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510(k) Data Aggregation
(374 days)
A.B. DENTAL DEVICES® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. A.B. DENTAL DEVICES® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Two Stage Implants: I22, I5, I55, I10.
P4 and P14 angled abutments are to be used only with standard platform implants 3.5 mm in diameter or larger.
A.B. DENTAL DEVICES® Dental Implants System consists of one and two stage endosseous form dental implants, internal hexagonal and one piece implants systems. Narrow platform implants are to be used with straight abutments only. The following components are being added:
| Implant | Platform | Diameter, mm | Length, mm |
|---|---|---|---|
| I22 | Standard | 3.75 | 8, 10, 11.5, 13, 16 |
| 4.2 | 8, 10, 11.5, 13, 16 | ||
| 4.5 | 8, 10, 11.5, 13, 16 | ||
| 5 | 8, 10, 11.5, 13, 16 | ||
| I5 | Narrow | 3.3 | 10, 11.5, 13, 16 |
| I55 | Narrow | 3.3 | 10, 11.5, 13, 16 |
| 3.5 | 8, 10, 11.5, 13, 16 | ||
| Standard | 3.75 | 8, 10, 11.5, 13, 16 | |
| 4.2 | 8, 10, 11.5, 13, 16 | ||
| 4.5 | 8, 10, 11.5, 13, 16 | ||
| 5 | 8, 10, 11.5, 13, 16 | ||
| 6 | 8, 10, 11.5, 13, 16 | ||
| I10 | Standard | 4.5 | 10, 11.5, 13, 16 |
Abutments:
- P0-14 Healing caps, 2.5 7 mm heights .
- P3-5 straight abutments, 5 mm diameter, 7 9 mm length ●
- P4 angled abutments, 15 - 25 degree angulation, standard platform, standard and long lengths
This is a 510(k) summary for a dental implant system. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive performance data against specific acceptance criteria for a novel AI/ML device. Therefore, much of the requested information regarding AI/ML device performance studies is not available in this document.
Here's an analysis of the provided text based on your request, highlighting what is present and what is not:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria in the typical sense for an AI/ML device, as it describes a dental implant system. The performance data presented are primarily related to mechanical and biological safety, not diagnostic accuracy or effectiveness against quantifiable metrics for an AI system.
However, we can infer some "performance data" or testing performed:
| Test Performed | Reported Device Performance |
|---|---|
| Fatigue testing per ISO 14801:2007 | Performed on worst-case implant and abutment combination for standard platform implants and abutments. Engineering analysis to determine novel worst-cases. (Implication: Device withstands fatigue as per standard) |
| Cytotoxicity testing per ISO 10993-5 | Performed. (Implication: Device is biocompatible) |
| Biological risk assessment | Performed. (Implication: Risks are assessed and managed) |
| Gamma sterilization validation per ISO 11137 | Validated. (Implication: Device is sterile) |
| Steam sterilization validation per ANSI/AAMI/ISO 17665-1:2006 | Validated. (Implication: Device is sterile) |
| Packaging validation and accelerated shelf-life testing | Performed. (Implication: Packaging maintains sterility, shelf life is established) |
| LAL testing | Performed. (Implication: Device is endotoxin-free) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The performance data listed (fatigue, cytotoxicity, sterilization, etc.) are standard engineering and biological tests for medical devices, not clinical studies with patient data.
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. The "ground truth" for these tests relates to established standards and physical/chemical properties, not expert consensus on medical images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided.
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 information is not applicable and not provided. This is a conventional dental implant, not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the performance tests (fatigue, cytotoxicity, sterilization) would be the established international standards themselves (ISO 14801, ISO 10993-5, ISO 11137, ANSI/AAMI/ISO 17665-1) and their defined pass/fail criteria. For LAL testing, it would be the absence of endotoxins as per FDA guidance.
8. The sample size for the training set
This information is not applicable and not provided. This is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable and not provided. This is not an AI/ML device.
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(368 days)
JDentalCare® implant system is intended for surgical placement in the upper or lower jaw. JDentalCare® implant system is comprised of dental implant fixtures and prosthetic devices. JDentalCare® implant system provides a means for prosthetic attachment in single tooth restorations and partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures. Prosthetic devices provide support and retention for screw-retained or cemented restorations in mandible and maxilla. JDentalCare® implant system is intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.
