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ELITech Clinical Systems PHOSPHORUS reagent is for the quantitative in vitro diagnostic determination of inorganic phosphorus in human serum and plasma on the Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

ELITech Clinical Systems URIC ACID MONO SL reagent is for the quantitative in vitro diagnostic determination of uric acid in human serum and plasma on the Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.

ELITech Clinical Systems UREA UV SL reagent is for the quantitative in vitro diagnostic determination of urea nitrogen in human serum and plasma on the Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.

ELITech Clinical Systems ELITROL I is a multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer. ELITech Clinical Systems ELITROL II is a multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior analyzer and the Vital Scientific Flexor Junior analyzers.

ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.

The device for this submission is available as kit only. It consists of 2 reagents: Reagent 1 contains Tris buffer (pH 7.60), Adenosine diphosphate potassium salt (ADP), alpha-Ketoglutarate, Urease (jack bean), Glutamate dehydrogenase (GIDH) (bovine liver) and sodium azide. Reagent 2 contains NADH and sodium azide

The device for this submission is available as kit only. It consists of 1 reagent R. Reagent R consists of sulfuric acid and ammonium molybdate.

The device for this submission is available as kit only. It consists of 1 reagent R. Reagent R consists of Phosphate buffer (pH 7.0), N-Ethyl-N-(2-Hydroxy-3-Sulfopropyl) m-Toluidine (EHSPT), Ferrocyanide, Amino-4-antipyrine (4-AAP), Uricase (microorganisms), Peroxidase (horseradich) and sodium azide.

ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.

The provided text describes several in vitro diagnostic (IVD) devices: ELITech Clinical Systems ELICAL 2 (calibrator), ELITech Clinical Systems UREA UV SL (reagent), ELITech Clinical Systems PHOSPHORUS (reagent), ELITech Clinical Systems URIC ACID MONO SL (reagent), and ELITech Clinical Systems ELITROL I and ELITROL II (controls).

The studies performed for these devices are primarily method comparison and precision studies, focusing on demonstrating substantial equivalence to predicate devices rather than proving a specific clinical utility through a multi-reader multi-case study or a standalone algorithm performance study.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating equivalence to the predicate devices. The performance metrics presented are directly compared.

For ELITech Clinical Systems UREA UV SL (K100263):

For ELITech Clinical Systems PHOSPHORUS (K100263):

For ELITech Clinical Systems URIC ACID MONO SL (K100263):

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

• UREA UV SL: The method comparison study gives a range of 4.4 to 139.8 mg/dL for the device. The R-value of 0.999 implies a good correlation across the study range. While a specific number of samples isn't explicitly stated, the R-value is usually calculated from a sufficiently large set of patient samples spanning the analytical range. The data provenance is not stated (e.g., country of origin, retrospective/prospective), but it is implied to be clinical samples used for method comparison.
• PHOSPHORUS: The method comparison study gives a range of 2.02 to 20.08 mg/dL for the device. The R-value of 0.999 implies a good correlation. Similar to UREA UV SL, the number of samples is not explicitly stated, and data provenance is not provided but implied to be clinical samples.
• URIC ACID MONO SL: The method comparison study gives a range of 1.49 to 24.40 mg/dL for the device. The R-value of 0.999 implies a good correlation. The number of samples is not explicitly stated, and data provenance is not provided but implied to be clinical samples.

For ELICAL 2, ELITROL I, ELITROL II: These are calibrators and controls; their performance is validated through stability studies and their intended use in calibrating and controlling assays. No "test set" in the sense of patient samples for diagnostic performance is applicable here. The device description for ELICAL 2, ELITROL I, and ELITROL II mentions they are "prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A." This suggests human-derived materials.

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

Not applicable. These are in vitro diagnostic devices for quantitative measurements, not imaging or subjective diagnostic interpretations requiring expert consensus for ground truth. "Ground truth" in this context refers to the measured values obtained by the predicate device or a reference method for the method comparison studies.

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.

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 requiring human reader studies.

