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Shina Syringe, Shina Safety Syringe is a plastic sterile syringe and hypodermic single lumen needle intended to be used for medical purpose to inject fluid into or withdraw fluid from body.

A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is (not) included. lt is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

This document describes the acceptance criteria and study proving the device meets those criteria for the Shina Syringe and Shina Safety Syringe.

The listed information primarily focuses on bench testing for mechanical, physical, and biocompatibility properties, rather than effectiveness studies involving human subjects or AI-assisted diagnoses. Therefore, several requested sections, particularly those related to clinical studies, human readers, ground truth establishment for training sets, and effect sizes of AI assistance, are not applicable based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is demonstrated by compliance with various ISO standards and USP . The document does not explicitly present specific numerical results for each test item but states that the tests demonstrated that the device performs in a substantially equivalent manner to the predicate device and meets the requirements.

Syringe

Needle

Syringe with needle (Model : WNLS0125)

Syringe with needle (Particulate test for various models including WNLG0123, WNLS0123, WNSG0125, WNLS0125, WNLG0323, WNLS0323, WNSG0325, WNLS0325, WNLG0523, WNLS0523, WNSG0525, WNLS0525, WNLG1023, WNLS1023, WNSG1025, WNLS1025)

Safety test

Biocompatibility (for 25G Model, 23G Model, and Syringe Model SSN2301)

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

The document does not explicitly state the sample size for each bench test conducted. The provenance of the data is that these are bench tests conducted by the manufacturer, Shina Med Corporation, in the Republic of Korea. The studies are by nature retrospective in the context of device development, where the device is manufactured and then tested to established standards.

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. The ground truth for these types of mechanical, physical, and biocompatibility tests is established by published international standards (ISO, USP, ASTM), not by expert consensus in diagnostic interpretation.

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

This section is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of medical data by multiple experts. The reported studies are bench tests against defined international standards.

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. No MRMC comparative effectiveness study was performed or discussed, as the device is a syringe and needle, not an AI-assisted diagnostic tool.

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

This section is not applicable. The device is a physical medical device (syringe and needle) and does not involve an algorithm or AI.

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

The ground truth used for these tests are established international and national standards for medical devices, specifically:

• ISO 7886-1: Sterile hypodermic syringes for single use
• ISO 7864: Sterile hypodermic needles for single use
• ISO 9626: Stainless steel needle tubing
• USP : Particulate Matter in Injections
• ISO 23908: Sharps injury protection
• ISO 10993 series for Biological evaluation of medical devices (Parts 4, 5, 7, 10, 11, 23)
• ASTM F756-17: Standard Practice for Assessment of Hemolytic Properties of Materials

8. The sample size for the training set

This section is not applicable. As this is a physical medical device submission focusing on bench testing, there is no AI model or "training set" in the context of machine learning.

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

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

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Monoject Magellan Insulin Safety Syringes are intended for delivery of U-100 insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.

The Monoject™ Magellan™ Insulin Safety Syringe consists of a piston syringe with a permanently attached needle, and safety shield designed to extend, fully cover, and permanently lock over the needle when activated by a fingertip or thumb to reduce the occurrence of accidental needle sticks. The device is provided sterile and is intended for single use only. An orange needle cap indicates for use with insulin. The barrel of the syringe is graduated for measuring a prescribed dose. The syringe is intended for use immediately after filling and is not intended to contain or store insulin for extended periods of time.

The provided text is a 510(k) summary for a medical device (Monoject Magellan Insulin Safety Syringe). It details the device's characteristics, intended use, and comparison to a predicate device to establish substantial equivalence.

However, this document does not contain any information about an AI/ML-driven device or its acceptance criteria and study results. The device described is a physical medical device (syringe), not a software or AI/ML product.

Therefore, I cannot fulfill the request to describe acceptance criteria and associated study results for an AI/ML device based on the provided text. The questions posed (e.g., sample size for test set, number of experts, MRMC study, standalone performance, training set data) are relevant to the evaluation of AI/ML models, but the provided document is not about such a device.

