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The MEDPOR CONTAIN CAN Implant is intended to stabilize, support and provide space maintenance for bone graft materials in the maxilla, mandible and zygoma.

The purpose of this Special 510(k) is to add the CAN configuration to MEDPOR CONTAIN Implants. The MEDPOR CONTAIN CAN Implant is a cylinder shaped, thin walled, highly porous, implant that is closed on one end and open on the other. It is made from the same biocompatible pure porous high-density polyethylene (pHDPE) material as MEDPOR CONTAIN Implants in sheet form. Like the sheet configuration, the CAN is non-resorbable, allows for host integration and is designed to stabilize and support bone graft materials and provide space maintenance necessary for regenerative healing. The CAN configuration will minimize the need for the surgeon to shape the MEDPOR CONTAIN Sheet Implant, which will reduce the time required for performing the procedure and reduce the possibility of introducing contaminants or debris to the surgical site.

The provided text is a 510(k) Summary for the MEDPOR® CONTAIN™ CAN Implant. This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

This document describes a medical device clearance process based on substantial equivalence, not a study designed to prove the device meets specific acceptance criteria through measured performance.

Therefore, most of the requested information (acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) cannot be extracted from the provided text. The text focuses on comparing the new device's characteristics to a predicate device to establish substantial equivalence, rather than detailing performance studies with specific metrics.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Cannot be answered from the provided text. The document does not describe specific acceptance criteria (e.g., a target accuracy or sensitivity) for the "MEDPOR® CONTAIN™ CAN Implant" nor does it report performance data against such criteria. The submission is for substantial equivalence to a predicate device. The "Safety & Effectiveness" row in the Substantial Equivalence Matrix states "No changes in function and intended use," implying that its safety and effectiveness are considered equivalent to the predicate without needing new performance metrics to be proven.

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

• Cannot be answered from the provided text. There is no mention of a "test set," "sample size," or data provenance, as a performance study of the device against specific metrics was not presented in this 510(k) summary.

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)

• Cannot be answered from the provided text. There is no mention of experts or ground truth establishment for a test set.

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

• Cannot be answered from the provided text. There is no mention of adjudication or a test set.

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

• Cannot be answered from the provided text. This device is an implantable medical device, not an AI or diagnostic imaging device that would typically involve human readers or MRMC studies.

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

• Cannot be answered from the provided text. This device is an implant, not an algorithm.

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

• Cannot be answered from the provided text. There is no mention of a "ground truth" as it pertains to a performance study for this device. The "ground truth" in this context would likely refer to the established safety and efficacy of the predicate device.

8. The sample size for the training set

• Cannot be answered from the provided text. There is no mention of a "training set" as this is not an AI/machine learning device. The "training" for such a device would refer to its manufacturing and design process.

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

• Cannot be answered from the provided text. As above, there is no mention of a "training set" or "ground truth" in the context of typical AI/ML studies.

Summary of what can be extracted from the text, relevant to the inquiry's spirit of evaluating the device:

The "study" presented here is a substantial equivalence comparison to a predicate device, as required for a 510(k) submission.

Predicate Device: MEDPOR CONTAIN Implant (K091120)

Basis of Equivalence: The MEDPOR CONTAIN CAN Implant is deemed substantially equivalent based on:

• Intended Use: Identical - to stabilize, support, and provide space maintenance for bone graft materials in the maxilla, mandible, and zygoma.
• Material: Identical - Linear high-density polyethylene biomaterial.
• Function and Design Principles: Substantially equivalent. The new "CAN" configuration (cylinder) is designed to minimize the need for the surgeon to shape the implant, compared to the predicate's "Sheet" configuration.
• Manufacturing and Sterilization: Manufactured, packaged, labeled, and sterilized the same as other MEDPOR CONTAIN Implants.

Key Differences and Why They Don't Jeopardize Equivalence (as implied by clearance):

• Shape: New device is Cylinder (Can), predicate is Flat (Sheet).
• Diameter: New device has specified diameters (8, 9, 10 mm), predicate is not applicable for this dimension.
• Thickness: New device is 0.40 mm, predicate devices were 0.25, 0.35, 0.45 mm. The new thickness is within the range of the predicate, and the change is considered minor in this context.

Conclusion from the document: The FDA determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. This determination is based on the information provided regarding the device's characteristics and comparison to the predicate, not on new performance data demonstrating specific acceptance criteria.

