(29 days)
The ATHLET™ System is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5). The ATHLET™ System is intended for use with supplemental fixation and should be implanted in pairs.
The ATHLET™ VBR System is a lordotic, modular vertebral body replacement system. Caudal and cranial components are offered in a variety of heights and are assembled to create a device construct. An intermediate component is also available and is used between one caudal and one cranial component. The device construct comprises a central cannula for bone graft and lateral fenestrations for bony in-growth.
Here's the analysis of the provided text regarding the ATHLET™ VBR device, focusing on acceptance criteria and supporting studies:
This document ([K081332](https://510k.innolitics.com/search/K081332)) is a 510(k) summary, which is a premarket notification for a medical device to demonstrate that it is substantially equivalent to a legally marketed predicate device. Therefore, it does not typically contain information about detailed acceptance criteria or standalone clinical studies demonstrating performance against specific metrics. Instead, the primary "study" is the demonstration of substantial equivalence to previously cleared devices.
Based on the provided text, many of the requested categories either do not apply or the information is not present.
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable. The document explicitly states: "Documentation was provided which demonstrated the ATHLET™ VBR to be substantially equivalent to previously cleared vertebral body replacement devices. The substantial equivalence is based upon equivalence in basic design, intended use, indications, anatomic sites and performance."
This means the "performance" is implicitly deemed acceptable because it is equivalent to already-approved devices, rather than being measured against new, explicit acceptance criteria in this submission. No specific numerical performance metrics are reported.
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable. There is no "test set" in the context of a performance study for this 510(k) submission. The submission relies on demonstrating equivalence to predicate devices, not on a new clinical or performance study with a distinct test dataset.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable. As no specific performance study with a test set is described, the concept of establishing ground truth by experts is not relevant to this 510(k) summary.
4. Adjudication Method for the Test Set
Not Applicable. No test set or corresponding adjudication method is mentioned in this 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, what was the effect size of how much human readers improve with AI vs without AI assistance?
Not Applicable. This device is a physical spinal implant (vertebral body replacement system), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical medical device, not an algorithm. Standalone performance studies in the context of AI are not applicable here.
7. The Type of Ground Truth Used
Not Applicable. For a 510(k) submission demonstrating substantial equivalence of a physical implant, the "ground truth" is typically the established safety and efficacy profiles of the predicate devices, as recognized by the FDA through their previous clearances. There isn't a new dataset with an independent "ground truth" established for this specific device's performance in the context of this submission.
8. The Sample Size for the Training Set
Not Applicable. This 510(k) summary does not describe an AI/ML device, and thus there is no concept of a "training set" in this context. The manufacturing process and materials are described, but not in terms of data training.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set mentioned, this section is not applicable.
Summary of the K081332 Submission:
The provided document K081332 is a 510(k) premarket notification for the ATHLET™ VBR (Vertebral Body Replacement) system. The core of this submission is demonstrating substantial equivalence to already legally marketed predicate devices. This means that instead of conducting new performance studies that establish acceptance criteria and collect extensive data, the sponsor (SIGNUS Medizintechnik GmbH) provided documentation showing their device is equivalent in basic design, intended use, indications, anatomic sites, materials (PEEK-OPTIMA® LT1 and Titanium alloy), and overall performance to existing FDA-cleared devices. The FDA's issuance of a substantial equivalence determination allows the device to be marketed.
§ 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.