Search Results

The Creatinine2 assay is used for the quantitation of creatinine in human serum, plasma, or urine on the ARCHITECT c System.

The Creatinine2 assay is to be used as an aid in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

The Creatinine2 assay is an automated clinical chemistry assay. At an alkaline pH, creatinine in the sample reacts with picric acid to form a creatinine-picrate complex that absorbs at 500 nm. The rate of increase in absorbance is directly proportional to the concentration of creatinine in the sample.

The provided document describes the Abbott Creatinine2 assay, an in vitro diagnostic device, and its performance relative to a predicate device. The information needed to answer the request is primarily found in Section 5: 510(k) Summary (Summary of Safety and Effectiveness), specifically subsections VIII (Summary of Nonclinical Performance) and VII (Comparison of Technological Characteristics).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a separate, pre-defined column. Instead, it presents the results of various performance studies. The "Reported Device Performance" below is extracted directly from the study results presented in the document. The comparable predicate device values are included for context where available.

Creatinine2 Assay - Performance Summary

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

The document describes several nonclinical laboratory studies.

• Precision (Within-Laboratory): For both Serum/Plasma and Urine, the studies tested 80 replicates per sample type for each of the two controls and three human panels (5 samples total). This was done in duplicate, twice per day, on 20 days. The provenance of the human panels (e.g., country of origin, retrospective/prospective) is not specified, but they are referred to as "human serum panels" and "human urine panels." This data is ex vivo laboratory testing.
• Accuracy: No specific sample size of "patient samples" is given. The study was performed using "material standardized to the Certified Reference Material NIST SRM 967a" for serum/plasma and "material standardized to the Certified Reference Material NIST SRM 914a" for urine.
• Lower Limits of Measurement (LoB, LoD, LoQ): n ≥ 60 replicates for zero-analyte and low-analyte level samples for LoB/LoD, and for low-analyte level samples for LoQ.
• Linearity: The sample size for linearity is not explicitly stated in terms of number of unique samples, but it covers the analytical measuring interval by spiking and dilution.
• Method Comparison:
  • Serum: 128 samples
  • Urine: 129 samples
    The provenance of these clinical samples (e.g., country of origin, retrospective or prospective) is not explicitly stated.
• Interference: "Each substance was tested at 2 levels of the analyte." No specific sample size (n) for the number of replicates per interference test is given beyond this, nor is the provenance of the base samples used.
• Tube Type: "Samples were collected from a minimum of 40 donors." The provenance is not explicitly stated.

The studies described are nonclinical laboratory studies, primarily involving analytical performance evaluation rather than clinical patient studies.

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

This information is not applicable (N/A) to this specific device (Creatinine2 assay). The device is an in vitro diagnostic for quantitative measurement of creatinine, not an imaging device or a device requiring expert interpretation of complex clinical data to establish ground truth for its performance evaluation (e.g., a diagnosis of a disease from imaging). The "ground truth" for its analytical accuracy is typically established against certified reference materials (NIST SRM 967a for serum/plasma and NIST SRM 914a for urine) or reference methods, not by human experts adjudicating cases for a test set.

4. Adjudication Method for the Test Set

This information is not applicable (N/A) for the same reasons as #3. Clinical adjudication by multiple experts (like 2+1, 3+1) is typically used for devices that rely on human interpretation of outputs (e.g., medical images, pathology slides) where consensus or expert opinion defines the ground truth for diagnostic accuracy. This device measures a biochemical analyte.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for medical devices where human readers or interpreters are part of the diagnostic workflow, such as imaging-based AI tools. The Creatinine2 assay is an automated clinical chemistry assay that directly measures creatinine levels in biological samples and does not involve human image interpretation or a "human-in-the-loop" effectiveness study as typically understood in the context of MRMC studies.

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

The Creatinine2 assay is a standalone (algorithm only) device in the sense that it performs a quantitative measurement without a human-in-the-loop for interpreting the output of the device to arrive at the creatinine value. The performance metrics described (precision, accuracy, linearity, lower limits of measurement, interference, method comparison) are all tests of the device's performance directly, independent of human interpretation or assistance in generating the result.

7. The Type of Ground Truth Used

The ground truth for the performance evaluation of the Creatinine2 assay was primarily established using:

• Certified Reference Materials: NIST SRM 967a for serum/plasma and NIST SRM 914a for urine were used for accuracy studies.
• Predicate Device/Reference Method: The Creatinine assay (K083809; List No. 3L81) was used as a comparator for the method comparison study to assess substantial equivalence.
• Defined Standards/Controls: For precision and lower limits of measurement, studies used control materials and low-analyte level samples with known or established concentrations to determine repeatability, detection, and quantitation limits.