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The MEDPOR Fixation System - Cranial is intended for use in cranial surgery to fixate MEDPOR cranial implants to the surrounding cranial skeleton.

The MEDPOR Fixation System - Cranial is a plate and screw system to be used in Cranial Surgery. The components that comprise the system are composed of titanium plates. titanium alloy bone screws, titanium alloy implant screws, and surgical stainless steel instruments for the installation of the plates and screws. The plates are manufactured of grade 4 titanium and adhere to the American Society of Testing Materials (A.S.T.M.) F67 Standard. The bone and implant screws are manufactured of 6-4 ELI titanium that meets the ASTM F136 standard. The implant screws are designed to be used with MEDPOR polyethylene implants manufactured by Porex Surgical under K832283. K922489. K952677, K040364 and K083621. The screws and plates have been color anodized for ease of use by a surgeon. The blue anodized side of the plate corresponds to the blue anodized bone screw and the magenta anodized side of the plate corresponds to the magenta anodized implant screw. The MEDPOR Fixation System -- Cranial is sterilized by ethylene oxide sterilization. The instruments and unused components can be resterilized via steam sterilization.

This document is a 510(k) premarket notification for the MEDPOR® Fixation System - Cranial. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed acceptance criteria and a study to prove device performance against those criteria. In the context of a 510(k) submission for a device like plates and screws, the "acceptance criteria" are generally related to demonstrating that the new device is as safe and effective as existing legally marketed devices (predicate devices) and that any differences do not raise new questions of safety or effectiveness.

Therefore, the requested information elements (1-9) which typically relate to performance studies for novel or significantly modified devices, are not explicitly provided in this 510(k) summary. A 510(k) does not usually include a formal "study" with stated acceptance criteria and device performance results in the same way a PMA or de novo submission might. Instead, it relies on comparisons to predicate devices and adherence to established material standards and manufacturing practices.

Here's a breakdown of what can be extracted and what is not applicable or stated:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as pass/fail criteria from a specific performance study in this 510(k) summary. The acceptance criteria for a 510(k) is generally the demonstration of "substantial equivalence" to predicate devices, meaning the new device has "similar technological characteristics" and "same intended use."
• Reported Device Performance: No specific performance metrics (e.g., tensile strength, fatigue life, etc.) are reported with numerical values in this summary. The submission implies that the material and design choices (titanium, specific alloys) meet established standards (ASTM F67, ASTM F136), which are themselves forms of performance criteria.

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

• Not applicable as no specific device performance testing study with a "test set" and "data provenance" is detailed in this 510(k) summary. The comparison is primarily against the characteristics of predicate devices.

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

• Not applicable as there is no "test set" ground truth established by experts in the context of this 510(k) summary. Substantial equivalence is assessed by regulatory reviewers based on design, materials, and intended use.

4. Adjudication method for the test set

• Not applicable for the same reasons as #3.

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 device for surgical fixation, not an AI or imaging diagnostic device.

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

• Not applicable. This is a medical device for surgical fixation, not an algorithm.

7. The type of ground truth used

• The "ground truth" for a 510(k) submission for this type of device is the evidence that the device's technological characteristics (materials, design, sterilization) and intended use are substantially equivalent to legally marketed predicate devices, which are themselves considered safe and effective. The reference to conformity with ASTM standards (F67 and F136) serves as a form of "ground truth" for material properties.

8. The sample size for the training set

• Not applicable as there is no "training set" in the context of this 510(k) submission. Design and manufacturing are based on established engineering principles and material standards.

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

• Not applicable for the same reasons as #8.

Summary based on the provided document:

The provided document is a 510(k) Summary. For devices like the MEDPOR® Fixation System - Cranial, the "acceptance criteria" are intrinsically linked to demonstrating substantial equivalence to predicate devices already on the market. The "study" proving this largely involves a comparison of technological characteristics (materials, design, indications for use, sterilization) and adherence to recognized standards.

