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When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the COLORADO™ II Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal turnor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the COLORADO™ II Spinal System is also indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral 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 (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the COLORADO™ II Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

When used as an anterolateral thoracic/lumbar system, the COLORADO™ II Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

The COLORADO™ II Spinal System consists of a variety of rods, hooks, screws, plates, staples, and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.

COLORADO™ II Spinal System implant components are fabricated from stainless steel conforming to ASTM F138 or ISO 5832-1 or ISO 5832-9. Alternatively, the implant components may be manufactured from titanium alloy conforming to ASTM F-136 titanium alloy, or ISO 5832-3 and may be sold sterile or non-sterile. Stainless steel implants are not to be used with titanium alloy implants in a spinal construct.

The provided text is a 510(k) summary for the COLORADO™ II Spinal System. This document details the device's description, indications for use, and a statement of substantial equivalence to other legally marketed devices.

However, the 510(k) summary does not contain information about acceptance criteria, detailed device performance metrics, or specific study designs (like sample sizes, ground truth establishment, or expert involvement) that would be expected for a clinical or AI-based device study.

Instead, the document states: "Mechanical testing data were provided or referenced to demonstrate substantial equivalence." This implies that the device's performance was evaluated against a predicate device based on mechanical properties rather than clinical outcomes or diagnostic accuracy.

Therefore, I cannot provide the requested information for an AI/clinical study as it is not present in the provided text. The device's approval is based on demonstrating "substantial equivalence" through mechanical testing, not a study evaluating its performance against specific acceptance criteria in a clinical setting with human readers or AI.

If this were an AI-based device, the 510(k) summary would include sections describing a clinical study, reader study, or similar performance evaluation. Since it's a spinal system (an implantable medical device), the focus is on mechanical and materials safety and equivalence.

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When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the COLORADO™ II Spinal System Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the COLORADO™ II Spinal System is also indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral 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 (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the COLORADO™ II Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

The COLORADO™ II Spinal System consists of a variety of rods, hooks, screws, plates, staples, and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.

The provided text is a 510(k) premarket notification for the COLORADO™ II Spinal System, indicating that the device's substantial equivalence was demonstrated through "Mechanical testing data were provided or referenced to demonstrate substantial equivalence."

This type of submission typically relies on comparing the new device's design and mechanical properties to a legally marketed predicate device, rather than clinical studies involving human subjects in the same way an AI-powered diagnostic device would. Therefore, most of the detailed information requested regarding clinical study design, acceptance criteria, multi-reader multi-case studies, or ground truth establishment is not present or applicable to this type of device submission.

Here's a breakdown based on the information available:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

For a 510(k) submission like this, the "acceptance criteria" are implicitly met if the mechanical testing demonstrates that the new device performs equivalently or better than the predicate device for its intended use. Performance is typically assessed through engineering tests (e.g., strength, fatigue, stiffness) rather than clinical outcomes.

Study Details (Applicable to Mechanical Testing for Substantial Equivalence):

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

• Sample size: Not specified in the provided text. Mechanical testing would involve a certain number of device components or constructs tested to failure or under specific conditions.
• Data provenance: Not explicitly stated, but mechanical testing data would typically be generated in a lab setting, either by the manufacturer or a third-party testing facility. The country of origin is not specified but based on the company's location (Memphis, TN, USA) it is likely US-based.

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

• Not applicable in the context of mechanical testing for substantial equivalence. "Ground truth" in this context would refer to established engineering standards or the performance of predicate devices, not expert human interpretation.

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

• Not applicable. Mechanical testing results are typically quantitative and objective measurements against established engineering limits or predicate device performance, not subjective interpretations requiring adjudication.

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 is a spinal implant, not an AI-powered diagnostic device.

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

• Not applicable. This is a spinal implant, not an AI-powered diagnostic device.

6. The type of ground truth used:

• For mechanical testing, the "ground truth" would be established engineering standards, material properties, and the known performance specifications of predicate devices.

7. The sample size for the training set:

• Not applicable in the context of device approval through substantial equivalence via mechanical testing. There is no "training set" in the machine learning sense.

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

• Not applicable.

In summary, the provided document is a regulatory submission for a physical medical device (spinal implant) seeking approval based on substantial equivalence to predicate devices through mechanical testing. It is fundamentally different from the regulatory pathway for AI/ML-based diagnostic software, which would require extensive clinical validation as detailed in your prompt questions.

