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Each BONE GRAFT WASHER is intended to stabilize the bone graft at one level (T1-S1) as an aid to spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials (e.g., commercially pure titanium or titanium alloy).

The BONE GRAFT WASHER is used with a 6.5mm low profile screw to provide bone graft stabilization during the development of a solid spinal fusion. Instrumentation is also available to facilitate implantation of the device components.

BONE GRAFT WASHER components are fabricated from medical grade titanium alloy described by such standards as ASTM F136 or ISO 5832-3. The BONE GRAFT WASHER may also be fabricated from commercially pure titanium described by such standards as ASTM F67 or ISO 5832-2. The implant components may be sold either sterile or non-sterile.

This document is a 510(k) summary for a medical device called the "BONE GRAFT WASHER." It's a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it does not contain acceptance criteria for device performance or a study demonstrating that the device meets those criteria.

Instead, the summary focuses on:

• Description of the device: What it is, what it's made of.
• Intended Use/Indications for Use: What the device is for.
• Substantial Equivalence: A statement that it's equivalent to other accepted devices.

Since the document is a 510(k) summary and not a clinical study report or a detailed performance validation, the specific information requested in your prompt (acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is not present within the provided text.

The FDA's finding of "substantial equivalence" in a 510(k) process typically relies on demonstrating that the new device has the same intended use, technological characteristics, and performance (or can be shown to be as safe and effective) as a predicate device, rather than requiring new, extensive clinical trials with pre-defined acceptance criteria for novel device performance. Performance testing might be referenced, but the acceptance criteria and detailed study results as you've requested are not part of this summary.

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The new CD HORIZON® ECLIPSE™ components are intended for the following indications:

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® system is also intended for the following indications:

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.

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.

CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE™ rods and screws are intended for anterior use only.

The purpose of this 510(k) submission is to add CD HORIZON® ECLIPSE™ (4.5mm rods and associated bone screws to the system.

This document is a 510(k) Pre-market Notification for the CD HORIZON® Spinal System. It seeks to add CD HORIZON® ECLIPSE™ (4.5mm rods and associated bone screws) to the existing system. The core of this document is demonstrating substantial equivalence to a predicate device, which in this case, is the CD HORIZON® Spinal System itself.

Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" as it would apply to a machine learning or diagnostic device with performance metrics (sensitivity, specificity, etc.) is not directly applicable here. This document is about regulatory clearance for a medical implant, not a diagnostic algorithm.

Let's break down why and how to interpret the provided information in the context of your request:

Key Takeaway: This is a 510(k) submission for a physical medical implant, not a software/AI device. The "acceptance criteria" here is primarily demonstrating "substantial equivalence" to a legally marketed predicate device, rather than meeting specific performance thresholds like accuracy or recall.

Here's how to address your specific points based on the provided text, recognizing the different nature of this medical device submission:

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

Since this is a 510(k) for a spinal implant system seeking substantial equivalence to itself, the "acceptance criteria" are not performance metrics in the way you might expect for a diagnostic device. Instead, the acceptance criterion is demonstrating that the new components (CD HORIZON® ECLIPSE™ rods and screws) are substantially equivalent in intended use, fundamental scientific technology, and safety/effectiveness considerations to the existing, legally marketed CD HORIZON® Spinal System.

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

This document does not describe a clinical study with a "test set" in the context of evaluating an AI or diagnostic device's performance. The "documentation" supporting substantial equivalence typically includes:

• Design specifications and materials: Showing the new components are similar in design and material to the predicate.
• Mechanical testing: Bench testing (e.g., fatigue, static strength) to demonstrate that the new components meet established standards or are comparable to the predicate.
• Biocompatibility testing: To ensure the materials are safe for implantation.

The text does not specify the details of any mechanical or biocompatibility testing, including sample sizes or data provenance. The focus of this summary is the regulatory conclusion.

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 is not applicable. "Ground truth" in this context would likely refer to engineering specifications and performance standards for an implant, not an expert panel's interpretation of medical data. The FDA's review process itself involves internal experts (e.g., engineers, medical officers) evaluating the submission, but they are not establishing "ground truth" for a test set in the way a radiologist panel would for an imaging AI.

