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The Sol-Guard™ XtraThin Wall Safety Pull button blood collection set is a sterile, multi-sample, single-use fixed winged blood collection set intended for venipuncture to obtain blood specimens from patients. When used without the male Luer adaptor, the device allows the clinician to obtain blood sampling to the female hub with a syringe, if necessary or can be used for short-term (up to 2 hours), single infusions with consideration given to patient size and appropriateness for the solution being infused. The device is not to be left in place and should remain under the direct supervision of a clinician.

The recommended use of the device is to activate the needle safety feature prior to removal from the venipuncture site. The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needlestick injury.

Sol-Guard™ XtraThin Safety Pull-Button Blood Collection Set is a single-use, sterile, winged blood collection needle that can be used for blood collection and/or the short-term (up to 2 hours) infusion of intravenous fluids. The device is offered with butterfly needle set which has either 21-, 23- or 25-gauge needle with integral butterfly wings, offered in two different flexible tubing lengths of 178mm and 305mm, and a safety tube with tubing leading to a female luer connector. The female luer connector is optionally attached to a luer adapter, or luer adapter plus a tube holder.

The device is designed with spring retractable needle technology that allows needle retraction after use to prevent needle stick injury and blood exposure. When the Button on the body of the butterfly is pulled back, the spring is released, and the needle is retracted into the clear plastic safety tube. In the activated position, the needle is completely enclosed within the clear plastic safety tube which guards against accidental needlesticks during normal handling and disposal.

While the provided FDA 510(k) clearance letter and summary meticulously detail the substantial equivalence of the "Sol-Guard™ XtraThin Safety Pull-Button Blood Collection Set" to its predicate device, it does not contain information related to software, artificial intelligence (AI), diagnostic accuracy, or human reader performance.

The document describes a physical medical device (a blood collection set) and its mechanical and material properties. The term "acceptance criteria" in this context refers to the bench and performance testing standards (e.g., ISO and ASTM standards) the device must meet to demonstrate its safety and effectiveness, particularly concerning the change in needle inner diameter.

Therefore, I cannot provide an answer that includes:

• A table of acceptance criteria for diagnostic performance or AI.
• Sample sizes for a "test set" in an AI/diagnostic context.
• Data provenance, expert qualifications, or adjudication methods for ground truth.
• MRMC comparative effectiveness studies or effect sizes for human readers with AI assistance.
• Standalone algorithm performance.
• Ground truth types like expert consensus, pathology, or outcomes data.
• Training set sample size or how its ground truth was established.

The document is entirely focused on the physical characteristics and performance of a blood collection device, not on any kind of diagnostic or AI-driven system.

If you are looking for information regarding acceptance criteria and studies for AI-powered medical devices, you would need a 510(k) submission or clearance letter for such a device. This document is for a conventional, non-AI medical device.

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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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The SOL-GUARD™ Safety Pull-Button Blood Collection Set is a sterile, multi-sample, single-use fixed winged blood collection set intended for venipuncture to obtain blood specimens . When used without the male Luer adapter, the device allows the clinician to obtain blood sampling to the female hub with a syringe, if necessary, or can be used for short-term (up to 2 hours), single infusions with consideration given to patient size and appropriateness for the solution being infused. The device is not to be left in place and remain under the direct supervision of a clinician.

The recommended use of the device is to activate the needle safety feature prior to removal the venipuncture site.

The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needlestick injury.

SOL-GUARD™ Safety Pull-Button Blood Collection Set, is a single-use, sterile, winged blood collection needle that can be used for blood collection and/or the short-term (up to 2 hours) infusion of intravenous fluids. The device is offered with butterfly needle set which has either 21-, 23- or 25-gauge needle with integral butterfly wings, offered in two different flexible tubing lengths of 178mm and 305mm, and a safety tube with tubing leading to a female luer connector. The female luer connector is optionally attached to a luer adapter, or luer adapter plus a tube holder.

The device is designed with spring retractable needle technology that allows needle retraction after use to prevent needle stick injury and blood exposure. When the Button on the body of the butterfly is pulled back, the spring is released, and the needle is retracted into the clear plastic safety tube. In the activated position, the needle is completely enclosed within the clear plastic safety tube which guards against accidental needlesticks during normal handling and disposal.

Acceptance Criteria and Device Performance for SOL-GUARD™ Safety Pull-Button Blood Collection Set (K213718)

This document describes the acceptance criteria and study proving the SOL-GUARD™ Safety Pull-Button Blood Collection Set meets those criteria, based on the provided FDA 510(k) summary.

