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The Reliance Spinal Screw System is a pedicle screw system 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: degenerative disc disease (DDD) (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, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis). The Reliance Spinal Screw 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 and having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

When used posteriorly, the Reliance Spinal Screw System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for: spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.

The Reliance Spinal Screw System, when used with staples and two rods as an anterior thoracic/lumbar screw fixation system, is indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

When used in a percutaneous, posterior approach with MIS instrumentation, the Reliance Spinal Screw System components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion in skeletally-mature patients.

The Posterior Reliance Spinal Screw System consists of longitudinal rods, monoaxial screws, polyaxial screws, reduction screws, cannulated polyaxial screws, cannulated reduction screws, hooks, reduction hooks, set screws and transverse connectors.

The Anterior Reliance Spinal Screw System consists of spinal rods, monoaxial screws, staples, and set screws. The Anterior Reliance staples and screws are intended to the lateral aspect of the vertebral bodies from T5 to L4, and SHOULD NOT be attached to the anterior aspect. Furthermore, only Titanium components should be used anteriorly. (See Precautions section)

The Reliance Spinal Screw System components are available in titanium alloy conforming to ASTM F-136 specifications as well as stainless steel conforming to ASTM F-138 specifications. Furthermore, various rods of the Reliance Spinal Screw System are available in Cobalt-Chrome conforming to ASTM F-75 and ASTM F-1537 specifications. Components of the differing diameter rod systems are NOT interchangeable. The components of one material should not be used with components of another material, with the exception that the Cobalt-Chrome rods may be used with titanium alloy implants. The extension tabs on the reduction screw and hook components are intended to be removed intraoperatively.

The subject Reliance Spinal Screw offers two new fenestrated screw systems (single and circumferential) for use with saline or radiopaque dye only, a percutaneous screw system, and two barend rod systems. These additions will be available in similar sizes, material and configurations as the currently approved Reliance Spinal Screws.

This document is a 510(k) Premarket Notification from the FDA regarding the Reliance Spinal Screw System. It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study to prove acceptance criteria for a new device's performance. Therefore, the requested information, which pertains to studies demonstrating a device's performance against defined acceptance criteria (common for AI/ML or diagnostic devices), is largely not applicable in this context.

However, I can extract the relevant information regarding acceptance criteria in the form of substantial equivalence and the type of data presented to support that equivalence.

Here's an analysis based on the provided text:

Device: Reliance Spinal Screw System

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

Since this is a 510(k) submission for a spinal screw system, the "acceptance criteria" are primarily related to substantial equivalence to predicate devices in terms of design, materials, intended use, and mechanical performance. There isn't a performance table in the typical sense of a diagnostic or an AI/ML device (e.g., sensitivity, specificity).

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

• Sample Size for Test Set: Not applicable. There is no "test set" in the context of clinical performance evaluation for this type of device in this document. The mechanical testing was done on the predicate device, and the current device is deemed to not require new testing due to no new worst-case scenario.
• Data Provenance: Not applicable for a typical clinical test set. The data cited are from non-clinical mechanical testing standards (ASTM F1717) applied to the predicate device. The information is retrospective in the sense that it relies on prior testing of the predicate.

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

• Not applicable. There is no "ground truth" established by experts in the context of a clinical test set from this document. The assessment is based on engineering principles, materials science, and regulatory comparison.

4. Adjudication method for the test set:

• Not applicable. No clinical test set requiring adjudication 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. This is not a diagnostic device or an AI-assisted device.

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

• Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

• The "ground truth" in this context is implicitly the historical safety and effectiveness of the identified predicate devices as demonstrated by their prior FDA clearance and adherence to recognized mechanical testing standards (ASTM F1717). This is a regulatory "ground truth" for substantial equivalence.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device so there is no training set.

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

• Not applicable. No training set is described.

In summary: This 510(k) submission for the Reliance Spinal Screw System demonstrates substantial equivalence to predicate devices primarily through non-clinical assessment of design, materials, and existing mechanical testing data from the predicate device, rather than presenting a performance study against specific acceptance criteria for a new clinical performance claim.

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The Reliance Spinal Screw System is a pedicle screw system 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis). The Reliance Spinal Screw 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 having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

When used posteriorly, the Reliance Spinal Screw System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis, and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar, and sacral spine.

