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The Safety Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the skin. The Safety sheath of Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential of syringe reuse.

The Disposable Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.

The proposed Syringes include Disposable Syringe with permanently attached needle and a Safety Syringe with permanently attached needle. The Disposable Syringe with permanently attached needle have one kind of product configuration, and the Safety Syringe with permanently attached needle has two kinds of product configurations. The proposed syringes are available in different combination of syringe volumes and/or needle sizes, and the syringe is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterile in packaging to maintain the sterility of the device during the shelf life of three years.

This is a 510(k) premarket notification for a medical device (Safety Syringe with permanently attached needle; Disposable Syringe with permanently attached needle), not an AI/ML powered device. Therefore, the common acceptance criteria and study designs applicable to AI/ML devices, such as those involving human readers, effect sizes, specific ground truth methods, and training/test set sample sizes for AI model development, are not relevant to this document.

The document describes performance testing for substantial equivalence to predicate devices, which focuses on various engineering and biocompatibility standards.

Here's the relevant information about the acceptance criteria and study (non-clinical) that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present acceptance criteria and performance in a direct "acceptance criteria vs. reported performance" table for all aspects. Instead, it refers to compliance with established international standards for medical devices. The "reported device performance" is implicitly that the device complies with these standards where listed.

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

The document does not specify the exact sample sizes for each of the non-clinical tests mentioned. The "tests" are laboratory-based and generally involve a specified number of samples needed to demonstrate compliance with the relevant ISO or ASTM standards. Data provenance is not described in terms of country of origin as it's not clinical data, but rather laboratory test results. All tests are non-clinical (laboratory-based).

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

Not applicable. These are non-clinical, laboratory-based tests for physical and material properties, not clinical evaluations requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set:

Not applicable for non-clinical laboratory testing. Results are typically objectively measured against standard specifications.

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 device is a manual medical device, not an AI-powered system that would involve human readers or AI assistance.

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

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

7. The type of ground truth used:

For this device, "ground truth" is defined by the objective specifications and acceptance criteria outlined in the referenced international standards (ISO, ASTM, USP). For example:

• Biocompatibility: The "ground truth" is the acceptable range of biological response according to ISO 10993 standards.
• Sterilization: The "ground truth" is a Sterility Assurance Level (SAL) of 10^-6, verified by methods validated to ISO 11135.
• Physical Performance: The "ground truth" is the specific functional and dimensional requirements set forth in standards like ISO 7886-1 or ISO 9626.

There is no "expert consensus" or "pathology" in the traditional sense for these types of mechanical and material tests.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device; there is no training set.

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

Not applicable. There is no training set for this type of device.

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The Auto-disable Syringe for Fixed-dose Immunization is intended for use in the aspiration and injection of fluids for medical purpose.

Not Found

Based on the provided FDA 510(k) letter, it is not possible to describe the acceptance criteria and the study that proves the device meets those criteria for the following reasons:

• Device Type: The document is a 510(k) clearance letter for an Auto-disable Syringe for Fixed-dose Immunization, which is a physical medical device (piston syringe), not a software or AI-based device.
• Study Type: For physical medical devices like syringes, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" typically refer to performance testing (e.g., plunger force, leakage, dose accuracy under various conditions, sterility, material biocompatibility, auto-disable mechanism function) rather than studies involving expert readers, ground truth establishment, or AI algorithm performance metrics (sensitivity, specificity, AUC).
• Lack of Performance Data: The provided text is an official FDA clearance letter, which confirms substantial equivalence to a predicate device and outlines regulatory obligations. It does not contain the detailed performance study results, acceptance criteria, sample sizes, or ground truth methodologies that would be submitted within the 510(k) application itself. These details are part of the technical documentation reviewed by the FDA but are not typically included in the public clearance letter.

Therefore, the requested information, which pertains to AI/software performance evaluation (e.g., MRMC studies, standalone algorithm performance, expert ground truth, training/test set details), is not applicable to the device described in this specific FDA document. The document describes a physical medical device, not an AI or imaging diagnostic software.

To answer your question, one would need to see the actual performance data and study reports submitted as part of the 510(k) application for a software device, not this physical syringe.

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The Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.

The Syringe with permanently attached needle is intended for single use only. The proposed device is available in 0.3ml, 0.5ml, 1ml volumes with a 20G-34G gauge needle. The product is for single use and provided sterile (EtO). The shelf-life of the product is five-years. The proposed syringes are available in different combination of syringe volumes and/or needle sizes.

The provided document is a 510(k) summary for a "Syringe with permanently attached needle" and does not contain information about acceptance criteria for an AI/ML powered device, nor a study proving such a device meets those criteria.

The document describes a traditional medical device (a syringe) and its substantial equivalence to a predicate device based on non-clinical performance testing against established ISO and ASTM standards. Therefore, most of the requested information regarding AI/ML device performance and testing is not applicable to this submission.