It's important to note that the provided text is a 510(k) summary for a Sharps Injury Protection Device, specifically a blood collection set. The regulatory pathway for this type of device primarily focuses on demonstrating substantial equivalence to a predicate device, rather than a full-scale clinical study that establishes performance against strict, quantifiable clinical acceptance criteria (like sensitivity/specificity for a diagnostic AI). Therefore, the "acceptance criteria" here are largely related to bench testing, biocompatibility, and usability demonstrating equivalent safety and effectiveness to the predicate, particularly regarding the safety mechanism.

The documentation focuses on comparing the subject device to a predicate device (BD Vacutainer® UltraTouch™ Push Button Blood Collection Set, K153309) and demonstrating that any differences do not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are largely derived from recognized international standards and a demonstration of equivalence to the predicate device. The performance data presented are primarily from bench testing, biocompatibility testing, and simulated usability studies.

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

Given the nature of a 510(k) submission for a sharps injury protection device, formal "test sets" of patient data (as one would see for an AI/diagnostic device) are not typically used. The "test set" here refers to:

• Physical device samples used for bench testing (e.g., for force measurements, retraction tests, flow rates). The exact number of samples for each test is not specified in the summary but would be detailed in the full test reports.
• Physical device samples used for biocompatibility testing (extracted materials).
• Volunteer participants for the "Simulated Usability Study." The number of participants is not specified.

Data Provenance: The studies are prospective bench and usability studies conducted by the manufacturer (Sol-Millennium Medical, Inc.). The country of origin for the data is implicitly the location where the manufacturer's testing facilities are based.

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

For this type of device, "ground truth" is not established by clinical experts in the sense of diagnosing a condition. Instead, the "ground truth" or "objective criteria" are defined by:

• International standards (ISO, ASTM, USP): These standards define measurable physical and chemical properties and performance benchmarks.
• Engineering specifications and regulatory requirements: Defining what constitutes "safe" and "effective" operation of the device's mechanisms.
• Predicate device performance: Used as a benchmark for equivalence.

Therefore, there wasn't a panel of "experts" (e.g., radiologists) used to establish a clinical ground truth for a test set. Rather, the "ground truth" is based on established engineering principles, validated test methods, and regulatory precedents. Individuals involved would include:

• Engineers and Quality Control personnel: Qualified to design, execute, and interpret bench tests in accordance with relevant standards.
• Toxicologists/Biocompatibility Specialists: Qualified to interpret biocompatibility test results.
• Regulatory Affairs Specialists: Qualified to interpret regulatory requirements and predicate device information.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are relevant for subjective interpretations by multiple human readers (e.g., in medical image analysis). For this device, where "ground truth" is based on objective measurements and adherence to standards, such a medical adjudication method is not applicable.

The "adjudication" is inherent in the validation of the test methods themselves (e.g., ensuring they are robust and reproducible) and the interpretation of results against pre-defined acceptance criteria derived from standards or engineering specifications. Any discrepancies in test results would be handled through and internal quality system's investigation and retesting procedures.

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

No MRMC study was conducted or is applicable for this type of device.

MRMC studies are typically performed for AI-assisted diagnostic devices to assess how AI impacts the diagnostic performance (e.g., accuracy, sensitivity, specificity) of human readers or to compare reader performance with and without AI assistance. This device is a blood collection set with a safety mechanism, not a diagnostic tool requiring human interpretation of complex medical data.

The "human factor" component was addressed through a "Simulated Usability Study" to ensure the safety mechanism is intuitive and effective for users, but this is distinct from an MRMC study.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical medical device, not a software algorithm. Therefore, there is no "standalone" algorithm-only performance to evaluate. The "standalone" performance for this device is its physical and mechanical performance as evaluated through bench testing.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily based on:

• Objective physical measurements: Forces, dimensions, flow rates, particulate counts, sterility (measured via biological indicators/analytical tests).
• Adherence to recognized industry standards: ISO, ASTM, USP, which define performance benchmarks and test methodologies.
• Biocompatibility test results: Based on standardized biological assays.
• Simulated use studies: Observing user interaction with the device under controlled, non-clinical conditions.

It does not involve expert consensus on clinical diagnoses, pathology, or patient outcomes data directly for determining the device's classification or performance in the 510(k) context. The device's safety mechanism aims to prevent adverse outcomes (needlestick injuries), and its effectiveness is demonstrated through mechanical reliability, not by analyzing patient outcome data from a clinical trial.

8. Sample Size for the Training Set

Not applicable. As this is a physical medical device and not an AI/machine learning algorithm, there is no "training set" of data in the computational sense. The device's design is based on engineering principles and iterative development, not on training a model with data.

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

Not applicable, as there is no training set. The design and manufacturing processes for the device are governed by quality management systems (e.g., 21 CFR Part 820 Quality System Regulation). Performance characteristics are verified through design validation and verification activities, not machine learning training.