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

This is an IVD reagent and calibrator kit, not an algorithm. The performance data presented (e.g., precision, method comparison, LoD, LoQ) represents the "standalone" analytical performance of the device on the specified analyzer (Selectra Junior/Flexor Junior).

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

The ground truth for the method comparison studies is the quantitative result obtained from the predicate device (ABX PENTRA UREA CP, ABX PENTRA PHOSPHORUS CP, ABX PENTRA URIC ACID CP) or a reference method assumed to be the "truth" for those studies. For precision studies, there isn't an external "ground truth" but rather a measure of the device's own reproducibility.

8. The sample size for the training set

Not applicable. These are traditional IVD reagents and calibrators, not machine learning algorithms that require a "training set."

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

Not applicable. As above, no training set for a machine learning algorithm is involved.

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The S-Test Inorganic Phosphorous Reagent is intended for the quantitative determination of inorganic phosphorous concentration in serum or heparin plasma using the S40 Clinical Analyzer. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test Uric Acid Reagent is intended for the quantitative determination of uric acid concentration in serum or heparin plasma using the S40 Clinical Analyzer. Uric acid measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test inorganic phosphorus (IP) reagent cartridge, used with the S40 Clinical Analyzer, is intended for quantitative in vitro diagnostic determination of IP in serum or heparin plasma based on a photometric test measuring the formation of molybdenum blue from IP and ammonium molybdate.

The S-Test uric acid (UA) reagent cartridge, used with the S40 Clinical Analyzer, is intended for quantitative in vitro diagnostic determination of UA in serum or heparin plasma based on a photometric test measuring the formation of a reddish-purple pigment.

Here's a breakdown of the acceptance criteria and study information for the Alfa Wassermann S-Test IP and S-Test UA reagent cartridges, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct pass/fail thresholds in a separate section. Instead, the "Performance Data" section describes the results of various tests, and the "Conclusions" section states that the device is "safe and effective" and demonstrates "substantial equivalence to the predicate devices" based on this data. I will present the reported performance data, which implicitly serves as the criteria met for acceptance.

S-Test Inorganic Phosphorus (IP) Reagent Cartridge

S-Test Uric Acid (UA) Reagent Cartridge

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

• S-Test IP:
  • Sample Size: 95 samples for the main correlation study. "Patient correlation studies at three separate POL sites" are also mentioned, implying additional samples, but the total number for these POL studies is not explicitly stated.
  • Data Provenance: Not explicitly stated, but "patient correlation studies at three separate POL sites" and "in-house" studies suggest data collected from different clinical settings and the manufacturer's laboratory, likely within the US given the context of a US FDA submission. It is reasonable to assume these were prospective or a mix of retrospective and prospective, as "patient samples" would either be freshly collected or archived. The summary does not specify.
• S-Test UA:
  • Sample Size: 183 samples for the main correlation study. Similar to IP, "patient correlation studies at three separate POL sites" were also conducted, with the total sample size for these not specified individually.
  • Data Provenance: Similar to IP, likely from various clinical sites (POLs) and in-house, presuming US origin. The summary does not explicitly state if the data was retrospective or prospective.

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

This information is not provided in the document. The "ground truth" for these types of diagnostic tests is typically established by comparison to a recognized predicate or reference method run on a different, established analyzer (as indicated by "comparison method" in the accuracy studies) rather than human expert interpretation of raw data.

4. Adjudication Method for the Test Set

This information is not applicable/not provided as the ground truth is established through a quantitative comparison method, not expert consensus 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

This information is not applicable. This is not an AI/imaging device that involves human readers or an MRMC study. It is an in vitro diagnostic device for chemical analysis.

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

This information is not applicable. This describes the performance of a reagent cartridge on a clinical analyzer, which is inherently a "standalone" measurement system for the biochemical assay it performs. There is no "algorithm" in the AI sense, nor a human-in-the-loop component for interpretation of the primary measurement.

7. The Type of Ground Truth Used

The ground truth was established by a "comparison method" using predicate or reference devices/methods. This means the results from the S-Test cartridges on the S40 Clinical Analyzer were compared against measurements from other commercially available, legally marketed diagnostic systems (e.g., ACE plus ISE/Clinical Chemistry System, Olympus AU640 Clinical Chemistry Analyzer, Piccolo® xpress Chemistry Analyzer reagents or similar) that measure inorganic phosphorus and uric acid.

