(479 days)
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.
| Acceptance Criteria (Implicit) | Reported Device Performance (VENTANA anti-H. pylori (SP48)) |
|---|---|
| Positive Agreement | Demonstrated in the method comparison study (specific percentage not explicitly stated in this summary portion, but confirmed as "demonstrated positive agreement"). |
| Negative Agreement | Demonstrated in the method comparison study (specific percentage not explicitly stated in this summary portion, but confirmed as "demonstrated negative agreement"). |
| Substantial Equivalence | Concluded to be substantially equivalent to the predicate device, Pylo-Plus, based on relevant characteristics and performance differences not adversely affecting safety and efficacy. |
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.
§ 866.3110
Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.(b)
Classification. Class I (general controls).