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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 Self-destruction Safety Syringes for Single Use are intended to be used for medical purposes to inject fluid into or withdraw fluid from body. Its secondary intended use is to retract inside the safety barrel, contain the contaminated needle and aid in the prevention of accidental needle stick injuries.

The Sterile Hypodermic Syringes for Single Use are intended to be used for medical purpose to inject fluid into or withdraw fluid from body.

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

The Sterile Safety Hypodermic Needles for Single Use are intended to be used with a luer slip or luer slip 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 Self-destruction Safety Syringes for Single Use are intended for single use only. The proposed device is available in 1mL, 3mL, 5mL, 10mL volumes with a 25 gauge, 25mm needle. The safety feature will be manually activated to retract the needle immediately after use to minimize risk of accidental needle sticks.

The Sterile Hypodermic Syringes for Single Use are intended for single use only, which consists of barrel, plunger and piston. The proposed device is available in 1mL, 2mL, 5mL, 10mL, 20mL, 30mL and 50mL volumes. The syringe is available in luer lock connector types which are intended to be connected with a hypodermic needle.

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 18-27 gauge and 6-50 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 14-30 gauge and 6-60 mm lengths.

The provided text is an FDA 510(k) summary for various medical devices, including "Self-destruction Safety Syringes for Single Use" and "Sterile Safety Hypodermic Needles for Single Use," which incorporate safety features to prevent accidental needle stick injuries. The summary describes the non-clinical tests performed to demonstrate substantial equivalence to predicate devices, focusing on physical, mechanical, chemical properties, sterility, shelf-life, and biocompatibility.

However, the provided document does not describe a study involving an AI-powered device or a multi-reader multi-case (MRMC) comparative effectiveness study. Instead, it focuses on the performance and safety of physical medical devices (syringes and needles). Therefore, I cannot extract the requested information related to acceptance criteria and study proving AI device performance, sample sizes for test and training sets, expert ground truth establishment, adjudication methods, or effects of AI assistance on human readers.

The section "Simulated Clinical Use" on page 8 of 13 does mention "pre-established criteria" and a study on 500 device samples for the safety features of the syringes and needles, but these are related to the physical device's function, not an AI or imaging diagnostic performance.

In summary, the provided document does not contain the information required to answer the prompt's specific questions about an AI device's acceptance criteria and performance study.

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