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510(k) Data Aggregation
(268 days)
A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
B. Failed osteotomy or unicompartmental replacements.
C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
D. The non-porous (uncoated and coated with CoCr beads without Titanium) components may only be used with cement.
E. The porous coated (CoCr beads with Titanium) components may be used with or without cement.
F. Stemmed baseplates of the CKS Plus Knee System are intended for cemented use only
The CKS Plus extension to the Consensus Knee System (CKS) is a primary fixed bearing total knee system offering flexibility to restore knee function using either cruciate retaining (CR) or posterior stabilizing (PS) components with the option of tibial cancellous screw, tibial intramedullary (IM) stem fixation, and tibial augments
The provided text describes a 510(k) premarket notification for the "CKS Plus Knee System." It details the device, its indications for use, and claims substantial equivalence to predicate devices. Crucially, as a 510(k) summary for a medical device (a knee prosthesis), the focus is on demonstrating substantial equivalence through comparison to existing devices and bench testing, not on clinical performance studies involving AI or complex statistical analyses of diagnostic accuracy. Therefore, many of the requested elements for an AI/diagnostic device study (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, and detailed ground truth establishment) are not applicable to this type of document.
The document primarily discusses non-clinical performance data (bench testing) to verify the safety and effectiveness of the CKS Plus Knee System's components, focusing on mechanical properties and stability rather than diagnostic accuracy or human interpretation.
Here's an attempt to address the request based only on the provided text, highlighting what is (and isn't) present:
A. Table of Acceptance Criteria and Reported Device Performance
The document does not present acceptance criteria in a formal table with reported performance side-by-side, as would be typical for a diagnostic device's clinical study. Instead, it lists the types of bench tests performed and implies that the device "meets" the requirements by stating it passed. The criteria are implicit in the ASTM standards and other specified tests.
| Acceptance Criteria (Implicit from Test Standards/Purpose) | Reported Device Performance (Implied from "Testing Performed") |
|---|---|
| Adequate tray fatigue strength (per ASTM F1800-12) | "the tray would not fail under fatigue when one compartment collapses" |
| Tibiofemoral joint stability (per ASTM F1223-14) | Tested for PS-C insert per ASTM F1223-14 |
| Adequate tibial insert locking mechanism strength | Tested per FDA's Class II Special Controls Guidance to ensure adequate connection strength and ease of insertion |
| No failure in PS Post Fatigue Testing | "PS Post Fatigue Testing, Report" (implies successful completion) |
| No failure in Baseplate Fatigue Testing | "Baseplate Fatigue Testing, Report" (implies successful completion) |
| No failure in Tibial Insert Dislocation Testing | "Tibial Insert Dislocation Testing, Report" (implies successful completion) |
| No failure in VitalitE PS Post Fatigue Testing | "VitalitE PS Post Fatigue Testing, Report" (implies successful completion) |
| No failure in Tray Fatigue (FEA Worst Case) | "Tray Fatigue: FEA Worst Case Scenario, Report" (implies successful completion) |
| No failure in Stem Fatigue (FEA Worst Case) | "Stem Fatigue: FEA Worst Case Scenario, Report" (implies successful completion) |
| Pyrogenicity absence | "Pyrogenicity testing has been performed" (implies successful completion) |
B. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in terms of number of devices or components tested. The document mentions "bench testing" was carried out, but does not provide specific sample quantities for each test.
- Data Provenance: The tests are "bench testing," meaning they are performed in a laboratory setting on components or full devices, not on human subjects. Thus, there is no country of origin for human data, nor is it retrospective or prospective in that context.
C. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Experts: Not applicable. This is not a study requiring expert consensus for ground truth on diagnostic performance. The "ground truth" for mechanical testing is adherence to validated ASTM standards and engineering principles.
D. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This is not an image-based or diagnostic study requiring adjudication of expert interpretations.
E. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.
- MRMC Study: No, an MRMC study was not done. This device is a knee prosthesis, not an AI or diagnostic tool that relies on human interpretation of cases. Therefore, there is no "effect size of how much human readers improve with AI vs without AI assistance" to report.
F. If a Standalone (algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical medical device (knee implant), not an algorithm or AI system.
G. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for the performance claims for this device is based on engineering standards, ASTM specifications, and mechanical testing results. For example, ASTM F1800-12 defines criteria for tray fatigue, and success is determined by meeting those predefined engineering benchmarks.
H. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This document describes the testing of a physical medical device, not the training of an AI algorithm.
I. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set mentioned or implied for an AI algorithm.
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(333 days)
The CKMB UDR assay is an in vitro diagnostic test used for the kinetic quantitative determination on Unicel DxC 600 System of the CK-MB isoenzyme activity of creatine kinase in serum and Liheparin plasma by inhibition method. The assay is intended for professional use only. Creatine Kinase (CK) catalyses the reversible phosphorylation of creatine by ATP. CK is a dimer composed of two subunits which form three active isoenzymes: BB (CK-1), MB (CK-2), MM (CK-3). CK-BB isoenzyme only rarely appears in serum.
Elevated CK values are due to muscular damages and associated pathologies. CK determination, usually performed with CK2 (also called CK-MB), is used for the diagnosis and follow-up of AMI (acute myocardial infarction) and some muscular diseases.
Anti CK-M mouse monoclonal antibodies in the reagent 1 inhibit the CK-M subunit in the sample without affecting the CK-B subunits. The CK-B activity is determined by the CK-NAC method and corresponds to half the CK-MB activity.
The provided text describes the performance characteristics of the CKMB UDR Assay, focusing on its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Method Comparison with Predicate Device: | |
| High correlation coefficient (r) with predicate device | r = 0.999 |
| Slope close to 1 with predicate device | Slope = 0.96 |
| Small intercept value with predicate device | Intercept = 2.40 U/L |
| Imprecision (within-run and inter-assay): | |
| Acceptable %CV values for various concentrations | 20-day Inter-assay Imprecision: |
| - Human sera pool #1 (Mean 10.7 U/L): Total Imprecision CV% = 4.2%, Within run CV% = 4.2% | |
| - Human sera pool #2 (Mean 19.0 U/L): Total Imprecision CV% = 2.6%, Within run CV% = 2.6% | |
| - Human sera pool #3 (Mean 25.4 U/L): Total Imprecision CV% = 2.0%, Within run CV% = 2.0% | |
| - Human sera pool #4 (Mean 33.4 U/L): Total Imprecision CV% = 3.6%, Within run CV% = 3.6% | |
| - Spiked Human sera pool (Mean 584.1 U/L): Total Imprecision CV% = 0.9%, Within run CV% = 0.6% | |
| Analytical Measurement Range (AMR): | |
| A defined and clinically relevant range of accurate measurement. | Found lower limit: 7.4 U/L; Found upper limit: 600.0 U/L. Claimed AMR: 9.0 to 600.0 U/L. |
Study Proving Acceptance Criteria (Type of Study):
The study described is a comparative performance study to demonstrate substantial equivalence to a predicate device (Roche CK-MB assay K003158). This is primarily an analytical validation study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: 306 human sera samples (for method comparison).
- Data Provenance: The text does not specify the country of origin. It implicitly describes a prospective study in the sense that samples were tested with both the new device and the predicate for comparison. However, the exact collection method (e.g., whether samples were collected specifically for this study or were existing banked samples) is not explicitly stated. It is referred to as "human sera samples," suggesting clinical samples.
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 is not applicable to this type of analytical device validation. The "ground truth" for an assay like CKMB is established by the reference method (in this case, the predicate device) and the intrinsic chemical/biological properties being measured, not by expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or adjudication of results. The comparison is quantitative between two analytical instruments.
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 an in vitro diagnostic assay, not an imaging device or AI-assisted diagnostic tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies described are standalone (algorithm/assay only) performance assessments. The device measures CK-MB activity directly, and its performance is evaluated based on its analytical characteristics (correlation, precision, range) against a predicate device, without human intervention in the result determination.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the results obtained from the legally marketed predicate device (Roche CK-MB assay K003158). The study aimed to demonstrate that the new device's measurements are substantially equivalent to those of the predicate device. For the imprecision and AMR studies, the ground truth is implicitly the inherent biological measurement of the samples at various concentrations using the new device.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-driven device that requires a training set in that sense. It is a chemical assay.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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(76 days)
X-ray imaging of whole body - Computerized Tomography
Including:
Axial Volumetric (Helical) CT Fluoroscopy
The CKIS-004A, Injector Synchronization Option is intended to facilitate contrast enhanced CT examinations by interfacing the CT system to a contrast injection system. When employed, the CKIS-004A will allow both the CT scan and the contrast bolus to occur by activation of either the CT or the injector. The communications between the devices is based upon the CiA-425 standard.