JDentalCare®implant system is composed by a fixture and an abutment, joined together by a through screw (JDEvolution). In this case the connection is done through an internal hexagon. Abutments and accessories are exclusive for JDentalCare®implant system. JDentalCare®implants are threaded, root-form dental implants, intended to provide a mean for prosthetic attachment in the rehabilitation of partial or total edentulism, in single tooth restorations or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures. JDentalCare®implants are machined from grade 4 or grade 5 titanium and tapered. Their surface is treated with a double acid etched treatment. JDentalCare®implants may be placed in the oral cavity using either a single stage surgical procedure or a two stage surgical procedure. If a single stage procedure is used, the implants may be placed anywhere in the upper or lower jaw where good initial stability can be obtained.
This document is a 510(k) Summary for the JDentalCare® Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailing a study that proves the device meets specific acceptance criteria in the way a clinical trial for an AI/CAD system would. Therefore, much of the requested information (like sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not directly applicable or available from this document.
However, I can extract the acceptance criteria as described for the device's characteristics and the "study" (which are performance tests and validation activities) demonstrating substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
Since this document is a 510(k) summary for a dental implant system (a physical medical device, not an AI/CAD software), the "acceptance criteria" are related to its physical, material, and functional properties being equivalent to legally marketed predicate devices, and demonstrating safety and effectiveness through various tests.
| Acceptance Criteria (Demonstrated Equivalence / Performance) | Reported Device Performance (JDentalCare® Implant System) |
|---|---|
| Intended Use Equivalence | Intended use is substantially equivalent to predicate devices for surgical placement in the upper or lower jaw, prosthetic attachment in single tooth restorations, partially or fully edentulous spans (delayed/immediate loading), and as an abutment for bridgework or overdentures. Immediate function for single/multiple tooth applications with good primary stability and appropriate occlusal loading. |
| Material Composition | Machined from Grade 4 or Grade 5 Titanium (for Ø 3.25mm) for implants; abutments are Titanium (Gr.5). This is equivalent to or the same as predicate devices (e.g., Nobel Active uses Titanium Grade 4, Implant Direct Legacy uses Titanium alloy (Ti6AL-4V ELI) (Grade 5)). |
| Design and Mechanical Features (Shape, Thread, Connection) | Two pieces, tapered screw, internal hexagon with double trapezoidal thread. This is consistent with predicate devices. |
| Dimensions (Diameter, Length) | Implants available in diameters: 3.25, 3.7, 4.3, 5, 6 mm and lengths: 8, 10, 11.5, 13, 15 mm. These dimensions fall within the range or are comparable to the dimensions offered by predicate devices. Abutment heights also consistent with predicate devices. |
| Surface Treatment | Double acid etched treatment (fluoride acid etching, then strong acids sulfuric + hydrochloric acid), followed by cool plasma cleaning. Surface validation tests (SEM, XPS) confirm complete removal of manufacturing materials. |
| Biocompatibility (ISO 10993-1:2010 Part 1) | Tested for Cytotoxicity, Intracutaneous reactivity, Delayed Hypersensitivity, Systemic Toxicity, Bacterial Reverse Mutation. Results: Not Cytotoxic, Satisfying requirements for intracutaneous reactivity, Not sensitizing, Satisfying requirements for systemic toxicity, Not Mutagenic. |
| Mechanical Performance (ISO 14801:2007) | Dynamic fatigue tests performed in compliance with "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and "ISO 14801: 2007 - Dynamic fatigue test for endosseous dental implants". The document states tests were performed in compliance, but specific quantitative acceptance criteria or results are not listed in this summary. The implication is that they meet acceptable engineering standards. |
| Sterilization & Packaging Shelf Life (ISO 11137-1, ASTM 1980) | Sterilized with gamma ray sterilization to assure a SAL level of 10⁻⁶. Shelf life is 5 years. Packaging and shelf life were tested and validated according to applicable international standards. The packaging type (plastic vial + blister) and method of sterilization (Gamma Radiation) are consistent with predicate devices. Abutments are noted as not sterile, consistent with one predicate, while another predicate's abutments are sterile. This difference is considered in the context of substantial equivalence. |
| Packaging | Plastic vial + blister, sterile. Consistent with predicate devices. |
2. Sample Size for Test Set and Data Provenance
This document does not describe a clinical study in the format of an AI/CAD device. Instead, "tests" refer to laboratory-based performance testing of the physical implant device and its materials. Therefore, there are no "test sets" of patient data in the conventional sense.
