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The Automatically Retractable Safety Syringe is used for aspiration of fluids from vials and a variety of fluid injections into the human body through subcutaneous and muscle.

It has a detachable needle with a dedicated fitting. The Automatically Retractable Safety Syringe contains an inner mechanism used to allow the needle to be retracted inside the plunger of the syringe after the operator's thumb force released. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.

Automatically Retractable Safety Syringe

The provided document is a 510(k) clearance letter from the FDA for the "Automatically Retractable Safety Syringe". It describes the indications for use and states that the device is substantially equivalent to legally marketed predicate devices. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in your prompt.

Therefore, I cannot provide the requested information based on the text provided. This document is a regulatory approval, not a technical study report.

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The Automatically Retractable Safety Syringes with Fixed Needle (Iml, 3ml, 10ml with 30G, 29G, 27G, 26G, 25G, 24G, 23G, 22G, 21G, or 20G) is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into a patient.

The Automatically Retractable Safety Syringes with Fixed Needle devices are piston syringes, intended for medical purposes and consist of a calibrated hollow barrel and a movable plunger. The syringe works like a conventional hypodermic syringe except that the contaminated needle is retracted inside the syringe immediately after patient injection. The needle retracting mechanism is activated by a spring action mechanism after injection is completed. The exposed needle remains safely inside the empty syringe barrel for disposal. The Automatically Retractable Safety Syringes with Fixed Needle are sterile, single use, disposable and non-reusable.

This document is a 510(k) premarket notification for an "Automatically Retractable Safety Syringe with Fixed Needle". It is primarily focused on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria in the context of an AI/algorithm-driven device.

Therefore, many of the requested categories related to AI/algorithm performance studies (like sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission for a physical medical device.

However, I can extract information related to "acceptance criteria" through the lens of performance testing conducted to show substantial equivalence.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance

The document does not provide a table of explicit, quantitative "acceptance criteria" and their corresponding "reported device performance" values in the format typically seen for algorithm validation. Instead, it refers to general performance testing to demonstrate substantial equivalence.

Explanation of "Acceptance Criteria" in this context: For a physical medical device like a syringe seeking 510(k) clearance, "acceptance criteria" are typically defined by recognized standards (e.g., ISO standards for syringes, biocompatibility standards) and the internal design specifications of the manufacturer. The document states that testing was done "appropriately for design verification, design validation, biocompatibility and sterilization," implying that the device met these established criteria without specifying the exact numerical thresholds.

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

• Sample Size for Test Set: Not specified in the document. The document mentions "performance testing" but does not detail the number of units tested.
• Data Provenance: Not specified. It's likely the testing was conducted by the manufacturer, Shantou Wealy Medical Instrument Co. Ltd, in China, given their location. The nature of the testing (design verification, biocompatibility, etc.) suggests it would be prospective testing of newly manufactured devices.

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/algorithm-driven diagnostic device that would require expert-established ground truth.

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

Not applicable. This is not an AI/algorithm study requiring adjudication of diagnostic outputs.

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/algorithm-driven device.

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

Not applicable. This is a physical device, not an algorithm.

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

Not applicable in the AI/algorithm sense. For a physical device, "ground truth" would be established by objective measurements against engineering specifications and relevant ISO/ASTM standards (e.g., fluid delivery accuracy, plunger force, needle retraction force, material biocompatibility test results). The document refers to "test results" concluding the device passed these standards.

8. The sample size for the training set

Not applicable. There is no AI/algorithm training set for this physical device.

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

Not applicable. There is no AI/algorithm training set for this physical device.

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Automatically Retractable Safety Syringe (with fixed needle) (5cc/ml 22×1-1/4) is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into a patient.

The Automatically Retractable Safety Syringe (with fixed needle) 5cc/ml 22×11/4 is a piston syringe. The device is intended for medical purposes and consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into the body. Automatically Retractable Safety Syringe (with fixed needle) (5cc/ml 22×11/4") works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. The needle retracting mechanism is activated by a spring action mechanism after injection is completed, while the exposed needle remains safety inside the empty syringe barrel for disposal.

The provided document describes a 510(k) premarket notification for an Automatically Retractable Safety Syringe. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria for device performance in the way typically seen for diagnostic algorithms.

Therefore, the requested information elements related to specific performance metrics (e.g., sensitivity, specificity), sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies, and ground truth types are not applicable to this document's content.

However, I can extract the acceptance criteria and a summary of how the device meets them based on the equivalence testing performed to satisfy the 510(k) submission.

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

The acceptance criteria are implied by the comparison to the predicate device and relevant industry standards. The reported device performance is that it meets these criteria, demonstrating equivalence.

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

This information is not provided in the document. The submission focuses on demonstrating substantial equivalence through comparison of design, intended use, and similar safety and performance testing to the predicate device. Details about the specific sample sizes or data provenance for these tests are not included.

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 is not applicable as the document describes a medical device (syringe) rather than a diagnostic algorithm that requires expert-established ground truth. The "ground truth" here is compliance with established standards and performance metrics for the device itself, verified through engineering and biocompatibility testing.

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

This is not applicable for the same reasons as #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

This is not applicable as the device is a syringe, not an AI-assisted diagnostic tool.

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

This is not applicable as the device is a syringe, not a standalone algorithm.

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

The "ground truth" for this device's performance is established by international standards (e.g., ISO 7886-1:1993, ISO 10993-1) and the performance characteristics of the legally marketed predicate device (VanishPoint™ Syringe K970803). The device demonstrates "conformance" to these standards and "similarity" to the predicate.

8. The sample size for the training set

This is not applicable as the document describes a medical device, not a machine learning model requiring a training set.

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

This is not applicable for the same reasons as #8.

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