8. The Sample Size for the Training Set

This information is not applicable (N/A). The Creatinine2 assay is a chemical assay, not a machine learning or AI-based device that requires a "training set" in the computational sense. Its performance is based on the chemical reaction and analytical methods described.

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

This information is not applicable (N/A) for the same reasons as #8.

Ask a specific question about this device

The Creavo Vitalscan Magnetocardiograph is intended for use as a tool which non-invasively measures and displays the magnetic signals produced by the electric currents in the heart.

The Creavo Vitalscan Magnetocardiograph is a transportable device, when not in use, which includes a scan head containing multiple sensors, a moveable arm, electronics, software, user touch screen, power supply, and a rechargeable battery. The wheeled chassis and handles allow the device to be transportable between patient beds. During use, the device is placed adjacent to the patient bed. The color touch screen allows the user to enter patient information (e.g., patient name and scan information) and serves as the visual display unit of the numerical and graphical results during testing. The device also incorporates the use of single use standard ECG electrodes and reusable AHA patient lead wires. The ECG electrodes, are used for gating of the magnetocardiograph signal with the patient's cardiac electrical signal and are used to assist triggering the device electronics and software.

The provided text describes a 510(k) premarket notification for the Creavo Vitalscan Magnetocardiograph. It confirms the device's substantial equivalence to a predicate device based on its intended use, design characteristics, and performance testing against various standards. However, the document does not contain information regarding acceptance criteria for specific performance metrics (like sensitivity, specificity, accuracy), nor does it describe a study that uses a test set, ground truth established by experts, or any details about human reader performance.

Therefore, most of the requested information cannot be extracted from the given text.

Here is what can be inferred or explicitly stated based on the provided document:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The document lists performance tests against general standards (IEC 60601 series, IEC 62366) and states that "design specifications were met," but it does not specify quantitative acceptance criteria or the reported performance relative to those criteria.

2. Sample sized 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 in the document. The document mentions "performance tests" and "software validation" but does not detail any specific clinical or non-clinical test sets, their sample sizes, or data provenance.

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)

This information is not provided in the document. No mention of experts or ground truth establishment for a test set is made.

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

This information is not provided in the document.

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

This information is not provided in the document. The device description and performance data summary focus on the device's ability to record magnetocardiograms and meet safety/EMC standards, not on its use in interpreting data or assisting human readers. There is no mention of AI.

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

The document does not detail any "standalone" algorithm performance study in the context of diagnostic accuracy. It states the device "measures and displays the magnetic signals," implying it's a measurement tool. Performance tests mentioned are related to safety, EMC, and usability, not diagnostic accuracy of an algorithm.

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

This information is not provided in the document.

8. The sample size for the training set

This information is not provided in the document. The device is not described as involving machine learning or a "training set."

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

This information is not provided in the document.

Ask a specific question about this device

The Creatine Kinase-MB assay is an in-vitro test for the quantitative determination of the catalytic activity of creatine kinase MB subunit (CK-MB) in human serum and plasma on Roche/Hitachi cobas c systems.

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

The Creatine Kinase-MB assay is a two reagent assay for the quantitative determination of creatine kinase-MB (CK-MB) in human serum and plasma on automated clinical chemistry analyzers. The rate of the NADPH formation is directly proportional to the catalytic CK-MB activity. It is determined by measuring the increase in absorbance photometrically.

This document is a 510(k) summary for a medical device called "Creatine Kinase-MB" by Roche Diagnostics. It describes the device, its intended use, technological characteristics, and performance evaluation data.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaway: This document is about a clinical chemistry assay (an in-vitro diagnostic test), not an AI/ML device. Therefore, many of the typical AI/ML study components (like multi-reader multi-case studies, expert adjudication, or separate training/test sets for AI models) are not applicable to this type of device. The "ground truth" here is the reference measurement method or the expected concentration of the analyte.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is an in-vitro diagnostic test and not an AI/ML device, the acceptance criteria are not typically expressed as sensitivity/specificity in an MRMC study for diagnostic imaging. Instead, the acceptance criteria relate to analytical performance characteristics. The document presents the performance data against established analytical standards (CLSI guidelines) and comparisons to a predicate device.

