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The Luer Lock/Slip Tip Syringe (Low Dead Space) without needle is to inject fluids into, or withdraw fluids from, the body.
The Luer Lock/Slip Tip Syringe (Low Dead Space) with exchangeable is used to inject fluids into, or withdraw fluids from, the body.
The Luer Lock Syringe (Low Dead Space) with Safety needle is used to inject fluids into, or withdraw fluids from, the body. The safety mechanism covers the needle after use. In the activated position, the protective arm guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination.

The Luer Lock and Slip Tip syringe (Low Dead Space) without Needle is a sterile, single-use, standard 3-piece piston hypodermic syringe.
The Luer lock and Slip Tip syringe (Low Dead Space) with exchangeable needle is a sterile, single-use, standard 3-piece piston syringe with a detachable pre-attached needle.
The Luer Lock Syringe (Low Dead Space) with Safety Needle is a Low Dead Space syringe in combination with a safety needle. The safety needle contains a mechanism that covers the needle point after use. In the activated position, the needle cover guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device (syringes). It details the device description, indications for use, comparison to a predicate device, and summaries of non-clinical testing.

However, it does not contain information related to an AI/ML powered device, acceptance criteria or a study proving that an AI/ML meets these criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device (AI/ML based) meets the acceptance criteria using this document.

The document discusses performance testing against established ISO standards for medical devices like sterile hypodermic syringes and needles, biocompatibility testing, sterility, and shelf life for physical devices, not AI/ML model performance.

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The syringe without needle is used to inject fluids into, or withdraw fluids from, the body.

The Slip Tip and Eccentric Tip Syringe without Needle is a sterile, single-use, standard 3 piece piston. The device is packed individually and EO sterilized with 10-6 SAL.

The proposed device includes different specifications:
1ml Slip Tip Syringe without Needle
3ml Slip Tip Syringe without Needle
5ml Slip Tip Syringe without Needle
10ml Slip Tip Syringe without Needle
20ml Slip Tip Syringe without Needle
30ml Slip Tip Syringe without Needle
60ml Slip Tip Syringe without Needle
10ml Eccentric Tip Syringe without Needle
20ml Eccentric Tip Syringe without Needle
60ml Eccentric Tip Syringe without Needle

The provided document is a 510(k) summary for a medical device called "Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle." It outlines the device, its intended use, comparison to a predicate device, and non-clinical performance testing.

Here's an analysis of the acceptance criteria and study information as requested:

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

The acceptance criteria for this device are based on compliance with several international and industry standards for medical devices, particularly those related to syringes and their components. The reported device performance indicates compliance with these standards.

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

The document primarily refers to compliance with international standards through non-clinical performance testing. It does not provide specific details on sample sizes for each non-clinical test conducted. The tests evaluate the physical, mechanical, chemical, and biological properties of the syringe. Given the nature of these tests, they are typically conducted in a controlled laboratory environment (prospective testing) to ensure adherence to the specified standards for medical devices. The country of origin of the data is not explicitly stated in this FDA submission document.

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 as the submission describes non-clinical performance testing against established engineering and biological standards, not clinical studies requiring expert consensus on medical conditions or interpretations. The "ground truth" here is adherence to specified parameters within recognized standards.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials where expert readers independently review medical images or patient data, and discrepancies are resolved. This submission details non-clinical laboratory 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

No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical study is included in this submission." This device is a basic medical syringe, and such studies are not typically required for its clearance.

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

This information is not applicable. The device is a physical medical instrument (syringe), not an AI algorithm or software. Therefore, there's no "standalone" algorithm performance to evaluate.

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

For the non-clinical performance testing, the "ground truth" is defined by the specifications and acceptable limits established within the cited international and industry standards. For example, for ISO 7886-1, the ground truth would be the defined force required for plunger operation, or the leakage limits. For biological compatibility tests, the ground truth would be the absence of toxicity or irritation as per ISO 10993 series.

8. The sample size for the training set

This information is not applicable. This is a submission for a physical medical device (syringe), not an AI/machine learning model that requires a training set.

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

This information is not applicable for the same reason as point 8.

