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The TECHFIT Patient-Specific Cranial System is intended to replace bony voids in the cranial skeleton. The devices are indicated for adults and adolescents from 18 years or older.

The TECHFIT Patient-Specific Cranial System is patient specific devices intended to replace bony voids in the cranial/craniofacial skeleton. The TECHFIT Patient-Specific Cranial System includes a cranial implant, cranial model and a software component for digital planning and visualization named Digitally Integrated Surgical Reconstruction Platform DISRP®.

TECHFIT Patient-Specific Cranial Implants are manufactured from Polyether Ether Ketone (PEEK). The TECHFIT Patient-Specific Cranial Implants are attached to the native bone using commercial plates and screws.

The TECHFIT Patient-Specific Cranial System matches the shape and dimensions of the missing skull bone fragments. The implants are manufactured from PEEK according to ASTM F2026 and are manufactured by machining process.

The TECHFIT Patient-Specific Cranial System models are patient specific devices manufactured from clear resin using 3D printing manufacturing process. Those models are a representation of the anatomy of the patient, and they are not indicated to enter to the OR (Operating Room).

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Fusion Craniofacial Implant (FCI) and Fusion Skull Implant (FSI) are intended to fill a bony void or defect area in a patient's specific cranial and craniofacial skeleton (orbital rim, zygoma, and adjacent bone).

Fusion Craniofacial Implant (FCI) and Fusion Skull Implant (FSI) are individually sized and shaped implantable prosthetic plates intended to fill a bony void or defect area in a specific patient's cranial and craniofacial skeleton, ranging from 2 mm to 10 mm thick (typically 4mm thick based on the patient CT Scan imaging data) x 25mm to 250 mm wide x 25 mm to 250 mm long.

A Fusion Skull Implant (FSI) is intended to fill a bony void or defect area in a specific patient's skull, whereas a Fusion Craniofacial Implant (FCI) is intended to fill a bony void or defect area in a specific patient's facial region of the skull, excluding the Maxilla (upper jaw area surrounding the teeth only) and Mandible, both considered load bearing areas of the facial region of the skull.

The size, asymmetrical shape, thickness, contour, and edge profile are design elements of the non-load bearing patient-specific base implant. These design elements are used to support the base implant in the bony void or defect area to provide a "Precise Fit."

The single-use alterable base implant (1) is fabricated from a billet block of implant grade Polyether ether ketone (PEEK) Thermoplastic Polymer formulated with biphasic calcium phosphate (BCP PEEK), using a patient's CT scan imaging data, (2) is provided clean (non-sterile) for steam sterilization prior to implantation at a hospital or surgical site, and (3) are attached to the native bone using commercially available cranioplasty hardware and fasteners.

The provided FDA 510(k) clearance letter (K250334) addresses the marketing of the Fusion Craniofacial Implant (FCI) and Fusion Skull Implant (FSI). However, this document does not describe a study involving an AI model or a human-in-the-loop system.

The device described is a physical implant (Preformed Alterable Cranioplasty Plate) intended to fill bony voids or defects in the cranial and craniofacial skeleton. The review focuses on the substantial equivalence of this implant to previously cleared predicate devices, primarily based on material composition (a new PEEK formulation: BCP PEEK) and manufacturing processes.

Therefore, the requested information regarding acceptance criteria and studies proving an AI-driven device's performance (including sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment) cannot be extracted from the provided text.

The performance data section in the document describes:

• Biocompatibility testing: Performed on the new material (Evonik Vestakeep iC4800R® BCP PEEK) according to ISO 10993 standards.
• Performance Testing: Refers to raw material certification and acceptance.
• Cleaning Validation: Conducted for previously cleared devices, and the process is identical for the subject devices.
• Steam Sterilization Validation: Conducted according to ANSI/AAMI ST79.
• Mechanical Testing Validation: A protocol developed by Kelyniam was used as there's no industry-accepted standard for non-load-bearing plates. It states that "all samples passed the acceptance criteria" and "performed equivalent to the predicate devices during mechanical testing using a worst-case scenario."
• Ship Testing Validation: Conducted for previously cleared devices, and the process is identical for the subject devices.
• Summary on Clinical Testing: States "Clinical Testing was determined not applicable" for these devices.

