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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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The CAREO Safety Syringe 1cc/mL is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into a patient.

The CARFO Safety Syringe 1cc/mL 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 1cc/mL is a sterile, single use and disposable, 1cc/mL piston syringe, provided with a permanently attached needle in fifteen product configurations. The CAREO Safety Syringe 1cc/mL 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 describes a medical device (CAREO Safety Syringe 1cc/mL) seeking 510(k) premarket notification. The filing focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study. Therefore, much of the requested information about acceptance criteria, study details, and AI-specific aspects (MRMC, standalone algorithm) is not applicable or cannot be extracted from this document.

Here's a breakdown of the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a formal table of acceptance criteria with corresponding performance metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable if it is equivalent to the legally marketed predicate devices.

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

• Sample size for the test set: Not explicitly stated. The document mentions "Side-by-side testing of the CAREO Safety Syringe Icc/mL and the 1cc SafePro* Safety Syringe" and "Simulated use testing," but does not specify the number of syringes or tests conducted.
• Data provenance: Not explicitly stated. It is implied that the testing was conducted by or for Life-Shield Products, Inc. (Taiwan, R.O.C.). The nature of the testing (simulated use, side-by-side comparison) suggests it would be prospective data collection for the purpose of this submission.

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

• Number of experts: Not applicable. This type of device (a syringe) typically does not involve expert-reviewed "ground truth" in the way an imaging diagnostic device would. Performance is assessed through engineering tests and simulated use.
• Qualifications of experts: Not applicable.

4. Adjudication method for the test set:

• Adjudication method: Not applicable. As there are no "experts" establishing a subjective ground truth, there is no need for an adjudication method like 2+1 or 3+1. Performance is based on objective measurements and observations during testing.

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:

• MRMC study: No. This is a physical medical device (syringe), not an AI diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable.

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

• Standalone algorithm performance: No. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• Type of ground truth: Not applicable in the context of expert consensus or pathology for diagnostic interpretation. For this device, the "ground truth" for performance is established by objective engineering specifications, observed mechanical functionality in simulated use, and compliance with relevant standards. The primary "ground truth" for regulatory approval is the performance and characteristics of the legally marketed predicate devices, against which substantial equivalence is claimed.

8. The sample size for the training set:

• Sample size for the training set: Not applicable. This document does not describe the development or training of an AI algorithm; it is for a physical medical device.

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

• Ground truth for the training set: Not applicable.

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The CAREO Safety Syringe is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into a patient. The syringe should not be used for blood collection.

The CAREO Safety Syringe aids in the prevention of needlestick injuries. In addition, when the user breaks the plunger, the CAREO Safety Syringe reduces the possibility of syringe reuse.

The Life-Shield Products, Inc., CAREO Safety Syringe is a sterile, single use and disposable, 3, 5, 10 mL piston syringe, provided with a permanently attached needle in twelve product configurations. The CAREO Safety Syringe is similar in appearance, size, materials, operation, and purpose to the cited predicate device and other conventional single use, sterile, disposable syringes.

The provided 510(k) summary for the CAREO Safety Syringe describes several aspects of the device and its testing but does not explicitly state specific acceptance criteria or an overarching study designed to prove the device meets those criteria in the typical format of a clinical trial for AI/software devices. This document is from 2005, predating the widespread use and regulatory frameworks for AI-driven medical devices.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through various tests and conformity to standards.

Here's an attempt to extract and interpret the information based on the provided text, acknowledging that many requested fields may not be directly applicable or explicitly stated in this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit numerical acceptance criteria for performance metrics are not stated in the provided document, we infer them from the nature of the tests conducted and the claim of substantial equivalence. The "reported device performance" is a general statement about meeting specifications rather than specific metrics.

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

The document does not explicitly state the sample sizes for any of the described tests (physiochemical, biocompatibility, standard conformity, simulated use). It only mentions "Testing provided in this premarket notification includes..." The data provenance (country of origin, retrospective/prospective) is also not specified for these tests. Given the nature of a 510(k) for a physical medical device like a syringe, these tests would typically be laboratory or bench tests rather than clinical studies with human patient data.

