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ENVOY®500 CK REAGENT KIT is intended for the quantitative in vitro determination of creatine kinase (CK) in buman serum and plasma using the ENVOY 500 Chemistry System.

It is not intended for use in Point of Care settings.

Creatine phosphokinase and its isoenzymes measurements are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

ENVOY CK REAGENT KIT is available as kit only. It consists of a bi-reagent R1 and R2 whose composition,

for R1: 125 mmol/L Imidazole buffer, pH 6.10; 25 mmol/L D-Glucose; 25 mmol/L N-Acetyl-L-Cysteine; 12.5 mmol/L Magnesium acetate; 2.4 mmol/L NADP; 2.0 mmol/L EDTA; > 6800 U/L Hexokinase (microorganism);

This document describes the performance characteristics and acceptance criteria for the ENVOY 500 CK REAGENT KIT, an in vitro diagnostic device for the quantitative determination of creatine kinase (CK) in human serum and plasma.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Precision Test Set: 80 measurements for each of 3 levels of samples (Level 1, Level 2, Level 3). Each level was measured two times per run, for two runs per day, for twenty operating days, on two instruments.
• Linearity Test Set: 11 levels of patient pools (for serum).
• Detection Limit Test Set: 15 measurements of 4 samples for LoD; 15 measurements of 4 samples for LoQ.
• Interference Test Set: For each potential interferent, 2 serum sample pools (a low activity pool at 150 U/L and a high activity pool at 1200 U/L) were used. Aliquots of each pool were spiked with increasing interferent concentrations (e.g., 9 concentrations for triglycerides, 7 for unconjugated bilirubin, etc.). Each point was measured in triplicate per run.
• Method Comparison (Serum) Test Set: 100 serum patient samples.
• Method Comparison (Lithium Heparin Plasma) Test Set: 40 plasma specimens (in lithium heparin).
• On Board Stability Test Set: At least 3 levels of sample (high/medium/low) were tested in duplicate at Day 0, and 4 activity levels were analyzed in duplicate for at least 30 days.

Data Provenance: The document does not explicitly state the country of origin for the patient samples or if the data was retrospective or prospective. Given the submitter is ELITech Clinical Systems SAS, France, and the testing was conducted for regulatory submission in the US, it is plausible the studies were conducted in Europe or at contract research organizations. The nature of the studies (e.g., precision, linearity, interference, method comparison) generally involves prospective collection or commercially available control/patient samples for analytical validation.

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

This document describes the analytical performance of an in-vitro diagnostic reagent kit (ENVOY 500 CK REAGENT KIT). For such devices, "ground truth" generally refers to reference methods or measurements by highly calibrated instruments, not expert human interpretation. Therefore, the concept of "number of experts used to establish ground truth" and their qualifications is not applicable in this context. The ground truth for analytical studies is established by:

• Reference materials or calibrators traceable to international standards (e.g., IFCC method for CK).
• Predicate devices or established methods for method comparison studies.
• Precise gravimetric or volumetric preparations for linearity and spiking studies.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (e.g., 2+1, 3+1) is typically relevant for studies involving subjective human interpretation of diagnostic images or data, where discrepancies between readers need to be resolved to establish ground truth for algorithm training or testing.

For the analytical performance studies described for the ENVOY 500 CK Reagent Kit, no such adjudication method was used or is applicable. The measurements are quantitative and objective, following established laboratory protocols and guidelines (e.g., CLSI protocols). Discrepancies would be resolved through re-testing, investigation of instrument or reagent issues, or statistical analysis (e.g., outliers).

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 document describes an in-vitro diagnostic reagent kit, not an AI-based diagnostic device intended for human reader assistance. Therefore, no MRMC comparative effectiveness study involving human readers or AI assistance was performed.

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

This document describes the performance of an in-vitro diagnostic reagent kit that functions on a chemistry analyzer (Envoy 500 Chemistry System). The device itself is the reagent kit, which works in conjunction with the instrument to provide quantitative results. It is not an algorithm or AI-based device. The performance described is inherently "standalone" in the sense that it measures the analytical capability of the reagent-instrument system to quantify CK levels without human intervention in the measurement process itself, beyond sample loading and system operation. No human-in-the-loop performance is relevant for the analytical measurement part of the device's function.

7. The Type of Ground Truth Used

The ground truth for the various analytical performance characteristics was established using:

• Reference Methods/Standards: For traceability, the calibration factor for the ENVOY 500 CK Reagent Kit has traceability to the IFCC method (International Federation of Clinical Chemistry and Laboratory Medicine) recommendations for CK activity determination.
• Predicate Device Comparison: For method comparison, the predicate device (ELITech Clinical Systems CK NAC SL on Selectra ProM analyzer) served as the reference for comparison using patient samples.
• Prepared Samples/Known Concentrations:
  • For linearity, patient pools were prepared by spiking a serum pool and dilution to obtain 11 levels with equidistant activities (known relative concentrations).
  • For detection and quantification limits, samples were prepared by diluting patient samples to obtain specific activities (e.g., approximately 3.5 U/L for LoD, 5 U/L for LoQ).
  • For interference, serum sample pools were spiked with increasing concentrations of known interferents against control samples.
• Statistical Analysis: Precision studies rely on repeated measurements to quantify variability, with "ground truth" derived from the calculated mean and statistical metrics.