In summary, the provided document does not contain any information about an AI/software-based device, nor does it detail acceptance criteria or studies related to AI performance.

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The VSP PEEK Cranial Implant is indicated for use to fill a bony void or defect area in the cranial skeleton of patients 21 years of age and older.

The VSP PEEK Cranial Implants are non-load bearing, single use devices showing the following characteristics:
• The implants are designed individually for each patient to correct defects in cranial bone.

• The implants are 3D printed using material extrusion technology.
• The implants are manufactured using Polyetheretherketone (PEEK) implantable grade filament (i.e., Evonik VESTAKEEP® i4-3DF).
• The VSP PEEK Cranial Implants are designed using CT imaging data and surgeon input.
• · The implant size is ranging from 35 mm x 35 mm to 150 mm x 150 mm, and its thickness is constant, ranging from 3 mm to 6 mm with a nominal thickness of 3 mm.
• If minor intra-operative adjustments are required, the implants can be modified by the surgeon with standard surgical burrs.
• The implants are fixed to the native bone using commercially available cranial fixation screws and/or systems
• The implants are provided non-sterile for sterilization prior to implantation.

The provided text describes the 510(k) premarket notification for the "VSP PEEK Cranial Implant," which is a Class II device intended to fill bony voids or defects in the cranial skeleton. The information pertains to a medical device's regulatory clearance rather than an AI/ML-driven device, so many of the requested criteria related to AI acceptance, ground truth, and human reader studies are not applicable.

However, I can extract the relevant information regarding the device's acceptance criteria and the studies performed to demonstrate its performance.

Here's a breakdown based on the provided document:

1. Acceptance Criteria and Reported Device Performance (Table)

There are two main categories of acceptance criteria and performance reporting mentioned: Biocompatibility and Performance Bench Testing.

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

• Sample Size: The document does not specify exact sample sizes (e.g., number of implants or test specimens) for each test. It uses phrases like "All samples" and "Several implantations."
• Data Provenance: The data is generated through laboratory bench testing and pre-clinical animal studies (rat model for implantation effects). The data origin is not specified by country, but it relates to the manufacturing and testing done by "3D Systems, Inc." located in Littleton, CO, USA. The studies are prospective in the sense that they were conducted for the purpose of this 510(k) submission.

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

• Experts: For the Anatomical Fit Testing, "surgeons" were involved in performing simulated surgical procedures and reviewing the results.
• Qualifications: The general qualification is "surgeons." No specific number or detailed qualifications (e.g., years of experience, subspecialty) are provided in this summary.
• Ground Truth: For the "anatomical fit," the ground truth was established by the subjective assessment of "surgeons" performing simulated implantations on anatomical models and completing a questionnaire.

4. Adjudication Method for the Test Set

• For the anatomical fit, the document states "reviewed by each surgeon." This suggests individual assessments, but it doesn't specify a formal adjudication method (e.g., consensus, majority vote) if multiple surgeons were involved. It can be inferred that simple agreement among the involved surgeons was sufficient for the "acceptable" conclusion.
• For other analytical and mechanical tests, adjudication would be based on predefined quantitative thresholds or qualitative observations against standards.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic devices that involve interpretation by human readers (e.g., radiologists interpreting images). The VSP PEEK Cranial Implant is a structural implant, and its performance evaluation does not involve differential human interpretation of medical images.

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

• Not applicable directly. This question primarily applies to AI/ML software devices. The "VSP PEEK Cranial Implant" is a physical device. While its design involves "CT imaging data and surgeon input," implying a design process that might be aided by software, the performance evaluation described here is for the physical implant itself, not a separate AI algorithm for image analysis or diagnosis. The "standalone" performance here refers to the device's intrinsic mechanical and biological properties.