The Reliance Spinal Screw System when used with staples and two rods as an anterior thoracic/lumbar screw fixation system, is indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

When used in a percutaneous, posterior approach with MIS Instrumentation, the Reliance Spinal Screw System components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The Posterior Reliance Spinal Screw System consists of longitudinal rods, monoaxial screws, polyaxial screws, reduction screws, cannulated polyaxial screws, cannulated reduction screws, hooks, reduction hooks, set screws and transverse connectors. The Anterior Reliance Spinal Screw System consists of spinal rods, monoaxial screws. staples, and set screws. The Anterior Reliance staples and screws are intended to be attached to the lateral aspect of the vertebral bodies from T5 to L4, and SHOULD NOT be attached to the anterior aspect. Furthermore, only Titanium components should be used anteriorly. (See Precautions section)

The Reliance Spinal Screw System components are available in titanium alloy conforming to ASTM F-136 specifications as well as stainless steel conforming to ASTM F-138 specifications. Furthermore, various rods of the Reliance Spinal Screw System are available in Cobalt-Chrome conforming to ASTM F-75 and ASTM F-1537 specifications.

Components of the differing diameter rod systems are NOT interchangeable. The components of one material should not be used with components of another material, with the exception that the Cobalt-Chrome rods may be used with titanium alloy implants. The extension tabs on the reduction screw and hook components are intended to be removed intraoperatively.

The provided document is a 510(k) premarket notification from the FDA for the Reliance Spinal Screw System. It details the device's indications for use, its description, and its substantial equivalence to previously marketed devices. However, it does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.

The document discusses "Non-Clinical Testing" which includes "Static Compressive and Dynamic Compressive in accordance with ASTM F1717." This refers to mechanical testing standards for spinal implant constructs, not a clinical study involving human patients or a study validating an AI algorithm.

Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving an AI device meets them using the provided text. The document is about a traditional mechanical spinal implant, not an AI/ML medical device.

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The RELIANCE Spinal Screw System is a pedicle screw systems 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The RELIANCE Spinal Screw System is also indicated for pedicle screw fixation for the treatment of severe degenerative spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally-mature patients receiving fusion by autogenous bone graft and having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

When used posteriorly, the RELIANCE Spinal Screw System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for: degenerative spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.

The RELIANCE Spinal Screw System, when used with staples and two rods as an anterior thoracic/lumbar screw fixation system, is indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

When used in a percutaneous, posterior approach with MIS instrumentation, the RELIANCE Spinal Screw System components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion in skeletally-mature patients.

The Posterior RELIANCE Spinal Screw System consists of longitudinal rods, monoaxial screws, polyaxial screws, reduction screws, cannulated polyaxial screws, cannulated reduction screws, hooks, reduction hooks, set screws and transverse connectors. The Anterior RELIANCE Spinal Screw System consists of two spinal rods, monoaxial screws, staples, and set screws. The Anterior RELIANCE staples and screws are intended to be attached to the lateral aspect of the vertebral bodies from T5 to L4, and SHOULD NOT be attached to the anterior aspect. Furthermore, only Titanium components should be used anteriorly.

The RELIANCE Spinal Screw System components are available in titanium alloy conforming to ASTM F-136 specifications as well as stainless steel conforming to ASTM F-138 specifications. Furthermore, various rods of the RELIANCE Spinal Screw System are available in Cobalt-Chrome conforming to ASTM F-75 and ASTM F-1537 specifications. Components of the differing diameter rod systems are NOT interchangeable. The components of one material should not be used with components of another material with the exception that the Cobalt-Chrome rods may be used with titanium alloy implants. The extension tabs on the reduction screw and hook components are intended to be removed intraoperatively.

The provided text describes a 510(k) premarket notification for a medical device called the "Reliance Spinal Screw System." This notification primarily focuses on establishing substantial equivalence to existing predicate devices based on material, intended use, size range, and strength. It also mentions non-clinical testing performed according to ASTM standards.

However, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically seen in detail for AI/software-driven medical devices. The Reliance Spinal Screw System is a physical orthopedic implant, not an AI/software device, and thus the type of information requested (e.g., sample sizes for test sets, expert ground truth, MRMC studies, standalone algorithm performance) is not applicable or present in this regulatory submission.

