(6 days)
The AutoTac System™ Titanium Tack is intended to fixate and stabilize bioresorbable and non-resorbable barrier membranes used for regeneration of tissue in the oral cavity or in other clinical situations that require membrane use or fixation.
The proposed membrane fixation tack is fabricated from titanium alloy as specified in ASTM F136 - Specification for Wrought Titanium 6AL-4V ELI Alloy for Surgical Implant Applications. This material was selected because of its known biocompatibility and mechanical properties. The tack is comprised of a low-profile, round, lens shaped head and a cvlindrical shaft that is tapered to a point at its free end. The shaft is provided with a circular rib (barb) that aids in retention of the tack under normal loading conditions. Three opposing tabs extend from the head of each tack and are designed to secure the tack within the delivery mechanism while transporting to the surgical site. The tack is designed for implantation during the healing period during which tissue regeneration takes place. The tacks are provided non-sterile and are to be sterilized by the user using accepted steam sterilization techniques. The autoclavable tack holder is manufactured from ULTEM medical grade material and consists of 21 receptacles for the tacks. A rotating lid serves to capture the tacks during handling so that the tacks do not dislodge from the autoclavable tack holder. Titanium inserts serve to hold the tack so that the end of the tack does not create wear debris after continued use. The autoclavable tack holder can hold up to 21 tacks.
Here's an analysis of the provided 510(k) summary regarding the BioHorizons Implant Systems, Inc. Titanium Tack, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Ability to insert into bone without pre-drilling. | The tack penetrated the bone analogs to a depth adequate enough to engage the tack barb. |
| Structural Integrity | No structural deformation after insertion. | The tacks showed no structural deformation. |
| Retention/Fixation | Membrane tears before the tack dislodges. | Further in-vitro testing demonstrated that the membrane would tear before the tack could be dislodged. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for the "non-clinical testing." It generally refers to "bone analogs" and "in-vitro testing" without quantifiable sample numbers for tacks or tests performed.
The data provenance is in-vitro laboratory testing. There is no information provided about the country of origin, nor is it stated whether the data is retrospective or prospective, as it's not a clinical study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to the "non-clinical testing" described. The "ground truth" for this type of testing is established by engineering and material science principles, measured directly through physical tests on bone analogs and the device itself, rather than expert interpretation.
4. Adjudication Method
This information is not applicable. Adjudication methods are typically used in clinical studies or multi-reader image interpretations to resolve discrepancies among experts. The non-clinical tests described are objective, physical measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The provided information details non-clinical, in-vitro mechanical testing of the device itself, not a study involving human readers or assessment of AI assistance.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study was not conducted. This device is a physical medical implant, not an AI algorithm. Therefore, "algorithm only" performance is not relevant.
7. Type of Ground Truth Used
The ground truth used for the non-clinical testing was based on:
- Objective physical measurements: Assessing the depth of penetration into bone analogs.
- Visual inspection: Confirming the absence of structural deformation.
- Mechanical force testing: Demonstrating that the membrane would tear before the tack dislodged, indicating superior retention force of the tack.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical implant, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above (no training set for a physical device).
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.