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Customized Abutment and Screw is used as a complement component for dental implants placed in the jawbone after tooth loss, to connect, support and retain the restoration or implant superstructure. Customized Abutment and Screw is indicated for single unit restorations.

Customized Abutment and Screw is compatible with following Implant Systems:

All digitally designed abutments for use with Customized Abutment and Screw are intended to be manufactured at a BESMILE validated milling center.

The Customized Abutment and Screw is composed of two parts: the customized abutment and screw. Among them, the customized abutment is machined from Ti-6Al-4V titanium alloy material in accordance with ASTM F1472, and the screw is machined from Ti-6Al-4V ELI titanium alloy material in accordance with ASTM F136. And the surface of product is not modified. The lower part of the product has a fixed interface shape, and the upper part is machined according to the needs of the patient. In the process of dental implant surgery, as the upper structure of the implant, it is installed on the implant platform anchored in the bone, which plays the role of supporting, retaining and stabilizing the prosthesis.

Customized Abutment and Screw is created via use of the Pre-milled Blank.

The information of the Implant Systems compatible with the product is detailed in Table 1.

N/A

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The Customized Abutments are intended use for attachment to dental implants in order to provide support for customized prosthetic restorations. Customized Abutments are indicated for screw-retained single restorations or cement- retained single or multi-unit restorations. The Customized Abutment will be attached to a dental implant using the included abutment screw.

Patient-Specific Abutment is compatible with following Implant System:

1. Neodent Implant System -GM Line / Implant Diameter (mm): 3.5, 3.75, 4.0, 4.3, 5.0, 6.0/ Restorative Platform Diameter: 3.0
2. BioHorizons Tapered Internal Implant System / Implant Diameter (mm): 3.8, 4.6, 5.8/ Restorative Platform Diameter: 3.5, 4.5, 5.7
3. Astra Tech Implant System / Implant Diameter (mm): 3.5, 4.0, 4.5, 5.0/ Restorative Platform Diameter: 3.5, 4.0, 4.5, 5.0
4. 3i OSSEOTITE® Certain® Dental Implants / Implant Diameter (mm): 4.1, 5.0, 6.0/ Restorative Platform Diameter: 4.1, 5.0, 6.0

All digitally designed abutments for use with Customized Abutment are intended to be manufactured at an ARUM DENTISTRY validated milling center.

Patient-specific abutment is made from Ti-6Al-4V Eli conforming to ASTM F136 to be used in fabricating patient-specific abutments. The subject devices are indicated for cemented or screwand cement retained prosthesis (SCRP) restorations. Each patient-specific abutment is individually prescribed by the clinician.

The diameters of patient-specific abutment are 3.5, 3.75, 3.8, 4.0, 4.3, 4.5, 4.6, 5.0, 6.0 mm and Hex connection design.

Customized abutments are supplied with an abutment and provided non-sterile.

This document is a 510(k) Premarket Notification from ARUM DENTISTRY Co., Ltd. for a dental device called "Customized Abutment." This notification aims to demonstrate the substantial equivalence of their device to legally marketed predicate devices, as required by the U.S. Food and Drug Administration (FDA).

Based on the provided information, the 510(k) summary (pages 4-12) details the device, its intended use, materials, and substantial equivalence comparison to a predicate device. The information is focused on a medical device clearance and does not describe an AI/ML-driven medical device, nor does it contain information typically associated with studies proving device performance against acceptance criteria in the context of AI/ML.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details, because the provided document does not pertain to an AI/ML device.

The document describes a physical medical device (Customized Abutment for dental implants) and its non-clinical testing to demonstrate substantial equivalence, primarily through:

• Reverse engineering of OEM implant bodies, OEM abutments, and OEM abutment screws to confirm compatibility.
• Static and fatigue testing according to ISO 14801.

The closest information provided to "acceptance criteria" relates to the design parameters of the abutment, such as post height, angle, wall thickness, diameter, and gingival height, which are likely evaluated against engineering specifications and performance standards like ISO 14801.

