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The KHEIRON Spinal 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 disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the KHEIRON System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the KHEIRON Spinal Fixation System is intended to treat pediatic patients diagnosed with spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion.

This system is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The KHEIRON® Spinal Fixation System may be used for a variety of conditions that affect the thoracic and lumbar spine. In cases in which the posterior elements are fractured, the pedicle screw offers an excellent means of stabilizing a specific spinal segment. KHEIRON Spinal Fixation System includes screws and connecting components in a wide variety of sizes and shapes, which can be locked in various configurations, each assembly being tailor-made. KHEIRON pedicular screws must be used with Ø 5.5mm and Ø 6mm rods.

The KHEIRON® Spinal Fixation System is a medical device and the provided document is a 510(k) summary for its premarket notification to the FDA. This summary focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance criteria through a standalone study of its capabilities in a clinical setting.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not directly available in the provided text. The document states "No clinical studies were performed."

However, the document does provide information on non-clinical testing to demonstrate the physical performance and safety of the device:

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

Since no specific numerical acceptance criteria (e.g., minimum strength values) are given, and only a comparative statement is made regarding performance against predicates, a direct table of acceptance criteria and the reported device performance as typically expected for an AI/diagnostic device is not applicable here.

Instead, the non-clinical test summary states:

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

• Test Set Sample Size: Not specified as clinical studies were not performed. For non-clinical tests (mechanical tests), the sample sizes for the devices tested were not provided.
• Data Provenance: Not applicable as no clinical data was used. Mechanical testing is typically done in a laboratory setting. No country of origin for the mechanical test data is mentioned.

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):

• Not applicable, as no clinical studies requiring expert consensus for ground truth were performed.

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

• Not applicable, as no clinical studies requiring ground truth adjudication 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. The document explicitly states, "No clinical studies were performed." This device is a mechanical spinal fixation system, not an AI or diagnostic tool that would typically involve human "readers."

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

• Not applicable. This device is a mechanical implant, not an algorithm.

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

• For the non-clinical mechanical tests, the "ground truth" would be the engineering standards (e.g., ASTM F1717 and ASTM F1798) and the performance characteristics of the predicate devices. The device's strength was directly measured against these established benchmarks.

8. The sample size for the training set:

• Not applicable, as this is a mechanical spinal fixation system and not an AI/machine learning device that requires a training set.

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

• Not applicable, as this is a mechanical spinal fixation system and not an AI/machine learning device.

Summary of Non-Clinical Testing:

The KHEIRON® Spinal Fixation System underwent the following non-clinical mechanical tests:

• Static and dynamic compression bending (according to ASTM F1717)
• Static torsion (according to ASTM F1717)
• Torsional and axial gripping capacity (according to ASTM F1798)

The results of these evaluations indicated that the KHEIRON Spinal Fixation System is "substantially equivalent to legally marketed predicate devices" and specifically noted that its "strength values" were "greater or equivalent" compared to other cleared devices for thoracolumbosacral spine use.

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The Black Diamond Pedicle Screw System, with or without MIS instrumentation, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Black Diamond Pedicle Screw System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Black Diamond Pedicle Screw System is intent patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatic pedicle screw fixation is limited to a posterior approach.

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

The provided text describes a 510(k) premarket notification for a medical device called the "Black Diamond Pedicle Screw System." This document focuses on demonstrating substantial equivalence to previously marketed predicate devices, primarily through non-clinical mechanical testing, rather than a clinical study involving human patients or complex AI algorithms. Therefore, much of the information requested about acceptance criteria for AI/ML performance, sample sizes for test sets, expert adjudication, MRMC studies, and ground truth establishment is not applicable to this specific submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" presented in this submission are not expressed as specific performance metrics and thresholds (e.g., accuracy > X%, AUC > Y%) typical for AI/ML devices. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through various comparisons, primarily mechanical testing.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not applicable in the context of human data or image data for AI/ML. The "test set" here refers to the Black Diamond Pedicle Screw System components themselves undergoing non-clinical mechanical testing. The specific number of physical components tested is not detailed, but standard mechanical testing involves multiple samples to ensure statistical validity.
• Data Provenance: Not applicable in the context of human data. The "data" comes from mechanical testing of the device components.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not human expert interpretation.