Study Details:

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

• Precision (Repeatability & Intermediate Precision):
  • 5 human serum samples and 2 control samples.
  • Measurements: Two aliquots per run, two runs per day for ≥ 21 days on the same analyzer using 3 lots of reagent.
  • Data Provenance: Not explicitly stated (e.g., country of origin), but implies laboratory-based prospective testing as per CLSI guidelines.
• Analytical Sensitivity (LoB, LoD, LoQ):
  • LoB: One analyte-free sample. Measured with three lots, 10-fold determination in 6 runs, over 3 days (60 measurements per lot).
  • LoD: Five samples with low analyte concentration. Measured with three lots, twofold determination in 6 runs, over 3 days (60 measurements per lot).
  • LoQ: 5 human serum samples diluted to low levels. Tested in 5 replicates per sample on 5 days, one run per day.
  • Data Provenance: Implies laboratory-based prospective testing as per CLSI guidelines.
• Linearity:
  • One serum pool and one plasma pool, diluted to 16 (serum) and 18 (plasma) concentrations.
  • Measurements: Measured in triplicate.
  • Data Provenance: Implies laboratory-based prospective testing.
• Endogenous Interferences:
  • Pooled human serum samples spiked with varying levels of interferent.
  • Measurements: Tested in triplicate.
  • Data Provenance: Implies laboratory-based prospective testing.
• Exogenous Interferences (Drugs):
  • Two sample pools (low and high CKMB concentration).
  • Measurements: Aliquots spiked with drugs, determined in triplicate.
  • Data Provenance: Implies laboratory-based prospective testing.
• Method Comparison to Predicate:
  • 105 human serum samples (plus 4 spiked with CK MB rec human).
  • Data Provenance: Not explicitly stated origins of human serum samples, but implies prospective collection for this comparison.
• Matrix Comparison (Anticoagulants):
  • 31 Li Heparin tubes, 30 K2 EDTA tubes, 31 K3 EDTA tubes, and 31 Gel Separation tubes.
  • Data Provenance: Implies prospective collection of samples drawn into different tubes.

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

Not applicable. This is an analytical performance study for an in-vitro diagnostic assay. Ground truth is established by reference methods, known concentrations, or comparison to a predicate device, not by expert medical image interpretation.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or adjudication component in the analytical performance testing described for this device. Measurements are objective quantitative values.

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 device is an in-vitro diagnostic test, not an AI-assisted diagnostic imaging tool or a device requiring human readers/interpreters in its primary use.

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

This is fundamentally a "standalone" device in the sense that its performance is measured analytically on its own, producing a quantitative result. There is no "human-in-the-loop" performance as would be relevant for an AI-powered diagnostic imaging tool. The device provides a direct measurement.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance studies is based on:

• Reference Methods/Known Concentrations: For precision, linearity, and analytical sensitivity, samples with known or expected concentrations (e.g., controls, highly purified analytes, or diluted samples) are used.
• Comparison to a Legally Marketed Predicate Device: For method comparison, the results from the new device are compared to those obtained from the established predicate device, which serves as a de facto "truth" or reference standard for equivalence.
• CLSI Guidelines: The studies follow CLSI (Clinical and Laboratory Standards Institute) guidelines (e.g., EP5-A3, EP17-A2, EP6-A), which define how analytical performance characteristics should be determined using standard laboratory practices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set" in the context of model development. The laboratory studies described are for system validation, not algorithm training.

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

Not applicable. As there is no "training set" for an AI/ML model, there is no ground truth established for such a set.

Ask a specific question about this device

Creatine Kinase is an in vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma on Roche/Hitachi cobas c systems. The determination of CK and CK isoenzyme activities is utilized in the diagnosis and monitoring of myocardial infarction and myopathies such as the progressive Duchenne muscular dystrophy.

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

The Creatine Kinase assay is a two reagent assay for the quantitative determination of creatine kinase (CK) in human serum and plasma on automated clinical chemistry analyzers. Photometrically measured NAPDP formation is directly proportional to CK activity in a human sample.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

