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The Sterile Safety Hypodermic Needles for Single Use are intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.

The Sterile Hypodermic Needles for Single Use- Disposable Needles are intended to be used with a luer slip or luer lock syringes and injection devices for general purpose fluid injection/aspiration.

The Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles are intended to be used with a luer slip or luer lock syringes and injection devices for general purpose fluid injection/aspiration.

The proposed devices are provided in two types of configurations; one type is a Sterile Safety Hypodermic Needles for Single Use, the other is Sterile Hypodermic Needles for Single Use. The Sterile Hypodermic Needles also divided into two types, one type is an ordinary disposable needle contained in a sterility maintenance package, the other is self-sealing hypodermic needle with an end cap, the protective cap and end cap form a sterility maintenance package.

The Sterile Safety Hypodermic Needles for Single Use are intended for single use only, which consists of a hypodermic needle with a safety sheath attached to the needle hub. The proposed device is available in 28-34 gauge and 4-32 mm lengths. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The Sterile Hypodermic Needles for Single Use are intended for single use only. The proposed device is available in 18-34 gauge and 2-40 mm lengths.

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

The provided text describes the 510(k) summary for hypodermic needles and does not contain information about an AI/ML-enabled medical device. Therefore, I cannot address the specific points regarding acceptance criteria and study details for such a device. The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing for physical, mechanical, chemical, biocompatibility, and sterilization properties of the needles.

• No AI/ML device: The document pertains to "Sterile Safety Hypodermic Needles for Single Use" and "Sterile Hypodermic Needles for Single Use-Disposable Needles," and "Sterile Hypodermic Needles for Single Use-Self-sealing Hypodermic Needles." These are physical medical devices, not AI/ML-enabled software.
• No AI/ML performance data: Consequently, there are no acceptance criteria or study details related to the performance of an AI/ML algorithm (e.g., sensitivity, specificity, AUC) or its impact on human reader performance.
• Non-clinical tests: The document lists numerous non-clinical tests conducted to prove the device meets standards like ISO 7864, ISO 9626, and ISO 80369-7, as well as biocompatibility tests (cytotoxicity, irritation, sensitization, systemic toxicity, hemolysis, pyrogen). It also mentions a "Simulated Clinical Study" and "Safety Feature Test" for the sharps injury prevention feature, though details on the study design or sample size are not provided beyond stating that pre-established criteria were met.

Therefore, I cannot generate the table or information requested as it is not present in the provided text.

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The Safety Insulin Syringe is a sterile, single use and non-reusable syringe intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse.

The Safety Insulin Syringe is a sterile, single use and non-reusable syringe with a permanently attached needle, which is intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse. The proposed device is available in 0.3ml, 0.5ml, 1ml volumes with a 26G-34G gauge needle. The safety feature will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The provided text describes a 510(k) premarket notification for a medical device, the "Safety Insulin Syringe," not an AI/ML medical device. Therefore, the information required to populate the fields related to AI/ML acceptance criteria and study design (such as training sets, test sets, expert adjudication, MRMC studies, etc.) is not present in the document.

The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing of the physical, chemical, and performance characteristics of the syringe itself, as well as its safety features.

However, I can extract the acceptance criteria and performance data that are relevant to this type of medical device submission.

Here's a summary based on the provided text, focusing on the available information:

Acceptance Criteria and Device Performance (for a non-AI/ML medical device)

The device, a "Safety Insulin Syringe," is evaluated based on its physical, chemical, and safety performance. The acceptance criteria are typically compliance with recognized international standards and demonstration of specific functional parameters.

Since this is not an AI/ML device, the following points are not applicable and are listed as "N/A":

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

   • Test Set Sample Size: N/A (for AI/ML test sets). For simulated clinical use of the physical device, 500 device samples were used.
   • Data Provenance: N/A (for AI/ML test sets, as no image/data input is being classified). The physical device performance testing was performed by the manufacturer, Berpu Medical Technology Co., Ltd. (China). The tests are non-clinical (laboratory/bench testing) and simulate real-world use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (no ground truth based on expert review of data is established for this type of device).

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

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: N/A.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A (for AI/ML ground truth). The "ground truth" for this medical device is adherence to physical/performance standards (e.g., ISO, ASTM, USP) and functional testing parameters for its mechanical safety features.

8. The sample size for the training set: N/A.

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

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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 Sterile Hypodermic Syringes for Single Use are intended to be used for medical purposes on adult and pediatric population to inject fluids into or withdraw fluids from the body.

The Sterile Hypodermic Syringe for Single Use is intended for single use only, which consists of barrel, plunger and piston. The proposed device is available in a variety syringe volume. The syringe is available in luer slip and luer lock two connector types which are intended to be connected with a hypodermic needle.

The provided text is a 510(k) summary for a medical device (Sterile Hypodermic Syringe for Single Use) and does not contain information about acceptance criteria and study details as typically found for AI/ML-based medical devices. The document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance, material comparisons, and adherence to recognized standards.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set specifics, as these are not discussed in the provided text.