4. Adjudication Method:

Not applicable.

5. MRMC Comparative Effectiveness Study:

Not applicable. No clinical studies involving human readers or AI assistance were performed.

6. Standalone Performance Study:

Not applicable. This is a physical medical device, not an AI algorithm. The performance evaluation is based on mechanical testing of the device itself.

7. Type of Ground Truth Used:

Ground truth for this submission is based on engineering standards and direct physical measurements derived from non-clinical mechanical testing (e.g., static and dynamic compression per ASTM F1717, static torsion per ASTM F1717).

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML model and does not have a "training set" in that context.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

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The ASTRA-OCT Spine System implants are intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7) and the thoracic spine (T1-T3):

• · Traumatic spinal fractures and/or Traumatic dislocations;
• Instability or deformity;
• · Failed previous fusions (e.g. pseudoarthrosis);
• · Tumors involving the cervical/thoracic spine: and
  · Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The ASTRA-OCT Spine System implants are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the ASTRA-OCT Spine System rods may be connected to other occipital cervical thoracic or thoracolumbar stabilization rod systems ranging in diameter from 3.5mm, including the ASTRA or APEX Spine Systems, using corresponding connectors.

The ASTRA-OCT Spine System consists of a series of polyaxial screws, occipital screws, occipital plates, hooks, rods, lateral connectors, rod-to-rod connectors, set screws, and cross connectors.

Materials:
Titanium alloy per ASTM F136 CoCr allov per ASTM F1537

This FDA 510(k) summary describes a new medical device, the ASTRA-OCT Spine System, and its substantial equivalence to a predicate device. The information provided is for a traditional medical device (spinal implant) and does not include acceptance criteria or a study proving device meets acceptance criteria in the context of an AI/ML powered device.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI/ML device.

The document states:

• "No clinical studies were performed" for the ASTRA-OCT Spine System.
• The substantiation for equivalence is based on non-clinical mechanical testing and comparison to predicate systems.

The requested information is typically found in submissions for AI/ML powered devices, which are assessed differently from traditional hardware devices like the ASTRA-OCT Spine System.

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The ASTRA 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 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; spinal tumor; and failed previous fusion (pseudo-arthrosis).

The ASTRA Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 to S1), and for whom the device is intended to be removed after solid fusion is attained.

The ASTRA System is also a sacral/iliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis).

When used in a percutaneous, posterior approach with AVANT Spine MIS instrumentation, the ASTRA Spine System is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis), tumor, pseudo-arthrosis, and failed previous fusion in skeletally mature patients . Levels of fixation are for the thoracic, lumbar and sacral spine.

The ASTRA Spine System is a top loading, multiple component, posterior spinal fixation system which consists of rods, cannulated and non-cannulated monoaxial, uniplanar and polyaxial screws, hooks, iliac connectors, rod connectors, and cross connectors. Most of the components are available in a variety of sizes to more closely match the patient's anatomy.

Materials:
Titanium alloy
CoCr alloy

Here's an analysis of the provided text regarding the ASTRA Spine System, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for a medical device (Spine System), not an AI/ML device. Therefore, many of the requested fields related to AI/ML specific studies (like sample sizes for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance) are not applicable to this type of medical device submission. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical (mechanical) testing.

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, the "acceptance criteria" are implicitly defined by performance equivalence to predicate devices in standardized mechanical tests. The "reported device performance" is a statement of comparative equivalence.

2. Sample Size Used for the Test Set and the Data Provenance

This is a physical device, and the "test set" refers to the tested device components.

