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Like other commercially available epidural needles, the Kendall Blunt Tip Tuohy Epidural Needle is used to administer anesthetic to the peridural space.

The Kendall Blunt Tip Tuohy Epidural Needle is a sterile single use device designed to be used for the induction of epidural anesthesia. The needle cannula and matched stylet are composed of stainless steel. A polycarbonate hub is insert molded onto the cannula. The hub is supplied in two configurations, a fixed wing design and a non-winged design. The cannula gauge, length and tip are equivalent to current commercially available epidural needles. A portion of the tip of a standard needle bevel is removed in a blunt grind process. The sharp cutting edges around the periphery of the needle bevel remain unchanged.

This document is a 510(k) summary for the Kendall Blunt Tip Tuohy Epidural Needle. It describes the device, its intended use, and compares it to a legally marketed predicate device (Kendall 18 Gauge Calibrated Tuohy Epidural Needle, K921288B).

However, the provided text does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of performance metrics like sensitivity, specificity, F-score, etc., which are common for AI/ML-based medical devices.

Instead, the "testing" described is focused on:

• Biocompatibility: Following ISO-10993, finding "no toxic diffusible substances." This is a material safety test, not a performance study in the AI sense.
• Functional/Mechanical testing: To determine "needle penetration force and hub pull-off force." These are engineering specifications, not performance criteria for a diagnostic or predictive device.

Therefore, I cannot provide the requested table and information based on the prompt. The provided document is for a physical medical device (an epidural needle) and not an AI/ML-based device.

If you intended to ask about the typical acceptance criteria and study designs for physical medical devices in a 510(k) submission (which often focus on safety, functionality, and substantial equivalence), the provided text partially addresses the testing performed, but it doesn't present "acceptance criteria" in the format of a table with reported performance against those criteria.

To answer your specific questions:

1. A table of acceptance criteria and the reported device performance: Not applicable for an AI/ML device. For this physical device, the "acceptance criteria" would be internal engineering specs (e.g., maximum penetration force, minimum hub pull-off force) which are not explicitly stated here, nor are the precise "reported performances" against those specs, only that testing was "performed to determine" them.
2. Sample size used for the test set and the data provenance: Not applicable. The "tests" described are laboratory/bench tests on the device materials and components, not a clinical study with a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML devices (e.g., expert consensus on medical images or diagnoses) is not relevant here.
4. Adjudication method: Not applicable.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable. The "ground truth" for a physical device is its adherence to design specifications and safety standards.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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