Search Results

For in vitro diagnostic use.

FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Dako Omnis), is intended for use in immunohistochemistry with the EnVision FLEX visualization system together with the Dako Omnis instrument to qualitatively detect human estrogen receptor in formalin-fixed, paraffin-embedded tissue sections of human breast cancer. The antibody binds estrogen receptor a expressing cells and is useful in the assessment of estrogen receptor status in human breast carcinomas.

The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist. This antibody is intended to be used after the primary diagnosis of tumor has been made by conventional histopathology using nonimmunologic histochemical stains.

The FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Dako Omnis) antibody is utilized to perform a qualitative immunohistochemical (IHC) assay to identify estrogen receptor (ER) expression in fixed human breast cancer tissues routinely processed and paraffin-embedded for histological examination.

The design of the proposed device is based on the design of its predicate FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor α. Clone EP1, Ready-to-Use (Link) with adaptation of the product configuration, to be used on the Dako Omnis Instrument instead of the Autostainer Link 48 Instrument.

The antibody is provided in liquid form in a buffer containing stabilizing protein and 0.015 mol/L sodium azide. The antibody is intended for automated immunohistochemical (IHC) slide staining with the Dako Omnis Instrument and the software performing and controlling the automated slide staining process is validated for its intended use.

This document describes the Dako FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor α, Clone EP1, Ready-to-Use (Dako Omnis) Immunohistochemistry (IHC) reagent system, referred to as GA084, and its equivalence to a predicate device (IR084).

Here's an analysis of the acceptance criteria and study findings based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All results from performance studies confirm that GA084 meets its acceptance criteria and is substantial equivalent to its predicate device IR084." However, it does not explicitly list the numerical acceptance criteria for each performance characteristic. Instead, it broadly indicates that the device met these criteria. The performance characteristics evaluated were:

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

The document does not specify the exact sample size used for the test set in the performance studies. It mentions that concordance studies were performed to establish equivalence.

The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth specifically for the test set. It mentions that clinical interpretation "should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist." This implies that qualified pathologists are involved in interpretation but doesn't detail their role in establishing ground truth for the study.

4. Adjudication Method for the Test Set

The document does not specify the adjudication method used for the test set.

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

This device is an immunohistochemistry (IHC) reagent system, not an AI or imaging device. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not applicable and was not reported. The focus is on the performance of the staining reagent itself.

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

As stated above, this is an IHC reagent system. There is no algorithm involved that operates in a standalone manner. The device's performance is inherently tied to the staining process and subsequent human interpretation by a pathologist.

7. The Type of Ground Truth Used

The type of ground truth used is expert evaluation by qualified pathologists of the stained tissue sections. The clinical interpretation of any staining or its absence "should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist." The antibody is intended to be used "after the primary diagnosis of tumor has been made by conventional histopathology using nonimmunologic histochemical stains." This implies that the 'ground truth' for whether a tumor is present and for the ER status would ultimately rely on comprehensive pathological assessment.

8. The Sample Size for the Training Set

The document does not mention a training set as this is not an algorithm-based device.

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.

Ask a specific question about this device

For in vitro diagnostic use.

FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor α, Clone EP1, Ready-to-Use, (LINK), is intended for use in immunohistochemistry with EnVision FLEX, High pH visualization kit together with Autostainer Link 48 to semiquantitatively detect human estrogen in formalin-fixed, paraffin-embedded tissue sections of human breast cancer. The antibody labels estrogen receptor a-positive cells and is useful in the assessment of estrogen receptor status in human breast carcinomas.

The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

For in vitro diagnostic use.

FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use, (Link), is intended for use in immunohistochemistry together with EnVision FLEX+, High pH visualization kit together with Autostainer Link 48 instrument to semi-quantitatively detect human progesterone receptor in formalin-fixed, paraffin-embedded human breast carcinoma. This antibody labels progesterone receptor-positive cells and is useful in the assessment of progesterone receptor status in human breast carcinomas.

The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

Not Found

The provided document is a 510(k) premarket notification for a modification to two existing immunohistochemistry reagents: FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor α, Clone EP1, Ready-to-Use (Link) and FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link).

The modification is specifically for the addition of the new Dako PT Link PT200 as recommended equipment for automated epitope retrieval pre-treatment. This is a special 510(k) submission, meaning it's for modifications to the submitter's own cleared devices where the intended use has not changed, and the fundamental scientific technology remains the same.

