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The Brånemark Integration AB, implants and accessories is intended for surgical placement into the bone of upper /lower jaw arches as a permanent anchorage for prosthetic devices and to restore chewing function.

The Brånemark Integration implants and accessories are subjected for one or two-stage surgical procedures, and either for cemented or screw retained prosthetic restorations. The implants are intended for immediate placement on a single tooth and/or multiple tooth applications recognizing sufficient bone stability (type I or II bone) and appropriate occlusal loading, to restore chewing and speech function. Multiple tooth applications may be connected with a bar.

The Brånemark Integration implant products that are subject of this 510(k) are threaded, root-form implants fabricated from commercially pure titanium, and machined and are commercially available.

The provided text is a 510(k) summary for the Brånemark Integration Dental Implant and Accessories. This document is a premarket notification for a medical device and does not contain a study that proves the device meets acceptance criteria in the format or with the details requested.

Instead, it asserts substantial equivalence to a predicate device. For devices seeking 510(k) clearance, the primary pathway is demonstration of "substantial equivalence" to a legally marketed predicate device, rather than explicit proof of meeting specific acceptance criteria through a clinical study in every case.

Therefore, many of the requested fields regarding a study and its details cannot be directly extracted from this document.

However, based on the provided text, here's what can be gathered or inferred about "acceptance criteria" and "performance data" in the context of this 510(k) submission:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The document refers to "Clinical result show that expanded Indications for Use are as safe and effective as the original Indications for Use," but it does not specify any sample size, design (retrospective/prospective), or data provenance for these "clinical results." This suggests that the clinical data might be derived from existing literature or previous predicate device data, rather than a specific new study with a "test set" for this particular 510(k).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided. The document does not describe a study involving expert-established ground truth. The pathway here is substantial equivalence to a known predicate.

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

• Not applicable/Not provided. No adjudication method is described as there's no mention of a specific test set requiring such expert evaluation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This device is a dental implant, not an AI diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant or described.

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

• No. This device is a dental implant, not an algorithm.

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

• Implied ground truth related to clinical outcomes and safety/effectiveness. The statement "Clinical result show that expanded Indications for Use are as safe and effective as the original Indications for Use" implies that clinical outcomes (e.g., implant success rates, integration, absence of adverse events) of the Brånemark System® (the predicate and likely the basis for this device's performance claims) are the "ground truth" against which the expanded indications are compared. However, no specific details on how this "ground truth" was established are provided for this 510(k).

8. The sample size for the training set

• Not applicable/Not provided. This is not a machine learning/AI device, so there is no concept of a "training set" as typically understood in that context. The "training" for proving equivalence would be based on the extensive existing clinical history of the predicate device.

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

• Not applicable/Not provided. (See point 8).

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The Brånemark Integration AB, FIXTURE ORIGINAL is intended for surgical placement into the bone of upper /lower jaw arches as a permanent anchorage for prosthetic devices and to restore chewing function.

The FIXTURE ORIGINAL consists of 4 implants, diameter 3,75 mm, and length from 8,5 to 15 mm.

The provided text describes a 510(k) submission for the "FIXTURE ORIGINAL" endosseous implant. However, it does not include detailed acceptance criteria or a study that directly proves the device meets specific acceptance criteria in the way typically expected for performance-based medical device submissions.

Instead, this submission primarily relies on substantial equivalence to a predicate device (Nobel Biocare AB standard fixture RP with a diameter of 3.75 mm). The core argument is that because the FIXTURE ORIGINAL is similar in material, dimensions, and intended use to the predicate device, further testing "will not raise new issues of safety and efficacy."

Therefore, many of the requested sections below cannot be fully populated as the information is not present in the provided document.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

• Explanation: The document does not define specific performance acceptance criteria (e.g., minimum tensile strength, fatigue life, osseointegration rates, etc.) for the FIXTURE ORIGINAL itself, nor does it present specific performance data against such criteria. The entire premise of the submission is that the device's characteristics are so similar to a legally marketed predicate that specific new performance testing is deemed unnecessary.

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

• Sample Size for Test Set: Not applicable / Not provided. The submission relies on substantial equivalence and does not describe a new performance test set for the FIXTURE ORIGINAL.
• Data Provenance: Not applicable / Not provided.

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

• Number of Experts: Not applicable. No new test set or ground truth determination described for the FIXTURE ORIGINAL.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. No new test set or ground truth determination described.

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

• MRMC Study: No. This is a submission for an endosseous implant, not an AI-powered diagnostic or assistive tool.

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

• Standalone Performance Study: No. This is not an algorithm or AI device.

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

• Type of Ground Truth: Not applicable for the FIXTURE ORIGINAL itself in this submission. The "ground truth" for the submission's argument is the established safety and effectiveness of the predicate device based on its existing regulatory clearance.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not a machine learning or AI device.

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

• Ground Truth for Training Set: Not applicable.

Summary of the Submission's Approach:

The K021355 submission for the Brånemark Integration AB FIXTURE ORIGINAL relies entirely on demonstrating substantial equivalence to a previously cleared predicate device (Nobel Biocare Standard Fixture, K925765). The argument is built on the following points:

• Identical Intended Use: Both devices share the same intended use for permanent anchorage of prosthetic devices and restoring chewing function.
• Similar Dimensions: The FIXTURE ORIGINAL's dimensions (diameter 3.75mm, length 8.5-15mm) fall within the range of the predicate device (diameter 3.75mm, length 7-20mm).
• Similar Material: Although not explicitly stated as "identical material" in the provided text, the phrase "substantially equivalent to Nobel Biocare Standard Fixture in material, dimensions, and intended use" strongly implies material similarity.
• Previous Testing of Predicate: The submission refers to existing "mechanical testing requested for Screw-type Endosseous Implants as described in the Guideline 'Information Necessary for Pre Market Notification Submission for Screw-Type Endosseous Implants', dated December 9, 1996," completed for the predicate device.

The conclusion drawn by Brånemark Integration AB is that "further testing will not raise new issues of safety and efficacy" because of this substantial equivalence. The FDA concurred with this assessment, granting 510(k) clearance based on this argument, not on new performance data for the FIXTURE ORIGINAL.

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