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The Implanova® Bone Level implants are intended for endosseous implantation in the mandible and maxilla for use as an artificial root structure. These root form implants can be used to replace single or multiple missing teeth and/or to support a fixed or removable prosthesis in partially or completely edentulous upper and lower dental arches. All devices in the Implanova® Bone Level system, including implant fixtures, abutments, healing caps, cover screws, and retention screws are intended for use by prescription only. Implanova® Bone Level implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Implanova® All-in-One3.0mm implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the mandibular central incisor and maxillary lateral incisor regions of partially edentulous jaws. The Implanova® All-in-One 3.0mm implant must be splinted if two or more are used adjacent to each other. Implanova® All-in-One 3.0mm implant are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

All Implanova® Bone Level implant fixtures are compatible with the straight type restorative components listed in the table below, including straight type abutments, straight type abutment screws and straight type temporary abutments that are intended to be on Astra Tech's OsseoSpeed 11 TX 3.5S and OsseoSpeed "M TX 4.0S implant fixtures.

All bone fixtures within Inplanova® system are endosseous dental implants and are available in Bone Level and All-In-One implants types. Fixtures are available in the following sizes.

· IMPLANOVA® BONE LEVEL IMPLANTS Narrow Medium: 3.5mm Diameter x 10mm Length Narrow Long: 3.5mm Diameter x 12mm Length Narrow XLong (Extra Long): 3.5mm Diameter x 14mm Length

Standard Short: 4.5mm Diameter x 8mm Length Standard Medium: 4.5mm Diameter x 10mm Length Standard Long: 4.5mm Diameter x 12mm Length Standard XLong: 4.5mm Diameter x 14mm Length

Wide Short: 5.5mm Diameter x 8mm Length Wide Medium: 5.5mm Diameter x 10mm Length Wide Long: 5.5mm Diameter x 12mm Length

· IMPLANOVA® ALL-IN-ONE IMPLANTS Slender Medium: 3.0mm Diameter x 10mm Length Slender Long: 3.0mm Diameter x 12mm Length Slender XLong (Extra Long): 3.0mm Diameter x 14mm Length

The material constituents of the all implant fixtures within the Implanova® system is Grade 23 Titanium Alloy per ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vnadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). In order to promote osseointegration, a variable portion of the implant surface, depending on the implant's overall length, is surface treated and passivated per ASTM F86 standard.

Abutments for bone level implants are utilized for cement retained restoration. Bone level abutments are available in straight and angled types as well as platform sizes ranging from 4.2mm to 6.5mm. All bone level angled abutments will utilize their respective abutment screw for installation. The material constituents of all Implanova® abutments is grade 23titanium alloy per ASTM F136 Standard Specification for Wrought Titanium 6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).

Implanova® Bone Level Abutments offer the following models.

· IMPLANOVA® BONE LEVEL ABUTMENTS

Narrow Platform - Straight: 4.2 mm Platform Diameter x 5.7 mm Post Height Narrow Platform – 15 Degrees: 4.2 mm Platform Diameter x 7.3 mm Post Height Narrow Platform – 20 Degrees: 4.2 mm Platform Diameter x 7.3 mm Post Height

Standard Platform - Straight: 4.8 mm Platform Diameter x 5.7 mm Post Height StandardPlatform – 15 Degrees: 4.8 mm Platform Diameter x 7.3 mm Post Height StandardPlatform – 20 Degrees: 4.8 mm Platform Diameter x 7.3 mm Post Height

Wide Platform - Straight: 6.5 mm Platform Diameter x 5.7 mm Post Height WidePlatform - 15 Degrees: 6.5 mm Platform Diameter x 7.3 mm Post Height WidePlatform - 20 Degrees: 6.5 mm Platform Diameter x 7.3 mm Post Height

The system also offers Healing Caps and Cover Screws.

This document is a 510(k) Pre-market Notification for the Implanova® Dental Implant System. It aims to demonstrate substantial equivalence to legally marketed predicate devices. The document does not describe acceptance criteria or a study proving the device meets specific performance criteria with numerical results for the device itself (Implanova®). Instead, it relies on demonstrating substantial equivalence to predicate devices through comparisons of design, materials, intended use, and non-clinical testing for safety and appropriate material and manufacturing characteristics.

Here’s a breakdown of the information that is available within the provided text, and what is not present based on your request:

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

This information is not explicitly provided in the format requested. The document asserts that "the fatiguetest result of the subject device supports that the subject device is substantially equivalent to the predicate devices" (Pages 11 and 12), and that non-clinical testing "supported that the subject device is substantially equivalent to the predicate devices and it is in conformance with the FDA guidance document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (Page 17). However, the specific acceptance criteria for these tests (e.g., minimum fatigue strength in MPa or N) and the numerical results achieved by the Implanova® device are not listed. The document focuses on similarity to predicate devices rather than meeting discrete performance metrics presented in a table.

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 document lists types of non-clinical tests but does not specify the sample sizes used for these tests, nor the data provenance. These are typically details found in the full test reports, which are not included here.