Creatine Kinase Device Performance Study Summary

1. Acceptance Criteria and Reported Device Performance

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

• Detection Limits (LoB, LoD):
  • LoB: One analyte-free sample, measured with three lots, 10-fold determination in 6 runs (total 60 measurements per lot).
  • LoD: Five low-analyte concentration samples, measured with three lots, two-fold determination in 6 runs (total 60 measurements per lot).
• Limit of Quantitation (LoQ):
  • Five human serum samples, tested in 5 replicates per sample on 5 days.
• Precision (Repeatability & Intermediate):
  • Not explicitly stated as a single number, but experiments conducted with multiple human serum samples (5) and control materials (2), with two aliquots per run, two runs per day for ≥ 21 days on the same analyzer using 3 lots of reagent.
• Linearity (Serum & Plasma):
  • Two separate dilution series (serum and plasma), each with 14 concentrations, measured in triplicate.
• Matrix Comparison - Anticoagulants:
  • For each of the four tube types (Serum Gel Separation, Li-heparin, K2-EDTA, K3-EDTA), 30 tubes were filled completely. This implies 30 samples for each comparison.
• Interferences - H, L, I Indices:
  • Pooled human serum samples spiked with varying levels of interferent. The resulting sample series (10 dilution steps per sample) were tested in triplicate.
• Interferences - Drugs:
  • Two sample pools (low and high CK concentrations), divided into aliquots. Each spiked aliquot measured in triplicate.
• Method Comparison to Predicate:
  • 132 human serum samples (9 of which were spiked with human recombinant CK MB). Samples tested in singlicate.

Data Provenance: The document explicitly mentions "human serum samples" and "pooled human serum samples." The manufacturer is Roche Diagnostics Operations, located in Indianapolis, IN, USA. Based on the context of FDA submission for a device to be marketed in the USA, it is highly probable the data is retrospective and likely collected in a clinical laboratory setting (possibly in the USA or aligned with international standards like CLSI), but the specific country of origin for the patient samples is not stated.

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

N/A. This is a submission for an in vitro diagnostic device that quantitatively measures a biomarker (Creatine Kinase). The "ground truth" for the test set is established by the reference measurement procedure or the known concentration of the analyte in calibrators/controls, not by expert interpretation of images or clinical data. Therefore, human experts for ground truth adjudication are not applicable in this context.

4. Adjudication Method for the Test Set

N/A. See explanation above. The measurements are quantitative chemical analyses against instrument-derived values and established reference methods/materials, not subjective interpretations.

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

No. This is an in vitro diagnostic device for quantitative measurement of a biomarker in biological samples. MRMC studies are typically performed for imaging devices or other diagnostic tools where human interpretation plays a significant role, to evaluate how AI assistance impacts human reader performance. This is not applicable here.

6. Standalone (Algorithm Only) Performance Study

Yes, the entire submission is a standalone performance study of the Creatine Kinase assay on the Roche/Hitachi cobas c systems. The device itself is an "algorithm only" in the sense that it is an automated analytical system (reagent + instrument) that produces quantitative results without human intervention in the measurement process itself, beyond sample loading and system maintenance. The studies described (Detection Limits, Precision, Linearity, Interference, Method Comparison) directly assess the performance of this standalone analytical system.

7. Type of Ground Truth Used

The ground truth for the performance studies relies on:

• Reference Materials/Methods: For calibration and verification of accuracy, the method is stated to be traceable to IFCC (International Federation of Clinical Chemistry and Laboratory Medicine) Method for Creatine Kinase.
• Known Concentrations: For studies like LoB, LoD, LoQ, linearity, and interference, samples are either analyte-free, spiked with known concentrations of analyte or interferents, or diluted from samples with established reference values. This essentially uses calibrated reference standards and materials as the ground truth.
• Predicate Device Measurements: For method comparison, the predicate device's results (COBAS INTEGRA Creatine Kinase cleared in K951595 on the COBAS INTEGRA analyzer) serve as a comparative ground truth to establish substantial equivalence.

8. Sample Size for the Training Set

N/A. This is not a machine learning or AI-based diagnostic device in the modern sense that requires a "training set" of data to learn from. It is a traditional in vitro diagnostic assay based on a defined enzymatic chemical reaction and photometric measurement. The development of such assays involves extensive research and development to optimize reagents and instrument parameters, but not in the framework of a "training set" as understood in AI/ML.

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

N/A. As explained above, there is no "training set" in the context of an AI/ML device for this product. The development of the assay involves chemical and enzymatic principles, optimized through laboratory experimentation and knowledge of biochemistry, rather than learning from a dataset via a specified ground truth.

Ask a specific question about this device

The Cream Stretch Vinyl Patient Examination Glove (Non-Sterile) and White Vinyl Patient Examination Glove (Non-Sterile) are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. They are both sold as non-sterile.

Cream Stretch Vinyl Patient Examination Glove (Non-Sterile) and White Vinyl Patient Examination Glove (Non-Sterile) are patient examination gloves available in S, M, L, XL. They are provided non-sterile and meet the entire requirement of ASTM standard D 5250-06, except for sterility requirements.

