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510(k) Data Aggregation
(60 days)
M.U.S.T. Pedicle Screw Extension and Long Tab Implants
The M.U.S.T. Pedicle screws system is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) and non-pedicle fixation, or anterolateral fixation (T8-L5). These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
The M.U.S.T. Extension and M.U.S.T. Long Tab is intended to be used as part of the M.U.S.T. Pedicle Screw system (K121115, K132878, K141988, K153664, K162061, K171170, K171758, K193365) for the stabilization and the fusion of the lumbar and thoracic spine. The M.U.S.T. pedicle screw system includes cannulated or non-cannulated poly-axial pedicle screws (K121115, K132878, K153664), cannulated or non-cannulated mono-axial pedicle screws (K132878), set screws (K121115, K171758), straight and pre-bent rods (K121115, K141988, K162061), lateral connectors (K162061) and cross connectors (K132878, K193365). The M.U.S.T. pedicle screw system also includes the enhanced screws and rods designed for percutaneous surgery (K141988).
The M.U.S.T. Extension and M.U.S.T. Long Tab introduce new sizes of sterile implantable devices intended to be used for posterior non-cervical pedicle fixation (T1-S2/ilium) or anterolateral fixation (T8-L5). The devices subject of this submission are:
- New size of Straight Rods (both Titanium and CoCr version): length 600mm Hex interface at the end
- New size of Straight Rods (Anodized Titanium version): length 600mm
- Pre-contoured Rods (both Titanium and CoCr version)
- New sizes of Lateral Connectors: length 80; 100; 125 & 150mm
- New sizes of Enhanced Cannulated Pedicle Screws: Ø8; Ø9; Ø10 length from 30 to 100mm
- New cannulated pedicle screws with thread 4 leads (15 and 25 mm)
- Setscrews in Titanium
This document is a 510(k) Premarket Notification from Medacta International SA for their M.U.S.T. Pedicle Screw Extension and Long Tab Implants. It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing detailed clinical study data on device performance against specific acceptance criteria for AI/ML-enabled devices.
Therefore, the requested information regarding acceptance criteria, study details, human reader improvement with AI assistance, standalone algorithm performance, and ground truth establishment cannot be found in the provided text. The document describes a traditional medical device submission (pedicle screws) which relies on bench testing and comparison to predicates, not AI/ML performance studies.
However, based on the structure of the provided document, I can infer the "acceptance criteria" and "study" are related to the engineering and design validation of the medical device, rather than the performance of an AI/ML algorithm.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document describes several non-clinical studies and tests with implied acceptance criteria, but it does not present them in a clear table format with specific quantitative performance results against those criteria. Instead, it lists the types of tests performed.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Design Validation: | Design Validation: |
| Sufficient fixation in bone (Geometrical Analysis MUST LT Thread Geometry) | A geometrical analysis was performed in comparison to approved and marketed implants, related to the most important dimensions of the threads (assumed to meet acceptance criteria through comparison). |
| Operability with MIS percutaneous technique (Cadaver surgery) | Cadaver surgery performed according to the well-known MIS percutaneous technique by experienced surgeons (assumed successful operation; no specific outcome metrics provided). |
| Sufficient flexural strength of the tulip (Tab welding MUST LT Flexion strength test) | Flexion strength test performed to characterize the specific design of the tulip in the dedicated breaking area (assumed to meet acceptance criteria for breaking area design; no explicit quantitative results provided). |
| Performance Testing: | Performance Testing: |
| Adequate mechanical performance under static and dynamic axial compression (ASTM F1717-18) | Mechanical evaluation performed according to ASTM F1717-18 (Endolab 970 200220 30 1413 part 1 rev.0 and 970 200220 30 1414 part 1 rev.0) for worst-case definition (assumed to demonstrate acceptable mechanical performance comparable to predicate; no specific quantitative results provided). |
| Adequate mechanical performance under static torsion (ASTM F1717-18) | Mechanical evaluation performed according to ASTM F1717-18 (Endolab 970 200220 30 1413 part 2 rev.0 and 970 200220 30 1414 part 2 rev.0) (assumed to demonstrate acceptable mechanical performance comparable to predicate; no specific quantitative results provided). |
| Adequate axial tensile force resistance (ASTM F543-17, ASTM F2193-18a) | Mechanical evaluation performed according to ASTM F543-17 and ASTM F2193-18a (Endolab 970.200227.120.868-part1 rev. 0) (assumed to demonstrate acceptable resistance; no specific quantitative results provided). |
| Adequate torsional force resistance (ASTM F543-17, ASTM F2193-18a) | Mechanical evaluation performed according to ASTM F543-17 and ASTM F2193-18a (Endolab 970.200227.120.867-part2 rev. 0 and 970.200227.120.868part2 rev. 0) (assumed to demonstrate acceptable resistance; no specific quantitative results provided). |
| Acceptable torsional yield strength, maximum torque, and braking angle (ASTM F543-17 A1) | Mechanical evaluation performed according to ASTM F543-17 - A1 (Endolab 970.200227.120.867-part3 rev. 0 and 970.200227.120.868-part3 rev. 0) (assumed to demonstrate acceptable properties; no specific quantitative results provided). |
| Acceptable risk of breakage during insertion (ASTM F543-17) | Characterization and evaluation performed according to ASTM F543-17 (Medacta test report ASTM F543 Summary Report) (claimed acceptable risk; no specific methodology or results provided besides the report reference). |
| Biocompatibility: | Biocompatibility: |
| Non-pyrogenic (Pyrogenicity Assessment) | Pyrogenicity Assessment Reports for MUST PEDICLE SCREWS IMPLANTS SURGICAL KITS (TF VI-PS-01, RAS-01.008.141 Rev. 5) and MUST LT IMPLANTS (VI-PS-01) (RAS-01.008.277, Rev. 0) were conducted (assumed to demonstrate non-pyrogenicity). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated for each test, but standard ASTM methods often define minimum sample sizes for mechanical testing. For the cadaver surgery, it states "experienced surgeons," implying at least one or more instances.
- Data Provenance: Not specified, but given the company is Medacta International SA (Switzerland) and the testing labs are mentioned (Endolab), the data is presumed to be from their internal testing facilities or contracted labs, likely within Europe. No mention of patient data or clinical data is made, so "retrospective or prospective" is not applicable in the context of this submission. This is a bench test and design validation submission.
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. This is not an AI/ML study involving human expert ground truth. The "ground truth" for these tests is defined by engineering standards (e.g., ASTM) and physical measurements. For the cadaver surgery, it states "experienced surgeons" performed the procedure, but their role was to evaluate the instrument's use in a simulated environment, not to establish a "ground truth" for an AI model.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is for resolving disagreements in expert labeling for AI/ML ground truth, 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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical pedicle screw system, not an AI/ML software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is based on:
- Engineering Standards: Adherence to established ASTM (American Society for Testing and Materials) standards for spinal implants and medical bone screws to define acceptable mechanical properties.
- Physical Measurements/Analysis: Geometrical analysis of threads and characterization of mechanical properties (tensile strength, torsion, etc.).
- Risk Analysis: Identification of new risks and verification against predefined acceptance criteria based on this analysis, likely conforming to ISO standards for medical device risk management.
- Biocompatibility Testing: Demonstrated through pyrogenicity assessment reports.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As above, no AI/ML device with a training set.
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