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The Medline Sure-Snap Safety Syringe is intended for use in the aspiration and injection of fluids for medical purposes. 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 needle stick.

The Medline Sure-Snap Safety Needle is intended for use with a luer-lock syringe for aspiration and injection of fluids for medical purposes. 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 needle stick.

The Medline Sure-Snap Safety Needle and Medline Sure-Snap Safety Syringe comprises hypodermic single lumen luer-lock safety needles alone (Identified in this submission as Medline Sure-Snap Safety Needles) and a combination of hypodermic single lumen luer-lock safety needles with luer-lock piston syringes (identified in this submission as Medline Sure-Snap Safety Syringes).

The provided text describes a 510(k) premarket notification for the Medline Sure-Snap Safety Needle and Medline Sure-Snap Safety Syringe. This type of submission aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving the device meets specific acceptance criteria through a clinical efficacy study. Therefore, much of the requested information regarding clinical study design (sample size, expert ground truth, MRMC studies, training set details) is not applicable or explicitly stated in this document because the regulatory pathway chosen focuses on device characteristics and bench testing.

However, based on the document, here's what can be extracted regarding acceptance criteria and the study performed, focusing on the "Performance Testing (Bench)" and "Usability Testing" sections as these are the closest to performance evaluation.

Acceptance Criteria and Device Performance (Summary based on available information)

The primary "acceptance criteria" from a regulatory perspective for this 510(k) submission is to demonstrate substantial equivalence to predicate devices. This is achieved by showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. Performance is evaluated through a series of bench tests and a simulated clinical use study as recommended by FDA guidance.

Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence and non-clinical testing, explicit numerical "acceptance criteria" and "reported device performance" are presented as compliance with established standards and successful outcomes of specific tests, rather than clinical efficacy metrics.

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Test Set (Simulated Clinical Use Study for Sharps Injury Prevention): 1,000 safety needles were tested (500 per "safety needle type" – though the document details multiple configurations, it doesn't specify if "safety needle type" refers to Sure-Snap Safety Needle vs. Sure-Snap Safety Syringe types or different gauge sizes).
   • Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) submission, the studies would typically be conducted prospectively as part of the premarket submission process, and are likely to be conducted under a quality system by the manufacturer (Medline Industries, Inc. in Northfield, Illinois, USA).

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

   • For the simulated clinical use study (usability testing), "Participating healthcare professionals assessed the function of the safety needle with a pass/fail criteria and provided feedback." The specific number of professionals or their detailed qualifications (e.g., years of experience, specific role like nurse, phlebotomist) are not specified in the document.

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

   • The document implies a direct "pass/fail criteria" assessed by the participating healthcare professionals during the simulated clinical use study. It does not mention any formal adjudication method (like 2+1 or 3+1 consensus) for the results, suggesting a direct observation of the device's functional activation.

4. 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:

   • No. This is a medical device (syringe and needle) and not an AI/imaging device. Therefore, an MRMC comparative effectiveness study is not applicable and was not conducted.

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

   • Not applicable. This device is a physical medical instrument, not an algorithm. Bench tests evaluate the physical properties and functional aspects of the device itself (e.g., needle sharpness, sheath activation), which could be considered a form of "standalone" performance testing for a physical object.

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

   • For the simulated clinical use study, the "ground truth" for the device's safety feature activation was based on direct observation of its functional activation against pre-defined pass/fail criteria by "participating healthcare professionals." It's a performance truth based on observed mechanical function in a simulated setting, rather than a diagnostic truth like pathology or outcome data.
   • For other performance tests (e.g., biocompatibility, functional performance under ISO standards), the "ground truth" is defined by the requirements and test methods specified in the cited international consensus standards. Compliance with these standards indicates the device performs as expected for its class.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set" for an algorithm. All listed tests are for device verification/validation.