The CKIS-004A will be added to the previously cleared TSX-101A Aquilion CT This addition requires hardware and software modifications to the system. existing device. Application of this option will facilitate contrast enhanced CT examinations by providing an interface between the CT system and the contrast injection device. This interface is based upon the protocol contained in the CIA-425 standard.
The provided document is a 510(k) summary for the Toshiba CKIS-004A Injector Synchronization Option. This device is an add-on to a CT scanner (TSX-101A Aquilion CT) that facilitates contrast-enhanced CT examinations by interfacing with a contrast injection device.
Based on the nature of the device (an injector synchronization option for a CT scanner), the document does not contain the typical acceptance criteria and a detailed study report that would be expected for a diagnostic AI/ML device. The device acts as an interface to coordinate existing medical equipment, rather than providing a diagnostic interpretation or measurement. Therefore, much of the requested information (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) is not applicable or detailed in this specific submission.
However, I can extract the relevant information from the document regarding the device's characteristics and safety/effectiveness concerns.
Here's a breakdown of the information that can be extracted, and an explanation of why other requested items are not present:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, etc., which are common for diagnostic devices. Instead, the "performance" is described in terms of its intended function and compliance with standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Facilitate contrast enhanced CT examinations by interfacing CT system and injection device. | "Application of this option will facilitate contrast enhanced CT examinations by providing an interface between the CT system and the contrast injection device." |
| "This interface is based upon the protocol contained in the CIA-425 standard." | |
| "The CKIS-004A will allow both the CT scan and the contrast bolus to occur by activation of either the CT or the injector." | |
| Compliance with relevant safety and communication standards. | "This system is in conformance with the applicable parts of the IEC 60601-1 {applicable portions}; IEC 60601-2-32, IEC 60601-2-44. - Medical Device Safety standards and CiA -425 communications standard." |
| Substantial equivalence to predicate devices in uses and applications. | "This package is similar in uses and applications as those of the predicate devices." |
| Predicate devices: Siemens Care Contrast CT (K043807), Medrad Stellant CT Injector (K033881). | |
| Compliance with Quality System Regulations and Federal Diagnostic Equipment Standard. | "This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR § 1020.30 and 1020.33, that apply to this upgrade, will be met..." |
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 in the document. As this device is an interface option and not a diagnostic algorithm, a typical "test set" in the context of image analysis or diagnostic performance is not relevant. The demonstration of performance primarily relies on compliance with technical standards and operational functionality.
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 applicable/provided. There is no "ground truth" in the diagnostic sense needed for this type of device, as it does not make diagnostic interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. No adjudication method is described, as there is no diagnostic outcome being evaluated.
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 applicable/provided. This device is an injector synchronization option, not an AI/ML diagnostic aid that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The device's function is to interface two existing pieces of equipment (CT scanner and injector) to facilitate a clinical procedure, not to perform a standalone diagnostic task.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable/provided. As explained, the concept of "ground truth" for diagnostic performance is not relevant to this device's function. The "ground truth" for its function would be its ability to successfully communicate between the CT and injector as specified by the CiA-425 standard, which is likely verified through engineering tests and compliance rather than clinical ground truth data.
8. The sample size for the training set
This information is not applicable/provided. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided. There is no ground truth for a training set in this context.
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(15 days)
The Access CK-MB assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CK-MB levels in human serum and plasma using the Access Immunoassay Systems. Measurement of creatine kinase is used in the diagnosis and treatment of myocardial infarction.
The Access CK-MB reagents, calibrators, and the Access Immunoassay Analyzers (Access, Access 2, and Synchron LXi 725) comprise the Access Immunoassay Systems for the quantitative determination of CK-MB in human serum and plasma.
This document describes the analytical studies performed for the Beckman Coulter Access CK-MB assay. The studies focus on demonstrating the performance of the device rather than comparing it to human readers or establishing ground truth from expert consensus or pathology, as typically seen in AI-based diagnostic device submissions.