This document describes the marketing authorization for examination gloves, not an AI/ML powered medical device. Therefore, the information regarding acceptance criteria, study details, and related elements specific to AI/ML device evaluations outlined in the request cannot be extracted from this document.

The document primarily focuses on demonstrating substantial equivalence of the "Cream Stretch Vinyl Patient Examination Glove (Non-Sterile)" and "White Vinyl Patient Examination Glove (Non-Sterile)" to a predicate device (K100978: Powder-Free Non-Sterile Vinyl Examination Glove).

Here's the relevant information that can be extracted, pertaining to the glove, not an AI device:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Sizes:
  • Pinhole: 500 gloves for each device type (Cream Stretch and White Vinyl).
  • Other tests (Dimensions, Physical Properties, Powder Residual, Biocompatibility) do not specify the exact sample size in this summary, but indicate compliance with ASTM standards which would define sample sizes.
• Data Provenance: Not explicitly stated beyond "provided in support of the substantial equivalence determination." This implies the tests were conducted by the manufacturer, Lifestyle Safety Products (Hui Zhou) Co., Ltd., which is based in China. The data would be derived from laboratory testing of the manufactured gloves. The document does not specify if the testing was retrospective or prospective in the context of an FDA submission, but it is typically prospective testing performed on representative samples for premarket submissions.

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

This information is not applicable. For physical and biocompatibility testing of medical gloves, "ground truth" is established by adherence to recognized international and national standards (e.g., ASTM standards, ISO 10993). The results are objective measurements and expert consensus is not typically required in the same way it would be for an AI diagnostic algorithm.

4. Adjudication method for the test set:

Not applicable. Testing involves objective measurements against established standard criteria, not subjective interpretations requiring 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 for an examination glove, not an AI/ML powered device.

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

Not applicable. This is for an examination glove, not an AI/ML powered device.

7. The type of ground truth used:

The "ground truth" for the device's performance is based on objective measurements obtained through laboratory testing against established international and national standards (e.g., ASTM D5250-06, ASTM D5151-06, ASTM D6124-06, ISO 10993-1, ISO 10993-5, 21 CFR 800.20) for medical devices, specifically patient examination gloves.

8. The sample size for the training set:

Not applicable. This is for an examination glove; there is no "training set" in the context of AI/ML.

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

Not applicable. There is no training set for this type of device.

Ask a specific question about this device

A creatinine test system is a device intended to measure creatinine levels in serum, plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Creatinine is an in vitro diagnostic assay for the quantitative analysis of creatinine in human serum, plasma, or urine. At an alkaline pH, creatinine in the sample reacts with picrate in the reagent to form a creatinine-picrate complex. The rate of increase in absorbance at 500 nm due to the formation of this complex is directly proportional to the concentration of creatinine in the sample.

Here's an analysis of the provided 510(k) summary, focusing on acceptance criteria and the supporting study:

The document describes a Special 510(k) submission for a modified Creatinine assay for urine application. The acceptance criteria for the modified assay are implicitly based on demonstrating substantial equivalence to a predicate device (Roche Creatinine assay urine application on the Hitachi 917 Analyzer) and a previously cleared version of the Creatinine assay (K061193) on the Abbott AEROSET® System and ARCHITECT® cSystems.

The primary study conducted is a comparative performance study.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "acceptable correlation" and "similar Performance Characteristics," implying the reported values met predetermined acceptance criteria for substantial equivalence to the predicate and the previously cleared device. Specific quantitative acceptance thresholds for correlation coefficients, slopes, intercepts, or %CV are not explicitly listed, but the reported values are presented as meeting these criteria.

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

• Sample Size: The document does not explicitly state the sample size (number of urine samples) used for the comparative performance studies. It mentions "Comparative performance studies were conducted" but does not quantify the number of samples.
• Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the study was retrospective or prospective. It only indicates that "Comparative performance studies were conducted."

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

This type of diagnostic device (Creatinine assay) does not rely on human experts to establish "ground truth" for individual test results in the way image analysis or clinical diagnosis devices do. The "ground truth" for the test set is established by the performance of the predicate device (Roche Creatinine assay urine application on the Hitachi 917 Analyzer) and the previously cleared device (Creatinine assay on the Abbott AEROSET® System). The performance metrics of the modified device are compared against the measurements obtained from these established methods.

