Search Results

Ready-to-Use Format

For in vitro diagnostic use.

BOND Ready-to-Use Primary Antibody Progesterone Receptor (16) is a monoclonal antibody intended to the qualitative identification by light microscopy of human progesterone receptor in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-III systems. Progesterone Receptor Clone (16) specifically binds to the progesterone receptor antigen located in the nucleus of progesterone receptor positive normal and neoplastic cells.

Progesterone Receptor Clone (16) is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer. 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.

Progesterone Receptor Clone (16) is optimized for use on the Leica Biosystems automated BOND-MAX or BOND-III systems using the BOND Polymer Refine Detection kit.

Concentrated Liquid Antibody Format

For in vitro diagnostic use.

Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone (16) (Concentrated Liquid Antibody Format) is intended to be used for the qualitative identification by light microscopy of human progesterone receptor in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining. Progesterone Receptor Clone (10) specifically binds to the progesterone receptor antigen located in the nucleus of progesterone receptor positive normal and neoplastic cells.

Progesterone Receptor Clone (16) Monoclonal Antibody (Concentrated Liquid Antibody Format) is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer. 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.

Progesterone Receptor (16) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant. This antibody is utilized to perform a qualitative immunohistochemical (IHC) assay to identify Progesterone Receptor expression in human breast cancer tissue routinely processed and paraffin-embedded for histological examination.

Progesterone Receptor (PGR) Clone 16 Primary Antibody is provided in a Ready-to-Use (RTU) and a concentrated liquid format. The RTU format is supplied in Tris buffered saline with carrier protein, containing 0.35% ProClin™ 950 as a preservative and is provided in two volumes (7 mL and 30 mL). The total protein concentration is approximately 10 mg/mL and the total antibody concentration is greater than or equal to 1 mg/L as determined by ELISA. The RTU format is optimally diluted for use on the automated BOND-MAX and BOND-III instrument staining platforms in combination with BOND Polymer Refine Detection (DS9800). The concentrated liquid format is provided so that customers may utilize manual staining protocols. The concentrated liquid format is a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative. The total protein concentration is determined on a per batch basis and is described on the vial label, and the antibody concentration is greater than or equal to 324.0 mg/L as determined by ELISA.

The BOND-MAX and BOND-III instruments are fully automated slide stainers that perform automated deparaffinization (dewaxing), antigen retrieval, immunohistochemistry (IHC) staining/in situ hybridization (ISH) staining, and counterstaining. The major components of the BOND staining platforms are the processing module, computer (BOND controller), handheld ID scanner, and slide label printer. The BOND staining platforms are composed of a number of discrete software components including the BOND application software, BOND instrument/processing module software, BOND service software, and Laboratory interface system - integration package (LIS-IP).

Here's a breakdown of the acceptance criteria and study details based on the provided text:

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

The document does not explicitly state numerical acceptance criteria for immunoreactivity or stability beyond "met acceptance criteria". However, the repeatability and reproducibility sections do provide numerical agreements and state that they met criteria. The method comparison also provides numerical agreements and states it met acceptance criteria.

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

• Intra-run Repeatability: 6 unique breast tumor tissue cases.
• Inter-day, Inter-instrument, Inter-lot Repeatability: 27 unique breast tumor tissue cases.
• Reproducibility (Inter-laboratory & Inter-pathologist): 135 unique FFPE breast tumor tissue cases.
• Method Comparison: A total of 455 cases (implied from the table total).
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "human progesterone receptor in formalin-fixed, paraffin-embedded tissue" and "breast tumor tissue cases."

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)

• Reproducibility (Inter-laboratory & Inter-pathologist): 3 pathologists were involved in scoring the slides, one per site. Their qualifications are not specified beyond "pathologist."
• Other studies (Repeatability, Method Comparison): The document does not explicitly state the number of experts used for establishing ground truth or their qualifications for these studies. The scoring for repeatability likely involved expert assessment, and method comparison relied on comparing the subject device to a predicate device, which would also implicitly rely on established expert assessment standards.

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

The document does not describe an explicit adjudication method (like 2+1 or 3+1) for resolving discrepancies. For the reproducibility studies, agreements are calculated between observers, suggesting individual pathologist assessments were compared rather than being subjected to a specific adjudication process to establish a single "ground truth" per case.