8. The Sample Size for the Training Set

This information is not provided. Given that this is a traditional in vitro diagnostic device measuring chemical concentrations, there isn't a "training set" in the machine learning sense. The device's performance characteristics (precision, accuracy, sensitivity) are inherently part of its design and manufacturing process, and validated through the performance studies described, rather than "trained" on data.

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

This information is not applicable as there is no "training set" in the context of this device. The reagents and analyzer are developed and manufactured to perform the specified chemical reactions, with their analytical performance validated through studies against established methods.

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PHS reagent, in conjunction with SYNCHRON® Systems and SYNCHRON PTIS reagent, in ochjanoued for use in the quantitative determination of inorganic phosphorus in human serum, plasma, or urine.

Measurements of phosphorus (inorganic) are used in the diagnosis and incasuromento of in disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

The SYNCHRON Systems PHS reagent is designed for optimal performance on the CX (CX4CE/4/4PRO, CX5CE/52/5PRO, CX7/7RTS/7A/7PRO, SYNCHRON CX9ALX/9PRO) and LX (LX20/PRO/LXi 725) Systems. The reagent kit contains two 300-test cartridges that are packaged separately from the associated calibrator.

Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and the study that demonstrates the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the SYNCHRON® Systems Phosphorus (PHS) Reagent does not explicitly state pre-defined acceptance criteria with numerical targets (e.g., "Slope must be between 0.95 and 1.05"). Instead, it presents performance data (method comparison, linearity, and imprecision) and implies that these results demonstrate substantial equivalence to the predicate device.

However, based on the common practices for in vitro diagnostic (IVD) device submissions and the provided predicate comparison, we can infer the implied acceptance criteria:

• Slope: Close to 1.0
• Intercept: Close to 0.0
• R (Correlation Coefficient): Close to 1.0 (indicating a strong linear relationship) | Serum:
• Slope: 0.997 (Very close to 1.0)
• Intercept: -0.04 (Very close to 0.0)
• R: 0.998 (Excellent linear correlation)
  Urine:
• Slope: 0.976 (Close to 1.0)
• Intercept: 0.25 (Reasonably close to 0.0)
• R: 0.996 (Excellent linear correlation)
  Meets Criteria: The reported values for both serum and urine demonstrate excellent agreement and strong correlation with the predicate device, indicating substantial equivalence in measurement accuracy across relevant sample types. |
  | Imprecision | The device should demonstrate acceptable within-run and total imprecision (reproducibility) for various concentrations of inorganic phosphorus in serum and urine. This is usually assessed by a low %CV (Coefficient of Variation) at different concentration levels. The acceptable %CV values would be determined by clinical relevance and comparison to the predicate or similar devices. | Within-Run Imprecision:
• Serum 1 (2.0 mg/dL): 2.4 %C.V.
• Serum 2 (6.6 mg/dL): 1.4 %C.V.
• Urine 1 (41.1 mg/dL): 1.0 %C.V.
• Urine 2 (78.3 mg/dL): 1.2 %C.V.
  Total Imprecision:
• Serum 1 (2.0 mg/dL): 2.7 %C.V.
• Serum 2 (6.6 mg/dL): 1.5 %C.V.
• Urine 1 (41.1 mg/dL): 1.5 %C.V.
• Urine 2 (78.3 mg/dL): 1.6 %C.V.
  Meets Criteria: The %C.V. values for both within-run and total imprecision are consistently low (all below 3%), indicating excellent precision and reproducibility across the tested concentrations and sample types. This is generally considered acceptable for clinical chemistry assays. |
  | Linearity | The device should provide measurements that are linear across its claimed analytical measurement range. (While not explicitly detailed with data in the summary, linearity experiments are mentioned as being performed to demonstrate equivalence). | Reported: "Equivalence is demonstrated through method comparison, linearity, and imprecision experiments."
  Meets Criteria: The submission states that linearity experiments were performed and contributed to the finding of substantial equivalence. While specific data isn't provided, its inclusion in the summary implies acceptable results. |