7. The Type of Ground Truth Used

• Bench Testing Standards & Expert Consensus/Subjective Assessment:
  • For biocompatibility, the ground truth is established by international standards (ISO 10993 series) and the measured physical/chemical properties or biological responses compared against the acceptance criteria defined by these standards.
  • For mechanical performance, the ground truth is established by literature research (as "there is no industry accepted standard governing mechanical testing for non-load bearing implantable prosthetic plates") and internal technical specifications, and the device's ability to withstand forces.
  • For anatomical fit, the "ground truth" is based on the subjective assessment and "acceptance" by the surgeons performing the simulated implantations.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical implant, not an AI/ML algorithm that requires a training set. The design of each implant is "individually for each patient" using their specific CT imaging data and surgeon input, which is a custom manufacturing process rather than a machine learning training process.

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

• Not applicable. As there is no AI/ML training set, there is no ground truth to establish for such a set.

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MCI - Neuro Fixation System is indicated for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure.

The MCI – Neuro Fixation System is composed of plates (including burr hole covers), screws, and meshes. The bone plates and meshes are made from commercially pure titanium (ASTM F67) and the bone screws are manufactured from titanium alloy - Ti-6Al-4V (ASTM F136) and are available in different sizes and shapes, according to the site of the implantation and the extension of the fracture. The surface of plates, meshes and screws are colored-anodized.

MCI - Neuro Fixation System devices are for single use. The devices are provided non-sterile and must be properly sterilized before use, according to the recommendations provided in the Instructions for Use.

The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in cranial surgery.

The provided text describes information about the MCI-Neuro Fixation System, a cranial fixation device. However, it does not contain the kind of detailed information about acceptance criteria, clinical study design, sample sizes, expert qualifications, or comparative effectiveness studies that your request asks for, especially concerning an AI/ML-driven device.

The document discusses:

• Regulatory Clearance (K212391): It's a 510(k) premarket notification for a Class II medical device.
• Device Description: The system consists of plates, screws, and meshes made from titanium.
• Predicate Device: K141911 - OPTIMUS NEURO SYSTEM.
• Performance Data: This section focuses on bench testing for physical and material properties (metallographic tests, cyclic polarization, cycle bend testing of plates, screw torsion yield test, pull-out testing, driving torque testing).
• Biocompatibility: Stated as supported by a reference device (K182758).
• Lack of Clinical Data: Explicitly states, "No clinical data were included in this submission."

Since this device is a physical fixation system and not an AI/ML driven diagnostic or prognostic tool, the concepts of human readers, AI assistance, ground truth establishment (beyond material specifications), training sets, and test sets in the context of diagnostic accuracy are not applicable to this document.

Therefore, I cannot provide a table of acceptance criteria and device performance, or details about clinical study design, sample sizes, expert qualifications, or adjudication methods as requested, because this information is not present in the provided text. The document focuses on demonstrating substantial equivalence through material and mechanical bench testing.

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Neuro Plating System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure.

The Neuro Plating System is comprised of plates and screws. The range of plate sizes is from 0.3mm to 0.6mm thick. It is made of commercially pure titanium of Gr 1, 2 and 3 (ASTM F67) and in 3 colors (silver, blue and gold) by anodizing. The range of screw diameter is from 0.8mm to 1.95mm in lengths of 3.0 to 6.0mm. It is made of Ti-6Al-4V ELI titanium alloy (ASTM F136) and in 3 colors (silver, green and gold) by anodizing.

Neuro Plating System consists of plates and screws to provide fixation and aid in the alignment and stabilization of fractures in reconstructive processes. The plate is placed on the fractured bone and the screw is inserted into the bone through a plate hole to fix. If necessary, the plate may be bent or cut to meet the anatomical needs of patient.