In summary, the ground truth is primarily based on reference methods (IFCC), comparison to a legally marketed predicate device, and precisely prepared samples with known (or highly characterized) concentrations/activities.

8. The Sample Size for the Training Set

Not applicable. This device is an in-vitro diagnostic reagent kit, not a machine learning or artificial intelligence-based device that requires a "training set" in the conventional sense. The "training" of such a system involves chemical formulation, optimization of reaction conditions, and calibration procedures using calibrators or reference materials.

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

Not applicable. As stated above, this device does not utilize a "training set" in the context of machine learning. The "ground truth" for developing and optimizing the reagent kit and its associated methods would involve:

• Chemical principles and stoichiometry: The understanding of the enzyme kinetics and chemical reactions being measured (e.g., the IFCC recommended method for CK).
• Reference materials and calibrators: Used to ensure accuracy and traceability of the quantitative measurements.
• Experimental optimization: Through iterative testing and modification of reagent concentrations, pH, and reaction conditions to achieve optimal performance characteristics (sensitivity, specificity, stability, etc.).

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The ENVOY® Distal Access (DA) Guiding Catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.

The ENVOY Distal Access (DA) Guiding Catheter is a variable stiffness, braided catheter with a large non-tapered lumen that facilitates the intravascular passage of interventional devices. The distal segment is flexible for navigation into distal vasculature. The catheter has an outer hydrophilic coating on the outer surface that reduces friction during manipulation in the vessel. The lubricious PTFE lined inner lumen is designed to facilitate movement of the guide wires and other devices. A luer fitting located on the end of the catheter hub can be used to attach accessories. The distal section of the catheter is radiopaque to aid visualization under fluoroscopy, and the distal tip is clearly distinguished by a radiopaque marker band which is approximately 3mm from the distal tip. The catheter is available with preshaped tips to facilitate positioning. A peel away introducer is included to facilitate insertion into the sheath.

I am unable to provide a description of acceptance criteria and a study proving device performance using the information provided. The document outlines a 510(k) premarket notification for a medical device (ENVOY Distal Access (DA) Guiding Catheter). This type of submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a study to prove a device meets specific, pre-defined acceptance criteria for performance metrics.

Here's why and what the document does provide:

1. Nature of the Submission (510(k)): The core purpose of a 510(k) is to show that a new device is "substantially equivalent" in terms of safety and effectiveness to a legally marketed predicate device. This is primarily done by comparing intended use, technological characteristics, and performance (often bench testing) to ensure no new questions of safety or effectiveness are raised. It is generally not about proving novel clinical or performance criteria against a predefined set of acceptance thresholds like in a clinical trial seeking primary endpoints.

2. No Clinical Study for Acceptance Criteria: The document explicitly states: "No clinical studies were required as appropriate verification and validation of the catheter and packaging modifications were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing." This confirms that a clinical study designed to demonstrate performance against specific acceptance criteria (like sensitivity, specificity, accuracy, or human reader improvement) was not conducted or deemed necessary for this submission.

3. Focus on Bench Testing and Equivalence: The document details extensive bench testing (e.g., Visual Inspection, Tensile Strength, Hydrophilic Coating Integrity, System Liquid Leakage Testing, etc.) and comparisons to predicate devices (Table 2A and 2B). These tests are designed to ensure the new device functions similarly to the predicate and meets relevant engineering standards, rather than demonstrating clinical efficacy against quantified acceptance criteria.

Therefore, since this is a 510(k) submission for a medical device that relies on substantial equivalence and non-clinical bench testing, the specific questions regarding acceptance criteria, reported device performance against those criteria, sample sizes for test/training sets, involvement of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to the provided text.

The closest information provided related to performance evaluation is the list of nonclinical (bench) tests conducted (Section H and Section on "Bench Testing"). These tests aim to demonstrate the device's physical and functional properties are adequate and comparable to the predicate.

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The ENVOY® Guiding Catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.

The ENVOY® Guiding Catheter is a single lumen, braided catheter with a large non-tapered lumen that facilitates the intravascular passage of interventional/diagnostic devices. The guiding catheter is pre-shaped to facilitate positioning.

The provided document, K140307, describes a 510(k) submission for a line extension of the ENVOY® Guiding Catheter to include a new 7 French (Fr) diameter size. The submission asserts substantial equivalence to the predicate ENVOY® 6 French (Fr) Guiding Catheter (K093184).

Here's an analysis based on the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a medical catheter. For such devices, acceptance criteria are typically defined by compliance with recognized performance standards and successful execution of specific bench tests designed to ensure safety and effectiveness. The document lists the tests performed, which inherently serve as the performance criteria. The "reported device performance" in this context is the successful completion of these tests, demonstrating that the 7Fr Guiding Catheter meets the design requirements and is substantially equivalent to the predicate.

Study Proving Acceptance Criteria Met:

The study that proves the device meets the acceptance criteria is a non-clinical bench testing program combined with biocompatibility testing.