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The Luer Lock Syringe with Exchangeable Needle is used to inject medicines and vaccines into, or withdraw fluids from. the body.

The Luer Lock Syringe with Safety Needle is used to inject fluids into, or withdraw fluids from, the body. The safety mechanism covers the needle after use. In the activated position, the protective arm guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination.

The Luer Lock Syringe with Blunt Fill Needle is used for aspiration from multi-dose medicine vials.

The Luer Lock Syringe with Exchangeable Needle is a sterile, single-use, standard 3-piece piston syringe with a detachable pre-attached needle.

The Luer Lock with Safety Needle is a syringe and needle combination with the safety needle. It contains a mechanism that covers the needle point after use. In the activated position, the needle cover guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination. The Safety needle can be pre-attached or aside the syringe.

The Luer Lock Syringe with Blunt Fill Needle is a sterile, single-use, standard 3-piece piston syringe with a detachable pre-attached needle. It is used for aspiration from multi-dose medicine vials.

The proposed devices are offered in various gauge sizes and length.

The proposed devices are available in EO sterilized to achieve a Sterility Assurance Level (SAL) of 10-6.

The device is for medical professionals use only and for prescription use only.

• Luer Lock Syringe with Safety Needle (Syringe range: 1ml, 3ml, 5ml,10ml; Needle range: 20G, 21G, 23G, 25G; Needle length from 5/8" to 1 1/2"). The Safety needle can be pre-attached or aside the syringe.

• Luer Lock Syringe with Exchangeable Needle (Syringe range: 3ml, 5ml, 10ml, Needle range: 20G, 21G, 22G, 23G, 25G; Needle length from 5/8" to 1 1/2").

• Luer Lock Syringe with Blunt Fill Needle (Syringe range: 3ml, 5ml, 10ml, Needle: 18G, Needle length:1 1/2").

The provided text describes a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria in the typical sense of algorithm performance. The device referenced is a "Luer Lock Syringe with Safety Needle: Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle."

Therefore, most of the requested information (sample size, data provenance, expert ground truth, adjudication method, MRMC studies, standalone performance, training set details) is not applicable as this is a physical medical device clearance, not an AI/algorithm-driven device.

However, I can extract the acceptance criteria (standards the device complies with) and the reported device performance (test results indicating compliance).

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of non-clinical performance tests detailed in the "8. Performance Data" section. These tests were conducted on representative samples of the proposed devices to demonstrate compliance with the listed international and ASTM standards and USP monographs.

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

• Sample Size: Not explicitly stated for each test. The document mentions "representative samples" were used.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). As these are bench tests and biocompatibility assessments for a physical device, the concept of "country of origin of data" in the AI sense is less relevant. The studies were non-clinical performance and biocompatibility tests conducted to industry standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable. This is a clearance for a physical medical device, not an AI/algorithm-driven device requiring expert consensus for ground truth. The "ground truth" here is compliance with established performance standards for syringes and needles.

4. Adjudication Method for the Test Set:

• Not Applicable. As above, this is for a physical device. Test results are typically objective measurements against a standard, not subjective expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This type of study is relevant for AI/imaging algorithms, not for physical syringes and needles. The document explicitly states: "No data from human clinical studies have been included to support the substantial equivalence of the proposed device."

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

• Not Applicable. This is a physical device; there is no embedded algorithm.

7. Type of Ground Truth Used:

• The "ground truth" for this device is compliance with internationally recognized scientific and engineering standards and biological safety standards as listed (e.g., ISO 7886-1, ISO 10993 series, ASTM, USP). The tests performed (e.g., cytotoxicity, pyrogenicity, seal strength, fluid dynamic performance) provide objective measurements against these predefined standards.

8. Sample Size for the Training Set:

• Not Applicable. This is a physical device, not an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable. (See point 8).

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The Sol-Guard Auto-Disable Syringe is intended for aspiration and injection of fluids into the body. In addition, the Sol-Guard™ Auto-Disable Syringe is designed to prevent syringe and needle reuse.

