(63 days)
The Endius TiTLE 2 Poly Axial Spinal System is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar, and sacral spine.
The Endius TiTLE 20 Poly Axial Spinal System is a pedicle screw 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 the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The Endius TiTLE 2 Poly Axial Spinal System is also indicated for pedicle screw fixation for severe spondylolisthesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.
In addition, the Endius TiTLE 2® Poly Axial Spinal System, when not used with pedicle screws is indicated for hook, wire, and/or sacral screw fixation from T1 to the ilium sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease, (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture, and previous failed fusion surgery.
The proposed Endius TiTLE 2® Poly Axial Spinal System that is intended to be used for posterior lumbar fusion procedures. The system is manufactured from titanium which complies with ASTM F136. The components, which are included as part of the system, include screws, rods, and connection components.
The provided text describes a 510(k) premarket notification for a medical device, the Endius TiTLE 2 Poly Axial Spinal System. This type of submission by the FDA focuses on establishing substantial equivalence to a predicate device, rather than conducting new clinical trials to prove safety and effectiveness from scratch. As such, the information you're requesting regarding acceptance criteria, study details, and AI performance metrics is not available in this document.
Here's a breakdown of why and what information is present:
Why the requested information is not available in this document:
- Premarket Notification (510(k)) Context: A 510(k) submission primarily demonstrates that a new device is as safe and effective as a legally marketed predicate device. This is often achieved through comparative testing (e.g., mechanical testing in the case of a spinal system) and analysis of existing clinical data for the predicate, rather than new, large-scale clinical studies with specific performance metrics and ground truth establishment as would be required for a PMA (Premarket Approval) or certain novel devices.
- Device Type: The Endius TiTLE 2 Poly Axial Spinal System is a spinal implant system (pedicle screw system, rods, connection components). The "performance" of such a device is typically assessed through mechanical properties (strength, fatigue, torsional stiffness, etc.) relative to the predicate, and biocompatibility, rather than diagnostic accuracy metrics.
- Date: The submission is from 2007. The methodologies for evaluating AI in medical devices (e.g., MRMC studies, specific ground truth protocols, training/test set provenance) are much more recent developments and would not be relevant to a spinal implant submission from this era.
Information that is present in the document:
- Acceptance Criteria (Implied by Substantial Equivalence): The implicit acceptance criterion is "substantial equivalence" to the predicate device, the existing Endius TiTLE 2 Poly Axial Spinal System (K060990). This means the modified device must perform equivalently in mechanical tests and have the same indications for use.
- Study Proving Acceptance Criteria: "Documentation, including mechanical test results, has been provided which demonstrate that the proposed Endius TiTLE 2® Poly Axial Spinal System components are substantially equivalent to the existing Endius TiTLE 2® Poly Axial Spinal System, K060990."
- Nature of the "Study": This refers to mechanical testing. The document does not provide specifics about the methodology, sample sizes, or the actual results of these mechanical tests beyond stating they were performed and demonstrated substantial equivalence.
- Device Performance: The document states that the mechanical test results demonstrate substantial equivalence to the predicate device. No specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or specific mechanical load values) are reported in the summary provided.
Therefore, I cannot populate the table or answer most of your detailed questions because the provided text is for a 510(k) submission of a spinal implant system prior to the widespread application of AI in medical devices and focuses on substantial equivalence through mechanical testing, not diagnostic performance or AI-specific evaluation metrics.
Based on the provided text, here is what can be inferred and explicitly stated:
- A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (K060990) based on mechanical test results. | Mechanical test results demonstrate components are substantially equivalent to the existing Endius TiTLE 2® Poly Axial Spinal System (K060990). |
| Same Indications for Use as predicate device. | The indications for use are consistent with the predicate. |
| Compliance with ASTM F136 (material). | Manufactured from titanium which complies with ASTM F136. |
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The text only mentions "mechanical test results" without detailing the specific tests, sample sizes, or methodology. This is typical for a 510(k) summary focused on substantial equivalence rather than a full study report.
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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/Not provided. For a spinal implant system, "ground truth" as it relates to expert consensus or pathology is typically not established for mechanical testing. The "truth" in this context would be the physical properties and performance measured against established mechanical standards or predicate device performance.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. Adjudication methods are relevant for subjective interpretations, often in clinical evaluations or image analysis, which is not the type of assessment described for this device.
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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. This is a spinal implant system from 2007, not an AI/diagnostic imaging device. An MRMC study would not be relevant.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not provided in detail. For mechanical testing, the "ground truth" would be the objective measurements of material properties and performance under stress, compared against a predefined standard or the predicate device's measured performance. The document does not specify these details.
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The sample size for the training set:
- Not applicable. This relates to AI/machine learning models, which are not described here.
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How the ground truth for the training set was established:
- Not applicable. This relates to AI/machine learning models, which are not described here.
§ 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.