The document states: "Results of verification and validation testing that was conducted on the proposed ENVOY® Guiding Catheter demonstrates that it performs as designed, is suitable for its intended use, is substantially equivalent to the predicate device and therefore, does not raise any new questions of safety and effectiveness."

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

The document does not specify the sample sizes used for each of the performed bench tests. It only lists the types of tests.

Regarding data provenance, the testing was conducted by Codman & Shurtleff, Inc., the device submitter. The document does not explicitly state the country of origin for the testing, but the submitter's address is in Raynham, MA, USA, suggesting the testing was likely conducted in the US. The study is retrospective in the sense that the testing was performed on manufactured devices after their design, as part of the verification and validation process for regulatory submission.

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

This information is not applicable to this type of submission. This 510(k) is for a medical device (catheter) based on substantial equivalence to an existing predicate. The "ground truth" for these types of submissions is established through engineering specifications, recognized standards, and the performance characteristics of the predicate device. Expert human interpretation of data for "ground truth" (like in AI/diagnostic device studies) is not relevant here.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, such as clinical trials or studies establishing ground truth from multiple expert opinions. The testing described here is objective bench testing and standard compliance.

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

No, an MRMC comparative effectiveness study was not done. This device is a guiding catheter, not an AI-assisted diagnostic tool or an imaging device requiring human reader interpretation with or without AI.

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

No, a standalone algorithm performance study was not done. This refers to AI algorithm performance without human intervention, which is not relevant for a physical medical catheter.

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

The "ground truth" for this device is based on engineering specifications, recognized national and international performance standards (e.g., ISO, AAMI, USP), and the established performance and safety profile of the predicate device. The tests conducted (e.g., dimensional verification, tensile strength, leakage, biocompatibility) are designed to verify that the device meets these pre-defined, objectively measurable criteria.

8. The Sample Size for the Training Set

This information is not applicable as this is not an AI/machine learning device. There is no "training set."

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

This information is not applicable as this is not an AI/machine learning device.

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The Envoy Distal Access Guiding Catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.

The ENVOY® Distal Access (DA) Guiding Catheter is a variable stiffness, braided catheter with a large non-tapered lumen that facilitates the intravascular passage of interventional devices. The distal segment is flexible for navigation into distal vasculature. The outer surface has a hydrophilic coating that reduces friction during manipulation in the vasculature. The lubricious PTFE lined inner lumen is designed to facilitate the passage of guide wires and other devices. A luer fitting located on the end of the catheter hub can be used to attach accessories. The distal section of the catheter is radiopaque to aid visualization under fluoroscopy, and the catheter has a radiopaque marker. The catheter is available with preshaped tips to facilitate positioning. A peel away introducer is included to facilitate insertion into the sheath.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the ENVOY® Distal Access Guiding Catheter:

Summary of Device Performance and Acceptance Criteria:

The provided document describes a special 510(k) submission, which means the device is substantially equivalent to a previously cleared device and does not introduce new technological characteristics. As such, the acceptance criteria are primarily focused on demonstrating that the new device performs as designed and is equivalent to the predicate devices in terms of safety and effectiveness, without raising new issues.

The device's performance is demonstrated through a battery of preclinical tests. Since this is a substantial equivalence claim for a new iteration of an existing device, the "acceptance criteria" are implied to be that the new device meets the same performance standards and safety profiles as the predicate devices in these tests. The document doesn't provide specific numerical thresholds for acceptance criteria, but rather states that the device "met all" requirements or "performs as designed."

Here's a table summarizing the tests, which serve as the de facto acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated. The document refers to "preclinical testing data" and "results of verification and validation." These are typically conducted on a sample of manufactured devices, but the exact number isn't quantified in this summary.
• Data Provenance: The tests are "preclinical testing data" and "verification and validation" conducted by Codman & Shurtleff, Inc. This indicates it's retrospective data gathered from tests performed on prototypes or early production samples during the device development and manufacturing process. The country of origin for the data is implicitly the United States, where Codman & Shurtleff, Inc. is located.
• Clinical Testing: The document explicitly states: "Clinical testing was not required to establish substantial equivalence."

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

• Not Applicable. This is a special 510(k) for a medical device (catheter) based on substantial equivalence and preclinical testing. There is no mention of human expert evaluation or a "ground truth" derived from expert consensus in the context of clinical images or patient data to establish the device's basic functional and safety characteristics. The "ground truth" here is the pass/fail criteria for the engineering and biocompatibility tests themselves.

4. Adjudication Method for the Test Set:

• Not Applicable. As per point 3, there was no expert evaluation requiring adjudication. The tests conducted are objective, pass/fail engineering and biocompatibility evaluations.

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

• No. An MRMC study is a type of clinical study often used for imaging diagnostic devices or AI algorithms evaluating human performance. This document explicitly states that "Clinical testing was not required to establish substantial equivalence" for this device. Therefore, no MRMC study was conducted, and no effect size for human reader improvement with AI assistance is provided.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not Applicable. This device is a physical medical instrument (a catheter), not an artificial intelligence (AI) algorithm. Therefore, the concept of a "standalone algorithm" performance study is not relevant.

