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The EZYPOR® orbital implants are designed to fill the orbital cavity following enucleation, evisceration or during secondary implantation.

EZYPOR® orbital implants are high density polyethylene (UHMWPE) implants designed to fill the orbital cavity following enucleation, evisceration or during secondary implantation procedures. The polyethylene material has an open porosity structure of 40 to 60%. The implants are available in six diameter sizes, 12, 14, 16, 18, 20 and 22 mm. EZYPOR® orbital implants are supplied sterile and are sterilized by ethylene oxide.

This is a 510(k) summary for the EZYPOR® orbital implant, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study proving the device meets specific performance criteria through clinical trials. Therefore, much of the requested information about acceptance criteria for device performance in a clinical context, sample sizes for test sets, expert ground truth establishment, MRMC studies, and training set details are not applicable or available within this type of submission.

The document discusses non-clinical bench testing to ensure the device meets predefined specifications for its physical characteristics and biocompatibility.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified for non-clinical bench testing. Standard engineering and material testing practices would imply a sufficient number of units were tested to ensure consistency and meet statistical requirements for demonstrating product specifications.
• Data Provenance: Not explicitly stated, but assumed to be from internal testing conducted by FCI S.A.S. (France Chirurgie Instrumentation SAS). The testing is non-clinical/bench-level, so concepts like "country of origin of the data" in a clinical sense or "retrospective/prospective" studies do not apply.

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

• Not applicable. Ground truth for non-clinical bench testing is established by engineering specifications, material standards, and validated test methods.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods are typically for clinical studies where subjective interpretations might be involved. For bench testing, results are objectively measured against predefined specifications.

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 device is an orbital implant, not an AI-powered diagnostic tool requiring human reader studies.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• For non-clinical bench tests (diameter, mass, sphericity, porosity, resistance, biocompatibility, sterilization, shelf life), the "ground truth" is defined by pre-established engineering specifications, material standards (e.g., ISO standards), and validated test methodologies.

8. The 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. No training set is used for this device.

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The Durette ocular acrylic (PMMA) implants in 4 models are permanent implants that occupy the eye cavity when it becomes necessary to surgically remove the eye (enucleation), the contents of the eye sac (evisceration), or space left after the removal of another ocular implant (used as a secondary implant). It is used to replace volume and to impart motion and stability to the eventual ocular prosthesis.

The Durette implant is a quasi-spherical ocular implant made in 4 models for variations in anterior surface. Each has a permanent smooth surface and many tunnels to allow direct suturing of the muscles. These 20 interconnected tunnels, all situated in the anterior 3rd of the implant, allow tissue integration or ingrowth to help stabilize the implant. Each has an off-center elongation.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Durette ocular implant (K123764):

Summary of Device and Context:
This 510(k) submission (K123764) is for a Durette ocular implant, a Class II device (21 CFR 886.3320). The submission is not for a new device concept but rather for changes to a previously cleared device (K073293). The primary changes are:

1. Welding process: Moving from laser welding (which used a liquid that left a dry residue) to ultrasonic welding (which uses PMMA only).
2. Packaging: Simplified and clearer.
3. Labeling: Revised instructions for use.

The submission explicitly states: "This change does not affect the indication for use, and does not alter the fundamental scientific technology of the device." Since the device is 100% acrylic, biocompatibility issues from the material itself are considered clear. The new welding process was validated for safety and effectiveness over a long period.

No clinical or comparative effectiveness study involving human readers or AI was performed or required for this 510(k) submission. The core of the submission revolves around demonstrating that the changes to the manufacturing process and packaging do not negatively impact the performance of the device, which is already established as substantially equivalent to its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for manufacturing and labeling changes to an existing, predicate device, the "acceptance criteria" are not framed in terms of clinical performance metrics like sensitivity, specificity, or accuracy for an AI system. Instead, they relate to standard manufacturing, sterilization, and material safety parameters to ensure the modified device remains as safe and effective as the predicate.

