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The SPIFE Lipoprotein-12 System is intended for the separation and quantitation of serum or plasma lipoproteins used in the diagnosis and treatment of lipid disorders, atherosclerosis, and various liver and renal diseases.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "SPIFE Lipoprotein-12 System." This document does not contain the detailed information required to describe the acceptance criteria, study design, or performance metrics in the format requested.

Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or expert details for ground truth.
• Information on adjudication methods, MRMC studies, or standalone algorithm performance.
• Details on the type of ground truth used or the training set sample size and its ground truth establishment.

The letter primarily confirms that the device is substantially equivalent to a predicate device and can be marketed, and it outlines the indications for use. It does not delve into the specifics of validation studies.

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The HYDRAGEL 7 LIPOPROTEIN(E) and HYDRAGEL LIPOPROTEIN(E) 15/30 kits are designed for determination of lipoprotein profiles in human serum. They all utilize the same composition of alkaline buffered agarose gels, same reagents and the same procedure. They are all designed for use with the semi-automated HYDRASYS electrophoresis apparatus. The only differences among the individual kits are the intended number of samples per gel: 7, 15 or 30 samples. The assay is carried out in two stages: · electrophoresis on agarose gel to separate the VLDL, LDL and HDL as well as chylomicrons when present. · visualization of lipoprotein fractions with a lipid specific Sudan black stain; the excess of stain is removed with an alcoholic solution. The resulting electrophoregrams can be evaluated visually for pattern abnormalities or by densitometry to obtain approximate, relative quantification of individual zones. Fredrickson classification of lipoproteins aids in the interpretation of lipoprotein patterns. Both the qualitative (presence of abnormal or absence of normal fractions) and semi-quantitative (relative increase or decrease of fractions) abnormalities necessitate further lipoprotein analyses. The procedure is indicated for the general population for determination of lipoprotein profiles.

The HYDRAGEL 7 LIPOPROTEIN(E) and HYDRAGEL LIPOPROTEIN(E) 15/30 kits are designed for determination of lipoprotein profiles in human serum. They all utilize the same composition of alkaline buffered agarose gels, same reagents and the same procedure. They are all designed for use with the semi-automated HYDRASYS electrophoresis apparatus. The only differences among the individual kits are the intended number of samples per gel: 7, 15 or 30 samples. The assay is carried out in two stages: · electrophoresis on agarose gel to separate the VLDL, LDL and HDL as well as chylomicrons when present. · visualization of lipoprotein fractions with a lipid specific Sudan black stain; the excess of stain is removed with an alcoholic solution. The resulting electrophoregrams can be evaluated visually for pattern abnormalities or by densitometry to obtain approximate, relative quantification of individual zones. Fredrickson classification of lipoproteins aids in the interpretation of lipoprotein patterns.

I am sorry, but the provided text does not contain the detailed information needed to answer your request about acceptance criteria and the study that proves the device meets them.

The document is a 510(k) clearance letter from the FDA for a device called "Hydragel 7 Lipoprotein(E) / Hydragel Lipoprotein(E) 15/30". It indicates that the device has been found substantially equivalent to a legally marketed predicate device.

However, it does not include:

• A table of acceptance criteria or reported device performance.
• Information about sample sizes for test sets or their data provenance.
• Details on the number or qualifications of experts used for ground truth.
• Adjudication methods.
• If an MRMC comparative effectiveness study was done, or its effect size.
• If a standalone (algorithm only) performance study was done.
• The type of ground truth used (e.g., pathology, outcomes data).
• The sample size for the training set.
• How the ground truth for the training set was established.

This document is primarily concerned with the regulatory clearance process based on substantial equivalence, not the detailed performance studies that would typically contain the information you are seeking.

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The Quantimetrix Lipoprint™ System LDL Subfractions is a device intended to measure lipoprotein cholesterol (for lipoprotein fractions and subfractions) in fasting serum or plasma with a Total Cholesterol concentration of ≥ 100 mg/dl. Lipoprotein cholesterol measurements are used as an aid in evaluating lipid metabolism disorders when used in conjunction with other lipid tests, patient risk assessment and clinical evaluation.

Quantimetrix is implementing an analysis software capability to the LipoPrint™ System LDL Subfractions. The software application is used in conjunction with commercially available hardware (computer, scanner and color printer) to analyze scanned tube images and generate characterizations of lipoprotein fractions and subfractions resolved by Lipoprint (VLDL, IDL, LDL, HDL).

