(98 days)
The Pectus Blu system is indicated for the treatment of Pectus Excavatum and other sternal deformities. It is intended to be used in pediatric (children and adolescents) and adult populations.
The Pectus Blu Support Bar and Stabilizers (including Pectus Blu TruLink™ Stabilizers) are surgical implants intended to aid treatment of Pectus Excavatum deformity in adults and pediatric patients (children and adolescents) for which the rib cage across the sternum measures 7 inches (17.78 centimeters) or larger. The Pectus Blu Support Bar provides the surgeon with a means to reposition bony structures (sternum, breastbone) by applying internal force outwardly eliminating the funnel shape deformity. Recommended implantation time is 2-3 years but may vary based on surgeon preference and patient. These devices are offered in a generic pre-bent shape that can be further shaped intraoperatively. These devices are intended to be used in professional healthcare facilities.
This FDA 510(k) summary (K241709) describes the Pectus Blu Support Bar System, which is indicated for the treatment of Pectus Excavatum and other sternal deformities in pediatric and adult populations. The submission is for a line extension to the previously cleared Pectus Blu Support Bar System (K212841), with the addition of Pectus Blu TruLink™ Stabilizers. As such, the FDA has determined substantial equivalence based on a comparison to the predicate device, rather than requiring a new clinical study with specific acceptance criteria related to disease detection or diagnosis.
Here's an analysis of your questions based on the provided document:
1. A table of acceptance criteria and the reported device performance
Based on the provided FDA 510(k) summary, specific acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) for the device are not applicable and not provided. The device is a surgical implant, not a diagnostic tool. The submission focuses on demonstrating substantial equivalence to a predicate device, meaning it performs as intended and is as safe and effective as the already cleared device.
The performance data mentioned (in section 8) refers to Verification and Validation attachments, which would typically include engineering tests, biocompatibility tests, mechanical strength tests, and other non-clinical performance characteristics to ensure the device meets its design specifications and performs as intended. These are not diagnostic accuracy metrics.
| Acceptance Criteria Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Clinical Performance | Not applicable | Not applicable |
| Device Characteristics | Indications for Use: Treatment of Pectus Excavatum and other sternal deformities in pediatric and adult populations. | The Pectus Blu Support Bar System, with Pectus Blu TruLink™ Stabilizers, maintains the same Indications for Use as the predicate device. |
| Support bar geometry and sizing: Similar to predicate. | Similar to predicate device. | |
| Materials of construction: Identical to predicate. | Identical to predicate device. | |
| Sterilization method: Similar to predicate. | Similar to predicate device. | |
| Safety and Effectiveness: No new questions of safety and effectiveness compared to predicate. | No new questions of safety and effectiveness were identified with the addition of the TruLink Stabilizer. | |
| Non-Clinical Performance | Standardized or equivalent test methods for all modifications. | All modifications were tested to standardized or equivalent test methods as established in the predicate device 510(k) K212841. (Specific results not detailed in this summary, but would be in the V&V attachments). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided in the FDA 510(k) summary. Since this is a submission for a surgical implant and not a diagnostic AI device, there isn't a "test set" in the context of diagnostic performance evaluation. The "performance data" refers to non-clinical testing of the device's physical properties.
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)
This information is not applicable and not provided. "Ground truth" in the context of expert review for a diagnostic test set is irrelevant for a surgical implant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are used in diagnostic studies to resolve discrepancies among expert readers, which is not relevant here.
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
This information is not applicable and not provided. MRMC studies are conducted to evaluate the performance of diagnostic devices, particularly those involving AI assistance for human readers. This device is a surgical implant, not a diagnostic tool with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. "Standalone" performance refers to the performance of a diagnostic algorithm without human intervention. This device is a physical surgical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and not provided. "Ground truth" typically refers to a definitive diagnosis or condition used to evaluate a diagnostic test. For a surgical implant, the "truth" is whether the device functions as intended, is biocompatible, and structurally sound, which is assessed through non-clinical testing and clinical experience (though a new clinical study wasn't required for this 510(k)).
8. The sample size for the training set
This information is not applicable and not provided. Training sets are used in the development of AI algorithms. This device is a physical surgical implant.
9. How the ground truth for the training set was established
This information is not applicable and not provided. This question is pertinent to AI algorithm development, which is not the subject of this 510(k) submission.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.