Specifically, the document lacks details on:

1. Acceptance criteria and reported device performance (in a table): The document states the device underwent "Non-Clinical Testing including Static Compressive, Static Torsion, and Dynamic Compressive in accordance with ASTM F1717," but it does not provide the specific acceptance criteria or the reported performance data from these tests.
2. Sample sizes for test set and data provenance: Not applicable in the context of an orthopedic implant device.
3. Number of experts and their qualifications for ground truth: Not applicable.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study and effect size: Not applicable as this is not an AI-assisted diagnostic device.
6. Standalone algorithm performance: Not applicable.
7. Type of ground truth used: Not applicable.
8. Training set sample size: Not applicable.
9. How ground truth for training set was established: Not applicable.

The core of this 510(k) submission is to demonstrate that the expanded Reliance Spinal Screw System (with new screw types and rods) is substantially equivalent to previously cleared versions and other predicate devices, primarily through comparison of its physical characteristics, materials, indications for use, and a statement of compliance with mechanical testing standards (ASTM F1717). The results of these mechanical tests are not detailed in this publicly available summary.

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The RELIANCE Spinal Screw System is a pedicle screw systems 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. Jumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The RELIANCE Spinal Screw System is also indicated for pedicle screw fixation for the treatment of severe degenerative 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.

When used posteriorly, the RELIANCE Spinal Screw System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for, degenerative spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.

The RELIANCE Spinal Screw System when used with staples and two rods as an anterior thoracic/lumbar screw fixation system, is indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

When used in a percutaneous, posterior approach with MIS Instrumentation, the RELIANCE Spinal Screw System components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curyatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The Posterior RELIANCE Spinal Screw System consists of longitudinal rods, monoaxial screws, polyaxial screws, reduction screws, cannulated poly axial screws, cannulated reduction screws, hooks, reduction hooks, set screws, transverse connectors.

The Anterior RELIANCE Spinal Screw System consists of two spinal rods, monoaxial screws, staples, and set screws. The Anterior RELIANCE staples and screws are intended to be attached to the lateral aspect of the vertebral bodies from T5 to L4, and SHOULD NOT be attached to the anterior aspect. Furthermore, only Titanium components should be used anteriorly. (See Precautions section.)

The RELIANCE Spinal Screw System components are available in titanium alloy conforming to ASTM F-136 specifications as well as stainless steel conforming to ASTM F-138 specifications. Furthermore, various rods of the RELIANCE Spinal Screw System are available in Cobalt Chrome conforming to ASTM F-75 and ASTM F-1537 specifications. Components of the differing diameter rod systems are NOT interchangeable. The components of one material should not be used with components of another material, with the exception that the Cobalt Chrome rods may be used with titanium alloy implants. The extension tabs on the reduction screw and hook components are intended to be removed intraoperatively.

This appears to be a 510(k) summary for a medical device (Reliance Spinal Screw System), which focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study proving the device meets specific performance acceptance criteria.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study demonstrating the device meets those criteria, as it's not a performance study report. Instead, it's a regulatory document for device marketing clearance based on equivalence.

Specifically:

• No acceptance criteria are mentioned for device performance. The document focuses on equivalence in terms of material, intended use, levels of attachment, size range, and strength compared to predicate devices.
• No study proving the device meets acceptance criteria is presented. The document explicitly states: "No additional testing was performed on the subject RELIANCE Spinal Screw System as none of the modifications resulted in a new worst-case scenario." This indicates a lack of new performance studies for the modifications.

Given this, I cannot provide the requested table or answer the specific questions about sample size, expert ground truth, adjudication, MRMC studies, or standalone performance, as this information is not present in the provided 510(k) summary. The document's purpose is to argue for "substantial equivalence," not to detail a new performance study.

Ask a specific question about this device

The RELIANCE Spinal Screw System is a pedicle screw systems 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The RELIANCE Spinal Screw 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 having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

When used posteriorly, the RELIANCE Spinal Screw System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for, spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis), tumor, and previous failed fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.