4. Adjudication Method for the Test Set

Not applicable. As this is a quantitative chemical assay, "adjudication" in the sense of multiple human readers resolving discrepancies is not relevant. The comparison is made directly between numerical measurements from different instruments/assays.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices that involve human interpretation (e.g., radiologists reading images) where the AI assists the human. This 510(k) is for an in vitro diagnostic assay, which provides a direct quantitative measurement, not an interpretation aid.

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

• Yes, in essence, standalone performance was assessed. The Creatinine assay itself is a standalone algorithm/method that directly measures creatinine levels. Its performance is evaluated by comparing its quantitative results against those of predicate methods. There is no "human-in-the-loop" once the sample is loaded and the assay begins to run.

7. The Type of Ground Truth Used

The ground truth for evaluating the modified Creatinine assay is the measurements obtained from the legally marketed predicate device (Roche Creatinine assay urine application on the Hitachi 917 Analyzer) and the previously cleared version of the same Creatinine assay (on the Abbott AEROSET® System). This is a form of comparative measurement ground truth, where the reference standard is another recognized and validated method.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of an algorithm that learns from data. This submission is for an assay, not a machine learning algorithm that requires a separate training phase. The "modifications" were to calibration and assay parameters, implying adjustments based on known chemical principles and potentially internal studies, rather than a data-driven machine learning training set.

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

Not applicable. As noted above, this is an in vitro diagnostic assay based on chemical reactions, not a machine learning algorithm with a training set. The "ground truth" for the calibration and assay parameters would be based on the principles of the Jaffe reaction, and reference standards like NIST SRM 914 and NIST SRM 967, which are IDMS traceable.

Ask a specific question about this device

The Creaspine SupStance Vertebral Body Replacement System, Line Extension, (SupStance VBR System) is a vertebral body replacement system intended to replace a vertebral body. The SupStance VBR System is designed for use in the thoraco-lumbar spine (T1- L5) to replace a collapsed, damaged, or unstable vertebral body during tumor or trauma (i.e., fracture) management procedures. The SupStance VBR System is intended to be used with supplemental internal fixation systems. Anterior thoracolumbar plates and screws or pedicle screw and rod systems are among the options for the surgeon to use.

The use of allograft and/or autograft with the SupStance VBR System is optional.

The proposed Creaspine SupStance VBR System, Line Extension, is a modification of the original Creaspine SupStance VBR System that was the subject of K072537. This device modification has been submitted as a Special 510(k) Premarket Notification because the proposed SupStance VBR System, Line Extension, is identical in intended use and fundamental scientific technology to the parent SupStance VBR System originally described in K072537.

The modifications made to the parent device to produce the proposed SupStance VBR System, Line Extension, are limited to the expansion of the implant (cage) dimensions available.

The provided document is a 510(k) summary for a medical device: the Creaspine SupStance Vertebral Body Replacement System, Line Extension. This document primarily focuses on establishing substantial equivalence to previously cleared devices through mechanical testing and does not describe a clinical study involving human patients or a software algorithm evaluated with clinical data.

Therefore, many of the requested items regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone algorithm performance are not applicable to this type of submission.

Here's a breakdown of the information that can be extracted based on the provided text, and where certain requested information is N/A:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for test set: Not applicable for a software algorithm evaluated with clinical data. This submission is for mechanical testing of a physical implant. The document does not specify the number of physical devices or tests performed, only that "Performance testing included the types of mechanical testing recommended..."
• Data provenance: Not applicable. The data is generated from mechanical testing in a lab setting, not from a clinical patient population.

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

• Not applicable. This submission involves mechanical testing of a physical implant, not a clinical study requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

• Not applicable. This submission involves mechanical testing of a physical implant, not a clinical study requiring adjudication of interpretations.

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

• No. An MRMC study is not relevant for this type of device (a physical spinal implant) or the type of data presented (mechanical testing). This study does not involve human readers interpreting clinical cases with or without AI assistance.

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

• Not applicable. This device is a physical spinal implant, not a software algorithm.

7. The Type of Ground Truth Used

• For the mechanical testing, the "ground truth" would be the engineering specifications and performance benchmarks established for vertebral body replacement systems, likely based on relevant standards and predicate device performance. The study aims to demonstrate that the new device's mechanical properties meet these established engineering benchmarks and are comparable to predicate devices.

8. The Sample Size for the Training Set

• Not applicable. This is mechanical testing of a physical medical device, not a machine learning model. There is no "training set" in this context.

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

• Not applicable. See point 8.

