(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 TPS-TL Spinal System is indicated 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 collapsed 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 designed to restore 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 provided text describes modifications to an existing medical device, the Interpore Cross Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal System, aiming for substantial equivalence to the previously cleared version (K010989). This document is a 510(k) summary, which typically focuses on demonstrating equivalence to a predicate device rather than presenting a full de novo clinical study with acceptance criteria and detailed performance metrics as one might find for a novel device.
Therefore, the information you requested about acceptance criteria and a study proving the device meets them, particularly regarding AI/algorithm performance, is largely not present in this document because it pertains to a mechanical spinal implant, not an AI/algorithm-driven device.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria:
The document states that "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." However, it does not explicitly list the quantitative acceptance criteria for these functional requirements (e.g., specific load capacities, fatigue cycles, or displacement limits).
Reported Device Performance:
The document does not include reported device performance values against specific acceptance criteria. It only makes a general statement that the device "meets or exceeds" functional requirements based on "nonclinical tests."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for the mechanical tests.
- Data Provenance: The document states "nonclinical tests," implying laboratory mechanical testing, not human data. Therefore, country of origin or retrospective/prospective status are not applicable in this context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a mechanical implant; performance is assessed through engineering and materials testing, not through expert-established ground truth on medical images or diagnoses.
4. Adjudication Method for the Test Set
Not applicable. This device is a mechanical implant.
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 device is a mechanical implant and does not involve AI or human readers for its primary function or assessment.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This document describes a physical medical device (spinal implant), not an algorithm or AI.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For a mechanical implant, the "ground truth" for performance is typically established by:
- Engineering design specifications
- Industry standards (e.g., ASTM F136 for materials, other ASTM standards for mechanical testing of spinal implants)
- Performance of the predicate device.
The document refers to "functional requirements" and "mechanical testing," suggesting the ground truth for performance is based on these engineering and standards-based metrics.
8. The Sample Size for the Training Set
Not applicable. This document does not describe the development or testing of an algorithm or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This document does not describe the development or testing of an algorithm or AI.
Summary regarding the provided text:
The provided 510(k) summary is for a physical spinal implant. It focuses on demonstrating substantial equivalence to a predicate device through:
- Comparison of indications for use.
- Comparison of materials (ASTM F136 Titanium alloy).
- Comparison of basic design concept.
- General statement of "mechanical testing" and "nonclinical tests" indicating the device "meets or exceeds all functional requirements."
It does not include the detailed performance metrics, acceptance criteria, or study design elements typically associated with the evaluation of AI/algorithm-driven medical devices, for which the requested information would be highly 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.