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The Customized Abutments are intended for attachment to dental implants in order to provide support for customized prosthetic restorations. Customized Abutments are indicated for screwretained single restorations or cement-retained single or multi-unit restorations. The Customized Abutment will be attached to a dental implant using the included abutment screw.

Patient-Specific Abutment is compatible with following Implant Systems:

1. Zimmer Tapered Screw-Vent®
   / Implant diameter size (mm): 3.7, 4.1, 4.7, 6.0/ Restorative Platform diameter (mm): 3.5, 4.5, 5.7
2. Straumann® Bone Level Tapered Implant
   / Implant diameter size (mm): 3.3, 4.1, 4.8/ Restorative Platform diameter (mm): 3.1, 3.7, 4.4

All digitally-designed Customized abutments are intended to be sent to an ARUM DENTISTRY validated milling center for manufacture.

Patient-specific abutment is made from Ti-6Al-4V Eli conforming to ASTM F136 to be used in fabricating patient-specific abutments. The subject devices are indicated for cemented or screwand cement retained prosthesis (SCRP) restorations. Each patient-specific abutment is individually prescribed by the clinician.

The diameters of patient-specific abutment are 3.3, 3.7, 4.1, 4.7, 4.8, 6.0 mm and Hex and square connection design.

Customized abutments are supplied with an abutment screw and provided non-sterile.

The provided text describes the regulatory clearance (K234112) for the ARUM DENTISTRY Co., Ltd. Customized Abutment, particularly focusing on its substantial equivalence to a predicate device (K223634). The information provided does not outline acceptance criteria for an AI/ML powered device, nor does it detail a study proving the device meets AI/ML specific acceptance criteria.

The information provided pertains to a traditional medical device (dental abutments) and focuses on engineering and material performance rather than AI/ML algorithm performance.

Therefore, many of the requested fields regarding AI/ML specific criteria cannot be extracted from the given text.

However, I can provide information on the non-clinical tests conducted for the Customized Abutment device, which are analogous to acceptance criteria and performance data for this type of medical device.

1. Table of Acceptance Criteria and the Reported Device Performance (Non-AI/ML):

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

• Mechanical Testing (Static and Fatigue): The document mentions "The worst-case construct was tested" for sterilization and that "static and fatigue testing according to ISO 14801" was conducted. Specific sample sizes are not provided.
• Data Provenance: The non-clinical tests were conducted internally or by contractors to ARUM DENTISTRY. The document does not specify a country of origin for the data beyond ARUM DENTISTRY Co., Ltd. being in the Republic of Korea. These are most likely prospective tests conducted specifically 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):

This information is not applicable and not provided as the approval is for a physical dental abutment, not an AI/ML algorithm requiring expert interpretation for ground truth.

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

This information is not applicable and not provided. "Adjudication" typically refers to resolving discrepancies in expert labeling or diagnoses for AI/ML ground truth, which is not 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:

This is not applicable. No MRMC study was conducted as the device is a physical dental abutment, not an AI-assisted diagnostic tool.

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 product, not an algorithm.

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

For the non-clinical tests, the "ground truth" is defined by the standards and specifications used (e.g., ASTM F136 for material, ISO 14801 for mechanical testing, ISO 17655-1 for sterilization, FDA guidance for MRI safety). The device's performance is compared against the requirements of these established standards.

8. The sample size for the training set:

This is not applicable. The device is a physical product, not an AI/ML model that requires a training set. The device design parameters are "trained" through engineering design principles and verified through physical testing.

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

This is not applicable. There is no training set as it's not an AI/ML algorithm. The design of the abutment relies on established engineering principles, material science, and compatibility specifications with existing implant systems.

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CustomizedBone Service (CustomizedBone) is intended to replace bony voids in the cranial and/or craniofacial skeleton (frontal bone including the brow ridge). This device is indicated for both adult and pediatric use (for children 7 years of age and above). CustomizedBone implants are suitable for reconstructing craniofacial defects resulting from:

• trauma and vascular pathologies, either associated or non-associated to cranial decompression;
• removal of tumours;
• reabsorption of autologous bone;
• rejection of other prosthetic materials;
• congenital malformations.

