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The ORI II is intended for augmentation or restoration in the craniofacial region.

The Orbital Reconstructive Implant II is indicated as an implant for augmentation, reconstruction, or restoration in and around the orbit of the eye, such as in reconstruction following orbital trauma or tumor excision, to treat orbital volume deficiencies, or in the correction of enophthalmos.

The Orbital Reconstructive Implant II (ORI II) is a non-absorbable, inert, sterile, porous, implant composed of porous silicone elastomer and expanded polytetrafluoroethylene (ePTFE). This polymeric implant is available in a range of lengths and widths to accommodate the surgical application and the needs of the individual surgeon practicing medicine.

The Orbital Reconstructive Implant II (ORI II) received 510(k) clearance based on demonstrating substantial equivalence to predicate devices through
non-clinical performance testing and biocompatibility evaluation.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not specified. The study involved bench testing of the Orbital Reconstructive Implant II (ORI II). This refers to a series of laboratory tests conducted on the device itself, rather than testing on biological samples or human patients.
• Data Provenance: The data is from non-clinical performance testing (bench testing) and biocompatibility evaluation. There is no information regarding the country of origin of the data as it's not clinically collected patient data. It is inherently prospective in the sense that the device was manufactured and then tested according to established protocols.

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

• This information is not applicable as the study is based on laboratory bench testing and biocompatibility assessment, not interpretation of clinical data or images by experts to establish a "ground truth" for diagnostic accuracy. The "ground truth" for mechanical properties is typically derived directly from the physical measurements themselves. Biocompatibility ground truth is established by standardized toxicity tests.

4. Adjudication Method for the Test Set:

• This information is not applicable as the study does not involve human readers interpreting data or making subjective judgments that would require adjudication. The testing methods are objective measurements of physical and chemical properties.

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:

• This information is not applicable as the device is an implant, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC comparative effectiveness study was performed.

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

• This information is not applicable as the device is an implant, not an algorithm or AI system.

7. The type of ground truth used:

• The "ground truth" in this context is based on objective measurements of physical properties (e.g., tensile strength, elongation, modulus) obtained through standardized engineering test methods (e.g., ASTM-D624, ASTM-D1777, ASTM-F88, ASTM-D412, ASTM-D3787).
• For biocompatibility, the ground truth is established by adherence to the ISO-10993 standard, specifically the long-term implant section, which involves standardized biological assessments to determine the device's compatibility with living tissues.

8. The sample size for the training set:

• This information is not applicable as the device is an implant and does not involve machine learning or an algorithm that requires a training set.

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

• This information is not applicable for the same reason as above; there is no training set for this type of device submission.

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The ORI is intended for augmentation or restoration and to separate tissues. The Orbital Reconstructive Implant is indicated as an implant for augmentation, reconstruction, or restoration in and around the orbit of the eye, such as in reconstruction following orbital trauma or tumor excision, to treat orbital volume deficiencies, or in the correction of enophthalmos. The ORI is also indicated as a temporary device to maintain the shape of the eye and prevent closure or adhesion during the postoperative period.

The ORI is a non-absorbable, inert, sterile, porous, surgical implant composed of silicone elastomer and expanded polytetrafluoroethylene (ePTFE). If desired, the thickness of the ORI can be augmented by adding a small volume of saline prior to implantation. This polymeric implant is available in a range of lengths, widths and thicknesses to accommodate the surgical application and the needs of the individual surgeon practicing medicine.

The provided text describes a 510(k) submission for the Orbital Reconstructive Implant (ORI), which is a medical device. This document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets specific performance acceptance criteria through a clinical study.

Therefore, the input document does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

The document states:

• "The safety and effectiveness evaluations based on biocompatibility and biomechanical performance data provided in this 510(k) demonstrate that the ORI is substantially equivalent to the cited predicate devices."
• "The results of these evaluations of the ORI support the conclusion that it is safe and effective for its intended use and that it is sub- stantially equivalent to the cited predicate device(s) with regards to its safety and effectiveness."

This indicates that the submission relies on demonstrating similarity to already approved devices (predicates) in terms of materials, intended use, and general characteristics, along with biocompatibility and biomechanical performance data, rather than a clinical study establishing specific quantitative or qualitative performance metrics against predefined acceptance criteria for a new clinical application or diagnostic capability.

To answer your specific questions:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text. The submission focuses on demonstrating substantial equivalence, not on meeting specific quantitative or qualitative performance acceptance criteria from a clinical trial.
2. Sample size used for the test set and the data provenance: Not applicable, as no clinical "test set" study is described in this document. The evaluations mentioned are likely pre-clinical (biocompatibility, biomechanical).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method 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 a medical implant, not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is an implant, not an algorithm.
7. The type of ground truth used: Not applicable in the context of a clinical performance study. The "ground truth" for this 510(k) is the regulatory acceptance of the predicate devices.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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