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The VENTANA CD30 (Ber-H2) Assay is intended for laboratory use in the qualitative detection of the CD30 protein in formalin-fixed, paraffin-embedded tissue stained with a VENTANA BenchMark ULTRA instrument and OptiView DAB IHC Detection Kit. CD30 positive staining may aid in the identification of classical Hodgkin lymphoma (cHL), anaplastic large cell lymphoma (ALCL) and cutaneous T-cell lymphoma (CTCL). This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information and proper controls. This antibody is intended for in vitro diagnostic (IVD) use.

The VENTANA CD30 (Ber-H2) Assay consists of the primary CD30 (Ber-H2) antibody, detection reagents and an instrument (BenchMark ULTRA automated staining instrument). The VENTANA CD30 (Ber-H2) Assay is a mouse monoclonal antibody (IgG1, kappa) directed against CD30. CD30 antigen is expressed in mononuclear Hodgkin's cells and multinucleated Reed Sternberg cells of Hodgkin Lymphoma as well as on anaplastic large cell lymphomas. This antibody variably produces membranous, cytoplasmic, and Golgi staining of both lymphoma cells and of scattered large activated B and T cells in lymph nodes, spleen, tonsil, and thymus. The OptiView DAB IHC Detection Kit is an indirect, biotin-free system for detecting mouse IgG, mouse IgM, and rabbit primary antibodies. This kit is intended to detect antigens by IHC in sections of formalin-fixed, paraffin-embedded (FFPE) and frozen tissues that are stained on the BenchMark ULTRA instrument (note: the VENTANA CD30 (Ber-H2) Assay will not be recommended for use in frozen tissue). The OptiView DAB IHC Detection Kit produces a visible dark brown precipitate (3, 3'-Diaminobenzidine) via a horseradish peroxidase (HRP) enzymatic reaction at the antigen site. The Pathologist evaluates the brown precipitate using Bright-field microscopy.

The provided text describes the 510(k) summary for the VENTANA CD30 (Ber-H2) Assay, an immunohistochemistry (IHC) assay. It details the device's intended use and compares it to a predicate device to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

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

The document implicitly defines acceptance criteria through the comparison to the predicate device. The primary stated performance metric is "overall percent agreement rate".

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

• Test Set Sample Size: The text mentions two sample sizes based on the number of readers:
  • 568 cases for the study involving three readers (resulting in 517 agreed cases).
  • 796 cases for the study involving four readers (resulting in 739 agreed cases).
• Data Provenance: The document does not explicitly state the country of origin. It indicates the study was a "premethod comparison study" conducted to demonstrate substantial equivalence. It's implied to be retrospective, as it compares the new device's staining results to those obtained with cases using the predicate device. The samples are described as "formalin-fixed, paraffin-embedded human tissue."

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

• Number of Experts: The study used three readers for one analysis and four readers for another.
• Qualifications of Experts: The document states that the product "should be interpreted by a qualified pathologist." While it doesn't provide specific experience levels (e.g., "10 years of experience"), it implies that the readers involved in the comparison study were qualified pathologists.

4. Adjudication method for the test set:

The document mentions "overall percent agreement rate between three readers" and "overall agreement rate between four readers." This strongly suggests a consensus-based adjudication method, where the aggregate agreement among the multiple readers determines the final result used for comparison. It doesn't specify if a particular threshold for agreement was used (e.g., 2 out of 3, or majority rule), but the "agreement rate" implies a comparison of individual reader interpretations against each other or potentially against a predefined "truth" established by the collective. It's not a 2+1 or 3+1 method explicitly stated, but rather a direct comparison of agreement.

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

• MRMC Study: Yes, a multi-reader multi-case comparison study was implicitly done, as the performance metrics are based on agreement rates between multiple readers on a set of cases using both the new and predicate devices.
• Effect Size (AI Assistance): This study is not an AI-assisted study. It compares a new IHC assay (VENTANA CD30 (Ber-H2) Assay) against a predicate IHC assay (DAKO K965022). Therefore, there is no AI component and no mention of human readers improving with AI assistance.

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

This is an IHC assay, not an AI algorithm. The performance is inherently tied to the visual interpretation of stained tissue by a pathologist. Therefore, a standalone (algorithm only) performance is not applicable or discussed. The device is a reagent and an automated staining instrument for pathologist interpretation.