• Sample Size: Not explicitly stated in terms of number of components tested for each test, but standard engineering practices for medical device testing would involve a sufficient number (e.g., n=5 or n=10 per test) to ensure statistical significance, though the exact numbers are not provided in this summary.
• Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory setting. There is no patient data provenance (e.g., country of origin, retrospective/prospective) since no human data was used for these mechanical tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• Not Applicable. For mechanical testing of a physical device, ground truth is established by standardized testing protocols (e.g., ASTM standards) and measured physical properties, not by expert consensus on clinical data. Engineers and lab technicians perform and analyze the tests according to these standards.

4. Adjudication Method for the Test Set

• Not Applicable. There is no adjudication in the sense of reconciling human expert opinions for clinical images or data. The results of mechanical tests are objective measurements against defined criteria.

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 physical spinal implant, not an AI/ML diagnostic or assistive device. No MRMC studies were performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This is a physical spinal implant; there is no algorithm or standalone performance.

7. The Type of Ground Truth Used

• Mechanical Test Standards and Predicate Device Performance: The "ground truth" for the non-clinical tests is based on the established performance characteristics and safety profiles of legally marketed predicate devices, as defined by FDA regulations for substantial equivalence, and adherence to relevant ASTM standards (ASTM F1717 and ASTM F1798).

8. The Sample Size for the Training Set

• Not Applicable. This is a physical device; there is no AI/ML model or "training set" in the context of machine learning. The device design and materials are based on engineering principles and knowledge of predicate devices.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no training set for an AI/ML model, this question is not relevant. The "ground truth" for developing the physical device is based on established biomechanical and medical understanding of spinal fixation and the performance of existing, cleared devices.

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The components of the Spiral Radius 90-D™ SST System are indicated for spinal fixation.

When used as an anterolateral/anterior system consisting of rods and screws, the levels of attachment are the lumbar, thoracic and cervical spines. The points of attachment and methods are screw fixation to the anterolateral bodies of the lumbar and thoracic spine (T6-L5) and the anterior vertebral bodies of the cervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion (pseudoarthrosis).

When used as a nonpedicle posterior system consisting of hooks, crosslinks and sacral/iliac screws the levels of attachments are the lumbar, thoracic and cervical spine and sacrum and ilium. Intended uses include hook and sacral screw fixation to the lumbar spine, noncervical spine and to the T1-S1 spine; and hook and sacraliliac screw fixation to the noncervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degenerative of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, pseudoarthrosis, or failed previous fusion (pseudoarthrosis).

When used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the Spiral Radius 90-D™ SST System is indicated for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of solid fusion mass.

In addition, when used as a pedicle screw system, in the noncervical spine of skeletally mature patients, the Spiral Radius 90-D™ SST System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The components of the Spiral Radius 90-D™ SST System are indicated for spinal fixation. The material used is medical grade stainless steel material that conforms to ASTM F138.

This document describes a spinal fixation device, the Spiral Radius 90-D™ SST System, that received 510(k) clearance. A 510(k) clearance is based on demonstrating substantial equivalence to a predicate device, not on demonstrating that the device meets specific acceptance criteria through a clinical study. Therefore, the provided text does not contain information about acceptance criteria, device performance, or a study to prove it meets them in the way a traditional clinical efficacy study would.

Here's an analysis of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

This information is not provided in the document. 510(k) clearance relies on substantial equivalence to a legally marketed predicate device, rather than meeting specific performance criteria demonstrated by new clinical data for the device itself.

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 provided. The document describes a 510(k) clearance for a spinal fixation system, which is based on demonstrating substantial equivalence to predicate devices (K992784, K000009, and K954696). This process typically involves comparison of design, materials, and intended use, along with non-clinical performance testing (e.g., mechanical testing to ASTM standards for materials as mentioned in the document), rather than a clinical trial with a "test set" in the context of device performance data from human subjects.