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

• Method Comparison Test Set:
  • Serum: 114 samples (n=114)
  • Urine: 81 samples (n=81)
• Imprecision Test Set:
  • For each of the 4 samples (Serum 1, Serum 2, Urine 1, Urine 2), the "N" value listed is 80. This typically refers to the number of replicates or data points used in the imprecision study.
• Data Provenance: Not explicitly stated. For 510(k) submissions, data is typically generated internally by the manufacturer or by a contracted lab. The document does not specify the country of origin or if the data was retrospective or prospective. Given the nature of a reagent performance study, it's most likely prospective data collected specifically for the submission.

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

This information is not applicable to this type of device (in vitro diagnostic reagent). For a phosphorus reagent, the "ground truth" is established by a reference method or a highly accurate clinical analyzer (in this case, the predicate device, Beckman Coulter SYNCHRON PO4 Assay on CX Systems). Expert consensus or human interpretation (like in imaging studies) is not used to establish the "ground truth" for quantitative chemical measurements.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (e.g., 2+1, 3+1) are used when human interpretation or expert opinion is involved in establishing a ground truth for qualitative or semi-quantitative results, particularly in areas like medical imaging. For a quantitative chemical assay, the comparison is directly between the candidate device's numerical output and the predicate device's numerical output.

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

No, an MRMC study was not done. This type of study is relevant for devices where human readers interpret diagnostic information (e.g., radiologists reading images) and the AI aims to assist or replace that human interpretation. The SYNCHRON PHS Reagent is an automated in vitro diagnostic assay where the output is a numerical value, not an interpretation by a human reader.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The entire performance summary (method comparison, linearity, and imprecision) is a demonstration of the SYNCHRON PHS Reagent's in vitro performance, independent of human interpretation or intervention beyond operating the analyzer. The results presented directly reflect the algorithm's (reagent's) ability to measure phosphorus.

7. Type of Ground Truth Used

The ground truth for the method comparison study was established by the predicate device, the Beckman Coulter SYNCHRON PO4 Assay on CX Systems. For imprecision studies, the ground truth is the "true" concentration of the sample, which is often determined through meticulous preparation of control materials or by a highly accurate reference method.

8. Sample Size for the Training Set

This information is not provided and is not typically relevant for a traditional chemical reagent assay like the SYNCHRON PHS Reagent. Chemical reagents are designed based on established chemical reactions and principles. They do not typically involve "training sets" in the machine learning sense. The performance data presented (method comparison, imprecision) serves as the validation of the reagent's performance.

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

As explained in point 8, a "training set" in the machine learning sense is not applicable here. The development of a chemical reagent involves chemical formulation, optimization of reaction conditions, and calibration using known reference materials. The "ground truth" for calibration and optimization would be highly characterized reference materials with known concentrations of inorganic phosphorus.

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The ATAC PAK Phosphorus Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of inorganic phosphorus in serum and plasma. Phosphorus results are used for the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

The ATAC PAK Phosphorus Reagent determines phosphorus through its reaction with molybdate to form a phosphomolybdate complex. The resulting increase in absorbance at 340 nm is proportional to the phosphorus concentration in the sample.

Here's a breakdown of the acceptance criteria and the study details for the ATAC PAK Phosphorus Reagent Kit, based on the provided text:

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

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The Piccolo Phosphorus Test System (presently contained on the Renal Function Panel Reagent disc) used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of phosphorus in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.

Phosphorus The phosphorus assay is used for the quantitiation of phosphorus in human heparinized whole blood, heparinized plasma or serum. Phosphorus measurements are used in the diagnosis and treatment of renal insufficiency, hypoparathyroidism, vitamin D imbalance, a high calcium diet, hyperparathyroidism, and insulin treatment of diabetic ketacidosis.

The Piccolo Renal Function Panel Reagent Disc (which contains the Piccolo Phosphorus Test System) is designed to separate a heparinized whole blood sample into plasma and blood cells. The disc meters the required quantity of plasma and diluent, mixes the plasma with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted plasma mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer. Alternately, the disc may also be used with serum.