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

This is not applicable for the reasons stated above.

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 is not applicable. An MRMC study is designed for evaluating diagnostic performance, typically with AI assistance for human readers. This submission is for a physical orthopedic implant.

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

This is not applicable. There is no algorithm being evaluated in this submission.

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

For a medical implant like the CD HORIZON® Spinal System, "ground truth" in terms of its safety and effectiveness is established through:

• Engineering principles and biomechanical testing standards: Demonstrating that the device can withstand the forces it will experience in the body.
• Material science: Confirming biocompatibility and durability of materials.
• Clinical experience (of the predicate): The existing CD HORIZON® Spinal System has a track record of safe and effective use, which the new components are leveraging through substantial equivalence.
  The document doesn't detail these underlying "truths" but relies on the FDA considering them established for the predicate device.

8. The sample size for the training set

This is not applicable. There is no AI model or "training set" in this context.

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

This is not applicable.

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The ATLANTIS™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.

The ATLANTIS™ Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates (locking mechanism is pre-assembled to plates), screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The implant components will be made from titanium alloy as described by ASTM F-136 or ISO 5832-3 and may be supplied either sterile or non-sterile.

The provided documents are a 510(k) premarket notification summary and an FDA clearance letter for the ATLANTIS™ Anterior Cervical Plate System. These documents are for a medical device (spinal implant) and do not contain information about acceptance criteria or a study proving device performance in the context of an AI/algorithm-driven medical device.

The 510(k) summary focuses on:

• Product Description: Materials, components, and general design.
• Intended Use/Indications: For temporary stabilization of the anterior cervical spine during fusion in various conditions.
• Substantial Equivalence: The key claim in a 510(k) submission, where the device is shown to be as safe and effective as a legally marketed predicate device. In this specific case, it states the device was claimed to be substantially equivalent to itself, which is unusual phrasing but generally means a modification or rebranding of an existing device.

The FDA clearance letter confirms that the device is substantially equivalent to a predicate device and can be marketed.

Therefore, based on the provided text, I cannot extract the requested information regarding acceptance criteria and study details for an AI/algorithm-driven device's performance.

The questions in your prompt (sample sizes for test/training, ground truth establishment, MRMC studies, standalone performance, etc.) are specific to the evaluation of AI/ML-based medical devices, which operate very differently from a physical implant like a cervical plate system. The safety and effectiveness of such implants are typically demonstrated through mechanical testing (e.g., fatigue, static strength), biocompatibility testing, and comparison to established designs (predicate devices), rather than through clinical studies involving expert consensus on algorithm output or multi-reader multi-case analyses.

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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-S1 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 disease (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, lordosis, 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 (T1 - 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, connectors, cross-connectors, nuts, washers, plates, and screws made of medical grade titanium alloy or stainless steel. The TENORM 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-SPAN™ 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) premarket notification for the TENOR™ Spinal System. It details the product description, indications for use, and a statement of substantial equivalence to itself. The FDA letter confirms the device is substantially equivalent to legally marketed devices.

This document does not report on any studies that prove the device meets specific acceptance criteria.

The concept of "acceptance criteria" and performance metrics (like accuracy, sensitivity, specificity) typically applies to medical devices that perform a diagnostic, analytical, or algorithmic function, such as AI-driven software, imaging systems, or lab tests. For these types of devices, performance is quantifiable and a "study" is conducted to demonstrate that the device meets predetermined thresholds.

The TENOR™ Spinal System is a physical spinal implant (components like clamps, screws, plates, rods). For such devices, "acceptance criteria" are usually based on:

• Biocompatibility: Demonstrated through testing to ensure the materials are safe for implantation in the human body.
• Mechanical Strength and Durability: Tested according to recognized standards (e.g., ASTM, ISO) to ensure the components can withstand the stresses and movements of the spine over time.
• Sterilization: Validated methods to ensure the device is sterile when implanted.
• Design and Manufacturing Controls: Adherence to Quality System Regulation (21 CFR Part 820) to ensure consistent quality.
• Substantial Equivalence: As explicitly stated in the document ("Documentation was provided which demonstrated the TENOR™ Spinal System to be substantially equivalent to itself."), the primary "study" or justification for market clearance of this type of device is often through demonstrating that it is substantially equivalent to a device already legally on the market. This means it has the same intended use and technological characteristics, or if there are different technological characteristics, they do not raise new questions of safety and effectiveness.

