(183 days)
The TRANSLACE™ Spinal Tethering System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:
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Spinal trauma surgery, used in sublaminar or facet wiring techniques;
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Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic, congenital and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and spondylolisthesis:
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Spinal degenerative surgery, as an adjunct to spinal fusions.
The TRANSLACE™ Spinal Tethering System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants.
The TRANSLACE™ Spinal Tethering System consists of temporary implants and a reusable instrument for use in orthopedic spinal surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. This system will allow the spine to be secured to a rod construct without the use of a bone screw. It will act as an alternative to sublaminar wires and hooks.
This system consists of:
Connector Tether Tensioner Accessory – system specific tray which may be used to transport and sterilize the subject instruments. The subject TRANSLACE™ Spinal Tethering System devices will be available in similar sizes as the predicate systems.
The provided text describes a 510(k) premarket notification for the Medtronic TRANSLACE™ Spinal Tethering System, which is a medical device. This document is a regulatory submission to the FDA seeking clearance based on substantial equivalence to existing predicate devices, not an AI or diagnostic device that would involve performance metrics like sensitivity, specificity, or reader studies. Therefore, the questions about acceptance criteria, study data, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training sets are not applicable to this type of device and submission.
The document discusses the following types of studies and criteria, relevant to medical hardware/implantable devices:
1. Acceptance Criteria and Device Performance (as related to spinal implants):
The acceptance criteria for this device are focused on biocompatibility and mechanical performance to ensure it is as safe and effective as its predicate devices. The document states that the device meets these criteria through various tests.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criterion (Test Type) | Reported Device Performance / Assessment |
|---|---|
| Biocompatibility | The biocompatibility evaluation was conducted in accordance with FDA's Guidance for Industry and FDA Staff "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process" issued June 16, 2016. |
The subject implants are classified as permanent, >30 day body contact. Tests conducted include:
• Chemical Characterization
• Cytotoxicity
• Acute Systemic Toxicity
• Material Mediated Pyrogenicity
• Implantation
Results: Based on the results, no additional testing was required, indicating the device met biocompatibility criteria. The materials (Titanium-6 Aluminum-4 Vanadium ELI, polyester, stainless steel) are identified as identical to or compliant with predicate devices and relevant ASTM standards (ASTM F136, ASTM F899, ASTM A564, ASTM A693, ASTM A276). |
| Mechanical Testing | Evaluated in accordance with "Guidance for Industry and FDA Staff – Spinal System 510(k)'s". A combination of engineering rationales and testing were used.
Tests Completed:
• Tether Grip Static Testing (ASTM F1798)
• Tether Grip Fatigue Testing (ASTM F1798)
• Static Axial Grip Testing (ASTM F1798)
• Static Axial Rotational Grip Testing (ASTM F1798)
• Compression Fatigue Testing (ASTM F1717)
• Static Weld Testing
• Cadaver and/or True-Trainer (Sawbone) Validation Testing
• Instructions to Support Reprocessing Validation
Results: The results of these tests demonstrated the substantial equivalence of the subject devices to the predicates. The validation activities were completed and met the predetermined acceptance criteria. |
2. Sample size used for the test set and the data provenance:
- Test set: The specific sample sizes for each mechanical and biocompatibility test are not explicitly enumerated in this summary. Instead, it refers to industry standards (ASTM) which would define the required sample sizes for such tests.
- Data Provenance: The data comes from bench testing and laboratory evaluations conducted by Medtronic Sofamor Danek USA, Inc. The document does not specify country of origin for the data beyond being part of a US submission by a US entity. It is the result of direct scientific and engineering evaluations, not retrospective or prospective clinical data from human subjects in the context of an AI study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the "ground truth" for a mechanical/biocompatibility study of a spinal implant is established through objective physical and chemical testing against defined standards (e.g., ASTM standards, ISO standards related to biocompatibility) and engineering principles, not through expert consensus on diagnostic images. No experts, in the sense of human readers/interpreters, are involved in generating the "ground truth" for these performance metrics.
4. Adjudication method for the test set:
- This question is not applicable. Adjudication methods are relevant for subjective interpretations, common in clinical studies or AI diagnostic performance evaluations (e.g., resolving disagreements among radiologists). The mechanical and biocompatibility tests described here rely on objective measurements and established protocols, not subjective human judgment requiring adjudication.
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 question is not applicable. MRMC studies are used to evaluate the diagnostic performance of software, often AI-powered, and how it impacts human reader performance. The TRANSLACE™ system is a physical spinal implant, not a diagnostic AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. "Standalone performance" refers to the performance of a diagnostic algorithm or AI system by itself. The TRANSLACE™ system is a physical surgical device, not an algorithm. Its "performance" is measured by its material properties, mechanical strength, and biological safety.
7. The type of ground truth used:
- The "ground truth" for this device's performance evaluation is based on objective engineering and biological standards. This includes:
- Biocompatibility standards: ISO-10993 and specific tests (cytotoxicity, implantation, etc.) providing a biological "ground truth" for safety.
- Mechanical standards: ASTM standards (e.g., F1798, F1717) and specific mechanical tests providing an engineering "ground truth" for strength and stability.
- Material specifications: Compliance with ASTM standards for specific materials (e.g., titanium, stainless steel).
8. The sample size for the training set:
- This question is not applicable. This is not an AI or machine learning device requiring a "training set." The device is evaluated against established physical and biological benchmarks, not a dataset from which an algorithm learns.
9. How the ground truth for the training set was established:
- This question is not applicable as there is no training set for this type of medical device submission.
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.