Here's a breakdown of the requested information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for each metric. Instead, it presents the results of analytical studies to demonstrate the device's performance characteristics. This is common for in-vitro diagnostic devices where the "acceptance" is often implied by meeting established scientific and regulatory standards for assay performance.
| Performance Metric | Reported Device Performance |
|---|---|
| Within-run Imprecision | 1.15%CV to 2.32%CV |
| Between-run Imprecision | 1.47%CV to 2.89%CV |
| Total Imprecision | 2.66%CV to 3.54%CV |
| Analytical Sensitivity (LoD) |
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(147 days)
The CSAM CKHEMO rev 1.0 software computer program is a stand-alone product used to calculate total urea clearance (Kt/V), total urea clearance (Kt/V) delivered using the natural log formula, residual renal urea clearance (KrU), normalized protein catabolic rate (NPCR), actual blood flow, urea reduction ratio, body water volume calculated by urea kinetic modeling, total body water volume calculated using Watson's formula, actual weight loss after treatment, percent deviation (%Dev), and treatment time. These values are calculated using the test results of blood drawn immediately prior to and upon completion of kidney hemodialysis treatment based on the existing scientific formulas for single pool urea kinetic modeling. The device software is not meant to serve as the sole tool for determining effectiveness of treatment but as an adjunct to assist the physician in making the determination.
The CSAM CKHEMO rev 1.0 software computer program is a stand-alone product used to calculate various parameters related to kidney hemodialysis treatment based on test results of blood drawn before and after treatment and existing scientific formulas for single pool urea kinetic modeling.
This document is a 510(k) clearance letter from the FDA for a device called "CKHEMO Version 1.0" by CSAM, Inc. It describes the device's indications for use. However, it does not contain any information regarding acceptance criteria, study details, performance data, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is essentially a regulatory approval letter, not a scientific study report.
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(167 days)
The Creatine Kinase assay is used for the quantitation of creatine kinase in human serum or plasma on the AEROSET™ instrument. Measurement of creatine kinase is used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
Creatine Kinase is an in vitro diagnostic assay for the quantitative determination of creatine kinase in human serum or plasma. The Creatine Kinase assay is a clinical chemistry assay in which the creatine kinase present in the sample catalyzes the transfer of a high energy phosphate group from creatine phosphate to ADP. The ATP produced in this reaction is subsequently used to phosphorylate glucose to produce glucose-6-phosphate (G-6-P) in the presence of hexokinase. G-6-P is then oxidized by glucose-6-phosphate dehydrogenase (G-6-PDH) with the concomitant reduction of NADP to NADPH. The rate of formation of NADPH is monitored at 340 nm and is proportional to the activity of creatine kinase in the sample.
Here's an analysis of the provided information regarding the Creatine Kinase assay, focusing on its acceptance criteria and the study that proves it meets those criteria:
Acceptance Criteria and Device Performance for Creatine Kinase Assay
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Method Comparison (vs. Predicate) | Correlation Coefficient | High correlation (e.g., >0.95) | 0.999 |
| Slope | Close to 1 (e.g., 0.95 - 1.05) | 0.988 | |
| Y-intercept | Close to 0 | -0.829 U/L | |
| Precision | Total %CV (Level 1) | Low (e.g., |
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(51 days)
The Intersect CK Reagent is an in-vitro diagnostic product intended for use in the quantitative determination of creatine kinasc in human serum.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called "CK-NAC Reagent" (K974833). It states that the device is substantially equivalent to a predicate device for the quantitative determination of creatine kinase in human serum.
Since this is an FDA clearance letter and not a detailed study report, it does not contain the specific information requested in your prompt regarding acceptance criteria, sample sizes, expert qualifications, or study methodologies. This type of document confirms regulatory approval based on demonstrating substantial equivalence, but it does not typically publish the full technical details of the underlying performance studies.
Therefore, I cannot provide the requested information based on the provided text.
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(44 days)
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(67 days)
This in vitro diagnostic procedure is a solid- phase enzyme immunoassay intended for the quantitative determination of CK-MB in human serum or plasma on the Technicon Immuno 1 system. When used in combination with other clinical data such as presenting symptoms and EKG values, measurement of CK-MB aids in the diagnosis of acute myocardial infarction.
