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The Mega Plus Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chromic instabilities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Mega Plus Spine System is 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 disc disease; spondylolisthesis; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Mega Plus Spine System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws (multi-axial, multi-axial long arm, mono and long-arm), iliac screws, rods, locking bolts, cross-links, and connectors. The Mega Plus Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Mega Plus Spine implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 or cobalt chromium alloy (Co28-Cr6-Mo) that conform to ASTM F1537. Various sizes of these implants are available. Specialized instruments are also available for the application and removal of the Mega Plus Spine System. Modifications to the Mega Plus Spine System from the clearance in K173180 include the addition of CoCr rods, the addition of LED and deformity type rods, and the inclusion of non-anodized screws for all screw types and sizes.

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested. The document is a 510(k) summary for a medical device (Mega Plus Spine System) and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailing specific performance criteria or a study designed to prove those criteria.

Therefore, I cannot generate the table or answer the specific questions about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details.

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The Mega Plus Spine System is 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 disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Mega Plus Spine System is a top-loading multiple component, posterior spinal fixation systems which consist of pedicle screws (multi-axial, multi-axial long-arm, mono and long-arm), iliac screws, rods, locking bolts, cross-links and connectors. The Mega Plus Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Mega Plus Spine System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to the ASTM F136. Various sizes of these implants are available. Specialized instruments are also available for the application and removal of the Mega Plus Spine System.

This document is a 510(k) summary for the "Mega Plus Spine System," a medical device intended for spinal fusion. The FDA has determined it is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the provided information, focusing on the absence of information rather than its presence, as this is a mechanical device, not an AI/software device.

1. Table of acceptance criteria and the reported device performance

The document lists performance tests conducted for the Mega Plus Spine System, all based on ASTM standards. However, it does not explicitly state specific quantitative acceptance criteria or detailed numerical results for these tests. It only makes a general concluding statement about the sufficiency of the device's strength.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify the sample size for any of the performance tests.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the tests were retrospective or prospective. It only mentions that BK MEDITECH Co., Ltd. is based in the Republic of Korea.

3. 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)

This question is not applicable to this document. The Mega Plus Spine System is a mechanical spinal implant, not a diagnostic or AI device that requires expert-established ground truth from medical imaging or clinical assessment for its performance evaluation (beyond internal engineering validation). The "ground truth" for this type of device is its mechanical integrity and compliance with engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable as there is no mention of human observation or assessment of the performance data that would require an adjudication method. The performance data seems to be derived from objective mechanical testing.

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. The Mega Plus Spine System is a mechanical implant, not an AI-assisted diagnostic tool or an imaging device. Therefore, MRMC comparative effectiveness studies involving human readers and AI assistance are irrelevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The Mega Plus Spine System is a mechanical implant; there is no algorithm or software component that operates in a standalone manner.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is established by conformance to recognized engineering and material standards (ASTM F1717-15 and ASTM F1798-13) and the mechanical properties of its constituent materials (titanium alloy Ti-6Al-4V ELI). These standards implicitly define what constitutes acceptable mechanical performance for spinal fixation devices.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of mechanical device testing for a spinal implant. Training sets are relevant for machine learning algorithms or AI models.

9. How the ground truth for the training set was established

This question is not applicable for the same reason as point 8.

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