The table below reflects the relevant parameters explicitly mentioned and the "reported performance" indicates how the new device aligns with these implicit or explicit criteria.

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

• Test Set Sample Size: Not explicitly stated as a distinct "test set" in the context of clinical performance data. The nonclinical tests (bioburden, endotoxin, sterilization validation) would have involved samples from manufacturing batches. The document does not specify the number of units tested for these validations.
• Data Provenance: The studies are nonclinical manufacturing and sterilization validation tests conducted by the manufacturer, Oculo Plastik, in Montreal, Quebec, Canada. These are retrospective in the sense that they are validations conducted on the redesigned product before market release.

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

• Not Applicable. This submission does not involve clinical studies requiring expert-established ground truth for a diagnostic or AI device. The "ground truth" here is compliance with engineering, material, and sterilization standards.

4. Adjudication Method for the Test Set

• Not Applicable. No human adjudication of clinical data was performed as part of this 510(k) submission.

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

• No. An MRMC study was not done. This device is an ocular implant, not a diagnostic imaging device or an AI-assisted diagnostic tool. Therefore, comparing human reader performance with and without AI assistance is irrelevant and was not performed.

6. Standalone (Algorithm Only) Performance Study

• No. This device is a physical medical implant made of PMMA, not a software algorithm. Therefore, no "standalone" algorithm performance study was done.

7. Type of Ground Truth Used

The "ground truth" in this context is based on:

• Biocompatibility Standards: PMMA's established biocompatibility in ophthalmology.
• Sterilization Standards: Compliance with recognized international and national standards (ISO 11135-1, AAMI ST72, AAMI TIR12:2010 for Ethylene Oxide sterilization).
• Quality Control Metrics: Bioburden and endotoxin specifications for manufactured products.
• Material Safety Standards: ISO 10993-5, ISO 10993-7.
• Risk Management Standards: ISO 14971.

8. Sample Size for the Training Set

• Not Applicable. This is not an AI or machine learning device. There is no concept of a "training set."

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

• Not Applicable. As there is no training set, there is no ground truth established for it.

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Ceramisys synthetic orbital implants of either hydroxyapatite or alumina oxide (alumina) are indicated for orbital implantation at the time of enucleation or evisceration of the natural eyeball. They may also be indicated for secondary implantation where extrusion, migration or other malfunction of the primary orbital implant has occurred.

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding "Ceramisys Synthetic Orbital Implants." It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance metrics.

The letter is an administrative notice approving the device for marketing and mentions the indications for use, but it does not include data from performance studies. Therefore, I cannot provide the requested information based on the provided text.

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Silicone eye sphere implants are permanent implants that occupy the eye cavity when it becomes necessary to surgically remove the eye (enucleation), the contents of the eye sac (evisceration), or the space left after the removal of another ocular implant (used as a secondary implant). It is used to replace volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis.

Silicone eye sphere implants are permanent implants that occupy the eye cavity when it becomes necessary to surqically remove the eye (enucleation), the contents of the eve sac (evisceration), or the space left after the removal of another ocular implant (used as a secondary implant). It is used to replace volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis. Silicone eye spheres have been used for decades and still are. As for any implant, spheres are single use. Users are ophthalmologists who are very qualified to use eve spheres. Furthermore, we provide instructions for use with each device. These instructions include: Description, Appearance, Indications, Silicone sphere, Mode of action, Contra-indications, Adverse effects, Recommendation for use, Precautions for use. They are available by units in a wide range of sizes, from 12 to 22mm.

This 510(k) premarket notification is for a Special 510(k), indicating a modification to an already cleared device, not a new device submission requiring extensive clinical studies to establish primary performance. The main change is the material grade and supplier for the silicone, along with labeling and packaging changes.

Therefore, the submission does not contain a traditional performance study comparing the device against acceptance criteria in the way a novel device might. Instead, the "study" demonstrating that the device meets the acceptance criteria is primarily biocompatibility testing to show the new material is equivalent to the old.