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 provided. As noted above, a clinical "test set" and associated ground truth established by experts is not described for this 510(k) submission.

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

This information is not provided.

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 provided. The device described is a spinal fixation system, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is not applicable and not mentioned.

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

This information is not provided. The device is a physical implant, not an algorithm, so a standalone performance evaluation in this context is not applicable.

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

This information is not provided. The 510(k) clearance process for this type of device does not typically involve establishing a "ground truth" for clinical performance in the same way a diagnostic device or AI algorithm would. Instead, it relies on demonstrating that the device performs as intended and is as safe and effective as a legally marketed predicate device. The materials used conform to ASTM F138, indicating reliance on established material standards.

8. The sample size for the training set

This information is not provided. A "training set" for an AI algorithm is not relevant to this type of device submission.

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

This information is not provided. Not applicable for this device.

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Non-Pedicle Screw Fixation

When used as an anterior spinal system the Rogozinski Spinal Rod System is intended for the treatement of DDD (degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies), pseudoarthrosis, stenosis, deformities (scollosis, kyphosis), spondylolisthesis, fracture, previous failed fusion, or tumor resection. The Rogozinski Spinal Rod System is limited to non-cervical use.

When used as a posterior, non-pedicle spinal system (consisting of hooks and sacral/iliac screws), the Rogozinski Spinal Rod System is intended for the treatement of DDD (degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies), pseudoarthrosis, deformities (scoliosis, kyphosis, lordosis), spondylolisthesis, fracture, previous failed fusion, or tumor resection. The Rogozinski Spinal Rod System is limited to non-cervical use.

Pedicle Screw Fixation

When used as a pedicle screw system, in the spine of skeletally mature patients, the Rogozinski Spinal Rod System is indicated for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the LS-S1 igint: (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

In addition, when used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the Rogozinski Spinal Rod System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine. degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Rogozinski Spinal Rod System consists of stainless steel rods attached to the spinal column through the use of interlaminal hooks and/or screws. Crossbars may be used to connect rods to rods to provide a more rigid construct, as well as screws to rods and hooks to rods.

This is a medical device submission, specifically a Summary of Safety and Effectiveness for the Rogozinski Spinal System (K983904), dated December 22, 1998. This document does not contain information about acceptance criteria or specific study data.

Medical device submissions like this primarily focus on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use. They typically do not include detailed performance studies with acceptance criteria in the way an AI/software device would. The "study" here is more about asserting equivalency to previously cleared devices rather than a performance study measuring metrics like sensitivity, specificity, or accuracy against a ground truth.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be extracted based on the nature of this document:

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

• Not applicable / Not present. This document does not describe acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) or report quantitative device performance data against such criteria. The device is a physical spinal fixation system, and its "performance" is generally established through material testing, mechanical testing, and clinical history of predicate devices, not through a statistical study with specific acceptance thresholds for diagnostics.

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

• Not applicable / Not present. This document does not detail a "test set" or clinical study data. It is a substantial equivalence submission for a physical implant.

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)

• Not applicable / Not present. No ground truth establishment for a test set is described.

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

• Not applicable / Not present. No test set or adjudication process is described.

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 / Not present. This is not an AI/software device.

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

• Not applicable / Not present. This is not an algorithm.

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

• Not applicable / Not present. No ground truth for device performance is defined or used in the context of a "study" here. The "truth" for this device lies in its mechanical properties meeting standards and its clinical use being consistent with predicate devices that have established safety and effectiveness.

8. The sample size for the training set

• Not applicable / Not present. This is not a machine learning/AI device, so there is no training set mentioned.

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

• Not applicable / Not present. See point 8.

In summary: The provided text is a 510(k) summary for a spinal implant, focusing on its substantial equivalence to previously cleared devices rather than providing performance metrics from a study that would include acceptance criteria, test sets, or ground truth establishment in the context of diagnostic or AI devices.

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