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When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the CD HORIZON® Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the CD HORIZON® Spinal System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the CD HORIZON® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

When used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

The CD HORIZON® Spinal System consists of a variety of rods, hooks, screws, CROSSLINK® plates, staples, and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.

Certain implant components from other Sofamor Danek spinal systems can be used with the CD HORIZON™ Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples and washers; GDLH™ rods, hooks, connectors and CROSSLINK® bar and connectors; LIBERTY® rods and screws; DYNA-LOK® bolts; and Sofamor Danek Multi-Axial rods and screws.

The purpose of this 510(k) submission is to add Shape Memory Alloy (SMA) Staples to the CD HORIZON® Spinal System.

The provided text is related to a 510(k) submission for the CD HORIZON® Spinal System from 1999 and focuses on its substantial equivalence to existing devices, specifically adding Shape Memory Alloy (SMA) Staples. This document does not describe a study involving acceptance criteria and device performance in the context of AI or diagnostic algorithms.

Therefore, I cannot extract the requested information such as a table of acceptance criteria and device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details. These concepts are not applicable to the type of regulatory submission presented.

The document primarily covers:

• Company and Product Description: Sofamor Danek USA and the components of the CD HORIZON® Spinal System.
• Indications for Use: Detailed descriptions of when and how the system is intended to be used, including various spinal conditions and configurations (pedicle screw fixation, posterior non-pedicle screw, anterolateral thoracic/lumbar).
• Substantial Equivalence: The core of a 510(k) submission, stating that the device is substantially equivalent to itself, implying it's an update to a previously cleared device.
• FDA Correspondence: A letter from the FDA confirming the 510(k) clearance and the device's regulatory classification.

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When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the DANEK® Plate and Screw System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the DANEK® Plate and Screw System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral 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 (4) who are having the device removed after the development of a solid fusion mass.

The DANEK® Plate and Screw System consists of plates, screws, hooks. CROSSLINK® Plates and other components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components. The purpose of the DANEK® Plate and Screw System is to provide stabilization during the development of a solid spinal fusion.

DANEK® Plate and Screw implant components are fabricated from medical grade stainless steel described by such standards as ASTM F138 or ISO 5832-1 or ISO 5832-9. The DANEK® Plate and Screw System implant components may be sold either sterile or non-sterile

The provided 510(k) summary (K991036) for the DANEK® Plate and Screw System does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

This document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a previously legally marketed device, not on presenting novel performance data from clinical trials or specific test criteria.

Therefore, I cannot populate the requested table or answer the specific questions related to acceptance criteria, device performance studies, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, or training set details from the provided text.

The core of the submission is described in Section V: "The DANEK® Plate and Screw System is substantially equivalent to itself. The new pedicle screw classification indications described in the classification Final Rule published in the July 27,1998 Federal Register were used to expand the previously cleared indications for the DANEK® Plate and Screw System. This system is also substantially equivalent to the DYNA-LOK® Spinal System."

The FDA's response letter also confirms this: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

In summary, the document states that the device is substantially equivalent to existing devices and references updated indications for use, but it does not include data from a study designed to prove acceptance criteria or demonstrate device performance as per your request.

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When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the DYNA-LOK PLUS™ Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the DYNA-LOK PLUS™ Spinal System is also indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral 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 (1.3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the DYNA-LOK PLUS™ Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

When used for posterior, non-pedicle screw fixation, the DYNA-LOK PLUS™ Spinal system is intended for thoracic, lumbar, and sacral (T1 - Sacrum) fixation only.

When used as an anterolateral thoracic/lumbar system, the DYNA-LOK PLUS™ Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

The DYNA-LOK PLUS™ Spinal System consists of a variety of shapes and sizes of rods, bolts, plates, screws, clamps, connectors, cross-connectors, washers and nuts. The DYNA-LOK PLUS™ Spinal System may be used with TSRH® Hooks and connectors, TSRH® Low Profile CROSSLINK® plates, CD HORIZON™ Low Profile MULTI-SPAN™ CROSSLINK® plates and/or MULTI-AXIAL Low Profile MULTI-SPAN™ CROSSLINK® plates. The DYNA-LOK PLUS™ Spinal System bolts and rod/bolt connectors may be used in conjunction with GDLH™ Spinal System rods, TSRH® Spinal System rods, TENOR™ Spinal System rods and CD® HORIZON Spinal System rods and their respective system indications. These components are assembled to fit the patient's anatomic specific needs. Instrumentation is also available to facilitate implantation of the device components.

