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The device is intended to be used with an endoscope to perform endoscopic vascular or submucosal injection in the GI tract.

The injection needle is intended to be used with an endoscope to perform endoscopic vascular or submucosal injection in the GI tract, which consists of needle, connector tube, outer tube, outer tube, outer tube, protective sleeve, front handle, injection handle, front handle cover and boosting tube. The proposed device is used to puncture the target tissue where guided by the endoscope. The fluid is injected to the target through the proposed device by an injector which is connected the proposed device.

The provided text is a 510(k) summary for an Injection Needle, a medical device used with an endoscope for various injections in the GI tract. It does not describe an AI/ML-enabled device nor does it contain information about acceptance criteria or studies related to AI/ML device performance.

Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details, as this information is not present in the provided document.

The document focuses on demonstrating substantial equivalence of the new Injection Needle to a predicate device (Single Use Injector NM600/610) based on non-clinical tests (biocompatibility, sterility, package integrity, etc.) and direct comparison of design and intended use specifications, as is common for traditional medical devices in a 510(k) submission. No clinical study was performed.

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The injection needle is 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 injection needle consists of a stainless steel needle attached to plastic tubing and luer lock hub where a standard syringe can be attached for injection of materials through the lumen of the needle into tissue. The minimum required working channel for this proposed product is 2.8mm.

The proposed products are intended for single use, an individual device is packed in a sealed pouch following ETO sterilization. The device is used for local injection via endoscope, with the average contact time of the product and the mucosa of the human digestive tract of less than 1 hour.

The provided document is a 510(k) summary for a medical device (Injection Needle) seeking FDA clearance based on substantial equivalence to a predicate device. It does not contain information about a study proving the device meets specific acceptance criteria in the way an AI/ML medical device would be evaluated. Instead, it focuses on demonstrating equivalence to another marketed device through comparative tables and testing that confirms safety and performance for its intended use.

Therefore, the requested information elements related to AI device evaluation (test sets, ground truth, expert adjudication, MRMC studies, standalone performance, training sets) are not applicable to this document.

However, I can extract the acceptance criteria and performance data that are present, related to the device's technical characteristics and performance based on engineering and biocompatibility testing.

Here's a breakdown of the information that can be extracted from the provided text, and an explanation of why other requested elements are not present:

Acceptance Criteria and Device Performance (Based on Technical Characteristics and General Performance Testing)

Information on AI-Specific Study Elements (Not Applicable to this Document):

The provided document is an FDA 510(k) summary for a physical medical device (an injection needle), not an AI/ML-driven diagnostic or treatment device. Therefore, the following information is not present and not applicable to this type of submission:

1. Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI algorithm. The device itself undergoes performance and safety testing.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" established by experts for a physical injection needle in this context.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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 device does not involve human readers interpreting images with or without AI assistance.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
7. The sample size for the training set: Not applicable. There is no AI model to train.
8. How the ground truth for the training set was established: Not applicable.

Summary of Relevant Information from the Document:

• Device: Injection Needle (K150434)
• Manufacturer: Micro-Tech (Nanjing) CO., Ltd.
• Predicate Device: Injectra Injection Needle (K061222)
• Regulatory Pathway: 510(k) for substantial equivalence.
• Testing Performed: Biocompatibility, accelerated aging, performance, and sterilization validation testing. These tests demonstrated that the device is safe and effective for its intended use and supports its substantial equivalence to the predicate device.
• Substantial Equivalence Conclusion: The manufacturer believes the proposed device is substantially equivalent to the predicate device, citing similarities in materials, intended use, function, and overall design. They acknowledge slight differences in needle length and working length, and minor differences in wording for indications for use, but state these differences do not raise new issues of safety or effectiveness.

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The injection needle is intended for endoscopic injection into the gastrointestinal mucosa.

The Injection Needle mainly consists of a cap, needle, boosting tube, and positioning ring, all made of 304 stainless steel. It also contains an outer tube and nut made of PTFE. The spring and spring tube are made of 302 stainless steel. The shell and injection handle are made of ABS. The bushing is made of TPE (SBS), and the inner tube is made of nylon. The products are intended for single use; an individual device is packed in a sealed pouch following ETO sterilization. The device is used for local injection via endoscope, with the average contact time of the product and the mucosa of the human digestive tract of less than 1 hour.

The provided text describes a 510(k) submission for an "Injection Needle" and focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria for the new device.

Therefore, many of the requested sections (Table of acceptance criteria, Sample size for test set, Number of experts, Adjudication method, MRMC study, Standalone study, Type and establishment of ground truth for test and training sets) cannot be fulfilled from the provided text, as this information is not present. The submission focuses on comparing the characteristics of the new device to a predicate device to claim substantial equivalence, which is a different type of evaluation than a direct performance study against defined acceptance criteria.

However, based on the provided text, here's what can be extracted:

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

The document does not explicitly state "acceptance criteria" and "reported device performance" in the context of a formal study with quantitative results against pre-defined thresholds. Instead, it presents a comparison of the new device's characteristics against a predicate device to demonstrate substantial equivalence. The "performance" described is in terms of similar technical characteristics and capabilities to the predicate.

2. Sample sized used for the test set and the data provenance

Not applicable. The submission describes a comparison of technical characteristics and an assessment of safety and effectiveness based on biocompatibility, accelerated aging, performance, and sterilization validation testing. There is no "test set" in the context of a clinical performance study with human data or a labeled dataset for AI evaluation. The data provenance simply refers to these internal engineering and biological safety tests.

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

Not applicable. No ground truth for a test set is mentioned.

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

Not applicable. No test set requiring expert adjudication is mentioned.

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 device or a diagnostic device where MRMC studies would typically be performed.

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

Not applicable. This is a medical device (an injection needle), not an algorithm or AI.

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

Not applicable. Ground truth, in this context, would relate to a clinical diagnostic or AI performance study, which is not what this submission describes. The "truth" considered here is that the device, through various engineering and biological tests, meets safety and performance requirements that are substantially equivalent to a legally marketed predicate.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI model.

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

Not applicable. This is a medical device, not an AI model.

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The TUNIS™ probes and devices are to be used independently or with commercially available rigid and flexible endoscopes, including laparoscopes, hysteroscopes, cystoscopes, resectoscopes for transurethral injection procedures. These devices can be used for laparoscopic, hysteroscopic, cystoscopic, and other endoscopic & open surgical procedures designed for interstitial injection/aspiration of biomaterials, fluids and solutions in the urinary bladder and lower urinary tract.

TUNIS™ - Transurethral Injection System Probe/Device

This document is a 510(k) clearance letter from the FDA for a medical device called the "Tunis™ Transurethral Injection/Aspiration System Probe Device." It signifies that the device has been found substantially equivalent to a predicate device and can be marketed.

Crucially, this document does not contain information about acceptance criteria, device performance details, or any study results proving the device meets acceptance criteria.

The 510(k) clearance process focuses on substantial equivalence to a legally marketed predicate device, ensuring similar safety and effectiveness. It does not typically require the submission of detailed performance studies against specific acceptance criteria in the same way a pre-market approval (PMA) would for novel, high-risk devices.

Therefore, I cannot extract the requested information from the provided text. To answer your questions, one would need access to the original 510(k) submission document (K983765) itself, which might contain summaries of performance testing, albeit less rigorous than what's typically expected for a PMA.

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