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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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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 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 510(k) submission seeks to add 6.5mm diameter hex screws to the TOWNLEY Pedicle Screw Plating System.

This document describes the TOWNLEY Pedicle Screw Plating System, a medical device designed to stabilize the spine. It is a 510(k) summary submission, indicating that the manufacturer, Sofamor Danek, claims substantial equivalence to a predicate device already on the market.

Acceptance Criteria and Device Performance:

The document does not provide explicit acceptance criteria or a study demonstrating that the device meets such criteria. Instead, it details the device's description, indications for use, and a regulatory clearance letter from the FDA. The letter confirms "substantial equivalence" of the device system to previously marketed devices.

Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission and not a study reporting performance against specific acceptance criteria, such a table cannot be directly generated from the provided text. The regulatory process relies on demonstrating equivalence to existing legally marketed devices, rather than establishing de novo performance metrics. The closest to "reported device performance" is the FDA's acceptance of its substantial equivalence for the specified indications.

The following information cannot be extracted from the provided text:

• Sample size used for the test set and the data provenance: No test set is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a test set is described.
• Adjudication method for the test set: No adjudication method is described.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No MRMC study or AI component is mentioned. This device is a mechanical implant, not an AI-assisted diagnostic or therapeutic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a medical implant, not an algorithm.
• The type of ground truth used: Not applicable as no specific study data or ground truth are discussed in relation to performance.
• The sample size for the training set: No training set is mentioned.
• How the ground truth for the training set was established: No training set is mentioned.

Summary of Device and Regulatory Clearance:

The TOWNLEY Pedicle Screw Plating System consists of broad-headed, partially threaded screws (ranging from 0.5 to 2.5 inches, with cortical and cancellous threads, and flat-head or hex configurations) and stainless steel DYNA-LOK® plates. The specific 510(k) submission seeks to add 6.5mm diameter hex screws to the existing system. All components are fabricated from medical grade stainless steel (ASTM F-138 or ISO equivalent).

Indications for Use (as cleared by FDA):

The system is intended to stabilize the spine as an aid to fusion, from C2 to S1 (inclusive) spinal levels. Bone graft must be used with each procedure.

The indications include:

• Trauma, including spinal fractures and/or dislocations.
• Spondylolisthesis (all grades and types).
• Spondylolysis.
• Pseudarthrosis or failed previous fusions which are symptomatic or may cause secondary instability or deformity.
• Degenerative disc disease and/or degenerative diseases, including:
  • Degenerative Disc Disease (DDD) as defined by neck and/or back pain of discogenic origin (confirmed by radiographic studies).
  • Degenerative disease of the facets with instability.

Substantial Equivalence:

The manufacturer submitted documentation asserting that the TOWNLEY Pedicle Screw Plating System is "substantially equivalent to itself," implying that the changes (addition of 6.5mm hex screws) do not alter the fundamental safety and effectiveness of the previously cleared system.

FDA Clearance (K982686):

The FDA reviewed the 510(k) submission and determined the device system is "substantially equivalent" for the stated indications. The FDA letter includes specific warnings and limitations on its use, emphasizing that pedicular screw fixation for other indications is considered investigational and requires an approved Premarket Approval (PMA) application. It also lists potential risks, including device component fracture, loss of fixation, non-union, vertebral fracture, neurological injury, and vascular or visceral injury.

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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.

Ask a specific question about this device

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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