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510(k) Data Aggregation
(422 days)
ALFA GATE® Dental Implants System is intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. ALFA GATE® Dental Implants System may be immediate loading when good primary stability is achieved and with appropriate occlusal loading. ALFA GATE® 3.00mm S-LINE & SLIM implants are intended for placement at the mandibular central and lateral incisors and maxillary lateral incisors. Indicated also for denture stabilization using multiple implants. Two Stage Implants: M+, S-LINE, SCI, SCIP, MAX. One Stage Implants: SLIM Implants.
ALFA GATE Dental Implants longer than 13mm are to be used with straight abutments only.
ALFA GATE® Dental Implant System is consist of endosseous form Dental Implants, Internal hex Implants, Internal Conical Connection Implants, One piece Implants, tapered design; cover screws, healing caps and abutment systems; Dental Implants are provided in two options of surface treatment (1) Bioactive Surface-CaP which is a calcium phosphate coating; or (2) Sand blast large particles with acid etched;
Dental Implants:
M+ IMPLANTS - Internal Hex, Conical Connection Implant
Measurements: Diameter mm 3.5, 4.3, 5.0, 6.0; with Length mm 8, 10, 11.5, 13, 16(not for 60 mm);
S-LINE Implants - Internal Hex implant, Narrow Implants
BIOACTIVE S-LINE Implant - Measurements: Diameter mm 3.0 with Length mm 10, 11.5, 13;
POROUS S-LINE Implant - Measurements: Diameter mm 3.0 with Length mm 10, 11.5, 13:
SCI Implants - Internal Hex implant, Spiral conical design
BIOACTIVE SCI Implant - Measurements: Diameter mm 3.3, 3.75, 4.2, 4.7, 5.2, 6.0 with Length mm 8, 10, 11.5, 13, 16 (not for 5.20,60 mm);
POROUS SCIP Implant - Measurements: Diameter mm 3.3, 3.75, 4.2, 4.7, 5.2, 6.0 with Length mm 8, 10, 11.5, 13, 16 (not for 5.2Ø,6Ø mm):
MAX Implant - Internal hex implant, cylindrical and conical body design
Measurements: Diameter mm 3.3, 3.75, 4.2, 4.7, 5.2 with Length mm 8, 10, 11.5, 13, 16;
SLIM Implant - One Piece implants
Measurements: Diameter mm 3.0, 3.3, 3.75 with Length mm 10, 11.5, 13, 15;
Dental Abutments:
Straight abutments (Regular, Thin, Wide, Narrow), Angled Abutments 15° (Regular, Short), Multi Unit, Shoulder abutments, Esthetic Abutments, Concave Esthetic Abutments, Esthetic Abutments 15°, Concave Angulated Abutments 15°, Esthetic Abutments , Alfa lock abutment (locator), Ball attachment Abutment, Ball attachment concave, Healing Caps (Narrow, Regular, Wide, Slim), Concave healing caps, Anatomic Abutment. Angled abutments are only to be used with S-Line, SCI, and MAX implants. M+ and SLIM implants are not to be used with angled abutments. Dental Abutments Conical Connection:
Anatomic straight Abutment (RP, NP), Standard straight abutment (RP, NP), Ball attachment (RP, NP), Healing Caps (RP, NP).
The provided text describes the 510(k) premarket notification for the ALFA GATE® Dental Implants System. The entire document focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on proving device performance against specific acceptance criteria for an AI/ML-based device.
Therefore, I cannot provide the requested information as the provided text does not contain:
- Acceptance criteria for an AI/ML device: The document pertains to traditional dental implants and abutments.
- Reported device performance for an AI/ML device: The performance tests conducted are for mechanical, biocompatibility, and sterilization properties of the physical implants, not for an AI/ML algorithm's diagnostic or predictive capabilities.
- Sample size or data provenance for AI/ML test sets: There are no mentions of test sets, training sets, or data used for AI/ML model evaluation.
