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This device is intended for use in surgical procedures to repair Pectus Excavatum and other chest wall deformities.

Pectus Pre-bent Support Bar: A stainless steel or titanium bar, variable length from 7 to 17 inches, and 0.50 inches wide, with two holes and notches on both ends for sutures to secure the bar to the lateral chest wall. The bar is pre-shaped based on a CT Scan provided by the Surgeon specifically for a certain patient. The titanium bar is only used when the patient has a nickel allergy.

Pectus Titanium Support Bar Stabilizer: A titanium elongated plate with 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 stabilizer. The stabilizers have 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.

The provided text is a 510(k) Summary for a medical device (Lorenz Pectus Support Bar System) and associated FDA correspondence. This type of document is a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device, not necessarily to prove that the device meets specific acceptance criteria through a clinical study with performance metrics in the way a clinical trial for a new drug or diagnostic algorithm would.

Therefore, the requested information about acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not present in this document. This 510(k) relies on comparison to previously cleared devices.

Here's why the information you're asking for isn't in this document:

• Acceptance Criteria & Reported Performance: The 510(k) process for this type of device (metallic bone fixation appliances) typically focuses on material safety, mechanical properties, and design similarity to a predicate device. Performance is largely inferred from the predicate device's established safety and effectiveness. There isn't a table of specific clinical "acceptance criteria" (e.g., sensitivity, specificity for a diagnostic device) and reported device performance in this context.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone: These are all elements typically found in clinical studies, especially for diagnostic or AI-driven devices. This 510(k) submission is for a surgical implant, where clinical outcomes are often assessed through post-market surveillance or through specific clinical trials if the device is novel enough to warrant a PMA (Premarket Approval) rather than a 510(k). The focus here is on engineering and material equivalence to existing devices.
• Ground Truth: For a surgical implant, "ground truth" wouldn't be established in the same way as for a diagnostic device (e.g., pathology slide for cancer detection). Clinical success (e.g., correction of deformity, absence of complications) would be the outcome measure, but this document specifies the device's intended use and substantial equivalence, not a trial demonstrating these outcomes.
• Training Set: This device is a physical implant, not an AI algorithm. Therefore, there is no "training set" in the computational sense.

Summary based on the provided document:

• No acceptance criteria for device performance (e.g., sensitivity/specificity) is defined or studied in this document. The acceptance is based on demonstrating substantial equivalence to predicate devices (K981789 and K972420).
• No clinical study demonstrating device performance against specific acceptance criteria is described.
• The document does not contain information about:
  • Sample sizes for test or training sets.
  • Data provenance.
  • Number or qualifications of experts.
  • Adjudication methods.
  • Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
  • Standalone algorithm performance.
  • Type or method of establishing ground truth in a clinical study context.

The "study" that proves the device meets "acceptance criteria" in the context of this 510(k) submission is the comparison of its technological features and materials to predicate devices, and the conclusion that it is substantially similar in application and function. The acceptance criteria here are regulatory: demonstrating that the new device is as safe and effective as a legally marketed predicate device.

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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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