(175 days)
The 3i Bioresorbable Fixation Tack is indicated for use as a means of membrane fixation in Guided Bone Regeneration (GBR) procedures.
The device will be manufactured from a well known copolymer. This material was selected because of its biocompatibility and proven metabolic pathway through which it is metabolized and eliminated from the body. Also, because alone or as copolymers, the materials can be adjusted to provide appropriate bioresorbtion timing for a GBR/GTR device.
The 3i fixation tack is a copolymer. Its molecular weight and copolymer ratio is based on current and predicate device materials and through extensive literature review. The composition resorbs slowly, providing 4 week structural integrity with adequate structural breakdown and fixation capabilities by 5 to 8 months.
The 3i Bioresorbable Fixation Tack is approximately .050 inch in diameter and .17 inch long. Small enough to effectively stabilize a membrane for an approximate 30 day period and be non-retentive by five to eight months.
The 3i Bioresorbable Fixation Tack is designed for membrane fixation in Guided Bone Regeneration (GBR) procedures and/or where other oral/maxillofacial clinical requirements necessitate use of bioresorbable or nonresorbable type membranes. The 3i Bioresorbable Fixation Tack is designed to maintain 50% of its original strength and retention capability structure through one month in actual use and effectively non-retentive at five to eight months.
The "Tack" is designed so that it may be pushed/tapped into a pre-drilled site by hand or by using a small surgical mallet, available from numerous device manufacturers including 3i.
The 3i Bioresorbable Fixation Tack may be distributed as individual devices, packaged in semi-rigid trays with moisture proof foil lids and presterilized to an SAL of 10-8. Validation is accomplished by Sterilization is accomplished by an FDA registered irradiation sterilization facility with validation to applicable Haronized Standards.
Packaged tacks may also be included in "convenience kits" containing a variety of site preparation and insertion tools and accessories
The provided text describes a submission for a 510(k) premarket notification for the "3i Bioresorbable Fixation Tack". This type of submission aims to demonstrate that a device is substantially equivalent to a legally marketed predicate device, rather than proving its effectiveness through a standalone clinical study against acceptance criteria. Therefore, the information provided does not contain a study explicitly designed to meet specific acceptance criteria in the way a clinical trial for a new medical device would.
Instead, the document focuses on demonstrating substantial equivalence by comparing the device's characteristics (materials, intended use, performance goals) to existing devices.
However, based on the text, we can infer the device's intended performance and what would constitute "acceptance" for its marketing, as well as the basis for these claims, which serves as a form of "study" or evidence.
Here's an analysis based on the information provided, framed to address your questions as closely as possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from intended use and predicate device comparison) | Reported Device Performance (as stated in the submission) |
|---|---|
| Provide retentive capabilities for a minimum of 30 days. | "The 3i Bioresorbable Fixation Tack is designed to maintain 50% of its original strength and retention capability structure through one month in actual use." |
| Be non-retentive (or devoid of structural integrity) by 5 to 8 months. | "effectively non-retentive at five to eight months." |
| "Small enough to effectively stabilize a membrane for an approximate 30 day period" | "approximately .050 inch in diameter and .17 inch long. Small enough to effectively stabilize a membrane for an approximate 30 day period..." |
| Biocompatible and proven metabolic pathway | "The device will be manufactured from a well known copolymer. This material was selected because of its biocompatibility and proven metabolic pathway through which it is metabolized and eliminated from the body." |
| Sterilized to an SAL of 10^-8 | "presterilized to an SAL of 10-8. Validation is accomplished by Sterilization is accomplished by an FDA registered irradiation sterilization facility with validation to applicable Haronized Standards." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not report a sample size for a specific test set in the context of a dedicated clinical or performance study for this device. The basis for the claims appears to be:
- Extensive literature review: "Its molecular weight and copolymer ratio is based on current and predicate device materials and through extensive literature review."
- Comparison to predicate devices: The entire submission relies on demonstrating substantial equivalence to existing devices like "Biologically Quiet Screw," "LactoSorb Resorbable Craniomaxillofacial Fixation," "Resolut" Membrane, "Bio-Anchor," and "GLS." The performance of these predicate devices, established through their own clinical use and studies, serves as the primary evidence.
- The data provenance is therefore largely based on retrospective literature and existing clinical data related to similar bioresorbable materials and fixation devices, rather than a prospective study specific to the 3i Bioresorbable Fixation Tack.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. Since there isn't a described "test set" with a ground truth established by experts in the context of a prospective study for this specific device, this aspect is not applicable directly. The "ground truth" for the claims in the 510(k) is essentially the established performance and safety profiles of the predicate devices and the general understanding of bioresorbable materials in the field, as affirmed by regulatory bodies and clinical consensus.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable given the nature of a 510(k) submission primarily relying on substantial equivalence and literature review, rather than a specific clinical study with an adjudicated test set.
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 is not applicable. The device is a bioresorbable fixation tack for surgical use, not an AI-powered diagnostic or assistive tool for human readers/clinicians, nor does the document describe a comparative effectiveness study of this nature.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the claims about the 3i Bioresorbable Fixation Tack being substantially equivalent is expert consensus, prior clinical outcomes data from similar devices, and established material science/biological pathways. The submission explicitly states:
- "A review of literature has identified a variety of devices and material variations used for years in general surgical applications (sutures), and plates, screws, pins, wires and other fixation devices used in orthopedic and craniomaxillofacial fixation applications with predictable outcomes and proven successes."
- "Its molecular weight and copolymer ratio is based on current and predicate device materials and through extensive literature review."
- The material was selected due to "its biocompatibility and proven metabolic pathway".
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of a computational model or AI for this physical medical device. The "training" for the device's design is based on extensive literature review and understanding of predicate device materials and clinical performance.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the AI/ML sense, this is not applicable. The design parameters and expected performance characteristics are established through established scientific principles, existing regulatory guidelines, and the accumulated clinical and scientific knowledge from years of experience with similar bioresorbable materials and fixation devices.
§ 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.