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The GEM® Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pCQ2, pO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb. OHb. COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions. Iiver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates. the level of total bilirubin is used to aid in assessing the risk of kernicterus.

Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier 4000 system. iQM is an active quality process control program designed to provide continuous monitoring of the analytical process with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls. Facilities should follow local, state and federal regulatory guidelines to ensure that a total quality management system is followed.

As part of this program, GEM CVP (Calibration Valuation Product) with CO-Ox, GEM CVP tBili and GEM CVP Hematocrit are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration following warm-up. The reported values for GEM CVP (two levels for pH, blood gases, electrolytes, total bilirubin, CO-Oximetry and hematocrit) must meet IL's specifications before the iQM cartridge can be used for patient sample measurements. Once the cartridge calibration is verified, the internal iQM program monitors the status of the system during the cartridge use life.

The GEM® Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pCQ2, pO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb. OHb. COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions. Iiver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates. the level of total bilirubin is used to aid in assessing the risk of kernicterus.

Software V3.0.0 introduces the following new functionality to further improve the service and support of the GEM® Premier 4000: Remote desktop sharing, Remote software upgrades, Remote diagnostics, Remote LIS tracing, Remote cartridge data (Copy IL Data) transfer.

Here's an analysis of the provided text regarding the GEM® Premier 4000 device, focusing on the acceptance criteria and study information:

Key Finding: This submission (K133407) is a Special 510(k) for a software modification only. It asserts that the modifications have no impact on the performance of the device and therefore, the performance data from the predicate device (K112995) still applies. As such, the document does not contain new acceptance criteria or new study data to demonstrate the device meets acceptance criteria for its analytical performance. It focuses on the verification and validation of the new software features.

Given this, I will extract information related to the device's original performance as described, but it's important to note that this document doesn't provide new studies for analytical performance.

Acceptance Criteria and Device Performance (Based on Predicate Device K112995)

Since this K133407 submission is a modification of a previously cleared device (K112995) and claims "Identical Performance Characteristics" and that the software changes "have no impact to the performance," the acceptance criteria and reported device performance are implicitly those established and accepted for the predicate device. However, this document does not explicitly list performance acceptance criteria or detailed performance reports for the analytes.

The document states:

• "The reported values for GEM CVP (two levels for pH, blood gases, electrolytes, total bilirubin, CO-Oximetry and hematocrit) must meet IL's specifications before the iQM cartridge can be used for patient sample measurements." This indicates that IL (Instrumentation Laboratory) has internal specifications that must be met for quality control (GEM CVP) to ensure accuracy.

Therefore, a table of acceptance criteria and reported device performance for the analytes cannot be fully created from this document. The document specifically states that "the performance data on record for the predicate device (K112995) still apply." To find the detailed acceptance criteria and performance, one would need to refer to the K112995 submission.

Study Details (for the K133407 Software Modification)

This special 510(k) focuses on the software modification and its impact, not on the analytical performance of the device.

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

   • Test set for analytical performance: Not applicable for this submission, as full analytical performance studies were not conducted. The submission states that the software changes have no impact on analytical performance, so the performance data of the predicate device (K112995) is referenced.
   • Test set for software verification/validation: The document mentions "design control principles (risk management, verification and validation) have been applied," but it does not specify sample sizes or data provenance for the software testing.

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

   • Not applicable for a software modification submission. No human expert "ground truth" was established for analytical performance in this specific document.

3. Adjudication method for the test set:

   • Not applicable.

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:

   • Not applicable. This device is an automated in vitro diagnostic analyzer, not an AI-assisted diagnostic imaging or interpretation tool for human readers.

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

   • The "standalone" performance of the analytical functions refers to the predicate device K112995. This submission K133407 focuses on software features (remote desktop sharing, remote upgrades, remote diagnostics, remote LIS tracing, remote cartridge data transfer) that improve service and support, not the core analytical algorithm's standalone performance.

6. The type of ground truth used:

   • For the analytical performance (referenced from K112995), the ground truth for blood gas, electrolyte, and metabolite measurements in IVDs typically involves reference methods, calibrated standards, or comparative studies against established laboratory instruments using patient samples. This document does not specify the type of ground truth used for the original analytical performance.
   • For the software modifications in this K133407, the ground truth would be adherence to functional and non-functional requirements established during the software development and verification process.

7. The sample size for the training set:

   • Not applicable. This is an IVD device, not a machine learning model that requires a training set in the AI sense.

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

   • Not applicable.

Summary of what's provided for K133407:

This document is a "Special 510(k)" for a software update (V3.0.0) to the GEM® Premier 4000. The primary claim is that the software changes (remote desktop sharing, remote upgrades, remote diagnostics, remote LIS tracing, remote cartridge data transfer) do not impact the fundamental scientific technology or performance characteristics of the device. Therefore, no new analytical performance studies were conducted, and the previous performance data (from K112995) still applies. The document emphasizes that "design control principles (risk management, verification and validation)" were applied to ensure the software release's safety and effectiveness, but it does not provide details on the specific testing performed for these software features (e.g., sample sizes of test cases, specific test protocols, or acceptance criteria for the software functions themselves).

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