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

The ground truth for this study appears to be expert consensus among the pathologists interpreting the slides stained with both the predicate and proposed devices. The "overall percent agreement rate" signifies how well the new device's results align with the interpretations obtained from the predicate device, or how consistently different pathologists interpreted the slides stained by the new device. The predicate device's performance, previously cleared by the FDA, serves as the reference for substantial equivalence.

8. The sample size for the training set:

The document does not explicitly mention a training set sample size. This is an analytical validation and method comparison study for a diagnostic assay, not a machine learning model. Therefore, the concept of a "training set" in the context of AI is not relevant here. The samples used are for the comparison study itself.

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

As this is not an AI/machine learning study, the concept of a "training set" and establishing its ground truth in that context is not applicable. The study focuses on demonstrating substantial equivalence of the new IHC assay to an existing, cleared predicate device through a comparison study. The "ground truth" in this context is the established performance and interpretation patterns of the predicate device, against which the new device's performance is measured by experienced pathologists.

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The kit is intended for the quantitation of lambda free light chains in serum and urine on Binding Site SPAPLUS. Measurement of free light chains in serum aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinaemia, AL amyloidosis, light chain deposition dissue diseases such as systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. Measurement of free light chains in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinaemia, AL amyloidosis and light chain deposition with other laboratory and clinical findings.

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This document is a 510(k) premarket notification from the FDA, indicating that the device, Freelite® Human Lambda Free Kit, has been deemed substantially equivalent to a legally marketed predicate device. This type of document typically does not contain detailed studies, acceptance criteria, or performance data as it's a notification of substantial equivalence, not a detailed clinical trial report or a comprehensive technical specification.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and expert involvement is not present in the provided text.

Here's what can be inferred or stated based on the document's content:

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

   • Not provided. The document states "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...". It does not include specific performance metrics or acceptance criteria for the Freelite® Human Lambda Free Kit itself. Substantial equivalence is often based on demonstrating that a new device is as safe and effective as a legally marketed predicate device, not necessarily by meeting pre-defined quantitative acceptance criteria in this document.

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

   • Not provided. The document does not describe any specific test set data or its provenance.

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 provided. No information about ground truth establishment or experts is included.

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

   • Not provided. There is no mention of an adjudication method as no test set details are given.

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 / Not provided. This device is an "Immunoglobulin (light chain specific) immunological test system" intended for the quantitation of free light chains in serum and urine. It is an in vitro diagnostic (IVD) test, not an AI-assisted diagnostic imaging or interpretation tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this type of device.

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

   • Not explicitly stated, but implicitly "yes" as an IVD. As an in vitro diagnostic kit, the device itself performs the "algorithm" (i.e., the chemical and immunological reactions and detection) to quantify free light chains. Its performance is measured directly, often against a reference method or known concentrations, rather than being part of a human-in-the-loop system in the way AI algorithms are evaluated. However, the document does not provide details of such standalone performance studies.

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

   • Not provided. The document does not specify how ground truth was established for any studies that may have been submitted for the 510(k). For an IVD, ground truth would typically involve reference methods, confirmed clinical diagnoses, or established standards for protein quantification.

8. The sample size for the training set:

   • Not applicable / Not provided. This is an in vitro diagnostic kit, not a machine learning or AI algorithm that typically uses a "training set" in the computational sense. If any form of 'training' or calibration was done for the assay, the sample size or details are not mentioned.

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

   • Not applicable / Not provided. See explanation for #8.

In summary, the provided FDA 510(k) clearance letter acknowledges the submission and declares substantial equivalence. It is a regulatory document and does not contain the detailed technical and clinical study results that would provide answers to most of your specific questions. These details would typically be found in the manufacturer's 510(k) submission itself, which is not publicly available in its entirety without a Freedom of Information Act (FOIA) request.

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The Lambda light chains assay is an in vitro diagnostic test used for the quantitative determination of Immunoglobulin bound and free Lambda light chains (LAMBDA) in serum and Li-heparin plasma by immunoturbidimetry. It is intended to measure Immunoglobulin Lambda light chains (bound and free) using Synchron LX20 System. Measurement of the different types of light chains aids in the diagnosis of multiple myeloma. Iymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins) and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus in conjunction with other clinical and laboratory findings.