The Neuro Plating System has two types of sterilization method; Neuro Plating System is non-sterile state packed in PE bag which must be sterilized before use and Neuro Plating System - Sterile Kit is provide sterile state with gamma sterilization packed in Tyvek and PET. Both are single use only.

The provided text is a 510(k) Pre-Market Notification for the Neuro Plating System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study.

Therefore, much of the requested information about acceptance criteria, study design, sample sizes, expert involvement, and ground truth is not directly available or applicable in the context of this 510(k) summary. This document primarily relies on non-clinical (mechanical and sterilization) testing to show equivalence.

However, I can extract information related to non-clinical testing and the comparison to predicate devices, which serves as the "proof" for substantial equivalence in this regulatory context.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence, there isn't a table of specific clinical "acceptance criteria" with numerical targets and reported clinical device performance. Instead, the "acceptance criteria" are implied by the performance of the predicate device, and the "reported device performance" refers to the non-clinical tests conducted on the subject device to show it is equivalent.

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

• Sample Size for Test Set: Not specified in the provided summary. For mechanical tests, this would typically involve a specific number of samples for each test (e.g., n=5 or n=10 per test), but the exact numbers are not present.
• Data Provenance: Not specified, but implied to be from laboratory testing conducted on device samples. Country of origin for testing is not stated. The data is "non-clinical" (bench testing), not patient data, so "retrospective or prospective" is not applicable.

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

This information is not applicable as the submission relies on non-clinical, laboratory bench testing (mechanical and sterilization) rather than clinical data requiring expert review or ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable as the submission relies on non-clinical, laboratory bench testing. Adjudication methods are typically relevant for clinical studies where subjective assessments or multiple interpretations of patient data might occur.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic imaging aids or AI assistance where human readers interpret cases. The Neuro Plating System is a surgical implant, not a diagnostic tool.

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

• No, a standalone (algorithm only) performance study was not done. This concept applies to AI/software as a medical device. The Neuro Plating System is a physical implant.

7. The Type of Ground Truth Used

• Not applicable in the sense of clinical ground truth (e.g., pathology, outcomes data). For the non-clinical tests, the "ground truth" would be the engineering specifications and established acceptable performance limits (often derived from the predicate device or relevant ASTM standards). For example, a "ground truth" for the 4-point bending test would be a minimum bending force or deformation standard that the device must meet, typically aligned with or surpassing the predicate's performance.

8. The Sample Size for the Training Set

• Not applicable. The Neuro Plating System is a physical medical device, not an AI/machine learning algorithm that requires a "training set."

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

• Not applicable. As above, there is no "training set" for this device.

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The PEEK Customized Cranial Implant Kit is indicated for the augmentation of bony and/or soft tissue deformities in the cranial and craniofacial skeleton (orbital rim, zygoma, and adjacent bone); including but not limited to, the correction and prevention of persistent temporal hollowing (PTH) in patients 3.5 years of age and older.

The PEEK Customized Cranial Implant Kit product provides a customized cranial or craniofacial patient specific implant solution based on patient CT/CBCT data and surgeon input. This submission is to expand the Stryker PEEK CCI product portfolio to include the single stage option.

The provided text describes a 510(k) premarket notification for the Stryker PEEK Customized Cranial Implant Kit (K203055). This submission expands an existing product portfolio to include a single-stage option. The device is a custom implant for cranial and craniofacial bone and soft tissue deformities.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:

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

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria is an End-User Validation Lab as part of Performance Bench Testing. The document explicitly states: "Additionally, an end-user validation lab was conducted to evaluate the subject device and to support the basis for substantial equivalence."

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

• Sample Size: The document does not specify the sample size (number of implants, tests, or end-users) used for the end-user validation lab.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It describes a "lab" setting, suggesting a controlled, prospective evaluation.

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

This information is not provided in the document. While an "end-user validation lab" implies involvement of relevant personnel (likely surgeons or qualified medical professionals), the number and specific qualifications are not detailed.

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

The document does not specify any adjudication method for the end-user validation lab.