Table of Acceptance Criteria (Implied by Substantial Equivalence) and Reported Features:

Explanation of Study (Substantial Equivalence Demonstration):

The "study" in this context is the detailed comparison provided in the "Substantial Equivalence" section and the comparative table on page 2 of the document. This comparison directly addresses how the MEDPOR Fixation System - Cranial aligns with the identified predicate devices:

• Comparison of Intended Use: The document argues that the intended use of the MEDPOR system (fixating cranial implants to the cranial skeleton) is comparable to the broad craniofacial, cranial, and reconstructive procedures of the predicate devices.
• Comparison of Materials: The use of specific titanium grades (CP 4 Titanium for plates, 6-4 ELI Titanium Alloy for screws) is stated to meet ASTM standards F67 and F136, respectively. The document highlights that titanium has a "long history of use in surgical implantable products" and that these materials are consistent with most predicate devices (Predicate Device #1 is an exception, being bioabsorbable).
• Comparison of Technological Characteristics: The document states that the "technological characteristics of the design are substantially equivalent to the predicate devices and any slight differences do not raise new issues of safety and effectiveness." This includes design as a plate and screw system, dedicated instrumentation, and sterilization methods.

Missing/Not Applicable Information:

• Sample Size for Test Set/Training Set: Not applicable for a 510(k) based on substantial equivalence comparison of device characteristics.
• Data Provenance: Not applicable.
• Experts/Ground Truth for Test/Training set: Not applicable in the sense of clinical study experts. The "ground truth" hinges on the established safety and effectiveness of the predicate devices and conformity to recognized standards.
• Adjudication Method: Not applicable.
• MRMC or Standalone AI Study: Not applicable as this is not an AI/diagnostic device.

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The Porex Fixation System for maxillofacial surgery is intended for rigid fixation in the repair of maxillofacial fractures and in maxillofacial reconstruction. The Porex Fixation System For Maxillofacial Surgery is intended for single use.

The Porex Fixation System is a plate and screw system to be used in maxillofacial surgery and is provided in various configurations. The components that comprise the systems are composed of unalloyed titanium plates, titanium alloy bone screws and surgical stainless steel instruments for the installation of the screws. The plates are manufactured of grade 4 titanium and adhere to the American Society of Testing Materials (A.S.T.M.) F67 standard. The screws are manufactured of 6-4 ELI titanium that meets the A.S.T.M F136 standard. The screws are provided in 1.5mm diameter and 4mm length. The rescue screws are green color annodized and provided in 1.8mm diameter and 4mm length. The Porex Fixation Systems are sterilized by ethylene oxide sterilization.

The provided document is a 510(k) summary for the Porex Fixation System for Maxillofacial Surgery. It details the device description, indications for use, and a statement of substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document focuses on regulatory approval based on substantial equivalence rather than presenting performance study results or acceptance criteria for a new device.

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The MEDPOR CONTAIN Implant is intended to stabilize, support and provide space maintenance for bone graft materials in the maxilla, mandible and zygoma.

MEDPOR CONTAIN Implant is a thin, highly porous, biocompatible semi-rigid sheet, made from the same biocompatible pure porous high-density polyethylene (pHDPE) material which allows for host tissue integration as other MEDPOR Surgical Implants. The MEDPOR CONTAIN Implant is designed to stabilize and support bone graft materials and provide space maintenance necessary for regenerative healing.

The provided document is a 510(k) summary for the MEDPOR® CONTAIN™ Implant. It describes the device, its intended use, technological characteristics, and compares it to predicate devices to establish substantial equivalence.

Crucially, this document is a premarket notification for a medical device and does not contain a study or data proving the device meets acceptance criteria. Instead, it is a submission to the FDA demonstrating that the new device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use and similar technological characteristics, and raises no new questions of safety or effectiveness.

Therefore, many of the requested sections, such as acceptance criteria, reported device performance, sample sizes, ground truth establishment, and details of comparative effectiveness studies (MRMC or standalone), cannot be extracted from this document, as they are not present.

However, I can provide information based on what is available regarding the comparison to predicate devices, which is the basis for its clearance.

1. A table of acceptance criteria and the reported device performance

This document does not specify "acceptance criteria" in the typical sense of a performance study with numerical targets and results. Instead, it relies on demonstrating substantial equivalence to predicate devices based on intended use, material, design, sterilization, and biocompatibility.

The "reported device performance" in this context is implicitly the assertion that the MEDPOR CONTAIN Implant performs similarly to its predicates due to shared characteristics.

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. This document is a 510(k) premarket notification based on substantial equivalence to existing predicate devices, not a clinical study report with a test set. There are no "test sets" or "data provenance" details for a performance study in this submission.

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

Not applicable. As no performance study with a test set is reported, there is no "ground truth" established by experts within this document. The assessment is regulatory by the FDA based on the submission.

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

Not applicable. No test set or performance data is presented, so no adjudication method is relevant here.

