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510(k) Data Aggregation
(302 days)
Blue Sky Bio Multi One Implant System is intended for surgical placement in the bone of the upper or lower jaw to provide support for prosthetic devices to restore chewing function. Implants may be used with single-stage or two-stage procedures. They can be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Blue Sky Bio Multi One Implants are indicated for multiunit restorations in splinted applications. Blue Sky Bio Multi One Implant System with a 45° angulation are indicated for surgical installation in the pterygoid region only, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function.
Blue Sky Bio Long Implant System is intended for surgical placement in the bone of the upper jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. Implants may be used with single-stage or two-stage procedures, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Blue Sky Bio Long implants can be placed bicortically in cases of reduced bone density. Blue Sky Bio Long implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. Blue Sky Bio Long Implant System with a 45° angulation are indicated for surgical installation in the pterygoid region only, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function.
Blue Sky Bio PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.
Blue Sky Bio BIO|MAX MULTI ONE Implants include a one-piece implant/abutment construct provided with body diameters of 3.0 mm to 4.3 mm. in multiple lengths from 10 mm to 20 mm. They are provided with a head angulation of 17°, 30°, or 45°. Multi One Implants with body diameters of 3.5 mm and 4.3 mm, in lengths ranging from 10 mm to 20 mm with a 45° angulation are indicated for the pterygoid region only. Implant body diameters of 3.0 mm and 3.25 mm are only intended for the alveolar ridge and not intended for placement in the pterygoid region.
Blue Sky Bio BIO|LONG implants and BIO|MAX MULTI ONE LONG implants include implant lengths designed for placement into the posterior maxillary region. including the pterygoid plate. The implants have one of three connections, an internal hexagon interface (3.5 mm platform), a tapered internal hexagon interface (NP platform) or a Multi One one-piece design. The implants are provided with a body diameter of 3.7 mm to 5.0 mm in implantable lengths ranging from 20 mm to 25 mm. BIO|MAX MULTI ONE LONG implants are provided with a head angulation of 17°, 30°, or 45°. Blue Sky Bio BIO/LONG implants and BIQIMAX MULTI ONE LONG implants are intended to be used with the TILT procedure in the maxilla as shown in the clinical literature. Implants with 45° angulation are indicated for the pterygoid region only. BIOJINTERNAL HEX LONG implants (3.5 mm Platform) are for use with abutments of up to 30° only.
Details of specific implant diameters and lengths are outlined in the table below. Abutment screws compatible with the BIOJLONG Implants were cleared in K060957. K102034 and K190491.
Blue Sky Bio PEEK abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation. Subject device PEEK abutments are provided with two implant/abutment connections, BIO|INTERNAL HEX (3.5 mm Platform) and BIO|MAX (NP).
The subject device implants are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium- 6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). Previously cleared abutments and abutment screws are made of material conforming to ASTM F136. Temporary PEEK abutments are made from TECAPEEK conforming to ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications.
The Blue Sky Bio Implant System (K212785) is a dental implant system. The document does not explicitly state acceptance criteria or a formal study that proves the device meets specific acceptance criteria in the typical sense of a clinical trial with predefined endpoints and statistical analysis. Instead, the submission focuses on demonstrating substantial equivalence to legally marketed predicate devices through non-clinical performance testing and a review of existing clinical literature.
Here's a breakdown of the information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of explicit acceptance criteria with corresponding reported device performance in terms of clinical outcomes (e.g., success rates, marginal bone loss) derived from a dedicated study of the subject device. Instead, it relies on:
- Non-clinical performance test data demonstrating compliance with ISO standards and FDA guidance for dental implants.
- Clinical literature review to support the safety and effectiveness of similar implant dimensions and placement techniques, concluding that the subject device's dimensions and indications do not raise new questions of safety and effectiveness.