CustomizedBone Service patient specific implants for the reconstruction of cranial/craniofacial defects are made of porous biomimetic hydroxyapatite with a chemical composition and structure that resembles the mineral component of human bones. This biomaterial is highly porous with trabecular structure and is composed of pores with the following characteristics:

• macro-pores,
• interconnecting pores,
• micro-pores.
  This material is biocompatible.
  The implants are designed and produced by Fin-Ceramica Faenza according to the surgeon's specifications and based on the patient's CT scan data, obtained through a standardized protocol. During the pre-operative planning phase, the final implant design. All the implants are accompanied by the patient's identification code.

The provided text describes a 510(k) premarket notification for a medical device called "CustomizedBone Service." It focuses on demonstrating substantial equivalence to a legally marketed predicate device. The information provided is primarily related to the device's design, material, intended use, and a minor change in fixation method.

Crucially, the document does NOT contain information about acceptance criteria or a study proving the device meets those criteria in the context of typical AI/ML medical device performance studies. The document describes a traditional medical device submission, not an AI/ML-driven device.

Therefore, I cannot extract the information required to populate the fields related to acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training data, or ground truth for training data as these concepts are not discussed in the provided text.

The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section mentions tests for "Stability verification of CustomizedBone Service stabilized with Cranial LOOP (L)" and "Usability of an alternative method of fixation." However, these are mechanical/usability tests for a physical implant, not performance metrics for an AI/ML algorithm.

In summary, the provided content is insufficient to answer the prompt because it describes a hardware medical device (cranioplasty plate) and not an AI/ML-driven device requiring the specified performance evaluations.

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ARUM Dentistry's Customized Abutments are intended for attachment to dental implants in order to provide support for customized prosthetic restorations. Customized Abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations. The Customized Abutment will be attached to a dental implant using the included ARUM Dentistry prosthetic screw.

Customized Abutments are compatible with the implant systems listed in the Compatibility Table:

All digitally-designed Customized Abutments are intended to be sent to an ARUM Dentistry-validated milling center for manufacture.

Patient-specific abutment is made from Ti-6Al-4V Eli conforming to ASTM F136 to be used in fabricating patient-specific abutments. The subject devices are indicated for cemented or screwand cement retained prosthesis (SCRP) restorations. Each patient-specific abutment is individually prescribed by the clinician.

The diameters of patient-specific abutment are 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 mm and two connection designs (Hex, Non-hex).

Patient-Specific Abutment is compatible with following Implant Systems:

Patient-specific abutments are supplied with an abutment screw previous cleared device as K222131 and 7 newly designed screws and provided non-sterile.

Patient-specific abutment design parameters:

The provided text describes the 510(k) submission for ARUM DENTISTRY Co., Ltd.'s "Customized Abutment." This is a Class II medical device (dental implant abutment). The document focuses on demonstrating substantial equivalence to a predicate device, which is a common pathway for FDA clearance.

Here's a breakdown of the requested information, based on the provided text. It's important to note that many of the typical "acceptance criteria" and "study proves that the device meets the acceptance criteria" details for AI/ML devices, such as those related to accuracy, sensitivity, specificity, or reader studies, are not applicable to this type of device. This is a physical, custom-fabricated medical device (dental abutment), not an AI/ML-driven diagnostic or treatment planning system. Therefore, the "acceptance criteria" here refer to performance testing (mechanical, biocompatibility, sterilization) to ensure the device is safe and effective and substantially equivalent to a predicate. The study that proves it meets criteria is the testing performed.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document does not specify a numerical "sample size" in terms of number of abutments tested for mechanical performance. It refers to "worst-case constructs" for each compatible implant line. This is typical for mechanical testing where a representative "worst-case" configuration is tested to demonstrate the device's limits.
• Data Provenance: The testing data is derived from non-clinical performance tests (mechanical testing, sterilization validation, biocompatibility) of the device and its predicate. The origin of the raw data (e.g., specific lab, country) is not detailed, but it is implied to be internal or from a contract testing lab as part of the manufacturer's quality system. It is prospective for the specific tests performed to support this submission.

