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The Phosphoplastin RL Prothrombin Time reagent is a liquid PT reagent containing thromboplastin derived from rabbit brain and calcium ions for use in the determination of Prothrombin Time (PT) and related coagulation procedures. The PT test is a one-stage test used in routine patient screening for disorders in the extrinsic pathway of coagulation and for monitoring patients undergoing Oral Anti-Coagulant (OAC) therapy. Phosphoplastin RL should only be used in an appropriate clinical laboratory by qualified laboratory personnel and is provided ready-to-use.

Phosphoplastin RL PT reagent is a liquid, ready-to-use reagent containing thromboplastin derived from rabbit brain, calcium ions, buffers, stabilizers and preservatives. Phosphoplastin RL is intended for use in a one-stage prothrombin time (PT) test on citrated human plasma.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the R2 Diagnostics Phosphoplastin RL device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Phosphoplastin RL device are not explicitly stated in a dedicated section with specific numerical thresholds. Instead, the document compares its performance to a predicate device (Phosphoplastin R) to demonstrate substantial equivalence. The implied acceptance criteria revolve around achieving similar performance characteristics.

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

• Sample Size: The document states that "normal and abnormal patient plasma, as well as plasma samples from patients undergoing oral anticoagulant therapy, were tested." However, the specific number of samples for the test set is not provided.
• Data Provenance: The correlation studies were conducted at "two sites." The information does not specify the country of origin, but given the applicant's address (South Bend, IN, USA) and the FDA submission, it's highly likely the studies were conducted in the USA. The studies appear to be retrospective in nature, using existing plasma samples.

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

There is no mention of experts being used to establish a ground truth for the test set. The study compares the performance of the new device against an existing, legally marketed predicate device (Phosphoplastin R), which itself would have established its own reference values during its development. For in-vitro diagnostics like this, the "ground truth" is typically the result obtained from the predicate device or a recognized reference method.

4. Adjudication Method for the Test Set

There is no mention of an adjudication method. As noted above, the study is a comparison against a predicate device, rather than an assessment needing expert interpretation of novel data to establish ground truth.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-reader Multi-case (MRMC) comparative effectiveness study was not done. This type of study is more common for imaging or diagnostic devices where human readers interpret results, and the AI's role is to assist or replace that interpretation. This device is an in-vitro diagnostic reagent, where the output is typically a numerical value (PT/INR), rather than an image or complex data requiring reader interpretation.

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

This is an in-vitro diagnostic reagent, not an algorithm in the typical sense of AI/ML. The "device" itself is the reagent. The performance described is inherently "standalone" in that it's the reagent's performance in generating a PT/INR value when exposed to plasma, independent of human interpretive intervention after the test is run. However, the test is performed in a clinical laboratory by “qualified laboratory personnel,” meaning it's always used with human involvement in its application and result interpretation within a broader clinical context.

7. The Type of Ground Truth Used

The "ground truth" here is the results obtained from the legally marketed predicate device, Phosphoplastin R. The new device's performance is validated by its ability to produce results that are highly correlated and similar to those produced by the predicate device on the same plasma samples.

8. The Sample Size for the Training Set

There is no mention of a training set sample size. This type of device is a chemical reagent, not an AI/ML algorithm that requires a training set. Its formulation is based on biochemical principles, not data-driven learning.

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

As there is no training set for this type of device, this question is not applicable.

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The Phospholin ES Activated Partial Thromboplastin Time reagent is a liquid activated reagent with phospholipids derived from soybean lecithin for use in the determination of Activated Partial Thromboplastin Time (APTT) and related coagulation procedures. Phospholin ES is to be used as an APTT reagent (qualitative assay) on patient plasma for the routine screening in the general patient population for deficiencies involving the intrinsic pathway of coagulation. Phospholin ES is sensitive to lupus-like inhibitors.

R2 Diagnostics Phospholin ES is a liquid reagent containing ellagic acid as the activator and phospholipids derived from soybean lecithin. The reagent also contains buffer and preservatives. Phospholin ES is an in vitro diagnostic reagent intended for use for the performance of the activated partial thromboplastin time two-stage test (APTT) and related coagulation factor assays. Phospholin ES is sensitive to lupus anticoagulants. Phospholin ES as with any APTT test requires the addition on 0.02-0.025M Calcium Chloride to perform the assay.