Here's an analysis based on the provided text, addressing your points:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a Special 510(k) for a material change, the "acceptance criteria" are primarily established by demonstrating equivalence to the predicate device and ensuring the new material does not introduce additional risks. The performance is largely implied as "same" or "equivalent" to the predicate, with specific biocompatibility tests performed.

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

• Sample Size: Not explicitly stated for the biocompatibility tests. It would typically involve a certain number of test specimens of the new silicone material.
• Data Provenance: The biocompatibility tests were performed by the silicone manufacturer and by Oculoplastik on the finished device. The location of these labs (e.g., country) is not specified. The studies are most likely retrospective in the sense that they are laboratory tests on manufactured materials, not prospective patient studies.

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

• Not Applicable. For a material change and biocompatibility testing, ground truth is established through standardized laboratory test protocols (e.g., ISO standards for biocompatibility), not through expert consensus on interpretation of, for example, medical images. The "ground truth" is the result of the physical/chemical/biological tests.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical image interpretation studies where there is subjective human assessment. This submission concerns laboratory testing of material properties. The results of the biocompatibility tests would be considered objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No. An MRMC study is relevant for assessing human reader performance, particularly with AI assistance. This submission does not involve AI or human interpretation of medical cases.

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

• No. This device is a passive silicone implant and does not involve any algorithm or software. The submission explicitly states "No software involved for this device."

7. The Type of Ground Truth Used

• Laboratory Test Results (Biocompatibility): The "ground truth" for the new material's equivalence is established by the results of standardized biocompatibility tests (e.g., cytotoxicity, sensitization, irritation, acute systemic toxicity), which compare the new material's biological response to known safe materials or to the predicate device's material.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" as this device does not involve machine learning or AI.

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

• Not Applicable. As there is no training set.

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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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Eye Spheres are permanent implants that occupy the eye cavity when it has become necessary to surgically remove the eye (enucleation) or the contents of the eye sac (evisceration)

Conformers are temporary devices which maintain the shape of the eye and prevent closure or adhesion during the healing process

When an eye is severely damaged by trauma or disease, it may be necessary to remove it surgically. The most common procedures are evisceration (removal of the contents of the eye) or enucleation (removal of the eye itself). Eye spheres are permanent implants to occupy the cavity that results from surgery. Conformers are temporary devices, which maintain the shape of the eye and prevent closure or adhesion during the healing process. When healing is complete, conformers are replaced with prosthesis. Eye Spheres and Conformers are made of polymethylmethacrylate (PMMA), a hard, clear plastic that is lightweight, inert and virtually unbreakable. Eye spheres are available in even diameters from 10mm through 22mm. Conformers are available in three sizes: small, medium, large. Conformers may be ordered with or without holes. Eye spheres and Conformers are FDA Class II products.

The provided text is a 510(k) summary for Product and Educational Services LLC's Eye Spheres and Conformers. This document describes the device, its intended use, and its substantial equivalence to legally marketed predicate devices. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The core of this submission is demonstrating "substantial equivalence" to existing devices, not presenting novel performance data against pre-defined acceptance criteria. The document states:

• "Product and Educational Services LLC (PES) Eye Spheres and Conformers are the same Eye Spheres and Conformers manufactured and marketed by Gulden Ophthalmics as 'non sterile'."
• "The only difference is that PES will be providing the same Eye Spheres and Conformers as sterile, single use devices."
• "Gulden Ophthalmics Eye Spheres and Conformers are 'preamendment' devices."

Therefore, the submission relies on the established safety and effectiveness of the predicate Gulden Ophthalmics devices, with the primary "non-clinical test" being a comparison of technological characteristics as shown in the table on page 2, and the change in sterilization method.

Regarding the specific questions you asked, the document does not provide the requested information because it describes a 510(k) submission based on substantial equivalence, not a performance study against acceptance criteria.