Here's a summary of the non-clinical performance and the basis of equivalence:
| Acceptance Criteria (Implied / Indirect) | Reported Device Performance (as stated in submission) |
|---|---|
| Fatigue Resistance (ISO 14801:2016 for Endosseous Dental Implants) | "Fatigue testing was performed according to the requirements of ISO 14801:2016, Dentistry - Dynamic loading test for Endosseous Dental Implants and following FDA Guidance, Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." (Implies satisfactory performance, no specific values given). |
| Biocompatibility (Cytotoxicity, per ISO 10993-1, 10993-5, 10993-12 for PEEK abutments) | "Cytotoxicity testing was performed on representative Temporary PEEK abutments (ASTM F2026-17) according to ISO 10993-1, ISO 10993-5, ISO 10993-12." (Implies satisfactory performance, no specific values given). |
| Packaging and Shelf-Life Stability | "The packaging for the subject device is the identical to the sponsor's own prior clearances as referenced in K102034 and K073713 in which accelerated aging testing was presented and leveraged for the subject devices." (Leveraged from predicate devices). |
| Sterilization (SAL of 10^-6 for sterile components) | "Test results and Sterilization Validations performed for the sponsor's own reference devices is also leveraged demonstrate suitable sterilization of the subject device sterile components with demonstration of a sterility assurance level (SAL) of 10-6." (Leveraged from predicate devices). |
| Pyrogenicity (LAL Endotoxin Analysis with testing limit of 20 EU/device) | "Pyrogenicity information provided is based on FDA Guidance... The method used to determine the device meets pyrogen limit specifications is LAL Endotoxin Analysis with testing limit of 20 EU/device, based on a blood contacting and implanted device." (Implies compliance). |
| End-user Sterility Validation (ISO 17665-2 for PEEK abutments) | "End-user sterility validation was conducted according to ISO 17665-2 for subject Temporary PEEK Abutments." (Implies compliance). |
| MRI Safety (Magnetically Induced Displacement Force and Torque) | "Non-clinical worst-case MRI review to evaluate the metallic devices in the MRI environment using scientific rationale and published literature... Rationale addressed parameters per the FDA guidance..." (Implies safety based on rationale and literature). |
| Clinical Safety/Effectiveness for Pterygoid Placement and Long Implants (Implied from clinical literature) | Clinical literature supports high success rates (e.g., 90.7% to 99%) for implants with similar dimensions and angulations in the pterygoid region and for the TILT procedure. The subject device's dimensions (10-25mm length, up to 45° angulation) fall within this window and are considered to not raise new questions of safety and effectiveness. |
2. Sample Size Used for the Test Set and the Data Provenance
- Non-clinical tests: The document does not specify sample sizes for the non-clinical tests. For leveraged data (packaging, sterilization, material biocompatibility), the sample sizes would refer to those used for the predicate devices, which are not detailed here. For fatigue, the ISO standard typically specifies a minimum number of samples (e.g., 11 per group for staircase method).
- Clinical Literature Review (not a "test set" in the traditional sense): This is a review of retrospective and prospective studies already published in scientific literature. The data provenance is global, as scientific literature authors are not limited by country. The "test set" here refers to the patient cohorts described in the reviewed articles, which would vary significantly. For example, one article mentions "1053 pterygoid implants in 676 patients" (Article 7).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This is not applicable as there was no dedicated clinical "test set" with a pre-established ground truth. The submission relies on scientific literature published by various researchers and clinicians, implicitly accepted by the regulatory body as supporting evidence.
4. Adjudication Method for the Test Set
Not applicable, as there was no dedicated clinical "test set" requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a dental implant system, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable, as this is a physical medical device (dental implant).
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the safety and effectiveness claims related to clinical use (e.g., implant success rates, complications, bone loss), the "ground truth" is derived from the clinical outcomes data reported in the published scientific literature that was reviewed. This literature typically involves various forms of clinical follow-up, radiographic assessment, and professional judgment by the treating clinicians/researchers in those studies.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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(149 days)
Blue Sky Bio CAD-CAM Abutments are intended to be used in conjunction with Blue Sky Bio endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations. All digitally designed abutments for use with Blue Sky Bio CAD-CAM Abutments are intended to be sent to a Blue Sky Bio validated milling center for manufacture.
