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The proposed device is intended for the subcutaneous injection of U-100 Insulin.
Kendall Monoject® Insulin Syringes are intended for subcutaneous injection of U-100 insulin.

These devices are sterile, single use, disposable hypodermic syringes with permanently affixed hypodermic needles. Monoject Insulin Syringes consist of a syringe barrel, a plunger rod, and a hypodermic needle permanently affixed to the tip of the syringe with epoxy. Monoject Insulin Syringes are available in 1.0 cc (100 units), 0.5 cc (50 Units) and 0.3 cc (30 units) syringe capacities with a 30g x 5/16 inch needle.

The provided text describes the 510(k) summary for the Monoject® Insulin Syringe, which focuses on a design change involving a new, smaller gauge needle. The submission aims to demonstrate substantial equivalence to existing legally marketed devices.

However, the document does not contain the detailed information required to fill out the table and answer the study-related questions thoroughly. Specifically, it lacks:

• Explicit acceptance criteria with specific numerical targets. The document mentions conformance to ISO 8537:1991(E) but doesn't detail which specific parameters were tested against which criteria.
• Reported device performance in a quantifiable manner against predefined criteria.
• Descriptions of a study methodology that would include sample sizes for test sets, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
• Details on the training set for an AI/algorithm, as this is a physical medical device (syringe with a needle), not an AI/software device.
• The type and establishment of ground truth in the context of an AI/algorithm, as it's not applicable here.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted or inferred based on the document's nature (510(k) for a physical device) and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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MONOJECT Insulin Syringes are used for subcutaneous injection of U-100 Insulin.

Monoject Insulin Syringes are sterile, single use, disposable hypodermic syringes with permanently affixed hypodermic needles. Monoject Insulin Syringes consist of a syringe barrel, a plunger rod, and a hypodermic needle permanently affixed to the tip of the syringe with epoxy. Monoject Insulin Syringes are available in 1.0 cc (100 units), 0.5 cc (50 Units) and 0.3 cc (30 units) syringe capacities with the following sizes of hypodermic needle: 28 GA x ½ inch, 29 GA x ½ inch and 30 GA x 5/16 inch.

The provided text is a 510(k) Premarket Notification for Monoject Insulin Syringes. It describes the device, its intended use, and argues for substantial equivalence to predicate devices. However, it does not include a study proving the device meets specific acceptance criteria. This type of regulatory submission typically focuses on demonstrating equivalence to existing legally marketed devices rather than presenting a performance study with detailed acceptance criteria.

Therefore, I cannot provide the requested information as the document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Details of a study for the device.
3. Sample size used for a test set or data provenance.
4. Number of experts and their qualifications for ground truth establishment.
5. Adjudication method for a test set.
6. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or related effect size.
7. Information on a standalone algorithm performance study.
8. Type of ground truth used (expert consensus, pathology, outcome data).
9. Sample size for a training set.
10. How ground truth for a training set was established.

The document primarily focuses on regulatory compliance, specifically the device's design, materials, and intended use being substantially equivalent to predicate devices, and its conformity to ISO 8537:1991(E) where applicable (with an exception for the new 30-gauge needle not covered by the standard).

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