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The B-D® Auto-Injector is indicated for assisting the injection of a fixed dose of an approved drug or biologic packaged in a HYPAK® Cartridge component which contains a HYPAK® syringe prefilled with the drug or biologic.

The B-D® Auto-Injector is a syringe needle introducer. Syringe needle introducers are devices that use a spring-loaded mechanism to perform an injection at a predetermined depth with an hypodermic needle. The B-D® Auto-Iniector is intended to be used exclusively with drugs or biologics packaged in the HYPAK® cartridge system which contains a HYPAK® prefilled syringe. It is intended for use only with FDA approved drugs or biologics in dosages indicated in their labeling. The B-D® Auto-Injector is made of molded plastic parts and springs. Similar technology characteristics are found in various commercially marketed auto-injectors which operate on the same principle.

The provided text is a 510(k) summary for the B-D® Auto-Injector, a device used for self-administering injectable drugs. It focuses on regulatory compliance and substantial equivalence to a predicate device, rather than detailed performance study results against specific acceptance criteria.

Based on the provided text, here's what can be extracted and what information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not specify a sample size for a "test set" in the context of device performance studies.
• The document does not specify the data provenance (e.g., country of origin, retrospective/prospective) for any specific performance testing beyond biocompatibility. The substantial equivalence argument relies on the predicate device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• This information is not applicable as the document describes a medical device, not a diagnostic algorithm that requires expert-established ground truth for its performance evaluation. Clinical trials with human subjects or detailed engineering performance studies would typically involve different types of experts, but those details are not provided here.

4. Adjudication Method for the Test Set

• This information is not applicable as there is no mention of a "test set" requiring adjudication in the context of an algorithm's performance.

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

• No, a MRMC study was not done. This type of study is relevant for diagnostic imaging or similar interpretation tasks, which is not the function of an auto-injector.

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

• This information is not applicable. The B-D Auto-Injector is a physical medical device, not an algorithm, so the concept of "standalone performance" in this context doesn't fit the typical definition for AI/algorithm evaluation. Its "standalone performance" would be its functional performance as a physical device (e.g., mechanical reliability, drug delivery) but these details are not provided beyond the general statement of substantial equivalence.

7. Type of Ground Truth Used

• For biocompatibility, the ground truth is conformance to ISO 10993-1.
• For overall safety and effectiveness, the "ground truth" is implied by its substantial equivalence to a previously cleared predicate device, meaning it performs as safely and effectively as a device already on the market.
• Specific ground truth for detailed performance metrics (e.g., accurate drug delivery, complete injection) is not detailed in this document.

8. Sample Size for the Training Set

• This information is not applicable as the B-D Auto-Injector is a physical medical device and not an AI/algorithmic system that requires a training set.

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

• This information is not applicable for the same reason as point 8.

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