- Information about experts or ground truth for AI/ML evaluation: The document does not discuss expert adjudication or establishing ground truth for evaluating AI/ML performance.
- MRMC studies or standalone AI performance: These are concepts specific to AI/ML device studies, which are not relevant to the content of this document.
The document primarily relies on bench testing (fatigue, sterilization, shelf-life, biocompatibility, surface tests) and comparison to predicates to demonstrate substantial equivalence for the physical dental implant system. There is no mention of any AI or machine learning component in the ALFA GATE® Dental Implants System.
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(432 days)
The Zuga™ Dental Implant System is indicated for immediate or delayed implant placement for surgical and restorative applications in maxillary and/or mandibular arches to support prosthetic devices, such as artificial teeth, crowns, bridges, and overdentures. The Zuga™ Dental Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The Zuga™ Dental Implant System includes endosseous dental implants, sealing caps, healing caps, dental implant abutments, and fixation screws in a variety of sizes to accommodate differing patient anatomy. Implantation is suitable for one-or two-stage procedures. Endosseous implants are bone level, self-tapping, root-form, threaded. The threaded surface is blasted, then passivated. Sizematched anterior and posterior abutments are offered. Thes are fastened to the implant using a fixation screw. Sealing caps and healing caps provide protection to the abutment connection threads during endosseous and gingival healing. The implants are provided sterile, the remaining components must be sterilized prior to use.
The provided text describes a 510(k) premarket notification for the Zuga™ Dental Implant System. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than proving that the device meets a set of specific acceptance criteria through clinical performance metrics like sensitivity, specificity, or accuracy, as would be common for AI-driven diagnostic devices.
Therefore, the document does not contain the information requested regarding acceptance criteria in terms of performance metrics for an AI/ML device, nor does it detail a study proving the device meets such criteria with respect to AI performance.
Instead, the "Performance Data" section ([15]) focuses on biological and mechanical compatibility/safety testing, which is standard for medical devices like dental implants. These tests are designed to show that the physical device itself is safe and performs as intended, not to evaluate an AI algorithm's diagnostic or predictive capabilities.
Here's an breakdown of the information present and what's missing, based on the prompt's requirements:
1. A table of acceptance criteria and the reported device performance:
- Present: The document lists various tests performed and their outcomes which act as "acceptance criteria" for a physical medical device. These are:
- Static fatigue tests and dynamic fatigue tests (per ISO 14801 and FDA Guidance): "The results show that the Zuga™ Dental Implant System has sufficient mechanical strength for the intended clinical application."
- Cytotoxicity testing (per ISO 10993-5 and USP ): "The results showed that the Zuga™ Dental Implant System received a passing score and is thus acceptable for clinical application."
- Sterility tests (per ISO 10993, ISO 11137-1, 11137-2, ISO 17665-1, 17665-2): "yielded no difference in performance between the Zuga™ Dental Implant System and the predicate device."
- LAL (Limulus Amebocyte Lysate) bacterial endotoxin tests (per ISO 10993 and USP , ): "yielded a EU/Device value that was less than the established acceptance criteria of 20 EU/Device".
- Shelf life tests (per ISO 11607): "established the shelf life to be five years provided the sterile seal is not breached."
- Missing (for an AI/ML device context): Specific performance metrics like sensitivity, specificity, accuracy, AUC, FROC, etc., and their corresponding acceptance thresholds.
2. Sample sized used for the test set and the data provenance:
- Present: For LAL tests, it states: "The sampling plan consists of selecting 3% of the batch up to a maximum of 10 samples to be pooled for testing."
- Missing (for an AI/ML device context): Sample size for a "test set" of patient data (e.g., medical images, clinical records) for an AI algorithm. Data provenance (country of origin, retrospective/prospective) is not applicable or mentioned for these physical/biological tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Missing: This information is not relevant to the mechanical/biological testing of a physical implant. It would be crucial for an AI/ML device based on clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Missing: Not applicable to the presented data.