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/provided. The document describes non-clinical, laboratory-based testing (e.g., fatigue, sterilization, cytotoxicity, SEM/EDS) rather than clinical studies requiring expert review of data for ground truth establishment.

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

This information is not applicable/provided. As above, this pertains to clinical study design and human interpretation of results, which is not described 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 information is not applicable/provided. This document describes an endosseous dental implant system, which is a physical medical device, not an AI-assisted diagnostic or decision support system that would involve human readers or AI improvement metrics.

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

This information is not applicable/provided. This is a physical medical device, not an algorithm.

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

This information is not applicable/provided in the context of clinical "ground truth." The ground truth for the non-clinical tests would be the established scientific methods and standards (e.g., ISO 14801 for fatigue testing, ISO 11137-1 for sterilization).

8. The sample size for the training set:

This information is not applicable/provided. As this is a physical medical device, there is no "training set" in the context of machine learning or AI models.

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

This information is not applicable/provided. As above, there is no "training set."

Summary of available information related to performance and predicate devices:

The document primarily demonstrates substantial equivalence by comparing the Implanova® device to several predicate devices.

Key similarities highlighted for Implanova® Bone Level Implants (compared to BioHorizons Tapered Internal Plus, BioHorizons Internal Implants, U fit Dental Implant System):

• Intended Use: Same intended use (endosseous implantation in mandible and maxilla for artificial root structure, single/multiple missing teeth, support prosthesis, immediate loading when primary stability achieved).
• Operating Principle: Same.
• Basic Design: Incorporates same basic design (self-tapping, bone-level type implant, micro-threaded implant collar, tapered implant body).
• Material: Titanium Alloy grade 23 (Ti6Al4V ELI).
• Surface Treatment: Resorbable Blast Texture Media (calcium phosphate), partial surface treatment.
• Sterile: Yes.
• Sterilization Method: Gamma Radiation.
• Size Range: Similar (e.g., Diameter: 3.5mm, 4.5mm, 5.5mm; Length: 8mm, 10mm, 12mm, 14mm).

Key differences and justification for substantial equivalence despite differences:

• Micro-machined grooves vs. Micro threads: Laser-Lok® micro-machined grooves on predicates vs. micro threads on Implanova®. Justification: "functionally identical" as osteocytes cannot differentiate microscopic differences for osseointegration.
• Flute Lengths: Implanova® has longer flute lengths. Justification: "more tapping edges simply ease the tapping processes but functions the same."
• Twist Direction of Vertical Flutes: Implanova® has a minor left-hand twist (18mm pitch) vs. straight or slight right-hand twist on predicates. Justification: "only slightly increases the sharpness of the edges... and passively guides the swarf materials to consolidate... should not render the device NSE."
• Partial Surface Treatment: Implanova® has partial surface treatment (apical 5mm untreated) vs. modified throughout the implant body on predicates. Justification: Untreated apical area maintains sharpness for cutting bone; surface treatment is not a requirement for osseointegration.
• Fatigue Test Result: The document states that "the fatiguetest result of the subject device supports that the subject device is substantially equivalent to the predicate devices." (No numerical results are provided in the excerpt).

Key similarities highlighted for Implanova® All-in-One 3.0mm Implants (compared to Zimmer One-Piece Implant System, NobelDirect 3.0):

• Intended Use: Similar indications for support and retention of fixed single tooth and fixed partial dentures in specific mandibular/maxillary incisor regions, with immediate loading when good primary stability is achieved and appropriate occlusal loading.
• Design & Size: 3.0mm diameter.
• Connection Type: N/A (one-piece design).
• Basic Design: Self-tapping, tissue-level type implant, micro-threaded implant collar, tapered implant body.
• Material: Titanium Alloy grade 23 (Ti6Al4V ELI) (NobelDirect uses CP Titanium grade 4).
• Surface Treatment: Resorbable Blast Texture Media (calcium phosphate), partial surface treatment (Zimmer uses Hydroxyapatite blast media, NobelDirect uses TiUnite).
• Sterile: Yes.
• Sterilization Method: Gamma Radiation.

Key differences and justification for substantial equivalence despite differences:

• Microthreads: Implanova® has microthreads vs. lack of microthreads on predicates. Justification: "only slightly increase the surface area... insignificant deviation... does not render the subject device NSE."
• Flute Lengths, Twist Direction, Partial Surface Treatment: Similar justifications to the bone-level implants regarding these differences.
• Surface Treatment Material: Implanova® uses calcium phosphate blast media; predicates use Hydroxyapatite or TiUnite. Justification: "chemical analysis data... supports that the blast media used for the subject device does not alter surface chemical compositions."