The purpose of this submission is to obtain marketing clearance for Blue Sky Bio CAD-CAM Abutments, to be used with compatible components from the Blue Sky Bio Dental Implant System cleared in K051507. K060957, and K102034. The subject device includes Titanium Base Abutments, Cobalt Base Abutments, and Titanium Blank Abutments. For the Titanium Base Abutments and the Cobalt Base Abutments, the final finished device is intended to be used as a two-piece abutment composed of the base bottom-half (titanium base or cobalt base) bonded to a CAD-CAM zirconia top-half. Each abutment type provided in six (6) internal implant connections to the previously-cleared compatible Blue Sky Bio implants (BIO | MAX; BIO | Internal Hex; BIO | Conus 12; BIO | One Stage; and BIO | Trilobe). Titanium Base Abutments are designed for retention of a CAD-CAM fabricated zirconia superstructure and are provided in both straight and 15° angled base designs, and with engaging, non-engaging, and nonengaging conical implant connections. Cobalt Base Abutments are provided in both straight and 15° angled base designs, and with engaging and non-engaging implant connections. Cobalt Base Abutments (Straight) are designed to be a base for a final abutment fabricated by either of two methods. The first method is the same as for the Titanium Base Abutments: a CAD-CAM fabricated zirconia superstructure is bonded to the Cobalt Base Abutment (Straight) and the final two-piece abutment is used for the prosthetic restoration. For the second method, the Cobalt Base Abutments (Straight) can be cast to a straight abutment only, no angulation. The design of the final abutment can be by CAD-CAM, fabricated in wax, and fixed to the Cobalt Base Abutment, or the final design be done using traditional wax-up technique. The final one-piece abutment is fabricated using standard lost wax casting techniques. Cobalt Base Abutments (Angled 15°) are designed to be a base for a CAD-CAM fabricated zirconia superstructure bonded to the Cobalt Base Abutment (Angled 15°) and the final two-piece abutment is used for the prosthetic restoration. Cobalt Base Abutments (Angled 15°) are not to be cast to a final abutment. Titanium Blank Abutments are designed for fabrication of a customized all titanium alloy abutment by CAD-CAM processes. Titanium Blank Abutments have an engaging implant connection. The subject device abutments are made of titanium alloy conforming to ASTM F136 , or cobaltchromium alloy conforming to ASTM F1537. The titanium alloy subject device components are manufactured from identical materials, in the identical facilities using the identical manufacturing processes as used for Blue Sky Bio products cleared previously in K051507, K060957, and K102034. All zirconia superstructures (copings) for use with the subject devices Titanium Base Abutments and Cobalt Base Abutments will be made at a Blue Sky Bio validated milling center under FDA quality system regulations, and the material will conform to ISO 13356. All wax designs for casting to the subject device Cobalt Base Abutments also will be made at a Blue Sky Bio validated milling center. For the lost wax technique, final one piece abutment may be cast in cobalt-chromium alloy or nickel-chromium alloy.
The provided text is a 510(k) Summary for Blue Sky Bio CAD-CAM Abutments, which is a dental device. It focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than providing detailed acceptance criteria and study results for a novel AI/ML device.
Therefore, the document does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving a device meets these criteria for an AI/ML product.
The text describes:
- Device: Blue Sky Bio CAD-CAM Abutments (dental implant components).
- Indications for Use: To be used with Blue Sky Bio endosseous dental implants to support single-unit or multi-unit prosthetic restorations. Digitally designed abutments are sent to a Blue Sky Bio validated milling center for manufacture.
- Performance Data (Non-clinical): Mentions sterilization validation (ISO 17665-1, ISO 17665-2), biocompatibility testing (ISO 10993-5, ISO 10993-12), and static and dynamic compression-bending testing (ISO 14801).
- Clinical Data: Explicitly states "No clinical data were included in this submission."
- Substantial Equivalence: Compares the subject device to various predicate and reference devices in terms of indications for use, design principles, materials, physical dimensions, packaging, and sterilization methods. The mechanical testing (ISO 14801) is mentioned as mitigating minor design differences.
Without information specific to an AI/ML device, I cannot fulfill the request to describe acceptance criteria and a study proving an AI/ML device meets them, nor can I populate the table or provide details on sample size, data provenance, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, or training set details.