7. The Type of Ground Truth Used:

• The "ground truth" in this context refers to the specified engineering and biocompatibility requirements and standards (e.g., ISO 10993 Part I, General Program Memorandum # G95-1, internal design specifications for dimensions, strength, flexibility, etc.). The device was tested against these predetermined objective criteria.

8. The Sample Size for the Training Set:

• Not Applicable. The device is not an AI algorithm, so there is no "training set." The development of the device would involve engineering design and iterative prototyping, but not in the same sense as training a machine learning model.

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

• Not Applicable. As there is no training set, this question is not applicable. The "ground truth" for the device's design and manufacturing is established through established engineering principles, material science, clinical needs for similar devices, and regulatory standards.

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The ENVOY® Guiding Catheter is intended for use un the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.

The ENVOY Guiding Catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.

Due to the nature of the provided text, which is an FDA 510(k) summary and clearance letter for a medical device (ENVOY® Guiding Catheter), it does not contain the kind of information typically found in a study describing acceptance criteria for an AI/device performance.

This document is a regulatory submission for a physical medical device, not a software or AI-driven diagnostic tool. Therefore, it does not involve:

• Algorithm performance metrics (like sensitivity, specificity, AUC)
• Sample sizes for test or training sets for AI models
• Expert consensus for ground truth on images (as there are no images being analyzed by AI)
• MRMC studies to compare human reader performance with and without AI assistance
• Standalone algorithm performance studies

The 510(k) summary focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria for an AI output.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or other details related to AI study design based on the provided text.

The document primarily states:

• Intended Use: The ENVOY guiding catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.
• Substantial Equivalence: The device is substantially equivalent to the previously cleared ENVOY Guiding Catheter (from Cordis Endovascular Systems, Inc.).
• Biocompatibility: All materials are biocompatible.

These points are the core "acceptance criteria" and "performance" relevant to this type of regulatory submission for a physical catheter. They don't lend themselves to the AI-specific questions requested.

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EnvoyCem is intended for use in otologic surgery for the following applications:

• Augmentation or coupling of the middle ear ossicles.
• Attachment of the middle ear ossicles to middle ear implants.
• Mechanical stabilization of middle ear prostheses.

EnvoyCem is glass ionomer cement that is provided as two components, a glass powder and polyalkenoic acid liquid. By mixing the two components, viscous moldable ionomeric cement is obtained which hardens in situ.

This submission is for a medical device (EnvoyCem, a glass ionomer cement) and as such, the performance testing described is focused on the device's physical and biological properties rather than an AI/ML algorithm's clinical performance. Therefore, many of the requested categories for AI/ML study components (like sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this 510(k) summary.

Here's a breakdown of the available information based on your request, with an explanation of why certain elements are not present:

1. Table of acceptance criteria and the reported device performance

The submission mentions that "All testing indicates that EnvoyCem meets its specification requirements." However, the specific acceptance criteria (numerical thresholds for success) and the detailed reported performance values for each test are not explicitly provided in this 510(k) summary. The document broadly states that the device successfully completed various tests.

• Shown to be equivalent to chemical composition of OTO-CEM via Fourier transform infrared spectroscopy. |
  | Sterilization Validation | Successfully completed; device meets specification requirements. (Specific criteria/results not detailed) |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. For non-AI/ML medical devices like this cement, "test sets" typically refer to lab-based studies on the material itself, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth for a cement's physical and biological properties is established through standardized laboratory testing methods, not expert consensus on patient data.

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

Not applicable, as this pertained to laboratory testing of device properties, not clinical assessment requiring expert adjudication.

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 a medical device for surgical applications (cement), not an AI-assisted diagnostic tool.

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

Not applicable, as this is a medical device (cement), not an AI algorithm.

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

The "ground truth" for this device's performance is established through standardized laboratory testing protocols for:

• Physical properties (functional stability, hardening time, etc. – implied by "functional testing").
• Shelf life properties (implied by "accelerated shelf life testing").
• Biocompatibility (MEM Elution extract testing, Fourier transform infrared spectroscopy for chemical equivalence).
• Sterility (sterilization validation protocols).

8. The sample size for the training set

Not applicable for a medical device (cement). "Training set" is a concept specific to AI/ML algorithms.

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

Not applicable for a medical device (cement).

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The Envoy® 500 HDL Cholesterol Reagent and Envoy® 500 HDL Calibrator are intended for use with the Envoy® 500 Chemistry System as a system for the quantitative determination of high density lipoprotein (HDL) cholesterol in serum and plasma. HDL cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease.

The Envoy® 500 HDL Cholesterol Reagent is a two-part reagent that is calibrated with the Envoy® 500 HDL Calibrator for use with the Envoy® 500 Chemistry System. This reagent determines high density lipoprotein cholesterol through the accelerator selective detergent methodology. This procedure measures HDL-cholesterol in a two step reaction sequence. In the first step, non-HDL cholesterol is rendered non-reactive. In the second step, HDL cholesterol is solubilized using a selective detergent and reacts to produce a red chromogen.

Here's an analysis of the acceptance criteria and study detailed in the provided text for the Envoy® 500 HDL Cholesterol Reagent and Envoy® 500 HDL Calibrator:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating the performance of the device without explicitly stating pre-defined "acceptance criteria" in a structured table. However, we can infer the acceptance criteria based on the reported performance for each study.