The RELIANCE Spinal Screw System when used with staples and two rods as an anterior thoracic/lumbar screw fixation system, is indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

When used in a percutaneous, posterior approach with MIS Instrumentation, the RELIANCE Spinal Screw System components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications:spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The Posterior RELIANCE Spinal Screw System consists of longitudinal rods, monoaxial screws, polyaxial screws, reduction screws, cannulated poly axial screws, cannulated reduction screws, hooks, reduction hooks, set screws, transverse connectors.

The Anterior RELIANCE Spinal Screw System consists of two spinal rods, monoaxial screws, staples, and set screws. The Anterior RELIANCE staples and screws are intended to the lateral aspect of the vertebral bodies from T5 to L4, and SHOULD NOT be attached to the anterior aspect. Furthermore, only Titanium components should be used anteriorly. (See Precautions section.) The RELIANCE Spinal Screw System components are available in titanium alloy conforming to ASTM F-136 specifications as well as stainless steel conforming to ASTM F-138 specifications. Furthermore, various rods of the RELIANCE Spinal Screw System are available in Cobalt Chrome conforming to ASTM F-75 specifications. Components of the differing diameter rod systems are NOT interchangeable. The components of one material should not be used with components of another material, with the exception that the Cobalt Chrome rods may be used with titanium alloy implants. The extension tabs on the reduction screw and hook components are intended to be removed intraoperatively.

The provided document is a 510(k) summary for the Reliance Spinal Screw System, a spinal fixation device. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific performance acceptance criteria through clinical studies in the same way an AI/software device would.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance from a test set, expert involvement, or details about training sets, as these are typically applicable to performance-based evaluations for AI/ML or diagnostic devices.

Here's why the requested information isn't available in this document:

• Device Type: The Reliance Spinal Screw System is a physical medical device (spinal implant), not a software or AI-driven diagnostic tool. Its evaluation relies on mechanical testing and comparison to existing, legally marketed similar devices, not on diagnostic accuracy metrics.
• 510(k) Pathway: The 510(k) premarket notification pathway aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing indications for use, technological characteristics (materials, design), and performance data (often non-clinical, such as mechanical testing). It does not usually require clinical studies to prove performance against specific acceptance criteria for diagnostic accuracy, sensitivity, or specificity.
• Non-Clinical Testing: The document mentions "Non-Clinical Testing including Static Compressive, Static Torsion, and Dynamic Compressive in accordance with ASTM F1717." These are mechanical strength tests, common for implants, to ensure they can withstand physiological loads. The acceptance criteria for these tests would be defined by the ASTM standard, but the document does not elaborate on specific values or results.

Summary of requested information as found/not found in the document:

1. A table of acceptance criteria and the reported device performance: Not found. The document describes non-clinical mechanical testing (Static Compressive, Static Torsion, Dynamic Compressive per ASTM F1717) but does not provide specific acceptance criteria or performance values from these tests. These mechanical tests are to demonstrate structural integrity, not diagnostic performance.
2. Sample size used for the test set and the data provenance: Not applicable/Not found. As this is a mechanical device, performance is evaluated through non-clinical mechanical testing, not a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not found. Ground truth based on expert consensus is relevant for diagnostic or AI devices, not for a spinal screw system whose performance is assessed mechanically.
4. Adjudication method: Not applicable/Not found.
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 found. This is for AI-assisted diagnostic devices.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable/Not found. This is for AI-driven algorithms.
7. The type of ground truth used: Not applicable/Not found.
8. The sample size for the training set: Not applicable/Not found. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established: Not applicable/Not found.

In conclusion, the document provides information relevant to the regulatory approval of a spinal implant device, focusing on its materials, design, intended use, and substantial equivalence to predicate devices, supported by non-clinical mechanical testing. It does not address the types of performance criteria or study designs typically associated with AI or diagnostic imaging devices.

Ask a specific question about this device

The RELIANCE Spinal Screw System is a pedicle screw systems 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The RELIANCE Spinal Screw 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 having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

When used posteriorly, the RELIANCE Spinal Screw System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for, spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.