Here's a summary of the acceptance criteria and the study details for the Abaxis Piccolo® Phosphorus Test System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" but rather presents performance characteristics derived from linearity and precision studies. The implicit acceptance is that these results demonstrate the device performs "as well as the legally marketed device."

2. Sample Size for the Test Set and Data Provenance

• Linearity Study: Sample range 2 - 17 mg/dL. The exact number of individual samples (data points) used to determine linearity properties (slope, intercept, correlation coefficient) is not explicitly stated, beyond the range.
• Precision Study: n = 80 for both within-run and total precision at each of the two levels tested. This n likely refers to the number of replicates over time or runs to calculate precision.
• Sample Type Comparison: The document does not specify the number of samples used for this comparison.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the context of a 510(k) submission for a clinical laboratory device, these studies are typically conducted under controlled laboratory conditions, which would be considered prospective for the purpose of device validation.

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

No experts were used to establish ground truth in this type of study. These are analytical performance studies for an in vitro diagnostic device measuring a chemical analyte. The "ground truth" for linearity and precision is established by the reference methods or highly accurate control materials used to create the samples and by the inherent statistical calculations for precision.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is an analytical performance study, not one requiring expert adjudication of clinical findings.

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

No MRMC comparative effectiveness study was done. This type of study is typically associated with image-based diagnostic aids or clinical decision support systems where human interpretation is involved. This device is an automated chemistry analyzer, so human reader improvement is not a relevant metric.

6. Standalone Performance Study

Yes, the studies described (linearity, precision, sample type comparison) represent the standalone performance of the algorithm/device (Piccolo® Phosphorus Test System). These tests evaluate the inherent analytical capabilities of the system without human intervention in the result generation process itself, beyond operating the instrument.

7. Type of Ground Truth Used

• Linearity: The ground truth is established by the known concentrations of the samples used in the linearity study (e.g., diluted reference materials or spiked samples).
• Precision: The ground truth is the mean concentration of the control materials or samples tested, against which the variability (SD, CV) is measured.
• Sample Type Comparison: The ground truth is the measured values from the different sample types (serum, plasma, whole blood) compared against each other, presumably with one acting as a reference or a comparison of their inherent differences.

8. Sample Size for the Training Set

The document does not mention a "training set" or "training data." This is because the Piccolo® Phosphorus Test System is a quantitative chemical analyzer based on established enzymatic endpoint reaction methodology. Its performance is characterized analytically, rather than through machine learning models that require training data. The device likely uses factory-calibrated lot-specific data for calibration, as mentioned in Table 1, but this is not a "training set" in the machine learning sense.

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

Not applicable, as no training set (in the machine learning context) was described or used.

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The FOSFATEMIA UV AA test system is a device intended to measure inorganic phosphorus in serum, plasma and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

End point method. Inorganic phosphate reacts with molybdate in the presence of acid to form a phosphomolybdate complex that is measured photometrically at 340 nm.

This document describes the Wiener lab. FOSFATEMIA UV AA Test System, an in-vitro diagnostic device for measuring inorganic phosphorus. The device's acceptance criteria and the study proving its performance are focused on demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Wiener lab. FOSFATEMIA UV AA Test System are primarily based on its equivalence and performance characteristics compared to the predicate device, the ROCHE DIAGNOSTICS / BOEHRINGER MANNHEIM CORP. INORGANIC PHOSPHORUS test system.

2. Sample Sizes Used for Test Set and Data Provenance

The provided document describes the device in terms of its characteristics and comparison to a predicate device for 510(k) submission. It does not present data from a clinical test set with specific sample sizes for patients or samples used to validate its performance. The information provided is about the device's technical specifications and a general claim of substantial equivalence.

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

This document does not mention the use of experts to establish ground truth for a test set. This type of information would typically be found in detailed performance studies, which are not included here. The "ground truth" for the comparison is the specifications of the predicate device.