Here's an analysis based on the information provided, noting where the requested AI/ML specific information is absent:

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

The document does not present acceptance criteria in a formal table with reported performance in the way typically expected for an AI/ML diagnostic or prognostic device. Instead, it states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."

The non-clinical tests performed are listed as compliance with various ISO and ASTM standards. The acceptance criteria for these standards are implicit within the standards themselves, and the document explicitly states the device "complies" with them and that "The test results demonstrated that the proposed device is as safe and as effective as the predicate device."

• Example from document:
  • Acceptance Criteria (implicit in standard): Sterile hypodermic syringes for single use must meet requirements of ISO 7886-1:2017.
  • Reported Device Performance: "Syringe performance: ISO 7886-1 [Compliant]" (from Table 2) and "Test results demonstrated that the proposed device complies with... ISO 7886-1:2017".

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

This information is not applicable/not provided as this is not an AI/ML device and no diagnostic test set or data provenance is mentioned beyond general non-clinical device testing.

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)

This information is not applicable/not provided as this is not an AI/ML device and no expert-adjudicated ground truth is established. The "ground truth" for a syringe is its physical and functional properties meeting specifications.

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

This information is not applicable/not provided as this is not an AI/ML device and no adjudication method is relevant.

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

There was no MRMC comparative effectiveness study done. This is not an AI/ML device designed to assist human readers. "No clinical study is included in this submission" (Section VIII).

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

This information is not applicable/not provided as this is not an AI/ML device and therefore no standalone algorithm performance was assessed.

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

The "ground truth" for the device's performance is established by compliance with recognized international and national standards (e.g., ISO, ASTM) for the physical and biological properties of the syringe and needle, along with material specifications for biocompatibility. For instance, sterility is confirmed by SAL (Sterility Assurance Level) compliance, and material safety by ISO 10993 series standards.

8. The sample size for the training set

This information is not applicable/not provided as this is not an AI/ML device and therefore no training set was used.

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

This information is not applicable/not provided as this is not an AI/ML device and therefore no training set ground truth was established.

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The Disposable Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.

The Safety Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin. The Safety sheath of Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential of syringe reuse.

The proposed Syringes include Disposable Syringe with permanently attached needle and Safety Syringe with permanently attached needle. The Disposable Syringe with permanently attached needle have one kind of product configuration (TKSPN01) and the Safety Syringe with permanently attached needle has two kinds of product configurations (TKSSPN01 and TKSSPN02).

The proposed syringes are available in different combination of syringe volumes and/or needle sizes. The syringe is sterilized by Ethylene Oxide Gas to achieve a SAL of 10f . The proposed device has a shelf life of three years.

The provided text is a 510(k) Premarket Notification for medical devices, specifically Disposable Syringes with permanently attached needles and Safety Syringes with permanently attached needles. This document focuses on demonstrating substantial equivalence to predicate devices, not on proving overall safety and effectiveness through clinical trials or the type of performance studies typically associated with AI/ML-driven devices.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device (e.g., ground truth
establishment, adjudication methods, MRMC studies, effect sizes of human reader improvement with AI) are not applicable to this submission.

This document describes the safety and performance testing for a physical medical device (syringes) based on established international and national standards and biocompatibility testing. The "acceptance criteria" here are compliance with these recognized standards and demonstrated equivalence to existing predicate devices.

Here's an attempt to extract the relevant information based on the provided document, addressing the requested points where applicable and noting when information is not present or not relevant to this type of submission:

Device: Disposable Syringe with permanently attached needle; Safety Syringe with permanently attached needle

Regulatory Pathway: 510(k) Premarket Notification (demonstrates substantial equivalence to predicate devices)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for traditional medical devices like syringes are generally defined by compliance with recognized consensus standards and successful completion of specific performance and safety tests. The document doesn't present a "performance table" in the typical sense of AI/ML device metrics (e.g., sensitivity, specificity). Instead, it lists the standards the devices adhere to and states that testing was performed and found acceptable.

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

• Sample Size: Not explicitly stated for each specific test. For medical devices like syringes, testing often involves a defined number of units per batch or per test series to meet statistical requirements of the standards (e.g., 30 samples for a particular mechanical test). The document confirms that various tests were "performed" according to the relevant standards, which implies the use of appropriate sample sizes as defined by those standards.
• Data Provenance: The tests are non-clinical (laboratory/bench testing, material analysis, sterility validation). The manufacturer is Anhui Tiankang Medical Technology Co., Ltd. in Tianchang City, Anhui, China. The data would originate from their internal testing or qualified third-party labs, but the specific country of origin for each test data set is not detailed beyond the manufacturer's location. The studies are by nature prospective in the sense that they are conducted specifically to support this regulatory submission, but they are not clinical studies.

