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The Calcium2 assay is used for the quantitation of calcium in human serum, plasma, or urine on the ARCHITECT c System.

Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

The Calcium2 assay is an automated clinical chemistry assay. Arsenazo III dye reacts with calcium in an acid solution to form a blue-purplex. The color developed is measured at 660 nm and is proportional to the calcium concentration in the sample.

Methodology: Arsenazo III

The provided text describes the performance validation of the Calcium2 assay, specifically for its use in quantitating calcium in human serum, plasma, or urine on the ARCHITECT c System. This is a Class II medical device (Calcium test system), regulated under 21 CFR 862.1145, product code CJY.

Here's an analysis based on the request:

Device: Calcium2 assay
Intended Use: Quantitation of calcium in human serum, plasma, or urine on the ARCHITECT c System. Used in the diagnosis and treatment of parathyroid disease, various bone diseases, chronic renal disease, and tetany.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly outline a pre-defined table of "acceptance criteria" against which each test result is measured, as would be common for AI/ML performance studies. Instead, it presents various performance characteristics with their measured values, often referencing CLSI guidelines for the methodology. The "acceptance" can be inferred from the reported values and the conclusion of substantial equivalence. For quantitative assays like this, performance is typically assessed against established industry standards for precision, accuracy, linearity, and interference.

However, we can infer some "acceptance criteria" implicitly from the context of "acceptable performance" and the ranges presented.

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

The provided information is for an in-vitro diagnostic (IVD) test, not an AI/ML model for image analysis. Therefore, the "test set" and "training set" terminology from an AI/ML perspective doesn't directly apply in the same way. Instead, the studies involved various types of samples (controls, panels, human serum/plasma/urine samples) tested under specific experimental designs.

• Precision Studies (Serum & Urine, 20-Day):
  • Sample Size: 80 replicates per sample type (2 controls, 3 human panels) for each of the 3 reagent lot/calibrator lot/instrument combinations in the 20-day study. (e.g., 5 samples * 80 replicates = 400 total data points per combination shown in the table).
  • Data Provenance: Not explicitly stated (e.g., country of origin). The studies are "within-laboratory" meaning they were conducted in a controlled lab setting, likely at the manufacturer's site or a designated testing facility. The nature of these samples (human serum/urine panels) suggests they are likely representative, but the specific collection method or origin (retrospective/prospective collection from patients) is not detailed.
• System Reproducibility Studies (Serum & Urine):
  • Sample Size: 90 replicates per sample type (2 controls, 3 human panels).
  • Data Provenance: Same as above, not explicitly stated.
• Accuracy Study:
  • Sample Size: Not explicitly stated for replicates, but involved 2 concentrations of NIST SRM 956d standard.
  • Data Provenance: NIST standard reference material, a highly controlled and traceable source.
• Lower Limits of Measurement Studies (Serum & Urine):
  • Sample Size: n ≥ 60 replicates for zero-analyte and low-analyte level samples for LoB, LoD, and LoQ determination.
  • Data Provenance: Not explicitly stated.
• Linearity Studies (Serum & Urine):
  • Sample Size: Not explicitly stated how many points were measured across the range, but demonstrated linearity from 2.0 to 24.0 mg/dL.
  • Data Provenance: Not explicitly stated.
• Interference Studies (Serum & Urine):
  • Sample Size: Not explicitly stated how many replicates, but each substance was tested at 2 levels of the analyte.
  • Data Provenance: Not explicitly stated.
• Method Comparison Studies (Serum & Urine):
  • Sample Size: 120 serum samples, 112 urine samples.
  • Data Provenance: Patient samples. Not explicitly stated if retrospective or prospective collection.
• Tube Type Equivalence Study (Serum):
  • Sample Size: Samples from 78 donors.
  • Data Provenance: Donor samples. Not explicitly stated if retrospective or prospective.
• Dilution Verification (Urine):
  • Sample Size: 5 samples prepared with calcium stock. Replicates for dilution recovery and imprecision were performed but the exact number isn't specified beyond "demonstrated acceptable performance."
  • Data Provenance: Prepared samples.