4. Adjudication Method for the Test Set

As no specific clinical performance study or test set evaluation is detailed, no adjudication method is mentioned or implied.

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

No MRMC comparative effectiveness study was performed or described in this document. This device is an in-vitro diagnostic test, not a medical imaging device or AI-assisted diagnostic tool that would typically involve human readers.

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

This device is an in-vitro diagnostic test, not an algorithm in the typical sense of AI/ML. Its performance is inherently standalone as it performs chemical reactions and provides a quantitative measurement. The information provided is essentially its standalone performance characteristics in comparison to a predicate device.

7. Type of Ground Truth Used

The "ground truth" implicitly used for the purpose of this 510(k) submission is the established performance characteristics and specifications of the legally marketed predicate device (ROCHE DIAGNOSTICS / BOEHRINGER MANNHEIM CORP. INORGANIC PHOSPHORUS test system). The Wiener lab. device is asserting its equivalency to these established standards.

8. Sample Size for the Training Set

This document does not report on a training set sample size. Such a concept is typically relevant for machine learning algorithms, which is not the nature of this in-vitro diagnostic device.

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

As there is no training set described for this device, the method for establishing ground truth for a training set is not applicable and therefore not provided.

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The inorganic phosphorus reagents: product No. 112-01 and 112-02 are intended for Invitro The morganic phosphords reagence from the determination of inorganic phosphate in serum, or plasma.

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Here's an analysis of the provided text regarding acceptance criteria and study details for the Inorganic Phosphorus (IP) device:

The provided documents are a 510(k) clearance letter from the FDA and the "Indications for Use" statement for the device. These documents do not contain the specific details required to answer all your questions about acceptance criteria, detailed study design, and performance metrics.

The 510(k) process primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring a detailed de novo clinical trial with explicit acceptance criteria and performance data as would be found in a Premarket Approval (PMA) application or a more extensive clinical study report for an in vitro diagnostic (IVD).

Therefore, many of your questions cannot be answered directly from the provided text. I will answer what is available and indicate where the information is missing.

Acceptance Criteria and Study for Inorganic Phosphorus (IP) Device (K991867)

Based on the provided documents, comprehensive details regarding acceptance criteria and the study that proves the device meets them are not fully available. The FDA clearance letter indicates a finding of "substantial equivalence" to a predicate device, which is the primary regulatory hurdle for a 510(k) submission. This suggests that the device's performance was compared to a known, legally marketed device, and found to be sufficiently similar.

The "Indications for Use" states: "The inorganic phosphorus reagents: product No. 112-01 and 112-02 are intended for Invitro quantitative determination of inorganic phosphate in serum, or plasma."

Here's an attempt to answer your questions based on the limited information:

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

   Acceptance Criteria	Reported Device Performance
   Not explicitly stated in the document. The primary "acceptance criterion" for 510(k) clearance is demonstrating "substantial equivalence" to a predicate device. This would typically involve showing comparable accuracy, precision, and linearity to the predicate.	Not explicitly stated in the document. Performance data (e.g., accuracy, precision studies) would have been submitted to the FDA to support substantial equivalence, but are not detailed in these public-facing letters.

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

   • Sample Size: Not specified in the provided documents.
   • Data Provenance: Not specified in the provided documents.

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

   • Not applicable / Not specified. For in vitro diagnostic assays like inorganic phosphorus, "ground truth" is typically established by comparing results to a reference method, a predicate device, or using certified reference materials, rather than expert consensus on images or interpretations. The concept of "experts establishing ground truth" in the way described for imaging studies is not directly relevant here.

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

   • Not applicable / Not specified. Adjudication methods are typically used in studies involving subjective interpretations (e.g., medical imaging reads). For a quantitative IVD, direct comparison to a reference standard or predicate device is more common.

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

   • No. This is an in vitro diagnostic (IVD) device for measuring a chemical analyte, not an AI-assisted diagnostic imaging tool. Therefore, MRMC studies and "human readers improve with AI" questions are not relevant to this device.