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. A MRMC comparative effectiveness study is not discussed. This device is a passive implant, not an AI-powered diagnostic tool.

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

Not applicable. This device is a medical implant, not an algorithm, so this type of study is not relevant.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. No ground truth data from a performance study is utilized in this 510(k) summary. The "ground truth" for the FDA's decision is the established safety and effectiveness of the predicate devices to which the new device is compared.

8. The sample size for the training set

Not applicable. This document describes a medical device, not a machine learning model, so there is no concept of a "training set" in this context.

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

Not applicable. As there is no training set for a machine learning model, there is no associated ground truth establishment method.

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The MEDPOR Customized Surgical Implant is intended for the augmentation or restoration of bony contour in craniofacial defects.

MEDPOR Customized Surgical Implants. are prescription devices tailored to a patient's same hiocompatible nure nown his his mized Surgical Implants are made from the same biocompatible pure porous high-density polyethylene (pHDPE) material as all MEDPOR Surgical Implants. An advantage of (pHDPE) is that the surrounding body tissue grows into the porous matrix, so the implant becomes integrated with and stabilized in the host tissues.

This 510(k) premarket notification describes a medical device, the MEDPOR® Customized Surgical Implant, and seeks to demonstrate its substantial equivalence to a predicate device, the MEDPOR Surgical Implant Material; Preformed Cranial & Facial Implants.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity for a diagnostic device, or specific strength/durability for an implant). Instead, the acceptance criteria in this context are primarily focused on demonstrating substantial equivalence to a predicate device. This is a common approach for 510(k) submissions.

The table presented in the document itself serves as the core of this comparison:

Reported Device Performance:
The document doesn't report specific quantitative performance metrics for the customized implant that would be typically seen in a study evaluating a device's effectiveness or safety against numerical criteria. Instead, the performance is implicitly demonstrated by showing that the customized implant shares fundamental characteristics (material, intended use, sterilization, biocompatibility, etc.) with a legally marketed device known to be safe and effective. The key difference noted is the customization aspect (patient-specific shapes) and the associated absence of a "Non-Pyrogenic Claim" and a specific labeling change reflecting "not tested for endotoxin."

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

The provided documentation does not describe a clinical study or a test set in the traditional sense that would involve a sample size of patients or data for evaluation. The "study" here is a comparison of characteristics between the new device and the predicate device, not an empirical performance trial with a patient cohort. Therefore, concepts like sample size, country of origin, retrospective/prospective do not directly apply to this type of regulatory submission. The data provenance is primarily the design specifications and manufacturing information of the device itself and the predicate.

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)

This regulatory submission (510(k)) does not involve the establishment of a "ground truth" by experts in the context of a clinical study or algorithm evaluation. The "ground truth" for demonstrating substantial equivalence is the predicate device's known characteristics and regulatory clearance. The experts involved are primarily the manufacturer's R&D, regulatory, and quality assurance teams who have compiled the technical specifications and performed the comparison, and subsequently, the FDA reviewers who evaluate the submission. Their qualifications are not detailed here, but they would be regulatory and scientific experts.

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

As there is no clinical or performance test set described that requires expert review and adjudication, this information is not applicable to this document. The "adjudication" is the FDA's regulatory review process.

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 is not applicable. The device is an implant for craniofacial defects, not a diagnostic imaging device involving human readers or AI assistance.

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

This is not applicable. The device is a physical implant, not an algorithm.

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

As explained above, the "ground truth" in this context is the established characteristics and regulatory clearance of the predicate device. The manufacturer demonstrated that their new customized implant has substantially equivalent characteristics for safety and effectiveness.

8. The sample size for the training set

This is not applicable. The device is a physical implant, not an AI model that requires a training set.

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

This is not applicable as there is no training set for an AI model.

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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 Porex Electrosurgery Needle is an electrosurgery electrode for use in monopolar electrosurgical handpieces. It is a single-use device intended for cutting, dissecting, and cauterizing of soft tissue.

The Porex Surgical, Inc. Electrosurgery Needle is an electrosurgical electrode for use with monopolar electrosurgical accessories (cautery handpieces). It is constructed of a tungsten tip held by a gold plated stainless shaft/sleeve. The electrode shaft has two layers of insulation.

The provided text is a 510(k) summary for the Porex Electrosurgery Needle. It does not contain any information about acceptance criteria or a study proving device performance against those criteria. The document focuses on regulatory approval based on demonstrating substantial equivalence to predicate devices, rather than presenting performance data from a specific study against predefined acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them from the provided text.