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The Sol-M Blood Collection Needle is intended to be used with vacuum blood collection tube for the collection of venous blood.

The Sol-Care Safety Blood Collection Needle is intended to be used with vacuum blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

The Sol-Care Safety Blood Collection Needle with Holder is intended to be used with vacuum blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

The Sol-M Blood Collecting Set is intended to be used with vacuum blood collection tube for the collection of venous blood.

The proposed devices are blood collection devices form a channel between patient's vein and the vacuum blood collection tube intended for collection of blood. The proposed devices are divided into several types, the configuration for each type of proposed device are provided as follows: Blood Collection Needle – one piece, Blood Collection Needle – Direct, Blood Collection Needle – Multi piece, Safety Blood Collection Needle – Direct, Safety Blood Collection Needle – Multi piece, Safety Blood Collection Needle w/Holder – One piece, Safety Blood Collection Needle w/Holder - Direct. In addition, the proposed devices are divided into several types and available in different specifications.

This document is a 510(k) Premarket Notification from Sol-Millennium Medical, Inc. for blood collection needles and sets. It demonstrates substantial equivalence to a predicate device and outlines the non-clinical tests performed. No acceptance criteria, device performance, or study results are provided in the document.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence through comparison of features and adherence to recognized standards, rather than presenting a performance study with acceptance criteria.

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The Sol-Care Safety Blood Collection Needle(with and without Pre-attached Tube Holder) is a single, winged blood collection needle to be used for blood collection or short-term infusion (up to 2 hours) of intravenous fluids. The device is designed with a safety mechanism to help reduce the risk of needlestick injury

The Sol-Care Safety Blood Collection Needle Set (Butterfly Needle) is a single-use, sterile, winged blood collection needle that can be used for blood collection and/or the short-term infusion of intravenous fluids. The Butterfly Needle Set is available with a 21, 23 or 25 gauge needle with Butterfly Wings and a Safety Shield with tubing leading to a covered needle assembly and Tube Holder. The product is available with and without the Tube Holder.

The Sol-Care Safety Blood Collection Needle consists of:

• Stainless steel cannula (Intravenous end and Non-patient end of Cannula)
• Wings (Color coded according to needles gauge)
• Tubing
• Female luer adaptor
• Intravenous (IV) needle protector (covers the needle before use)

The optional SOL-M™ Blood Collection Tube Holder and SOL-M™M Blood Culture Holder include a male luer adapter for attachment to the Sol-Care Safety Blood Collection Needle.

The Sol-Care Safety Blood Collection Needle has a sharps injury prevention feature. The Butterfly Wing Assembly consists of a needle assembly and a Safety Shield. After use, the health care professional can pull back on the tubing while holding the butterfly wing and the needle will retract and lock into the Safety Shield. In the activated position the needle cover guards against accidental needlesticks during normal handling and disposal.

The devices are sterilized by Ethylene Oxide Gas. The Safety Blood Collection Needle is supplied in a hard Tray Pack while the Safety Blood Collection Needle with a preattached Tube Holder is supplied in a soft Tray Pack. Twenty-Five Safety Blood Collection Needles with a pre-attached Tube Holders are packaged in a chipboard box while fifty Safety Blood Collection Needles are packaged in a chipboard box. Each Tray Pack is labeled with the contents and the appropriate information per the Medical Device Directive and FDA's Quality System Regulation and Labeling requirements, 21CFR Part 801.

The provided text describes specific acceptance criteria and the studies conducted to demonstrate that the Sol-Care Safety Blood Collection Needle (with and without Pre-attached Tube Holder) meets these criteria. Since this is a medical device submission, the "acceptance criteria" are derived from recognized ISO standards and specific internal test protocols, and the "reported device performance" is the successful completion of these tests.

Here's the information extracted and formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document consistently states "met the appropriate requirements" or "Protocol and Report successfully completed" for each test, implying that the device successfully passed all established criteria within those tests/standards. The specific quantitative acceptance thresholds are not detailed in this summary document but would be part of the full test reports (e.g., PRJ001_096).

Here's the remaining information based on the provided text:

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

• Sample Size: Not explicitly stated for each test, but a "Simulated Use Study with Nurse Evaluators" was conducted, implying human interaction with the device. For the accelerated aging tests, product testing occurred at "time 0, years 1, 2 and 3," which points to batches of devices being tested.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be conducted by the manufacturer or their contracted laboratories as part of their premarket submission. The regulatory context (FDA 510(k) submission in the USA) implies the data is generated for US regulatory standards. All nonclinical tests are listed, indicating these are internal or contract lab results rather than clinical data from human subjects.