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

This type of IVD device (quantitative chemical assay) relies on objective measurement against a known reference (e.g., NIST standard) or internal validated methods, rather than subjective expert consensus. Therefore, "ground truth" is established through highly controlled laboratory procedures and certified reference materials, not typically through multiple human experts adjudicating results. The "experts" involved are likely laboratory scientists and metrologists operating under strict quality systems (CLSI guidelines, ISO standards).

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

Not applicable for a quantitative chemical assay. Results are objectively measured by the instrument and verified through calibration and quality control. There is no subjective interpretation 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 an in-vitro diagnostic test, not an AI/ML-driven imaging or diagnostic tool that assists human readers.

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

This is a standalone quantitative assay. The Calcium2 device automatically measures calcium concentration. Human involvement is in sample preparation, loading, and interpreting the numerical output. Its performance is evaluated entirely as an automated system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this device's performance validation is established primarily through:

• Reference Materials: For accuracy (e.g., NIST SRM 956d for bias estimation).
• Known Concentrations: For linearity, lower limits of measurement, and dilution verification, samples are prepared with known concentrations of calcium or spiked with calcium.
• Comparative Methods: For method comparisons, the "ground truth" is implicitly the performance of the legally marketed predicate device (Abbott Clinical Chemistry Architect/Aeroset Calcium, K062855), which serves as the comparator.
• Statistical Models/Guidelines: CLSI guidelines (EP05-A3, EP09c, EP17-A2, EP06, EP07, EP34) provide the statistical framework and methodology for validating performance characteristics like precision, linearity, and interference.

8. The Sample Size for the Training Set

Not applicable in the typical AI/ML sense. This is a chemistry assay, not a machine learning model that undergoes a "training" phase with a large dataset. The "training" for such a device involves rigorous engineering, chemical formulation, and calibration development, rather than data-driven model training.

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

As above, "training set" is not a concept for this type of device. The accuracy and reliability of the assay are built into its chemical design, reagent formulation, and instrument calibration process. These processes rely on highly accurate reference standards (like NIST) and established analytical chemistry principles to ensure the device measures calcium correctly across its analytical range.

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CALCIUM-CRESOLPHTHALEIN: Reagent for the measurement of calcium concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

GLUCOSE: Reagent for the measurement of glucose concentration in human serum and plasma. The obtained values are useful as an aid in the diagnosis and treatment of the diabetes mellitus. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

UREA/BUN - UV: Reagent for the measurement of urea concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of certain renal and metabolic diseases. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

Not Found

This document is an FDA 510(k) clearance letter for three BioSystems S.A. reagents: CALCIUM-CRESOLPHTHALEIN, GLUCOSE, and UREA/BUN-UV. As such, it does not contain the information requested regarding acceptance criteria and study details for an AI/ML medical device.

The information typically provided in a 510(k) summary for in vitro diagnostic (IVD) reagents like these focuses on analytical performance characteristics (e.g., linearity, precision, accuracy, interference, stability) and correlation with a predicate device, rather than the AI/ML-specific criteria requested in the prompt.

Therefore, it is impossible to answer the questions based on the provided text. The document is about chemical reagents for laboratory testing, not an AI-powered diagnostic device.

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Calcium Bridge is a resin-based composite recommended for use as a liner or initial layer beneath all composite resins, or as flowable composite in preventive resin restorations. For Use only by a Licensed Dentist. Rx Use Only.

Calcium Bridge is a resin-based, flowable polymerizable composite paste recommended as a lining material beneath composite resins or as a preventive resin restoration (PRR) material (a minimally invasive procedure to protect a tooth). A PRR restoration is not intended to prevent caries but intended to be used in the treatment of caries. Because Calcium Bridge is highly radio-opaque this allows for easy radio-graphic observation compared to enamel, dentin, and possible secondary caries.

This document is a 510(k) summary for a dental device called "Calcium Bridge." It compares the device to a predicate device, "Tetric EvoCeram," to demonstrate substantial equivalence. It does not contain information about a study proving the device meets acceptance criteria related to AI or digital image analysis. Therefore, it's not possible to provide the requested information.

