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The FITme Customized Silicone Implant is intended for augmentation, reconstructive and cosmetic surgery of the facial regions. The FITme Customized Silicone Implant is pre-shaped to the surgeon's specification to meet the needs of a particular patient.

The FITme Customized Silicone Implant is a patient-specific medical device intended for augmentation, reconstructive and cosmetic surgery of facial region, specifically the nasal contour, the malar cheek contour, and chin contour. The device is a single use implant intended for long term implantation as a space occupying device to form a contoured feature. The customized implant, FITme Customized Silicone Implant, is made of implant grade silicone elastomer, in a range of durometers as specified by the surgeon.

The patient's own medical imaging (e.g., Computed Tomography (CT) scan) is translated into a digital model of the patient's skull using the software, Mimics by Materialise. At the recommendation of the surgeon, the Mimics is used either to 3D-print a skull model for the surgeon to fashion a solid implant model with commercially available plaster or to create a digital implant model as an STL file.

KEOSAN TRADING Co. manufactures the customized molds from the solid implant model provided by the surgeon, or the digital implant model provided by KEOSAN TRADING Co., using plaster molds or 3D-printed molds as appropriate. The FITme Customized Silicone Implant is manufactured from the customized molds and provided to the surgeon, non-sterile.

The provided text is a 510(k) premarket notification for a medical device (FITme Customized Silicone Implant). It asserts substantial equivalence to a predicate device, but does not describe acceptance criteria, a study proving device performance against those criteria, or any details related to AI/algorithm performance.

Therefore, I cannot provide the requested table and information based on the given document. The document describes a traditional medical device (silicone implant) and its manufacturing process, not an AI or software algorithm.

To answer your request, a document detailing the validation of an AI/software as a medical device (SaMD) or an AI-powered medical device would be required. This would typically include performance metrics like sensitivity, specificity, accuracy, and confidence intervals, along with details on test sets, ground truth establishment, and expert involvement.

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The Customized Contour Implant is intended for augmentation, reconstructive and cosmetic surgery. The Customized Contour Implant is pre-shaped to the surgeon's specification to meet the needs of a particular patient, for example facial implants, gluteal implants, calf implants, or pectoralis implants.

The Customized Contour Implant is a patient-matched device intended for augmentation, reconstructive and cosmetic surgery. The device is a single use implant intended for long term implantation as a space occupying device to form a contoured feature. The customized implant is made of medical grade silicone elastomer, in a range of durometers as specified by the surgeon.

This document is about the FDA 510(k) clearance for Implantech Associates Inc.'s Customized Contour Implant. It is a premarket notification, and as such, it does not typically contain detailed studies with acceptance criteria in the same way a clinical trial for a new drug or a more complex medical device would. The purpose of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device.

Therefore, the information regarding acceptance criteria and studies proving the device meets them, especially in the context of AI/ML performance, human readers, sample sizes for test/training sets, and ground truth establishment, is not applicable to this document.

The document primarily focuses on:

• Device Description: A patient-matched device made of medical-grade silicone elastomer for augmentation, reconstructive, and cosmetic surgery (facial, gluteal, calf, pectoralis implants).
• Predicate Device Identification: Listing several previously cleared Implantech implants (K191130, K052504, K052505, K952708) with similar materials and intended uses.
• Non-Clinical Testing: The only "studies" mentioned are non-clinical tests to demonstrate safety based on industry standards, including:
  • Sterilization validation per ISO 17655-1 and ANSI/AAMI/ISO 20857
  • Packaging validation per ISO 11607
  • Shelf life validation with accelerated and real-time aging studies
  • Cytotoxicity testing per ISO 10993-5
  • 3D printer validation
• Conclusion: These non-clinical tests indicate that the device does not raise new issues of safety or effectiveness compared to the predicate device and is substantially equivalent.

No information is provided in the document regarding:

1. A table of acceptance criteria and reported device performance (in the context of clinical/AI performance): Not applicable for this type of device and submission.
2. Sample sizes used for the test set and data provenance: No clinical test set discussed.
3. Number of experts used to establish ground truth and their qualifications: Not applicable; no ground truth establishment for AI performance.
4. Adjudication method for the test set: Not applicable.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not done; this is not an AI-assisted diagnostic device.
6. Standalone (algorithm only) performance: Not applicable; this is a physical implant, not an algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable; there is no training set for an AI algorithm.
9. How the ground truth for the training set was established: Not applicable.