DYNA-LOK PLUS™ Spinal System implant components are fabricated from stainless steel conforming to ASTM F138 or ISO 5832-1 or ISO 5832-9. Alternatively, the implant components may be manufactured from titanium alloy conforming to ASTM F-136 titanium alloy, or ISO 5832-3. These implants may be sold sterile or non-sterile. Stainless steel implants are not to be used with titanium alloy implants in a spinal construct.

The provided text is a "Summary of Safety and Effectiveness" for the DYNA-LOK PLUS™ Spinal System, a medical device. This type of document is a regulatory submission to the FDA (specifically a 510(k) premarket notification) to demonstrate that a new device is "substantially equivalent" to an already legally marketed device.

This document describes the device, its indications for use, and a statement of substantial equivalence. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as one would typically find for performance-based acceptance for AI/ML devices or novel technologies.

Instead, for devices like spinal systems, the "acceptance criteria" for regulatory clearance through a 510(k) pathway are generally met by demonstrating substantial equivalence to a predicate device. This often involves:

• Same intended use.
• Same technological characteristics, or different characteristics that do not raise different questions of safety and effectiveness.
• Performance data (e.g., mechanical testing, biocompatibility) demonstrating that newly introduced differences do not compromise safety or effectiveness.

The document states: "The DYNA-LOK PLUS™ Spinal System is substantially equivalent to other legally marketed devices. Mechanical testing data were provided or referenced to demonstrate substantial equivalence."

Given this context, I cannot provide a table of acceptance criteria and reported device performance in the manner you've requested for AI/ML devices, nor can I detail specific studies for a performance-based criteria as that's not how this device's regulatory pathway (510(k) substantial equivalence) is typically fulfilled.

Here's a breakdown of what can be extracted or inferred from the provided text regarding the device's regulatory acceptance, recognizing that it's not a direct answer to the AI/ML-focused questions:

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

Regarding the specific questions about AI/ML studies:

• 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 provided. This device is a mechanical implant, not an AI/ML diagnostic or therapeutic device.
• 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 provided. Ground truth in this context would relate to the mechanical and biological performance of the implant, typically evaluated through engineering tests and clinical follow-up, not expert image interpretation.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
  • Not applicable/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
  • Not applicable/Not provided.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
  • Not applicable/Not provided.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
  • For substantial equivalence of a spinal implant, "ground truth" would be established through:
    • Mechanical testing standards: Adherence to ASTM/ISO standards for strength, fatigue, etc.
    • Biocompatibility testing: According to ISO 10993.
    • Clinical outcomes data: Often referenced from predicate devices or previous clinical studies (though this document doesn't detail new clinical studies performed for this specific 510(k) submission beyond mechanical data).
• 8. The sample size for the training set
  • Not applicable/Not provided.
• 9. How the ground truth for the training set was established
  • Not applicable/Not provided.

In summary, the provided document serves as a regulatory clearance summary for a spinal implant device based on substantial equivalence, not a performance study report for an AI/ML product. Therefore, most of the requested information regarding AI/ML study specifics is not present or applicable.

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The TENOR™ Spinal System, when used for pedicle screw fixation, is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar – first sacral (LS-S1) vertebral 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 (levels of pedicle screw fixation may be from L3 to sacrum); and (d) who are having the device removed after the development of a solid fusion mass.

TENOR™ Plates are intended for the LS-S I pedicle screw indication described above only.

The TENOR™ Spinal System, when used as a posterior, non-pedicle screw fixation system, is intended for the following indications: 1. Degenerative disc discase (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); 2. Pseudarthrosis; 3. Stenosis; 4. Spondylolisthesis; 5. Spinal deformities: scoliosis, kyphosis; 6. Fracture; 7. Unsuccessful previous attempts at spinal fusion; 8. Tumor resection. When used for posterior non-pedicle screw fixation, the TENOR™ Spinal System is intended for thoracic, lumbar, and sacral (TI - Sacrum) fixation only.

