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The Biomet Microfixation LactoSorb® Pectus Stabilizer is intended to be used with Lorenz Pectus Support Bars cleared via K972420 and K061384 for repairing Pectus Excavatum and other sternal deformities when additional stabilization is necessary.

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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For use during surgical procedures to repair Pectus Excavatum and other sternal deformities with Lorenz Pectus Support Bar 510(k) number K972420 when additional stabilization is necessary.

Stabilizer for a single bar: Two designs will be offered for stabilization of a single bar. One design will be an elongated plate and one will be a triangular plate which will be added at the ends of the Lorenz Pectus Support Bar. The stabilizers have a dovetail slot in the center of the plate for the pectus bar to slide into. Two lips come up over the bar to secure the pectus bar within the slot of the stabilizers bave two holes on either side of the slot to suture the stabilizer to the lateral chest wall together with the support bar preventing lateral movement and flipping of the bar.

Stabilizer for two bars: The design is a triangular plate with two dovetail slots to slide the Lorenz Pectus Support Bars into. Two lips will come up over the bars to secure the pectus bars within the stabilizer. The stabilizer will have a single hole to suture the stabilizer and the bars to the lateral chest wall preventing lateral movement and flipping of the bar.

This document is a 510(k) summary for a medical device modification, the Lorenz Pectus Support Bar Stabilizer. It describes the device's intended use and design but does not contain information about a study proving the device meets acceptance criteria.

Therefore, many of the requested details, such as specific acceptance criteria and study parameters, cannot be extracted from the provided text.

Here is a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The document describes the device modification and its intended use but does not present any performance data or acceptance criteria for a study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. No study or test set information is present in the document.

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)

• Cannot be provided. No study or ground truth establishment information is present.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be provided. No study or adjudication method information is present.

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

• Cannot be provided. This device is a mechanical stabilizer, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with AI assistance would not be applicable.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done

• Cannot be provided. This device is a mechanical stabilizer, not an algorithm. Standalone performance as described (algorithm only) is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Cannot be provided. No study or ground truth establishment information is present.

8. The sample size for the training set

• Cannot be provided. No study or training set information is present.

9. How the ground truth for the training set was established

• Cannot be provided. No study or training set information is present.

Summary of available information related to the device:

• Device Modification Name: Lorenz Pectus Support Bar Stabilizer
• Previously cleared 510(k) for base device: Lorenz Pectus Support Bar - 510(k) K972420
• Classification Name and Reference: Plate, Fixation, Bone 87 HRS (CFR 888.3030)
• Intended Use: For use during surgical procedures to repair Pectus Excavatum and other sternal deformities with Lorenz Pectus Support Bar (K972420) when additional stabilization is necessary.
• Device Description: Two designs for single bar stabilization (elongated plate, triangular plate) and one design for two bars (triangular plate with two dovetail slots). All designs feature dovetail slots for the pectus bar(s) and holes for suturing to the lateral chest wall to prevent lateral movement and bar flipping.
• Potential Risks: The same as the pectus support bar alone and any long-term metallic implant (e.g., metal sensitivity, pain, surgical trauma, skin irritation, infection, pneumothorax, fracture, migration, loosening, inadequate remodeling or return of deformity).
• Regulatory Decision: Substantially equivalent to legally marketed predicate devices. The FDA clearance letter (K981789) indicates that the device can be marketed.

Conclusion: The provided document is a regulatory submission for device clearance, focusing on safety and effectiveness based on substantial equivalence to existing devices. It does not include data from a clinical or performance study that would answer the requested questions about acceptance criteria and study methodology.

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