(53 days)
The LactoSorb® Bone Pin is indicated for use in the presence of appropriate immobilization in the following procedures:
- correction of hallux valgus (bunion)
- repair of metacarpal and phalangeal fusion and fractures
The LactoSorb® Bone Pin is made of bioresorbable and biocompatible polymers that have been used in surgical procedures for numerous years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic acid (PLLA/PGA) copolymer degrades and resors 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® Bone Pin, focusing on acceptance criteria and the supporting study, organized according to your requested points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Initial Strength | Demonstrated "adequate initial strength" compared to currently marketed resorbable pins. |
| Strength Retention | Retained "at least 80% of that strength at 8 weeks." |
| Comparison to Marketed Resorbable Pins | In the same test environment at eight weeks, comparative pins exhibited "little or no strength," implying LactoSorb® Bone Pin performed better. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size for the comparative in vitro mechanical testing. It refers to "the LactoSorb® pins" and "comparative pins" in the plural, without providing numerical details.
- Data Provenance: The study was conducted as "In VITRO mechanical comparative testing." This indicates the data was generated in a lab setting, not from human or animal subjects. The provenance of the comparative pins (e.g., specific manufacturers or models) is not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This was an in vitro mechanical testing study, not a study requiring expert clinical review to establish ground truth. The "ground truth" here is the mechanical properties measured by the test equipment.
4. Adjudication Method for the Test Set
Not applicable. As this was an in vitro mechanical test, there was no need for adjudication of results by experts.
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
Not applicable. This device is not an AI-assisted diagnostic or imaging device, and the study described is in vitro mechanical testing. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical device (bone pin), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this study was the measured mechanical properties (initial strength and strength retention over time) obtained through standardized in vitro testing. This is a direct measurement of physical attributes rather than an expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
Not applicable. This information is irrelevant for an in vitro mechanical comparative testing study of a physical device. There is no machine learning model being trained here.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set as this is not a machine learning study.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.