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The RX Epidural Needle is intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia.

The RX Epidural Needle consists of a stainless steel cannula with a ground beveled distal tip. A plastic hub is molded onto the proximal end of the cannula. A stylet is also provided with the device which consists of a custom trimmed shaft and a molded plastic hub. The RX Epidural Needle will be provided as a sterile, single use, disposable device. The RX Epidural Needle will be available in a variety of lengths and gauges.

The provided text is a 510(k) summary for a medical device called the "RX Epidural Needle" and the FDA's response letter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance data on a pre-defined test set.

Therefore, many of the requested categories for describing acceptance criteria and study details cannot be filled from the given text. This type of submission relies on the established safety and effectiveness of a predicate device, not on a new clinical or performance study with defined acceptance criteria for a novel device.

Here's a breakdown of what can and cannot be answered based on the provided document:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided from the text. The document does not describe specific acceptance criteria (e.g., in terms of sensitivity, specificity, accuracy, or other performance metrics) because it's a 510(k) submission for substantial equivalence. It compares the device to a predicate based on "similar physical and technical characteristics" rather than new performance data against numerical targets.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Cannot be provided from the text. No specific test set or associated data provenance is mentioned as this is a substantial equivalence submission, not a de novo study with a test set.

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 / Cannot be provided from the text. Ground truth establishment is not described as there is no specific "test set" and corresponding study in the provided text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Cannot be provided from the text. No adjudication method 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 / Cannot be provided from the text. This device is an epidermal needle, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable / Cannot be provided from the text. This device is an epidermal needle, not an algorithm, so standalone performance in that context is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable / Cannot be provided from the text. No ground truth is described.

8. The sample size for the training set

• Not applicable / Cannot be provided from the text. No training set is mentioned.

9. How the ground truth for the training set was established

• Not applicable / Cannot be provided from the text. No training set or ground truth establishment is mentioned.

Summary based on the document:

The provided document describes a 510(k) summary for a medical device. The core of a 510(k) submission is to demonstrate substantial equivalence to a predicate, legally marketed device. This means the device is as safe and effective as a legally marketed device and does not require a new Premarket Approval (PMA) application.

In this specific case, the RX Epidural Needle is deemed substantially equivalent to the Epimed International Epidural Needle (K030562). The "study" (or rather, the basis for approval) is this comparison.

• Acceptance Criteria: Implicitly, the acceptance criterion for a 510(k) is demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate device.
• Reported Device Performance: The document states, "The RX Epidural Needle has similar physical and technical characteristics to the Epimed International Epidural Needle marketed under K030562." This is the reported "performance" in the context of this type of submission. Specific numerical performance metrics were not required or provided in the summary.
• Study Design: This was a comparison study based on device characteristics, not a clinical trial or performance study with a test set of data.

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