The Lambda light chains assay is an in vitro diagnostic test used for the quantitative determination of Immunoglobulin bound and free Lambda light chains (LAMBDA) in serum and Li-heparin plasma by immunoturbidimetry. It is intended to measure Immunoglobulin Lambda light chains (bound and free) using Synchron LX20 System. The determination of Lambda light chains is based on the specific turbidimetric reaction, which occurs between a polyclonal antiserum against human Immunoglobulin Lambda light chains and its corresponding antigen under optimal pH conditions and in the presence of polyethylene glycol (PEG). The turbidity of the immune complex is proportional to the concentration of the analyte in the sample.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

The primary study conducted was a performance characteristic study for the Lambda light chains assay on the Synchron LX20 System. The goal was to demonstrate substantial equivalence to a predicate device, the Beckman IMMAGE Immunochemistry System Lambda light chain (K964260).

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

• Test Set Sample Size: The document does not explicitly state the total number of patient samples used for the method comparison study. It only mentions that precision studies were conducted on "5 levels (N=80 for each level)," totaling 400 precision test samples. For method comparison, it refers to "acceptable correlation," implying a comparison of results from unknown patient samples run on both devices.
• Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the study was retrospective or prospective.

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

This type of study (in vitro diagnostic assay verification) does not typically involve human experts establishing "ground truth" in the same way an image analysis or diagnostic AI study would. The ground truth for this assay is the quantitative concentration of Lambda light chains, as determined by the accepted scientific methods and calibration standards.

For the method comparison, the "truth" for the comparison samples would have been the results obtained from the predicate device (Beckman IMMAGE Immunochemistry System Lambda light chain). The predicate device itself (K964260) would have undergone its own validation to establish its accuracy.

4. Adjudication Method for the Test Set

Not applicable. As this is an in vitro diagnostic assay comparing quantitative measurements to a predicate device, there is no human adjudication process involved in establishing the "ground truth" for individual test results. The comparison is based on numerical agreement and statistical correlation.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic study or an imaging study involving human readers. It's an in vitro diagnostic assay.

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

Yes, the device performance described (method comparison, precision, AMR) represents the standalone performance of the Lambda light chains assay on the Synchron LX20 System. It measures the analytical capabilities of the assay itself, independent of a human interpretation loop required for diagnostic imaging or similar applications.

7. The Type of Ground Truth Used

The ground truth for the method comparison was established by the results from the legally marketed predicate device (Beckman IMMAGE Immunochemistry System Lambda light chain, K964260). The predicate device's results are considered the established "truth" for the purpose of demonstrating substantial equivalence of the new device.

For the assay's own internal calibration and reference, it is stated that "Both assays are traceable to ERM-DA 470 (European Reference Material) from BCR (EG Community Bureau of Reference), corresponding to RPPHS (Reference Preparation for Protein in Human Serum)." This indicates the use of certified reference materials and established scientific standards to define the quantitative values.

8. The Sample Size for the Training Set

Not applicable in the context of this traditional in vitro diagnostic assay. There isn't a "training set" in the machine learning sense. The assay is developed and validated based on chemical and immunological principles, not by training an algorithm on a dataset. The calibration material used ("calibrator material with assigned Lambda Light chains concentration based on definition of Lambda Light chains as Whole IgG content (MW 150000)") could be considered analogous, but it's not a "training set" in the AI sense.

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

Not applicable for a "training set" in the AI sense. For the calibrator material, its "ground truth" or assigned concentration is established by its traceability to ERM-DA 470 and RPPHS (Reference Preparation for Protein in Human Serum), which are internationally recognized reference materials.

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FREELITE® Human Kappa Free Kit For Use on the Olympus AU analyzer. This kit is intended for the quantitation of kappa free light chains in serum and urine on the Olympus AU series analysers. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of lymphocytic neoplasms, multiple myeloma, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus.

FREELITE® Human Lambda Free Kit For Use on the Olympus AU analyzer. This kit is intended for the quantitation of kappa free light chains in serum and urine on the Olympus AU series analysers. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of lymphocytic neoplasms, multiple myeloma, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus.

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This document is a FDA 510(k) clearance letter for an in vitro diagnostic (IVD) device, not a study report or scientific publication describing acceptance criteria and a study to prove a device meets them. Therefore, many of the requested items are not present in this type of document.