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:

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This device is a passive implant, not an AI-assisted diagnostic or therapeutic tool.
• Effect Size: Not applicable.

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

Not applicable. The device itself is an implant, not a standalone algorithm. The "single stage surgical procedure with/without surgical aid options" described in the performance bench testing evaluates the implant's fit and the use of aids, which inherently involves human interaction.

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

The "ground truth" for the end-user validation lab appears to be based on successful completion of tasks and meeting pre-defined acceptance criteria for implant fit and surgical procedure performance, likely evaluated by the participating end-users and study observers. The document doesn't mention pathology or long-term outcomes data for this specific validation.

8. The sample size for the training set:

Not applicable. This device is a physical implant, not an AI or machine learning model that requires a training set in the conventional sense.

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

Not applicable, as there is no training set for this type of device. The design and manufacturing processes are validated against established standards and predicate device characteristics.

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The Optimus Neuro Plating System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedures.

The Neuro Plating System is comprised of plates and screws. The range of plate sizes is from 0.3mm to 0.6mm thick. It is made of commercially pure titanium of Gr 1, 2 and 3 (ASTM F67) and comes in 3 anodized colors (silver, blue and gold). The screws range in diameter from 0.8mm to 1.95mm and in lengths of 3.0mm to 6.0mm. They are made of Ti- 6Al-4V ELI titanium alloy (ASTM F136) and come in 3 anodized colors (silver, green and gold).

The Neuro Plating System consists of plates and screws to provide fixation and aid in the alignment and stabilization of fractures in the reconstructive process. The plate is placed on the fractured bone and the screw is inserted into the bone through a plate hole to achieve fixation. If necessary, the plate may be bent or cut to meet the anatomical needs of the patient.

The Neuro Plating System has two types of sterilization methods: 1.) the Neuro Plating System is non-sterile state packed in a PE bag which must be sterilized before use; and 2.) the Neuro Plating System - Sterile Kit is provided sterile using gamma sterilization packed in Tyvek and PET. Both are single use only.

The provided text describes the regulatory clearance of a medical device, the Optimus Neuro Plating System, and details its substantial equivalence to predicate devices. It does not present a study proving the device meets specific acceptance criteria in terms of AI or algorithm performance.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to regulatory acceptance for market clearance based on substantial equivalence to existing devices, rather than performance metrics for an AI-powered system or diagnostic accuracy study.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable to this type of submission.

Here's how the provided information relates to your request:

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

The document doesn't present "acceptance criteria" in the sense of performance metrics for an AI system. Instead, it presents a comparison table demonstrating the "substantial equivalence" of the modified device to its predicate devices across various attributes. The "performance" here refers to the device proving it is as safe and effective as the predicate, not a quantifiable clinical outcome or AI accuracy.

Table: Comparison of Modified Device to Predicate Devices for Substantial Equivalence

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

• Test Set Description: The "test set" in this context refers to the samples of the physical device that underwent non-clinical laboratory testing (e.g., mechanical strength, sterilization validation).
• Sample Size: The document does not specify the exact number of units used for each test (e.g., how many plates/screws for the 4-point bending test). It only states that "The following tests were performed on the modified devices."
• Data Provenance: The tests were performed by Osteonic Co., Ltd. (the manufacturer) in South Korea. The data would be internally generated "non-clinical tests." The provenance typically refers to the source of the clinical data (e.g., patient records), which is not relevant here as this is a device clearance based on engineering and material testing. The tests are prospective as they were conducted for this submission.

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 submission is for a physical medical implant, not an AI or diagnostic imaging device that requires interpretation by medical experts to establish ground truth for performance evaluation. The "ground truth" for the device's characteristics (e.g., material strength, sterility) is established by standardized engineering tests and established quality control methods, not expert consensus on medical images.

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

• Not applicable. This refers to a method used to resolve discrepancies in expert interpretations (e.g., for image annotations or diagnoses), which is not relevant to the non-clinical engineering and material tests performed for this device.