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

   • Yes, in essence. An IVD device performs autonomously in a lab setting to generate a result. The "performance" assessed would be the analytical performance of the assay itself (e.g., accuracy, precision, linearity, interference). There isn't an "algorithm" in the typical sense of AI, but rather a chemical reaction and measurement process.

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

   • Likely a combination of:
     • Reference Methods: Comparison against established, highly accurate laboratory methods for inorganic phosphorus.
     • Predicate Device Comparison: Direct comparison of results from the subject device to results from the legally marketed predicate device using patient samples.
     • Certified Reference Materials: Using materials with known, traceable concentrations of inorganic phosphate to verify accuracy.

8. The sample size for the training set

   • Not specified. This pertains to the analytical performance evaluation rather than a machine learning "training set". The development and validation of the chemical reagents and measurement system would involve various sample types and numbers, but it's not described as a "training set" in the context of typical AI/ML studies.

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

   • Not applicable / Not specified in this context. As noted, this is not an AI/ML device with a "training set" in the modern sense. The "ground truth" for developing and validating the chemical assay would rely on established analytical chemistry principles, reference methods, and quality control materials.

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The Roche Diagnostics, Boehringer Mannheim Inorganic Phosphorus reagent is intended for use for the quantitative in vitro determination of phosphorus in human serum, plasma and urine with automated clinical chemistry analyzers.

According to the Code of Federal Regulations, Title 21 (Food and Drugs), Part 862.1580, a Phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

Endpoint method with sample blanking.

Inorganic phosphate forms an ammonium phosphomolybdate complex with ammonium molybdate in the presence of sulfuric acid. The complex is determined photometrically in the ultraviolet region (340 nm).

The provided text describes the 510(k) summary for the Roche Diagnostics, Boehringer Mannheim Inorganic Phosphorus Reagent. This submission seeks substantial equivalence to an existing device, focusing on extended claims for specimen collection, reportable range (urine), imprecision, and method comparison (urine).

Here's an analysis of the provided information concerning acceptance criteria and the study:

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

The document describes the changes and similarities to the predicate device but does not explicitly state specific acceptance criteria (e.g., performance targets, accuracy thresholds) or provide a table directly comparing acceptance criteria with reported device performance for the extended claims.

However, it implicitly refers to performance characteristics for the extended claims. The "Limitations - Interferences" section provides some performance details related to interference, which could be considered partial performance data, though not directly tied to explicit acceptance criteria:

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

The provided text does not specify the sample size used for the test set for any of the performance characteristics or the data provenance (country of origin, retrospective/prospective nature). It only states that specific data on the performance of the system has been incorporated into the draft labeling in Section V and that data related to extended claims is described in Section VI. These sections are not included in the provided document.

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 to this type of in vitro diagnostic device (reagent for chemical analysis). Ground truth for chemical assays is typically established through reference methods and calibrated instruments, not expert human interpretation.

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

This information is not applicable to this type of in vitro diagnostic device. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective human interpretation (e.g., medical imaging, pathology).

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 to this type of in vitro diagnostic device. MRMC studies and concepts of human reader improvement with AI assistance are relevant to AI-based diagnostic tools that assist human interpreters (e.g., radiologists, pathologists). This device is a chemical reagent.

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

This information is not applicable in the context of an AI algorithm. For this chemical reagent, "standalone performance" refers to the performance of the reagent on an automated clinical chemistry analyzer without manual human intervention in the measurement process, which is inherent to its intended use with "automated clinical chemistry analyzers." However, the document does not explicitly detail the standalone performance study protocol or results beyond general statements about "performance characteristics."

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

For this type of chemical reagent, the ground truth for performance evaluation (e.g., accuracy, precision) would typically be established using:

• Reference materials/calibrators: Samples with known, validated concentrations of inorganic phosphorus.
• Reference methods: Established, highly accurate analytical methods considered the gold standard for measuring inorganic phosphorus.

The document does not explicitly state the type of ground truth used, but these are the standard practices for verifying the performance of such devices.

8. The sample size for the training set:

This information is not applicable because the device is a chemical reagent, not an AI or machine learning algorithm that requires a "training set."

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

This information is not applicable as there is no "training set" for this chemical reagent.

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