Here's a breakdown of the acceptance criteria and study information for the R2 Diagnostics Phospholin ES device, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document frames its "acceptance criteria" and "device performance" in terms of substantial equivalence to a predicate device. The performance criteria are primarily correlation coefficients and precision for various sample types.

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Phosphate Buffered Saline (PBS) and Phosphate Buffered Saline, with calcium, magnesium, glucose, pyruvate and phenol red are for in vitro procedures involving the manipulations of gametes and embryos such as oocyte retrieval or embryo transfer, gamete washing, or micromanipulation. They may also be used for cryopreservation of qametes and embryos after the addition of appropriate cryopreservation agent(s).

Phosphate Buffered Saline (PBS) and PBS with calcium, magnesium, glucose, pyruvate and phenol red Medium

This document is a 510(k) clearance letter from the FDA for Phosphate Buffered Saline (PBS) and PBS with additional components, intended for use in in-vitro procedures involving gametes and embryos.

The provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the input text. The letter is a regulatory approval document and not a performance study report.

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The Phosphorus assay is used for the quantitation of inorganic phosphorus in human serum, plasma, or 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.

Phosphorus is an in vitro diagnostic assay for the quantitative determination of inorganic phosphorus in human serum, plasma, or urine. The Phosphorus assay is a clinical chemistry assay in which the inorganic phosphorus in the sample reacts with ammonium molybdate to form a heteropolyacid complex. The absorbance is measured at 340 nm and is directly proportional to the amount of inorganic phosphorus present in the sample.

The Abbott Laboratories Phosphorus assay is an in vitro diagnostic assay for the quantitative determination of inorganic phosphorus in human serum, plasma, or urine. The device's performance was evaluated through comparative studies against the Boehringer Mannheim® Phosphorus Assay (K872494) on the Hitachi® 717 Analyzer to demonstrate substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not explicitly state the sample sizes used for the comparative studies. The data provenance is not specified (e.g., country of origin, retrospective or prospective), but it can be inferred that the samples were human serum, plasma, or urine as per the intended use.

3. Number of Experts and Qualifications

Not applicable. This device is an in vitro diagnostic assay, and its performance is evaluated against a predicate device using analytical parameters rather than expert interpretation of results.

4. Adjudication Method

Not applicable. Adjudication methods are typically employed in studies involving human interpretation or subjective assessment.

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

Not applicable. This is an in vitro diagnostic assay for quantitative measurement, not an AI or imaging device requiring human-in-the-loop performance evaluation.

6. Standalone Performance Study

Yes, a standalone performance study was conducted to determine the device's characteristics such as precision, linearity, and limit of quantitation. These studies were performed using the AEROSET™ System.

7. Type of Ground Truth Used

The "ground truth" for comparison was the performance characteristics of a legally marketed predicate device, the Boehringer Mannheim® Phosphorus Assay (K872494) on the Hitachi® 717 Analyzer. For precision, linearity, and sensitivity, the performance was established directly through the assays themselves, using control materials for precision and known concentrations for linearity and sensitivity.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI algorithm. The assay operates based on chemical reactions and photometric measurements, not a learned model from a training set.

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

Not applicable. There is no training set for this type of in vitro diagnostic assay.

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The Phosphorus assay is used for the quantitation of inorganic phosphorus in human serum, plasma, or 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.

Phosphorus is an in vitro diagnostic assay for the quantitative determination of inorganic phosphorus in human serum, plasma, or urine. The Phosphorus assay is a clinical chemistry assay in which the inorganic phosphorus reacts with ammonium molybdate in dilute sulfuric acid to form the unreduced phosphomolybdate complex. The formation of the unreduced phosphomolybdate is measured at 340 nm and is directly proportional to the amount of inorganic phosphorus present.

The provided text describes a 510(k) summary for the Abbott Laboratories Phosphorus assay, which is an in vitro diagnostic device. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria or conducting studies to meet such criteria for a new type of device. The information requested aligns more with the evaluation of AI/ML-driven medical devices or other devices where performance metrics like sensitivity, specificity, accuracy, and expert consensus are central to the acceptance criteria.

