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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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The CAREO Safety Syringe for U-100 Insulin is a sterile, single-use, disposable, 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 is also intended to prevent needlestick injuries. In addition, when the user breaks the plunger, reuse of the syringe is prevented.

The Life-Shield Products, Inc., CAREO Safety Syringe for U-100 Insulin is a sterile, single use and disposable, 1cc/mL piston syringe, provided with a permanently attached needle in nine product configurations. The CAREO Safety Syringe for U-100 Insulin is similar in appearance, size, materials operation, and purpose to the cited predicate device and other conventional single use, sterile, disposable syringes.

The provided text does not contain detailed acceptance criteria or a study proving the device meets those criteria. Instead, it describes a medical device (CAREO Safety Syringe for U-100 Insulin) and its substantial equivalence to predicate devices. The document explicitly states that "Therefore, no new tests are necessary." because the materials, safety features, and functional/performance characteristics are identical to those already verified and validated for other CAREO Safety Syringes in previous 510(k) premarket notifications.

Therefore, many of the requested fields cannot be filled as the information is not present in the provided text.

Here's an attempt to populate the table and answer the questions based on the available information:

Acceptance Criteria and Device Performance

Since the document states "no new tests are necessary" due to substantial equivalence, specific numerical acceptance criteria for the CAREO Safety Syringe for U-100 Insulin are not presented in this 510(k) submission. The acceptance criteria would likely be implied to be "equivalent to the predicate devices" which have already met their respective criteria.

Study Details:

1. Sample size used for the test set and the data provenance:

   • No new test set was used for this specific 510(k) submission because "no new tests are necessary." The device's performance is asserted based on its identical characteristics to previously cleared devices. Data provenance for the original predicate devices' testing is not provided in this document.

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

   • Not applicable, as no new test set was used for this submission.

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

   • Not applicable, as no new test set was used for this submission.

4. 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 device is a manual safety syringe, not an AI-assisted diagnostic tool.

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

   • Not applicable. This device is a manual safety syringe, not an algorithm.

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

   • For the predicate devices, the ground truth for performance characteristics would have been established through physical testing (e.g., force required for needle retraction, plunger break functionality, material strength, biocompatibility assays). The specific details are not in this document.

7. The sample size for the training set:

   • Not applicable, as no new training was performed for this 510(k). The basis is substantial equivalence to predicate devices.

8. How the ground truth for the training set was established:

   • Not applicable, as no new training was performed for this 510(k). The basis is substantial equivalence to predicate devices, implying their ground truth was established through standard testing for medical devices of this type.

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