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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 Facial Reconstructive Mesh is intended for use in plastic and reconstructive surgery of the face and head to provide soft tissue repair or reinforcement.

The FRM is a non-absorbable, inert, sterile, porous, surgical mesh composed of reinforcing woven polyester fabric, silicone elastomer and expanded polytetrafluoroethylene (ePTFE). This polymeric mesh is available in a range of lengths and widths to accommodate the surgical application.

The provided document is a 510(k) summary for a medical device called "Facial Reconstructive Mesh" (FRM). It details the device's description, intended use, indications for use, and a comparison to predicate devices, ultimately concluding that the FRM is substantially equivalent to existing devices.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC comparative effectiveness studies. The 510(k) summary focuses on demonstrating substantial equivalence based on the device's characteristics and its similarity to predicate devices, rather than on new performance data from a dedicated clinical study with acceptance criteria.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document implicitly claims that the device meets safety and effectiveness criteria because it is substantially equivalent to predicate devices that are already deemed safe and effective.

Here's why the specific information requested is missing from this type of document:

• 510(k) Premarket Notification: This is a submission pathway for medical devices that are "substantially equivalent" to an already legally marketed device (predicate device). The primary goal is to show similarity, not necessarily to conduct a new clinical study from scratch with fresh acceptance criteria and extensive performance data.
• Safety and Effectiveness: For 510(k)s, safety and effectiveness are often demonstrated by showing that the new device has the same technological characteristics and intended use as predicate devices, and that any minor differences do not raise new questions of safety or effectiveness. This can involve bench testing (biocompatibility, biomechanical performance), but typically not large-scale clinical trials measuring performance against defined acceptance criteria in the way a PMA (Premarket Approval) submission would.

Information I can extract from the provided text, related to the request:

1. Acceptance Criteria and Reported Device Performance: Not explicitly stated in terms of numerical thresholds or metrics. The "performance" is implicitly tied to biocompatibility and biomechanical performance data which, according to the document, was provided in the 510(k) submission and demonstrated substantial equivalence to predicate devices. The conclusion states: "The results of these evaluations... support the conclusion that it is safe and effective for its intended use and that it is substantially equivalent to the cited predicate device(s) with regards to its safety and effectiveness." This means the "acceptance criterion" was effectively "substantially equivalent to predicate devices based on safety and effectiveness evaluations."

   Acceptance Criteria	Reported Device Performance
   Device is safe and effective for its intended use, and substantially equivalent to predicate devices (K851086, K013625, K952898, K971745).	"The safety and effectiveness evaluations based on biocompatibility and biomechanical performance data provided in this 510(k) demonstrate that the FRM is substantially equivalent to the cited predicate devices."

"The results of these evaluations of the FRM support the conclusion that it is safe and effective for its intended use and that it is substantially equivalent to the cited predicate device(s) with regards to its safety and effectiveness." |

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not provided. This type of detail would be expected from a clinical study, which is not described. The evaluations were based on biocompatibility and biomechanical performance data, which usually involves laboratory testing rather than human subject test sets.

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, as no human-expert-validated test set is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no human-expert-validated test set is described.

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. The device is a physical surgical mesh, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical surgical mesh.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for substantial equivalence was established by comparing the FRM's characteristics and performance (biocompatibility, biomechanical properties) to those of the predicate devices already on the market and considered safe and effective. This isn't a "ground truth" in the clinical data sense, but rather a regulatory benchmark.

8. The sample size for the training set: Not applicable, as no AI model or training set is mentioned.

9. How the ground truth for the training set was established: Not applicable, as no AI model or training set is mentioned.

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