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The Customized Contour Implant is intended for augmentation, reconstructive and cosmetic surgery of the facial regions. The Customized Contour Implant is pre-shaped to the surgeon's specification to meet the needs of a particular patient.

The Customized Contour Implant is a patient-matched for augmentation, reconstructive and cosmetic surgery of the facial regions, specifically the nasal contour, the malar cheek contour, and the chin contour. The device is a single use implant intended for long term implantation as a space occupying device to form a contoured feature. The customized implant is made of medical grade silicone elastomer, in a range of durometers as specified by the surgeon.

The patient's own medical imaging (e.g., Computerized Tomography (CT) scan) is translated into a digital model of the patient's skull using VSP® Software from 3D Systems. At the recommendation of the surgeon, the VSP® Software is used either to 3D-print a skull model for the surgeon to fashion a solid implant model with commercially available plaster or silicon kits, or to create a digital implant model as an STL file. Implantech Associates manufactures the customized molds from the solid implant model provided by the surgeon, or the digital implant model provided by 3D Systems, using plaster molds or 3D-printed molds as appropriate. The Customized Contour Implant is manufactured from the customized molds and provided to the surgeon, sterile or non-sterile.

The provided text describes a 510(k) premarket notification for a medical device called the "Customized Contour Implant." This document primarily focuses on demonstrating substantial equivalence to a predicate device and includes information about non-clinical testing.

Based on the provided text, there is no information related to acceptance criteria, a study proving device meets acceptance criteria, sample size for test set, data provenance, number of experts, adjudication method, MRMC comparative effectiveness study, standalone performance, type of ground truth used, sample size for training set, or how ground truth for training set was established, as these typically pertain to studies involving AI/ML-driven devices or clinical trials, which are not detailed here.

The document describes non-clinical testing for the Customized Contour Implant:

1. A table of acceptance criteria and the reported device performance
No specific acceptance criteria or reported device performance in terms of metrics like sensitivity, specificity, accuracy, etc., are provided, as this document focuses on non-clinical testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This information is not provided in the context of the non-clinical tests performed.

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. This is not a study requiring expert-established ground truth.

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
No MRMC study was done, nor is there any mention of AI assistance in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a physical medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the non-clinical tests described, "ground truth" would relate to established standards or validated measurements. For example, for "3D printer validation," the ground truth would be the known dimensions of the predetermined shape (1 inch cube, 1 inch diameter sphere).

8. The sample size for the training set
Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.

Summary of Non-Clinical Testing Performed (as reported in the document):

The manufacturer conducted the following non-clinical tests to demonstrate safety based on current industry standards:

• Sterilization validation: Per ISO 17655-1 and ANSI/AAMI/ISO 20857.
• Packaging validation: Per ISO 11607.
• Shelf life validation: Included accelerated and real-time aging studies.
• Cytotoxicity testing: Per ISO 10993-5.
• Bacterial endotoxins testing: Per ANSI/AAMI ST72.
• 3D printer validation: The Fortus 360MC 3D Printer and its ancillary equipment were validated to accurately print a 3D image of a predetermined shape (1 inch cube, 1 inch diameter sphere) using STL file inputs. STL file creation using the VSP® software was validated prior to the 3D printer validation.

Conclusion: The results of these tests indicated that the Customized Contour Implant is substantially equivalent to the predicate device and does not raise different questions of safety or effectiveness.

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The Stryker CMF MEDPOR Customized Implant is indicated for the augmentation of bony and/or soft tissue deformities in post-traumatic, post-surgical, or congenital craniofacial defects, including, but not limited to, the correction and prevention of persistent temporal hollowing (PTH).

The Stryker CMF MEDPOR Customized Implant, also referred to as MEDPOR CIs, product offerings provide customized cranial or craniofacial patient specific implants based on CT data and surgeon input. These MEDPOR CIs are currently packaged into MEDPOR CI Kits with a patient-specific Host Bone Model (HBM) that represents the 3D patient's anatomy surrounding the defect location. This Special 510(k) is submitted specifically to include the customer option to sell new Stryker CMF MEDPOR Priority Customized Implant Kits without the Host Bone Model subcomponent.

The Stryker CMF MEDPOR Priority Customized Implant Kit is a medical device that has been cleared by the FDA. The device is intended for the augmentation of bony and/or soft tissue deformities in post-traumatic, post-surgical, or congenital craniofacial defects.

