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The Endotine Device is intended for use in browplasty surgery. The Endotine device is specifically intended for use to fixate the sub-dermis to the cranial bone in browplasty procedures.

The Endotine Device is a device fabricated from L-PLA that is intended for use in browplasty procedures. The device is molded with a post that is inserted directly into the cranial bone. A series of barbs along its face provides a feature that allows for the direct fixation the sub-dermis without the use of suture. The device is inserted into the bone with the use of an installation instrument. Additional instruments include a stepped drill and sterilization tray.

Here's an analysis of the provided text regarding the Endotine Device's acceptance criteria and studies:

The provided document is a 510(k) summary for the Coapt Systems Endotine Device, seeking substantial equivalence to a predicate device. It focuses on the device's design, intended use, and a high-level overview of performance data. This type of document typically does not contain detailed acceptance criteria or extensive study results as would be found in a full study report or clinical trial.

Based on the provided text, the following information can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for shear strength or adequacy. Instead, it relies on a comparison to the predicate device.

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

The document does not specify the sample sizes for the bench testing or animal testing.

• Data Provenance: Not explicitly stated, but "In-Vitro" implies laboratory testing, and "Animal Testing" refers to an animal model. The country of origin for the data is not mentioned. The nature of these tests (bench, animal) suggests they were prospective studies designed to evaluate the device.

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

This type of information is generally not applicable to bench or animal testing in the context of device performance directly related to mechanical properties or biological response in an animal model. Ground truth for these tests would be established through scientific measurements and observations, not expert consensus on human data.

4. Adjudication Method for the Test Set

Not applicable for bench or animal testing of mechanical properties and biological response.

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

No, an MRMC comparative effectiveness study was not done, nor would it be relevant for this type of device and the performance data presented. MRMC studies are typically used for diagnostic devices involving human interpretation of images or other data.

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

Not applicable. This device is a bioabsorbable fixation device, not an algorithm or AI system.

7. Type of Ground Truth Used

• Bench Testing: The ground truth would be precise engineering measurements of shear strength under defined conditions.
• Animal Testing: The ground truth would be a combination of direct observation of device function, histological analysis of tissue response, and possibly mechanical testing of the fixation in the animal model.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set." The materials and design are established through engineering principles.

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

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

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