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 type of study performed for diagnostic AI tools to evaluate their impact on human interpretation. This submission is for a physical neuro plating system.

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

• Not applicable. This describes the performance evaluation of an AI algorithm in isolation. The Optimus Neuro Plating System is a physical implant, not an algorithm.

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

• For the physical device, the "ground truth" for demonstrating substantial equivalence is based on:
  • Engineering specifications and standards: ASTM F67, ASTM F136, ISO 10993.
  • Validated test methods: 4 Point Bending Test, Torsion Test, Axial Pullout Strength Test, Packaging Process Validation Test, Gamma Sterilization Validation, Shelf life, MR safety tests.
  • Comparison to predicate device performance data in these established physical and biological safety metrics.

8. The sample size for the training set:

• Not applicable. This is relevant for AI/ML models. This document describes a physical medical device.

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

• Not applicable. Relevant for AI/ML models.

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The PEEK Customized Cranial Implant Kit is indicated for the augmentation of bony and/or soft tissue deformities in the cranial and craniofacial skeleton (orbital rim, zygoma, and adjacent bone); including but not limited to, the correction and prevention of persistent temporal hollowing (PTH) in patients 3.5 years of age and older.

The Stryker PEEK Customized Cranial Implant (CCI) product offerings provide customized cranial or craniofacial patient specific implants based on CT data and surgeon input.

The Stryker PEEK Customized Cranial Implant is a medical device intended for the augmentation of bony and/or soft tissue deformities in the cranial and craniofacial skeleton for patients 3.5 years of age and older.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define quantitative acceptance criteria for this device in the same way one might for a diagnostic AI. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to a predicate device and the discussion of benefits outweighing risks.

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

This document does not describe a "test set" in the context of an algorithm or diagnostic device. The evaluation relies on a review of existing scientific peer-reviewed publications. The sample sizes are derived from these referenced clinical studies:

• Nguyen et al. 2018: 136 cases utilizing custom CAD/CAM implants for complex craniofacial reconstruction in children. (Data provenance not specified, but likely multi-center based on similar studies).
• Rocque et al. 2018: Multicenter study at 13 institutions. (Specific sample size for PEEK implants not given, but context suggests a larger cohort of cranioplasty patients).
• Ma et al. 2018: 84 cases of cranioplasty (6 PEEK implants, 36 split calvarial grafts, 33 titanium meshes).
• Sainsbury et al. 2017: Cases involving bilateral malar reconstruction with customized PEEK implants. (Specific sample size not given, but likely a smaller case series).
• Fu et al. 2016: Pediatric patients, 73% received alloplastic implants (PEEK, PMMA, MEDPOR, titanium), 28% autologous reconstructions. (Specific sample size not given, but implied to be substantial given the percentages).

The data provenance is from published clinical literature, which often encompasses retrospective and/or prospective studies conducted in various clinical settings. Specific country of origin is not detailed for each individual study in this summary.

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

Not applicable. This is not a study evaluating a diagnostic algorithm where "ground truth" is established by experts on a test set. The clinical evidence is derived from existing peer-reviewed literature, where the outcomes of the surgical procedures serve as the "truth" regarding the device's performance in patients.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" or adjudication process described as part of this 510(k) submission.

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

Not applicable. This device is a customized cranial implant, not an AI-assisted diagnostic tool. Therefore, studies on human readers improving with or without AI assistance are not relevant.

6. Standalone (Algorithm Only) Performance

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

7. Type of Ground Truth Used

The "ground truth" for the effectiveness and safety of the PEEK customized cranial implant is derived from:

• Clinical Outcomes Data: Published results detailing patient outcomes following the implantation of PEEK and other alloplastic cranioplasties (e.g., successful augmentation, restoration of bony defects, complication rates, follow-up over time).
• Clinical Experience/Expert Consensus (within referenced studies): The studies reflect the collective experience and findings of clinicians and surgeons regarding the use and performance of these types of implants.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model requiring a training set. The design of the custom implant for a specific patient is based on that individual patient's CT data, not a general training set.