Here's an analysis of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify a separate "test set" in the traditional sense for evaluating device performance. The evaluation was primarily a comparison to a predicate device and focused on changes related to sterilization with a new facility.

• Sterilization Testing: The sample size for the "Product Adoption" and "EO Residual" testing is not explicitly stated. The text describes "tests were performed to adopt the MEDPOR Priority CI Kit into existing Cycle 51 at Stryker Sustainability Solutions." This implies samples of the MEDPOR CIs were used for these sterilization validation tests.
• Data Provenance: The new sterilization location is Stryker Sustainability Solutions, so the data would originate from that facility's testing protocols. The nature of this testing (e.g., in-house lab testing for sterility assurance) is inherently prospective for the validation of the new sterilization site.

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

Not applicable in the context of this submission. The submission primarily addresses a change in offering (removal of a subcomponent) and validation of an additional sterilization location. It does not involve a diagnostic or interpretive device where "ground truth" would be established by experts reviewing a test set of cases. The ground truth for sterilization is established through established ISO standards and validation protocols for sterility assurance levels.

4. Adjudication Method for the Test Set

Not applicable. There was no test set requiring multi-expert adjudication described for this submission. The validation focused on physical and chemical properties related to sterilization and ensuring consistency with the predicate device.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical implant, not an AI-assisted diagnostic tool or an imaging system that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The Stryker CMF MEDPOR Priority Customized Implant Kit is a physical implant, not an algorithm or software-based device.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

• Sterilization Standards: Industrial sterilization validation standards (likely ISO 11135 for Ethylene Oxide sterilization) serve as the ground truth for confirming product sterility and acceptable EO residuals.
• Predicate Device Equivalence: The established physical, chemical, and biological properties of the previously cleared predicate device (K153508) serve as the ground truth for substantial equivalence, given that the core implant design, materials, and intended use have not changed.

8. The Sample Size for the Training Set

Not applicable. This device is a physical implant, not an AI/ML-based device that would require a "training set."

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

Not applicable. (See #8)

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The Stryker CMF MEDPOR Customized Implant is indicated for the augmentation of bony and/or soft tissue deformities in post-traumatic, post-surgical, or congenital craniofacial defects; including but not limited to, the correction and prevention of persistent temporal hollowing (PTH).

The Stryker CMF MEDPOR Customized Implant (CI) product offerings provide customized craniofacial patient specific implants designed at the request of a surgeon. The customized craniofacial implants are molded from porous high density polyethylene (HDPE) and the MEDPOR material provides a porous structure which allows for tissue ingrowth. The MEDPOR CI is manufactured to the specific reconstruction boundaries indicated by the surgeon via submission of CT scans and a customized implant request.

This document is a 510(k) premarket notification for a medical device called the "Stryker CMF MEDPOR Customized Implant." The purpose of this notification is to demonstrate that the device is substantially equivalent to a previously cleared predicate device.

The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory submission focused on demonstrating substantial equivalence to a predicate device, primarily through comparison of technological characteristics and indications for use, rather than presenting de novo performance data against specific acceptance criteria.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them because this information is not present in the provided document. The document explicitly states:

• "Biocompatibility and sterility testing of the device is not required as a basis for substantial equivalence." (Page 5)
• "Performance Bench testing was not required as a basis for substantial equivalence." (Page 5)
• "Animal testing was not required as a basis for substantial equivalence." (Page 5)
• "Clinical Testing: To support the inclusion of the PLUS design option, and the corresponding indication for use, Stryker has leveraged clinical literature and case history." (Page 6) - This indicates a literature review, not a new clinical study with acceptance criteria.

The document is a declaration of substantial equivalence, which often relies on demonstrating that a new device is "as safe and effective" as a legally marketed predicate device without requiring new performance data against specific acceptance criteria, especially if the changes are minor or relate to a new indication for a similar device.

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SU-POR Patient-Specific Surgical Implant in Customized shapes to meet the needs of Individual patients are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. SU-POR Patient-Specific Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillifacial skeleton.