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

   • Not applicable. As there is no training set for an AI model.

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The Automatically Retractable Safety Syringes with detachable needle devices are indicated for use where a safe and reliable method for intramuscular and subcutaneous injection of medication in a patient is desired.

The Disposable Automatically Retractable Safety Syringes (with Detachable Needle) devices are piston syringes, intended for medical purpose 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 syringe plunger for disposal. The Disposable Automatically Retractable Safety Syringes (with Detachable Needle) devices are sterile, single use, disposable and non-reusable.

The provided document, a 510(k) Premarket Notification summary for Disposable Automatically Retractable Safety Syringes, does not describe the acceptance criteria and study that proves the device meets the acceptance criteria in the manner typically found for AI/ML-based medical devices. This document specifically pertains to a physical medical device (syringes) and not an AI/ML diagnostic or therapeutic system.

Therefore, the requested information regarding acceptance criteria, performance metrics, sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance for an AI/ML device is not applicable to this document.

The document discusses the substantial equivalence of a new syringe design to a predicate device based on non-clinical testing of physical and chemical properties and a simulated clinical study for sharps injury prevention.

Here's an interpretation of the closest relevant sections to your request formats, acknowledging the fundamental difference in device type:

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

The document lists "Non-Clinical Tests performed on the subject device" and references various ISO standards for syringe and needle properties. These standards implicitly define the acceptance criteria, and the statement "The proposed devices were tested per the following standards, to evaluate its performance" implies that the device met these standards. However, the document does not report specific quantitative performance data or explicit acceptance thresholds met by the device for each test. It only lists the tests performed.

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

• Sample Size for Test Set: Not explicitly stated, but the "Simulated Clinical Study Summary" mentions a study "conducted as recommended in FDA guidance document for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features." While the exact number of devices tested is not provided, the claim of "99% reliability of device activation is achievable" implies a statistically significant sample was used to arrive at this figure.
• Data Provenance: Not explicitly stated for specific test data, but the manufacturer is "Shantou Wealy Medical Instrument CO.,Ltd." located in Guangdong, China. The testing was conducted to international ISO standards.

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 device; "ground truth" as it applies to AI/ML diagnostic or annotation data is not relevant here. Performance is measured against physical standards and functional requirements.

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

• Not Applicable. This is a physical device. Adjudication methods are relevant for subjective interpretations of data, typically in diagnostic imaging or clinical assessments, usually involving multiple human readers. Here, performance is based on objective lab measurements and functional tests.

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 a physical device and involves no human "readers" or AI assistance. The "Simulated Clinical Study" refers to evaluating the sharps injury prevention feature, not an AI-assisted diagnostic task.

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

• Not Applicable. This is a physical device. There is no algorithm to run in a standalone fashion.

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

• Not Applicable. For this physical device, "ground truth" is established by the specifications of the relevant ISO standards (e.g., a certain force must be applied, there should be no leakage, specific dimensions are met, activation must occur). The "99% reliability of device activation" from the simulated clinical study would be considered a performance outcome, not a "ground truth" in the AI/ML sense.

8. The sample size for the training set:

• Not Applicable. This is a physical device; there is no AI/ML training set.

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

• Not Applicable. This is a physical device; there is no AI/ML training set or associated ground truth.

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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 Sterile Safety Syringes for Single Use are intended for use in the aspiration 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 mimize risk of accidental needle sticks. The Sterile Safety Syringes for Single Use are single use, disposable devices, provided sterile.

The proposed device consists of a safety hypodermic needle and a luer slip or luer lock syringe. Models of Sterile Safety Syringes for Single Use shown in Table 11.1 and 11.2 are available in various models according to different syringe volume and needle specifications.