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

This concept is not relevant or applicable to the type of device (a safety syringe) and the testing described in this 510(k) submission. "Ground truth" established by experts is typically associated with diagnostic AI/imaging devices.

4. Adjudication Method for the Test Set

Not applicable. The tests described are laboratory/bench tests, not clinical studies requiring expert adjudication methods like 2+1 or 3+1.

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

No. This type of study is specifically for evaluating the effectiveness of AI with human readers, typically in image interpretation. The device is a physical safety syringe, not an AI or imaging device.

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

No, this is not an AI or software algorithm. The "performance" relates to the physical and functional aspects of the syringe itself.

7. Type of Ground Truth Used

The "ground truth" for the tests mentioned (physiochemical, biocompatibility, standard conformity, simulated use) would be based on:

• Scientific principles and material properties for physiochemical compatibility.
• Established biological safety standards for biocompatibility.
• Recognized industry standards (e.g., ISO for medical devices) for standard conformity.
• Pre-defined performance specifications for simulated use testing.

It is not based on expert consensus, pathology, or outcomes data in a clinical sense for this device.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable, as there is no training set for this physical device.

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The CAREO Retractable Safety Syringe is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into a patient. The syringe should not be used for blood collection.

The CAREO Retractable Safety Syringe aids in the prevention of needlestick injuries. In addition, when the user breaks the plunger, the CAREO Retractable Safety Syringe reduces the possibility of syringe reuse.

The Life-Shield Products, Inc., CAREO Retractable Safety Syringe is a sterile, single-use and disposable, 3 mL piston syringe, provided with a permanently attached needle in eight product configurations. The CAREO Retractable Safety Syringe is similar in appearance, size, materials, operation, and purpose to the cited predicate device and other conventional single-use, sterile, disposable syringes.

Here's a breakdown of the acceptance criteria and study information for the Life-Shield Products, Inc. CAREO Ret retractable Safety Syringe, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria in a table format. Instead, it refers to "specifications" for the simulated use testing. However, it does provide a statement of performance against these implied criteria.

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

• Sample Size (Test Set): 500 syringes were used for the "Simulated use testing."
• Data Provenance: The document states the sponsor is "Life-Shield Products, Inc. 3F, No. 10, Wuchiuan 7th Rd Wugu Shiang Taipei 248 Taiwan, ROC". This suggests the data originates from Taiwan. The study is implicitly prospective as it involves new testing of the device.

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

The document does not mention the use of experts to establish a ground truth for the simulated use testing. The "ground truth" for this type of device likely relies on engineering specifications and direct observation of the device's mechanical function, rather than expert interpretation of data.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned, as the study described is a performance test against specifications, not a comparative study with subjective outcomes.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging devices where human interpretation is a key factor. This device is a medical instrument where performance is largely objective and mechanical.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The concept of "standalone" performance (algorithm only) is not applicable here as the device is a physical syringe, not an algorithm or AI. The simulated use testing can be considered a standalone performance assessment of the device itself (without human-in-the-loop in a comparative sense, but of course with a human operating the syringe in the simulation).

7. The Type of Ground Truth Used:

For the "Simulated use testing," the "ground truth" would be the engineering specifications and functional requirements for the syringe. The testing observed whether the syringe performed its intended actions (e.g., needle retraction, plunger breakage) correctly and consistently, as defined by its design specifications. For the "Side-by-side testing," the ground truth was the performance of the predicate device (SECUREGARD® Ret retractable Safety Syringe) against which the CAREO syringe was compared for equivalence.

8. The Sample Size for the Training Set:

The document does not mention a "training set" in the context of device development or testing. This term is typically used in machine learning or AI development. The testing described is for a physical medical device.

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

As there is no mention of a "training set" in the context of this device's testing, how its ground truth was established is not applicable.

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