The document primarily outlines:

1. Device Description: Sterile Hypodermic Syringe for Single Use, consisting of a barrel, plunger, and piston, available in various volumes and luer slip/luer lock connector types.
2. Indication for Use: Intended for medical purposes on adult and pediatric populations to inject fluids into or withdraw fluids from the body.
3. Predicate Device: K210227, Sterile syringe for single use with/without needle.
4. Comparison to Predicate: Differences noted include volume specifications, piston material (Polyisoprene Rubber vs. Silicone Rubber), patient population explicit mention, and shelf-life (5 years vs. 3 years). These differences are argued not to affect safety and effectiveness.
5. Non-Clinical Test Performance Testing: The device was tested for conformance with:
   • ISO 7886-1:2017 (Sterile hypodermic syringes for single use)
   • ISO 80369-7: 2016 (Small-bore connectors for liquids and gases in healthcare applications)
   • Biocompatibility Testing (ISO 10993-1): Cytotoxicity, Sensitization, Intracutaneous Reactivity Test, Acute Systemic Toxicity, Hemocompatibility, Pyrogenicity.
   • Particulate Matter Testing: USP <788>.
   • Sterile Barrier Packaging Test: Visual inspection (ASTM F1886/F1886M-16), seal strength (ASTM F88/F88-15), and dye penetration test (ASTM F1929-15).
   • Sterilization and Shelf Life Test: Validated per ISO 11135, including EO residue, ECH residue (ISO 10993-7:2008), Bacteria Endotoxin Limit (USP <85>), and Shelf Life Evaluation (physical, mechanical, chemical, package tests on aging samples).

The document declares that the device is substantially equivalent to the predicate based on these non-clinical tests and comparisons. It does not involve AI/ML components or the types of studies typically associated with such technologies.

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The Safety Pen Needle for Single Use is intended for use with pen injector devices for the subcutaneous injection of insulin.

The Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.

The devices are provided in two types of configurations: Safety Pen Needle for Single Use and Insulin Pen Needle.

The Safety Pen Needle for Single Use is intended for use with pen injector devices for the subcutaneous injection of insulin. It consists of a needle cap, needle hub, safety protective cover, self-destruction seat and sealed paper. The safety protective cover is manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin. It consists of protective cap, needle tube, needle protective cover and sealed paper.

The provided document describes a 510(k) premarket notification for a medical device, specifically Safety Pen Needles for Single Use and Insulin Pen Needles. It focuses on demonstrating substantial equivalence to a predicate device (K181447) rather than presenting a study for general acceptance criteria alone.

Therefore, the response will be structured to address the acceptance criteria as derived from the comparative and standalone testing performed to establish substantial equivalence.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document lists numerous non-clinical tests and standards that the proposed device was tested against. The acceptance criteria are implicit in compliance with these standards and the comparisons to the predicate device. The performance is stated as "complied with" or "met the requirements".

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

The document does not specify the exact sample sizes for each test in the acceptance criteria. It broadly states "Non-clinical tests were conducted..." and "Physical, Mechanical, and Chemical testing listed in following table were performed on the proposed device."
Regarding data provenance, the manufacturer is Berpu Medical Technology Co., Ltd. in Wenzhou, Zhejiang, China. Therefore, the data provenance is China, and the data is prospective as it involves direct testing of the proposed devices.

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

This section is not applicable as the document describes non-clinical laboratory and performance testing for a medical device (pen needles), not a diagnostic algorithm requiring expert ground truth for interpretation of images or other data. The "ground truth" here is defined by compliance with established international and ASTM standards.

4. Adjudication method for the test set

This section is not applicable for the same reasons as point 3. The evaluation is based on objective measurements against specified standard criteria, not subjective expert judgment requiring adjudication.

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 section is not applicable. The device is a physical medical device (pen needle), not an AI-powered diagnostic tool, and therefore, no MRMC study or AI assistance evaluation was performed or is relevant.

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

This section is not applicable as the device is a physical medical instrument, not an algorithm or software. The non-clinical tests described are "standalone" in the sense that they evaluate the device's intrinsic properties against standards, without human interaction influencing the core performance metrics being measured (e.g., flow rate, bond strength).

7. The type of ground truth used

The "ground truth" for the non-clinical tests and the product's performance is established by international and national standards (e.g., ISO, ASTM, USP) and the specifications derived from these standards. For example, the criteria for cytotoxicity or sterility assurance level (SAL) are defined by the respective ISO and USP standards. The "pre-established criteria" mentioned for the simulated clinical study and safety feature test would also fall under this category, likely derived from the relevant standards (ISO 23908:2011) and FDA guidance.

8. The sample size for the training set

This section is not applicable. The document describes the testing of a physical medical device. There is no "training set" in the context of an AI/ML algorithm. The training in device manufacturing typically refers to process validation and quality control, not data training.

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

This section is not applicable for the same reason as point 8; there is no training set mentioned in the context of this device's approval process.

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