The provided text describes the 510(k) premarket notification for "Sterile Safety Syringes for Single Use." This document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study of the device's performance against specific acceptance criteria in the manner one would see for an AI/ML medical device or a novel product requiring a clinical trial.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" (especially those related to clinical studies, human expert involvement, ground truth, and training data for AI/ML) are not applicable to this type of submission.

However, I can extract information related to the technical performance tests conducted to show equivalence.

Here's a breakdown based on the provided document:

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

The document doesn't explicitly state "acceptance criteria" as pass/fail thresholds for clinical outcomes, but rather lists the standards to which the device conforms and the results of the tests confirming that conformity. The "acceptance" is that the device's performance meets the requirements of these recognized standards.

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

• Sample Size: The document does not specify the exact number of units tested for each standard. This level of detail is typically found in the full test reports, which are summarized in the 510(k) submission.
• Data Provenance: The tests were non-clinical performance tests conducted for the purpose of demonstrating substantial equivalence. The document doesn't explicitly state the country of origin for the testing data, but the manufacturer is based in Shanghai, China. The tests are "retrospective" in the sense that they were completed prior to this submission for regulatory review.

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 submission refers to a traditional medical device (syringes), not an AI/ML device or one requiring human expert interpretation of complex data for "ground truth" establishment. The "ground truth" for these tests is defined by the objective measurements and pass/fail criteria specified within the referenced ISO and ASTM standards.

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:

• No. This type of study is relevant for diagnostic devices interpreting complex data (e.g., radiology images) and involving human readers. It is not applicable to a safety syringe.

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

• Not applicable. This isn't an algorithm. The "performance" is mechanical and material integrity.

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

• For this device, the "ground truth" is established by the objective, quantitative requirements and methods defined in the listed international and national standards (ISO, ASTM, USP) for sterility, biocompatibility, and physical performance of hypodermic needles and syringes. For instance, a test for "Force to activate safety mode" would have a defined NMT (Not More Than) value (e.g., 10N), and passing means the device operates within that mechanical specification.

8. The sample size for the training set:

• Not applicable. This refers to machine learning. No training set was used for a physical syringe.

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

• Not applicable. See point 8.

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Jeesung safety syringe and single use needles is a sterile, single-use, disposable and non-reusable, manual retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.

Jeesung Safety Syringe and Single Use Needles is an integrated needle and piston syringe with an anti-needle-stick mechanism. There is a swell on the top of inside barrel, which can be used to fix the top of inside barrel. Four legs on the bottom of hub are caught on the top of inside barrel when the hub is pulled. After using this syringe (such as injecting medicine into body etc.), the hub of needle is pulled back to the inside of the barrel. Because the four legs of hub is bound to the top of the plunger which has a smaller swell part than the top of inside barrel for being caught. Therefore, by pushing plunger until it makes a binding sound, the hub can follow with the plunger. Then the plunger is broken off and the needle cannot be come out of the barrel. This renders the needle unusable and safe from accidental needle sticks.

The provided text details a 510(k) submission for the Jeesung Safety Syringe and Single Use Needles, a Class II medical device. However, the document does not contain the specific acceptance criteria and detailed device performance results that you requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9.

This document is a regulatory submission summary that outlines the device, its intended use, comparison to a predicate device, and a list of the types of performance testing conducted. It states that "Test results were acceptable" but does not provide the quantitative acceptance criteria or the reported performance values.

Therefore, I cannot fulfill your request for:

• 1. A table of acceptance criteria and the reported device performance: The document lists the types of tests performed (e.g., limits for acidity, force to operate piston, cytotoxicity) but does not provide the specific "acceptance criteria" (e.g., "pH between X and Y," "force less than Z N") or the actual "reported device performance" (e.g., "pH was P," "force was Q N").
• 2. Sample size used for the test set and the data provenance: Not specified.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a physical device and not an AI/imaging diagnostic device requiring expert interpretation for ground truth.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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, as this is a physical medical device, not an AI diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For physical device performance, ground truth typically refers to established standards and physical measurements, and the document states conformance to ISO standards (e.g., ISO7864, ISO7886, ISO10993).
• 8. The sample size for the training set: Not applicable, as this is a physical device, not a machine learning model.
• 9. How the ground truth for the training set was established: Not applicable.