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(165 days)
Blue Sky Bio Zygomatic Implant System is indicated for surgical installation in the zygoma region, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Blue Sky Bio zygomatic implants are recommended for the posterior (pre-molar) region, one implant on each side, with at least two standard dental implants in the anterior region to support a fixed restoration. Blue Sky Bio zygomatic implants may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
The purpose of this submission is to expand the Blue Sky Bio Zygomatic Implant System cleared in K153064. This submission includes abutments with two interface connection designs for attachment to the previously cleared zygomatic implants: an internal hexagon connection (with a 45° bevel) and a tapered internal hexagon connection (with a 12° taper). The internal hexagon connection abutments are provided in platforms of 3.5 mm and 4.5 mm. The tapered internal hexagon connection abutments are provided in platforms of 3.5 mm (NP) and 4.3 mm (RP). All subject abutments have an angulation of 45° and are for support of screw-retained overdenture prosthetic restorations. Except for the angulation, the subject device abutments have the same designs as corresponding abutments cleared in K153064. The abutment screws compatible with the subject device abutments were cleared in K060957 and K102034. The subject device abutments are made of titanium alloy conforming to ASTM F136. The previously cleared abutment screws also are made of material conforming to ASTM F136.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
The document is a 510(k) Premarket Notification from the FDA for the Blue Sky Bio Zygomatic Implant System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than proving safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" and "study" described are primarily related to non-clinical performance testing to support this equivalence, particularly for an expanded indication (new abutment angulation).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the performance testing performed to demonstrate equivalence to the predicate device. For devices like this, the "acceptance criteria" generally align with established standards for dental implants and their components.
| Acceptance Criteria (Implied Standard) | Reported Device Performance (as stated in the document) |
|---|---|
| Biocompatibility (conformance to relevant standards for implantable materials) | Biocompatibility (referenced from K153064) |
| Sterilization Validation (effective sterilization method) | Sterilization validation according to ISO 17665-1 and ISO 17665-2 (referenced from K153064 and K073713) |
| Mechanical Strength/Fatigue Life (sufficient strength for intended use, especially under dynamic loading) | Dynamic compression-bending testing of the 45° NP (3.5 mm platform) abutment on a compatible tapered internal hexagon connection 4.3 mm body diameter implant according to ISO 14801. |
| Result: The fatigue limit data demonstrated that constructs of the subject device abutments in combination with the previously-cleared compatible zygomatic implants, and used according to the proposed labeling, have sufficient strength for their intended use. | |
| Engineering Analysis (structural integrity and design suitability) | Engineering analysis |
| Material Conformance (materials meet specified standards) | Abutments made of titanium alloy conforming to ASTM F136; abutment screws also conform to ASTM F136. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a precise sample size in terms of number of abutments or implants tested for the mechanical performance data. It mentions "constructs" for dynamic compression-bending testing. For ISO 14801, a typical number of samples for fatigue testing is outlined in the standard, usually involving multiple samples at different load levels to determine a fatigue limit. However, the exact number is not explicitly stated in this summary.
- Data Provenance: The data is non-clinical performance testing performed by the manufacturer (Blue Sky Bio, LLC) or a contracted lab. It is inherently prospective in the sense that the tests were conducted specifically for this submission. There is no mention of country of origin for the data, but it can be assumed to be from a lab adhering to the relevant ISO standards typically accepted in the US for regulatory submissions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the described studies are non-clinical (mechanical and material testing), not clinical studies involving patient data or expert interpretation of medical images/outcomes. Ground truth in this context is established by adherence to specified engineering standards (e.g., ISO 14801, ASTM F136).
4. Adjudication Method for the Test Set
This section is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation or outcome assessment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This submission explicitly states: "No clinical data were included in this submission." MRMC studies typically assess the diagnostic performance of a device or algorithm in a clinical context, often with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study in the context of an algorithm or AI is not applicable here. This device is a physical dental implant system, not a software algorithm. The "standalone" performance relates to the mechanical integrity of the physical components.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance data primarily consists of established engineering standards and material specifications.
- For mechanical testing, the ground truth is the pass/fail criteria defined by ISO 14801 (e.g., meeting a certain fatigue limit without failure).
- For material composition, the ground truth is conformity to ASTM F136 specifications for titanium alloy.
- For sterilization, the ground truth is validation against ISO 17665-1 and ISO 17665-2.
8. The Sample Size for the Training Set
This section is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as point 8.