However, I can extract the information provided in the context of demonstrating substantial equivalence for this IVD, mapping it as closely as possible to your requested structure.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of IVD, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices, meaning the new device should have "similar performance characteristics." The reported performance metrics are comparative.

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

The document mentions "Comparative performance studies were conducted" and "Precision studies were conducted using the Phosphorus assay. Within-run, between-run, and between-day studies were performed using two levels of control material." However, it does not specify the sample size used for these studies (e.g., number of serum/urine samples, number of replicates).

The data provenance is not explicitly stated in terms of country of origin but is from "human serum, plasma, or urine." The studies appear to be prospective as they were conducted to demonstrate equivalence for this 510(k) submission.

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

This information is not applicable to this type of IVD study. The "ground truth" (or reference method) is established by the predicate devices themselves (Roche Cobas Mira Plus Phosphorus assay and Boehringer Mannheim Phosphorus assay on the Hitatchi 717 Analyzer), which are established clinical chemistry assays. There is no mention of experts establishing ground truth for individual samples.

4. Adjudication method for the test set

This information is not applicable. As it's a quantitative chemical assay, expert adjudication for results is not typically performed in the way it would be for image interpretation or diagnosis. The "reference" or "ground truth" values for comparison come from the predicate devices.

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. MRMC studies are relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) often with AI assistance. This device is an in vitro diagnostic chemical assay, not an AI-assisted diagnostic tool.

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

This is not applicable in the context of an "algorithm only" device as described for AI/ML. The Phosphorus assay itself is a standalone chemical assay without human interpretation in the workflow of its quantitative result. Its performance is measured directly as an analytical device.

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

The "ground truth" for this device's performance comparison is the results obtained from legally marketed predicate devices:

• Roche Cobas Mira Plus Automated Chemistry System Phosphorus assay (for serum)
• Boehringer Mannheim Phosphorus assay on the Hitatchi 717 Analyzer (for urine)

These predicate devices serve as the reference methods to which the new Phosphorus assay is compared.

8. The sample size for the training set

This information is not applicable to this type of IVD, as there is no "training set" in the context of machine learning or AI models. The assay is a chemical reaction-based method.

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

This information is not applicable as there is no training set.

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For the quantitative determination of inorganic phosphorus in serum. For IN VITRO diagnostic use. Increased serum inorganic phosphorus levels (hyperphosphatemia) are usually the result of Vitamin D overdose, hypoparathyroidism, or renal failure. Decreased serum levels (hypophosphotemia) usually result from rickets, hyperparathyroidism, or Fanconi Syndrome (a defect in absorption of phosphorus and other metabolites from the glomerular filtrate). (1)

The majority of methods for determining inorganic phosphorus are based on the reduction of a phosphorus-molybdate complex with a reducing agent resulting in the subsequent formation of molybdenum blue. In 1972, Daly and Ertingshausen introduced a method for inorganic phosphorus which measured the unreduced phosphorus-molybdate complex. This procedure is a modification of the Daly and Ertingshausen technique (2).

The provided text is a letter from the FDA regarding a 510(k) clearance for a device called "Phosphorus-SL Assay." It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance tables, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document specifically mentions:

• Device Name: Phosphorus-SL Assay
• Indications for Use: For the quantitative determination of inorganic phosphorus in serum. For IN VITRO diagnostic use. Increased serum inorganic phosphorus levels (hyperphosphatemia) are usually the result of Vitamin D overdose, hypoparathyroidism, or renal failure. Decreased serum levels (hypophosphotemia) usually result from rickets, hyperparathyroidism, or Fanconi Syndrome (a defect in absorption of phosphorus and other metabolites from the glomerular filtrate).
• Methodology: The majority of methods for determining inorganic phosphorus are based on the reduction of a phosphorus-molybdate complex with a reducing agent resulting in the subsequent formation of molybdenum blue. In 1972, Daly and Ertingshausen introduced a method for inorganic phosphorus which measured the unreduced phosphorus-molybdate complex. This procedure is a modification of the Daly and Ertingshausen technique.

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria and study information because that information is not present in the provided text. The document is solely a regulatory clearance letter, not a detailed study report.

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