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

• This question is largely not applicable in the context of this device and report. The "ground truth" for a blood collection needle in this submission is established by adherence to recognized engineering and biocompatibility standards (e.g., ISO, ASTM). Performance is measured against physical, chemical, and biological criteria, not against expert medical interpretations of complex images or patient outcomes in the same way an AI diagnostic device would be.
• A "Simulated Use Study with Nurse Evaluators" was conducted, indicating that nurses (experts in using such devices) evaluated the device. However, the number and specific qualifications (beyond "nurse") are not detailed, and their role was likely to assess usability and safety features in a simulated environment, rather than establishing a "ground truth" diagnosis.

4. Adjudication method for the test set

• Not applicable in the context of this submission. Adjudication methods like 2+1 or 3+1 panels are typically used to establish a definitive "ground truth" when interpreting subjective data (e.g., medical images). This submission focuses on objective engineering, material, and biological performance criteria against established standards, where the test results themselves constitute the "ground truth" of performance.

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, an MRMC comparative effectiveness study was not done. This device is a physical medical instrument (blood collection needle), not an AI diagnostic tool. Therefore, the concept of "human readers improving with AI assistance" is not 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.)

• For this device, the "ground truth" for performance is based on fulfilling the requirements of International Standards (ISO, ASTM) and internal validated test protocols. This includes:
  • Engineering specifications (e.g., flow rate, puncture force, needle dimensions).
  • Material properties (e.g., chemical compatibility, strength).
  • Safety features physical performance (e.g., pulling force for shield activation, locking mechanism).
  • Sterility assurance levels.
  • Biocompatibility testing results (e.g., cytotoxicity, hemolysis).
  • Packaging integrity (e.g., seal strength, transit simulation).
• The Simulated Use Study with Nurse Evaluators provides practical "ground truth" for usability and effective activation of the safety mechanism by intended users.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not a machine learning algorithm requiring a training set.

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

• Not applicable. As above, no training set for an algorithm is involved.

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The 0.5ml Sol-Care™ Retractable Safety Syringe is used to inject fluids into, or withdraw fluids from, the body. In addition, the 0.5ml Sol-Care™ Retractable Safety Syringes is designed to aid in the prevention of needle stick injuries.

The 0.5ml Sol-Care™ Retractable Safety Syringe with Fixed Needle is a sterile, single use, safety syringe with a fixed needle that is used to inject fluids into, or withdraw fluids from, the body. The 0.5ml Sol-Care™ Retractable Safety Syringe with Fixed Needle is also designed to aid in the prevention of needle stick injuries. The retractable piston syringe is a plastic disposable syringe made of the following components: Barrel, Plunger, Stopper, Cannula, Locking Ring, Needle Cap, O-Ring, Protective Cap. After use, the health care professional firmly pushes the plunger past the zero line to engage the safety mechanism. Once the safety mechanism is engaged, pulling back the plunger causes the needle to be retracted into the barrel. In this position against the flange, lateral pressure on the plunger results in a controlled fracture of the plunger. Both the syringe and the plunger are discarded into a sharps container. The 0.5ml Sol-Care™ Retractable Safety Syringe with Fixed Needle are sterilized by Ethylene Oxide and supplied sterile in a blister pack or tray pack.

The provided document is for a medical device called "0.5ml Sol-Care™ Ret retractable Safety Syringes" and primarily focuses on its substantial equivalence to a predicate device for FDA clearance. Therefore, the information requested about acceptance criteria and study details related to performance metrics like sensitivity, specificity, or AI assistance is not typically found in this type of submission for a physical medical device.

However, I can extract information regarding performance in terms of meeting established standards for the device. The document explicitly states that the device met the requirements of several ISO standards.

Here's the closest representation of the requested information based on the provided text:

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

Regarding the other points, the document states or implies the following limitations:

• 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 does not specify sample sizes for each test in the ISO standards, nor the country of origin or whether the studies were retrospective or prospective. It only generically states that tests were conducted.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For these types of device performance tests (e.g., sterility, material strength, retraction mechanism function), a "ground truth" established by experts in the clinical or diagnostic sense is not relevant. The ground truth is defined by the objective pass/fail criteria of the engineering and biocompatibility standards.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. The tests against ISO standards typically involve objective measurements or pass/fail observations, not subjective adjudication methods.
• 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 medical device (safety syringe), not an AI/software-based diagnostic or imaging device. There are no "human readers" or "AI assistance" involved in its intended use.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as detailed above.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" implicitly referred to is the objective criteria and methodologies defined within the cited ISO standards for device performance and safety (e.g., successful retraction, material biocompatibility limits, sterility assurance levels).
• 8. The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of machine learning.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, the document details a regulatory submission for a physical medical device. Its "acceptance criteria" and "study" revolve around demonstrating compliance with established international standards for the design, manufacturing, and biological safety of such devices, rather than clinical performance metrics of an AI or diagnostic tool.

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