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

This document describes the performance of an immunohistochemistry reagent/antibody, not an AI-assisted diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers improving with AI assistance is not applicable and was not performed. The studies focus on the analytical performance and reproducibility of the staining process and the antibody's interpretation by pathologists.

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

This is an immunohistochemistry reagent, not an algorithm. Therefore, a standalone algorithm-only performance study is not applicable and was not performed. The performance is intrinsically linked to its use in a laboratory setting by human interpretation.

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

The ground truth for the evaluations appears to be based on pathology assessments by qualified pathologists, specifically following ASCO/CAP guidelines (≥1% cut-off) for determining PR status in breast cancer tissue. This is indicated by phrases like "scored according to ASCO/CAP guidelines" and "clinical interpretation of any staining or its absence should be complemented by morphological studies... by a qualified pathologist."

8. The sample size for the training set

The document describes performance studies, not the development or training of an AI model. Therefore, there is no mention of a "training set" or its sample size.

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

As this is not an AI model, there is no training set and thus no ground truth establishment process described for one. The "training" of the antibody is inherent to its development and optimization for specific antigen binding, which is evaluated through immunoreactivity and analytical performance studies.

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Ready-to-Use Format

Progesterone Receptor (16) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human progesterone receptor (PR) in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-MAX system. Progesterone Receptor Clone (16) [PR (16)] specifically binds to the PR antigen located in the nucleus of PR positive normal and neoplastic cells.

PR (16) is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer. 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.

Concentrated Liquid Antibody Format.

Progesterone Receptor (PGR) Clone 16 monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human progesterone receptor in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining. PGR Clone 16 specifically binds to the PGR antigen located in the nucleus of PGR positive normal and neoplastic cells.

PGR Clone 16 is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer. 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's clinical history and other diagnostic tests by a qualified pathologist.

Not Found

I am sorry, but the provided text from the FDA 510(k) summary for the BOND™ Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) and Concentrated Liquid Mouse Monoclonal Antibody (Novocastra™) does not contain any information about a study proving the device meets acceptance criteria.

The document is a clearance letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices for its intended use. It outlines the regulatory classification, product code, and general controls applicable to the device. The "Indications for Use" section describes what the antibody is intended for (qualitative identification of human progesterone receptor in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining as an aid in the management, prognosis, and prediction of therapy outcome of breast cancer).

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about a study design (sample size, data provenance, expert panels, adjudication, MRMC studies, standalone performance).
• Information on ground truth establishment for test or training sets.
• Training set sample size.

This type of detailed study information is typically found in the applicant's 510(k) submission document itself, which is often much more extensive and not usually fully released in the public "summary" letter. The FDA clearance letter primarily confirms the regulatory status and substantial equivalence determination based on the submitted data, but it doesn't present the raw study data or acceptance criteria in the format requested.

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For in vitro diagnostic use.

FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis), is intended for use in immunohistochemistry with the En Vision FLEX visualization system together with the Dako Omnis instrument to qualitatively detect human progesterone receptor in formalin-fixed, paraffin-embedded tissue sections of human breast cancer. The antibody binds progesterone receptor-expressing 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. This antibody is intended to be used after the primary diagnosis of tumor has been made by conventional histopathology using nonimmunologic histochemical stains.

FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Readyto-Use (Dako Omnis) is utilized to perform a qualitative immunohistochemical (IHC) assay to identify progesterone receptor (PR) expression in formalin fixed human breast cancer tissues routinely processed and paraffin-embedded for histological examination. The proposed device is a variant of FLEX Monoclonal Mouse Anti-Human Progesterone Receptor intended for use with the automated slide staining instrument Dako Omnis.

The design of the proposed device is developed to provide equivalent performance to its predicate FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, 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 proposed device 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.

The provided text is a 510(k) summary for the FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis). This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria for a new AI/software device. Therefore, a direct response to some of the requested points (e.g., human reader improvement with AI, standalone performance, specific ground truth methods with expert numbers) is not fully achievable from this document.

However, I can extract information related to the device's performance evaluation and its acceptance criteria as presented for regulatory approval.