• Linear regression: (Envoy Recoveries) = - 0.6 mg/dL + 19.284 x (Dilution Factor), r = 0.9998, syx = 1.11 mg/dL, n = 44, range = 0.1 to 173.5 mg/dL. |
  | Limit of Detection (LoD) | - LoD with proportions of false positives (a) less than 5% and false negatives (B) less than 5%. | - Limit of Blank (LoB): 0.29 mg/dL.
• Reported LoD: 0.46 mg/dL.
• Proportions of false positives (a) less than 5% and false negatives (B) less than 5%. |
  | Precision | - Precision to be demonstrated by replicate assay of control sera. | Level 1 (mean 36.8 mg/dL):
• Within Run: 1 SD = 0.52, %CV = 1.4%
• Total: 1 SD = 0.72, %CV = 2.0%
  Level 2 (mean 71.1 mg/dL):
• Within Run: 1 SD = 0.68, %CV = 1.0%
• Total: 1 SD = 1.25, %CV = 1.8% |
  | Correlation | - Comparison to a commercially available method using least squares linear regression and Passing-Bablok regression. | Least Squares Linear Regression:
• Envoy 500 = 0.7 mg/dL + 1.021 × Competitive Method
• r = 0.995
• S = 2.42 mg/dL
• 95% CI y-intercept: 0.07 to 1.38 mg/dL
• 95% CI slope: 1.010 to 1.032
  Passing-Bablok Regression:
• Envoy 500 = 0.7 mg/dL + 1.015 × Competitive Method
• 95% CI y-intercept: 0.2 to 2.0 mg/dL
• 95% CI slope: 1.000 to 1.029 |
  | Stability | - Statistical estimates of total imprecision to be less than 1.5 mg/dL over claimed stability periods (14-day onboard reagent, 7-day calibration). | - Total imprecision less than 1.5 mg/dL for 14-day onboard reagent stability and 7-day calibration stability. |

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

• Usable Range:

  • Sample Size: n = 44 (reference pools prepared by diluting human HDL cholesterol concentrate with stripped human serum pool).
  • Data Provenance: Not explicitly stated (e.g., country of origin). The samples are referred to as "human HDL cholesterol concentrate" and "stripped human serum pool," suggesting they are derived from human biological materials.
  • Retrospective/Prospective: Not specified.

• Limit of Detection:

  • Sample Size: 40 blank samples and 40 low-level samples.
  • Data Provenance: Not explicitly stated.
  • Retrospective/Prospective: Not specified.

• Precision:

  • Sample Size: Level 1: n = 45; Level 2: n = 48 (replicate assays of commercially available control sera).
  • Data Provenance: "Commercially available control sera." Not explicitly stated (e.g., country of origin).
  • Retrospective/Prospective: Not specified, but generally implies a prospective experimental setup for precision studies.

• Correlation:

  • Sample Size: n = 312 (mixed serum and plasma specimens).
  • Data Provenance: "Collected from adult patients." Not explicitly stated (e.g., country of origin).
  • Retrospective/Prospective: Not specified, but "collected from adult patients" often implies a retrospective collection or a prospective collection for this specific study.

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

This device is an in-vitro diagnostic (IVD) reagent for determining a biochemical analyte (HDL cholesterol). The ground truth for such devices is established through reference methods or by the intrinsic properties of reference materials, not typically by human experts making diagnoses or interpretations like in imaging studies.

• For Usable Range, ground truth is based on known dilution factors of a reference standard.
• For Limit of Detection, ground truth is based on blank samples and low-level samples, with expected very low or zero concentrations.
• For Precision, ground truth is the "true" concentration of the control sera, established by the manufacturer of the control sera or a reference lab, not individual experts.
• For Correlation, the ground truth is the measurement obtained by a "commercially available method" (the predicate or another established method), not human experts.

Therefore, the concept of "number of experts" and "qualifications of those experts" as typically applied in AI/ML performance evaluation (e.g., radiologists interpreting images) is not directly applicable here.

4. Adjudication Method for the Test Set

As explained in point 3, the ground truth for chemical analyte measurements is typically established by reference methods or material properties, not through expert adjudication in the classic sense. Therefore, no adjudication method (like 2+1 or 3+1 consensus) is described or applicable for this type of device.

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

No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) reagent, not an imaging or diagnostic AI tool that assists human readers. Its performance is evaluated biochemically against reference methods and statistical parameters.

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

Yes, the studies presented (Usable Range, Limit of Detection, Precision, Correlation, Stability) evaluate the performance of the Envoy® 500 HDL Cholesterol Reagent and Calibrator directly on serum/plasma samples using the Envoy® 500 Chemistry System. This represents a standalone performance evaluation of the assay system without human interpretation being a primary variable in the measurement outcome. The role of "human-in-the-loop" would be limited to operating the analyzer and interpreting the numerical results, not making subjective diagnoses from raw data.