The assay is an enzyme label sandwich assay using two monoclonal antibodies. A CK-MB specific antibody is labelled with fluorescein and the Fab' fragment of an antibody specific for the B subunit is labelled with alkaline phosphatase( ALP) The solid phase consists of a suspension of magnetizable particles coated with antibody to fluorescein ( IMP reagent). Sample or calibrator. R1 reagent containing fluorescein - antibody conjugate, R2 reagent containing ALP-antibody conjugate and IMP reagent are mixed and incubated at 37°C. In the presence of CK-MB a fluorescein-conjugate: CK-MB: ALP-conjugate complex is formed and captured by the anti fluorescein antibodies on the magnetic particles. The particles are washed and pNPP (paranitrophenyl phosphate) substrate is added. The ALP in the antibody conjugate reacts with the pNPP to form para-nitrophenoxide and phosphate. Increasing absorbance due to the formation of paranitrophenoxide is monitored at 405 nm and 450 nm. The dose response curve is directly proportional to the concentration of CK-MB in the sample. A quadratic fit through zero is used to construct the dose response curve.
The assay has a range of 0 to 300 ng/ml and calibrators are provided with values of 0, 5, 10, 30, 100 and 300 ng/ml.
All the results reported herein were obtained by using a quadratic fit through zero algorithm to construct the standard curve.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Immuno 1 CK-MB method:
Understanding the Context:
This document describes the performance of the Immuno 1 CK-MB method, an in vitro diagnostic procedure for measuring CK-MB in human serum or plasma. The primary focus of the provided sections is to demonstrate the comparability and stability of results when using plasma samples as opposed to serum, and to establish storage guidelines.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state formal "acceptance criteria" in a tabulated format with pass/fail thresholds. Instead, it presents performance data (regression analysis, imprecision, and storage stability) and implicitly suggests that the observed performance validates the use of plasma samples under specified conditions.
Based on the provided data and the intent to show plasma is comparable and stable, here's a table reflecting implied acceptance or expected performance:
| Performance Metric | Implied/Observed Acceptance Criteria (for plasma as alternative to serum) | Reported Device Performance (Plasma vs. Serum) | Reported Device Performance (Plasma Imprecision) | Reported Device Performance (Plasma Stability) |
|---|---|---|---|---|
| Comparability (Plasma vs. Serum) | Regression analysis showing a strong correlation (r close to 1), a slope close to 1, and a small intercept, indicating comparable results between serum and plasma samples. | Site 1: N=45, Range 0.34-24.75 ng/mL, Slope=1.06, Intercept=0.23 ng/mL, r=0.984, Sy.x=1.30 ng/mL | ||
| Site 2: N=60, Range 0.30-334.20 ng/mL, Slope=1.06, Intercept=0.70 ng/mL, r=0.999, Sy.x=2.45 ng/mL | ||||
| Site 3: N=55, Range 0.64-202.36 ng/mL, Slope=1.06, Intercept=0.56 ng/mL, r=0.995, Sy.x=4.69 ng/mL | ||||
| (Overall: Strong correlation and slopes close to 1 across sites, supporting comparability) | N/A | N/A | ||
| Imprecision (Plasma) | Within-run and Total CVs for plasma samples expected to be comparable to established serum performance, indicating good analytical reliability. "No significant difference between the imprecision obtained for serum or plasma" is stated. | N/A | Plasma Samples (N=10, 3 replicates each): |
- Plasma 1 (Mean 5.61 ng/mL): Within-run CV 2.6%, Total CV 3.2%
- Plasma 2 (Mean 6.65 ng/mL): Within-run CV 2.1%, Total CV 2.8%
- Plasma 3 (Mean 5.28 ng/mL): Within-run CV 2.9%, Total CV 2.6%
- Plasma 4 (Mean 4.48 ng/mL): Within-run CV 2.1%, Total CV 2.4%
- Plasma 5 (Mean 6.14 ng/mL): Within-run CV 1.9%, Total CV 2.1%
- Plasma 6 (Mean 6.03 ng/mL): Within-run CV 1.4%, Total CV 1.7%
- Plasma 7 (Mean 5.23 ng/mL): Within-run CV 2.3%, Total CV 2.3%
- Plasma 8 (Mean 4.27 ng/mL): Within-run CV 2.1%, Total CV 2.3%
- Plasma 9 (Mean 4.51 ng/mL): Within-run CV 2.3%, Total CV 2.4%
- Plasma 10 (Mean 7.27 ng/mL): Within-run CV 2.3%, Total CV 7.4%
Serum Controls (for comparison): - Serum Control 1 (Mean 3.31 ng/mL): Within-run CV 3.3%, Total CV 3.7%
- Serum Control 2 (Mean 12.75 ng/mL): Within-run CV 1.2%, Total CV 1.2%
(Conclusion: Stated there is no significant difference between imprecision for serum and plasma) | N/A |
| Plasma Sample Stability | Results for refrigerated (2-8°C) and frozen (-20°C) plasma samples should remain consistent with immediate testing over specified periods, demonstrating stability for clinical use. An implied acceptable deviation (e.g., within a certain % or SD) from the baseline. | N/A | N/A | Refrigerated (2-8°C): Samples stable for at least 7 days.