Acceptance Criteria and Reported Device Performance

The document states that "All results from performance studies confirm that the device meets its acceptance criteria and is substantial equivalent to its predicate device." While specific numerical acceptance criteria are not explicitly tabulated, the performance characteristics evaluated were focused on:

• Analytical specificity for normal tissue: This implies the device should not show staining in normal tissues that do not express progesterone receptor, thus minimizing false positives.
• Reproducibility: This measures the consistency of results within a run, between different lots of reagents, across different laboratories, and among different observers.
• Concordance with the predicate device: This is a key acceptance criterion for substantial equivalence, aiming to show that the new device produces results that agree sufficiently with an already approved device.

Since the document concludes that the device meets its acceptance criteria, the reported device performance is implicitly that these aspects were successfully demonstrated.

Study Details from the Document:

1. Sample size used for the test set and the data provenance: The document mentions a "concordance study" but does not specify the sample size for the test set (number of cases or tissue sections) or the data provenance (e.g., country of origin, retrospective/prospective).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: The document states that "The clinical interpretation of any staining or its absence... should be evaluated 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 specify the number or specific qualifications (e.g., years of experience) of experts used to establish the ground truth for the test set in the analytical or concordance studies mentioned.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified in the provided text.
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: This is not an AI/software device. It is an immunohistochemistry (IHC) reagent used with an automated staining instrument. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed. The study evaluates the performance of the IHC reagent itself.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This question is not directly applicable as the device is an IHC reagent and an automated staining platform, not an AI algorithm. The performance evaluation is inherently "standalone" in terms of the reagent's analytical performance, but its interpretation requires a "human-in-the-loop" (a pathologist).
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this type of device, aimed at detecting progesterone receptor expression, is typically established by pathological assessment of the stained tissue sections, often comparing the new device's staining patterns and intensity against a gold standard or the predicate device's results. The interpretation is done by "qualified pathologists."
7. The sample size for the training set: The document does not describe a "training set" in the context of machine learning. For an IHC reagent, "training" would refer to internal development and optimization, not a distinct dataset for algorithm training.
8. How the ground truth for the training set was established: As above, the concept of a "training set" and its ground truth in the AI/ML sense is not applicable to this device. Quality control and optimization during the development of the reagent and staining protocol would rely on expert pathological evaluation.

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Ready-to-Use Format: Progesterone Receptor (16) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human progesterone receptor (PR) in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BONDMAX system. Progesterone Receptor Clone (16) [PR (16)] specifically binds to the PR antigen located in the nucleus of PR positive normal and neoplastic cells. PR (16) is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer. 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.

Concentrated Liquid Antibody Format: Progesterone Receptor (PGR) Clone 16 monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human progesterone receptor in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining. PGR Clone 16 specifically binds to the PGR antigen located in the nucleus of PGR positive normal and neoplastic cells. PGR Clone 16 is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer. 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

I apologize, but the document you provided does not contain information about acceptance criteria, device performance, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or the type of ground truth used.

The document is a 510(k) premarket notification letter from the FDA to Leica Biosystems, Inc. regarding their BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) and Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16. It focuses on:

• FDA's substantial equivalence determination: Stating the device is substantially equivalent to legally marketed predicate devices.
• Regulatory information: Listing regulation numbers, names, and class.
• General controls and additional controls: Informing the manufacturer about applicable FDA regulations.
• Indications for Use: Describing the intended use of the devices for qualitative identification of human progesterone receptor in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining, primarily as an aid in breast cancer management, prognosis, and prediction of therapy outcome.

To provide the information you requested, I would need a different document, such as a study report, clinical trial summary, or a more detailed technical submission that includes performance data and methodology.

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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.

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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 with EnVision™ FLEX +, High pH visualization kit together with the Autostainer Link 48 instrument to semiquantitatively 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.

Dako FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use, (Link) antibody is utilized to semi-quantitatively detect human progesterone receptor in formalin-fixed, paraffin-embedded (FFPE) human breast carcinoma. This product is pre-diluted and optimized for use with the Dako Autostainer Link 48 automated slide staining platform. Anti-PR, Clone PgR 636 is provided in liquid form in a buffer containing stabilizing protein and 0.015 mol/L sodium azide. The target concentration of Anti-PR, Clone PgR 636 is 0.5 ug/mL; the acceptable concentration range is 0.4 ug/mL to 0.6 ug/mL.