Since the provided text does not contain information about a study with performance metrics or acceptance criteria for algorithm output or diagnostic accuracy, I cannot fill out the requested table or answer most of the questions.

Here's what can be inferred or stated based on the given document, acknowledging its limitations for the specific request:

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

2. Sample size used for the test set and the data provenance
Not applicable. No "test set" of patient data in the context of device performance metrics is described. The "study" mentioned for substantial equivalence is a comparison to a predicate device, not a clinical trial with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "test set" with ground truth established by experts is described for this type of device submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.

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 an AI or imaging device where human readers would be involved in interpreting outputs.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical spinal implant, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. For this device, "ground truth" would relate to the physical and biocompatible properties of the materials, and the established safety and effectiveness of the predicate device it is equivalent to.

8. The sample size for the training set
Not applicable. No "training set" in the context of AI or algorithmic development is mentioned.

9. How the ground truth for the training set was established
Not applicable.

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The ZPLATE-ATL™ Anterior Fixation System is intended for screw/bolt fixation/ attachment to the anterolateral intervertebral bodies from T1 to L5 only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible.

When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
2. Pseudoarthrosis.
3. Spondylolysis.
4. Spondylolisthesis.
5. Fracture.
6. Neoplastic disease.
7. Unsuccessful previous fusion surgery.
8. Lordotic deformities of the spine.
9. Idiopathic thoracolumbar or lumbar scoliosis
10. Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.
11. Neuromuscular deformity (i.e., scoliosis, lordosis, and / or kyphosis) associated with pelvic obliquity.

Warning: This device is not approved for screw attachment to the posterior elements (pedicle) of the cervical, thoracic, or lumbar spine.

The ZPLATE-ATL™ Anterior Spinal Fixation System consists of a variety of shapes and sizes of plates, bolts, screws and nuts, as well as ancillary products and instrument sets. The components can be locked into a variety of configurations, with each construct tailor-made for the individual case.

The provided text is a 510(k) summary for the ZPLATE-ATL™ Anterior Spinal Fixation System, which describes a medical device, not an AI or software device. Therefore, the questions related to acceptance criteria, study design, ground truth, and expert evaluation for AI performance are not applicable to this document.

The document focuses on:

• Product Description: "The ZPLATE-ATL™ Anterior Spinal Fixation System consists of a variety of shapes and sizes of plates, bolts, screws and nuts, as well as ancillary products and instrument sets. The components can be locked into a variety of configurations, with each construct tailor-made for the individual case."
• Indications for Use: Listing specific spinal conditions (degenerative disc disease, pseudoarthrosis, spondylolysis, spondylolisthesis, fracture, neoplastic disease, unsuccessful previous fusion surgery, lordotic deformities, idiopathic thoracolumbar or lumbar scoliosis, deformity with deficient posterior elements, neuromuscular deformity with pelvic obliquity) for which the device can be used for "screw/bolt fixation/attachment to the anterolateral intervertebral bodies from T1 to L5 only."
• Substantial Equivalence: Stating that "Documentation was provided which demonstrated the ZPLATE-ATL™ Anterior Spinal Fixation System to be substantially equivalent to itself." This implies it's either a new version of an already cleared device or a direct claim of equivalence to a predicate without listing a different predicate upfront. The FDA letter confirms the FDA's finding of substantial equivalence to "devices marketed in interstate commerce prior to May 28, 1976."

Since this is a physical medical device and not an AI/software device, the questions regarding acceptance criteria and study design for AI evaluation cannot be answered from the provided text.

