(131 days)
The Scient'x Spinal System is a posterior, noncervical pedicle and non-pedicle system 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 thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, disfocation, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The Scient'x Spinal System consists of monoaxial pedicle screws, rigid rods and crosslink members, semi-rigid rods, polyaxial screws, cross link and closed and open screws. It can be used for single or multiple level fixations. The modifications included in this submission is the addition of Polyaxial LP Screws, and additional sizes of Polyaxial TTL U Screws, Polyaxial TTL High U-screw, Monoaxial TTL U Screws, Polyaxial Hemispherical Screws, MX Polyaxial Screws, MX Monaxial Screws - Closed and MX Monaxial Screws - Open.
This a medical device, not an AI/ML powered device, so acceptance criteria and study data would differ from AI/ML device requirements.
Here's an analysis of the provided text in relation to your request about acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the mechanical properties of the pedicle screw systems as the focus of testing. It directly states that testing was performed following the protocol of ASTM F1717 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model."
However, the provided text does not explicitly list specific numerical acceptance criteria (e.g., minimum load to failure, maximum displacement) or the reported device performance metrics (the actual test results). It only states that the testing was undertaken and the standard followed.
To create the table you requested, we would need the actual test report which would detail:
| Acceptance Criterion (Based on ASTM F1717) | Reported Device Performance |
|---|---|
| Specific mechanical property 1 (e.g., Static Compression Bending Yield Load) | Value achieved for property 1 |
| Specific mechanical property 2 (e.g., Static Torsion Stiffness) | Value achieved for property 2 |
| Specific mechanical property 3 (e.g., Dynamic Fatigue Strength at X cycles) | Value achieved for property 3 |
| ... and so on for all relevant tests within ASTM F1717 | ... |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the sample size used for the mechanical testing. ASTM F1717 would typically specify a minimum number of samples for each test, but this information is not present in the 510(k) summary.
- Data Provenance: The testing was "undertaken to determine the mechanical properties of the pedicle screw systems." This is a pre-market, non-clinical study conducted by the device manufacturer (Scient'x) or a contracted lab. The country of origin for the data is implied to be France (where Scient'x is based) or where their testing facility is located, but not explicitly stated. It is entirely retrospective in the sense that it's laboratory testing, not patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This question is not applicable to this type of device and study.
- Ground truth in the context of mechanical testing for a medical implant is established by validated engineering principles and standards (like ASTM F1717), not by expert consensus or medical diagnosis.
- The 'experts' involved would be bioengineers or mechanical engineers specializing in medical device testing, not radiologists or pathologists. Their qualifications would be in engineering and materials science, with experience in performing and interpreting mechanical tests according to international standards. The document does not specify who performed the tests or any qualifications.
4. Adjudication Method for the Test Set:
This question is also not applicable to this type of device and study. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in human expert interpretations (e.g., in medical image analysis or clinical trial endpoint assessment). Mechanical testing results are objective measurements that do not require such adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done.
- MRMC studies are relevant for evaluating diagnostic or prognostic tools that involve human readers (e.g., radiologists interpreting images) and are designed to assess the impact of a new technology (like AI) on reader performance.
- This device is a spinal implant system, and its evaluation focuses on mechanical integrity and biocompatibility, not on diagnostic accuracy or human reader performance.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done:
No, a standalone performance study was not done.
- This question is relevant for AI/ML algorithms where "standalone" refers to the algorithm's performance without any human intervention or interpretation.
- Since the Scient'x Spinal System is a physical implant, this concept does not apply. The "performance" here refers to its mechanical response under simulated physiological loads.
7. The Type of Ground Truth Used:
The "ground truth" for this study is derived from:
- Engineering Standards and Specifications: Specifically, ASTM F1717 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model." This standard defines the parameters, loads, and methods for evaluating spinal implants, effectively setting the "truth" for what constitutes acceptable mechanical behavior.
- Material Specifications: Compliance with ASTM F136 and ISO 5832-3 for Ti6Al4V alloy is also a "ground truth" for material composition and quality.
8. The Sample Size for the Training Set:
This question is not applicable.
- A "training set" refers to data used to train a machine learning model.
- The Scient'x Spinal System is a physical medical device, not an AI/ML algorithm. Therefore, there is no training set involved in its evaluation.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable as there is no training set for a physical medical device.
In summary:
The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices primarily through non-clinical mechanical testing and material compliance. While it mentions the standard followed (ASTM F1717), it lacks the specific numerical acceptance criteria and the actual performance data that would typically be found in a detailed test report. The evaluation paradigm for a spinal implant is entirely different from that of an AI/ML diagnostic algorithm, rendering many of your specific questions regarding AI/ML irrelevant to this document.
§ 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.