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

Not applicable, as there is no training set for this device in the context of an algorithm.

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The Customized Craniofacial Implant (CCI) and Customized Skull Implant (CSI) is intended to fill a bony void or defect area in a patient's specific cranial and craniofacial skeleton (orbital rim, zygoma, & adjacent bone).

Customized Craniofacial Implant (CCI) and Customized Skull Implant (CSI) is an individually sized and shaped implantable prosthetic plates intended to fill a bony void or defect area in a specific patient's cranial and craniofacial skeleton (orbital rim, zygoma, & adjacent bone), ranging from 2 mm to 10 mm thick (typically 4mm thick based on the patient CT Scan imaging data) x 25mm to 250 mm wide x 25 mm to 250 mm long. A Customized Skull Implant (CSI) is intended to fill a bony void or defect area in a specific patient's skull whereas a Customized Craniofacial Implants (CCI) is intended to fill a bony void or defect area in a specific patient's facial region of the skull, excluding the Maxilla (upper jaw area surrounding the teeth only) and Mandible, which are both considered load bearing areas of the facial region of the skull. The size, asymmetrical shape, thickness, contour, and edge profile are design elements of the non-load bearing patient-specific Base Implant that are used to support the base implant in the bony void or defect area while providing for a "Precise Fit". The single patient use base implant is (1) fabricated from a billet block of natural implant grade Polyether ether ketone (PEEK) Thermoplastic Polymer using the patient's CT Scan imaging data, (2) provided clean but non-sterile for steam sterilization prior to implantation at a hospital or surgical site with neurosurgery capabilities, and (3) attached to the native bone using commercially available cranioplasty hardware and fasteners. The additional features listed below are additional design elements that may be added to the Base Implant and Base Implant with Perfusion Holes, as requested by the Physician. The Base Implant, as defined above (as previously cleared on K103582 and K121755).

The provided document outlines the Kelyniam Global Inc. (KGI) Customized Craniofacial Implant (CCI) and Customized Skull Implant (CSI) for which a 510(k) premarket notification (K182711) was submitted.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not present a formal table of acceptance criteria versus reported device performance for specific clinical or diagnostic metrics. Instead, the "Performance Data" section details the types of validations and tests conducted to demonstrate the device's substantial equivalence to predicate devices and its safety and effectiveness.

Here's a summary of the performance data and "accepted" findings:

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

The document does not specify a "test set" in the context of clinical data for performance evaluation in the way one might for an AI/diagnostic device. The studies performed are primarily bench testing and material characterization studies.

• Sample Size: The sample sizes for the various bench tests (e.g., cleaning, sterilization, mechanical, ship testing) are not explicitly stated in the summary. It generally mentions "all samples passed the acceptance criteria," implying that a sufficient number of units were tested as per the respective validation protocols.
• Data Provenance: The data provenance is internal to the manufacturer (KGI) through their own validation protocols and testing, or from material suppliers (Invibio PEEK Optima LT-1® and Evonik Vestakeep i4®) for material specifications and certifications of analysis which are then reviewed by KGI. This data is generally considered prospective in the sense that the tests were conducted specifically to validate the device, rather than analyzed retrospectively from existing clinical datasets.

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

This information is not applicable as the device is an implant (Customized Craniofacial/Skull Implant), not a diagnostic or AI device that requires expert interpretation for establishing ground truth in clinical cases. The "ground truth" for this device relates to its material properties, manufacturing quality, biomechanical integrity, and biocompatibility, which are verified through standardized testing and material certifications.

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

This is not applicable for the type of device and studies performed. Adjudication methods are typically used in clinical studies, especially those involving human interpretation of diagnostic results, to reconcile discrepancies and establish a consensus ground truth. The studies cited are laboratory and bench tests relying on objective measurements and established standards.

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 a physical, custom-made implant, not an AI-powered diagnostic tool. Therefore, an MRMC study or an evaluation of human reader improvement with AI assistance is not relevant to this submission.

