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510(k) Data Aggregation
(270 days)
KLS Martin Pure Pectus System
The KLS Martin Pure Pectus System is indicated for use in surgical procedures to repair pectus excavatum. It is indicated for use in adult and pediatric (children and adolescents) populations.
The KLS Martin LP Pure Pectus system consists of metallic implants comprised of straight and angled pectus bars and connector bars that provide support to the thoracic cavity undergoing repair for pectus excavatum. The implants are provided non-sterile in multiple sizes and are manufactured using tradition methods. Pectus bars are manufactured from CP Titanium. Connector bars are manufactured from Ti-6Al-4V. The system also instruments to facilitate placement of the implants.
The KLS Martin Pure Pectus System is a metallic implant system designed for surgical repair of pectus excavatum in both adult and pediatric populations. The submission K221938 received FDA clearance. Given the information provided, here's a detailed breakdown of the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission and not a standalone algorithm, the "acceptance criteria" are not reported as specific performance metrics like sensitivity, specificity, or AUC, as would be the case for an AI/ML device. Instead, the acceptance criteria are related to mechanical and biological performance designed to demonstrate substantial equivalence to an existing predicate device.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from Report) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Mechanical Performance (Static Load) | Equivalent or superior static 4-point bending performance compared to the primary predicate device (Lorenz Pectus Support Bar K972420). Detailed thresholds for deflection, failure load, or stiffness would have been defined in test protocols, but are not explicitly reported in this summary document. | "Comparative head-to-head bench testing was conducted to determine substantial equivalence to the primary predicate device in static and dynamic 4-point bending. The testing met all predetermined acceptance criteria and the results demonstrate that the subject device's performance is substantially equivalent to the primary predicate device." |
| Mechanical Performance (Dynamic/Fatigue Load) | Equivalent or superior dynamic (fatigue) 4-point bending performance compared to the primary predicate device. Detailed thresholds for fatigue life or fracture mechanics would have been defined. | Same as above. |
| Biocompatibility | Biocompatible for its intended use, complying with ISO 10993-1:2018 standards for medical devices with prolonged tissue contact. No unacceptable cytotoxic, genotoxic, sensitization, irritation, or systemic toxicity effects. | "Biological safety risk assessments in compliance with ISO 10993-1:2018 were completed on the subject devices and concluded the devices are biocompatible and appropriate for their intended use." |
| Material Properties | Acceptable material composition (CP Titanium and Ti-6Al-4V) that does not adversely affect safety and effectiveness compared to the predicate's stainless steel. | "The subject device is manufactured from CP titanium (ASTM F67:2017) and Ti-6Al-4V (ASTM F136:2013) and the predicate device is manufactured from stainless steel. Performance testing demonstrated that the differences in material does not affect the safety and effectiveness of the subject devices and can be determined substantially equivalent." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of "cases" or "patients" because this was bench testing on physical devices, not a clinical trial or algorithm evaluation with data. The sample size would refer to the number of bars tested for each mechanical test (static and dynamic bending). While not specified, these types of tests typically involve a statistically significant number of samples per variant (e.g., 5-10 samples per size/configuration for fatigue, 3-5 for static).
- Data Provenance: The data provenance is from non-clinical "bench testing" conducted by the manufacturer, KLS Martin L.P. This is not patient data; it's laboratory test data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. For this type of submission (mechanical and biocompatibility testing for a medical device), "ground truth" is not established by human experts in the way it would be for an AI diagnostic algorithm. Ground truth is established by validated laboratory testing procedures and international standards.
4. Adjudication Method for the Test Set
Not applicable. This was not an expert review/adjudication of clinical images or patient cases. The "adjudication" in this context is the comparison of test results against pre-defined acceptance criteria per established test protocols and standards.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic tools that assist human readers in interpreting medical images or data. The KLS Martin Pure Pectus System is a metallic implant; its evaluation focused on its physical and biological performance, not its interpretive capabilities.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance evaluation was not done. This is also not relevant for an implantable medical device. Standalone performance is assessed for algorithms that provide diagnostic or prognostic outputs without human oversight.
7. The Type of Ground Truth Used
For the mechanical testing, the "ground truth" is the measured physical properties and performance of the subject device compared against the measured physical properties and performance of the predicate device, with both tested under standardized conditions. The benchmark for "ground truth" for biocompatibility is conformance to ISO 10993-1:2018 standards.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is not an AI/ML algorithm that requires a "training set" or ground truth for training.
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