The TENOR™ Spinal System is a spinal device intended to provide temporary, bilateral stabilization and augment the development of a solid spinal fusion. The system comprises a variety of shapes and sizes of clamps, cross-connectors, nuts, washers, plates, and screws made of medical grade titanium alloy or stainless steel. The TENORTM Spinal System may be used in conjunction with GDLH™ 5.5mm rods, TSRH® hooks and connectors, TSRH® Low Profile CROSSLINK® plates, CD HORIZON™ Low Profile MULTI-SPAN™ CROSSLINK® plates, and/or MULTI AXIAL Low Profile MULTI-SPANTM CROSSLINK® plates for attachment to the posterior thoracic and lumbar spine. These components are assembled to fit the patient's specific anatomic needs.

The provided text is a 510(k) summary for the TENOR™ Spinal System. It details the device's description, indications for use, and a claim of substantial equivalence. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The statement "Documentation was provided which demonstrated the TENOR™ Spinal System to be substantially equivalent to itself" is a very unusual and likely erroneous statement within the context of a 510(k). Typically, substantial equivalence is demonstrated by comparing the new device to a legally marketed predicate device. This implies that the device is either (a) a re-submission of a previously cleared device with minor changes, or (b) the sentence is a typo and refers to a known predicate device that is not explicitly named here. Without further documentation, it's impossible to determine the true basis for substantial equivalence.

Therefore, I cannot fulfill your request for the detailed breakdowns of acceptance criteria, study methodologies, and performance metrics as this information is not present in the provided text.

Here's a breakdown of what is and is not available in the provided document, in relation to your request:

1. Table of acceptance criteria and the reported device performance:

• Not provided. The document states that the system is "substantially equivalent" but does not offer specific performance metrics or acceptance criteria for those metrics.

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

• Not provided. No information about a test set, its sample size, or data provenance is present.

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

• Not provided. There is no mention of a test set, ground truth, or experts establishing it.

4. Adjudication method for the test set:

• Not provided. No information about a test set or adjudication method is present.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable/Not provided. This device is a mechanical spinal system, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human-AI collaboration is irrelevant. No information about any comparative effectiveness study is provided.

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

• Not applicable/Not provided. As stated above, this is a mechanical device, not an algorithm. No standalone performance data is provided for the device in general.

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

• Not provided. No information about ground truth is present.

8. The sample size for the training set:

• Not applicable/Not provided. As a mechanical device, there wouldn't typically be a "training set" in the sense of machine learning. There is no information about any study sample sizes.

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

• Not applicable/Not provided. There is no mention of a training set or its ground truth.

In summary, the provided 510(k) pertains to regulatory clearance based on substantial equivalence, and it does not include the detailed study results or performance data that would typically be found in a clinical study report or a more comprehensive technical document.

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When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the CD HORIZON® Spinal System is indicated for one or more of the following: (1) deqenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the CD HORIZON® Spinal System is also indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral 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 (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the CD HORIZON® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

When used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). (2) spinal stenosis. (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

The CD HORIZON® Spinal System consists of a variety of rods, hooks, screws, CROSSLINK® plates, staples, and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.

Certain implant components from other Sofamor Danek spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples and washer; GDLH™ rods, hooks, connectors and CROSSLINK® bar and connectors; LIBERTY™ rods and screws: DYNA-LOK® bolts; and Sofamor Danek Multi-Axial rods and screws.

The provided text is a government document for the CD HORIZON® Spinal System, outlining its description, indications for use, and a letter from the FDA affirming its substantial equivalence to other legally marketed devices. It does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes for testing or training, expert qualifications for ground truth, adjudication methods, or MRMC studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. This document is a regulatory clearance, not a study report detailing performance metrics.

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When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the CDTM Spinal System is indicated for one or more of the following: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the CD TM Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (13 and below); and (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the CD™ Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

The CDTM Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, and connecting components. The components can be rigidly locked into a variety of configurations, with each construct tailor-made for the individual case.

The provided document is a 510(k) summary for the CD™ Spinal System from 1998, which is a premarket notification to the FDA for a medical device. This type of document establishes substantial equivalence to a predicate device rather than presenting detailed studies with acceptance criteria for device performance as would be expected for a novel device or a more recent submission.

Therefore, the document does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 of your prompt regarding acceptance criteria and a detailed study proving device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for training and test sets.

Instead, it states:

V. Substantial Equivalence
The CD™ Spinal System is substantially equivalent to itself and other predicate or preamendments devices. Mechanical testing and historical data were provided or referenced to demonstrate substantial equivalence.

