Counter System, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a dedicated table. However, it implicitly defines successful performance by stating that "Results were shown to meet acceptance criteria" for accuracy and "The results of the repeatability study met acceptance criteria." The reproducibility study also "met acceptance criteria." Based on the reported data, the implicit acceptance criteria would relate to achieving results within the stated ranges, slopes, intercepts, and CVs.

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

• Accuracy Study (Hemocytometer vs. GloCyte):
  • TNC Pediatric: 129 samples
  • TNC Adult: 223 samples
  • RBC Pediatric: 196 samples
  • RBC Adult: 267 samples
  • Data Provenance: "clinical sites and in-house using clinical and contrived CSF specimens." This indicates a mix of prospective (clinical) and possibly retrospective (clinical) or laboratory-prepared (contrived) data. The country of origin is not specified but implicitly US, given the FDA submission.
• Repeatability Study:
  • TNC: 26 samples
  • RBC: 29 samples
  • Data Provenance: "three clinical sites and in-house using clinical and manipulated CSF specimens as well as GloCyte® Low and High Level Controls." Similar to accuracy, a mix of data types and locations.
• Precision/Reproducibility Study:
  • Each TNC and RBC level (Low/High) had 480 measurements (likely 2 operators * 2 measurements/day * 20 days * 3 sites).
  • Data Provenance: "three clinical sites," using GloCyte® Low and High Level Controls.
• Linearity Study:
  • Used "Contrived RBC and TNC CSF samples, created by dilution of human blood cells into blank CSF." Tested on three GloCyte® Automated Cell Counter Systems.
• Determination of LoB, LoD, LoQ:
  • No specific sample size mentioned, but studies were conducted "according to CLSI EP17-A2."
• Interfering Substances:
  • No specific sample size mentioned for each interferent, but "Interference testing was conducted."

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

The document does not specify the number or qualifications of experts used to establish ground truth for the test sets. For the accuracy study comparing GloCyte to Hemocytometer, the Hemocytometer results would serve as the comparative method. However, who performed the hemocytometer counts and their qualifications are not detailed.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for establishing the ground truth or resolving discrepancies in the test set.

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. The device is an automated cell counter, which aims to replace or assist manual counting, but the study described focuses on the device's analytical performance against established methods, not human reader performance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Yes, the studies described are standalone performance evaluations of the GloCyte® Automated Cell Counter System. The device is designed to be an automated system, and the reported accuracy, repeatability, precision, linearity, and reportable range studies all reflect the algorithm and instrument's performance without direct human intervention in the cell counting process for the test results.

7. The Type of Ground Truth Used

• For the accuracy study, the ground truth for TNC and RBC counts was established by comparison against Hemocytometer counts ("Hemocytometer vs. GloCyte TNC and RBC counts").
• For repeatability, precision/reproducibility, linearity, LoB, LoD, LoQ, and interfering substances, the ground truth was implicitly the expected value or reference method result derived from standard laboratory practices and controlled preparations, rather than expert consensus on individual cases or pathology reports. For example, linearity uses "true concentrations of the analyte" and "expected values."

8. The Sample Size for the Training Set

The document does not mention the sample size for a "training set." The GloCyte® Automated Cell Counter System uses digital image analysis principles to count cells. While such systems are often developed using training data, this submission focuses on the validation or performance testing datasets. It does not provide details about model development or the data used to "train" its algorithms.

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

Since no training set is discussed or implied in the provided text, the method for establishing its ground truth is also not elaborated upon.

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PM-2000XL Pro: The monitor monitors parameters such as ECG (3-lead, 5-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (Sp02), lovasive or noninvasive blood pressure (2/4 channels IBP NIBP), Cardiac Output (CO), Temperature (dual-TEMP), Expired C02 and Anesthetic gas (AG). The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.

PM-2000XL: The monitor monitors parameters such as EGG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (dual-IBP, NIBP), Temperature (dual-TEMP), Expired C02 and Quick Temperature (Quick TEMP. The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both. The arrhythmia detection and ST Segment analysis are not intended for neonatal patients.