- Sample Size for Test Set: Not applicable. Tests involve physical samples of the implant devices and materials. The number of samples for each mechanical or biocompatibility test is not specified in this summary but would be standard for such device testing.
- Data Provenance: Not applicable for patient data. The tests are laboratory-based, performed on manufactured devices.
3. Number of Experts and their Qualifications for Ground Truth
Not applicable. Ground truth for a physical medical device like a dental implant is established through validated laboratory tests against engineering standards and material specifications, not through expert clinical consensus on patient data.
4. Adjudication Method
Not applicable. No clinical expert adjudication is mentioned or relevant for the types of tests described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a physical dental implant, not an AI/CAD system, so an MRMC study is not relevant.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical dental implant, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device, which refers to its performance and safety, is established through:
- Compliance with international standards (e.g., ISO 10993-1 for biocompatibility, ISO 14801 for mechanical fatigue).
- Material specifications (e.g., ASTM F67 for Titanium Grade 4, ASTM F136 for Titanium-6Aluminum-4Vanadium ELI Alloy).
- Laboratory test results (e.g., cytotoxicity, fatigue strength, surface analysis).
- Comparison to predicate devices with an established history of safe and effective use.
8. Sample Size for the Training Set
Not applicable. This is a physical device, not an AI/CAD system that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
Not applicable.
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(160 days)
OsteoReady ® ZircoSeal® Dental Abutments are intended to be used with an endosseous implant to aid prosthetic rehabilitation in order to restore the patient's chewing function. OsteoReady® ZircoSeal® Abutments are compatible with DENTIN® Dental Implant System - Prestige Implant System diameters 3.75, 4.2, 5 & 6;
OsteoReady® ZircoSeal® Abutments are Straight Anti-Rotation Abutments made of titanium alloy. OsteoReady® ZircoSeal® Abutments are available in the following measurements:
Slim Anti-Rotation Titanium Abutment with ZircoSeal®: Length 5,7,9,11,13 mm with Diameter 3.75 mm.
Anti-Rotation Titanium Abutment with ZircoSeal®: Length 5,7,9,11,13 mm Diameter 4.5 mm.
Anti-Rotation Straight Titanium Abutment with ZircoSeal®: Shoulder Length 1,2,3,4 mm Diameter 4.5 mm.
OsteoReady® ZiroSeal® Abutments are straight only and are not intended to be modified chairside or by CAD/CAM to provide an angle correction.
The ZircoSeal surface treatment is the trade name of zirconium nitride.
The ZircoSeal® simply indicates the signature zirconium nitride surface treatment of the abutment. The trade name is unrelated to claims of "sealing" of implant/abutment connection platform.
This document is a 510(k) premarket notification for the OsteoReady® ZircoSeal® Abutments, asserting substantial equivalence to previously marketed devices. It does not describe a study to prove a device meets specific acceptance criteria in the way one might expect for a diagnostic or AI-powered device.
Instead, the "acceptance criteria" here refer to meeting the requirements for demonstrating substantial equivalence to predicate devices, primarily through performance testing, biocompatibility testing, and comparison of device characteristics.