7. The Type of Ground Truth Used

• Usable Range: The ground truth is based on the known concentrations of HDL cholesterol in reference pools prepared by diluting a human HDL cholesterol concentrate with stripped human serum. The dilution factors provide the expected "true" values.
• Limit of Detection: The ground truth is based on blank samples (expected zero concentration) and low-level samples with known, very low concentrations.
• Precision: The ground truth is the assigned value of commercially available control sera, which are typically established through rigorous inter-laboratory comparisons or against reference methods by the control manufacturer.
• Correlation: The ground truth is the measurement obtained by a "commercially available method" (the predicate device or another established method) used as a comparative standard.
• Stability: The ground truth is again the assigned value of serum controls.

In summary, the ground truth is established through a combination of:

• Reference materials with known concentrations.
• Established analytical methods.
• Commercially validated control materials.

8. The Sample Size for the Training Set

The provided summary describes performance evaluation studies. For an IVD reagent like this, the "training set" doesn't apply in the same way as it would for an AI/ML algorithm. Reagents and calibrators are developed through a formulation and optimization process that involves wet lab experimentation, but this experimental data is not typically referred to as a "training set" in the context of device submission. The studies detailed here are for validation of the finalized product.

Therefore, no specific sample size for a "training set" is mentioned because it's not a relevant concept for this type of device.

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

Given that the concept of a "training set" is not applicable here as for AI/ML algorithms, the establishment of ground truth for such a set is also not relevant or described. The performance data presented demonstrates the analytical characteristics of the final reagent and calibrator.

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The ENVOY Monitor is a physiological patient monitor intended to be used for monitoring vital signs of critically ill adult and pediatric patients in the hospital environment, such as: ECG/Heart Rate, Invasive Blood Pressure, Respiration, Temperature, Noninvasive Blood Pressure, CO, Pulse Oximetry, and EtCO2. The ENVOY may be used to monitor a wide range of patient conditions in many different clinical specialties within the hospital. The device is intended for use by qualified health care providers, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

The Mennen Medical Envoy BIS module is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals.

The BIS Index, a processed parameter may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

• The Bispectral Index is a complex technology, intended for use only as an adjunct to clinical judgment and training.
• In addition, the clinical utility, risk/benefit, and application of this device have not undergone full evaluation in the pediatric population.

The Envoy is a multiparameter physiological patient monitor, capable of monitoring:

• ECG/Heart Rate .
• Invasive blood pressure .
• Non-invasive blood pressure ●
• Respiration ●
• Pulse oximetry
• Two temperature channels ●
• Cardiac output ●
• EtCo2 .
• Spirometry ●
• EEG ●
• BIS module (new subject of this application) .

The Envoy bedside patient monitor consists of a main processing unit, a mountable color monitor, and a module rack housing the various Mennen Medical plug-in vital signs modules. The modules monitor the patient's vital signs. Up to six internal modules can be plugged into a module rack. The Envoy can accommodate two module racks. The vital sign data derived from the modules by the Envoy are presented on the monitor as waveform and numeric displays. The Envoy vital signs modules acquire vital signs data from the patient, and display their waveforms and alarms indications on the Envoy display unit. Vital signs and waveform information are displayed simultaneously on the Envoy Display Unit. Up to 8 traces can be displayed at any one time.

The vital signs modules interface with readily available physiologic transducers through electrically isolated patient input connections. After amplification, the signals are digitized, analyzed and displayed. All processing and alarm determination for ECG, Respiration and Invasive Blood Pressure is made using proprietary algorithms and software based on previously marketed Mennen Medical monitoring devices tested against well known and accepted data bases that present representative examples of waveform artifact to be encountered in real case conditions. The SpO2, Non-Invasive Blood Pressure, ExCO2 and Spirometry modules incorporate software and/or hardware technology developed by vendors whose products are marketed in the USA.

The BIS Module is used to monitor dual channel EEG waveform and the BIS index, used to estimate the level of conciseness of patient under anesthesia, or patients in the ICU that may be with limited conciseness.

The BIS index together with several quality parameters are displayed and stored by the Envoy monitor.

The Mennen Medical Envoy BIS module is a modification to the existing Envoy Patient Monitor, adding Bispectral Index (BIS) monitoring capabilities. The device claims substantial equivalence to the predicate device, the Spacelab Medical Bispectral Index (BISx) Analysis Module 91482 (K060900).

The provided text outlines the functional description of the new BIS module and its comparison to the predicate device, focusing on display formats, data storage, and alarm functionalities. It also references "performance testing" and "SW Validation" but lacks specific details regarding acceptance criteria and the results of these studies.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly present a table of acceptance criteria with corresponding reported device performance values. Instead, it relies on demonstrating substantial equivalence by comparing the functional and technical specifications of the Envoy BIS module with the predicate device. The primary claim for acceptance is that the Envoy BIS module's function to display BIS parameters and quality parameters, and its alarm capabilities, are equivalent to the predicate device.

The document highlights the following parameters and their ranges as displayed and stored by the Envoy monitor, which are derived from the BISx unit:

The "Similarities" and "Differences" sections (Page 9) act as an indirect comparison of performance criteria, stating that differences in display options between the two devices "do not change the efficiency of BIS and EEG displays of both monitors," implying an equivalence in performance.

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

The document does not provide details on the sample size used for any specific test set related to the BIS module. There is no mention of human subject data, country of origin, or whether it was retrospective or prospective. The testing described primarily appears to be technical validation against the predicate device's performance.