Here's a breakdown of why each point cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The submission focuses on technological characteristics comparison with predicate devices.
2. Sample size used for the test set and the data provenance: No test set data is provided. The document implies no new performance testing (beyond sterilization validation, which is not detailed here) was conducted to demonstrate equivalence for the device itself, as it's the "same" as the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no test set described for performance evaluation.
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 device is an ophthalmic implant/conformer, not a diagnostic AI system involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no performance study data is presented.
8. The sample size for the training set: Not applicable, as there is no mention of a training set for an AI model.
9. How the ground truth for the training set was established: Not applicable.

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The Durette ocular acrylic (PMMA) implants in 4 models are permanent implants that occupy the eye cavity when it becomes necessary to surgically remove the eye (enucleation), the contents of the eye sac (evisceration), or space left after the removal of another ocular implant (used as a secondary implant). It is used to replace volume and to impart motion and stability to the eventual ocular prosthesis.

The Durette Implant is an acrylic (PMMA) ocular implant available in 4 models. It is quasi-spherical with a smooth surface and a network of 20 interconnected tunnels in the anterior third for suturing muscles and tissue ingrowth. Each model has a slight off-center medial elongation. The models vary in the amount of anterior surface detail, ranging from as spherical as possible with a slight double radius front (#1), to having minute details (#2), low mounds (#3), and still higher mounds (#4). The implants are molded in 2 parts and welded together.

The provided text describes a 510(k) submission for the Durette Implant, an ocular acrylic implant. However, it does not contain information about specific acceptance criteria, a clinical study proving performance against those criteria, or the detailed aspects of a study typically requested (e.g., sample sizes for test/training, expert qualifications, adjudication methods for ground truth, MRMC studies, or standalone performance evaluation).

Instead, the document focuses on:

• Device Description: Explaining the design, materials, and function of the Durette Implant, emphasizing its four models and features like tunnels for suturing and tissue ingrowth.
• Substantial Equivalence Claim: Comparing the Durette Implant to existing predicate devices (e.g., Allen implant, Iowa implant, Universal implant, acrylic sphere implants) based on common characteristics (material, smooth surface) and distinguishing features (quasi-spherical design, tunnels for suturing/ingrowth, suitability for evisceration and secondary implantation).
• Non-Clinical Tests: Mentioning internal quality assurance (ISO 13485, ISO 9000), mold tests for tunnel specifications, and pull-tests for welding integrity.
• Absence of Clinical Data: Explicitly stating that "No clinical trials were made with this estimated equivalent implant device" and that "It is not felt any clinical trials would be needed, as this implant is rather a consolidation of all previously used implants..."

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance based on a study, nor can I provide information on sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance, as these were not part of the 510(k) submission for this particular device. The FDA approved the device based on its substantial equivalence to predicate devices, without requiring new clinical trials for this specific submission.

The ground truth for the predicate devices would have been established through their long-standing clinical use and acceptance in the ophthalmology field. For the Durette implant itself, the "proof" of meeting criteria was established through its similarity to already approved devices and the non-clinical tests described.

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The MEDPOR ATTRACTOR Implant is intended for patients who require replacement of volume of an enucleated or eviscerated orbit and who wish to gain improved prosthetic eye motility by coupling the MEDPOR ATTRACTOR Implant to the prosthetic eye.

MEDPOR Orbital Implant made of porous polyethylene with a titanium nitride coated stainless steel screw or insert. The screw or insert acts as an attractor to a magnet that is embedded into the posterior of a prosthetic eye. The magnets are gold plated and designed small enough to remain entirely within the prosthesis material of the prosthetic eye, and powerful enough to provide a coupling force between the implant and the prosthesis.

Due to the nature of the provided document, which is a 510(k) summary for a medical implant and not a study report, it does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of the requested AI/algorithm-related metrics.

This document describes a physical medical device (an orbital implant with a magnetic component), not a software algorithm or AI device. Therefore, the concepts of "test set," "ground truth," "training set," "experts," "adjudication," "MRMC study," and "stand-alone algorithm performance" as typically applied to AI/ML device evaluations are not applicable to the information provided.