The PM-2000XL & PM-2000XL Pro Patient Monitors provide the following primary features:

PM-2000XL & PM-2000XL Pro Patient Monitor can perform long-time continuous monitoring of multiple physiological parameters. Also, they are capable of storing, disnlaying, analyzing and controlling measurements, and they will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time.

PM-2000XL Patient Monitor can monitor parameters including SpO2, NIBP, EGG RESP, TEMP, C02, IBP

PM-2000XL Pro Patient Monitor can monitor parameters including SpO2, NIBP, ECG RESP, TEMP, C02, IBP, C.O. and AG

PM-2000XL is outfitted with a 8.4-inch display screen, PM-2000XL Pro is 15-inch, as well as an equal large touch screen, which enables the operation by touching the screen, thus offering convenience for doctors and nurses.

PM-2000XL Patient Monitor has parameter modules including SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, EGG RESP, C02, IBP and Quick Temp.

PM-2000XL Pro Patient Monitor has parameter modules including SpO2 with EDAN-Sp02 module or Nellcor SPO2 module, NIBP with EDAN NIBP module or Omron M3600. TEMP, EGG, RESP, C02, CO, IBP, AG.

The EDAN SpO2 module used in PM-2000XL Pro and PM-2000XL is also used by H1 100B Pulse Oximeter which has been cleared by FDA under K110922. The C02 module and Nellcor SpO2 module used in PM-2000XL Pro are the same to those used in M3B3, which has been cleared by K083821 in May 14, 2009.

PM-2000XL Pro could be configured with two different NIBP modules, one is EDAN NIBP module, the other one is Omron M3600 NIBP module; M3600 module used in PM-2000XL Pro is the same to that used in BX-10, which has been cleared by K032857 in April.21.2003.

The C02 module and Nellcor SpO2 module used in PM-2000XL are the same to those used in M3B, which has been cleared by K083821 in May 14, 2009.

Arrhythmia and ST Analysis used in PM-2000XL Pro is the same to that in PC EGG which has been cleared by FDA under K102854 and K092010.

This is a 510(k) summary for a patient monitor and, as such, typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed studies for device performance against specific acceptance criteria. The document explicitly states:

"This premarket notification submission demonstrates that PM-2000XL & PM-2000XL Pro Patient Monitor is substantially equivalent to the predicate device."

Therefore, the information you've requested regarding acceptance criteria, specific device performance studies, and ground truth establishment for a new device's algorithms (which would be necessary for AI/software-as-a-medical-device submissions) is not present in this document. This submission is for a patient monitor, which is a hardware device that incorporates various modules for physiological parameter monitoring. The performance of these modules is either cleared through previous 510(k)s (as explicitly stated for components like the EDAN SpO2 module, Nellcor SpO2 module, and Omron NIBP module) or is expected to meet established performance standards for such physiological monitors, without requiring a novel performance study to prove it for this specific integration.

Here's an analysis based on the provided text, explaining why much of the requested information is not available and what is stated:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not provide a table of acceptance criteria and reported device performance for the PM-2000XL & PM-2000XL Pro as a whole using new data. Instead, it relies on the substantial equivalence to a predicate device (M50 & M80 Patient Monitor K110922) and the prior clearance of its individual components/modules.

• Implied Acceptance Criteria: The implied acceptance criteria are that the device performs equivalently to the predicate device and that its individual modules meet their previously established performance standards.

The document mentions that:

• The EDAN SpO2 module is also used by H1 100B Pulse Oximeter cleared under K110922.
• The C02 module and Nellcor SpO2 module are the same as those used in M3B3 (cleared under K083821) and M3B (cleared under K083821).
• The Omron M3600 NIBP module is the same as that used in BX-10 (cleared under K032857).
• Arrhythmia and ST Analysis used in PM-2000XL Pro are the same as that in PC EGG (cleared under K102854 and K092010).

This signifies that the performance of these individual components has already been evaluated and deemed acceptable in their preceding 510(k) clearances.

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

Not applicable in this submission. The document relies on the existing clearances of its components and the substantial equivalence to the predicate device. New clinical performance data for the integrated system is not presented.