Ask a specific question about this device

The Creaspine SupStance Small Vertebral Body Replacement System is a vertebral body replacement system intended to replace a vertebral body. The SupStance Small VBR System is designed for use in the thoracolumbar spine (T1- L5) to replace a collapsed, damaged, or unstable vertebral body during tumor or trauma (i.e., fracture) management procedures. The SupStance Small VBR System is intended to be used with supplemental internal fixation systems. Anterior thoracolumbar plates and screws or pedicle screw and rod systems are among the options for the surgeon to use.

The use of allograft and/or autograft with the SupStance Small VBR System is optional.

The Creaspine SupStance Small Vertebral Body Replacement System is a vertebral body replacement system intended to replace a vertebral body. The SupStance Small VBR System consists of the SupStance Small VBR implants and the instrumentation required for implantation of the device. The SupStance Small VBR implant is a cage composed of fused hollow trapezoidal tubes with open sides and integral end caps. The SupStance Small VBR cages are available in three sizes (12mm, and 16mm) and cover a range of heights from 18mm to 50mm.

Like the sides of the cages, the SupStance Small VBR end caps have large openings for introduction of allograft and/or autograft and evenly spaced round serrations for fixation to the vertebral endplates. The end caps have a various (total) sagittal angle of 0°, 5°, and 8° to accommodate spinal anatomy.

The SupStance Small VBR cages are fabricated from poly-ether-ether-ketone (PEEK) with 6% BaSO4 contrast filler. The implants are provided non-sterile and may be implanted via an anterior approach or a costo-tranverse approach.

Here's an analysis of the provided text regarding the Creaspine SupStance Small Vertebral Body Replacement System, focusing on acceptance criteria and the supporting study:

The provided text is a 510(k) Summary for a medical device. It does not describe a study involving human or animal subjects, or an AI/algorithm-based device, in the typical sense of testing diagnostic accuracy or clinical effectiveness with patient data.

Instead, this document focuses on mechanical performance testing to demonstrate substantial equivalence to predicate devices. The "acceptance criteria" and "device performance" are related to mechanical properties, not diagnostic or clinical outcomes in a biological system.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, MRMC study, standalone performance, training set) are not applicable to this type of regulatory submission.

Here's the breakdown based on the provided document:

Description of the Acceptance Criteria and Supporting Study for the Creaspine SupStance Small Vertebral Body Replacement System

1. Table of Acceptance Criteria and Reported Device Performance:

• Static compression testing
• Dynamic compression testing
• Static torsion testing
• Dynamic torsion testing
• Expulsion testing | The document states, "Performance testing included the types of mechanical testing recommended... (static and dynamic compression testing, static and dynamic torsion testing, and expulsion testing)." While specific quantitative results aren't provided in this summary, the conclusion is that the data confirms comparability. |
  | Intended Use Equivalence: | The device's intended use must be substantially equivalent to that of predicate devices. | The device "share[s] the same intended use... as that of the predicate devices." (Paragraph 2, "Statement of Technological Comparison") |
  | Design Concepts & Materials Equivalence: | The device's basic design concepts and materials must be substantially equivalent to those of predicate devices. | The device "share[s] the same... basic design concepts, and materials as that of the predicate devices." (Paragraph 2, "Statement of Technological Comparison") The material (PEEK with 6% BaSO4) and design (fused hollow trapezoidal tubes with open sides and integral end caps) are described. |
  | Substantial Equivalence to Predicate Devices (Overall): | The device must demonstrate substantial equivalence to legally marketed predicate devices in terms of safety and effectiveness, meaning it is as safe and effective as a legally marketed device that is not subject to premarket approval. | "The information and data collected support a claim of substantial equivalence for the proposed SupStance Small VBR System to the specified predicate devices." This conclusion is affirmed by the FDA's 510(k) clearance letter. |

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

• Sample Size for Test Set: Not explicitly stated. The "test set" in this context refers to the number of physical device units or samples subjected to mechanical testing. The FDA guidance for such devices typically specifies the number of samples per test.
• Data Provenance: The testing was conducted by Creaspine or their contracted laboratories to support the 510(k) submission. The exact country of origin for the testing itself isn't specified, but the applicant company (Creaspine) is based in France. The data is prospective in the sense that the testing was performed specifically for this submission.

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

• Not Applicable. For mechanical performance testing of a physical device, "ground truth" isn't established by human expert consensus or clinical observation. The ground truth is determined by the physical properties measured according to standardized engineering test methods (e.g., ASTM standards or ISO standards for medical devices).