The document discusses the following properties, which could be considered acceptance criteria for a dental material:

Table of Acceptance Criteria and Reported Device Performance (as inferred from the provided test values):

Missing Information (based on your request, but not present in the document):

The document does not describe a study involving human readers, AI, or ground truth establishment in the context of diagnostic performance. Therefore, I cannot answer the following parts of your request:

• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How the ground truth for the training set was established.

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Calcium Hydroxylapatite Vocal Fold Implant is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue-bulking agent. Calcium Hydroxylapatite Vocal Fold Implant injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved phonation. Vocal fold insufficiency associated with serious aspiration difficulties may be an urgent indication.

Calcium Hydroxylapatite Vocal Fold Implant is a ready to use product. Calcium Hydroxylapatite Vocal Fold Implant is comprised of calcium hydroxylapatite particles, blended into an aqueous gel formulated from sodium carboxymethyicellulose, glycerin, and a phosphate buffer. The gel acts as a carrier for the particles to facilitate placement. The main component of Calcium Hydroxylapatite Vocal Fold Implant is synthetic calcium hydroxylapatite, a material with over thirty years of use as an implant material used in orthopedics, neurosurgery, dentistry, otolaryngology, plastic surgery and ophthalmology. Calcium hydroxylapatite is also the main mineral component found in bones and teeth so it is a major component of the body. The calcium hydroxylapatite meets the requirements of ASTM F1185. The carrier consists of glycerin (USP) sodium carboxymethylcellulose (USP) and phosphate buffer (USP). The carrier resorbs in vivo, so that the calcium hydroxylapatite remains at the site of implantation, providing a scaffold for local tissue infiltration. This cellular infiltrated hydroxylapatite scaffold provides the longterm restoration and augmentation.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Calcium Hydroxylapatite Vocal Fold Implant:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, no specific, quantifiable acceptance criteria (e.g., specific performance metrics, thresholds for success) for the device are detailed. The submission primarily focuses on establishing substantial equivalence to a predicate device rather than fulfilling pre-defined performance criteria through a separate clinical trial with specific endpoints.

The reported device performance is largely qualitative and comparative:

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

The document does not describe a clinical "test set" in the context of a performance study with human subjects for the Calcium Hydroxylapatite Vocal Fold Implant. The primary evidence presented is comparison to a predicate device and pre-clinical (in vitro and animal) studies.

• Pre-clinical tests: In vivo and in vitro tests were performed for biocompatibility. No specific sample sizes (e.g., N for animal studies or specific in-vitro replicates) are provided.
• Data Provenance: The biocompatibility studies cited are "preclinical safety studies and animal implant studies" (source not specified further, but assumed to be internal or from contract labs) and "in vivo and in vitro tests" (source not specified). There's no mention of country of origin for this data or if it was retrospective or prospective in the context of a clinical trial.

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

Not applicable. The submission does not describe a test set requiring expert-established ground truth for performance evaluation in the way a diagnostic AI would (e.g., reading images). The "ground truth" for the device's properties (biocompatibility, material composition, mechanism of action) comes from established scientific principles, ASTM standards (F1185 for the material), and laboratory testing.

4. Adjudication Method for the Test Set

Not applicable, as there is no described test set with human assessments 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 device is an implantable material, not an AI-assisted diagnostic or therapeutic tool for human readers. Therefore, an MRMC study is not relevant to its regulatory submission.

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

Not applicable. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" used for this submission is based on:

• Material Science and Chemistry: Adherence to ASTM F1185 for calcium hydroxylapatite.
• Biocompatibility Testing: Results from in vivo and in vitro tests, as well as animal implant studies.
• Sterilization Standards: Conformance to ISO 17665.
• Risk Management Standards: Adherence to ISO 14971.
• Predicate Device Equivalence: The primary ground truth for its intended use, mechanism of action, and safety profile is implicitly the established track record and regulatory approval of the legally marketed predicate device (K070090, Radiesse Laryngeal Implant).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device.