What the document does provide regarding the study:

• Study Type: Performance testing (mechanical, chemical, biological) as required for a physical medical device under the MEG product code. This includes:
  • Needle Performance Testing (e.g., Appearance, Limits for acidity/alkalinity, Extractable metals, Lubricant, Graduated scale, Barrel, Plunger stopper/plunger assembly, Nozzle, Dead space, Freedom from liquid/air leakage, Force to operate the piston, Fit of plunger stopper/plunger in barrel).
  • Biocompatibility Testing (Cytotoxicity test, Intracutaneous Reactivity Test, Acute Systemic Toxicity Test, Pyrogen Test, Hemolysis Test, Skin Sensitization study, Particulate matters).
  • Sterilization Validation (EO Sterilization Validation in accordance with ISO 11135).
  • Shelf Life Study (Accelerated Aging, Packaging Integrity test).
  • Packaging Process Validation Study (Sealing condition).
  • Shipping Validation Study (ISTA 2018 Integrity Test Procedure 2A, ASTM D4169-16).
• Ground Truth for Physical Device Testing: Conformance to established international standards (ISO7864, ISO7886, ISO10993, ISO 11135, ISTA 2018, ASTM D4169-16) and relevant regulations (21 CFR Part 801).
• Clinical Testing: "Clinical testing was not required to support substantial equivalence." This means no human subject studies were conducted for this 510(k) submission.
• Conclusion: The manufacturer concluded that "The proposed device... have similar technological characteristics... Appropriate performance testing was conducted... results of this testing demonstrates that the subject device is substantially equivalent in safety and performance to the predicate device."

To obtain the specific quantitative acceptance criteria and detailed performance data, one would typically need to refer to the full 510(k) submission document, which is generally not publicly available in its entirety beyond the summary provided.

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The Sterile Safety Syringe for Single Use (Retractable) is intended to provide a safe and reliable method of injecting fluids into or withdrawing fluids from the body. The Sterile Safety Syringe for Single Use (Retractable) is designed to aid in the prevention of needle stick injuries and reduce the potential for syringe reuse. The Sterile Safety Syringe for Single Use (Retractable) is a single use, disposable device, provided sterile.

The proposed device, Sterile Safety Syringe for Single Use (Retractable), is available in 1ml. The proposed device consists of seven components:(1) protective cap, (2) needle tube, (3) connecting seat, (4) plunger stopper, (5) sliding sleeve, (6) barrel, (7) plunger. The proposed devices are sterilized by ethylene oxide to achieve a SAL 10-6 and supplied in sterility maintenance small package which could maintain the sterility of the device during the shelf life of 5 years.

The provided document is a 510(k) premarket notification for a medical device: "Sterile Safety Syringe for Single Use (Retractable)". It declares the device's substantial equivalence to a predicate device.

However, the document does not contain the acceptance criteria and performance data for a study proving the device meets those criteria in the format requested (i.e., a table of "acceptance criteria vs. reported device performance").

Instead, it lists various standard tests and their respective ISO/ASTM/USP standards that were applied to the device to demonstrate its safety and effectiveness and its substantial equivalence to the predicate device. These tests primarily focus on:

• Biocompatibility: Adhering to ISO 10993 standards for biological evaluation.
• Sterility, Shipping and Shelf-Life: Meeting ISO 10993-7, USP, and ASTM standards for sterilization residuals, bacterial endotoxins, packaging integrity (seal strength, leak detection), and accelerated aging for a 5-year shelf life.
• Performance Testing: Conforming to ISO 7864 (hypodermic needles), ISO 7886-1 (hypodermic syringes for manual use), ISO 9626 (stainless steel needle tubing), and ISO 23908 (sharps injury protection features).
• Simulated Clinical Use Study: Conducted to evaluate the effect of the safety feature per FDA Guidance "Medical Devices with Sharps Injury Prevention Features" and stated that "The test results demonstrated that the subject device complies with the requirements."