The SOL-GUARD Auto-Disable syringe is a sterile, single-use, 3-part hypodermic syringe with an auto-disable feature that is intended to deliver a fixed dose of medicine/vaccine immediately after filling. The SOL-GUARD Auto-Disable syringe has a fixed needle and plunger rod with affixed metal clip which is designed for the prevention of the syringe and needle re-use by automatically activating the clip and locking the plunger after injection. The syringe is individually blister packaged, and EtO sterilized with SAL of 106. This syringe is intended for aspiration and injection of fluids.

This document is an FDA 510(k) summary for a medical device (Sol-Guard Auto-Disable Syringe). It does not describe an AI medical device or a study involving AI, nor does it use terms like "acceptance criteria," "test set," "ground truth," "MRMC," or "standalone performance" in the context of AI algorithm validation.

Therefore, I cannot extract the requested information regarding acceptance criteria and study proving device meets acceptance criteria for an AI device from this document. The document describes the non-clinical (bench) testing performed for a mechanical syringe to demonstrate its substantial equivalence to a predicate device, with a focus on the new auto-disable feature.

If you are looking for information about the validation of an AI medical device, you would need a different type of document, typically a clinical study report or a 510(k) summary for an AI/ML-enabled device.

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The Sol-M Luer Lock Syringe is intended for aspiration of medications and fluids into the body.

The Sol-M Luer Lock Syringe is used to aspirate and inject fluid/medication into the body. The syringe is a sterile, single-use, 3-part syringe with luer lock conical connection. The Sol-MTM Luer Lock Syringe consists of the following components: Barrel, Plunger, Gasket. In addition to being used manually, the Sol-MTM Luer Lock Syringe can also work with a powerdriven syringe pump, with the luer lock tip connected to the IV administration line to deliver specific volume of fluid/medication. The syringe is individually blister packaged, and EtO sterilized with SAL of 10-6. The Sol-M™ Luer Lock Syringe is provided in 1, 3, 5, 10, 20, 30, and 60ml volume.

The provided text describes the Sol-M Luer Lock Syringe (K222744) and its acceptance criteria, particularly focusing on its suitability for use with power-driven syringe pumps.

Here's an analysis of the provided information, framed by your requested criteria:

The study primarily focuses on demonstrating the suitability of the Sol-M Luer Lock Syringe for use with power-driven syringe pumps, referring to ISO 7886-2 as the key standard.

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that the device was tested according to ISO 7886-2:2020. The acceptance criteria are implicitly those defined by this standard. The reported performance is that the device met these criteria.

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

• Sample Size: The document does not explicitly state the specific number of syringes used for each test (e.g., for critical dimensions, flow rate, compliance tests). It only refers to "testing per ISO 7886-2."
• Data Provenance: Not explicitly stated, but based on the context of a 510(k) submission, this would be prospective testing conducted by the manufacturer, Sol-Millennium Medical Inc. The country of origin of the data is generally where the manufacturer performs their testing, which for Sol-Millennium Medical Inc. is based in Suwanee, Georgia.

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

Not applicable. This is a bench testing (non-clinical) submission involving a physical medical device (syringe). "Ground truth" in this context refers to standardized measurements and performance specifications outlined in ISO 7886-2, not expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially those involving human interpretation of data where consensus is needed to establish a "ground truth" or resolve disagreements. For bench testing against a standard like ISO 7886-2, objective measurements are taken, compared against predefined limits, and either pass or fail.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret data (e.g., radiologists reading images) and the AI aims to improve their performance. This submission is for a physical medical device (syringe) and focuses on engineering performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is for a physical medical device, not an algorithm or AI. The testing described is "standalone" in the sense that the syringe's performance is measured directly, not in conjunction with human interpretation of its output.

7. Type of Ground Truth Used

The "ground truth" for the test set is established by international standards and specifications, specifically ISO 7886-2:2020 (for use with power-driven syringe pumps) and ISO 7886-1:2017 (for manual use). These standards define acceptable ranges for dimensional requirements, flow rate error, pump forces, and syringe compliance.

8. Sample Size for the Training Set

Not applicable. There is no AI/algorithm component requiring a training set mentioned in this submission. This is a traditional medical device (syringe) bench test.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an algorithm.

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