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The fructosamine reagent (R1), product No. FR10-01 is intended for Invitro Diagnostic use in the automated, quantitative determination of fructosamine in serum, or plasma.

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The document provided is a 510(k) clearance letter from the FDA for a Fructosamine reagent, not a study report or technical documentation for a medical device with an algorithm/AI component. Therefore, it does not contain the information requested regarding acceptance criteria and a study proving device performance.

Specifically, the letter:

• Grants substantial equivalence to a predicate device. This means the device is considered as safe and effective as a legally marketed device, but it does not detail the specific performance metrics or studies conducted by the manufacturer to demonstrate this.
• Mentions "Indications For Use" but does not provide performance criteria or study results.
• Does not refer to any AI/algorithm component, human reader performance, or ground truth establishment.

Therefore, I cannot extract the requested information from this document.

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This Magnesium procedure is invitro Diagnostic use in the automated, quantitative determination of Magnesium in serum. Magnesium measurements are use in the diagnostics and treatment of hypomagnesemia (abnormally low levels of serum magnesium) and hypermagnesimia (abnormally high levels of serum magnesium).

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Unfortunately, the provided text does not contain the specific information needed to answer your request. The document is a 510(k) clearance letter from the FDA for a "Magnesium" diagnostic device, indicating its substantial equivalence to a predicate device for the in vitro quantitative determination of magnesium in serum.

However, it does not provide details about:

1. Acceptance criteria and reported device performance: This letter confirms clearance, but doesn't detail the performance metrics.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, or type of ground truth for the test set. These are typically found in the summary of safety and effectiveness, clinical study reports, or validation documents, which are not included here.
3. Sample size for the training set or how its ground truth was established. This information is also absent from the provided FDA clearance letter.

To answer your questions, you would need access to the actual 510(k) submission, specifically the sections dealing with device performance studies and validation.

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This Alkaline Phosphatase procedure is intended for Invitro Diagnostic use in the automated, in serum. Measurments of Alkaline quantitative determination of Alkaline Phosphatase or its isoenzymes are use in the diagnostics and treatment of liver, bone, Phosphatase parathyroid, and intestinal diseases.

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The provided text is a 510(k) premarket notification approval letter for a device called "Alkaline Phosphatase." It does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This document simply approves the device for marketing based on substantial equivalence to a legally marketed predicate device.

Therefore, I cannot extract the requested information from the provided text.

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This LDL-Cholesterol procedure is intended for Invitro Diagnostic use in the automated, quantitative determination of low-density lipoprotein-cholesterol (LDL) in serum. Lipoproteins measurements are use in the diagnosis and treatment of lipid disorders(such as diabetes melitus), artherosclerosis and various liver and renal diseases.

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The provided document is a 510(k) summary from the FDA for a device named "LDL-CHOLESTEROL." It is a regulatory clearance letter and does not contain information about the acceptance criteria, study details, or performance metrics of the device.

Therefore, I cannot provide the requested information based on the given input. The document confirms the device is substantially equivalent to legally marketed predicate devices, but it does not describe the specific studies or data that led to this determination.

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This HDL-Cholesterol procedure is intended for Invitro Diagnostic use in the automated, quantitative determination of high-density lipoprotein-cholesterol (HDL) in serum. Lipoproteins measurements are use in the diagnosis and treatment of lipid disorders(such as diabetes melitus), artherosclerosis and various liver and renal diseases.

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This document is a 510(k) clearance letter from the FDA for a device named "HDL-CHOLESTEROL." 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, or details of a study that proves the device meets specific criteria.

Therefore, I cannot provide the requested information from this document. The letter focuses on regulatory approval based on substantial equivalence, not on the results of a performance study with detailed acceptance criteria.

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The total and direct bilirubin reagents, product No. 122-01,122-02,122-03 and 122-04 are intended for Invitro Diagnostic use in the automated, quantitative determination of total and direct bilirubin in serum, or plasma.

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The provided text is a 510(k) clearance letter from the FDA for a device named "Bilirubin, Total and Direct." This document does not contain information about the acceptance criteria or a study proving the device meets those criteria. It is a regulatory approval document confirming substantial equivalence to a predicate device, not a performance study report.

Therefore, I cannot extract the requested information from the provided text.

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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 ISE Electrolyte (Na+, K+ and Cl-) reagents, product No. 114-01, 1114-02 and 114-03 are intended for Invitro Diagnostic use in the automated, quantitative determination of sodium, potassium and chloride in serum, or plasma.

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This document is a 510(k) clearance letter from the FDA for an "ISE Electrolytes" device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document primarily focuses on the regulatory clearance process and the substantial equivalence determination.

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The AST (SGOT) reagents, product No. 117-01 and 117-02 are intended for Invitro determination of AST (SGOT) in serum, or plasma.

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This document is a 510(k) clearance letter from the FDA for a device named "AST (SGOT)". The document states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has met the regulatory requirements for marketing. However, this letter does not contain specific acceptance criteria or details of a study proving the device meets those criteria in the way a clinical trial report or performance study summary would.

Therefore, I cannot provide the requested information from the given text because the document is a regulatory clearance letter, not a detailed performance study report.

Here's why and what's missing:

• Acceptance Criteria & Reported Performance: The letter states the device is "substantially equivalent," which is the regulatory hurdle, but doesn't define quantitative performance metrics (like accuracy, sensitivity, specificity, or precision) that would be acceptance criteria, nor does it list the specific results of a study against such criteria.
• Sample Size, Data Provenance, Experts for Ground Truth, Adjudication, MRMC, Standalone Performance, Ground Truth Type, Training Set Size & Ground Truth Establishment: These are all details typically found in a clinical study report or a 510(k) summary (which sometimes includes more detail than the clearance letter itself). This letter only grants clearance based on the submission, it doesn't contain the specifics of that submission's performance data.

The "Indications For Use" section on page 2 simply states the device's intended use: "The AST (SGOT) reagents... are intended for In vitro determination of AST (SGOT) in serum, or plasma." This describes what the device does, not how well it does it or the data proving its performance.

To answer your questions, one would need to review the actual 510(k) submission (including the summary of safety and effectiveness data) that the FDA reviewed to make this substantial equivalence determination, not just the clearance letter.

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The Total Iron Binding Capacity (TIBC) reagents, product No. FE109-01, FE109-02 and The Total Iron Binding Capacity (TIDO) reagones processor seni-automated, quantitative determination of TIBC in serum, or plasma.

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This document is a 510(k) clearance letter from the FDA for a Total Iron Binding Capacity (TIBC) device. It confirms the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain the detailed study information required to answer your questions regarding acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment. The document is primarily an FDA regulatory approval letter and an "Indications For Use" statement.

Therefore, I cannot provide the requested information based on the given input.

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