Therefore, the document does not contain a performance study designed to establish new acceptance criteria or demonstrate the performance of the device against new criteria. Instead, it relies on the predicate devices' prior clearances and focuses on demonstrating that the modification does not negatively impact the device's functionality or intended use.

Here's an breakdown of why the requested information isn't directly available in this document:

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

   • This document is a modification submission, not an initial clearance. It doesn't present new performance data against specific acceptance criteria for the modified device itself. It hinges on the fact that the intended use has not changed and the fundamental scientific technology has not changed.
   • The "acceptance criteria" here relate to the design control activities for the modification, ensuring that the change (adding a new pre-treatment instrument) does not alter the device's fundamental performance. The document only mentions that the submitter identified "verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied" based on a risk analysis, but it does not provide the actual table of those criteria or the results.

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

   • No new test set data is presented for performance evaluation because the modification does not warrant it in a Special 510(k) (where the fundamental scientific technology and intended use are unchanged).
   • The original clearance (K120663 and K130861) for the predicate devices would contain this information.

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

   • Not applicable to this modification document for the reasons stated above.

4. Adjudication method:

   • Not applicable to this modification document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • Not applicable to this modification document. These are reagents, not AI-powered diagnostic devices.

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

   • Not applicable. These are reagents for immunohistochemistry, which require human interpretation by a pathologist.

7. The type of ground truth used:

   • Not applicable to this modification document. For the original clearances, the ground truth for IHC reagents typically involves expert consensus (pathology review), often comparing staining results to established clinical outcomes or other validated methods.

8. The sample size for the training set:

   • Not applicable. These are reagents, not AI algorithms requiring training sets.

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

   • Not applicable. These are reagents, not AI algorithms.

In summary, this 510(k) is a "Special 510(k)" for a device modification (adding a new recommended pre-treatment instrument to already cleared IHC reagents). It explicitly states that the "INDICATION/INTENDED USE...HAS NOT CHANGED" and the "FUNDAMENTAL SCIENTIFIC TECHNOLOGY...has not changed." Therefore, it does not present new performance data or acceptance criteria for the device itself but rather demonstrates that the modification does not alter the device's previously established performance or intended use.

Ask a specific question about this device

For in vitro diagnostic use.

FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, Readyto-Use, (LINK), is intended for use in immunohistochemistry with EnVision™ FLEX, High pH visualization kit together with Autostainer Link 48 to semiquantitatively detect human estrogen receptor in formalin-fixed, paraffinembedded tissue sections of human breast cancer. The antibody labels estrogen receptor a-positive cells and is useful in the assessment of estrogen receptor status in human breast carcinomas.

The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

Dako Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone EP1 (Dako Anti-Human ER a, clone EP1) antibody is utilized to perform a semi-quantitative immunohistochemical (IHC) assay to identify estrogen receptor (ER) expression in human breast cancer tissues routinely processed and paraffin-embedded for histological examination. The ER a antibody is available in Ready-to-Use (RTU) format and is optimized for use with Dako Automated stainer Link 48. The RTU Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone EP1 is provided in one vial of ready-to-use monoclonal rabbit antibody contains 12 ml of reagent provided in liguid form in a buffer containing stabilizing protein and 0.015 mol/L sodium azide. The working Ig concentration of the antibody is approximately 3.7 ug/mL. Total protein concentration is approximately 10mg/mL.

The provided text is a 510(k) Pre-Market Notification for a medical device, specifically the Dako Anti-Human ER $\alpha$ Clone EP1. It describes the device, its intended use, and claims substantial equivalence to a predicate device, but does not contain typical acceptance criteria or a detailed study section with performance metrics like sensitivity, specificity, or concordance rates against a ground truth.

Instead, it states: "Performance characteristics evaluated in support of the Dako Anti-Human ER $\alpha$, clone EP1 IHC assay include results on specificity, sensitivity, reproducibility, and concordance testing. Results of all testing conducted have demonstrated a substantial degree of equivalency to the predicate device listed above." However, the actual results of these tests are not present in this document.

Therefore, I cannot populate the table or answer the specific questions about sample sizes, ground truth establishment, or expert details because this information is not included in the provided text.

The document only states that such studies were performed and showed "substantial equivalency" to the predicate device (ER $\alpha$ component of the Dako ER/PR pharmDx™ Kit, K042884).

If this were a typical AI/ML device submission, a dedicated section detailing these performance characteristics would be expected. Since this is an Immunohistochemistry (IHC) reagent, the performance evaluation methods might differ from those for an image-based AI device.