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:
- Missing: Not applicable. This device is a physical dental implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Missing: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Present (for physical device tests): The "ground truth" here is adherence to international standards (ISO, ASTM) and USP guidelines for mechanical strength, biocompatibility, sterilization, and endotoxin levels.
- Missing (for an AI/ML device context): Clinical ground truth established by experts or pathology for diagnostic purposes.
8. The sample size for the training set:
- Missing: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Missing: Not applicable.
In summary: The provided document is an FDA 510(k) clearance letter for a physical dental implant system. Its "acceptance criteria" and "performance data" relate to the mechanical, chemical, and biological safety and efficacy of the implant itself, demonstrated through adherence to various international and US standards. It contains no information relevant to the development, testing, or performance of an AI/ML device.
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(389 days)
TAV Medical Dental Implant 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 and in order to restore the patient chewing function. The Implants are indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
TAV Medical Dental Implant System is a two piece dental implant system for one stage or two stage surgical implantation of dental implant provided with cover screw and supported by a compatible abutment systems and surgical instruments. The implant is fabricated from a medical grade titanium alloy 6Al 4V ELI, according to ASTM F136. TAV Medical implant includes a body portion and a collar. The body portion is configured to extend into and Osseo integrate with the alveolar bone. The top surface of the collar lies flush with the crest of the jawbone bone. TAV Medical abutment lies on the top surface and extends through the soft tissue, which lies above the alveolar bone. The abutment supports the final prostheses. TAV Medical implants include the following brands: Silhouette, Sirius, and iCone. TAV Medical Abutments are intended for used as an adapter between the implant and the crown. The abutments are characterized by four distinct geometrically features: Height/length, angle, diameter and internal/external hex lock or conical connection. Anodized Color coding is used for categorical consideration only. TAV Medical abutments, as other available in the market of dental prosthetics are dental components composed either of titanium (Ti 6AL 4V ELI), PEEK and Yttrium Stabilized Zirconia (ZrO2). All the abutments fixation screws are composed of Ti 6AL 4V ELI. The abutments are supplied non-sterile to be sterilized by the physician before use according to the accompanied instruction for use. Abutment device refers to the fixture that is assembled on the implant. The crown is then built on the abutment. The prosthetic parts are divided into 3 main categories: Cemented retained restorations, Screw retained restorations, and Overdenture retained. Various abutment types are available: Titanium Abutments, Temporary Esthetic PEEK Abutments, Ball attachment, Locker overdenture, and Healing caps.
Here's an analysis of the provided text regarding the acceptance criteria and study for the TAV Medical Dental Implant System:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria" in the format typically used for AI/ML device performance. Instead, it details that the device underwent various non-clinical tests to demonstrate equivalence to predicate devices and adherence to established standards. The acceptance criteria for each test (e.g., biocompatibility according to ISO 10993-1, SAL of 10^-6 for sterilization, satisfactory results for mechanical and biological tests where material differences exist) are implicitly linked to the relevant standards or the statement of "satisfactory results" or "meets design specifications."