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

• Not Applicable. This is a physical medical device. "Ground truth" in the context of expert consensus and adjudication is typically relevant to AI/ML devices where the "truth" for image interpretation or diagnosis needs to be established by human experts. For syringes, the "truth" is determined by objective measurements, chemical analyses, and adherence to physical performance specifications outlined in the referenced ISO/ASTM standards. The "experts" involved would be qualified laboratory technicians, engineers, and quality assurance personnel performing the tests according to the standard operating procedures.

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

• Not Applicable. See point 3. This concept is for AI/ML device performance evaluation methods, not for physical medical device testing.

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 device is a manual syringe, not an AI-assisted diagnostic tool. No human reader involvement or AI assistance is mentioned or relevant.

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's performance is established by objective measurements against defined specifications in international and national consensus standards (e.g., ISO, ASTM, USP). This includes:
  • Physical and Mechanical Performance: e.g., plunger force, needle pull-out force, fluid leakage, needle sharpness, volume accuracy based on ISO 7886-1, ISO 7864, ISO 9626.
  • Material Properties and Biocompatibility: Chemical analysis, in vitro and in vivo biological tests (Cytotoxicity, Hemolysis, Skin Sensitization, etc.) as per ISO 10993 series for specific material components.
  • Sterility Assurance: Sterility testing, bacterial endotoxin testing, and ethylene oxide residue testing according to ISO 11135 and USP standards.
  • Shelf-Life Stability: Accelerated aging and real-time stability studies confirming physical properties, sterility, and package integrity over time per ASTM standards.

8. The sample size for the training set

• Not Applicable. This is a traditional medical device, not an AI/ML model that requires training data.

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

• Not Applicable. See point 8.

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1ml Luer Slip or Luer Lock Syringe is intended to be connected with the luer slip or luer lock needle and intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.

The Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.

The Safety Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin. The Safety sheath of Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse.

The proposed Syringes include 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle.

Each of the 1ml Luer Slip or Luer Lock Syringe, Safety Syringe with permanently attached needle. have one kind of product configuration, and the Syringe with permanently attached needle has two kinds of product configurations (Type A and Type B).

The proposed syringes are available in different combination of syringe volumes and/or needle sizes (refer to Table 1).

The proposed Syringe is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.

The provided text describes a 510(k) premarket notification for three types of syringes. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving the device meets acceptance criteria through a clinical study or performance evaluation in the typical sense of AI/medical imaging device submissions.

Therefore, many of the requested criteria (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable to this type of regulatory submission, as it's a conventional medical device and not an AI-powered one. The submission relies on non-clinical performance testing against established international standards to show equivalency in safety and efficacy.

Here's a breakdown of the available information based on your request, with an emphasis on what is and isn't present in this specific 510(k) summary:

Acceptance Criteria and Device Performance (Non-Clinical)

The acceptance criteria for these devices are defined by adherence to various international and national standards for medical syringes and needles. The "reported device performance" is a statement that the device complies with these standards, indicating successful non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not present a single "acceptance criteria table" with specific numerical thresholds and corresponding "reported performance values" in the way one might see for an AI algorithm's sensitivity/specificity. Instead, the performance is demonstrated by compliance with the referenced standards.

Study Details (Non-Clinical Performance Testing)

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

• Sample Size: Not explicitly stated in the provided text. The document refers to compliance with standards, which typically involve specific sample sizes for their respective tests, but these are not enumerated here.
• Data Provenance: The tests were non-clinical performance tests conducted by the manufacturer, Jiangsu Caina Medical Co., Ltd. The country of origin for the data is China, implicitly, as that is the manufacturer's location. The tests are prospective in the sense that they were performed to support this submission.

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

• Not Applicable. This is a conventional medical device, typically manufactured and tested according to engineering standards. "Ground truth" in the clinical sense (e.g., diagnosis by experts) is not relevant for proving substantial equivalence of a syringe. Compliance with ISO and ASTM standards is the "truth" here.

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

• Not Applicable. See point 3.

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/imaging device. No MRMC study was conducted.

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 its adherence to established engineering, manufacturing, and performance standards for syringes and needles (e.g., ISO, ASTM). Biocompatibility is confirmed by referencing a previously cleared device with identical patient-contact materials (K150758).

8. The sample size for the training set

• Not Applicable. This is a physical device, not an AI model.

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

• Not Applicable. This is a physical device, not an AI model.

Summary of Approach:

The provided K192551 document demonstrates substantial equivalence based on:

1. Direct comparison of the proposed devices' characteristics (e.g., configuration, materials, volume, needle size, performance standards) to legally marketed predicate devices.
2. Non-clinical performance testing to ensure compliance with relevant international and national consensus standards (ISO, ASTM, USP). The "acceptance criteria" are the thresholds and requirements defined within these standards.
3. Biocompatibility assessment by referencing a previously cleared device (K150758) that uses identical patient-contact materials.

No clinical studies or expert-driven evaluations of performance (like those for AI/imaging devices) were part of this submission, as stated clearly: "No clinical study is included in this submission."

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