(30 days)
The TPS-TL Spinal System implants are vertebral body replacement devices intended for use in the thoracic and/or thoracolumbar spine (i.e., T3 to L5). The Intended for accommissindicated to replace a diseased vertebral body(ies) resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collansed vertebral body(ies). The TPS-TL Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The TPS-TL Spinal System is treating trestore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
The TPS-TL Spinal System implants function as a single construct that combines an anterior plate and a vertebral body spacer which may be telescopically adjusted in situ to the required height. The TPS-TL Spinal System implants are composed of seven components: one (1) female chamber, one (1) male chamber, one (1) set screw, and four (4) bone screws. The TPS-TL Spinal System implants are made from medical implant grade titanium alloy as described by ASTM F136 (Ti 6Al-4V ELI) and are available for one and two levels.
The deferral for this device, K020204, is for the Interpore Cross Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal System. This is a spinal vertebral body replacement device, not an AI/ML powered device. Due to the nature of the device being a physical implant rather than a software algorithm, many of the requested categories related to AI/ML device studies (such as sample sizes for test and training sets, number of experts for ground truth, adjudication methods, MRMC studies, and standalone performance) are not applicable in this context.
Here's the information that can be extracted from the provided text:
1. Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not specify explicit numerical "acceptance criteria" in the way a performance study for an AI/ML device would. For a medical implant like the TPS-TL Spinal System, acceptance criteria are typically met by demonstrating substantial equivalence to a predicate device through materials, design, indications for use, and mechanical testing. The "reported device performance" refers to the successful completion of these tests.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Requirements | Met or Exceeded: "The test data indicates that the proposed Interpore Cross TPS-TL Spinal System meets or exceeds all functional requirements and support its suitability for use." This implies the device performs its intended mechanical functions (e.g., support, adjustability) adequately. |
| Biomechanical Integrity Restoration | Demonstrated: Indicated "to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period." While not a direct performance measurement in this section, the device's design and mechanical testing are intended to support this claim. |
| Substantial Equivalence to Predicate | Achieved: "sufficient evidence exists to reasonably conclude that this device is substantially equivalent to the existing legally marketed implants." This is the overarching acceptance criterion for 510(k) clearance, based on comparisons in design, materials, indications for use, and mechanical testing. The predicate device is the "Interpore Cross Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal System which was previously cleared under 510(k) K010989." This means the new device's performance aligns with the safety and effectiveness established for the predicate device. |
| Material Composition | Compliant: Composed of "medical implant grade titanium alloy as described by ASTM F136 (Ti 6Al-4V ELI)." This meets material standards for medical implants. |
| Indications for Use (IFU) | Consistent: The device treats "the same conditions, have the same precautions and contraindications for use" as the predicate device. |
| Potential for Complications | Equivalent: Has "equivalent potential for complications associated with the risk of use" compared to the predicate device. |
| Basic Design Concept (Safety & Effectiveness) | Equivalent: "they both represent a basic design concept in terms of safety and effectiveness." |
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable in the context of an AI/ML test set. The study refers to "test data," but this would be mechanical engineering tests on physical devices (e.g., fatigue testing, compression strength testing), not a dataset of patient information.
- Data provenance: Not applicable. The "data" refers to the results of nonclinical mechanical tests, not patient data from a specific country or collected retrospectively/prospectively.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable: Ground truth in this context would be engineering specifications and validated test methods for mechanical performance. There is no mention of "experts" establishing a clinical "ground truth" for a test set as would be done for an AI/ML device. The "experts" involved would be the engineers designing and testing the device, and those reviewing the results against established standards.
4. Adjudication method for the test set
- Not applicable: Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies among human readers in interpreting clinical data for AI/ML performance studies. This is not relevant for a mechanical device.
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: This is a physical implant, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable: This device is a physical implant and does not involve an algorithm.
7. The type of ground truth used
- Not applicable/Implied: For a medical device like this, the "ground truth" would be established engineering standards, material specifications (e.g., ASTM F136), and validated biomechanical test methods that define acceptable performance and safety. The goal is to demonstrate the device meets these pre-defined physical and mechanical requirements.
8. The sample size for the training set
- Not applicable: This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable: As there is no training set for this type of device, ground truth establishment for a training set is not relevant.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.