(90 days)
The LactoSorb® Trauma Plating System is indicated for use in the following midface or craniofacial procedures.
A. General Indication: trauma procedures of the midface or craniofacial skeleton
Specific Indications:
- comminuted fractures of the naso-ethmoidal infraorbital areas
- comminuted fractures of the frontal sinus wall
- pediatric midface or craniofacial trauma
- LeFort (I,II,III) fractures
- orbital floor fractures
- fractures of the maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones
- trauma of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones
B. General Indication: reconstructive procedures of the midface or craniofacial skeleton
Specific Indications: - Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma, etc.)
- LeFort (I,II,III) osteotomies
- tumor reconstruction in midface or craniofacial procedures
- bone graft procedures in the midface or craniofacial skeleton
- pediatric reconstructive procedures
- reconstructive procedures of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones
- craniotomy flap fixation
This system is not designed for use in the mandible and/or full load bearing procedures.
The LactoSorb® plates/mesh/screws are made of bioresorbable and biocompatible polymer that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic (PLA/PGA) acid copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids which are then metabolized by the body.
Here's an analysis of the provided text regarding the LactoSorb® Trauma Plating System, structured to address your specific points.
The provided document is a 510(k) summary for the LactoSorb® Trauma Plating System, submitted in 1997. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through extensive clinical trials with pre-defined acceptance criteria in the way a PMA submission would. Therefore, much of the information you've requested regarding acceptance criteria, specific performance metrics, and clinical study details (like sample sizes for test/training sets, expert ground truth, MRMC studies, etc.) is not present or explicitly defined in this summary document. The summary primarily focuses on material biocompatibility and general effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Strength/Fixation (Implicit - device must provide adequate fixation for its intended use.) | "The LactoSorb® system was found to provide adequate fixation in the craniomaxillofacial region." (No specific quantitative metrics or thresholds are provided in this summary.) |
| Biocompatibility (Implicit - material must be safe for implantation.) | "The safety of PLA/PGA material has been well documented since the early 1970's when the FDA first approved the use of resorbable PLA/PGA sutures." |
| "The exact same LactoSorb® material has been implanted in humans for over 10 years in the Poly Surgiclip@ device... The LactoSorb® material has been found to be biocompatible in both soft and hard bone tissue." | |
| Resorption Time (Implicit - device must resorb within a reasonable timeframe, as it's a bioresorbable system.) | "The devices completely resorbs by 12 months IN VIVO." |
| Device-Related Complications (Implicit - must not introduce unacceptable risks.) | "no device related complications reported." |
| Equivalence to Predicate (Substantial equivalence is the primary regulatory criterion for a 510(k).) | "This system is as effective as similar metal micro fixation systems on the market." |
| The FDA letter explicitly states, "...we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." |
2. Sample Size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not explicitly stated in the provided text. The document mentions an "FDA approved clinical study" and "mechanical testing," but does not provide details on the sample size of patients or data sets used in these studies.
- Data Provenance: Not specified.
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 stated. This information is generally not part of a 510(k) summary, especially for a device like a trauma plating system where the "truth" is typically evaluated via clinical outcomes and imaging rather than expert assessment of AI output. The clinical study mentioned would have involved surgeons and possibly other medical professionals, but their role in "ground truth establishment" for a test set (in the context of an AI device) is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not stated. Adjudication methods are typically relevant for studies validating diagnostic or AI tools where there might be disagreement in expert interpretation. This is a physical implant device.
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 is not an AI device, therefore MRMC studies (which are designed to evaluate human reader performance with and without AI assistance) are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. Not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the "effectiveness" of the device, the implied "ground truth" or evidence appears to be:
- Clinical Outcomes/Observation: "adequate fixation in the craniomaxillofacial region with no device related complications reported." This suggests direct observation of patient outcomes.
- Resorption Data: "completely resorbs by 12 months IN VIVO." This would be verified through follow-up imaging or possibly histological studies.
- Biocompatibility Data: Established through "years" of use of the base material (PLA/PGA sutures since early 1970s) and "over 10 years" in the Poly Surgiclip device. This would likely involve historical clinical data, pathology, and toxicology studies.
- Mechanical Testing: This would use engineering performance metrics as ground truth.
8. The sample size for the training set
- Not applicable/Not stated. This is not an AI/algorithm-based device requiring a training set. The "training data" for the safety component implicitly comes from decades of biological use for PLA/PGA.
9. How the ground truth for the training set was established
- Not applicable/Not stated. As it's not an AI device, there's no "training set" in the context of an algorithm. The safety and biocompatibility of the material (PLA/PGA) were established over many years through widespread clinical use in other FDA-approved devices (sutures, Surgiclip), historical data, and likely pre-clinical testing, forming the basis for its known biological behavior and "ground truth" regarding its safety profile.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.