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The GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is intended for use in the noncervical spine. The GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is used as an adjunct to fusion, using autograft or allograft, in the treatment of the following instabilities and deformities in skeletally mature patients:

1. Degenerative Disc Disease (DDD, defined as back pain of discogenic origin with degeneration of disc confirmed by history & radiographic studies)
2. Spondylolisthesis
3. Trauma (Fracture or Dislocation)
4. Spinal Stenosis
5. Scoliosis, Kyphosis and/or lordosis
6. Pseudoarthrosis
7. Failed Previous Fusion
   The system is indicated for use in adult patients only. All implants are for single use only.

The Monoaxial & Polyaxial screw consists of a body, bushing, and ball head screw. Inner Screw, rods and transverse connectors assemblies complete the spinal construct. The body portion of the screw rotates about the ball head on the screw, which provides increased motion over a fixed post or monoaxial screw. An increase in motion facilitates the capture of rods that are not perfectly aligned.
The Screws, Rods &Transverse Connectors are fabricated from Titanium.
The system contains several models based on the size of the device and application site such as fixation/reconstruction spine.

• Single Lock Monoaxial Screw
• Single Lock Polyaxial Screw
• Transverse connector
• Rod
  The diameter of these screw varies from 4mm to 7mm with length 25mm to 50mm.
  The corresponding connector are small & large in size.
  The diameter of Rod is 5.5mm with length 75mm to 150mm
  These implants are supplied non-sterile; the products have to be sterilized prior to use.

The document describes a 510(k) premarket notification for the "GPC Brand Posterior, Non cervical Pedicle Screw Spinal System". This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, and thus does not typically involve extensive clinical studies with specific acceptance criteria as would be found for a novel device requiring a PMA. Instead, the focus is on a comparison to existing devices and adherence to relevant performance standards.

Based on the provided document, here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the sense of predefined thresholds for performance metrics. Instead, it relies on demonstrating compliance with recognized industry standards for spinal implants, and equivalence to predicate devices. The "reported device performance" is essentially that the device met these standards and was found equivalent.

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

The document refers to "non-clinical testing" performed against ASTM standards. It does not specify a "sample size" in terms of human subjects or a clinical test set. Instead, it refers to mechanical testing of the physical implants. The provenance is internal testing by the manufacturer (GPC Medical Limited) to verify compliance with the standards. This is not a clinical study in humans, but rather laboratory testing of the device components.

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

This is not applicable to this type of submission. There was no clinical "test set" requiring expert ground truth establishment for diagnostic accuracy or clinical outcomes. The "ground truth" for the non-clinical testing was defined by the ASTM standards themselves (e.g., specific loads, displacement limits).

4. Adjudication method for the test set

Not applicable. There was no clinical test set or subjective assessment requiring adjudication.

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 spinal implant, not an AI-powered diagnostic device. No MRMC study was performed.

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

Not applicable. This is a spinal implant, not an algorithm.

7. The type of ground truth used

For the non-clinical testing, the "ground truth" was defined by the specifications of the referenced ASTM standards (ASTM F136 for material, ASTM F1717 for mechanical performance). These standards provide established methodologies and criteria for evaluating spinal implant constructs. For substantial equivalence, the "ground truth" was the characteristics of the legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This device is a physical spinal implant, not an AI or machine learning model that requires a training set.

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

Not applicable, as there was no training set.

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