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The DPZ Pedicular Fixation 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 chronic instabilities or deformities of thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e., scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

The DPZ Pedicular Fixation System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e., fracture or dislocation); spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudarthrosis and failed previous fusion.

The DPZ Pedicular Fixation System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to more closely match the patient's anatomy.

The provided text describes the DPZ Pedicular Fixation System, its intended use, and the non-clinical tests conducted to demonstrate its equivalence to predicate devices. However, it explicitly states: "No clinical studies were performed."

Therefore, I cannot provide information on acceptance criteria based on human performance or studies involving human readers/experts, as no such clinical data is presented in this document.

Here's the information that can be extracted from the provided text regarding the device's acceptance criteria and the study that proves it meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for the non-clinical tests. The document only mentions "The following analyses were conducted."
• Data Provenance: Not explicitly stated, but it refers to "non-clinical tests" which typically involve laboratory or bench testing of the device hardware.

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

• Not applicable. The "ground truth" for non-clinical mechanical testing is based on the specifications within the ASTM F1717 standard and the measured performance of the device compared to predicate devices. Human experts are not involved in establishing this ground truth for a mechanical test.

4. Adjudication method for the test set:

• Not applicable, as this refers to human reader review and consensus, which was not performed.

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:

• No MRMC study was done, as "No clinical studies were performed."

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

• Not applicable. This is a medical device (pedicle fixation system), not an algorithm or AI. The standalone performance refers to the device's mechanical integrity under specified ASTM standards.

7. The type of ground truth used:

• The ground truth for the non-clinical tests was based on the performance requirements and methodologies outlined in the ASTM F1717 standard for spinal implant constructs. The device's performance was then compared to that of predicate devices to establish substantial equivalence.

8. The sample size for the training set:

• Not applicable. This is a non-AI/algorithm medical device. "Training set" refers to data used to train an AI model.

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

• Not applicable for the same reason as above.

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The CosmoLock Pedicle Screw 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 chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

The CosmoLock Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra 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. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.

The CosmoLock Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to match more closely the patient's anatomy.

Materials:

Ti-6Al-4V per ASTM F136 CoCr per ASTM F1537

This document is a 510(k) Summary for the CosmoLock Pedicle Screw System. It describes the device and its intended use and claims substantial equivalence to predicate devices. However, it does not contain the detailed information needed to answer many of your questions, as it explicitly states that no clinical studies were performed.

Here's an analysis based on the provided text:

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

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

This information is not provided in the document. The studies mentioned are non-clinical (mechanical tests), and details about sample sizes for these tests are not specified.

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 information is not applicable/provided. No clinical studies were performed, and therefore no ground truth established by experts is relevant to the data presented.

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

This information is not applicable/provided. No clinical studies were performed.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document states, "No clinical studies were performed."

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

This information is not applicable. The device is a mechanical pedicle screw system, not an AI or algorithm-based device. No standalone performance study in this context was performed.

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

The ground truth for the non-clinical tests would be the established mechanical testing standards (ASTM F1717) and the performance of the predicate devices. There is no biological or expert-defined "ground truth" in the typical medical imaging/diagnosis sense, as this is a mechanical implant.

8. The sample size for the training set

This information is not applicable/provided. No clinical studies were performed, and there is no mention of an algorithm or AI requiring a training set.

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

This information is not applicable/provided. No training set or associated ground truth was established, as no clinical studies or AI development are described. The focus is on demonstrating mechanical equivalence to predicate devices.

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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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The Zodiac® Polyaxial Spinal Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.

It is intended that this device, in any system configuration, be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral-iliac screw indications are limited to the sacrum-iliac crest only.

1. The Zodiac® Polyaxial Spinal Fixation System when used as a hook and sacral iliac screw fixation system (nonpedicle screw) is intended for:

a. Patients having fractures of the thoracic and lumbar spine,

b. Patients having deformity (i.e. idioscoliosis, neuromuscular scoliosis or kyphoscoliosis with associated paralysis or spasticity),

c. Patients having spondylolisthesis (i.e. isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).

