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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 device is intended to be used with an endoscope to perform endoscopic vascular or submucosal injection in the GI tract.The Disposable Injection Needles are consist of needle tube, inner tube, outer tube, protective sleeve, booster tube, handle, limitation ring, buckle and conical connector. The needle tube and booster tube are made of 06Cr19Ni10. The inner tube are made of PP.The handle, limitation ring, buckle and connector are made of ABS. The diameter of the outer tube is available in two specifications, respectively are 1.8mm and 2.3mm. There are five specifications for the working length of the outer tube, respectively are 1200mm,1800mm,2000mm and 2300mm. There are three specifications for outer diameters of needle tube, respectively are 21G, 23G and 25G. Five specifications for lengths of needle tube, respectively are 4mm, 5mm, 7mm and 8mm.

The device is sterilized by ethylene oxide. The shelf life is 3 years.

The inner, middle and transportation packaging ways respectively are sealed pouch, box and carton.The corresponding product quantities is 1 pc per bag, 10 pcs per box and 5 boxes per carton.

This is a 510(k) premarket notification for a medical device (Disposable Injection Needles), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than complex performance criteria for AI/ML devices. Therefore, many of the requested categories for AI/ML device performance are not applicable to this submission.

Based on the provided document, here's an analysis of the acceptance criteria and supporting studies:

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

The document does not present a formal table of "acceptance criteria" in the way one might expect for a digital health or AI device (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly defined by compliance with established medical device standards and demonstrating performance comparable to the predicate device. The Reported Device Performance is stated as meeting the requirements of these standards.

The document concludes that "The conclusions drawn from the non-clinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device Injection Needle (K213914)." This general statement serves as the overall reported device performance and proof that it meets the implicit acceptance criteria of substantial equivalence.

The following information is not applicable to this traditional medical device submission, as it pertains to AI/ML device evaluations:

2. Sample size used for the test set and the data provenance: Not applicable. The tests are physical and chemical bench tests on the device materials and functional aspects, not AI performance on 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 for an AI/ML device often involves expert annotation. For this physical device, "ground truth" is measured by adherence to established engineering and biocompatibility standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI/ML ground truth. For this device, the "ground truth" is adherence to performance specifications outlined in the referenced ISO and ASTM 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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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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Wilson disposable injection needle has been designed to be used with an endoscope to perform following therapy:

1. Endoscopic sclerotherapy within the esophagus, stomach, duodenum, small intestine, large intestine.
2. Endoscopic hemostasis within the esophagus, stomach, duodenum, small intestine, large intestine.
3. Endoscopic submucosal injection within esophagus, stomach, duodenum, small intestine, large intestine.

The subjected Disposable Injection Needle is operated together with an endoscope to conduct an endoscopic injection for the treatment of esophageal and gastric varices and submucosal injection in the digestive tract, such as esophagus, stomach, duodenum, small intestine, large intestine.

The subjected device is primarily constituted of handle, tube and needle. The models include PN series, PM series and PM(H) series.

The provided document is a 510(k) premarket notification for a medical device: "Disposable Injection Needle" (PN series, PM series, PM (H) series) by Wilson Instruments (Shanghai) Company Limited. This type of document is a regulatory submission for medical devices, primarily demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a specific study proving the device meets those criteria, as one might find in a clinical trial report or a performance study for AI/software as a medical device (SaMD).

Here's an analysis based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of quantitative acceptance criteria for performance, nor does it present specific device performance results in a measurable, quantifiable way against such criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device through:

• Similar intended use.
• Similar technological characteristics (materials, design, sterilization method).
• Compliance with biocompatibility, sterility, and performance testing in accordance with FDA guidance and international standards.

For medical devices like injection needles, "performance" is often assessed through bench testing for things like needle sharpness, force of injection, material integrity, sterilization effectiveness, and biocompatibility, rather than diagnostic accuracy metrics. The document states that "Test data and report information included in this submission demonstrate that the subjected device is substantially equivalent to the predicate device," but these specific test results are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a "test set" in the context of data for an AI/SaMD product. It refers to "test data and report information" for biocompatibility, sterility, and performance, which would typically involve physical samples of the device undergoing laboratory testing. The sample sizes for these types of tests are not disclosed in this summary. Data provenance (country of origin, retrospective/prospective) is not applicable in the context of this device and type of submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable to a disposable injection needle. Ground truth, expert consensus, or clinical outcome data are typically relevant for diagnostic or AI devices where there's an interpretation or prediction being made that can be compared against a 'truth'. For an injection needle, the "ground truth" related to its function is derived from engineering specifications and objective physical/chemical tests.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used to resolve discrepancies in expert interpretations in diagnostic studies.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done for this device. This type of study is relevant for diagnostic devices (especially those involving image interpretation by human readers) to assess the impact of AI assistance on human performance. The Disposable Injection Needle is a physical therapeutic/interventional device.

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

No, a standalone performance study (algorithm only) was not done. This is also specific to AI/SaMD products.

7. The Type of Ground Truth Used:

As noted, the concept of "ground truth" in the diagnostic/AI sense is not applicable. For this physical device, the "truth" is established by:

• Engineering specifications: Meeting defined physical dimensions, material properties, and functional performance (e.g., needle sharpness, strength).
• Biocompatibility testing: Adhering to standards (e.g., ISO 10993) to ensure no adverse biological reactions.
• Sterility testing: Confirming the absence of viable microorganisms per established standards.
• Material safety data: Ensuring components are safe for their intended use.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" for a physical medical device like an injection needle. Training sets are used in machine learning for AI algorithms.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set.

Summary of Acceptance Criteria and Evidence from the Document:

The document states that the device is "substantially equivalent" to the predicate device (Olympus Injector NM-4-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1 cleared via K011484). The "acceptance criteria" can be inferred as meeting the same performance, safety, and effectiveness profiles as the predicate device.

Inferred Acceptance Criteria (not explicitly quantitative in the document):

In conclusion, this 510(k) summary focuses on demonstrating substantial equivalence of a physical medical device (Disposable Injection Needle) to a legally marketed predicate. It does not contain the specific detail about acceptance criteria, study design, and performance metrics typically seen for AI/SaMD or clinical trial reports. The "study" proving the device met the criteria would consist of laboratory tests for biocompatibility, sterility, and various physical performance tests, the details of which are not included in this summary but would have been part of the full 510(k) submission.

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