(230 days)
Resorb-X G is intended for use in non-load bearing fracture repair and reconstructive procedures in pediatric and adult populations. In addition, resorbable meshes, plates and pins may be used in non-load bearing applications for maintaining the relative position of, and/or containing, bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in cranial reconstruction.
The Resorb-X G product line consists of plates, meshes and pins manufactured in a variety of sizes and configurations to provide fixation and aid in the alignment and stabilization of fractures in reconstructive procedures. Resorb-X G is implanted using ultrasonic force generated by an ultrasonic unit that causes a phase transition in the pin, allowing the pin to adapt to the previously drilled pilot hole in the surgical site and utilize the micro undercuts of the bone for retention.
The plate, mesh and pin sizes and configurations are identical to components previously cleared in K080862, Sonic Weld RX (Resorb-X). The PLLA/PGA material is identical to that cleared in K 12064, Resorb-X G. This premarket notification is being submitted to expand the indications for use for Resorb-X G to include cranial use in pediatric and adult populations and includes additional sizes and configurations in the PLLA/PGA material for cranial use.
The provided text describes a 510(k) summary for the Resorb-X G Resorbable Fixation System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a study proving the device meets specific acceptance criteria with quantifiable metrics like sensitivity, specificity, or accuracy which are common for AI/ML device performance studies.
Therefore, many of the requested sections related to acceptance criteria, device performance, ground truth, and statistical study designs are not directly applicable or available in this document. The information provided heavily emphasizes the technological characteristics and intended use for demonstrating substantial equivalence.
Here's an analysis based on the provided text, addressing the points where information is available or noting its absence:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define acceptance criteria as typically seen for AI/ML device performance (e.g., minimum sensitivity, specificity). Instead, it relies on demonstrating similar performance or conformance to standards for chemical analysis, cytotoxicity, and mechanical degradation compared to predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Chemical Analysis (ISO 10993-18) | Conformance to the standard tested. |
| Cytotoxicity (ISO 10993-5) | Conformance to the standard tested. |
| Mechanical Degradation Comparison (Resorb-X G vs. Resorb X (K080862)) | Resorb-X G showed higher tensile strength for the first 12 weeks (97% strength retention after 4 weeks, 80% after 8 weeks, 15% at conclusion). Higher viscosity for Resorb-X G was observed during the first 11 weeks. Profile for both polymers remained relatively constant. |
| Biocompatibility (ISO 10993-1, -5, -12, -18) | Tested to ISO 10993-1, -5, -12, -18. |
| Sterility | Provided Sterile (Gamma Radiation). |
| Chemical Safety (ISO 10993-12, -18) | Tested to ISO 10993-12, -18. |
| General Safety & Effectiveness (Substantial Equivalence) | Demonstrated through similarities in intended use, fundamental technology, design, and material compared to predicate devices, and performance testing results. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of AI/ML algorithms evaluated on patient data. The "testing" refers to laboratory-based performance testing of the device materials.
- Sample Size for Test Set: Specific sample sizes for the chemical analysis, cytotoxicity, and mechanical degradation tests are not provided. The mechanical degradation comparison mentions testing "gamma-sterilized material," implying a laboratory sample rather than a clinical patient cohort.
- Data Provenance: Not applicable as the testing involves materials rather than patient data.
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)
Not applicable. The "ground truth" for this device's testing relates to established scientific methods and standards for material properties (e.g., tensile strength, chemical composition, cytotoxicity), not expert interpretation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is relevant for reconciling discrepancies in expert annotations for AI/ML models. For material testing, results are typically determined by standardized laboratory procedures.
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
Not applicable. This is not an AI/ML device that assists human readers. It is a resorbable fixation system for surgical procedures.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance testing described is based on established scientific and engineering standards and validated laboratory methods for material characteristics (e.g., ISO 10993 for biocompatibility, chemical analysis, cytotoxicity, and standard methods for measuring tensile strength and viscosity).
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.
Summary of Performance Testing (as described in the document):
The performance testing focused on demonstrating the material properties and safety of Resorb-X G.
- Chemical Analysis (ISO 10993-18) and Cytotoxicity (ISO 10993-5): Conformance to these recognized standards was reported. These tests assess the device's chemical composition and its potential to cause harm to living cells.
- Mechanical Degradation Comparison: A comparative test was performed between Resorb-X G (PLLA/PGA) and Resorb X (PDLLA, from K080862) to evaluate tensile strength and viscosity over 22 weeks for gamma-sterilized material.
- Resorb-X G: Showed higher tensile strength for the first 12 weeks, with 97% strength retention after 4 weeks, 80% after 8 weeks, and 15% at the conclusion of the test (22 weeks).
- Resorb-X (PDLLA): Showed higher tensile strength in the later weeks due to a lower resorption rate.
- Viscosity: Resorb-X G showed higher viscosity for the first 11 weeks, while Resorb-X showed higher viscosity for the last 11 weeks. Both profiles remained relatively constant.
The conclusion drawn from this testing is that Resorb-X G's performance results and technological characteristics demonstrate substantial equivalence to predicate devices and do not raise new issues of safety or effectiveness.
§ 882.5320 Preformed alterable cranioplasty plate.
(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).