Non-Clinical Testing Performed (Page 17):

• Fatigue Testing (ISO 14801)
• 3rd Party Compatibility
• Sterilization Validation (ISO 11137-1, ISO 11137-2, ISO11737-1, ISO11737-2, ISO 17665-1 and ISO 17665-2)
• Shelf-life Validation (ASTM F1980, ISO 11607-1, ISO 11607-2, ASTM F88, and ASTM F 1929)
• Cytotoxicity Testing (ISO 10993-5)
• SEM/EDS Chemical Surface Analysis

These tests are stated to have "supported that the subject device is substantially equivalent to the predicate devices and it is in conformance with the FDA guidance document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments."

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Implants:
The Astra Tech Dental Implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:

• replacing single and multiple missing teeth in the mandible and maxilla, ●
• immediate placement in extraction sites and in situations with a partially or completely . healed alveolar ridge,
• especially indicated for use in soft bone applications where implants with other implant ● surface treatments may be less effective,
• immediate loading in all indications, except in single tooth situations on implants shorter . than 8 mm or in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate.

The intended use for OsseoSpeed™ Plus 3.0S is limited to replacement of maxillary lateral incisors and mandibular incisors.

Abutments:
Astra Tech Implant System Plus abutments are intended to be used in conjunction with Astra Tech Implant System Plus in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.

Atlantis Abutments:
The Atlantis™ Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

The Atlantis™ Crown Abutment in Zirconia is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in partially or completely edentulous patients. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant.

The purpose of this submission is to expand the OsseoSpeed™ Plus Implant System to include all the components of the previously cleared OsseoSpeed System. The OsseoSpeed Plus Implant System, cleared September 26, 2011 under K111287, has the same design as the OsseoSpeed system, except for addition of an anti-rotation feature to the implant/abutment interface.

The OsseoSpeed Plus System includes implants with diameters ranging from Ø3.0 mm to Ø5.4 mm and lengths ranging from 6 mm to 17 mm. Radiographic guides are available for all implant sizes. Abutments sizes range from Ø3.0 mm to Ø5.4 mm in straight and angled designs ranging from 15° to 30°. Abutment designs include coverscrews, healing abutments, temporary abutments, cast-to abutments, ball abutments, straight and angled abutments.

This 510(k) Premarket Notification for the OsseoSpeed™ Plus Dental Implant System primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices. Therefore, the information provided does not detail specific acceptance criteria for a new clinical study and a study that proves the device meets those criteria, as one would typically find for a novel device.

The submission is for an expansion of an existing system (OsseoSpeed™ Plus) to include components from the previously cleared OsseoSpeed System (K111287). The core argument for substantial equivalence is based on the device having the "same intended use and design principles" and "same technological characteristics" as predicate devices, supported by non-clinical testing.

Here's an analysis of what is available in the document, acknowledging that typical clinical study acceptance criteria and results are not present:

1. Table of Acceptance Criteria and Reported Device Performance

As this submission relies on substantial equivalence and non-clinical testing, explicit acceptance criteria tied to a clinical performance study with defined metrics (e.g., success rates, complication rates) are not provided in the document.

The "acceptance criteria" here are implicitly linked to demonstrating that the OsseoSpeed™ Plus system is as safe and effective as the predicate devices. The non-clinical data presented aims to show that any differences in technological characteristics do not raise new issues of safety or efficacy.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission, as there is no specific clinical test set described from a prospective study. The evaluation relies on non-clinical engineering and bench testing data, and the historical performance of the predicate devices. The document does not specify sample sizes for the non-clinical tests, other than referencing the types of tests performed (e.g., ISO 14801).
• Data Provenance: The referenced predicate devices would have been previously marketed (interstate commerce prior to May 28, 1976, or reclassified devices). The non-clinical testing data would typically be generated in a lab setting by the manufacturer (Astra Tech AB, Sweden, or its testing partners).

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

• This question is not applicable for this submission. The ground truth, in the absence of a clinical study, is the established safety and efficacy of the predicate devices, supported by the non-clinical testing confirming that the new device variant performs similarly. Expert consensus on clinical outcomes for a novel test set is not described.

4. Adjudication Method for the Test Set

• Not applicable. There is no clinical test set requiring an adjudication method by experts for ground truth establishment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

• No. This type of study is not mentioned or implied in this 510(k) submission, as it focuses on dental implants, not image-based diagnostic aids or similar devices where MRMC studies are common.

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

• Not applicable. The OsseoSpeed™ Plus is a physical dental implant system, not a software algorithm or AI-driven device.

7. The type of ground truth used

• The "ground truth" for this 510(k) clearance is primarily:
  • The established safety and efficacy profile of the legally marketed predicate devices.
  • Bench test results and engineering analyses (e.g., mechanical strength, dimensional accuracy, surface characteristics) demonstrating that the subject device performs comparably to the predicates and meets relevant standards (like ISO 14801).
  • The regulatory precedent set by the predicate devices.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of a machine learning algorithm for this physical device. If referring to product development and testing, the sample size for non-clinical tests would be defined by engineering standards and internal validation protocols, but specific numbers are not provided in this summary.

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

• Not applicable. As there is no training set for an AI algorithm, this question doesn't apply. The "ground truth" for the overall submission is based on regulatory precedent and engineering validation against established standards and predicate devices.

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