The RELIANCE Spinal Screw System when used with staples and two rods as an anterior thoracic/lumbar screw fixation system, is indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

When used in a percutaneous, posterior approach with MIS Instrumentation, the RELIANCE Spinal Screw System components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications:spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The Posterior RELIANCE Spinal Screw System consists of longitudinal rods, monoaxial screws, polyaxial screws, reduction screws, cannulated poly axial screws, cannulated reduction screws, hooks, reduction hooks, set screws, transverse connectors.

The Anterior RELIANCE Spinal Screw System consists of two spinal rods, monoaxial screws, staples, and set screws. The Anterior RELIANCE staples and screws are intended to the lateral aspect of the vertebral bodies from T5 to L4, and SHOULD NOT be attached to the anterior aspect. Furthermore, only Titanium components should be used anteriorly. (See Precautions section.) The RELIANCE Spinal Screw System components are available in titanium alloy conforming to ASTM F-136 specifications as well as stainless steel conforming to ASTM F-138 specifications. Furthermore, various rods of the RELIANCE Spinal Screw System are available in Cobalt Chrome conforming to ASTM F-75 specifications. Components of the differing diameter rod systems are NOT interchangeable. The components of one material should not be used with components of another material, with the exception that the Cobalt Chrome rods may be used with titanium alloy implants. The extension tabs on the reduction screw and hook components are intended to be removed intraoperatively.

The provided text describes a medical device, the Reliance Spinal Screw System, and its acceptance criteria are based on non-clinical testing for substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of clinical data or human subjects. The testing described is non-clinical testing (mechanical testing) conducted in accordance with ASTM F1717. Therefore, information about sample size for a test set of data, data provenance (country of origin, retrospective/prospective), or human subject-related data is not applicable. The samples would be physical components of the spinal screw system.

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

Not applicable. The ground truth for this device's acceptance is based on the mechanical performance against established ASTM standards (F1717) and an engineering comparison for "substantial equivalence" to predicate devices, not on expert clinical evaluation of a test set of data.

4. Adjudication Method for the Test Set

Not applicable, as this refers to non-clinical mechanical testing, not a study involving human subjects or clinical data requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states "Non-Clinical Testing." There is no mention of a clinical study, human readers, or assessment of human improvement with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical spinal implant system, not an AI algorithm.

7. Type of Ground Truth Used

The ground truth used for proving the device meets acceptance criteria is based on:

• Mechanical performance standards: Compliance with ASTM F1717 for Static Compressive, Static Torsion, and Dynamic Compressive strengths.
• Engineering comparison: A detailed engineering comparison to predicate devices to demonstrate "substantial equivalence" in terms of material, intended use, levels of attachment, size range, and strength.

8. Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. This device does not involve a "training set" or AI, and therefore no ground truth was established for such.

Ask a specific question about this device

The RELIANCE Spinal Screw System is a pedicle screw systems 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The RELIANCE Spinal Screw 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 having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

When used posteriorly, the RELIANCE Spinal Screw System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for, spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis), Levels of fixation are for the thoracic, lumbar and sacral spine.

The RELIANCE Spinal Screw System when used with staples and two rods as an anterior thoracic/lumbar screw fixation system, is indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or . kyphosis), tumor, and previous failed fusion (pseudarthrosis).

When used in a percutaneous, posterior approach with MIS Instrumentation, the RELIANCE Spinal Screw System components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications:spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The Posterior RELIANCE Spinal Screw System consists of longitudinal rods, monoaxial screws, polyaxial screws, reduction screws, cannulated poly axial screws, cannulated reduction screws, hooks, reduction hooks, set screws, transverse connectors, The Anterior RELIANCE Spinal Screw System consists of two spinal rods, monoaxial screws, staples, and set screws. The Anterior RELIANCE staples and screws are intended to be attached to the lateral aspect of the vertebral bodies from T5 to L4, and SHOULD NOT be attached to the anterior aspect. Furthermore, only Titanium components should be used anteriorly. (See Precautions section.)

The RELIANCE Spinal Screw System components are available in titanium alloy conforming to ASTM F-136 specifications as well as stainless steel conforming to ASTM F-138 specifications. Furthermore, various rods of the RELIANCE Spinal Screw System are available in Cobalt Chrome conforming to ASTM F-75 specifications. Components of the differing diameter rod systems are NOT interchangeable. The components of one material should not be used with components of another material, with the exception that the Cobalt Chrome rods may be used with titanium alloy implants. The extension tabs on the reduction screw and hook components are intended to be removed intraoperatively.