Here's an analysis based on the provided text, addressing your questions where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of "acceptance criteria" paired with "reported device performance" in the context of clinical accuracy or performance metrics for an AI/diagnostic device. Instead, it lists the types of tests conducted and their successful outcomes as proof of equivalence and safety.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sterilization Validation | Achieve a Safety Assurance Level (SAL) of 10⁻⁶ | Met all applicable criteria; SAL of 10⁻⁶ was achieved. |
| Biocompatibility Testing | Meet all applicable criteria as per ISO 10993-5 (cytotoxicity) | Met all applicable criteria. |
| Surface Treatment Eval. | (Implied) Consistency with predicate device characteristics | Chemical analysis and abrasion characteristics evaluated (details not provided beyond being "similar"). |
| Material Composition | (Implied) Same or equivalent to predicate devices (GR-5 Titanium) | GR-5 Titanium Ti-6Al-4V ELI (consistent with most predicates). |
| Design Characteristics | (Implied) Similar to predicate devices | Straight Anti-Rotation Abutments, various lengths/diameters, Internal Hex connection (similar to predicates). |
| Indications for Use | (Implied) Substantially equivalent to predicate devices | Minor verbiage differences, but determined not to change intended use. |
| Risk Assessment | Conducted in accordance with ISO 14971:2012 | Determined that differences raise no new safety or effectiveness issues. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a test set or data provenance in the context of a clinical performance study (e.g., for AI/diagnostic algorithms). The "tests" mentioned are non-clinical, such as sterilization, biocompatibility, and material characterization. Therefore, information about "sample size for a test set" or "data provenance" (country of origin, retrospective/prospective) is not applicable or provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This device is a dental abutment, not an AI or diagnostic device requiring expert interpretation for ground truth.
4. Adjudication Method
Not applicable. There is no clinical study involving human interpretation or ground truth adjudication in this submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document does not mention an MRMC study. The device is a physical dental abutment, not a diagnostic tool requiring human-AI comparative effectiveness evaluation.
6. Standalone Performance Study
Yes, in a non-clinical sense. The testing performed (sterilization, biocompatibility, surface treatment evaluation) assessed the standalone performance of the OsteoReady® ZircoSeal® Abutments against established standards (ISO, AAMI) and similarity to predicate devices. However, this is not a "standalone algorithm performance" study as would be relevant for an AI device.
7. Type of Ground Truth Used
The concept of "ground truth" as typically applied to diagnostic or AI studies is not directly relevant here. The "truth" in this context is established by:
- Standards compliance: E.g., ISO 10993-5 for biocompatibility, ISO 17665-1/2 and ANSI/AAMI ST79:2010 for sterilization.
- Material specifications: GR-5 Titanium Ti-6Al-4V ELI.
- Manufacturing specifications: Device design features (diameters, lengths, connection type).
- Chemical analysis: For surface treatment evaluation.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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(137 days)
NOVA® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. NOVA® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
NOVA® Dental Implants System consists of internal hex dental implants. cover screws and healing caps; abutments system and superstructures; impression copy system & surgical instruments.
Internal hex implants:-
PSI implants are provided in diameters: 3.3, 3.75, 4.2, 5 & 6 with lengths 8, 10, 11.5, 13, & 16 mm. (16 mm is not provided for 6 mm diameter).
PCI implants are provided in diameters: 3.3, 3.75, 4.2, 5 & 6 with lengths 8, 10, 11.5, 13, & 16 mm. (16 mm is not provided for 6 mm diameter).
NOVA Dental Abutments internal hex system provides:
Healing Caps:
HC Series - Narrow (3.75 mm) - Platform height 2,3,4,5,6,7
HC Series - Standard (4.7 mm) - Platform height 2.3.4.5.6.7
HCW Series - Wide (6.00 mm) - Platform height 3,4,5,6
PMI Series - Premium (3.75, 4.7, 6.0 mm) - Platform height 2,3,4,5,6,7
Straight Abutments (Long, straight, narrow, anatomic, curve):
ST Series: Length 8.5, 9.5, 11.5, 12.5 mm.
STA Series: With Shoulder profile height 1, Length 9 mm; profile height 2, Length 10; profile height 3, Length 11; profile height 4 Length 12.
STN: Narrow length 11 mm.
SLM Series: Anatomic Straight Abutment: profile height 1,2,3 length 9,10,11 mm.
SCM Series: Anatomic Straight Abutment: profile height 1.2.3 length 9.10.11 mm.
Angulated Abutments (standard, anatomic, curve):
Standard Angulated Abutment Length 7,9,11 Angulations 15°, 25°.
Anatomic Angulated Abutments Platform height 1,2,3,4 Angulations 15°, 25°.
Anatomic Angulated Curve Platform height 1,2,3, Angulations 15°, 25° .
Ball Attachments Platform height 1.2.3.4.5.6 and related components covers and caps.
Material:
NOVA® Dental Implants System and Dental Abutments System is made of Titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136.
The provided document is a 510(k) premarket notification for the NOVA® Dental Implants System. It aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing new acceptance criteria or proving performance through a clinical study.