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

• This is not applicable to this type of medical device submission. Ground truth (in the AI/ML sense) is not established by human experts for mechanical/biocompatibility testing. The "ground truth" for proving the device meets acceptance criteria relies on the results of standardized engineering and biological tests conducted according to recognized standards (e.g., ISO, ASTM).

4. Adjudication method for the test set

• Not applicable. There is no human adjudication process involved in interpreting the results of mechanical, biocompatibility, or sterilization tests for this device. The results are compared directly to pre-defined criteria in the standards.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done

• No, an MRMC study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. This is a physical, custom-fabricated dental device, so such a study is not applicable.

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

• Not applicable. This device is not an algorithm. Performance evaluation for this device is based on physical and material properties, not algorithmic output.

7. The type of ground truth used

• The "ground truth" for this device's performance is established by objective, standardized test methods (e.g., stress-strain measurements for mechanical testing, biological assays for biocompatibility, sterility indicator results for sterilization). It is based on engineering and scientific standards rather than expert consensus on medical images or pathology.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML or software device that undergoes "training." Its design and manufacturing are based on established engineering principles for dental abutments.

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 "ground truth" for its development and validation relies on adherence to design specifications, material standards, and validated manufacturing processes.

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Customize for ankle arthroplasty is intended to be used as a software interface to assist in:

• Visualization, modification, validation of the planning of total ankle arthroplasty
• Communication of treatment options
• Segmentation of CT-scan data
• 3D CAD models generation
• use x-ray scan information to enhance the planning of ankle arthroplasty
• Managing timeline and cases

Customize is not intended to be used for

• Spine surgeries
• Implant and instrument design

Experience in usage and clinical assessment are necessary for a proper use of the software. It is to be used for adult patients only and should not be used for diagnostic purposes.

Customize is intended to be used during the preparation of ankle arthroplasties. It visualizes surgical treatment options that were previously created based on 3D CAD files generated from multi-slice DICOM data from a CT scanner. It consists of a single software user interface where the physician can review the CAD files in 3D, CT and X-Ray images in 2D and modify the position and orientation of the different 3D objects. Customize includes an implant library with 3D digital representations of various implant models so that the right implant positioning and sizing can be achieved based on the physician's input. After approval by the physician, the treatment plan is saved on the server and can be used as a reference during surgery. It is also possible to export the treatment plan for further processing such as designing and manufacturing of patient specific devices (the design of those later is done using an external software).

Here's a breakdown of the acceptance criteria and the study details for the "Customize" device based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

The provided document describes performance testing for the "Customize" device, focusing on segmentation validation, repeatability and reproducibility (R&R) of segmentation, and 3D model generation accuracy. While explicit "acceptance criteria" in terms of specific numeric thresholds are not directly stated in a table format, the narrative implies that the device successfully met the requirements of these tests to demonstrate substantial equivalence.

Implied Acceptance Criteria and Reported Device Performance:

Study Details

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

• Segmentation validation and R&R study: The document states the AI-based ankle algorithm was trained on a dataset of 126 medical images (CT scans). It doesn't explicitly state the size of a separate "test set" for validation, but for these types of studies, a portion of the overall dataset or a new, unseen dataset is typically used for testing. Without further information, it's difficult to distinguish a test set size beyond the training dataset described.
• Data Provenance: Not explicitly stated whether the data was retrospective or prospective, nor the country of origin. The mix of patients (30% eligible for ankle arthroplasty, 70% cadaveric cases) suggests a blend of clinical and research data.

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. The general statement about "human supervision by a 3D-Side engineer" applies to the device's operational use (editing AI output), but not necessarily to the establishment of ground truth for the validation studies.

4. Adjudication method for the test set:

• This information is not provided in the document.

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, an MRMC comparative effectiveness study is not described. The document mentions that the AI produces an "initialization" that "requires manual editions" and human supervision, suggesting it functions as an assistive tool rather than a standalone diagnostic or decision-making system. The focus is on the software's performance metrics (segmentation, R&R, 3D model generation), not on comparing human performance with and without AI assistance.