The Dako FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use, (Link) antibody is intended for semi-quantitative detection of human progesterone receptor in formalin-fixed, paraffin-embedded (FFPE) human breast carcinoma using immunohistochemistry with the EnVision™ FLEX+, High pH visualization kit and the Dako Autostainer Link 48 automated slide staining platform. The device's clinical interpretation should be made by a qualified pathologist considering morphological studies, proper controls, patient's clinical history, and other diagnostic tests.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device are not explicitly stated in terms of numerical thresholds for agreement values. However, the study aims to demonstrate "substantial equivalency" to the predicate device, the PR component of the Dako ER/PR pharmDx™ Kit. The reported performance metrics are:

Inter-Laboratory Reproducibility of Anti-PR, Clone PgR 636

The repeated statement of "Study results demonstrate a substantial degree of equivalency to the predicate device" serves as the overarching acceptance criterion, which the provided agreement percentages are used to support.

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

For the concordance study (comparison with the predicate device), the test set involved 236 breast carcinoma samples.
For the reproducibility study, 21 unique breast cancer specimens were used across three testing laboratories over five non-consecutive days, resulting in a total of 315 evaluations.

The document does not explicitly state the country of origin of the data. The studies appear to be retrospective, using formalin-fixed, paraffin-embedded (FFPE) human breast carcinoma samples.

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

The document does not specify the number of experts or their qualifications who established the ground truth for the test set. It mentions that staining was "scored according to ASCO/CAP guidelines (≥1% cut-off)" and that "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 implies that qualified pathologists were involved in the scoring, but the specific number and their experience levels are not provided.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method used for the test set. It refers to scoring "according to ASCO/CAP guidelines" and "Allred scoring guideline described in the package insert" for the predicate, which implies a standardized scoring protocol rather than a specific multi-reader adjudication method (e.g., 2+1, 3+1).

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

A MRMC comparative effectiveness study, in the sense of evaluating how human readers' performance improves with AI vs. without AI assistance, was not done. This device is an immunohistochemistry (IHC) assay, not an AI-assisted diagnostic tool.

However, the reproducibility study can be considered a multi-reader study as it involved testing in "three testing laboratories" over several days for inter-laboratory reproducibility, implying different readers/technicians performing and/or interpreting the tests.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is an IHC assay, not an algorithm, so a standalone performance study in the context of an algorithm's performance without human intervention is not applicable. The device (the antibody and associated staining platform) is inherently a tool for human interpretation by a pathologist.

7. Type of Ground Truth Used

The ground truth for the concordance study involved comparing the results of the new device (Anti-PR, Clone PgR 636) with those of the predicate device (PR component of the Dako ER/PR pharmDx™ Kit). The results from both were scored based on established guidelines (ASCO/CAP for the new device, and both ASCO/CAP and Allred for the predicate). This suggests a comparative "ground truth" established by an existing, FDA-cleared diagnostic method.

For the reproducibility study, the "ground truth" was based on repeated evaluations of "21 unique breast cancer specimens" scored according to ASCO/CAP guidelines. This would typically involve expert pathologist interpretation to establish the status of the samples.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" as this is not an AI/machine learning device. The antibody and assay development would involve internal validation and optimization, but these are not typically referred to as a "training set" in the context of regulatory submissions for IVD reagents.

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

Since there is no explicit "training set" or "ground truth for the training set" in the context of this type of diagnostic reagent, this information is not applicable. The development of such an antibody assay primarily involves analytical validation (specificity, sensitivity, precision) and clinical validation (concordance, reproducibility) against established methods and clinical endpoints.

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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.

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Vision BioSystems Progesterone Receptor Clone 16 (PGR Clone 16) Mouse Monoclonal antibody is intended for laboratory use to qualitatively identify by light microscopy, progesterone receptor (PGR) antigen in sections of formalin fixed, paraffin embedded tissue. PGR Clone 16 specifically binds to the PGR antigen located in the nucleus of PGR positive normal and neoplastic cells.

PGR Clone 16 is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer. 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.

Novocastra™ antibodies are intended for manual use. Origin™ antibodies are optimized for use with the Ventana® Medical Systems, NexES® and BenchMark™ Immunohistochemistry Staining Systems in combination with Ventana® Defection Kits. Bond™ Ready-to-Use Primary Antibodies are optimized for use on the Vision BioSystems Bond-max™ system.

PGR Clone 16 is a monoclonal mouse antibody that detects a human progesterone receptor epitope located in the nucleus of PGR positive cells.