Therefore, many of the requested details about acceptance criteria and a study proving the device meets those criteria are not available in this document. This submission focuses on demonstrating that the new device is as safe and effective as existing, predicate devices by comparing their characteristics and performance through non-clinical testing.
Here's what can be extracted and inferred from the document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, formal "acceptance criteria" for a new, standalone clinical study are not explicitly stated for individual performance metrics in the way you might find in an efficacy trial. Instead, the "acceptance" is based on the new device's performance being comparable to or meeting standards similar to the predicate devices, as demonstrated through various tests.
| Characteristic | Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (NOVA® Dental Implants System) |
|---|---|---|
| Biocompatibility | Conform to ISO 7405:2008 (Dentistry Evaluation of biocompatibility of medical devices used in dentistry) and demonstrate no evidence of causing cell lysis or toxicity, equivalent to predicate devices. | Test results demonstrated no evidence of causing cell lysis or toxicity and thus present equivalent performance as its predicate devices. |
| Dynamic Fatigue Strength | Comply with ISO 14801:2007 (Dentistry-Implants-Dynamic fatigue test for endosseous dental implants), demonstrating equivalent fatigue load strength to predicate devices. | Fatigue - Static & Cycling tests conducted comply with ISO 14801:2007. The results demonstrate that the subject devices are substantially equivalent to the predicate devices. |
| Sterilization | Achieve a Sterility Assurance Level (SAL) of 10-6 and meet all testing requirements. | Test results demonstrated that the SAL of 10-6 was achieved and all testing requirements were met. |
| Material Composition | Conform to ASTM F136 (Titanium alloy Ti-6Al-4V ELI) and be identical to predicate devices. | Made of Titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136. Shares the same raw material as its predicate devices (GR-5 Titanium Ti-6Al-4V ELI). |
| Primary Stability for Immediate Loading | (Implied to be achieved and maintained upon implantation, comparable to predicate devices stated for immediate loading with good primary stability and appropriate occlusal loading). | Indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading, similar to predicate devices. (No specific numerical data on primary stability is provided as this is a non-clinical submission). |
| Intended Use / Indication for Use | Equivalent to the predicate devices: surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices (artificial teeth) to restore chewing function. Also, for immediate loading when good primary stability is achieved and with appropriate occlusal loading. | Identical to the predicate devices. |
| Technological Characteristics (Design) | Similar to predicate devices: threaded, root form endosseous implants. Internal hex dental implants, cover screws, healing caps, abutments, superstructures, impression copy system, surgical instruments. Dimensions (diameters and lengths) comparable to predicate devices. Surface treatments (sand blast with acid etched, anodized) comparable to predicate devices. | Described as internal hex dental implants with various diameters (3.3, 3.75, 4.2, 5, 6 mm) and lengths (8, 10, 11.5, 13, 16 mm). Includes PCI (straight contour) and PSI (tapered contour) implants. Surface treatment includes sand blast with acid etched and anodized. Shares similarity with predicate devices in design and technological characteristics. |
| Risk Management | Conducted in accordance with ISO 14971:2007. | Risk management process was carried out with accordance to ISO 14971:2007. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This submission relies on engineering bench tests and comparisons to predicate devices, not patient-based test sets.
- Data Provenance: The document does not specify the country of origin for the data used in the biocompatibility, sterilization, or mechanical tests, nor does it refer to retrospective or prospective patient data. This is a non-clinical submission.
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 the context of expert consensus or pathology data is used for clinical studies diagnosing a condition. This document is for a dental implant system being cleared via substantial equivalence, which primarily involves engineering, material, and biocompatibility testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically for clinical performance evaluations, especially for diagnostic devices.
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 premarket notification for a physical medical device (dental implants), not an AI-powered diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical dental implant and abutment system, not an algorithm or software. No standalone algorithm performance was studied.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The compliance of the device with established international standards (ISO 7405, ISO 5832-3, ISO 14801, ISO 14971), and the direct comparison of its design, materials, and intended use against already cleared predicate devices, serves as the basis for "truth" in this regulatory context of substantial equivalence. This is primarily engineering and material science compliance with standards, and logical deduction for equivalence to predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth established for one.
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