Without the actual performance data from the specific studies mentioned, I cannot complete the requested information.

Ask a specific question about this device

This antibody is intended for in vitro diagnostic (IVD) use.

CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody is intended for laboratory use for the qualitative detection of estrogen receptor (ER) antigen in sections of formalin-fixed, paraffin-embedded breast tissue on a Ventana automated slide stainer with Ventana detection kits and ancillary reagents. CONFIRM anti-ER (SP1) is directed against an epitope present on human ER alpha protein located in the nucleus of ER positive normal and neoplastic cells. CONFIRM anti-ER (SP1) is indicated as an aid in the management, prognosis, and prediction of hormone therapy for breast carcinoma.

This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.

Prescription use only.

CONFIRM anti-ER (SP1) binds to human estrogen receptor alpha (ER) in paraffin embedded tissue sections. The antibody is diluted in 0.05 M Tris-HCl with 2% carrier protein, and 0.10% ProClin 300, a preservative. There is trace (~0.2%) fetal calf serum of U.S. origin from the stock solution. Total protein concentration of the reagent is approximately 20 mg/mL. Specific antibody concentration is approximately 1 ug/mL. CONFIRM anti-ER (SP1) is a rabbit monoclonal antibody produced as a cell culture supernatant.

CONFIRM anti-ER (SP1) is optimized for use on the BenchMark XT and BenchMark ULTRA automated slides stainers using iView DAB and ultraView DAB detection chemistries.

Here's a breakdown of the acceptance criteria and the study details for the CONFIRM anti-Estrogen Receptor (SP1) Rabbit Monoclonal Primary Antibody, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • Method Comparison Study (BenchMark XT vs. BenchMark ULTRA): 120 ER negative and 132 ER positive breast cancer cases (total 252 cases). Data provenance is not explicitly stated in terms of country of origin but is presumed to be retrospective clinical samples. It is a prospective study in terms of evaluating the newly stained slides.
   • Equivalence to Predicate Study (CONFIRM vs. FLEX and LBA): 820 invasive breast cancer cases in the clinical cohort, from which 594 breast cancer cases with primary tumor underwent IHC staining on 1907 tissue microarray cores. The study is described as having "available from the cohort database," suggesting retrospective data for patient outcome and LBA, but the IHC staining and evaluation of the tissue microarrays were performed as part of this study. The origin is implied to be a clinical cohort, but specific country is not mentioned.

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

   • Method Comparison Study: Evaluated by "pathologists" for determining the percentage of stained tumor cells. The exact number of pathologists per case is not specified beyond "multi-reader study", nor are their qualifications.
   • Equivalence to Predicate Study: Evaluated by "three independent pathologists" who determined the percentage of stained tumor cells. Their specific qualifications (e.g., years of experience, subspecialty) are not provided.

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

   • The document implies that pathologists independently evaluated the slides and their interpretations were used to determine ER status. There is no explicit mention of an adjudication method for discordant reads (e.g., 2+1 rule). For the "Equivalence to Predicate Study," three independent pathologists evaluated the slides, but it's not stated how disagreements were resolved for the final ER status used in the analysis.

4. 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 not a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human readers improvement with or without AI assistance. This study evaluates the performance of an immunohistochemistry (IHC) antibody (CONFIRM anti-ER (SP1)) as a diagnostic reagent, comparing it to an existing predicate device and patient outcomes. The "multi-reader" aspect refers to multiple pathologists reading the slides to generate the initial data, not to an AI-assisted workflow.

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

   • No. This device is an immunohistochemistry antibody reagent, not an algorithm or AI product. Its performance is assessed through the staining of tissue samples, which are then interpreted by human pathologists. Therefore, a "standalone algorithm performance" study is not applicable.

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

   • For ER status determination on stained slides: The immediate "ground truth" used for calculating agreement percentages (OPA) was the interpretation by pathologists based on the percentage of stained tumor cells.
   • For comparing against clinical relevance: Progression-free survival outcome data in tamoxifen-treated patients and Ligand Binding Assay (LBA) data were used as ground truth comparators for the "Equivalence to Predicate" study to assess the clinical utility and biological agreement of the IHC assays.

7. The sample size for the training set:

   • This document describes a performance study for an antibody reagent, not a machine learning model. Therefore, there is no "training set" in the context of an algorithm. The antibody itself is "optimized" for use on specific instruments, which implies internal development and testing, but not a dataset-driven training process in the AI sense.