4. Adjudication method for the test set:

• Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies among human readers/experts in clinical or image interpretation studies. For mechanical testing, the results are quantitative measurements, and reconciliation would involve engineering analysis of test setup, measurement precision, and adherence to protocols.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• No. This type of study (MRMC) is relevant for evaluating the performance of diagnostic tools (e.g., AI with radiologists) where human interpretation is a key component. This submission is for a physical implantable device, not a diagnostic algorithm.

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

• Not Applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used:

• Engineering Measurement & Standardized Test Methods: The "ground truth" for mechanical testing is established by objective, verifiable measurements obtained from standardized tests (static/dynamic compression, torsion, expulsion) conducted according to established engineering and regulatory guidelines (e.g., FDA guidance, ASTM/ISO standards). The performance is compared against known characteristics of predicate devices.

8. The sample size for the training set:

• Not Applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

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

• Not Applicable. (See point 8)

Summary Takeaway:

The provided document details a regulatory submission for a physical medical device (vertebral body replacement system). The "study" referenced is a series of mechanical performance tests designed to demonstrate the device's physical properties are substantially equivalent to already-approved predicate devices, thereby establishing its safety and effectiveness for its intended mechanical function within the human body. The acceptance criteria are largely implicit in the FDA guidance for such devices, requiring performance comparable to established benchmarks or predicate devices under specified test conditions.

Ask a specific question about this device

The Teco Diagnostics Creatine Kinase liquid reagent is intended for in vitro diagnostic test for the quantitative determination of creatine kinase activity in human serum. Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Creatine Kinase Liquid Reagent (Kinetic Method)

{
"1. A table of acceptance criteria and the reported device performance": null,
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": null,
"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)": null,
"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": null,
"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": null,
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": null,
"7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": null,
"8. The sample size for the training set": null,
"9. How the ground truth for the training set was established": null
}

Ask a specific question about this device

The Creaspine SupStance Vertebral Body Replacement System (SupStance VBR System) is a vertebral body replacement system intended to replace a vertebral body. The SupStance VBR System is designed for use in the thoracolumbar spine (T1- L5) to replace a collapsed, damaged, or unstable vertebral body during tumor or trauma (i.e., fracture) management procedures. The SupStance VBR System is intended to be used with supplemental internal fixation systems. Anterior thoracolumbar plates and screws or pedicle screw and rod systems are among the options for the surgeon to use.

The use of allograft and/or autograft with the SupStance VBR System is optional.

The Creaspine SupStance Vertebral Body Replacement System (SupStance VBR System) is a vertebral body replacement system, intended for use as an aid in spinal fusion. The SupStance VBR System consists of the SupStance VBR implant and the associated instrumentation required for implantation of the device. The SupStance VBR implant is a cage constructed of fused hollow cylindrical tubes with integral endcaps and open sides for introduction of bone graft material and bone reconstruction. The SupStance VBR cages are available in three diameters (22mm, 25mm, 28mm) and cover a range of heights from 35mm to 55mm with a total fixed sagittal angle of 5°.

The SupStance VBR cages are fabricated from poly-ether-ether-ketone (PEEK) and include markers made from titanium alloy. The implants are provided non-sterile and will be implanted via an antero-lateral approach.

The provided text describes the 510(k) summary for the Creaspine SupStance Vertebral Body Replacement System. However, it does not contain information regarding acceptance criteria or a study that proves the device meets specific performance criteria in terms of diagnostic accuracy or effectiveness related to AI or human-in-the-loop performance.

The document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing, which is a different type of evaluation.

Therefore, the following information cannot be extracted from the provided text:

1. Table of acceptance criteria and reported device performance: Not available. The document refers to "Performance testing included the types of mechanical testing recommended for vertebral body replacement systems (static and dynamic compression testing, static and dynamic torsion testing, and expulsion testing)" and states "The data collected confirms that the mechanical properties of the proposed SupStance VBR System are comparable to those of the predicate devices." However, specific quantitative acceptance criteria or reported performance values are not provided.
2. Sample size used for the test set and data provenance: No test set related to diagnostic or AI performance is mentioned. The mechanical testing details do not include sample sizes in this summary.
3. Number of experts and their qualifications: Not applicable, as there's no diagnostic or AI performance study described.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. The device is a physical implant, not an AI-assisted diagnostic tool.
6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable.
7. Type of ground truth used: Not applicable in the context of diagnostic performance. For mechanical testing, the "ground truth" would be established engineering standards or predicate device performance.
8. Sample size for the training set: Not applicable, as no AI model is being trained.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device