The SU-POR Patient-Specific Surgical Implant is provided as a kit of two identical implants, one of which serves as a back-up implant. The SU-POR Patient-Specific Surgical Implant also provides the surgeon an option of a non-sterile non-implantable template made of the same high-density porous polyethylene to be utilized by the surgeon to assist in modifying the implant prior to placement. The SU-POR Patient-Specific Surgical Implant is manufactured from high-density porous polyethylene to fit the individual needs of a patient based on design input identified by the surgeon. The interconnecting porous structure of the material allows for host tissue ingrowth. The SU-POR Patient-Specific Surgical Implant may be fixed into place using surgical plates and screws. The SU-POR Patient-Specific Surgical Implant is provided as a single-use sterile device.

I am sorry, but the provided text does not contain the acceptance criteria and study details you are asking about. The document is an FDA 510(k) clearance letter and summary for a medical device (SU-POR Patient-Specific Surgical Implant).

It primarily focuses on establishing substantial equivalence to predicate devices based on:

• Device Description: Material (porous high-density polyethylene), design (patient-specific), sterility, sterilization method (EtO), packaging, biocompatibility, and reusability.
• Indications for Use: Non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma, and augmentation or restoration of contour in the craniomaxillofacial skeleton.
• Technological and Operational Characteristics: Implants are designed using individual patient data (CT scan, physical model, drawing, etc.) in collaboration with a surgeon.
• Performance Data Summary:
  • Biocompatibility Testing: Not required for this submission because the material, duration, location of contact, and sterilization method are unchanged from the cleared predicate SU-POR Surgical Implants (K140437).
  • Performance Bench Testing: Not required for this submission because there is no functionality or performance change compared to the cleared predicate SU-POR Surgical Implants (K140437).
  • Software Verification and Validation Testing: Software is only used in the design process, not in the implant itself or its manufacturing. No new testing was required.
  • Animal Testing: Previously conducted for the predicate device (K140437) and no additional testing was required for this submission.
  • Clinical Testing: Not required as a basis for substantial equivalence.

The document does not describe specific acceptance criteria in terms of numerical performance metrics (like sensitivity, specificity, accuracy) for a device, nor does it detail a study proving the device meets such criteria. Instead, it concludes substantial equivalence based on a comparison to existing, legally marketed predicate devices without requiring new performance testing for the reasons stated above.

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

The Stryker CMF MEDPOR® Customized Implant is sold as a kit of two identical implants plus one host bone model. The Stryker CMF MEDPOR Customized Implants are molded from porous high density polyethylene (HDPE) to the specific reconstruction boundaries indicated by the surgeon via submission of CT scans and a customized implant request. The porous structure of the MEDPOR material allows for tissue ingrowth. The implant is fixed into place using compatible Stryker fixation systems. The implants and host bone model are provided sterile for single use only.

This document describes a 510(k) premarket notification for the Stryker CMF MEDPOR® Customized Implant. The submission focuses on adding two additional surgeon design options to an already cleared predicate device (K121315). As such, the information provided primarily addresses the differences and similarities to the predicate device rather than a comprehensive, standalone performance study for the original device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative numerical format typically found in performance studies for new algorithms or devices with new functionalities. Instead, the "acceptance" for this 510(k) hinges on demonstrating substantial equivalence to the predicate device.

The performance data supplied is for the modifications to the device and demonstrates that the modifications do not negatively impact the device's equivalence to the predicate.

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

This document does not describe a "test set" in the context of typical AI algorithm validation (e.g., a dataset of images with ground truth). The performance data cited are primarily bench tests and software/material assessments against the predicate device.

• Screw Pullout Testing: The specific sample size for this test is not mentioned.
• End User Validation Testing: The number of end-users or cases involved is not specified.
• Data Provenance: Not applicable in the context of this 510(k) where clinical dataset provenance is not the focus. The documentation comes from Stryker Leibinger (Germany and USA).

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

Not applicable. This 510(k) is not for an AI algorithm that requires expert-established ground truth on a test set. The validation revolves around maintaining safety and effectiveness equivalent to a predicate device.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication of ground truth is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a customized implant, not an AI diagnostic algorithm, so such a study would not be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This device is a physical customized implant, not an AI algorithm, and therefore does not have a "standalone" or "human-in-the-loop" performance in the sense of AI. While software is used in its design process, the 510(k) states that the addition of design options does not change the manufacturing process or internal control systems, implying that the existing software validation (from the predicate K121315) is sufficient, and no new standalone software performance study was required.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically applied to AI algorithms (e.g., pathology, expert consensus) is not directly applicable here. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate device (K121315). The aim of the submission is to demonstrate that the proposed modifications do not alter this established safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This 510(k) is not for an AI algorithm developed using a training set.