Therefore, I cannot extract the requested table of acceptance criteria and reported device performance from this document as it is not presented in that specific comparative format. The document primarily asserts compliance with established regulatory standards and guidelines through various tests, rather than detailing specific quantitative acceptance criteria and their corresponding empirical results in a side-by-side comparison for each performance aspect.

Moreover, the document explicitly states: "No clinical study is included in this submission." This means that information regarding human-in-the-loop performance, multi-reader multi-case studies, sample sizes for test sets involving human readers, expert consensus for ground truth, or adjudication methods are not applicable and thus not provided in this document. The device's safety feature validation was done through a simulated clinical use study, not a true clinical study with human subjects.

Given the limitations of the provided document, I can only state what is addressed and what is not:

Based on the provided document, here's what can be inferred and what information is absent:

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

• Not explicitly provided in the requested comparative "acceptance criteria vs. reported performance" table format. The document lists the standards and guidances that the device was tested against (e.g., ISO 7864, ISO 7886-1, ISO 9626, ISO 23908, ISO 10993 series, USP standards, ASTM standards). It generally states that the device "met" acceptance criteria or "complies with the requirements" of these standards.
• Example from text: "Particulate matter testing was conducted in accordance with USP Particulate Matter in Injection and met the USP acceptance criteria." This implies the acceptance criteria are those defined by USP , and the reported performance was "met" these criteria, but specific quantitative values are not given.
• Example from text: "The safety feature of the proposed device has been validated to verify the prevention function." and "a simulated clinical use study was conducted on the subject device... to evaluate the effect of safety feature per FDA Guidance... The test results demonstrated that the subject device complies with the requirements." This indicates compliance with FDA guidance on sharps injury prevention.

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

• Test Set Sample Size: Not specified for any of the performance tests (e.g., ISO 7864, ISO 7886-1 tests, biocompatibility tests). Standard industrial testing often relies on predefined sample sizes per standard, but these are not enumerated here.
• Data Provenance: The manufacturing entity, Shanghai Kindly Enterprise Development Group Co., Ltd., is based in China. The location where the testing was performed (country of origin of the data) is not explicitly stated, but it's implied to be associated with the manufacturer or their chosen testing labs. The studies are pre-market notification tests to demonstrate substantial equivalence, implying they are conducted for regulatory submission. Whether specific tests were retrospective or prospective is not detailed, but routine device testing for regulatory submission is typically prospective for the purpose of the submission.

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

• Not applicable. The document states "No clinical study is included in this submission." Ground truth, in the context of expert consensus, is typically established for diagnostic or screening devices evaluated in clinical settings, often for image interpretation or diagnosis. This document pertains to a medical device (syringe) where performance is assessed against engineering standards and simulated use.

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

• Not applicable. As there's no clinical study involving human interpretation or subjective assessment, adjudication methods are not relevant here.

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 syringe, not an AI-assisted diagnostic tool. No MRMC study was performed.

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

• Not applicable. This is a mechanical device, not an algorithm. Performance tests are inherently "device only" without human-in-the-loop performance in terms of interpretation, but involve human operation for mechanical tasks.

7. The type of ground truth used:

• Engineering Standards and Specifications: The "ground truth" for the device's performance is established by the specified international (ISO), national (USP, ASTM), and FDA standards/guidances (e.g., ISO 7864 for needle requirements, ISO 7886-1 for syringe performance, ISO 23908 for sharps injury protection, FDA guidance on sharps injury prevention). The device's physical and functional properties are tested against the objective, measurable criteria defined within these standards.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device, so there is no "training set."

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

• Not applicable. No training set exists for this device.

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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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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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