Here's a summary of the non-clinical testing performed and the reported performance, as extracted from the text:
| Test/Characteristic | Acceptance Criteria (Implicit from Standards/Statements) | Reported Device Performance |
|---|---|---|
| Premarket Equivalence | Substantial equivalence to predicate devices in: Indications for Use, technological characteristics, mode of operation, performance specifications. Minor differences justified by testing and reference devices. | TAV Medical Dental Implant System is stated to be substantially equivalent to predicate devices (MIS Dental Implant System, Hahn Tapered Implant System, Noris Medical Dental Implant System, SGS Dental Implants System, AB DENTAL Devices Ltd., Implant Direct, Ditron Dental Ltd.) in all device features, indications for use, materials, dimensions (with minor differences justified by other predicate devices or testing), prosthetic connection, device features, and sterilization method. Minor differences in implant diameter, packaging, healing cap dimensions, and abutment materials (Zirconia) and duration of use (PEEK abutments) were addressed by referencing other predicate devices or conducting specific mechanical/biological tests with "satisfactory results." |
| Material Biocompatibility | Conformance to ISO 10993-1, ISO 10993-5 (cytotoxicity), ISO 10993-11 (systemic toxicity), ISO 10993-10 (irritation/sensitization), ISO 10993-18 (chemical characterization). FDA guidance "Use of International Standard ISO 10993-1" also followed. | "TAV Medical Dental Implant System products were tested and evaluated for materials biocompatibility... in order to demonstrate the biocompatibility of the system." (Implies successful demonstration). |
| Sterilization Validation | ANSI/AAMI/ISO 11137 parts 1 and 2 standards. Sterility Assurance Level (SAL) of 10^-6. All testing requirements met. | "Test results have demonstrated that the SAL of 10^-6 was achieved and all testing requirements were met." |
| Pyrogenicity | Acceptance criteria as required by USP and . | "Tested using LAL method with satisfactory results that met the acceptance criteria." |
| Shelf Life | Successful accelerated aging validation, followed by real-time shelf-life validation for 5 years. | "Accelerated aging have been applied on the final packaging followed by a real time shelf life aging validation for 5 years shelf life." (Implies successful validation for 5 years). |
| Human Factors Study | Safe handling of the sterile single unit packaging, meeting study criteria. | "The study's criteria were met and passed successfully. Positive feedbacks received from the users participated in the study." |
| Performance Testing | Meets design specifications and performs as intended, similar to predicate devices. Includes: Implant to abutment compatibility, Static and Dynamic fatigue testing (ISO 14801:2007), Corrosion testing (ASTM F746-04), Surface finish analysis, Zirconia Material testing (ISO 13356:2008). | "Descriptive information, laboratory bench testing, and biocompatibility testing are provided to demonstrate Tav Medical Dental Implant System meets its design specifications, performs as intended... The non-clinical testing results showed that the proposed dental implant system meet the device requirements and is considered equivalent to its predicate device." Specific tests mentioned performed with "satisfactory results" where material differences existed (e.g., Zirconia locker). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of patient cases or imaging data, as this is a medical device (dental implant system) and not an AI/ML diagnostic software. The "test set" refers to the physical devices and materials undergoing various engineering, biological, and material tests. The specific number of implants, abutments, or material samples used for each test is not detailed.
- Data Provenance: Not applicable in the context of clinical/imaging data provenance, as no such data was used. All testing appears to be non-clinical (bench testing, biocompatibility, sterilization validation).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. Ground truth in this context refers to the defined parameters and expected outcomes of the physical and chemical tests performed on the dental implants. This is established by engineering standards, material specifications, and regulatory guidelines, rather than expert interpretation of data.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for resolving discrepancies in expert interpretations (e.g., radiological reads). Here, the performance is measured against objective, measurable criteria from established scientific and engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Readers with vs. without AI Assistance
Not applicable. This is not an AI/ML medical device, so no MRMC studies involving human readers or AI assistance were performed or are relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML medical device.
7. The Type of Ground Truth Used
The "ground truth" for the TAV Medical Dental Implant System is based on:
- Mechanical and Material Standards: Compliance with ISO (e.g., ISO 14801 for fatigue testing, ISO 13356 for Zirconia materials) and ASTM (e.g., ASTM F746 for corrosion) standards.
- Biocompatibility Standards: Conformance to ISO 10993 series and FDA guidance on biocompatibility.
- Sterilization and Packaging Standards: Compliance with ANSI/AAMI/ISO 11137 and ISO 11607-2.
- Design Specifications: The device met its own established design specifications, which are implicitly derived from the intended use and comparison to predicate devices.
- Predicate Device Equivalence: The performance results were considered "satisfactory" if they demonstrated equivalence to the safely and effectively marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML medical device.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/ML medical 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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