Specifically, the document contains:

• Device Identification: Name, submitter, contact, common name, classification details.
• Predicate Device Identification: List of devices to which the Porex Electrosurgery Needle is considered substantially equivalent.
• Description: Physical construction details of the needle.
• Intended Use: How the device is designed to be used (cutting, dissecting, cauterizing soft tissue).
• FDA Correspondence: Letter from the FDA confirming the 510(k) clearance and substantial equivalence determination.
• Indications for Use: Formal statement of the device's intended applications.

There is no mention of:

1. A table of acceptance criteria or reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
6. Standalone algorithm performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for training sets.
9. How ground truth for training sets was established.

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The MEDPOR ATTRACTOR Magnetic Coupling System is indicated for patients who have a MEDPOR Ocular Implant, and wish to gain improved prosthetic eye motility by coupling the occular implant to the prosthetic eye.

Titanium nitride coated stainless steel screw, ATTRACTOR SCREW, is designed to be placed into the MEDPOR implant, so that the head of the screw is placed at the anterior appx of the implant as it site in the orbit. The flat head of the screw is flush with the surface of the implant and is covered with the verlying tissue. Magnets of appropriate material, shape, and size to be imbedded into the posterior of the prosthetic eye. The magnets are designed small enough to remain enlinely within the posterior of the prostinents and and any and a belgives onlike the sgrowing force between the imaterial (typically accylic) of the prosthelic eye, and powerful enough to provide a coupling force between th

The provided text describes a 510(k) premarket notification for the MEDPOR Attractor Magnetic Coupling System. It includes information about the device, its indications for use, and a study conducted to demonstrate its performance. Here's a breakdown of the requested information based on the text:

1. A table of acceptance criteria and the reported device performance

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MEDPOR Biomaterial with Embedded Titanium Mesh Implants are intended for non-weight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma.

This device is a MEDPOR/titanium mesh craniofacial implant available in three configurations: (1) A titanium mesh encapsulated within a thin coating of solid high density polyethylene. (2) A titanium mesh encapsulated within a MEDPOR Biomaterial porous polyethylene sheet with a nonporous barrier on one side. (3) A titanium mesh encapsulated within a MEDPOR Biomaterial porous polyethylene sheet.

The provided text is a 510(k) summary for the MEDPOR Craniofacial Implants with Embedded Titanium Mesh. This document focuses on establishing substantial equivalence to previously marketed predicate devices, rather than detailed performance studies against specific acceptance criteria. Therefore, the document does not contain the requested information about acceptance criteria, device performance, validation study details, or AI-related metrics.

Specifically, the document includes:

• Device Description: A description of the implant configurations (titanium mesh encapsulated in various MEDPOR biomaterials).
• Indications for Use: Non-weight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma.
• Predicate Devices: A list of devices to which the new device is considered substantially equivalent.

The document does NOT provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Information on experts used to establish ground truth or adjudication methods.
4. Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or AI assistance.
5. Information about standalone algorithm performance.
6. The type of ground truth used in any study.
7. Sample size for a training set.
8. How ground truth for a training set was established.

This is typical for 510(k) summaries which primarily aim to demonstrate substantial equivalence based on existing predicate device performance and material characteristics, rather than new comprehensive clinical or engineering validation studies against predefined acceptance criteria for novel performance claims.

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MEDPOR Surgical Implants in block, sheet and preformed shapes are intended for augmentation or restoration in the craniofacial region.

The devices of this submission are orbital volume replacement implants formed by blending Bioglass® Synthetic Bone Graft Particulate with the polyethylene used to produce MEDPOR Surqical Implant Material.

This document is a 510(k) summary for a medical device (MEDPOR® Plus Orbital Volume Replacement Implants) and, as such, it does not contain the type of detailed information about acceptance criteria, study design, and performance metrics typically found in clinical trial reports or validation studies for AI/ML devices.

The information provided describes the device, its intended use, and its substantial equivalence to previously cleared devices. It confirms that the device is cleared for marketing but does not include any performance data or clinical study results in the manner requested by your prompt (e.g., acceptance criteria tables, sample sizes for test/training sets, expert qualifications, effect sizes of AI assistance, etc.).

Therefore, I cannot extract the requested information from this document. The prompt asks for details that are not present in this 510(k) summary.

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