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510(k) Data Aggregation
(90 days)
The LactoSorb® Pectus Stabilizer provides the surgeon with a means to secure the Pectus Support Bar to the chest wall. The Biomet Microfixation Pectus Bar is used to reposition bony structures (sternum, breastbone) by applying internal force outwardly eliminating the funnel shaped deformity. The LactoSorb® Pectus Stabilizer is a resorbable implant and does not require removal.
The provided text is a 510(k) summary for the Biomet Microfixation LactoSorb® Pectus Stabilizer. It describes the device, its intended use, possible adverse effects, and claims substantial equivalence to predicate devices.
However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or any other data related to a clinical or performance study demonstrating the device meets specific acceptance criteria.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo clinical performance studies with acceptance criteria, as might be seen for novel devices or PMAs.
Therefore, I cannot provide the requested table and study details from the given text.
Summary of what is missing in the provided text to fulfill your request:
- Acceptance Criteria and Reported Device Performance: No specific performance metrics or thresholds are mentioned. The document focuses on device description and intended use.
- Study Details: There is no description of any study (clinical or non-clinical) conducted to evaluate the device's performance against defined acceptance criteria.
- Sample Sizes, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth Type, Training Set Details: All these elements relate to a performance study, which is not present in the provided 510(k) summary.
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