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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-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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