(67 days)
The LactoSorb® Hand System is indicated for use in closed noncomminuted diaphyseal metacarpal fractures in the presence of appropriate immobilization.
The LactoSorb® plates and screws are made of bioresorbable and biocompatible polymer that have been used in surgical procedures for a number of years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic (PLLA/PGA) acid copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids, which are then metabolized by the body. The safety of PLLA/PGA material has been well documented since the early 1970s when the FDA first approved the use of resorbable PLLA/PGA sutures. The LactoSorb® material has been found to be biocompatible in both soft and hard bone tissues.
The provided text describes the LactoSorb® Hand System, a bioresorbable fixation system for metacarpal fractures. The effectiveness of this system was determined by mechanical testing, comparing it to similar metal fixation systems and the LactoSorb® Bone Pin.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Effectiveness (Mechanical Performance) | "as effective as similar metal fixation systems on the market as well as the LactoSorb® Bone Pin." |
| Resorption Time | "completely resorb by 12 months IN VIVO" |
| Biocompatibility | "biocompatible in both soft and hard bone tissues." |
| Safety of Material | "Safety of PLLA/PGA material has been well documented since the early 1970s when the FDA first approved the use of resorbable PLLA/PGA sutures." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for the mechanical testing (test set) or the data provenance (country of origin, retrospective/prospective). It only states that effectiveness was determined by "mechanical testing."
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)
This information is not applicable as the effectiveness was determined by mechanical testing, not by expert review of patient data or images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the effectiveness was determined by mechanical testing, not by human adjudication of clinical outcomes or images.
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
An MRMC study was not mentioned and is not applicable. The device's effectiveness was established through mechanical testing, not through an assessment of human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to this medical device, which is a physical implant (plate and screws). There is no "algorithm" in the context of device performance as described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for effectiveness was established through mechanical testing. This implies that the performance metrics (e.g., strength, stiffness, fatigue resistance) were measured and compared against established benchmarks or predefined performance standards for similar orthopedic fixation devices. For biocompatibility, reliance was placed on historical data and documentation regarding the PLLA/PGA material.
8. The sample size for the training set
This information is not applicable. The device is a physical implant, not an AI or software device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this type of medical device.
§ 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.