The document primarily focuses on:

• Device Description: What the device is and how it works (a magnetic orbital implant to improve prosthetic eye motility).
• Indications for Use: For whom the device is intended and its purpose.
• Substantial Equivalence: A comparison to legally marketed predicate devices to establish that the new device is as safe and effective.

Therefore, I cannot extract the requested information in the format of the provided table and subsequent bullet points because the source material does not contain it.

If you have a document describing an AI/ML medical device study, I would be happy to analyze it for the requested criteria.

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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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The AlphaSphere Orbital Implant is intended to replace orbital volume after loss of an eye through enucleation or evisceration, including secondary implantation after removal of an existing, unsatisfactory, orbital implant. The device is indicated in any situation where silicone, acrylic, polyethylene, coral, glass, or other traditional orbital implants are used.

The AlphaSphere Orbital Implant is aspherical orbital volume replacement prosthesis with a posterior gel hemisphere resistant to tissue ingrowth and an anterior hemisphere with a spongy outer surface designed to encourage tissue attachment. The implant is made entirely of a flexible hydrogel, poly (2-hydroxyethyl methacrylate). (PHEMA). The physical differences between the gel and spongy portions of the implant are created by varying the conditions during the hydrogel polymerization process. The transition between the two hydrogel regions is reinforced with a biocompatible synthetic mesh (MERSILENE) beneath the device surface to improve mechanical strength for the passage of sutures.

Here's an analysis of the provided text regarding the AlphaSphere Orbital Implant, focusing on the acceptance criteria and the study used to demonstrate its performance:

Summary of Acceptance Criteria and Device Performance

It is important to note that this 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices rather than setting and meeting specific quantitative acceptance criteria for the new device's performance. The "acceptance criteria" here are implicitly tied to the safety, efficacy, and performance of the predicate devices and the AlphaSphere Orbital Implant's ability to demonstrate similar outcomes.

Detailed Study Information:

1. Sample Size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • AlphaSphere Study: 8 rabbits. The study was prospective as it involved implanting devices and then monitoring them over time. The country of origin for the study is not explicitly stated, but the applicant's address is in Australia.
   • Predicate MEDPOR Study (for comparison): 10 rabbits. This was also a prospective animal study. Country of origin not explicitly stated.

2. 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):

   • The studies mentioned (Hicks et al. for AlphaSphere and Jordan et al. for MEDPOR) involved animal models and histological examination.
   • AlphaSphere: The "ground truth" was established through gadolinium-enhanced Magnetic Resonance Imaging (MRI) and subsequent histopathology (light and electron microscopy) evaluation of the implants after sacrifice. The number and qualifications of the experts performing these assessments (e.g., veterinary radiologists, pathologists) are not specified in the provided text.
   • MEDPOR: The "ground truth" involved histopathology to evaluate implant vascularization. The number and qualifications of the experts are not specified.

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

   • The provided text does not describe an adjudication method for establishing ground truth in terms of expert consensus or arbitration. For animal studies with histological and imaging assessments, it's typical for a pathologist/radiologist to interpret findings, but no explicit adjudication process among multiple experts is detailed.

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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an orbital implant, not an AI-assisted diagnostic tool, so such a study would not be applicable.

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

   • Not applicable. This is a physical medical device, not an algorithm.

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

   • For the animal studies, the "ground truth" for assessing device performance (tissue integration, muscle attachment, complications) was primarily based on histopathology (microscopic examination of tissues) and imaging (gadolinium-enhanced MRI for AlphaSphere). The ultimate "outcome data" was whether the implants were retained without complications and exhibited the desired biological responses.

7. The sample size for the training set:

   • Not applicable. This device is a physical implant, not a machine learning model. There is no "training set" in the context of AI. The development process involved prior research on the materials and prototypes, but this is not analogous to an AI training set.

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

   • Not applicable, as there is no training set in the AI sense. The developmental work and existing literature on PHEMA and Mersilene would have informed the design and expected performance, but this is not "ground truth" establishment for a training set.

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