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The Calcium Gen.2 assay is an in vitro diagnostics reagent system intended for the quantitative determination of calcium in human serum, plasma, and urine on Roche/Hitachi cobas c systems. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany.

The Calcium Gen. 2 test system employs a photometric test method where calcium ions react with a calcium specific polyamino carboxylic acid under alkaline conditions to form a complex. This complex reacts in the second step with EDTA. The calcium concentration is directly proportional to the change in absorbance which is measured photometrically.

Here's an analysis of the provided text regarding the Calcium Generation 2 Assay, focusing on acceptance criteria and study details.

Note: This document is a 510(k) summary, which typically presents performance data to demonstrate substantial equivalence to a predicate device, rather than explicitly stating pre-defined "acceptance criteria" and then proving them met in the same way a clinical trial protocol would. The acceptance criteria are implied by the comparisons made to the predicate device and the typical performance expectations for such assays. The "study" described is the performance characterization of the new device.

Acceptance Criteria and Device Performance

The "acceptance criteria" are implicitly set by the performance of the predicate device and general expectations for clinical chemistry assays, particularly in terms of precision and measuring range. The submission demonstrates that the Calcium Gen. 2 assay performs comparably or better than the predicate device in key areas.

Study Details

The provided document describes the performance characteristics of the Calcium Gen. 2 assay to demonstrate its substantial equivalence to a legally marketed predicate device (Calcium, K921661). This means the "study" is primarily a standalone performance characterization of the new assay.

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

   • Precision: The precision study used multiple samples, including "Human serum" (3 levels) and "Human urine" (4 levels), plus "Precinorm U" and "Precipath U" controls for serum, and "Control Level 1" and "Control Level 2" for urine. The exact number of replicates or individual patient samples per level is not specified beyond "Mean" and "CV Repeatability/Intermediate precision," which typically imply multiple measurements (e.g., n=20, n=40 etc. as per CLSI guidelines) over several days.
   • Interference: Various samples spiked with interferents (icterus, hemolysis, lipemia, magnesium, specific drugs, MRI contrast media) were used. The number of samples for each interference test is not specified, but the results (e.g., "no significant interference up to an X index") indicate a panel of concentrations was tested.
   • Data Provenance: Not explicitly stated but clinical chemistry assay validation studies are typically conducted by the manufacturer in a controlled laboratory setting. The origin (e.g., country) of the specific samples (human serum/urine) or controls used is not provided, but it's reasonable to assume they are representative of patient populations where the assay would be used. The studies are retrospective in the sense that they are laboratory characterizations rather than prospective patient follow-up studies.

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

   • This question is not applicable to this type of device and study. For a quantitative in vitro diagnostic assay, the "ground truth" is typically established by the reference method (e.g., an established highly accurate chemical method) or by the established concentration of a control material. There are no "experts" interpreting images or clinical data to establish ground truth in this context.

3. Adjudication method for the test set:

   • Not applicable. Adjudication methods (like 2+1 or 3+1) are relevant for studies where human interpretation of data (e.g., imaging, pathology slides) contributes to ground truth determination. For an automated quantitative assay, the result is a numerical value, and "adjudication" is not a concept used.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, this device is a laboratory reagent system, not an AI-powered diagnostic imaging or interpretation tool. Therefore, an MRMC study and effects on human reader performance are not relevant.

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

   • Yes, this is a standalone performance study. The Calcium Gen. 2 assay is an in vitro diagnostic reagent system used on an automated analyzer (Roche/Hitachi cobas c systems). The performance data presented (precision, measuring range, interference) directly reflects the algorithm/assay's performance. Human interaction is limited to operating the instrument, performing quality control, and interpreting the numerical result, not in generating the result itself.

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

   • For precision, the ground truth is the "true" concentration of calcium in the control materials or pooled human samples, as determined by a reference method or validated assignment, which is then measured repeatedly by the device.
   • For measuring range (LoB, LoD, LoQ), the ground truth is the analytical performance characteristics empirically determined through dilution series and statistical analysis around the lowest measurable concentrations.
   • For interference, the ground truth is the known concentration of calcium in samples, both with and without the interferent, often compared against a reference method or the predicate device, to see if the interferent causes a clinically significant deviation in the measured calcium value.