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

   • As there is no training set for an AI/algorithm, this question is not applicable. The antibody's specificity and reactivity are inherent to its design and manufacturing process, and its performance is validated in clinical studies like the ones described.

Ask a specific question about this device

This antibody is intended for in vitro diagnostic (IVD) use. CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal (IgG) Primary Antibody is intended for laboratory use for the qualitative detection of progesterone receptor (PR) antigen in sections of formalin-fixed, paraffin-embedded tissue on a VENTANA automated slide stainer with VENTANA detection kits and ancillary reagents. CONFIRM anti-PR (1E2) is directed against an epitope present on human progesterone receptor protein located in the nucleus of PR positive normal and neoplastic cells. CONFIRM anti-PR (1E2) is indicated as an aid in the management, prognosis, and prediction of hormone therapy for breast carcinoma. This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. Prescription use only.

Ventana's CONFIRM anti-Progesterone Receptor (1E2) Rabbit Monoclonal Primary Antibody specifically binds to progesterone receptor antigen located in the nuclear region of a variety of normal and neoplastic tissues. The antibody is diluted in 0.05 M Tris-HCl with 2% carrier protein, and 0.1% ProClin 300, a preservative. There is trace (0.2%) fetal calf serum of U.S. origin from the stock solution. Total protein concentration of the reagent is approximately 10 mg/mL. Specific antibody concentration is approximately 1 µg/mL. CONFIRM anti-PR (1E2) is a rabbit monoclonal antibody produced as a cell culture supernatant.

The provided text describes the 510(k) summary for the CONFIRM anti-Progesterone Receptor (1E2) Rabbit Monoclonal Primary Antibody. This document focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving against specific acceptance criteria for a novel device. Therefore, the information typically requested for acceptance criteria and a study proving a device meets those criteria is not explicitly presented in the same way as for a de novo device or a device with new performance claims.

Instead, the study aims to show agreement between the new device and the predicate device. The acceptance criteria, therefore, are implicitly related to achieving a high level of agreement.

Here's an interpretation based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Implicit Acceptance Criteria for Substantial Equivalence:

Note: The document states "greater than 85%" for agreement rates, implying this was the threshold for acceptable performance for substantial equivalence to the predicate.

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

• Sample Size for Test Set: Approximately 120 negative and 216 positive cases of breast cancer (total = 336 cases).
• Data Provenance: Not explicitly stated, but the study design suggests retrospective use of archived breast cancer tissue samples, representing a "clinical range of the assay." The cases were "randomly assigned to three study sites," which implies that the data was collected at multiple institutions. Country of origin is not mentioned.

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

The document does not explicitly state the number of experts used to establish the ground truth for the test set. It mentions that "This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls." However, for the study to compare performance, it's not detailed how the initial classification of positive/negative cases was done or if an independent panel established a reference standard for the test set. Given it's a comparison study to a predicate, it's possible that the "ground truth" was established by the predicate device's results as an established standard, or by routine pathology reports prior to the study.

4. Adjudication Method for the Test Set

The adjudication method for establishing the ground truth of the test set is not explicitly mentioned. The study design focuses on comparing the staining performance of the new device against the predicate device. It does not detail a process for resolving discrepancies in initial diagnosis or a separate ground truth establishment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

Yes, a multi-site, multi-reader study was conducted.

• Type of Study: "A randomized, multi-site, multi-reader study was conducted to compare the staining performance of the CONFIRM anti-PR (1E2) on the BenchMark ULTRA instrument and on the BenchMark XT instrument to that of the Dako FLEX Monoclonal Mouse Anti-Human Progesterone Receptor Clone PgR 636 Ready-To-Use (FLEX anti-PgR (636)) on the Dako Autostainer Plus."
• Effect Size of Human Readers with vs. without AI Assistance: This information is not applicable here. This study is for an immunohistochemistry (IHC) antibody, which is a diagnostic reagent, not an AI or software device that assists human readers. The readers (pathologists) interpret the stained slides, but there is no "AI assistance" component described in this context. The study compares the performance of different reagents/platforms as interpreted by human readers.

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

This information is not applicable. The device is an antibody (reagent) for immunohistochemistry, which requires a human pathologist for interpretation. There is no algorithm or standalone performance without human interpretation.