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

• The description implies that standalone performance was assessed to some extent for the "initialization" step. The AI algorithm generates a "temporary label" which then undergoes "human supervision." The "performance testing included 1) segmentation validation" of the software, suggesting its initial output (before human intervention) was evaluated against a ground truth. However, the device's intended use is described as AI followed by human supervision, so the final, clinical performance relies on the human-in-the-loop.

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

• The document implies that the "corresponding segmentation" data was used as ground truth for training the AI. For the performance studies, it is logical that similar "ground truth" segmentations (likely created by experts, though their number and qualifications are not specified) would be used for comparison, especially for segmentation accuracy and 3D model generation. Pathology or outcomes data are not mentioned.

8. The sample size for the training set:

• 126 medical images (CT scans).

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

• The ground truth for the training set was established through "corresponding segmentation." This typically means that experts manually segmented the anatomical structures (bones in this case) on the CT scans, and these expert-generated segmentations were used as the gold standard to train the AI model. The details of who performed these segmentations (e.g., number of experts, their qualifications) are not provided.

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Customize for shoulder arthroplasty is intended to be used as a software interface to assist in:

• Visualization, modification, validation of the planning of shoulder arthroplasty
• Communication of treatment options
• Segmentation of CT-scan data
• 3D CAD models generation
• Managing timeline and cases

Customize is not intended to be used for

• Spine surgeries
• Implant and instrument design

Experience in usage and clinical assessment are necessary for a proper use of the software. It is to be used for adult patients only and should not be used for diagnostic purposes.

Customize is intended to be used during the preparation of shoulder arthroplasties. It visualizes surgical treatment options that were previously created based on 3D CAD files generated from multi-slice DICOM data from a CT scanner. It consists of a single software user interface where the physician can review the CAD files in 3D and modify the position and orientation of the different 3D objects. Customize includes an implant library with 3D digital representations of various implant models so that the right implant positioning and sizing can be achieved based on the physician's input. After approval by the physician, the treatment plan is saved on the server and can be used as a reference during surgery.

Customize is prescription use only.

This 510(k) summary for the "Customize" device describes its intended use for shoulder arthroplasty planning. However, it does not provide specific acceptance criteria or a dedicated study report that details how the device meets those criteria with numerical performance metrics.

The document states that "Non-clinical performance data was included in the 510(k)-submission demonstrating Customize has been validated for its intended use and substantial equivalence to the predicate device." It also mentions "Software verification and validation was performed" and "performance testing included 1) segmentation validation of the Customize software, 2) Repeatability and Reproducibility study on the segmentation of shoulder anatomies and 3) accuracy study on 3D model generation for humerus and scapula."

However, the summary itself does not contain the detailed results, acceptance criteria, or study methodologies that would allow for a comprehensive answer to your request. It only broadly states that these tests were performed and that the device was deemed "substantially equivalent."

Therefore, I cannot populate the table or provide the detailed information requested regarding acceptance criteria and study particulars based solely on the provided text. The requested data points (sample sizes, ground truth details, expert qualifications, etc.) are not present in this summary.

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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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CustomizedBone Service (CustomizedBone) is intended to replace bony voids in the cranial and /or craniofacial skeleton (frontal bone including the brow ridge). This device is indicated for both adult and pediatric use (for children 7 years of age and above).

CustomizedBone implants are suitable for reconstructing craniofacial defects resulting from:

• · trauma and vascular pathologies, either associated or non-associated to cranial decompression:
• · removal of tumours:
• · reabsorption of autologous bone:
• rejection of other prosthetic materials:
• · congenital malformations.

Not Found

This document, K193547, is a 510(k) premarket notification decision letter for the "CustomizedBone Service" device. It is not an imaging AI device, but rather a preformed nonalterable cranioplasty plate. As such, the information you've requested regarding acceptance criteria and study data for an AI/ML device (e.g., sample sizes, expert ground truth, MRMC studies) is not present in this document.

The document primarily focuses on the FDA's determination of substantial equivalence for this medical device to existing predicate devices, its intended use, and regulatory compliance.

Therefore, I cannot provide the requested information about acceptance criteria and study data for an AI/ML device based on this specific input.

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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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