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

Not applicable. Ground truth establishment for a novel algorithm's test set performance is not part of this 510(k) submission, as it's not demonstrating the performance of a new algorithm.

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

Not applicable.

5. 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:

Not applicable. This is not an AI-assisted diagnostic or interpretative device requiring MRMC studies. It is a physiological monitoring device.

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

Not applicable in the context of a new, standalone algorithm. The "algorithms" present are for the interpretation of physiological signals (e.g., arrhythmia detection, ST segment analysis), which are noted to be the "same to that in PC EGG which has been cleared by FDA under K102854 and K092010." This implies their standalone performance was assessed in those prior submissions, not in this one.

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

Not applicable to this 510(k). The ground truth for the performance of the various physiological monitoring parameters (SpO2 accuracy, NIBP accuracy, ECG arrhythmia detection accuracy, etc.) would have been established during the development and clearance of the individual modules or the predicate device, likely using recognized clinical standards and reference methods for each physiological parameter.

8. The sample size for the training set:

Not applicable. This submission is not for a new machine learning algorithm that requires a training set.

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

Not applicable.

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The Vital Signs Monitors models VSM-300 and VSM-300A (hereinafter called monitor) are intended to be used for non-invasive continuous monitoring of SpO2 (oxygen saturation of the blood), NIBP (non-invasive blood pressure) and TEMP (temperature).

The monitors are intended to be used only under regular supervision of clinical personnel. It is applicable to adult, pediatric, and neonatal usage in hospitals, hospital type facilities and intra-hospital moves.

The monitors are equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.

VSM-300 & VSM-300A Vital Signs Monitors are patient monitoring devices providing the patient with a continuous vital physiological monitoring of noninvasive continuous monitoring of SpO2 (oxygen saturation of the blood), NIBP (non-invasive blood pressure) and TEMP (temperature) in a hospital, hospital type facilities environment and intra-hospital moves. The following lists the detailed features of the subject device.

• · LCD or LED display
• · SpO2, Pulse Rate NIBP and TEMP measurement
• · Nellcor or EDAN SpO2 module
• · Display numeric and waveform information simultaneously
• · Nurse call feature
• · Built-in Lithium-ion Battery
• · Suitable for adult, pediatric and neonate patients
• · Visual and audible alarm

This 510(k) submission for the VSM-300 & VSM-300A Vital Signs Monitors does not contain the information requested in your prompt.

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

The provided text focuses on:

• Administrative details: Device name, classification, submitter information, date prepared, 510(k) number.
• Device description: What the device measures (SpO2, NIBP, TEMP), display type, features, and patient populations (adult, pediatric, neonate).
• Intended Use: Reinforces the measurements and settings of use.
• Non-clinical tests: Lists general categories like "Software testing," "Safety testing," "Performance testing," "Risk analysis," and "Final validation."
• Predicate device comparison: States that the device is similar in technology and intended use to the predicate.
• FDA correspondence: The official letter from the FDA determining substantial equivalence.

Crucially, it is missing all the detailed study information you requested, such as:

• Specific acceptance criteria: The document only mentions "Performance testing" without detailing the specific thresholds or metrics being evaluated for NIBP, SpO2, or TEMP.
• Reported device performance: There are no actual performance data (e.g., accuracy, bias, precision values) presented for any of the measured parameters.
• Study design details:
  • No mention of sample sizes for any test sets.
  • No data provenance information (country, retrospective/prospective).
  • No information on ground truth establishment (number of experts, qualifications, adjudication method, type of ground truth).
  • No details about MRMC studies.
  • No details about standalone algorithm performance (as this is a hardware device, not an AI/ML algorithm).
  • No training set sample size or how its ground truth was established, as this is not an AI/ML device.

To answer your prompt, I would need a different type of document, typically a detailed test report or clinical study summary, that is often referenced or included as an appendix in a 510(k) submission, but is not present in the provided text.

Therefore, I cannot populate the table or answer the specific questions based on the input given.

This 510(k) summary is extremely high-level and does not delve into the granular details of performance validation studies.

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