This looks like a 510(k) premarket notification for an immunohistochemistry reagent, not a typical AI/ML-powered medical device. The provided text describes the device (Vision BioSystems Progesterone Receptor Clone 16), its intended use, and its substantial equivalence to a predicate device.

Therefore, the requested information about acceptance criteria, study data, sample sizes, ground truth, experts, and AI-specific performance metrics (like MRMC studies) are not typically found in this type of submission for a an IHC reagent. These details are much more relevant for diagnosing, detecting or predicting disease with AI/ML systems.

I cannot extract the detailed information requested in your prompt because it is not present in the provided document. The document describes a traditional in-vitro diagnostic device (an antibody for pathology) and not an AI/ML-based device that would have the kind of performance studies and statistical analyses you're asking for.

However, I can provide a general interpretation based on the nature of 510(k) submissions for such devices:

Likely "Acceptance Criteria" for such a device would relate to:

• Analytical Performance:
  • Specificity: The antibody should bind only to the progesterone receptor (PGR) antigen and not to other irrelevant antigens. This is typically assessed through staining of known positive and negative tissues.
  • Sensitivity: The antibody should detect PGR wherever it is present in the tissue.
  • Reproducibility/Repeatability: Consistent staining results when tested multiple times by the same operator or different operators, and across different lots of the reagent.
  • Stability: The reagent maintains its performance characteristics over its shelf life.
• Clinical Performance (in comparison to predicate):
  • Concordance: The results obtained with the new device (PGR Clone 16) should be substantially equivalent (highly concordant) with those obtained using the legally marketed predicate device (DAKO Corporation Mouse Monoclonal Progesterone Receptor PgR 636) in terms of positive and negative staining, and often, the intensity and pattern of staining.

The "Study That Proves the Device Meets Acceptance Criteria" would fundamentally be:

• A "Bridging Study" or "Comparative Study" against the predicate device. This involves testing a set of clinical tissue samples (often breast cancer tissues, given the intended use) with both the new device and the predicate device.
• Internal Verification/Validation Studies: These are conducted by the manufacturer to establish the analytical performance characteristics mentioned above.

Given the limitations of the provided text, I can only fill in the table and address the other points based on what is typically done for such a device, rather than explicit details from this particular 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided text. For IHC antibody 510(k)s, comparison studies against a predicate typically involve tens to hundreds of clinical cases, covering a range of positive and negative expressions.
• Data Provenance: Not specified. Would typically involve anonymized tissue samples from pathology archives, likely retrospective since it's a validation study against an existing predicate. Country of origin not specified.

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

• Number of Experts: Not specified. For a comparative study, results for both the candidate and predicate device would ideally be read by at least one, and often two or more, qualified pathologists. For concordance, disagreements might be resolved by consensus or a third expert.
• Qualifications of Experts: Must be qualified pathologists ("evaluated by a qualified pathologist" is mentioned in the Intended Use, implying this for clinical interpretation). Typically board-certified pathologists with experience in breast pathology.

4. Adjudication method for the test set

• Adjudication Method: Not specified. If multiple pathologists were involved in reading the comparative slides, common methods include consensus review, majority vote (e.g., 2 out of 3 agree), or an independent third pathologist for discordant cases.

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: No. This is not an AI-powered device. It is a laboratory reagent (an antibody). MRMC studies, especially those comparing human readers with and without AI assistance, are not applicable here.

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

• Standalone Performance: No. This is a manual or automated (with specific staining systems) laboratory reagent that requires interpretation by a human pathologist. There is no AI algorithm involved in its primary function of detecting the antigen.

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

• Ground Truth: For comparative studies, the "ground truth" is often established by:
  • Predicate Device Results: The results from the legally marketed predicate device (DAKO PgR 636) would serve as the primary reference for comparison for the new device.
  • Pathology Review/Expert Consensus: Confirmation of the presence/absence and classification of PGR status by qualified pathologists reviewing H&E (hematoxylin and eosin) stained slides and potentially the predicate IHC stain.
  • Clinical Diagnosis/Outcomes: While specific outcomes data might not be the direct "ground truth" for assay performance, the clinical utility is linked to established correlations between PGR status and breast cancer management/prognosis/therapy outcome.