7. The sample size for the training set:

   • Not explicitly mentioned, and likely not applicable in the context of this device. This is a chemical assay, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a system would be the R&D and optimization process of the chemical reagents and instrument parameters, based on extensive pre-clinical testing, rather than a distinct "training set" of patient data as might be used for AI/ML models.

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

   • Not applicable as there isn't a "training set" in the AI/ML sense. The development of the assay would involve iterative testing and optimization against known calcium standards and samples with established reference values to ensure accuracy and precision across the intended measuring range.

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The Calcium test system is intended for in vitro diagnostic use in the quantitative determination of the calcium concentration in human serum or plasma on T60 instruments. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.

For in vitro diagnostic use on T60 instrument. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy.

For in vitro diagnostic use for quantitative testing on T60 instrument. Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.

For in vitro diagnostic use for quantitative testing on T60 instrument. Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.

Not Found

The provided text describes the Thermo Fisher Scientific Calcium Test System (Calcium, sCal, Nortrol, Abtrol) and its substantial equivalence to a predicate device, the Bayer ADVIA Calcium assay. The information largely focuses on comparing performance metrics between the new device and the predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text, structured according to your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as a set of pre-defined thresholds the new device had to meet. Instead, it presents a comparison table (Table 1) of various performance attributes between the new device (Calcium) and the predicate device (Bayer ADVIA Calcium assay). The implicit "acceptance" is that the new device's performance is substantially equivalent to or better than the predicate's.

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

• Method Comparison (Serum):

  • Sample Size: N = 112
  • Data Provenance: Not explicitly stated, but it's a comparison to the Bayer ADVIA 2400. Given the submission is from Thermo Fisher Scientific Oy in Finland, and the clinical chemistry context, it's highly likely to be prospective clinical samples, but the country of origin is not specified. It is an in vitro diagnostic device, so the samples used for this study would be human serum/plasma.

• Precision Studies:

  • Sample Size: Not explicitly stated as "N" for the precision studies, but rather by "levels" (e.g., Level 4.0 mg/dL). Typically, precision studies involve running a sample multiple times within a run and across multiple runs. The 'SD' and 'CV(%)' values are calculated from these repeated measurements. The exact number of replicates is not provided.
  • Data Provenance: Not explicitly stated. Likely laboratory-prepared control samples or spiked patient samples.

• Limitations (Interference):

  • Sample Size: Not explicitly stated. Interference studies typically involve spiking samples with known interferents at various concentrations.
  • Data Provenance: Not explicitly stated.

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

For this type of in vitro diagnostic device (a chemical assay), the "ground truth" is established through analytical reference methods or highly accurate laboratory instruments, not by human experts in the way image analysis or clinical diagnosis might be.

• Method Comparison: The new device was compared to the predicate device (Bayer ADVIA 2400). The predicate device itself would have been validated against a reference method. The text also mentions the Bayer ADVIA Calcium assay's traceability to a NIST atomic absorption reference method.
• Traceability: The new device's value has been assigned by using NIST SRM 909b as a primary reference. This implies that NIST standards and reference methods are the "ground truth" for calibrating and validating the assay.

Therefore, there were no human "experts" establishing ground truth in the sense of clinical reviewers for this device. The ground truth relies on established analytical standards and reference measurement procedures.

4. Adjudication Method for the Test Set

Not applicable. As this is an in vitro diagnostic assay, adjudication methods such as 2+1 or 3+1 (often used in clinical image interpretation) are not relevant. The "adjudication" is inherent in the analytical process, where results are compared against reference methods or statistically analyzed for agreement.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is not an AI-assisted diagnostic tool or an imaging device requiring human interpretation. It is a chemical reagent and calibrator system for measuring calcium concentration. Therefore, MRMC studies and "human readers improving with AI" are not relevant to this submission.