The provided text is a 510(k) summary for the LipoPrint™ System LDL Subfractions, detailing its intended use and classification. However, it does not contain the specific information required to answer the question about acceptance criteria and the study proving the device meets those criteria.

The document states that Quantimetrix is implementing an analysis software capability to the LipoPrint™ System LDL Subfractions, and the modification was determined to be "moderate," concerning only the software. It also indicates that the intended use of the modified device remains the same as the unmodified device.

Therefore, crucial information such as acceptance criteria, reported performance, sample sizes, data provenance, expert qualifications, ground truth establishment, adjudication methods, multi-reader multi-case study details, or standalone algorithm performance are not present in the provided text.

Without this information, it is impossible to create the requested table and provide descriptions of the studies.

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HYDRAGEL LDLIHDL CHOL Direct K20, HYDRAGEL 7 LDLIHDL CHOL Direct and HYDRAGEL LDLHDL CHOL Direct 15/30 kits are designed for quantification of the cholesterol canied by the Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) fractions of human serum. The analysis is performed in two stages:

· electrophoresis on agarose get to separate the VLDL, LDL and HDL as well as chylomicrons,

· visualization of lipoprotein fractions based on a sensitive and cholesterol-specific enzymatic procedure involving the cholesterol esterase / cholesterol dehydrogenase system coupled with nitro blue tetrazolium chromogen.

The stained electrophoregrams are intended for visual interpretation to confirm identification of the individual fractions and for densitometry to obtain relative concentrations of cholesterol in the individual lipoprotein fractions. When the sample's total cholesterol value is known, cholesterol distribution in a/dL or mol/L concentrations can be calculated.

The test system is intended for the measurement of the LDL cholesterol and HDL cholesterol. The cholesterol values of only these two fractions are indicated as an aid in the diagnosis and treatment of lipid disorders.

The procedure is indicated for the general population for a direct measurement of:

• . the LDL cholestero! level regardless the triglyceride levels
• the HDL cholesterol level .
• the ratio LDL/HDL cholesterol .

The HYDRAGEL LDUHDL CHOL Direct K20 kit is designed for use with a manual electrophoresis apparatus, K20. The kit is intended to run up to 7 samples per gel.

The HYDRAGEL 7 LDL/HDL CHOL Direct and HYDRAGEL LDL/HDL CHOL Direct 15/30 kits are designed for use with the semi-automated Hydrasys electrophoresis apparatus. These kits are intended to run up to 7, 15 and 30 samples per gel, respectively.

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This document is a 510(k) premarket notification from the FDA, granting clearance for a medical device. It does not contain the detailed acceptance criteria and study information typically found in a clinical study report or a detailed validation document.

The document states that the FDA has reviewed the 510(k) and determined the device is "substantially equivalent" to legally marketed predicate devices. This means the manufacturer demonstrated that their device is as safe and effective as a device already on the market, but it does not typically involve the rigorous clinical study details you're asking for.

Therefore, I cannot provide the requested information from this document. The document refers to the device's "indications for use" and states that "The analysis is performed in two stages," but does not provide performance metrics, acceptance criteria, sample sizes, ground truth methodology, or expert qualifications.

The information you are requesting would usually be found in the 510(k) submission itself (which is not fully provided here) or in a separate validation report prepared by the manufacturer.

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The SPIFE 2000/3000 Lipoprotein System is useful in the prevention of coronary heart disease. Increased dietary fats and cholesterol are associated with atherosclerosis which leads to cardiovascular disease and strokes.

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These two pages contain a Food and Drug Administration (FDA) Substantial Equivalence Determination letter for the "Spife 2000/3000 Lipoprotein System" and an "Indications for Use" statement.

Unfortunately, this document does not contain the information requested regarding acceptance criteria, device performance tables, study details (sample sizes, provenance, ground truth, experts, adjudication, MRMC, standalone performance), or training set information.

This letter is a regulatory approval document stating that the device is substantially equivalent to a previously marketed predicate device and can be marketed. It summarizes the regulatory classification and general controls but does not delve into the specific technical studies or performance data that led to that determination.

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The Cholesterol Profile test system is useful in monitoring LDL, VIDI, and Lp(a)-C cholesterol when present in concentrations HDL. However in some patients Lp(a)-C may not be greater than 2.5 mg/dL. present at concentrations detectable by electrophoresis. Patients at risk include males over the age of 45 years and females over 55 years, those with family history of coronary heart disease, strokes, hypertension or diabetes and those who smoke. Depending on a patient's number of risk factors, treatment can be medication or diet restrictions.