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The ZPLATE-ATL™ Anterior Fixation System is intended for screw/bolt fixation/ attachment to the anterolateral intervertebral bodies from T1 to L5 only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible.

When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
2. Pseudoarthrosis.
3. Spondylolysis.
4. Spondylolisthesis.
5. Fracture.
6. Neoplastic disease.
7. Unsuccessful previous fusion surgery.
8. Lordotic deformities of the spine.
9. Idiopathic thoracolumbar or lumbar scoliosis
10. Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.
11. Neuromuscular deformity (i.e., scoliosis, lordosis, and / or kyphosis) associated with pelvic obliquity.

Warning: This device is not approved for screw attachment to the posterior elements (pedicle) of the cervical, thoracic, or lumbar spine.

The ZPLATE-ATL™ Anterior Spinal Fixation System consists of a variety of shapes and sizes of plates, bolts, screws and nuts, as well as ancillary products and instrument sets. The components can be locked into a variety of configurations, with each construct tailor-made for the individual case.

The provided text is a 510(k) premarket notification for the ZPLATE-ATL™ Anterior Spinal Fixation System. It focuses on the substantial equivalence of the device to itself, indicating that it is a modification or re-filing of an already cleared device.

Therefore, this document does not contain information about acceptance criteria and a study proving a device meets those criteria, as it would for a novel device. The FDA's letter explicitly states: "Documentation was provided which demonstrated the ZPLATE-ATL™ Anterior Spinal Fixation System to be substantially equivalent to itself." This means the current submission is for an already cleared device, possibly with minor modifications that do not warrant new clinical studies or the establishment of new performance acceptance criteria.

To answer your request, if this were a submission for a new device, the information you're asking for would typically be found in sections detailing performance data, clinical studies, or non-clinical tests. This document instead states that the device is substantially equivalent to itself, which bypasses the need for the kind of studies you describe in your prompt.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text.

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When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the TSRH® 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 TSRH® 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 ioint: (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 TSRH® 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.

When used as an anterolateral thoracic/lumbar system, the TSRH® 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 purpose of this 510(k) submission is to add the 3D Connector and associated screws to the TSRH® Spinal System.

The TSRH® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, and connecting components. In addition, GDLH® rods, DYNA-LOK® bolts, CD HORIZON™ Low Profile MULTI-SPAN™ CROSSLINK® Plates, GDLH® rod/bolt connectors, GDLH® Variable Angle T-Bolts, and GDLH® and CD HORIZON™ set screws and locking screws may be used with the TSRH® Spinal System.

The TSRH® Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The hooks are intended for posterior use only and the staples are for anterior use only. The TSRH-3D™ connectors and TSRH-3D™ screws are intended for posterior use only. All CROSSLINK® Plates are for posterior use and the CROSSLINK Axial and Offset Plates may be used anteriorly as well.

The TSRH Spinal System components are fabricated from either stainless steel conforming to ASTM F-138 or ISO 5832-1 or ISO 5832-9, or titanium alloy conforming to ASTM F-136 or ISO 5832-3. The TSRH Spinal System may sold sterile or non-sterile.

This 510(k) summary (K984522) describes the addition of 3D Connectors and associated screws to the existing TSRH® Spinal System. The submission primarily focuses on establishing "substantial equivalence" to predicate devices rather than providing detailed acceptance criteria and performance study results in the manner common for AI/ML device submissions.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, and adjudication methods is not available in this document. This is typical for a 510(k) submission for a physical medical device from this era, where the focus is on demonstrating that the new components are essentially the same as previously cleared components and do not raise new questions of safety or effectiveness.

Here's an attempt to answer the questions based on the provided text, while highlighting what is missing due to the nature of the document:

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

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

Not available/Applicable. This document does not describe a performance study with a test set of data points in the way an AI/ML device would. Instead, substantial equivalence is claimed based on similarities in design, materials, and intended use to existing predicate devices.

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 available/Applicable. No expert-derived ground truth for a test set is described.

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

Not available/Applicable. No test set or adjudication method 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 available/Applicable. This is not an AI-assisted device, and no MRMC study is mentioned.