This indicates that the device was deemed substantially equivalent based on mechanical testing and historical data, rather than a clinical study evaluating specific performance metrics against defined acceptance criteria in the manner you've outlined. The focus of a 510(k) is to demonstrate that the new device is as safe and effective as a legally marketed predicate device, not necessarily to prove efficacy or performance against a set of predefined quantitative acceptance criteria with a detailed clinical study.

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When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the DYNA-LOK® Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal turnor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the DYNA-LOK® Spinal System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral 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 (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the DYNA-LOK® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

When used as an anterolateral thoracic/lumbar system, the DYNA-LOK® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

The DYNA-LOK® Spinal System consists of plates, bolts, screws, hooks, CROSSLINK® Plates and other components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components. The purpose of the DYNA-LOK® Spinal System is to provide stabilization during the development of a solid spinal fusion.

The DYNA-LOK® Spinal System implant components are fabricated from medical grade stainless steel described by such standards as ASTM F138 or ISO 5832-1 or ISO 5832-9. Alternatively, the entire system may be made out of medical grade titanium alloy described by such standards as ASTM F136 or ISO 5832-3. The DYNA-LOK® Spinal System implant Components may be sold either sterile or non-sterile

This document is a 510(k) summary for the DYNA-LOK® Spinal System, a medical device. It describes the device, its indications for use, and its substantial equivalence to a predicate device.

There is no information in the provided text regarding acceptance criteria, device performance studies, or details about data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

The document is a regulatory submission for premarket notification (510(k)) to the FDA, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than detailing specific performance studies with acceptance criteria in the manner of an AI/software as a medical device (SaMD) submission.

Therefore, I cannot provide the requested table and detailed study information based on the given input. The content is about the device's description, indications for use, and a regulatory approval letter.

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The TOWNLEY Pedicle Screw Plating System is intended to stabilize the spine as an aid to fusion. After first making drill holes in the pedicles, a DYNA-LOK® Plate is positioned over the pedicles. TOWNLEY Pedicle screws are then inserted through the plate, down the center of the pedicles, and into the vertebral body. Bone graft must be used with each procedure.

This system is indicated for the treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels: (a) Trauma, including spinal fractures and/or dislocations, (b) Spondylolisthesis, all grades and types, (c) Spondylolysis, (d) Pseudarthrosis, (e) Degenerative disc disease and/or degenerative diseases which include: (1) degenerative disc disease (ddd) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (2) degenerative disease of the facets with instability.

For all these indications, bone graft must be used and the system is limited to screw fixation from C2 to S1.

This system consists of a broad-headed, partially threaded screw designed to compress bone grafts. Screw lengths range from 0.5 to 2.5 inches. Both cortical and cancellous screw threads are available. The screw comes in two configurations: flat-head or hex. The hex screws are wider in diameter. The DYNA-LOK® plates are used to interconnect two or more vertebrae together via screw fixation through the pedicles. The components are made of titanium alloy such as described by ASTM F-136. or ISO 5832-3. Alternatively, the entire system may be made out of medical grade stainless steel such as described by ASTM F-138 or ISO 5832-1 or ISO 5832-9. This 510(k) submission seeks to add the titanium alloy components to the TOWNLEY Pedicle Screw Plating System.

This document describes the TOWNLEY Pedicle Screw Plating System but does not contain information regarding acceptance criteria or a study proving the device meets said criteria.

The document is a 510(k) summary from 1998, focused on demonstrating substantial equivalence to a predicate device. For medical devices, "substantial equivalence" means that the new device is as safe and effective as a legally marketed device (the predicate). This typically involves comparing features, materials, indications for use, and performance data, often relying on existing data or widely accepted engineering principles rather than a new clinical study with specific acceptance criteria in the way a clinical trial for a drug or a novel AI software might.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study as the provided text does not contain that information. The document explicitly states:

"Documentation was provided which demonstrated the TOWNLEY Pedicle Screw Plating System to be substantially equivalent to itself."

This phrase, while perhaps unusual in its wording ("to itself"), implies that the submission focused on changes to an existing device already on the market (in this case, adding titanium alloy components to a system previously described). The FDA's response confirms that the device is "substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified." This reaffirms the focus on equivalence rather than meeting new, specific performance metrics from a dedicated study.

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