7. The Type of Ground Truth Used

The type of ground truth used is not explicitly stated as a separate, independently established reference standard. Given the nature of a substantial equivalence study for an IHC antibody, the "ground truth" for comparison is likely the performance or results obtained using the predicate device (Dako FLEX Monoclonal Mouse Anti-Human Progesterone Receptor Clone PgR 636) or potentially prevailing clinical consensus based on established pathological diagnosis of the breast cancer cases included in the study. The study measures agreement with the predicate.

8. The Sample Size for the Training Set

No training set is mentioned or applicable for this type of device. The CONFIRM anti-PR (1E2) is a monoclonal antibody (a biological reagent), not a machine learning model that requires training data. Non-clinical performance data included testing on a "required panel of normal tissues" for tissue specificity, but this is not a "training set" in the context of an AI/ML device.

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

Not applicable as there is no training set for this type of device.

Ask a specific question about this device

VENTANA anti-Helicobacter pylori (SP48) Rabbit Monoclonal Primary Antibody (VENTANA anti-H. pylori (SP48)) is designed to qualitatively detect the presence of Helicobacter pylori in formalin-fixed, paraffin-embedded gastric biopsy tissue via light microscopy. Immunohistochemical staining with this antibody product may aid in the diagnosis of Helicobacter pylori infection. 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.

IHC in vitro diagnostic antibody directed against H. pylori organisms and visualized though the application of either of two standard chromogenic secondary detection kits to locate and bind primary antibodies bound to tissue samples. Use of either detection system results in a dark brown colored precipitate at the site of specific antibody binding.

Here's an analysis of the provided text regarding the acceptance criteria and study for the VENTANA anti-Helicobacter pylori (SP48) Rabbit Monoclonal Primary Antibody:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state pre-defined acceptance criteria (e.g., "the device must achieve X sensitivity and Y specificity"). Instead, it presents a comparison study against an existing method (Ventana Giemsa Staining Kit) and mentions the predicate device (Pylo-Plus). The performance is reported in terms of agreement rates.

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

• Sample Size for Test Set: A total of 294 cases were considered evaluable and included in the analyses of agreement rates.
• Data Provenance: The study was conducted at three independent clinical sites. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, so it is likely either U.S. data or data from regions with comparable medical practices. The study is described as a "Method Comparison study," implying it is prospective or at least utilizes current samples for comparison rather than solely historical data.

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

The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience").

However, the "Intended Use" section for the proposed device states: "This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information and proper controls." This implies that the interpretation of both the proposed device and likely the comparator (Giemsa staining) for establishing agreement would involve qualified pathologists, consistent with standard practice in pathology.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for resolving discrepancies in the test set. It mentions "agreement rates between VENTANA anti-H. pylori (SP48) and Ventana Giemsa Staining Kit," suggesting a direct comparison of results rather than a complex arbitration process involving multiple independent interpretations to establish a gold standard.

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

The provided text does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study where human readers' performance with and without AI assistance is evaluated. The study described is a direct comparison of the proposed immunohistochemistry (IHC) stain (an in vitro diagnostic antibody) against a traditional histologic stain (Giemsa) for detecting H. pylori. This is a comparison of diagnostic methods, not an assessment of human reader performance improvement with an AI device. Therefore, no effect size of human readers improving with AI vs. without AI assistance is reported.

6. Standalone (Algorithm Only) Performance

This product is an immunohistochemistry (IHC) antibody, not an AI algorithm. Therefore, no standalone (algorithm only) performance was conducted or reported as it's not applicable to this type of diagnostic device. The interpretation of the stained slides is performed by a qualified pathologist.

7. Type of Ground Truth Used

The primary "ground truth" or reference standard used in the method comparison study was the Ventana Giemsa Staining Kit for determining the presence of H. pylori. The summary also mentions "H. pylori diagnosis obtained from enrollment pathology reports," which suggests that the initial selection of cases might have been based on clinical diagnoses or previous pathology reads. However, the direct comparison for evaluating the new device’s performance was against the Giemsa stain results.

8. Sample Size for the Training Set

The document does not specify a sample size for a training set. This is because the device is an in vitro diagnostic reagent (antibody), not an AI algorithm or a device that requires machine learning training. The "training" for this type of product development would typically involve optimization of the antibody and staining protocol, not data-driven machine learning.

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

As explained in point 8, there is no mention of a "training set" in the context of machine learning. The "ground truth" for the development and validation of an IHC antibody would traditionally derive from:

• Known positive and negative control tissues: Tissues confirmed by established methods (e.g., bacterial culture, PCR, or highly experienced pathologist review with other stains) to either contain or be free of H. pylori.
• Pathological assessment: Confirmation by qualified pathologists using established diagnostic criteria and other relevant techniques.

