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The Disposable Injection Needle is intended to be used in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.

The Disposable Injection Needle is a sterile, single-use device as a kind of accessories for digestive endoscopy. The Disposable Injection Needle is intended to be used in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.

The Disposable Injection Needle is designed to insert through the suitable endoscope's forceps to inject harden agent to target lesion in treatment for bleeding of esopha-gastric varix or to mark the lesions of the digestive tract.

The Disposable Injection Needle has different model specifications depending on different working length and the needle size.

This document is a 510(k) summary for a Disposable Injection Needle. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria for a complex AI/software-driven medical device. Therefore, the requested information, which pertains to such a study (sample sizes, expert adjudication, MRMC studies, ground truth establishment for AI/ML models), is not present in the provided text.

The document discusses non-clinical bench testing to demonstrate that the Disposable Injection Needle meets design specifications and performs comparably to a predicate device. This is a physical device, not an AI/ML-driven one.

Here's an analysis of the provided text in relation to your request:

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

The document doesn't provide a direct "acceptance criteria" table in the sense of performance metrics for an AI/ML model (e.g., sensitivity, specificity, AUC). Instead, it lists various physical and chemical performance tests for the medical device. The "acceptance criteria" for these tests would be meeting the specified thresholds or demonstrating equivalence to the predicate device. The "reported device performance" is that the tests were carried out and demonstrated substantial equivalence.

Non-Clinical Performance Tests Performed:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated for specific tests. The document mentions tests were performed on "both the subject device (Alton Disposable Injection Needle) and the predicate device (Anrei Single Use Injection Needle)." It doesn't specify the number of units tested for each.
• Data Provenance: Not applicable in the context of clinical or image data. The "data" here refers to the results of bench testing. There is no mention of country of origin of data, nor whether it's retrospective or prospective, as these terms apply to clinical studies.

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. This device is a physical medical instrument, not an AI/ML system that requires expert annotation for ground truth. The "ground truth" for these tests would be established by validated test methods and reference standards.

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

Not applicable. This is not a study involving human readers or interpretation.

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 not an AI-assisted device. The document explicitly states: "N/A, no clinical studies are available for the subject device."

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

Not applicable. This is not an algorithm.

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

The ground truth for this device's performance is based on established engineering and materials testing standards (e.g., ISO, ASTM, USP) and the performance of the legally marketed predicate device. For example, for biocompatibility, the ground truth is compliance with ISO 10993. For mechanical performance, it's demonstrating equivalence to the predicate and meeting specified functional requirements.

8. The sample size for the training set:

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

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

Not applicable.

In summary: The provided FDA 510(k) summary is for a physical medical device (Disposable Injection Needle) and demonstrates substantial equivalence through non-clinical bench testing against a predicate device and adherence to recognized standards. It does not contain the information requested regarding AI/ML device performance studies, as those types of studies (MRMC, standalone algorithm performance, expert adjudication, ground truth for training/test sets) are not relevant to this specific device submission.

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