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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 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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The Sol-M TB Syringe is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
The Sol-M Insulin Syringe with needle, with the calibration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.

The Sol-M Syringe is a sterile, single use, standard 3 piece piston syringe with a fixed needle. The Sol-M 0.3, 0.5 and 1 ml Insulin Syringe will be labeled with a Units Scale calibrated for U-100 Insulin. The 0.5 and 1 ml TB Syringe will be labeled with a mL Scale. The piston type syringe is a plastic disposable syringe made of the following components: 1. Barrel – The barrel has a scale showing the capacity of the syringe as well as the company brand name with the Do Not Reuse symbol. 2. Plunger - The plunger is used to aspirate fluid into the barrel or push fluid out of the barrel. 3. Stopper - The Stopper maintains the fluid in the barrel between the base of the barrel and Plunger. 4. Cap The Cap is used to cover and protect the tip of the barrel from being damaged.

This is a 510(k) premarket notification for a medical device (syringes), not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, MRMC studies, and standalone performance is generally not applicable in the context of AI/ML device evaluations. Traditional medical device clearances like this one focus on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical bench testing.

Based on the provided document, here's what can be extracted related to performance and testing, framed in the closest possible way to your request, but acknowledging the difference in context:

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

For the Sol-M Insulin Syringes:

For the Sol-M TB Syringes:

For both devices (general characteristics):

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

The document mentions "Bench tests were conducted to verify that the proposed devices met all design specifications." However, it does not specify the sample sizes for these bench tests. The data provenance is not explicitly mentioned as country of origin, but these are non-clinical tests performed to regulatory standards. The testing is prospective in the sense that new samples of the device were tested against established standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as this is a traditional medical device (syringes) and not an AI/ML device relying on expert-annotated ground truth for performance evaluation in the way an AI would. Performance is measured against engineering and material standards (e.g., ISO standards).

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

Not applicable in the context of traditional device bench testing against ISO standards. Test results are typically objective measurements.

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 not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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

The "ground truth" for this device's performance is established by international and national standards for medical syringes (e.g., ISO 8537, ISO 7886-1, ISO 9626, ISO 10993-1, 21 CFR 801). The device's physical and functional characteristics are objectively measured against these established parameters.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device and does not involve training data.

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

Not applicable, as this is not an AI/ML device and does not involve a training set or its ground truth.

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For Insulin Use: The Sol-Guard Insulin Safety Syringe is intended for the delivery of U-100 insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle sticks.
For TB Use: The Sol-Guard Tuberculin (TB) Safety Syringe is intended for the delivery of Tuberculin. The needle stick prevention feature of the device, once activated, guards against accidental needle sticks.

The Sol-Guard Safety Syringe is a sterile, single use, standard hypodermic syringe with an attached Safety Shield to cover the needle. The Sol-Guard Safety Syringe will be labeled as either an Insulin Safety Syringe for U-100 insulin or as a Tuberculin Safety Syringe. The Safety Shield is extended by the user's finger or thumb. To lock the Safety Shield in place, the user turns the Safety Shield either right or left until it locks in place. Once the Safety Shield is locked in place, the Safety Shield can't be pulled back exposing the needle. The Safety Shield on the Sol-Guard Safety Syringc covers the needle point after use. In the activated position, the Safety Shield guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination. The Sol-Guard Safety Syringe are sterilized by Ethylene Oxide Gas and I the Dot Gaire Saile Sare pack. One hundred blister packs are packaged in a chipboard box. Each Blister pack and chipboard box is labeled with the contents and the appropriate information per the FDA's Quality System Regulation and Labeling requirements.

Here's a breakdown of the acceptance criteria and study information for the Sol-Guard Insulin and Tuberculin Safety Syringe, based on the provided text:

Sol-Guard Insulin and Tuberculin Safety Syringe: Acceptance Criteria and Study Information

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on establishing substantial equivalence to a predicate device and adherence to recognized standards. It does not explicitly list quantitative acceptance criteria in a dedicated table format with corresponding numerical performance results for the device itself. Instead, it states that the device "met the appropriate requirements contained in the following standards." The reported device performance is implicitly that it complies with these standards.

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

The document does not explicitly state the specific sample sizes used for the "Simulated Use Study" or for testing adherence to the various ISO standards. It mentions a "Simulated Use Study" but does not detail its methodology, sample size, or data provenance (e.g., country of origin, retrospective or prospective nature). The other tests refer to compliance with standards, which would imply a certain number of units were tested, but these numbers are not provided.

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

This information is not provided. The study mentioned is a "Simulated Use Study," likely evaluating the safety feature, but no details about experts establishing ground truth or their qualifications are given. For general compliance with ISO standards, the "ground truth" is defined by the standard's specifications and test methods, not typically by expert consensus in a clinical sense.

4. Adjudication Method for the Test Set

This information is not provided. There is no mention of an adjudication method for the "Simulated Use Study" or any other tests.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The submission focuses on substantial equivalence to a predicate device and adherence to safety and performance standards rather than comparing the device's diagnostic or therapeutic effectiveness in a clinical setting with human readers.

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

This question is not applicable as the device is a physical medical device (safety syringe), not an algorithm or AI software. Therefore, there is no "algorithm only" or "human-in-the-loop" performance to evaluate in this context.

7. Type of Ground Truth Used

For the various ISO and FDA guidance documents, the "ground truth" is defined by the specifications and test methods outlined within those standards and guidance documents. For example, the ground truth for "hub/needle bond strength" is achieving the strength specified in ISO 8537 (Insulin) & ISO 7886 (TB). The "Simulated Use Study" would have an implied ground truth related to the successful activation and prevention of needle sticks as per the FDA Guidance for Sharps Injury Prevention, but the specific metrics used to define this "ground truth" are not detailed.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical medical device, not an AI or machine learning model that requires a "training set."

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

This information is not applicable, as there is no "training set" for this physical medical device.

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