The focus is on the antibody's specificity and sensitivity to H. pylori organisms in situ, rather than training an algorithm to identify them.

Ask a specific question about this device

For in vitro diagnostic use.

Monoclonal Rabbit Anti-Human Estrogen Receptor a (ER a) antibody, Clone SP1, may be used in the semi-quantitative detection of human estrogen receptor in formalin-fixed, paraffin-embedded tissue sections of human breast cancer by immunohistochemistry. The information gained by this assay can aid in assessing the likelihood of response to therapy as well as in the prognosis and management of breast cancer patients.

Clinical interpretation of any positive staining or its absence should be complemented by morphological and histological studies with proper controls. Evaluations should be made within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

Dako Monoclonal Rabbit Anti-Human Estrogen Receptor a antibody, Clone SP1 is a semiquantitative immunohistochemical (IHC) kit assay to identify estrogen receptor (ER) expression in normal and neoplastic tissues routinely processed and paraffin-embedded.

The provided text describes the Dako Monoclonal Rabbit Anti-Human Estrogen Receptor a antibody, Clone SP1, an immunohistochemical (IHC) assay. The document is a 510(k) summary and associated FDA correspondence, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria and detailed study results for a novel device.

Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, and MRMC studies is not explicitly present in the provided text.

Here's an analysis of what can be extracted based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "Performance characteristics evaluated for the Estrogen Receptor Clone SP1 IHC assay include results on analytical specificity and sensitivity, precision, reproducibility and method comparison testing." It then states: "Results of all testing conducted substantial equivalence to the predicate device listed above."

This implies that the acceptance criterion was achieving substantial equivalence to the predicate device, especially across these performance characteristics. However, specific numerical targets for these characteristics are not provided.

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

• Sample size: The document does not specify the sample size (number of cases or samples) used for the testing that established substantial equivalence.
• Data provenance: Not explicitly stated. The document refers to "testing conducted," but provides no details on the origin, retrospective, or prospective nature of the data.

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

• Number of experts: Not specified.
• Qualifications: "Evaluations should be made within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist." This indicates that pathologists are involved in interpretation but does not detail their role in establishing a ground truth for testing.

4. Adjudication method for the test set:

• Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• An MRMC study is not mentioned. The focus is on the device's performance against a predicate device, not direct human reader improvement with or without the device.

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

• This device is an IHC antibody, which is a reagent used in a laboratory setting for manual or automated staining, subsequently interpreted by a pathologist. It is not an "algorithm" in the sense of AI. Therefore, the concept of "standalone performance" for an algorithm without a human-in-the-loop is not applicable in this context. The assay itself requires human interpretation.

7. The type of ground truth used:

• The document implies that the ground truth for comparing the new device against the predicate device would be based on the established accuracy of the predicate device and potentially agreement with clinical and morphological findings. The statement "Clinical interpretation of any positive staining or its absence should be complemented by morphological and histological studies with proper controls" suggests that the ultimate ground truth incorporates pathological and clinical evaluation, but the specific method for establishing a gold standard for the comparison study is not detailed.

8. The sample size for the training set:

• This device is a biological reagent (antibody), not a machine learning algorithm that requires a "training set" in the conventional sense. Therefore, the concept of a training set size is not applicable.

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

• As explained above, the concept of a training set is not applicable to this type of device.

In summary:

The provided document is a regulatory submission focused on demonstrating substantial equivalence of a new IHC reagent to an existing one. It does not provide the detailed study design, acceptance criteria, specific performance metrics, or ground truth establishment methods that would be expected for a novel diagnostic algorithm or AI device as the questions imply. The study described is primarily a comparative study to establish equivalency to a predicate, rather than a de novo performance validation with detailed acceptance criteria.

Ask a specific question about this device

NeoMarkers Rabbit Monoclonal anti-Human ER Antibody (Clone SP1) is an immunohistochemical (IHC) assay intended for laboratory use for the qualitative detection of ER antigen by light microscopy in sections of formalin fixed, paraffin embedded normal and neoplastic tissues on a Lab Vision automated slide stainer. It is indicated as an aid in assessing the likelihood of response to therapy as well as in the prognosis and management of breast cancer patients.