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

This is not applicable. The device is an implant. No algorithm or standalone AI performance was evaluated.

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

The "ground truth" for this medical device is established through:

• Standards Compliance: Adherence to recognized national and international standards for biocompatibility (ISO 10993-1), materials (ASTM F2026-16), cleaning (ANSI/AAMI ST72, USP <85>), and sterilization (ANSI/AAMI/ISO 17665-1, 14937).
• Material Certifications: Certifications of analysis/compliance from raw material suppliers.
• Engineering Specifications: Internal KGI specifications and validation protocols for mechanical testing and ship testing.
• Objective Measurements: Laboratory measurements to confirm physical properties, absence of contaminants, and sterility.

No clinical outcomes data or pathology reports were used here as "ground truth" in this specific 510(k) summary, as the submission focused on demonstrating substantial equivalence through non-clinical testing. This is explicitly stated: "Clinical Testing was determined not applicable for Kelyniam Global Inc. Customized Craniofacial Implant (CCI) and Customized Skull Implant (CSI)."

8. The sample size for the training set

This is not applicable. The device is a physical implant and not an AI or machine learning model that requires a training set.

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

This is not applicable for the same reasons as point 8.

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Optimus Neuro System is intended for use in selective trauma of the cranial surgery and reconstructive procedure.

The Optimus NEURO System is comprised of plates and screws. The range of plate sizes is from 0.3mm to 0.6mm thick. It is made of commercially pure titanium of Gr 1, 2 and 3 (ASTM F67) and in 3colors (silver, blue and gold) by anodizing. The range of screw diameter is from 0.8mm to 1.8mm in lengths of 3.0 to 6.0mm. It is made of Ti-6AI-4V ELI titanium alloy (ASTM F136) and in 3 colors (silver, green and gold) by anodizing.

The device is packed separately in a PE bag. The plate and screw are single use only, non-sterile products. The devices must be sterilized before use.

Optimus NEURO System consists of plates and screws to provide fixation and aid in the alignment and stabilization of fractures in reconstructive processes. The placed on the fractured bone and the screw is inserted into the bone through a plate hole to fix. If necessary, the plate may be bent or cut to meet the anatomical needs of patient

This document describes the Optimus Neuro System, a device intended for use in cranial surgery and reconstructive procedures. It's important to note that this submission focuses on the device itself (plates and screws), not an AI algorithm. Therefore, many of the requested AI-specific details are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for the "4 Point Bending Test" or "Packaging Process Validation Test." It refers to "the subject device and the predicate devices," suggesting that a sufficient number of units were tested to draw conclusions.

• Data Provenance: The manufacturing company, Osteonic Co., Ltd., is based in Seoul, Korea. The tests were likely conducted in a controlled lab environment. The study is retrospective in the sense that it's comparing a modified device to an existing predicate, and the testing isn't on human subjects for clinical outcomes, but rather on the physical properties of the device.

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 this is a submission for a medical device (plates and screws), not an AI algorithm requiring expert ground truth for image or data interpretation. The "ground truth" here is based on engineering standards and physical test results.

4. Adjudication Method for the Test Set

This is not applicable as it pertains to expert disagreement in AI-driven diagnostic tasks, which is not relevant to this device's testing.

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 as this is a medical device (plates and screws), not an AI algorithm.

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

This is not applicable as this is a medical device (plates and screws), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Engineering Standards: Adherence to material specifications (ASTM F67, ASTM F136) and performance standards (e.g., implied stress/strain limits for the 4-point bending test).
• Physical Test Results: Direct measurements of mechanical properties (bending strength) and packaging integrity.
• Previous Validation Data: Relying on sterilization and biocompatibility data from the primary predicate device (K141911).

8. The Sample Size for the Training Set

This is not applicable as this is a medical device (plates and screws) and does not involve AI or machine learning models that require a training set.

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

This is not applicable for the same reasons as above.

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