FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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:

Acceptance Criteria	Reported Device Performance
Not explicitly stated as numerical criteria. The equivalence determination is based on:	"The performance claims on the BD Bifurcated needle are equivalent to those of the predicated device"
- Intended use	Intended use is equivalent.
- Single use	Single-use status is equivalent.
- Sterile (including statement on package integrity)	Sterility and package integrity claims are equivalent.
- Package open instruction	Package open instruction is equivalent.

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.

Summary

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).