Lab Vision's NeoMarkers Rabbit Monoclonal Anti-Human Estrogen Receptor (ER) Antibody (Clone SP1) binds to ER in the paraffin embedded tissue section. The specific antibody is localized by a biotin conjugated secondary antibody formulation that recognizes rabbit immunoglobulins. This step is followed by the addition of an avidin/streptavidin enzyme conjugate that binds to the biotin present on the secondary antibody. The specific antibody secondary antibody avidin/streptavidin enzyme complex is then visualized with a precipitating enzyme reaction product, which is readily detected by light microscopy. Each step is incubated for a precise time and at room temperature. At the end of each incubation step, the Lab Vision automated slide stainer (Lab Vision Autostainer) washes the sections to stop the reaction and remove unbound material that would interfere the desired reaction in subsequent steps.

This is a submission for a medical device called NeoMarkers Rabbit Monoclonal Anti-Human ER Antibody (Clone SP1), an in vitro diagnostic immunohistochemical (IHC) assay. Therefore, the "acceptance criteria" and "device performance" in this context refer to the demonstration of substantial equivalence to a predicate device, as opposed to a standalone performance study with predefined numerical metrics.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For in vitro diagnostic devices seeking 510(k) clearance, the primary "acceptance criterion" is often substantial equivalence to a legally marketed predicate device. The "device performance" is then the evidence presented to support this claim.

Predicate Device: Ventana ER Primary Antibody (Clone 6F11) is intended for laboratory use for the qualitative detection of ER antigen in sections of formalin fixed, paraffin embedded tissue on a Ventana automated immunohistochemistry slide staining device. It is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer.

(The intended uses are functionally equivalent.) |
| Target Epitope: Binds to the same biological target. | Subject Device: Estrogen Receptor

Predicate Device: Estrogen Receptor |
| Matrix: Used with the same sample type. | Subject Device: Tissue (Breast)

Predicate Device: Tissue (Breast) |
| Storage: Similar storage conditions. | Subject Device: 2°C to 8°C until expiration date

Predicate Device: 2°C to 8°C until expiration date |
| Stability: Similar stability profile. | Subject Device: Until expiration date noted on package

Predicate Device: Until expiration date noted on package |
| Technological Characteristics: Does not raise new questions of safety or effectiveness. | The main difference is the Clone: Subject device uses Rabbit Monoclonal Ab (Clone SP1), while the predicate uses Murine Monoclonal Ab (Clone 6F11). The submission implies that this difference does not raise new safety/effectiveness concerns, as substantial equivalence was granted. |

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

The provided document does not specify a separate "test set" with a particular sample size or data provenance (e.g., country of origin, retrospective/prospective). This submission relies on demonstrating substantial equivalence to a predicate device primarily through comparison of intended use and physical properties, rather than a new clinical performance study with a dedicated test set designed to establish quantitative performance metrics like sensitivity, specificity, or AUC.

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

As there is no mention of a traditional "test set" and a study to establish performance against a ground truth, this information is not applicable and not provided in the document. The submission focuses on comparing the new device's characteristics against a cleared predicate.

4. Adjudication Method for the Test Set

Since there is no described test set with human observer interpretations and ground truth, an adjudication method is not described or applicable in this submission.

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. The submission does not describe any study involving human readers or comparing their performance with or without AI assistance. This device is an antibody for immunohistochemistry, not an AI-powered diagnostic tool.

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

No, a standalone performance study (algorithm only) was not done. This is an in vitro diagnostic antibody, not an algorithm or software. Its performance is demonstrated by its inherent binding characteristics and consistency with the predicate device.

7. The Type of Ground Truth Used

The term "ground truth" in the traditional sense of a clinical benchmark for diagnostic accuracy is not directly used or established in this submission. The "truth" for this 510(k) is the established performance and safety of the predicate device. The claim of substantial equivalence relies on the new device having similar characteristics and intended use to the predicate, assuming the predicate itself is safe and effective. The intrinsic validation of the antibody's binding to ER in tissues serves as the basis for its function, but this isn't detailed as a specific "ground truth" study in this document for 510(k purposes.

8. The Sample Size for the Training Set

This information is not applicable and not provided in the document. This device is an antibody, not a machine learning model that requires a training set.

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

This information is not applicable and not provided in the document. As this is an antibody, there is no "training set" in the context of machine learning.