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

Not applicable. This 510(k) is not for an AI algorithm.

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The Implantech ePTFE Facial Implants are intended for implantation to augment or reconstruct underdeveloped areas of the face. The devices are available in various chin, nasal, malar and carving block three dimensional shapes all which may be additionally carved to allow the surgeon to further shape the device should additional shaping be desired.

The Implantech ePTFE Facial Implants are intended for implantation to augment or reconstruct underdeveloped areas of the face. The devices are available in various chin, nasal, malar and carving block three dimensional shapes all which may be additionally carved to allow the surgeon to further shape the device should additional shaping be desired.

The provided text is an FDA 510(k) clearance letter for the Implantech ePTFE Facial Implants. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details.

Therefore, I cannot provide the requested table and information based on the input text. The letter is a regulatory approval document, not a detailed study report.

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

The Stryker CMF MEDPOR Customized Implant is sold as a kit of two identical implants plus one host bone model. The customized craniofacial implant is molded from porous high density polyethylenc (HDPE) to the specific dimensions indicated by the surgeon via submission of CT scans. The porous HDPE Implant is fixed into place using compatible Stryker screws.

The provided text details a 510(k) submission for the Stryker CMF MEDPOR Customized Implant. This is a traditional 510(k) for a medical device (implant), not an AI/ML software. Therefore, the typical "acceptance criteria and study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (such as sensitivity, specificity, F1-score, etc.) and studies with ground truth established by experts, MRMC studies, or standalone algorithm performance are not applicable here.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through various non-clinical performance data.

Here's a breakdown of the requested information based on the provided text, adapted to the context of a medical implant:

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

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

This information is not applicable to this type of submission. The performance data is based on bench testing of the physical implant, manufacturing process validation, and biocompatibility testing, not on clinical patient data in the way an AI/ML study would utilize it. No "test set" in the context of patient data is mentioned.

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 is not applicable. Ground truth for an AI/ML model is established by experts reviewing data. For a medical implant, "ground truth" relates to material properties, strength, sterility, and biocompatibility, which are verified through laboratory tests and engineering validations, not expert consensus on medical images or clinical outcomes.

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

Not applicable. Adjudication methods are typically used in clinical studies or expert review processes, which are not described 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. MRMC studies are specific to evaluating diagnostic devices, especially those involving human interpretation, often in conjunction with AI. This submission is for a physical implant.

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

Not applicable. This is not an AI/ML algorithm.

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

The "ground truth" for this device is derived from:

• Standards Compliance: Demonstrating adherence to established ISO and ASTM standards for biocompatibility, sterilization, packaging, and pyrogenicity.
• Bench Test Results: Objective measurements of the implant's physical and mechanical properties.
• Validation of Manufacturing Processes: Ensuring that the Virtual Implant Design Process (VIDP) consistently produces implants to specifications.
• Predicate Device Data: Leveraging the safety and effectiveness data of previously cleared, substantially equivalent devices.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of device submission.

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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PureForm ePTFE Facial Implants are indicated for use in facial plastic and reconstructive surgery.

The PureForm ePTFE Facial Implants are threedimensional facial prosthesis (Nasal, Chin, and Malar) that are made from expanded Polytetraflouroethylene (ePTFE). The device is offered sterile in multiple sizes.

I am sorry, but based on the provided text, there is no information available about acceptance criteria or a study proving the device meets those criteria.

The document is a 510(k) summary for a medical device (PureForm ePTFE Facial Implants). This type of submission focuses on demonstrating substantial equivalence to predicate devices already on the market, rather than presenting a performance study with defined acceptance criteria.

The key points of the provided text are:

• Identification of the device: PureForm ePTFE Facial Implants (Nasal, Chin, Malar)
• Applicant: Surgical Technology Laboratories, Inc.
• Date Prepared: April 8, 2009
• Predicate Devices: Several existing facial implants.
• Conclusion: The device is deemed substantially equivalent to the predicate devices based on indications, intended use, material, design, and biocompatibility. This is a regulatory finding, not a demonstration of performance against specific, quantitative acceptance criteria through a study.
• FDA Letter: The FDA letter confirms the substantial equivalence determination but does not mention any performance studies or acceptance criteria met by the device.

Therefore, I cannot populate the requested table or answer the specific questions about sample size, expert qualifications, ground truth, or study types because the provided text does not contain this information.

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