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This product is intended for the aspiration and preparation of medical fluid, not including injection.

The Filter Needle for Single Use is a single use, irradiation sterilized device that is designed to be used for use in conjunction with luer taper infusion sets conforming to EN ISO 80369-7 for the extraction, filtration and configuration of medicinal solutions and is not intended for injection purposes. Filter Needle for Single Use consists of cap, needle cannula, needle hub, sheath and filter. The cap, needle hub and sheath are made of polycarbonate (PC), the needle tube is made of medical stainless steel (SUS304), and filter is made of polyamide (PA).

The needle holder is a 6% standard tapered connector with good connectivity to the infusion apparatus.

The provided text describes the 510(k) premarket notification for a "Filter Needle for Single Use" (K233277) and its substantial equivalence to a predicate device. However, it does not contain information about a study proving that an AI/Software as a Medical Device (SaMD) meets acceptance criteria, nor does it refer to performance metrics typically associated with AI/SaMD (e.g., sensitivity, specificity, AUC).

The document focuses on the substantial equivalence of a physical medical device (a filter needle) based on material, design, performance, biocompatibility, sterilization, and shelf-life testing, primarily against established international standards.

Therefore, I cannot extract the requested information regarding AI/SaMD acceptance criteria and studies from this document. The tables and study details you've asked for (e.g., sample size for test set, data provenance, number of experts, MRMC studies, standalone performance, ground truth establishment for training and test sets) are relevant to the validation of AI/SaMD, but are not present in this clearance document for a conventional medical device.

To directly answer your request based on the provided text, I must state that the information is not available.

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The Vial adapter with filter is intended for use by Healthcare Professionals for the transfer and mixing of drugs contained in vials within clinical, hospital, or healthcare environments.

The sterile device pierces the elastomeric septum of a drug vial with its integrated piercing spike. The device is then pushed fully onto the drug vial and seats securely around the ferrule of the drug vial utilizing the housing of the vial adapter. The connector on opposite side of the vented vial adapter is for the connection of a standard luer syringe for the reconstitution and removal of the contents of the drug vial.

The device is intended for use by Healthcare Professionals (HCPs) in a clinical, hospital, or other healthcare environment. The subject device is available by prescription use only and has no known contraindications.

The proposed vented vial adapter is available in 13mm, 20mm diameter to accommodate respective sizes of drug vials.

This document is a 510(k) Premarket Notification from the FDA regarding a Vial Adapter with Filter. It does not present information about an AI/ML medical device, but rather a physical medical device. Therefore, the request to describe acceptance criteria and a study proving an AI/ML device meets these criteria cannot be fully answered from the provided text.

The provided text details the regulatory approval process for a physical medical device (Vial Adapter with Filter) and its substantial equivalence to a predicate device. It focuses on the physical, chemical, and biological performance of the device, rather than the performance of an AI/ML algorithm.

However, I can extract the general types of performance criteria and testing mentioned for this physical device, and point out what information is missing to answer the AI/ML-specific questions.

Based on the provided text, here's what can be inferred about the physical device's "acceptance criteria" and "study" (non-AI/ML context), and why AI/ML specific questions cannot be answered:

Device: Vial Adapter with Filter (physical medical device)
Regulatory ID: K233284

1. A table of "Acceptance Criteria" and "Reported Device Performance":

For a physical device, acceptance criteria are typically defined by compliance with recognized standards and internal performance specifications. The "reported device performance" are the results of tests conducted against these standards/specifications.

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

• The document does not specify the sample sizes for any of the performance tests. It only states that "performance data were provided."
• Data Provenance: The manufacturer is Hangzhou Qiantang Longyue Biotechnology Co., LTD, based in China (implied by address and country code in phone number). The nature of the studies (retrospective/prospective) for a physical device's performance testing is implicitly "prospective" as new devices would be tested to these standards.

Regarding AI/ML specific questions (which are not applicable to this physical device):

The following points are not addressed in the provided document because it pertains to a physical medical device, not an AI/ML algorithm:

• Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. Ground truth for a physical device is established through direct measurements, chemical analyses, and biological assays against established standards, not expert annotation of data.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a study design for AI-assisted diagnostic devices.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a physical device, ground truth is based on the results of validated physical, chemical, and biological tests according to international and internal standards (as listed in the table above).
• The sample size for the training set: Not applicable. This device is not an AI/ML algorithm.
• How the ground truth for the training set was established: Not applicable. This device is not an AI/ML algorithm.

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The Vial Adapter is indicated for the transfer and mixing of drugs contained in vials.

The Vial Adapter consists of luer connector, housing and piercing spike, all of which are made of polycarbonate (PC). The sterile device pierces the elastomeric septum of a drug vial with its integrated piercing spike. The device is then pushed fully onto the drug vial and seats securely around the ferrule of the drug vial utilizing the housing of Vial Adapter. The connector on opposite side of the Vial Adapter is for the connection of a standard Luer syringe for the reconstitution and removal of the contents of the drug vial. The proposed Vial Adapter is available in 13mm, 20mm and 28mm diameter to accommodate respective size of drug vials.

This is a 510(k) Premarket Notification for a medical device called "Vial Adapter". The document describes the device, its intended use, and the evidence provided to demonstrate its substantial equivalence to a legally marketed predicate device.

Here's the breakdown of the acceptance criteria and study information, as requested:

1. Table of acceptance criteria and the reported device performance:

The document doesn't explicitly define "acceptance criteria" in a quantitative format for specific performance metrics in the way a clinical trial might, but rather lists various tests performed and reports a "Pass" result for each. These effectively serve as the acceptance criteria for ensuring the device's functional integrity and safety.

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

The document does not specify the sample size for individual performance tests (e.g., how many devices were tested for leakage or puncture force). The tests are described generally and report a "Pass" result. Data provenance is not explicitly stated beyond being "internal performance standards" and compliance with international standards (ISO, ASTM). It is implied these are lab-based tests, not human/patient data.

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

This information is not applicable as the document describes non-clinical performance testing of a physical medical device. Ground truth, in the sense of expert consensus on medical conditions or image interpretation, is not relevant here. The "ground truth" for the performance tests would be the established scientific and engineering principles and standards against which the device's physical properties and functionality are measured.

4. Adjudication method for the test set:

This information is not applicable as the document describes non-clinical performance testing. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or for establishing ground truth in AI/ML performance evaluations involving human readers.

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:

This information is not applicable. This submission is for a physical medical device (Vial Adapter) and does not involve AI or any form of human-in-the-loop performance evaluation. A MRMC comparative effectiveness study would not be relevant in this context.

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

This information is not applicable. The device is a physical Vial Adapter; there is no algorithm or software component for which standalone performance would be relevant.

7. The type of ground truth used:

For the performance tests, the "ground truth" implicitly refers to:

• Established industry standards: Such as ISO 80369-7 for Luer connectors, ISO 11137-1/2 for sterilization, ISO 10993-1/4/5/10/11 for biocompatibility, and ISO 11607-1/2 and ASTM F1980-16 for shelf life and packaging.
• Internal performance standards: These are criteria developed by the manufacturer to ensure the device meets its design specifications, based on engineering principles and intended use.

8. The sample size for the training set:

This information is not applicable. There is no "training set" as this is a physical medical device, not an AI/ML product.

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

This information is not applicable. Since there is no training set, there is no ground truth to establish for it.

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