Search Results

The Bifurcated Needle is intended for use in administering vaccines by the scarification method or administering epidermal allergens.

The proposed Bifurcated Needle have two prongs. A small drop of smallpox vaccine was placed between the prongs and approximately fifteen punctures would be made into the skin. The needles were sterilized by EO to achieve a SAL of 10-6 and supplied sterile in packaging with a shelf life of five years.

The provided document is a 510(k) summary for a "Bifurcated Needle" and primarily focuses on proving substantial equivalence to a predicate device based on material properties, manufacturing processes, and adherence to performance standards. It explicitly states that "No clinical study is included in this submission." Therefore, the document does not contain information regarding a study that proves the device meets acceptance criteria related to AI/algorithm performance, human reader improvement, or clinical effectiveness.

The request asks for details typically found in submissions for AI/ML-driven medical devices or diagnostic tools, which involve evaluating algorithm performance, human-in-the-loop studies, and the establishment of "ground truth" for test and training sets. Since this document is for a physical, non-AI medical device (a bifurcated needle for administering vaccines), these types of studies were not conducted or presented.

Therefore, I cannot fulfill the request as the necessary information is not present in the provided text. The document does not describe:

• A table of acceptance criteria and reported device performance in the context of AI/ML or diagnostic accuracy.
• Sample sizes for a test set for AI performance or data provenance.
• Number of experts or their qualifications for establishing ground truth for AI.
• Adjudication methods for AI test sets.
• MRMC comparative effectiveness studies.
• Standalone (algorithm only) performance.
• Type of ground truth (expert consensus, pathology, outcomes data) for AI performance.
• Sample size for training set for AI.
• How ground truth for training set was established for AI.

The "performance data" section in the document refers to biocompatibility, sterilization, shelf life, and general physical performance testing for the needle itself, against standards like ISO 10993, ISO 11135, and ASTM standards. This is for the device's physical properties and safety, not for diagnostic or AI/ML performance.

Ask a specific question about this device

The BD Eclipse™ Bifurcated Needle is intended for use in administering vaccines by the scarification method or administering epidermal allergens.
The BD Eclipse™ Bifurcated Needle contains a mechanism that covers the needle point after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle.

Not Found

I am sorry, but based on the provided documents, there is no information about acceptance criteria or a study that proves the device meets any specific acceptance criteria.

The documents are FDA letters regarding a 510(k) premarket notification for the "BD Eclipse Bifurcated Needle." These letters confirm the device's substantial equivalence to legally marketed predicate devices and reclassify its product code. They do not contain details about performance studies, acceptance criteria, or specific performance metrics.

Therefore, I cannot provide the requested information.

Ask a specific question about this device

The BD Bifurcated needle is intended for use in administering vaccines by the scarification method or administering epidermal allergens.

The BD Bifurcated Needle will be offered in the following reorder numbers: 301754; 301755; 301756; 301757.

The provided text is a 510(k) premarket notification for a medical device: the BD Bifurcated Needle. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive de novo clinical study data with detailed acceptance criteria, sample sizes, and ground truth methodologies as might be found in a PMA (Premarket Approval) application or a more complex de novo classification request.

Based on the provided document, the device is a BD Bifurcated Needle, which is intended for "administering vaccines by the scarification method or administering epidermal allergens."

Therefore, much of the requested information regarding acceptance criteria and performance studies, particularly related to AI/algorithm performance, multi-reader studies, and detailed ground truth establishment, is not applicable to this type of device and submission.

Here's an attempt to answer the questions based only on the available information:

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

The document does not explicitly state numerical acceptance criteria or report specific performance metrics from a formal study for the BD Bifurcated Needle. The equivalence determination is based on comparing "Labeling" and "performance claims" to a predicate device.

Table:

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

• Sample Size for Test Set: Not specified. The document does not describe a clinical test set with a specified sample size for performance evaluation.
• Data Provenance: Not specified. The submission relies on "equivalence determination" to a predicate device rather than novel clinical data.

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. The submission does not describe a study involving expert-established ground truth for a test set. This type of device (a needle) does not typically require such a ground truth establishment process for a 510(k) submission.

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

• Not applicable. No test set requiring adjudication is described.

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 physical medical instrument (needle), not an AI-powered diagnostic or assistive tool. MRMC studies or AI assistance are not relevant.

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

• Not applicable. This refers to AI algorithms, which is not what the BD Bifurcated Needle is.

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

• Not applicable. No ground truth is established in the context of a new performance study. The "ground truth" for this 510(k) is implicitly the established safety and effectiveness of the predicate device to which it is being compared.

8. The sample size for the training set

• Not applicable. No training set is mentioned as this is not an AI/machine learning device.

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

• Not applicable. No training set is mentioned.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" that proves the device meets "acceptance criteria" (in the context of a 510(k) for this type of device) is an equivalence determination to a legally marketed predicate device.

The document states:
"We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices..."

And in the "Summary of Safety and Effectiveness":
"The elements of comparison between the BD Bifurcated Needle and the Precision Medical Products predicate device are as follows: Labeling: The performance claims on the BD Bifurcated needle are equivalent to those of the predicated device, i.e.: Intended use, Single use, Sterile (including statement on package integrity), Package open instruction."

This means the submission relies on the established safety and effectiveness of the predicate device(s):

• Precision Medical Products - K012515
• BD Vacutainer® Brand Blood Collection Needle - Pre-Amendment

The "study" here is essentially the comparison and justification of substantial equivalence based on characteristics like intended use, design (implied by the device name, but not detailed in the provided snippets), and labeling claims, rather than a de novo clinical trial with specific performance metrics and acceptance criteria.

Ask a specific question about this device