(176 days)
The 2.5 mm LactoSorb® Screws are indicated for use as fixation in mandibular osteotomy procedures, including but not limited to:
- sagittal split osteotomy
- vertical ramus osteotomy
- inferior border osteotomy
- subapical osteotomy
- genioplasty
The 2.5 mm LactoSorb® Screws are composed of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/pclyglycolic acid copolymer degrades and rescrbs IN vIVO by hydrolysis to lactic and glycolic acids which are then metabolized by the body. In animal studies LactoSorb® has been found to be biocompatible in both soft tissue and bone tissue. Lact:oSorb® devices have been marketed for over two years for use in trauma and reconstructive procedures in the craniomaxillofacial skeleton and have been found to be both safe and effective.
The provided text describes the 510(k) summary for the 2.5 mm LactoSorb® Screws. It outlines the device's indications for use, material composition, and how its efficacy was demonstrated. However, it does not contain the detailed information required to fully answer all aspects of your request, especially regarding specific acceptance criteria, study design details, and statistical analysis.
Based on the provided text, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Explicitly Stated/Implied) | Reported Device Performance |
|---|---|
| Maintain strength for a specified period | Maintains strength for at least 6-8 weeks |
| Complete resorption within a specified period | Completely resorbs in approximately one year |
| Biocompatibility | Found to be biocompatible in both soft tissue and bone tissue (in animal studies) |
| Safety and Effectiveness | Found to be both safe and effective (based on previous marketing of LactoSorb® devices for over two years) |
Missing Information:
- Specific quantitative acceptance criteria (e.g., minimum tensile strength, degradation rates) are not provided.
- Details of the "biomechanical testing" are not given, so specific performance metrics from these tests are unavailable.
- The "clinical use" is mentioned, but no specific performance data from clinical studies are reported in this summary.
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "animal studies" for biocompatibility and "clinical use" (referring to previous marketing of LactoSorb® devices).
- Sample Size for Test Set: Not specified for animal studies or clinical use. The summary does not describe a distinct "test set" in the context of the requested AI/ML study design.
- Data Provenance:
- Animal studies mentioned.
- Clinical use mentioned, referring to devices marketed for over two years. No country of origin is specified, and it's unclear if the data were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The document describes a medical device for surgical fixation, not an AI/ML diagnostic or prognostic tool that would typically involve establishing ground truth from expert interpretations of medical images or data.
4. Adjudication Method for the Test Set:
Not applicable. This is relevant for studies involving human interpretation or consensus, which is not the primary focus of this device's demonstration of efficacy based on the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. The document describes biomechanical testing and general clinical use, not a comparative effectiveness study involving human readers with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This device is a physical surgical screw, not an algorithm. Therefore, "standalone algorithm performance" is not relevant here.
7. Type of Ground Truth Used:
- For Biocompatibility: Histological assessment, gross observation, and potentially other biological markers from "animal studies."
- For Strength/Resorption: Mechanical property testing (biomechanical testing) and potentially in-vivo imaging or explant analysis to confirm resorption rates. The "clinical use" implies real-world observation of device performance and patient outcomes.
8. Sample Size for the Training Set:
Not applicable. This device is a physical product, not an AI/ML model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. (See #8)
Summary of Device Efficacy Demonstration from the Text:
The document states: "The efficacy of the 2.5 mm LactoSorb® Screws have been demonstrated by biomechanical testing and clinical use. The screws maintain their strength for at least 6-8 weeks and completely resorb in approximately one year." It also highlights that LactoSorb® polymer has been found biocompatible in animal studies and that LactoSorb® devices have been "marketed for over two years for use in trauma and reconstructive procedures in the craniomaxillofacial skeleton and have been found to be both safe and effective." This suggests that the predicate device's established safety and effectiveness, combined with biomechanical testing confirming similar properties for the new screw dimensions, were the basis for demonstrating efficacy.
§ 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.