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

No information is provided regarding the number or qualifications of experts used to establish ground truth for any test set. The validation primarily focuses on comparing technical specifications and functional equivalence.

4. Adjudication Method for the Test Set

No information on an adjudication method for a test set is provided.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study is mentioned, nor is any effect size for human reader improvement with or without AI assistance. The device is a patient monitor, not an AI diagnostic tool involving human reader interpretation. The BIS module aids in monitoring the effects of anesthetic agents to help guide administration and potentially reduce awareness with recall, but this is a clinical utility, not a reader study.

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

The BIS module itself processes EEG signals to generate the BIS index and related parameters. This processing can be considered "standalone" in the sense that the algorithm generates these outputs without direct human intervention in the calculation process. The device functions to "display the BIS parameter and the quality parameters" and to "provide alarm limits for the BIS index and provide visual and audible alarms." These outputs are generated by the device's algorithms based on the input from the BISx unit. However, the context of the question often implies a comparison to a clinical ground truth, which is not detailed here.

7. The Type of Ground Truth Used

The "ground truth" implicitly used in this submission is the established performance and output of the predicate device, the Spacelab Bispectral Index (BISx) Analysis Module 91482. The entire submission is built on demonstrating substantial equivalence to this legally marketed device. The "Substantial Equivalence Discussion" (Page 5) directly compares the Envoy BIS module's specifications and functionality to the predicate.

8. The Sample Size for the Training Set

No information is provided regarding a training set sample size. The device is not described as utilizing machine learning or AI that would typically involve a training set for model development. Its function appears to be based on established algorithms for processing EEG signals and deriving the BIS index, which are derived from the OEM (Aspect BISx).

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

As no training set is mentioned for the Envoy BIS module itself, there is no information on how its ground truth was established. The core processing capabilities for the BIS index are derived from the Aspect BISx unit (OEM agreement), suggesting that any fundamental ground truth for the BIS algorithm would have been established during the development and clearance of the original BISx device (K040183 and subsequently K060900 for the predicate).

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The Envoy is intended for use as a multiparameter monitoring system. The Envoy can monitor ECG/heart rate, two invasive blood pressure channels, two temperature channels, pulse oximetry, respiration, non-invasive blood pressure, EtCO2 and EEG. The EEG module is not intended for use on infants. This effectively allows the Envoy to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital. Functions include display of multiparameter waveforms, vital signs, alarm & status messages. The Mennen Medical Envoy is intended for sale as a system for monitoring and recording patient information or any in-hospital application requiring patient monitoring. Intended clinical applications: Critical Care Patients, Cardiac Step-down/Telemetry Units, Emergency Departments, Intra-operative (Anesthesia) Monitoring, Post Anesthesia Care.

The Envoy is intended for use as a multiparameter physiological patient monitoring system for the monitoring and recording of patient information or any in-hospital application that requires patient monitoring. The Envoy can monitor ECG/heart rate, two invasive blood pressure channels, two temperature channels, pulse oximetry, respiration, non-invasive blood pressure, eTCO2 and EEG. Functions include display of multiparameter waveforms, vital signs, alarm & status messages. This effectively allows the Envoy to monitor a wide-range of adult, pediatric, and neonatal patient conditions, in many different areas of the hospital. The Envoy consists of a main processing unit, a mountable color monitor, and a module rack housing the various Mennen Medical plug-in vital signs modules monitor the patient's vital signs. The vital sign data derived from the modules by the Envoy are presented on the monitor as waveform and numeric displays. The Envoy vital signs modules acquire vital signs data from the patient; the modules display the patient waveforms, vital signs information, and alarms indications on the Envoy display unit. The Envoy is not a life supporting, nor life-sustaining device; nor is it implantable; therefore sterility is not a consideration. The Envoy is not a kit and does not contain any drug or biological products.

The Envoy EEG module can monitor up to 4 differential EEG channels and display processed trend and real-time EEG waveforms. EEG monitoring is continuous and in real time. The Envoy EEG module does not have derived parameters such as Aspect BIS or other derived parameters. The Envoy EEG module can be used as an indicator of brain damage or cerebral activity. The EEG module is commonly used to monitor the cerebral activity of patients who have suffered serious head injury or to evaluate the state of consciousness of a patient. The EEG module of the Envoy patient monitor is not sold as a stand-alone EEG device, but as part of a multiparameter physiological patient monitoring system (Envoy). The primary purpose of the EEG module is to determine the need for more detailed EEG recordings. The EEG module is not a replacement for a comprehensive multi-channel (16 to 36 or more) EEG diagnosis by a neurology specialist. Since four channels are displayed simultaneously, qualitative assessments can be made regarding right and left hemispheric activity. The EEG module of the Envoy monitor consists of the following main parts/components: 5 lead input cable, Four channel differential amplifier, Processing and Storage circuit block (P&SB). The P&SB of the EEG module is identical to the Mennen Medical P&S Boards located in the other Envoy input modules. The P&SB consists of a communications processor and memory, and performs local data storage and protocol translation from low-level protocol to high level protocol. The Envoy can display between one and four EEG channels on and the user can control the sensitivity and the frequency response of the EEG waveforms. Both sensitivity and filters are common to all four channels. The top displayed EBG channel is stored in Overview for up to 72 hours.

