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The intended use of the BioHorizons BioLok Micro-Lok endosseous implants is in the mandible and maxilla as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and denture retention.

The BioLok Micro-Lok Implant System may be used in edentulous sites for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework or partial dentures, or a single tooth replacement, overdenture, or hybrid denture.

The BioHorizons BioLok Micro-Lok dental implants are machined titanium, root-form implants supplied in 3.45mm, 3.75mm, 4mm, and 4.75mm diameters across lengths of 8mm, 10mm, 11,5mm, 13mm, and 15mm. Implant and accessory surgical component raw material is titanium alloy as specified in ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).

The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10°, validated in compliance to ANSI/AAMI/ISO 11137, Sterilization of healthcare products - Requirements for validation and routine control - Radiation Sterilization.

This is a 510(k) premarket notification for a medical device (BioLok Micro-Lok Implant System), not a study demonstrating the performance of an AI/ML powered device. As such, the concept of "acceptance criteria" in the context of device performance metrics and a "study that proves the device meets the acceptance criteria" in the way one would describe an AI performance study does not directly apply here.

A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device, either by having the same technological characteristics and intended use, or by having different technological characteristics but not raising new questions of safety and effectiveness, and being as safe and effective.

Therefore, the provided document does not contain the detailed information requested regarding acceptance criteria, performance metrics, sample sizes for test sets, expert adjudication methods, MRMC studies, or standalone performance of an AI/ML algorithm.

Here's how I can address your request given the nature of the provided text:

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

This document does not specify performance acceptance criteria in terms of quantitative metrics (e.g., accuracy, sensitivity, specificity) nor does it report such performance for the BioLok Micro-Lok Implant System. The assessment is based on substantial equivalence to a predicate device.

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

Not applicable. This is a premarket notification, not a clinical trial or performance study in the context of AI/ML. No "test set" of patient data in this sense is described.

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. Ground truth establishment for a test set is not part of this 510(k) submission described here.

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

Not applicable.

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 not an AI/ML device, nor does the document describe an MRMC study.

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

Not applicable.

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

Not applicable.

8. The sample size for the training set

Not applicable.

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

Not applicable.

Summary of Device and 510(k) Submission:

The BioHorizons BioLok Micro-Lok Implant System is a conventional dental implant device. The 510(k) submission, K081818, aims to demonstrate its substantial equivalence to a predicate device (Minimatic Various Implant Systems, K952905).

Key elements from the provided text relevant to the 510(k) process:

• Intended Use: The device is intended for artificial root structure for single tooth replacement, abutments for fixed bridgework, and denture retention in the mandible and maxilla.
• Technological Characteristics: The manufacturer states that the fundamental scientific technology is identical to the predicate device. Materials, specifications (with a minor exception for ASTM standard titanium, which is still a commonly used type in other legally marketed devices), processing, and sterilization methods are the same.
• Predicate Device: Minimatic (BioLok International) Various Implant Systems (K952905).
• Basis for Substantial Equivalence: Similarities in design, material, and intended use. The submission argues that these similarities ensure the new device is as safe and effective as the predicate and does not raise new questions of safety or effectiveness.
• FDA Conclusion: The FDA reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

In essence, for this type of device and submission, the "acceptance criteria" are met by successfully demonstrating substantial equivalence to a predicate device through comparison of intended use, technological characteristics, and safety/effectiveness profiles, rather than through a performance study with quantitative metrics.

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