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

Yes, in a sense, the entire performance evaluation presented is "standalone" for the device itself. The studies on precision, measuring range, and interference demonstrate the performance of the Calcium test system (reagents, calibrators, and the T60 instrument) independently. The method comparison study also assesses the direct output of the new device relative to the predicate without human intervention in result generation.

7. The Type of Ground Truth Used

The ground truth used for establishing the performance and enabling substantial equivalence determination includes:

• NIST Standards: NIST SRM 909b for primary reference, and the predicate's traceability to a NIST atomic absorption reference method. (This is a form of highly certified reference measurement procedure/material).
• Predicate Device Output: The Bayer ADVIA 2400 Chemistry System's Calcium assay served as the comparative "ground truth" for the method comparison study. The predicate itself would have been validated against a reference standard.
• Laboratory Control Materials/Spiked Samples: Likely used for precision and interference studies.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device that requires a "training set" in the computational sense. It is a chemical reagent-based assay. Its performance is characterized through traditional analytical validation, not by training an algorithm on a dataset.

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

Not applicable, as there is no "training set" for this chemical assay device.

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A calcium test system is a device intended to measure the total calcium level in serum, plasma, and urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Calcium is an in vitro diagnostic assay for the quantitation of Calcium in human scrum, plasma, or urine. Arscnazo-III dye reacts with calcium in an acid solution to form a blue-purple complex. The color developed is measured at 660 nm and is proportional to the calcium concentration in the sample.

The provided text describes the performance characteristics of the Abbott Laboratories Calcium assay (K062855) and its equivalence to a predicate device (Abbott Calcium assay, LN 7D61, K981578). This is an in vitro diagnostic assay, so the acceptance criteria and study data relate to analytical performance, not human-AI collaboration for image analysis.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as a separate, pre-defined set of thresholds. Instead, it demonstrates performance by comparing it to a predicate device and showing acceptable correlation and precision. The "acceptance" is implicitly defined by the substantial equivalence to the predicate.

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

The document indicates "comparative performance studies were conducted" and "precision studies were conducted," but does not specify the sample sizes used for these studies. The data provenance (country of origin, retrospective/prospective) is also not mentioned.

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

This is an in vitro diagnostic assay that measures a chemical concentration. Therefore, the concept of "experts" and "ground truth" in the context of image analysis or diagnostic interpretation by human readers does not apply. The ground truth for such devices is typically established through reference methods or by comparison to legally marketed predicate devices, which is the case here.

4. Adjudication method for the test set

Not applicable, as this is an in vitro diagnostic device measuring a chemical concentration, not a subjective interpretation requiring adjudication of expert opinions.

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 device, not an AI-assisted diagnostic tool for human readers interpreting images or other data.

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

Yes, a standalone performance evaluation was done for the device (K062855) by comparing its results directly against the predicate device (K981578) and also between the two systems (AEROSET and ARCHITECT c8000). The reported performance characteristics (correlation, slope, Y-intercept, precision, linearity, sensitivity) reflect the algorithm's performance in quantitating Calcium. There is no human-in-the-loop component for this type of device.

7. The type of ground truth used

The ground truth was established by:

• Comparison to a Legally Marketed Predicate Device: The performance of the new Calcium assay (K062855) was compared directly to "the Abbott Calcium assay, LN 7D61, (K981578) on the AEROSET and ARCHITECT c8000 Systems (Predicate Device)." This means the established performance of the predicate served as the reference for determining substantial equivalence.

8. The sample size for the training set

The document does not mention a training set or any machine learning/AI components. For a traditional in vitro diagnostic assay, there isn't a "training set" in the sense of AI model development. The assay's parameters would have been optimized during its development, but this process is not detailed here.

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

Not applicable, as there is no mention of a training set for an AI model. For the development of the assay itself, the ground truth would typically be established through rigorous analytical chemistry principles and potentially reference methods, but this information is not provided in the summary.

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For the quantitative determination of Total Calcium in serum, plasma (Lithium Heparin) and urine. For IN VITRO diagnostic use.

