(54 days)
The M.U.S.T. Pedicle Screw System is intended for posterior non-cervical pedicle fixation (T1-S2/ilum) and 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 purpose of this submission is to add the M.U.S.T. MC Cross Connectors to the M.U.S.T. Pedicle Screw System (K132878, K171170, K121115, K153664, K141988) for the stabilization and fusion of the non-cervical spine. The M.U.S.T. Pedicle System includes a wide range of implants: Rods, Polyaxial and Mono-axial Pedicle Screws, Hooks, Connectors of various design and size, that are used in combination to compose a spinal construct.
The provided text describes a 510(k) premarket notification for the M.U.S.T. Pedicle Screw System, which is a medical device for spinal fixation. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than performing novel clinical studies to prove performance against specific acceptance criteria.
Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert validation, ground truth, MRMC studies, standalone performance, training set) typically associated with a de novo or PMA submission for a new device's efficacy and safety is not applicable to this 510(k) summary.
Here's how the provided information aligns with the request, highlighting what is and isn't available from this document:
1. A table of acceptance criteria and the reported device performance
- Not Applicable in this Context. For a 510(k), the "acceptance criteria" for the device's performance are primarily established by the performance of the predicate devices. The study performed is to demonstrate that the new device (M.U.S.T. MC Cross Connectors) performs equivalently to the predicate devices and meets relevant industry standards rather than achieving specific performance metrics against a disease outcome.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable for clinical data.
- Mechanical Testing:
- Sample Size: The document states that "worst-case implants" were tested, but it does not specify the exact number of samples used for each test (Static compression/bending, Dynamic compression bending).
- Data Provenance: The provenance of the data is from internal testing conducted by Medacta International SA. The country of origin for the testing facility is not explicitly stated, but Medacta International SA is based in Switzerland. The studies are prospective in the sense of being planned tests on newly manufactured components.
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 a mechanical device, not a diagnostic or AI-driven system that requires expert interpretation for ground truth establishment. The "ground truth" for mechanical testing is derived from engineering principles and validated test standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving expert review of images or clinical outcomes. For mechanical performance testing, the results are typically quantitative and objective, based on physical measurements and material properties.
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. An MRMC study is relevant for diagnostic devices, particularly those involving image interpretation by human readers, often comparing human performance with and without AI assistance. This device is a surgical implant, not a diagnostic tool, and involves no human "readers" in the context of interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This question is also relevant for AI/software as a medical device (SaMD). The M.U.S.T. Pedicle Screw System is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Mechanical Testing Standards. For the non-clinical performance tests, the "ground truth" is implied by the adherence to and successful completion of established industry standards for spinal implant testing, specifically ASTM F1717 (Static compression/bending and Dynamic compression bending) and European Pharmacopoeia §2.6.14 / USP chapter and for pyrogenicity. The acceptance criteria are embedded within these standards.
8. The sample size for the training set
- Not Applicable. The concept of a "training set" doesn't apply to the mechanical testing of a physical medical device like this, which doesn't involve machine learning algorithms.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an algorithm, this question is not relevant.
Summary of Relevant Information from the Document for a 510(k):
The document explicitly states:
- "No clinical studies were conducted." This reinforces that the focus is on non-clinical, mechanical performance and comparison to predicate devices.
- Performance Tests: The device underwent "Non-Clinical Studies" including:
- Static compression / bending per ASTM F1717
- Dynamic compression bending per ASTM F1717
- Cadaver studies (though no specifics are given beyond "Cadaver studies O")
- Pyrogenicity testing (Bacterial Endotoxin Test per European Pharmacopoeia §2.6.14/USP chapter and pyrogen test per USP chapter ).
- Acceptance Criteria for Non-Clinical Tests: "Testing was conducted according to written protocols with acceptance criteria that were based on standards." The implicit acceptance criteria are that the device meets or exceeds the performance of legally marketed predicate devices, as defined by the standards (e.g., ASTM F1717) and the specific testing protocols.
In essence, for a 510(k) for a physical implant, the "study that proves the device meets the acceptance criteria" is primarily the non-clinical performance testing demonstrating that the device is substantially equivalent to existing, legally marketed predicate devices, by meeting relevant recognized standards. This is a comparison of technological characteristics and performance, not a clinical efficacy study with human subjects.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.