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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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The Auto-Disable Sterile Safety Syringe for Single Use ,5ml, is used to inject fluids into, or withdraw fluids from the body. In addition, the retractable needle of the syringe goes into the barrel after use. It is designed to aid in the prevention of needle stick injuries.

The Auto-Disable Sterile Safety Syringe for Single Use is used to inject fluids into, or withdraw fluids from the body. In addition, the retractable needle of the syringe goes into the barrel after use. It is designed to aid in the prevention of needle stick injuries. The retractable type of piston syringe is a plastic disposable anti-needle stick syringe made of the below components: Cap, Needle, Needle house, Hub, Barrel, Gasket, Plunger.

This looks like a 510K submission for a medical device. I will break down the information section by section as requested.

Acceptance Criteria and Device Performance Study for Auto-Disable Sterile Safety Syringe For Single Use, 5mL (K121637)

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria in a table format for a specific "device performance" study that would typically involve sensitivity, specificity, accuracy, etc., for an AI/diagnostic device. Instead, the performance testing focuses on compliance with various ISO and ASTM standards relevant to the physical and biological aspects of a sterile safety syringe.

However, the "Simulated Clinical Use Study" directly addresses the safety and usability of the device's main feature. We will infer the acceptance criteria from the study design and the conclusion of substantial equivalence.

Inferred Acceptance Criteria and Reported Device Performance for Simulated Clinical Use:

Other Performance Testing (Compliance with Standards):

The device underwent and passed a series of standard tests for biological evaluation, sterilization, packaging, and general syringe functionality to demonstrate substantial equivalence to the predicate device. These are not performance metrics in the sense of sensitivity/specificity but rather compliance with established safety and quality standards.

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

• Sample Size for Simulated Clinical Use:
  • Test Device (Auto-Disable Syringe): 500 samples
  • Predicate Device (Invirosnap Safety Syringe): 100 samples
• Data Provenance: The study was a "simulated clinical use study" conducted by Sunwell Biotech Co., Ltd. The document does not explicitly state the country of origin for the data or if it was retrospective or prospective. However, "simulated clinical use" implies a prospective collection of data in a controlled environment, likely in the country of the submitting company (China) or a contracted facility.

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

• Number of Experts: 10 nurses.
• Qualifications of Experts: They are identified as "nurses," implying healthcare professionals with practical experience in using syringes for injections and withdrawals. Specific years of experience or specialization are not provided.

4. Adjudication Method for the Test Set

The document states that the 10 nurses "reported their experience with each sample." This suggests a direct user feedback or observation method rather than a formal adjudication process where multiple experts collectively establish a single ground truth for each case. Given the nature of a safety syringe (does it retract or not, is it easy to use), direct user experience reports serve as the primary data. There is no mention of a 2+1, 3+1, or similar adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted in the context of an AI/diagnostic device improving human reader performance. This device is a physical medical instrument (syringe), not a diagnostic algorithm. The "simulated clinical use study" involved human users (nurses) testing the device, but it was not designed to measure an effect size of how much human readers improve with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, this question is not applicable. The device is a physical auto-disable safety syringe, not an algorithm or AI system. Therefore, there is no "standalone" algorithm performance to evaluate.

7. The Type of Ground Truth Used

For the simulated clinical use study, the "ground truth" was based on user experience and observation of functional performance by the participating nurses, guided by the objective to assess the "reliability and usability of the safety feature." The success or failure of the needle retraction, ease of use, and overall experience reported by the nurses effectively constitute the ground truth for this type of device performance evaluation.

8. The Sample Size for the Training Set

• This device is a physical safety syringe, not an AI/ML algorithm that requires a "training set" of data. Therefore, the concept of a training set sample size is not applicable to this submission.

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

• As the concept of a training set is not applicable to this physical device, there is no information on how ground truth for a training set was established.

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