Frozen (-20°C): Samples stable for at least 1 month.
(Individual results for 10 samples provided, showing minimal variation over time, supporting the stated stability conclusions) |
2. Sample Sizes Used for the Test Set and Data Provenance
- Comparability Study (Plasma vs. Serum):
- Sample Size:
- Site 1: 45 samples
- Site 2: 60 samples
- Site 3: 55 samples
- Total: 160 samples
- Data Provenance: Retrospective and prospective. "Specimens submitted for CK-MB analysis from patients with suspected acute myocardial infarction" (implying clinical samples). "Only specimens from patients who had both serum and lithium heparin plasma samples drawn at the same time were used." The study was conducted at "three independent sites." The country of origin is not specified, but the context generally suggests a developed country (e.g., US or Europe) where such diagnostics are common.
- Sample Size:
- Imprecision Study (Plasma):
- Sample Size: 10 volunteer blood donations, from which plasma was spiked and aliquoted. Each aliquot was tested in three replicates. So, 10 samples, with 3 replicates per measurement point.
- Data Provenance: Prospective (samples from volunteers specifically for the study). Country of origin not specified.
- Stability Study (Plasma):
- Sample Size: 10 volunteer blood donations (same as imprecision study).
- Data Provenance: Prospective (samples from volunteers specifically for the study). Country of origin not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this study. The "ground truth" here is the actual concentration of CK-MB in a sample, a quantitative value determined by the Immuno 1 system itself (or implied by its calibration). This is a measurement performance study, not an diagnostic interpretation study by human experts. The comparison baseline for plasma is serum results on the same device.
4. Adjudication Method for the Test Set
This is not applicable. There is no "adjudication" in the sense of resolving discrepancies between human readers or between an AI and human readers. The study involves comparing quantitative measurements from a diagnostic device.
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 is not applicable. This is an in vitro diagnostic device performance study, not an AI-assisted diagnostic study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described are standalone performance studies of the Immuno 1 CK-MB method. The method itself is an automated laboratory assay (solid-phase enzyme immunoassay). The algorithm used is to "construct the dose response curve" (a quadratic fit through zero) and process results directly from the instrument's optical readings. There is no human interpretation or intervention in the measurement of CK-MB concentration by the algorithm/device. The "performance" being evaluated is the accuracy, precision, and stability of this automated measurement.
7. The Type of Ground Truth Used
The ground truth used in these studies is the quantitative CK-MB concentration as measured by the Immuno 1 system.
- For the comparability study, the "ground truth" for plasma is effectively established by the corresponding serum samples run on the same system, assuming serum is the validated or reference matrix. The regression analysis aims to show that plasma measurements are equivalent to serum measurements.
- For the imprecision and stability studies, the "ground truth" is the established concentration of the spiked CK-MB in the plasma samples, and the consistency of the device's readings against this established value over time and repeated measurements.
8. The Sample Size for the Training Set
- Training Set for the assay's dose response curve: This is built into the assay's calibration process. Calibrators are provided with values of 0, 5, 10, 30, 100, and 300 ng/mL. So, there are 6 calibration points that form the basis for the quadratic fit.
- No other "training set" in the context of machine learning (AI model training) is mentioned or relevant here, as this is a traditional immunoassay.
9. How the Ground Truth for the Training Set Was Established
The "ground truth" for the calibrators (the training set for the dose-response curve) is established through:
- Known concentrations: The calibrators are prepared with specific, pre-defined concentrations of CK-MB (0, 5, 10, 30, 100, and 300 ng/mL). These concentrations would be meticulously prepared and verified using highly accurate reference methods or gravimetric techniques by the manufacturer (Bayer Corp.).
- These known concentrations are then used to build the standard curve, allowing the system to convert absorbance measurements into quantitative CK-MB concentrations.
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