2. The Zodiac® Polyaxial Spinal Fixation System, when used a pedicle screw system in the thoraco-lumbo-sacral iliac region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor and failed previous fusion (pseudoarthrosis).

3. In addition, the Zodiac® Polyaxial Spinal Fixation System, when used as a pedicle screw system is intended for:

a. Patients receiving only autogenous bone graft

b. Patient having the device fixed or attached to the lumbar and sacral iliac spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.

4. The Zodiac® Polyaxial Spinal Fixation System, when used as a laminar hook and bone screw system is intended for:

a. Patients having fractures of thoracic and lumbar spine.

b. Patients having thoracolumbar deformity (i.e. idioscoliosis, neuromuscular scoliosis, kyphoscoliosis or kyphoscoliosis with associated paralysis or spasticity),

c. Patients having spondylolisthesis (i.e. Isthmic spondylolisthesis, degenerative spondylolisthesis and acute pars fracture allowing spondylolisthesis).

The Zodiac® Polyaxial Spinal Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoracolumbo-sacral iliac portion of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.

This document describes a 510(k) submission for the Zodiac® Polyaxial Spinal Fixation System, which is a medical device. As such, the "acceptance criteria" and "device performance" are not related to diagnostic accuracy or clinical outcomes as would be the case for AI/ML devices. Instead, they refer to the device's mechanical properties and its substantial equivalence to previously approved devices. The "study" refers to mechanical testing.

Here's a breakdown of the requested information based on the provided text:

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

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

This information is not applicable as this is a mechanical device, not an AI/ML diagnostic or prognostic device that uses data for testing. The "test set" would refer to the physical samples of the device undergoing mechanical testing. The document states "Mechanical and dynamic testing was performed," implying laboratory testing of device components.

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 information is not applicable. For mechanical devices, "ground truth" is established by engineering specifications, material properties, and standardized testing protocols, not by expert consensus on clinical data.

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

This information is not applicable. Adjudication methods are used for resolving discrepancies in expert interpretations of data, which is not relevant for mechanical testing of a spinal fixation system.

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 information is not applicable. This is a physical spinal fixation device, not an AI/ML diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

This information is not applicable. This is a physical spinal fixation device, not an algorithm.

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

For mechanical devices, the "ground truth" is typically derived from engineering specifications, material science principles, and established international and national consensus standards (e.g., ASTM, ISO standards for spinal implants) that define performance requirements for strength, fatigue life, and other mechanical properties. The document explicitly states, "Performance testing was performed per the recognized consensus standards and per the guidance document, Spinal System 510(k)s - Guidance for Industry and FDA Staff," indicating adherence to these established engineering "ground truths."

8. The sample size for the training set

This information is not applicable. This is a physical medical device. "Training set" refers to data used to train AI/ML models, which is not relevant here.

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

This information is not applicable. As no training set is used for a mechanical device.

Summary of the Study:

The study described is a series of mechanical and dynamic performance tests conducted on the Zodiac® Polyaxial Spinal Fixation System and its additional components.

• Objective: To provide reasonable assurance of the safety and effectiveness of the device for its intended use and to demonstrate substantial equivalence to predicate devices.
• Methodology: Testing was performed according to "recognized consensus standards and per the guidance document, Spinal System 510(k)s - Guidance for Industry and FDA Staff." This involved evaluating both "static and fatigue performance characteristics."
• Results: The testing "clearly demonstrated that the performance characteristics satisfy the requirements of posterior lumbar fixation." Furthermore, the "mechanical performance of the Zodiac® Polyaxial Spinal Fixation System additional components is substantially equivalent to the predicate Zodiac® Polyaxial Spinal Fixation System device."
• Conclusion: The tests confirmed that the device's mechanical properties were comparable to previously approved predicate devices, supporting its substantial equivalence claim to the FDA.

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