Ask a specific question about this device

NeoMarkers Rabbit Monoclonal anti-Human PR Antibody (Clone SP2) is an immunohistochemical (IHC) assay intended for laboratory use for the qualitative detection of PR by light microscopy in sections of formalin fixed, paraffin embedded normal and neoplastic tissues on a Lab Vision automated slide stainer. It is indicated as an aid in assessing the likelihood of response to therapy as well as in the prognosis and management of breast cancer patients.

Immunohistochemistry Assay, Antibody, Progesterone Receptor. Antibody for detection of progesterone receptor in histological tissue sections. NeoMarkers Rabbit Monoclonal Anti-Human Progesterone Receptor Antibody (Clone SP2)

The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria. Instead, it is a 510(k) summary for a medical device called "NeoMarkers Rabbit Monoclonal Anti-Human PR Antibody (Clone SP2)".

The document focuses on:

• Device Identification: Name, classification, regulation number, product code, and regulatory class.
• Submission Details: Submitter information, contact person, and preparation date.
• FDA Correspondence: A letter from the FDA indicating that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
• Indications for Use: The intended purpose of the device, which is an immunohistochemical (IHC) assay for the qualitative detection of Progesterone Receptor (PR) in formalin-fixed, paraffin-embedded tissues. This assay is intended as an aid in assessing response likelihood to therapy, prognosis, and management of breast cancer patients.

Therefore, I cannot provide the requested table and information, as the input does not describe a study with acceptance criteria, performance metrics, sample sizes, expert ground truth establishment, or comparative effectiveness.

Ask a specific question about this device

The Rabbit is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

The Candidate Device is a coaxial breast biopsy system, which is intended to retrieve tissue samples from the breast for histological analysis .The device is provided sterile for single use only. The system includes a disposable biopsy device, Localization needle, stylet, and hook wire. The biopsy device includes a circular scalpel and a Garrote wire to transect the specimen.

This document focuses on the Rabbit breast biopsy instrument, a conventional medical device, rather than an AI-powered system. Therefore, most of the requested information regarding AI-specific criteria (like acceptance criteria for AI performance, MRMC studies, standalone AI performance, or training set details) is not applicable.

Here's an analysis based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a non-AI device relying on substantial equivalence, there are no explicit quantitative "acceptance criteria" for diagnostic performance in the way one would define them for an AI algorithm (e.g., specific sensitivity/specificity thresholds). Instead, the acceptance is based on demonstrating equivalence to predicate devices and meeting general device safety and performance standards.

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

• Not applicable for this type of device. The provided text does not describe a clinical study with a "test set" for diagnostic performance in the context of an AI algorithm. Substantial equivalence for this device relies on demonstrating that its design, materials, and intended use are comparable to legally marketed predicate devices, implying similar safety and effectiveness.

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. As above, there's no diagnostic test set in the AI sense for which ground truth would need to be established by experts for this 510(k) submission.

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

• Not applicable. No adjudication method is described for a test set.

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 device is a biopsy instrument, not an AI diagnostic tool. No MRMC study is mentioned.

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

• Not applicable. This is a physical biopsy device, not an algorithm.

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

• Pathology/Histology: The primary "ground truth" related to the device's function is the histological examination of the tissue samples it retrieves. The device's purpose is to provide these samples, which are then analyzed by pathologists. The K-number does not detail specific studies proving the accuracy of the biopsy in comparison to a gold standard, but rather establishes equivalence to predicate devices that are accepted for providing such samples.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device.

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

• Not applicable. This is not an AI/machine learning device.

Summary of Device and 510(k) Process:

The provided documents detail a 510(k) premarket notification for the "Rabbit" breast biopsy instrument. The FDA reviewed this submission and determined the device to be substantially equivalent to three predicate biopsy devices already on the market (Auto Suture ABBI System, SiteSelect Breast Biopsy Device, Mammotome).

For conventional medical devices under a 510(k) pathway, "acceptance criteria" largely revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. This typically involves comparing:

• Indications for Use: The "Rabbit" is indicated for providing breast tissue samples for diagnostic sampling of breast abnormalities for histologic examination, identical or very similar to predicate devices.
• Technological Characteristics: The device description details its coaxial design, components (scalpel, Garrote wire), and single-use sterile nature. This is compared to the predicate devices.
• Performance Data: While not explicitly detailed as specific diagnostic performance metrics in this summary, the submission would have included verification and validation testing (e.g., mechanical strength, cutting performance, material biocompatibility per ISO 10993-1, sterility) to demonstrate that the device performs as intended and is safe. The FDA's finding of substantial equivalence implies these tests were sufficient.

Ask a specific question about this device