Identification. A calcium test system is a device intended to measure total calcium in serum, plasma (Lithium Heparin) and urine. Calcium measurements are used in the diagnosis and treatment of hypercalcemia as a result from hyperparathyroidism, hypervitaminosisD, multiple myeloma and some neoplastic diseases of the bones. It is also used in the diagnosis and treatment of hypocalcemia as a result from hypoparathyroidism, steatorreah, nephritis and pancreatitis

Not Found

This document is a 510(k) premarket notification decision letter from the FDA for the Calcium ADVANCE Assay. It acknowledges the device is substantially equivalent to legally marketed predicate devices. However, this type of document does not contain the detailed study information, acceptance criteria, or performance data that you are requesting.

The information you are asking for, such as specific acceptance criteria for performance, sample sizes used in testing, details about ground truth establishment, or information about MRMC studies, would typically be found in the actual 510(k) submission document itself, which is often a large technical file not publicly released in its entirety in this format. The letter only states that the device is deemed "substantially equivalent" for the stated indications of use.

Therefore, I cannot provide the requested information based on the text provided.

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GenChem Calcium Reagent is intended for the quantitative determination of total calcium in serum, plasma and urine on the Beckman SYNCHRON CX3® System to aid in the diagnosis of diseases associated with hypercalcemia and hypocalcemia.

GenChem's Calcium reagent is a liquid composed of Arsenazo III and buffer for the quantitative determination of Calcium in serum, plasma and urine on the Beckman Synchron CX3® System.

Here's a breakdown of the acceptance criteria and the study details for the GenChem Calcium, Azo Dye Reagent, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Study Details:

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

   • Precision:
     • 60 data points for each of 5 samples (3 serum controls, 2 urine pools). Total 300 measurements.
     • Data provenance: Not explicitly stated, but implies laboratory-prepared control sera and diluted urine pools, likely internal to GenChem or the testing facility.
   • Linearity:
     • Commercially available linearity standards (0 to 15 mg/dL) analyzed in triplicate. Specific number of standards not given, but at least 2 points are needed to determine a slope.
     • Data provenance: Commercially available standards.
   • Sensitivity:
     • 21 replicates of a diluted serum control.
     • Data provenance: Diluted serum control.
   • Analytical Specificity:
     • Hemoglobin, Bilirubin, Lipemia (stock solutions tested with a base pool containing 9.4 mg/dL calcium). Number of samples not specified, but typically involves a few replicates for each interferent.
     • Data provenance: Prepared stock solutions and a base pool.
   • Patient Comparison (Method Comparison):
     • Serum: N = 82 patient specimens
     • Plasma: N = 84 patient specimens
     • Urine: N = 76 patient specimens
     • Data provenance: "collected from adult patients." Country of origin is not specified, but the context implies it was likely from a clinical site in the US. The data is retrospective, as the samples were "collected" and then assayed.

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

   • For Precision, Linearity, Sensitivity, Analytical Specificity: Not applicable. The "ground truth" for these tests comes from known concentrations in control materials or the inherent chemical properties of analytes and interferents.
   • For Method Comparison: The ground truth is established by the results obtained from the predicate device (HICHEM Calcium Reagent for the CX3) on the Beckman CX3 Synchron Analyzer. There is no mention of human experts establishing ground truth for these quantitative measurements.

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

   • Not applicable. This is a quantitative diagnostic device, not one requiring subjective interpretation that would necessitate adjudication among human readers. The performance is assessed by comparing numerical results to expected values or a predicate device.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This is a chemical reagent for an automated analyzer, not an AI-assisted diagnostic imaging or interpretative device. Therefore, MRMC studies and human reader improvement with AI are not relevant.

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

   • Yes, implicitly. The entire performance evaluation describes the standalone performance of the GenChem Calcium Reagent on the Beckman CX3® System. The test results are generated by the algorithm (reagent and instrument's measurement process) without human interpretive input affecting the quantitative result itself (though human interaction is needed for sample loading, running the test, and interpreting the final numerical value in a clinical context).