The document states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA reviewed performance data provided by the manufacturer and determined that the new device performs as well as, or is sufficiently similar to, a device already on the market. The specific acceptance criteria and the detailed study proving equivalence are typically included in the 510(k) submission itself, which is not fully provided here.

However, based on the information that is available in this clearance letter, here's a breakdown of what can and cannot be answered:

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

This information is not provided in this FDA clearance letter. The letter confirms that The Binding Site, Limited’s FREELITE® Human Kappa and Lambda Free Kits for Use in the Olympus AU series Analyzers are substantially equivalent to predicate devices. The specific performance metrics (e.g., sensitivity, specificity, accuracy, precision) and their acceptance criteria would have been part of the 510(k) submission, which is not contained within this document.

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

This information is not provided in this FDA clearance letter. Such details would be found within the 510(k) submission 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 provided in this FDA clearance letter. For IVD devices like this, ground truth is typically established through reference methods or clinical diagnosis, not by experts reviewing images.

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

This information is not provided in this FDA clearance letter. As above, adjudication methods like 2+1 or 3+1 are more relevant to image-based diagnostic aids and not typically for quantitative IVD tests where results are numerical values.

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/Not provided. This is an in vitro diagnostic (IVD) device for quantitating kappa and lambda free light chains in serum and urine. It is not an AI-assisted diagnostic tool for human readers; therefore, an MRMC comparative effectiveness study involving human readers would not be relevant.

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

Yes, the device is inherently standalone. This is an automated in vitro diagnostic test performed on an analyzer. The "algorithm" is the reagent and analyzer system itself, producing quantitative results. Its performance is evaluated in a standalone manner. The FDA's substantial equivalence determination is based on the performance of the device as a system.

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

The type of ground truth used is not explicitly stated in this letter. For an IVD device quantifying biomarkers, the ground truth would typically be established by:

• Reference methods: A highly accurate and precise analytical method.
• Clinical diagnosis/Patient outcomes: Correlating the device's results with the ultimate clinical diagnosis of conditions like "lymphocytic neoplasms, multiple myeloma, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus."

8. The sample size for the training set

Not applicable/Not provided. This device is a reagent/analyzer system, not an AI model that requires a "training set" in the conventional machine learning sense. The development of such a system involves analytical validation and clinical validation, but not typically a training set for an algorithm.

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

Not applicable/Not provided. As explained in point 8, this is not an AI-based device that relies on a "training set" and corresponding ground truth for algorithm development.

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This kit is intended for the quantitation of kappa free light chains in serum and urine on the Dade Behring Nephelometer II (BNII). Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythemoatosus.

This kit is intended for the quantitation of lambda free light chains in serum and urine on the Dade Behring Nephelometer II (BNII). Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythemoatosus.

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I am sorry, but the provided text from the FDA 510(k) letter does not contain information about acceptance criteria for device performance or a study proving that the device meets such criteria. This document is primarily an FDA clearance letter for a medical device (FREELITE® Human Kappa Free Kit and FREELITE® Human Lambda Free Kit) regarding its substantial equivalence to a legally marketed predicate device.

The letter confirms that the device can be marketed subject to general controls and specifies the regulation number, regulation name, and product codes. It also includes the "Indications for Use" for both kits, but it does not detail any performance metrics, studies, sample sizes, expert involvement, or adjudication methods that would be required to answer your specific questions.

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

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This kit is intended for the quantitation of lambda free light chains in serum and urine on the Roche Hitachi 911 and Hitachi 912. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myelomas, lymphocytic neoplasms, Waldenstrom's macroglobulinemia and connective tissue diseases, such as systemic lupus erythematosus.

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I am sorry, but the provided text from the FDA 510(k) summary (Re: K023131) does not contain the specific information required to describe the acceptance criteria and the study that proves the device meets those criteria.

The document is a clearance letter from the FDA, stating that "FREELITE Human Lambda Free Kit for Use on the Hitachi 911/912 Analyzer" is substantially equivalent to a legally marketed predicate device. It defines the indications for use but does not detail the performance metrics, study design, or results that would demonstrate the device's accuracy or efficacy.

Therefore, I cannot provide a table of acceptance criteria, reported performance, sample sizes, expert details, adjudication methods, MRMC study results, standalone performance, or training set details based on the information given. This type of information would typically be found in the 510(k) submission itself or a more detailed performance study report.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device