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Dr. J Spinal and Epidural Needles are intended to be used for injection of local anesthetics into a patient to provide regional anesthesia

Dr. J Spinal and Epidural Needles are intended to be used for injection of local anesthetics into a patient to provide regional anesthesia. The Dr. J Spinal and Epidural Needles are supplied sterile, intended to be single use.

Dr. J Spinal Needles are composed of a stainless-steel cannula, a hub, a stainless-steel stylet and plunger.

A guide needle may be attached to this product. The spinal needle is supplied in either the Quincke Point (=K-3 Point) or the Pencil Point.

The Dr. J Epidural Needle is composed of a stainless-steel cannula with depth marker, a hub, a stainlesssteel stylet, a plunger and a wing. The Dr J Epidural Needle is supplied in Detachable wing type which has a curved needle tip design to protect the catheter from damage during catheterization.

This document is a 510(k) Premarket Notification from Dr. Japan Co., Ltd. for their Dr. J Spinal and Epidural Needles. It argues for substantial equivalence to a predicate device (Myco Medical Supplies, Inc.'s Dr. Japan's Phoenix Spinal & Epidural Needles, K990519). The core argument is that the "new" device is essentially the same as the predicate, with only a "modification to the outer box." As such, this is not a study proving a device meets acceptance criteria as would be done for a novel AI/ML medical device. Instead, it's a demonstration that the new version of an existing device continues to meet the safety and performance standards established for the old (predicate) device.

Therefore, the information regarding acceptance criteria and performance of an AI/ML device, as outlined in your prompt, is not directly applicable to this document. This document describes the "acceptance criteria" and "proof" in terms of adherence to established medical device standards and demonstrating that minor changes to a device do not negatively impact its existing, proven performance.

Here's a breakdown of how the provided text relates to your prompt, modified to reflect the nature of a 510(k) submission for a non-AI/ML device:

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

This document doesn't provide a table of acceptance criteria in the sense of performance metrics for an AI/ML system (e.g., sensitivity, specificity). Instead, it lists various non-clinical tests performed to ensure the safety and effectiveness of the device (spinal and epidural needles) against established industry standards. The "reported device performance" is a statement that the device "passed all the testing and successfully demonstrate that subject device is as safe, as effective, and performs as well as legally marketed device predicate."

Table: Non-Clinical Testing and Acceptance Criteria (from the document)

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

This document refers to "bench testing" and compliance with international standards (ISO, ASTM, EN, and Chinese/Japanese national standards). The sample sizes are not explicitly stated for each test, but it is implied that sufficient samples were tested to meet the requirements of the cited standards. Given the nature of medical device testing (e.g., destructive testing for mechanical properties, sterility, biocompatibility), these test sets are typically derived from production batches.

• Sample Size: Not specified quantitatively for each test, but implied to be sufficient as per the referenced standards (e.g., ISO, ASTM).
• Data Provenance: The document refers to the manufacturer as "Dr. Japan Co., Ltd." with an address in Tokyo, Japan, and "Tianjin Hanaco Medical Co., Ltd." potentially involved in manufacturing. The testing standards cited include those from China (e.g., GB/T14233) and Japan (e.g., ISO10993-7 reference for Japan). Therefore, the data provenance is likely from manufacturing and testing facilities in Japan and China.
• Retrospective or Prospective: These tests are generally prospective, as they are performed on newly manufactured devices specifically for the purpose of demonstrating compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable to this type of device submission. Ground truth, in the context of an AI/ML device, refers to expert-annotated data for training and evaluating an algorithm's performance. For a physical medical device like a needle, "ground truth" is established by the performance characteristics defined in international standards and verified through laboratory testing. There are no "experts" establishing a "ground truth" for the test set in the way you've described for AI/ML. The experts here are the engineers and quality control personnel performing the tests according to the established protocols.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used in AI/ML studies to resolve disagreements among human annotators or readers for ground truth establishment. For physical devices, "adjudication" is inherent in successfully meeting the specified limits/criteria of the referenced test standards.

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. This is a physical medical device (needles), not an AI/ML system. There are no "human readers" or "AI assistance" involved in its primary function or evaluation.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device is defined by established international and national standards for medical device performance, safety, and biocompatibility. These standards represent a consensus within the medical device industry and regulatory bodies regarding the acceptable physicochemical, mechanical, sterile, and biological properties of such devices. For example, "ISO 7864 Sterile hypodermic needles for single use" defines the performance characteristics that a hypodermic needle must meet. The "proof" is the successful completion of tests demonstrating adherence to these standards.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML model that requires a training set.

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

Not applicable. There is no "training set" or "ground truth for training" for this physical device. The device is manufactured to precise specifications, and its performance is verified through testing against established standards.

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