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

   • Precision, Linearity, Sensitivity, Analytical Specificity: Known concentrations of control materials, linearity standards, or stock solutions.
   • Method Comparison: Results from a legally marketed predicate device (HICHEM Calcium Reagent for the CX3), assuming the predicate device provides accurate measurements, served as the reference for comparison.

7. The sample size for the training set:

   • Not applicable. This device is a chemical reagent and not an AI/machine learning algorithm that requires a training set in the conventional sense. The development of such reagents relies on chemical formulation, optimization, and validation studies rather than data-driven "training."

8. 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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BioForm's Calcium Hydroxylapatite Implant is intended to fill and/or augment dental intraosseous and oral/maxillofacial defects including:

• · Periodontal Defects
• · Ridge Augmentation
• · Extraction Sites
• · Craniofacial Augmentation
• · Cystic Defects

Calcium Hydroxylapatite Implant is a sterile, non-pyrogenic, flexible, semi-solid, cohesive paste containing calcium hydroxylapatite particles. Calcium Hydroxylapatite Implant is intended to fill and/or augment dental intraosseous and oral/maxillofacial defects. Calcium Hydroxylapatite Implant contains calcium hydroxylapatite particles in a pasty gel of glycerin, water and sodium carboxymethylcellulose that acts as a binder for the particles. The calcium hydroxylapatite meets ASTM F1185. The gel ingredients are pharmacoutical grade excipients and are listed as GRAS materials.

Here's an analysis of the provided text regarding the Calcium Hydroxylapatite Implant, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) Premarket Notification Summary from 2003. This type of submission primarily focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing de novo acceptance criteria through rigorous performance studies against predefined metrics. Therefore, the information provided below will reflect this regulatory context. Direct "acceptance criteria" as you might find in a performance study with specific quantitative targets and "reported device performance" against those targets are not explicitly presented in this type of submission. Instead, the "performance" is demonstrated through equivalence to predicates.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission based on substantial equivalence, there are no explicit quantitative acceptance criteria defined for the Calcium Hydroxylapatite Implant. Instead, the "acceptance criteria" are implicitly met by demonstrating that the device is substantially equivalent to legally marketed predicate devices in terms of intended use, technological characteristics, and safety and effectiveness.

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

This document does not describe a clinical performance study with a "test set" in the traditional sense (i.e., a group of patients receiving the device for evaluation against specific clinical endpoints). The submission is based on substantial equivalence to predicate devices, which are already legally marketed.

• Sample Size: Not applicable for a traditional test set in this 510(k) submission.
• Data Provenance: The 'data' supporting equivalence comes from:
  • Descriptions and regulatory filings of the cited predicate devices (e.g., K882682, K852742, K852765, etc.).
  • General understanding of the biocompatibility and mechanism of action of calcium hydroxylapatite and similar bone graft materials, often based on "history of use in many medical devices as well as from preclinical testing and clinical experience" of the material itself.
  • Assertions about the device's characteristics and how they compare to predicates.
  • The document does not refer to prospective or retrospective clinical data collected specifically for this device's performance demonstration.

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

Not applicable. There was no "test set" in a clinical study sense where expert adjudication of ground truth was required for the Calcium Hydroxylapatite Implant.

4. Adjudication Method for the Test Set

Not applicable. No "test set" and no adjudication of ground truth for performance.

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

No. An MRMC comparative effectiveness study was not performed or described in this document. This submission is for a material implant, not an imaging AI diagnostic device. The concept of "human readers" and "AI assistance" improving performance is not relevant to this type of medical device submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a bone graft material, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" in the context of this 510(k) is the established safety and effectiveness profile of the predicate devices and the general scientific understanding of calcium hydroxylapatite as a bone graft material. The submission argues that the Calcium Hydroxylapatite Implant shares fundamental characteristics with these predicates, making it equally safe and effective.

• Ground Truth Sources (Implied):
  • Regulatory history and approvals of predicate devices.
  • Preclinical and clinical experience with similar materials (calcium hydroxylapatite, calcium phosphate glasses) cited indirectly.
  • ASTM standard F1185 for the calcium hydroxylapatite.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. No training set for an AI/ML device.

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