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The provided text is a letter from the FDA regarding the clearance of the "REP® Cholesterol Profile Kit" and does not contain details about acceptance criteria or specific study data proving the device meets them. This type of document typically confirms that a device has been found substantially equivalent to a legally marketed predicate device, rather than providing the detailed performance study results.

Therefore, I cannot extract the requested information based on the input text. The document states that the device is "substantially equivalent" to predicate devices, implying that its performance is considered comparable, but it does not describe the specific studies or acceptance criteria used to establish that equivalence.

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The HYDRAGEL-MINI LIPO, HYDRAGEL LIPO, HYDRAGEL LIPO MAXI, HYDRAGEL, 7 LIPO, and HYDRAGEL 15/30 LIPO kits are designed for determination of lipoprotein profiles in human serum.

All HYDRAGEL LIPO kits utilize the same composition of alkaline buffered HYDRAGEL LIPO agarose gels, same reagents and the same procedure. The only differences among the individual kits are the number of samples per gel and that some kits are for the manual and some for the automated format:

The HYDRAGEL-MINI LIPO , HYDRAGEL LIPO and HYDRAGEL LIPO MAXI kits are designed for use with a manual electrophoresis apparatus. These kits are intended to run up to 5, 8 and 10 samples per gel, respectively.

The HYDRAGEL 7 LIPO and HYDRAGEL 15/30 LIPO kits are designed for use with the semiautomated Hydrasys electrophoresis apparatus. These kits are intended to run up to 7, 15 and 30 samples per gel, respectively,

The resulting electrophoregrams can be evaluated visually for pattern abnormalities or by densitometry to obtain approximate, relative quantification of individual zones. Fredrickson classification of lipoproteins aids in the interpretation of lipoprotein patterns. Indication of the qualitative (presence of abnormal or absence of normal fractions) or semi-quantitative (relative increase or decrease of fractions) abnormalities necessitates further lipoprotein analyses.

I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter for the HYDRAGEL LIPO Kits from the FDA in 1998. This type of document declares substantial equivalence to a predicate device but does not typically include detailed information about specific acceptance criteria or a comprehensive study report with the level of detail you are requesting, especially regarding AI algorithms, multi-reader multi-case studies, and ground truth establishment, which are more relevant to modern AI/ML medical device submissions.

The document mainly focuses on:

• The product names and their indications for use.
• Confirmation of substantial equivalence.
• Regulatory classifications and requirements.
• Contact information for various FDA offices.

There is no mention of acceptance criteria, device performance metrics, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or the ground truth types in the context of an AI/ML device. The device described appears to be a laboratory kit for manual or semi-automated electrophoresis, not an AI-powered diagnostic tool.

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The Cholesterol test system is useful in monitoring LDL and HDL cholesterol levels. Patients at risk include males over 45 years and females over 55 years, those with family history of coronary heart disease, strokes, hypertension or diabetes and those who smoke. Depending on a patients' number of risk factors, treatment can be medication or diet restrictions.

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This is a medical device approval letter from the FDA in 1998, which predates the widespread use of AI in medical devices and the structured reporting of AI-specific performance metrics. Therefore, the document does not contain the information requested regarding a study that proves the device meets AI acceptance criteria. The device described, "REP Cholesterol Profile Template" and "REP Vis Cholesterol", are likely in vitro diagnostic devices, and their "performance" would refer to analytical performance characteristics (e.g., accuracy, precision) as measured in a lab setting, not AI algorithm performance.

Here's why the requested information cannot be extracted:

• No AI Component: The document refers to a "Cholesterol test system." In 1998, this would undoubtedly be a physical diagnostic kit or instrument, not an AI software algorithm.
• Approval Date: The letter is dated May 1, 1998. AI in medical devices, particularly for diagnostic imaging or risk prediction, was not a common or recognized field requiring specific "AI acceptance criteria" or "AI a test sets" at this time.
• Focus of the Letter: The letter is a 510(k) clearance, indicating "substantial equivalence" to predicate devices. This process primarily focuses on intended use, technological characteristics, and safety and effectiveness data (often analytical performance for IVDs) to demonstrate equivalence to a device already legally marketed, rather than novel AI performance evaluation.

Therefore, I cannot provide the requested information in the specified format because the provided document is not relevant to AI-powered medical devices or their specific performance criteria.

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