8. The sample size for the training set

• Training Set Sample Size: Not applicable in the context of an antibody reagent. Antibodies are not "trained" like AI algorithms. They are developed and validated. The development process would involve extensive analytical testing on various tissues, but there isn't a "training set" in the AI sense.

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

• Ground Truth for Training Set: Not applicable. For antibody development, quality control (QC) references (known positive/negative tissues) are used to assess the binding characteristics, but this is part of analytical validation, not "training."

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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.

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The DakoCytomation ER/PR pharmDx™ assay is an immunohistochemical (IHC) kit system to identify human estrogen receptor (ER) and human progesterone receptor (PR) expression in breast cancer tissues routinely processed and paraffin-embedded for histological evaluation. ER/PR pharmDx specifically detects the ER alpha protein as well as the PR located in the cell nucleus of ER and/or PR-expressing cells.

ER/PR pharmDx is indicated as an aid in identifying patients eligible for treatment with antihormonal or aromatase inhibitor therapies, as well as an aid in the prognosis and management of breast cancer.

The DakoCytomation Monoclonal Mouse Anti-Human Progesterone Receptor, clone PgR 1294, is intended for laboratory use as a semi-quantitative detection of progesterone receptor by light microscopy in routinely processed normal and pathological human paraffinembedded tissue. This antibody is indicated for use as an aid in the management, prognosis and prediction of outcome of breast cancer. The 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 individual

The DakoCytomation ER/PR pharmDx™ assay is a semi-quantitative immunohistochemical (IHC) kit system to identify estrogen receptor (ER) and progesterone receptor (PR) expression in normal and neoplastic tissues routinely processed and paraffin-embedded for histological expressing cells respectively.

ER/PR pharmDx assay is available in two configurations, both manual and automated and is optimized for use with DakoCytomation detection systems.

The DakoCytomation Monoclonal Mouse Anti-Human Progesterone Receptor, clone PgR 1294, is a component of the ER/PR pharmDx kit, which will also be commercially available as a concentrate.

Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and study proving device performance for the DakoCytomation ER/PR pharmDx™ Kit and the Monoclonal Mouse Anti-Human Progesterone Receptor, clone PgR 1294:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of numerical acceptance criteria with corresponding reported device performance values. Instead, it describes performance characteristics that were evaluated and states that the results demonstrated "a substantial degree of equivalency to the predicate devices" and "substantially equivalent staining results" to a reference method.

The primary acceptance criteria appear to be substantial equivalence to predicate devices and high concordance with a recognized reference method.

Table of Acceptance Criteria and Reported Device Performance (Inferred)

Study Description and Details:

The summary refers to a single study that encompassed evaluations of specificity, sensitivity, reproducibility, and concordance testing.

1. Sample Size and Data Provenance:

   • Test Set Sample Size: Not explicitly stated for any of the performance characteristics.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

2. Number of Experts and Qualifications for Ground Truth:

   • The document does not provide information on the number of experts used to establish ground truth or their specific qualifications.

3. Adjudication Method:

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

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study is mentioned. The comparison is between the new device and predicate devices/reference methods, not an assessment of human reader improvement with or without AI assistance.

5. Standalone Performance (Algorithm Only):

   • Yes, the performance characteristics (specificity, sensitivity, reproducibility, and concordance) are described for the device itself (the IHC kit and its components) when used according to its intended purpose. This represents a standalone assessment of the assay's performance.

6. Type of Ground Truth Used:

   • The ground truth for the concordance testing was established using the "Allred method." The Allred score is a semi-quantitative scoring system for ER/PR expression in breast cancer, combining the proportion of positive cells and the staining intensity. This can be considered a type of expert consensus/established semi-quantitative scoring method based on histopathology. For specificity, sensitivity, and reproducibility, the ground truth would also be based on established histopathological evaluation or comparison to the predicate devices, which are already considered validated.

7. Training Set Sample Size:

   • Not specified. The document primarily focuses on the validation study demonstrating substantial equivalence. It does not provide details about any internal development or training data used in the creation of the assay itself, as this would typically be a chemical/biological assay rather than a machine learning algorithm requiring a separate "training set" in the computational sense.

8. How Ground Truth for Training Set was Established:

   • Not applicable as this is not a machine learning device and no "training set" is described. The development of such IHC kits typically involves chemical formulation, antibody selection, and optimization against known positive and negative tissue samples, but these are not referred to as a "training set" in the context of this document.

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