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The AEGIS and AEGIS II Spinal Systems are 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).

When used as an anterior screw fixation system, The AEGIS I and AEGIS II Spinal Systems are indicated for patients with deqenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, Spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, lordosis, turnor, pseudoarthrosis, or revision of failed fusion attempts.

The AEGIS® Pedicle Screw System is comprised of pedicle screw with diameters from 4.5mm to 8.5mm with increments of 1mm and length ranging from 20mm to 55 mm with increments of 5mm, a sleeve of standard diameter of 14 mm, and a set screw of M10XP1.0 & rods with standard diameter of 6 mm. All the components are manufactured from medical grade titanium alloy (Ti6Al4V-Eli).

The mono axial pedicle screw is used as an adjunct to spinal fusion surgery, provides a means of gripping a spinal segment. The screws themselves do not fixate the spinal segment, but act as firm anchor points that can then be connected with a rod. The screws are placed at two or three consecutive spine segments (e.g. lumbar segment 4 and 5) and then a short rod is used to connect the screws. This construct prevents motion at the segments that are being fused.

The Corentec® AEGIS II® Spinal system consists of various Pedicle Screws (mono / poly) with standard and guided type designs, Rod and Rod Link with a set screw, the assembly of which is intended to provide temporary stabilization following surgery to fuse the spine. This system is designed on the basis of long standing spinal technology which is already in the market for more than few decades.

The provided text describes mechanical performance testing for the AEGIS & AEGIS II Spinal Systems. This is not a study involving AI, human readers, or image analysis, but rather physical stress tests on the device itself. Therefore, many of the requested categories are not applicable.

Here's the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample size for each mechanical test. The "data provenance" in this context refers to the manufacturing and testing of the physical device components. The tests were performed on the AEGIS and AEGIS II Spinal Systems themselves. The country of origin for the submitter is Korea. The tests are prospective in the sense that they are conducted on newly manufactured devices to ensure they meet standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This was mechanical testing of a medical device, not a human reader study or clinical evaluation requiring expert interpretation of data. The ground truth refers to the physical properties and performance of the device under stress, as measured by standard engineering tests.

4. Adjudication method for the test set

Not applicable. This was mechanical testing against established ASTM standards, not a diagnostic or interpretive study requiring adjudication of human readings.

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 was a mechanical performance study of a spinal implant system, not a study involving human readers or AI assistance.

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

Not applicable. This was mechanical testing of a physical medical device, not an algorithm.

7. The type of ground truth used

The ground truth used was the performance of the device under specific mechanical stress tests, compared against the performance of "legally marketed predicate devices" as defined by established ASTM (American Society for Testing and Materials) standards (F1717-04, 543-07, F1798-97).

8. The sample size for the training set

Not applicable. This was not a machine learning study with a training set.

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

Not applicable. There was no training set.

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