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The BD Integra™ Syringe is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin. It is not intended to be used for phlebotomy. The insulin syringe has scale lines in insulin units and is used for insulin injections. The tuberculin syringe can be used for any of the 3 types of common injections (intra-dermal, intra-muscular or subcutaneous).

The BD Integra™ 1ml Syringe has a permanently attached needle. The BD Integra™ 1ml Syringe contains a tool used to cut through the hub and stopper allowing the needle to become retracted inside the plunger rod of the syringe after use. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.

Single-use syringe with a needle protection system. Needle sizes: 30G-25G, Syringe sizes: 1ml.

The BD Integra™ Iml Syringe has a permanently attached needle. The BD Integra™ Iml Syringe contains a tool used to cut through the hub and stopper allowing the needle to become retracted inside the plunger rod of the syringe after use. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.

The provided document describes the BD Integra™ 1ml Syringe and its equivalence to predicate devices, but it does not contain the specific details about acceptance criteria or a formal study proving the device meets particular acceptance criteria as you've requested.

Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed devices (K980580 BD Insulin Syringe, K011103 BD Spring Based Syringe, RTI VanishPoint® Syringe K980069) for the purpose of a 510(k) premarket notification to the FDA.

Here's an analysis of the information available in the document, addressing your points where possible, and highlighting what is not provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance characteristics that were compared to predicate devices for equivalence, but it does not specify numerical acceptance criteria or quantitative performance metrics within a table.

Instead, it states:

• "The BD Integra™ Syringes performed in a similar manner to the predicate devices."
• "A Simulated Use Study was performed on the BD Integra™ 1ml Syringe. The BD Integra™ 1 ml Syringe performed equivalently to the BD conventional insulin and tuberculin syringes with respect to the following characteristics:
  • Overall performance
  • Ease of maintaining standard injection technique
  • Ability to maintain aseptic technique
  • Ability to aspirate medication from a vial
  • Ability to read the syringe scale on the barrel
  • Ability to passively re-shield and transport
  • Ability to easily and safely dispose of the used device in a sharps container
  • Perceived safety of the device"

Therefore, a table of acceptance criteria and reported device performance cannot be generated from the provided text. The evaluation was qualitative ("similar manner," "equivalently") against existing devices, not against specific predefined numeric thresholds.

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

The document mentions a "Simulated Use Study" but does not specify the sample size for this study or whether it was a test set in the context of an AI/algorithm evaluation.

The data provenance (country of origin, retrospective/prospective) is not mentioned.

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

This information is not provided in the document. The "Simulated Use Study" likely involved human users, but details on their number or qualifications are absent.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method.

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

There is no mention of an MRMC comparative effectiveness study, nor any evaluation of human reader improvement with or without AI assistance. This document predates widespread AI in medical device regulatory submissions in this context.

6. Standalone (Algorithm Only) Performance Study

There is no mention of an algorithm or standalone performance study. The device described is a physical medical device, not an AI/software algorithm.

7. Type of Ground Truth Used

For the "Simulated Use Study," the "ground truth" seems to have been based on observational equivalence or user feedback regarding the listed characteristics (e.g., ease of use, ability to aspirate, perceived safety) compared to conventional syringes. It's not explicitly stated as expert consensus, pathology, or outcomes data.

For the physical tests (shield removal, cannula removal, leakage, forces, etc.), the "ground truth" would be the measured physical properties and performance of the device, compared against predicate devices.

8. Sample Size for the Training Set

Since there is no mention of an algorithm or AI component, there is no training set, and therefore no sample size for it.

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

As there is no training set, this information is not applicable.

In summary: The provided document is a 510(k) summary for a physical medical device (syringe) seeking substantial equivalence. It describes comparative testing against predicate devices and a simulated use study; however, it does not detail specific acceptance criteria, sample sizes, expert involvement, or AI-related metrics that are typical for an AI/algorithm-based device's validation.

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