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(190 days)
Blue Sky Bio Zygomatic Implant System is indicated for surgical installation in the zygoma region, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Blue Sky Bio zygomatic implants are recommended for the posterior (pre-molar/molar) region, one implant on each side, with at least two standard dental implants in the anterior region to support a fixed restoration. Blue Sky Bio zygomatic implants may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
Blue Sky Bio Zygomatic Implant System submission includes threaded root-form dental implants and mating abutments designed for placement into the zygomatic bone. The zygomatic implants are provided with an internal hexagon connection and a tapered internal hexagon interface for connection to the subject abutments. The internal hexagon connection implants are provided with a body diameter of 4.7 mm and platform diameters of 3.5 mm and 4.5 mm. The tapered internal hexagon connection implants are provided with a body diameter of 4.3 mm and a narrow platform (NP) connection, and with a body diameter of 5.0 mm with a regular platform (RP) connection. All implants are provided in multiple overall threaded lengths ranging from 35 mm to 55 mm. This submission includes mating abutments with platform diameters of 3.5, 4.3, and 4.5 mm. and each abutment diameter is provided with 17° and 30° of angulation. All subject device abutments are for support of screw-retained overdenture prosthetic restorations. The abutment screws compatible with the subject device abutments were cleared in K060957 and K102034. The subject device zygomatic implants are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The previously cleared abutment screws also are made of material conforming to ASTM F136.
This is a 510(k) premarket notification for a dental implant system, which primarily relies on demonstrating substantial equivalence to already legally marketed predicate devices rather than proving a device meets specific performance acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable in this context.
The document mainly focuses on comparing the new device's characteristics to those of predicate devices and showing that any differences do not raise new questions of safety or effectiveness.
Here's a breakdown of the information that is available or applicable from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a substantial equivalence submission, formal "acceptance criteria" in the sense of predefined thresholds for clinical performance against a disease are not provided. Instead, the device demonstrates performance through engineering analysis, dimensional analysis, and dynamic compression-bending testing to show it is comparable to predicate devices.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Referenced from predicate devices K102034 and K060957, implying the new device materials are biocompatible. |
| Dimensional Analysis | Compared to predicate devices. The subject device implants are in the same overall length range as the primary predicate K141777 (35 mm to 52.5 mm), and the 55 mm length is supported by reference predicate K093562. Smaller body diameter (4.3 mm) is supported by reference predicate K093562 (4.05 mm) and dynamic compression-bending testing. Abutment platform diameters (3.5, 4.3, 4.5 mm) and angulations (17°, 30°) are presented. |
| Dynamic Compression-Bending Testing (Fatigue Performance) | According to ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants). Demonstrated fatigue performance substantially equivalent to that of the primary predicate K141777, especially for worst-case constructs (smallest diameter implant - Taper Hex 4.3 mm body diameter - and largest angulation - 30°). This implies meeting or exceeding the predicate's fatigue resistance as tested per the standard. |
| Material Composition | Ti-6Al-4V conforming to ASTM F136, same as previously cleared components in K102034 and K060957. |
| Surface Finish | Grit blasted and acid etched for endosseous surface, same as predicate implants in K102034 and K060957. |
| Sterilization & Packaging | Similar materials and processes as described in K102034 and K060957 (implants sterilized, abutments provided non-sterile for sterilization by user). |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated in terms of a "number of cases" or "number of patients" as this was a non-clinical submission. For the dynamic compression-bending testing per ISO 14801, the standard typically specifies the number of samples required for fatigue testing, but the exact number used in this specific test is not provided in the summary.
- Data Provenance: Non-clinical (lab-based engineering and material testing). Not applicable in terms of country of origin or retrospective/prospective for clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth in a clinical sense (e.g., disease presence/absence determined by expert radiologists) is not relevant for this type of non-clinical device submission.
4. Adjudication method for the test set:
Not applicable. No expert adjudication process as this was a non-clinical submission.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a physical dental implant system, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used:
- For Biocompatibility: Material specifications (ASTM F136) and prior clearance of similar materials in predicate devices (K102034 and K060957).
- For Dimensional Analysis: Engineering drawings and measurements, compared against predicate device specifications.
- For Dynamic Compression-Bending Testing: The performance requirements of the ISO 14801 standard and the comparative performance of the primary predicate device (K141777).
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. No training set was used.
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