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The Renovis S 100 Pedicle Screw 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 thoracic, lumbar, and sacral spine: failed previous fusion (pseudoarthrosis), spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors or trauma (fracture and dislocation).

When used as a pedicle screw system, the Renovis S 100 Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

As a posterior pedicle screw system designed for temporary stabilization of the posterior spine during the development of spinal fusion, the Renovis S 100 Pedicle Screw System is comprised of polyaxial pedicle screws, rods, and crosslinks. The S 100 System can be used for single or multiple level fixations

The screws are a top loading tulip design and are available in multiple diameters and lengths. Reduction screws are available for cases of spondylolisthesis where the short arms of the tulip of the standard screw are not long enough to engage the rods are available in straight and pre-lordosed (curved) configurations. The system also has variable and fixed crosslinks.

The purpose for this Premarket Notification is for the addition of iliac screws and connectors.

Here's a breakdown of the acceptance criteria and the study that proves the S 100 Pedicle Screw System meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • The document does not specify the sample size for the test set (number of devices tested).
   • The data provenance is not explicitly mentioned, but the tests were performed "per ASTM F1717," which is an international standard for mechanical testing of spinal implant constructs. Without further information, it's presumed these were laboratory tests rather than human subject data.

2. 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 is not applicable as the study involved mechanical testing against a standard (ASTM F1717) rather than human interpretation or clinical outcomes requiring expert ground truth.

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

   • Not applicable for mechanical testing. The results are quantitative and objective based on the ASTM standard.

4. 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:

   • No MRMC study was conducted. The document explicitly states: "No clinical studies were performed." This is a mechanical device, not an AI-driven diagnostic tool.

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

   • Not applicable. This is a mechanical pedicle screw system, not an algorithm.

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

   • The "ground truth" for the mechanical performance was the established mechanical properties and performance of legally marketed predicate devices, as well as the specifications outlined in ASTM F1717. The device's performance was compared to these existing standards and predicate devices.

7. The sample size for the training set:

   • Not applicable. This is a mechanical device, not a machine learning algorithm requiring a training set.

8. How the ground truth for the training set was established:

   • Not applicable as there was no training set.

Summary of the Study:

The study conducted for the S 100 Pedicle Screw System was a non-clinical, mechanical testing study designed to demonstrate substantial equivalence to predicate devices. The tests were performed according to ASTM F1717, which covers static and dynamic compression, and static torsion for spinal implant constructs.

The acceptance criteria were met by demonstrating that the mechanical performance (static and dynamic compression, static torsion) of the S 100 Pedicle Screw System was equal to, or higher than, the predicate devices. This means the device met or exceeded the established safety and performance benchmarks.

Since this was a physical medical device and not an AI or diagnostic tool, concepts like ground truth established by experts, clinical studies, MRMC studies, or training/test sets for algorithms are not applicable and were explicitly stated as not performed (e.g., "No clinical studies were performed"). The regulatory approval (510(k)) was based solely on demonstrating substantial equivalence through these non-clinical, mechanical tests.

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The Renovis S 100 Pedicle Screw 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 thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion {pseudoarthrosis}, spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors.

When used as a pedicle screw system, the Renovis S 100 Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

As a posterior pedicle screw system designed for temporary stabilization of the anterior spine during the development of spinal fusion, the Renovis S 100 Pedicle Screw System is comprised of polyaxial pedicle screws, rods, and crosslinks. The S 100 System can be used for single or multiple level fixations

The screws are a top loading tulip design and are available in multiple diameters and lengths. Reduction screws are available for cases of spondylolisthesis where the short arms of the standard screw are not long enough to engage the rod. The rods are available in straight and pre-lordosed (curved) configurations. The system also has variable and fixed crosslinks.

The provided text describes a 510(k) summary for the Renovis S 100 Pedicle Screw System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies that would establish acceptance criteria and device performance in the same way as an AI/ML medical device.

Therefore, many of the requested categories are not applicable to this document. The "acceptance criteria" here refers to demonstrating equivalence to predicate devices through mechanical testing and comparison of design and materials.

Here's a breakdown of the information as it relates to the provided text:

Acceptance Criteria and Device Performance (as applicable for a 510(k) of this nature)

• Testing per ASTM F1717
• Testing per ASTM F1798
• Component dissociation testing
  The results “were equal or higher than the predicate system” (ZODIAC™ Polyaxial Spinal Fixation, and other predicates for specific components). This indicates the device meets or exceeds the mechanical performance of established similar devices. |

Study Information (Based on the provided K101682 document):

Because this is a 510(k) for a pedicle screw system, the "study" is primarily a non-clinical, mechanical testing comparison to predicate devices, rather than a clinical trial or AI/ML model validation.

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

   • The document does not specify the exact sample sizes (e.g., number of screws, rods, or crosslinks) used for the mechanical tests (ASTM F1717, ASTM F1798, component dissociation testing).
   • Data Provenance: The tests conducted are standard ASTM (American Society for Testing and Materials) standards, implying laboratory-based mechanical testing. No geographical origin of the data is specified beyond the company's location (Redlands, CA, USA). The testing is prospective for this device, comparing its new components against existing standards and predicates.

2. 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):

   • Not Applicable. For mechanical performance testing of a physical medical device, "ground truth" is established by adherence to recognized national/international standards (like ASTM) and comparison to the published properties/performance of legally marketed predicate devices. Expert consensus in the clinical sense is not directly relevant here. The manufacturing and testing would be performed by qualified engineers and technicians.

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

   • Not Applicable. Mechanical testing under ASTM standards typically involves precise measurements and quantitative outcomes. There isn't an "adjudication" process in the sense of resolving disagreements among human observers for image interpretation or diagnosis. The "acceptance" is based on meeting the quantitative performance metrics relative to the predicate devices and applicable standards.

4. 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 pedicle screw system, a physical orthopedic implant. It is not an AI/ML-driven diagnostic or assistive technology, so MRMC studies involving human "readers" or AI assistance are irrelevant.

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

   • Not Applicable. As above, this is a physical implant, not an algorithm or software device.

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

   • The "ground truth" for this 510(k) submission is based on established mechanical engineering principles, recognized industry standards (ASTM F1717, F1798), and the performance characteristics of legally marketed predicate devices. The claim of "substantial equivalence" is the central "truth" being established through these comparisons.

7. The sample size for the training set:

   • Not Applicable. There is no "training set" in the context of a physical medical device like a pedicle screw system. This term is relevant for AI/ML models.

8. How the ground truth for the training set was established:

   • Not Applicable. As there is no training set, this question is not relevant.

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