The Envoy Patient Monitor with the new EEG module was determined to be substantially equivalent to the predicate device (EEG module of the Mennen Medical Horizon 2000 patient monitor (K910945)) through performance testing and comparison of technological characteristics.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Monitored Parameters and Features" table and the "Displayed Parameters" table, alongside the claim of compliance with relevant IEC standards. The "Reported Device Performance" is directly listed within these tables.

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The Envoy is intended for use as a multiparameter monitoring system.

The Envoy can monitor ECG/heart rate, two invasive blood pressure channels, two temperature channels, pulse oximetry, respiration, non-invasive blood pressure, etCO2 and Spirometry. This effectively allows the Envoy to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital.

The Envoy also includes a spirometer intended for continuous monitoring of adult and pediatric patients with tidal volumes greater than 100mL. Functions include display of multiparameter waveforms, vital signs, and status messages.

The Spirometry module is used to provide an objective measurement of lung function. The Spirometry module is intended for use in the hospital clinical environment only (e.g. in the RICU). The module is used for the continuous monitoring of mechanically ventilated adult and pediatric patients, or adult and pediatric patients able to breathe spontaneously. In both cases, the patient is connected to the module via an endotracheal tube or mask. The module is to be used only for patients with tidal volumes greater than 100 ml.

The Envoy is a multiparameter physiological patient monitor consisting of a main processing unit, a mountable color monitor, and a module rack housing the various Mennen Medical plug-in vital signs modules to monitor the patient's vital signs. Up to six internal modules can be plugged into a module rack. The Envoy can accommodate two module racks. Data presented from the modules by the Envoy are presented on the monitor as waveform and numeric displays.

The Envoy vital signs modules acquire vital signs data from the patient, and display their indications on the Envoy display unit. Vital signs and waveform information are displayed simultaneously on the Envoy Display Unit. Up to 8 traces can be displayed at any one time.

The Envoy is a reusable, software driven, patient monitor, intended for use as part of a physiological monitoring system in a hospital environment. As such, it is not a life supporting, nor is it implantable and therefore sterility is not a consideration.

The Envoy is not a kit and does not contain any drug or biological products. The Spirometry module of the Envoy patient monitor is not sold as a stand-alone spirometry device, but as part of a multiparameter physiological patient monitoring system (ENVOY).

The provided document is a 510(k) premarket notification for a new Spirometry module added to the Envoy Patient Monitor. The document indicates that the device has been subject to "extensive safety and performance testing" but does not contain the detailed study results needed to fully answer your request.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides some specifications for the OEM Airway Adapter/Flow sensor which can be considered performance criteria and reported performance:

Missing Information for Table: The document states that the system included "various performance tests designed to ENSURE that the device complies to applicable requirements and performance specifications" but does not explicitly list the acceptance criteria or the full detailed results for all monitored parameters (Vt_e, PIP, PEEP, MAP, Plat, PF_i, PF_e, RR, Ve, I:E, COMP, RES, RSBI).

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

• Sample Size for Test Set: Not specified. The document mentions "extensive safety and performance testing" but does not provide details on the number of samples or cases used.
• Data Provenance: Not specified. It is not clear whether the testing involved retrospective or prospective data, or the geographical origin of any patient data, if used.

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

• Not specified. The document does not describe a process for establishing ground truth using experts. The testing seems to be based on engineering performance specifications rather than clinical reads.

4. Adjudication method for the test set

• Not applicable/Not specified. Since expert ground truth establishment is not described, adjudication methods are also not mentioned.

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

• No. This is not an AI/CAD device. It is a physiological patient monitor with a spirometry module. An MRMC study is not relevant to this type of device.

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

• Yes, implicitly. The performance testing described refers to the device itself and its components. The document explicitly states, "The Spirometry module of the Envoy patient monitor is not sold as a stand-alone spirometry device, but as part of a multiparameter physiological patient monitoring system (ENVOY)." However, the performance specifications are for the module's technical capabilities (e.g., flow range, accuracy), which would be tested in a standalone capacity within the system.

7. The type of ground truth used

• Engineering Specifications/Reference Standards. The reported accuracy and flow range suggest comparison against known, calibrated inputs or reference standards rather than clinical consensus or pathology. Examples: "Accuracy: ± 5 % reading, or 0.5 lpm."

8. The sample size for the training set

• Not applicable/Not specified. This device is a hardware-based physiological monitor, not an AI/machine learning algorithm that requires a training set.

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

• Not applicable. No training set is mentioned or implied for this type of device.

Study Proving Device Meets Acceptance Criteria:

The document states: "The Envoy Spirometry module has been subject to extensive safety and performance testing. The survey of the system included various performance tests designed to ensure that the device complies to applicable requirements and performance specifications. Safety testing and EMC testing were performed by an independent testing laboratory to ensure that the device complies to applicable industry and safety standards."

This is a general statement that indicates testing was done, but the document does not detail the specific study, methodology, or results of this "extensive safety and performance testing" beyond the specifications provided in the table above. It does not provide a formal "study" report within this 510(k) summary.

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