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

Not available/Applicable. This is not an algorithm-only device.

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

Not available/Applicable. The concept of "ground truth" for a performance study is not relevant here as the submission focuses on substantial equivalence of physical components. The "truth" in this context is that the new components are comparable in design, material, and function to previously cleared devices.

8. The sample size for the training set

Not available/Applicable. No training set for an algorithm is discussed.

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

Not available/Applicable. No training set or ground truth establishment for it is discussed.

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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 of the pedicles. TOWNLEY Pedicle screws are then inserted through the DYNA-LOK® 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; (c) Spondylolysis; (d) Pseudarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; (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 radiographic studies; and/or (2) degenerative disease of the facets with instability.

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 slightly wider in diameter. The stainless steel DYNA-LOK® plates are used to interconnect two or more vertebrae together via screw fixation through the pedicles. All components are fabricated from medical grade stainless steel (ASTM F-138 or its ISO equivalent).

This document is a 510(k) summary for the TOWNLEY Pedicle Screw Plating System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria in the way a clinical trial for a new drug or an AI-powered diagnostic device would.

Therefore, the requested information components related to an AI/diagnostic device study (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission.

The "acceptance criteria" here are essentially the demonstration of "substantial equivalence" to a legally marketed predicate device, as required for a 510(k) clearance by the FDA. The "study" proving it meets these criteria is the provided documentation itself, which asserts its similarity.

Here's a breakdown of what can be extracted from the provided text, aligned as much as possible with your request, but highlighting the inapplicability of many points:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable. This document describes a 510(k) submission, which relies on demonstrating substantial equivalence to a predicate device, not primary clinical performance data from a test set. There is no mention of a "test set" in the context of device performance 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)

• Not applicable. No such test set or ground truth establishment by experts is described for this type of regulatory submission. The "ground truth" for a 510(k) is typically the established safety and effectiveness of the legally marketed predicate device.

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

• Not applicable. No test set or adjudication process is mentioned.

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 device is a mechanical implant, not an AI-powered diagnostic tool, and therefore MRMC studies are irrelevant.

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.)

• Not applicable. For a 510(k) of this nature, the "ground truth" is typically the regulatory acceptance of the predicate device based on its known characteristics, indications, and safety/effectiveness profile, which has already been established through prior regulatory processes (potentially including clinical data or consensus standards). The submission argues the new device is sufficiently similar to that predicate.

8. The sample size for the training set

• Not applicable. This device is a mechanical implant, not an AI model requiring a training set.

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

• Not applicable. This device is a mechanical implant, not an AI model, and therefore has no training set or associated ground truth establishment.

In summary, the provided document is a 510(k) premarket notification, a regulatory pathway for medical devices that are substantially equivalent to already legally marketed devices. It does not contain information on clinical studies or performance data in the way a submission for a novel diagnostic or AI device would. The "study" demonstrating criteria fulfillment is the comparison and argument for substantial equivalence to a predicate device.

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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 DYNA-LOK 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.
C. Spondylolysis.
D. Pseudarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity.
E. Degenerative disc disease and/or degenerative diseases which include:
(a) 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
(b) degenerative disease of the facets with instability.

This system consists of a broad-headed, partially threaded screw designed to compress bone grafts. Screw lengths range from 0.5 to 2.5 inch. Both cortical and cancellous screw threads are available. The stainless steel DYNA-LOK® Plates are used to interconnect two or more vertebrae together via screw fixation through the pedicles. All components are fabricated from medical grade stainless steel (ASTM F-138 or its ISO equivalent).

The provided text is a 510(k) Pre-market Notification for the TOWNLEY Pedicle Screw Plating System from 1997. This document focuses on establishing substantial equivalence to a predicate device and defining the indications for use. It does not contain any information about acceptance criteria, device performance metrics, or the results of a study (clinical or otherwise) that would "prove" the device meets such criteria.

Therefore, I cannot provide the requested information. The document is strictly about regulatory clearance based on substantial equivalence, not a performance study report.

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Ask a specific question about this device