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The CAREO Safety Syringe for U-100 Insulin 0.5cc/mL is a sterile, single-use, disposable and nonreusable, retractable safety syringe which is intended to provide a safe and reliable method for injection of insulin into a patient.

The CAREO Safety Syringe for U-100 Insulin 0.5cc/mL is also intended to prevent needlestick injuries. In addition, when the userbreaks the plunger, reuse of the syringe is prevented.

The Life-Shield Products, Inc., CAREO Safety Syringe for U-100 Insulin 0.5cc/mL is a sterile, single use and disposable, 0.5cc/mL piston syringe, provided with a permanently attached needle in nine product configurations. The CAREO Safety Syringe for U-100 Insulin 0.5cc/mL is similar in appearance, size, materials operation, and purpose to the cited predicate device and other conventional single use, sterile, disposable syringes.

This document is a 510(k) Premarket Notification for a medical device, a safety syringe. It does not describe an AI/ML device or a study with acceptance criteria and performance metrics of the kind typically associated with AI. Instead, it demonstrates substantial equivalence to predicate devices based on design, materials, and intended use.

Therefore, most of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is not applicable to this document.

The relevant information from the provided text is as follows:

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

• Acceptance Criteria: Not explicitly stated as quantifiable metrics in the provided text. The overall criteria for acceptance are based on substantial equivalence to predicate devices, particularly regarding safety features and functionality. The text states: "The materials of construction, safety feature, and other functional and performance characteristics of CAREO Safety Syringe for U-100 Insulin 0.5cc/mL are identical to those for the other CAREO Safety Syringes." This implies the performance must be "identical" or equivalent to previously cleared devices.
• Reported Device Performance: The document states that no new tests were necessary because "The material safety test, biocompatibility, and safety feature were already indicated, verified, and validated as shown in the previous 510(k) premarket notifications [K030976, K052397, K060208, and K061055]." This means the device is expected to perform in line with its predicate devices, which are designed to prevent needlestick injuries and syringe reuse.

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

• Not applicable. The document refers to "material safety test, biocompatibility, and safety feature" verification and validation from previous 510(k)s, rather than a specific test set for this submission.

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)

• Not applicable. Ground truth establishment with experts is not relevant for this type of device submission.

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

• Not applicable.

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 not an AI device.

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

• Not applicable. This is not an AI/algorithm-driven device.

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

• Not applicable. The "ground truth" for this device relates to its physical performance characteristics (e.g., proper retraction, prevention of reuse, material safety) as demonstrated by engineering and biocompatibility testing previously conducted on substantially equivalent devices.

8. The sample size for the training set

• Not applicable. This is not an AI device with a training set.

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

• Not applicable.

In summary, the provided document is a 510(k) Premarket Notification for a conventional medical device (safety syringe) establishing substantial equivalence to previously cleared predicates. It does not contain information related to AI/ML device performance or clinical studies with the acceptance criteria framework you've outlined.

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