The provided text describes a 510(k) premarket notification for a medical device called the "Reliance Spinal Screw System". This type of document is a submission to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Key issues based on the request regarding acceptance criteria and study proving device meets them:

This document does not contain the level of detail typically found in a clinical study report or a robust performance study that would establish specific acceptance criteria and then demonstrate performance against them for an AI/software as a medical device (SaMD).

Instead, this 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices. For mechanical orthopedic implants like spinal fixation systems, the primary "study" to meet acceptance criteria often involves non-clinical (bench) testing to ensure mechanical performance, safety, and compatibility with the human body, rather than a clinical effectiveness study with human subjects, especially for a 510(k) pathway.

Therefore, for many of the requested points, the answer will be "Not applicable" or "Not specified in this document," as this information is generally not part of a 510(k) summary for a hardware medical device.

Here's the breakdown based on the provided text:

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

   This document mentions non-clinical testing but does not provide a table of acceptance criteria or specific reported device performance values. It states:

   • Acceptance Criteria Mentioned: "The RELIANCE Spinal Screw System has undergone Non-Clinical Testing including Static Compressive, Static Torsion, and Dynamic Compressive in accordance with ASTM F1717." ASTM F1717 is a standard test method, implying the device met the performance requirements specified within that standard for spinal implant constructs. However, the exact numerical acceptance values or the specific numerical results obtained by the device are not listed.
   • Reported Device Performance: Not explicitly stated in numerical terms within this summary. The successful 510(k) clearance implies that the device did meet the required performance criteria of the referenced ASTM standard. The device's performance is implicitly "substantially equivalent" to predicate devices, meaning it performs similarly or better on the relevant non-clinical tests.

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

   • This question is most relevant to clinical studies involving patient data.
   • For the non-clinical (bench) testing mentioned (Static Compressive, Static Torsion, Dynamic Compressive), the "sample size" would refer to the number of physical device constructs tested. This information is not specified in the provided document.
   • Data Provenance: Not applicable, as this refers to non-clinical bench testing, not patient data.

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 question is most relevant for diagnostic accuracy studies, especially with AI systems requiring expert interpretation for ground truth.
   • This document describes physical spinal implants and their mechanical testing. Therefore, this information is not applicable. Ground truth for mechanical testing is typically established by physical measurements and engineering specifications, not expert consensus.

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

   • This question is most relevant for clinical studies or studies involving expert consensus (e.g., in diagnostic image interpretation).
   • For the non-clinical (bench) testing, adjudication methods for establishing ground truth are not applicable. The "ground truth" (e.g., load to failure, fatigue life) is determined by the testing equipment and adherence to standard protocols.

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 question is specifically for diagnostic accuracy studies, particularly those involving AI algorithms assisting human readers.
   • This document is for a physical medical implant (spinal screw system). Therefore, this information is not applicable. An MRMC study would not be performed for this type of device.

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

   • This question is specifically for AI/Software as a Medical Device performance.
   • This document is for a physical medical implant. Therefore, this information is not applicable. There is no "algorithm only" performance for a spinal screw system.

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

   • For the non-clinical (bench) testing, the "ground truth" is based on the physical properties and mechanical behavior of the device components and constructs, as measured against the specifications outlined in the ASTM F1717 standard. This involves quantifiable engineering measurements (e.g., force, displacement, cycles to failure). It's not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

   • This question is specifically for machine learning/AI models.
   • This document describes a physical medical implant. There is no "training set" in the context of an AI model for this device. Therefore, this information is not applicable.

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

   • This question is specifically for machine learning/AI models.
   • This document describes a physical medical implant. There is no "training set" or corresponding ground truth establishment in this context. Therefore, this information is not applicable.

Summary of Device Acceptance Criteria and Performance (as much as can be extracted):

Important Note: This 510(k) summary is for a traditional physical medical device, not a software or AI-driven diagnostic device. Therefore, many standard questions about AI/SaMD studies are not applicable. The primary "study" for this device is non-clinical bench testing to demonstrate mechanical integrity and comparability to predicate devices.

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