Search Results

The Synthes Spine Auterior Thoracolumbar Rod Clamp (ATRC) System consists of a rod, a choice of three clamps, one bone screw and one set screw. It is intended for use in stabilizing

• · bone graft following anterior decompression of hurst fractures.
• · vertebrectorny and vertebral body replacement in turnor patients.
• · anterior fusion following failed posterior lumber surgery.
• · suterior following severe disc degeneration. Degenerative Dise Disease is defined as back pain of a discogenic origin with degeneration of the disc confirmed by history and radiographic studies
• · correction of anterolateral lordone deformities for the spine, lumbar scolliosis and pseudoardirosis of the thoracolitm spine.

This system is intended for anterolaters interventebral hady secew tixation/attachment to the T8 - LS spine.

The Syathes Spine Anterior Thoracolumbar Rod Clamp (All'RC) System consists of a rod, a choice of three clamps, one bone screw and one serew. It is intended for use in stabilizing

• · bone graft following anterior decompression of burst liactures.
• verrebrectorny and vertebral body replacement in turnor patients. f
• · anterior fusion following failed posterior lumbar surgery.
• · anterior fusion following severe disc degenerative Disc. Disease is defined as back pain of a discogenic origin with degeneration of the disc confirmed by hUstory and rulivyruphic studies
• · correction of anterolateral locatic deformities for the spinc, lumber scollosis and peeudearthrosis of the thoracolumbar spine.

This system is meaded for anterolateral littervertebral body screw fixasion/auculuncul to the T8 - LS spinc.

The rod and set screw used in this system are identical to that of the USS. The bone screw is identival to that in the ATLP system.

The rwo ends of two rods, of upprupriate length, are inserted into the two (unthreadod) holes of each clamp and locked into position by the set serews included in the construct is then placed on the anterolateral aspect of the spinal segment to be subilized. The cousunct is anached to the vertebral bodies by four 7.5mm self-tapping unicortical screws.

All implantable ways are manufactured from cither CP timium, which conforms to ASTM Standard F67, or TAN, which conforms to ASTM F1795. The instruments used to attach the spine are made from various grades of Stainless Steel.

This system is provided non-sterile; moist heat sterilization is recommended

The provided text is a 510(k) summary for the SYNTHES Spine Anterior Thoracolumbar Rod Clamp (ATKC) System. It details the device's intended use and claims substantial equivalence to previously marketed devices. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested table and study details. The document is primarily a regulatory submission demonstrating substantial equivalence, not a scientific study report with performance metrics.

Here's why the requested information cannot be extracted:

• Acceptance Criteria and Reported Device Performance: These are typically quantitative measures (e.g., accuracy, sensitivity, specificity, mechanical strength tolerances) that a device must meet. This document focuses on equivalency to existing devices for safety and effectiveness, not on specific performance criteria derived from a new study.
• Sample Size and Data Provenance for Test Set: No specific test set or study is described to evaluate the ATKC System's performance against defined criteria. The comparison is based on the components and indications being similar to predicate devices.
• Number of Experts and Qualifications: There's no mention of experts establishing ground truth because no specific performance study is detailed.
• Adjudication Method: Not applicable as no ground truth establishment is described.
• Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: This type of study is for evaluating human performance with and without AI assistance. The ATKC system is a mechanical implant, not an AI diagnostic tool, so such a study would not apply.
• Standalone Performance: While the device acts in a "standalone" mechanical capacity, the document doesn't provide quantitative performance data for it in isolation. It rather states that the "implantable components are equivalent in terms of safety and effectiveness" to predicate devices.
• Type of Ground Truth: No ground truth is mentioned because no study directly measuring the ATKC's performance is presented.
• Sample Size for Training Set: Not applicable. This is a medical device, not a machine learning algorithm that requires a training set.
• How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided document is a regulatory submission for premarket notification (510(k)) that focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study with acceptance criteria and performance data for the new device.

Ask a specific question about this device

The Synthes TiLPS is intended for anterior intravertebral body screw fixation/attachment to the LI-S1 spine over one vertebral body extending onto the adjacent intervetebral space. Due to variations in the anatomy, the plate is designed for applications caudal to the bifurcation of the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one motion segment following anterior structural reconstruction for degenerative disc disease. DDD is defined as follows: back pain of a discogenic origin with degeneration of the disc confirmed by history and radiographic studies

The system consists of a two hole locking plate, 4.35 mm expansion screws with 1.8 mm locking screws. The two hole plate is available in various lengths and is manufactured from commercially pure titanium.

The provided document is a 510(k) premarket notification for the Synthes Titanium Locking Plate System (TiLPS). This document establishes substantial equivalence to previously marketed devices and outlines the intended use and limitations. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically expected for a diagnostic or AI-based device.

The concept of "acceptance criteria" and "device performance" in this context refers to the device being substantially equivalent to existing predicate devices, primarily in terms of materials, design principles, and intended use. The "study" proving this is the 510(k) submission itself, where the manufacturer provides a comparison to legally marketed predicate devices.

Here's an attempt to answer your questions based only on the provided information, interpreting "acceptance criteria" and "device performance" in the context of a 510(k) submission for a spinal implant:

1. Table of Acceptance Criteria and Reported Device Performance

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

This document does not describe a "test set" in the context of clinical studies for performance metrics. The "test set" here refers metaphorically to the comparison set of predicate devices.

• Sample Size: Three predicate devices (Synthes Anterior Cervical Vertebrae Plate System (K926453 and K945700) and Synthes Anterior Spinal Plate System (K925351)).
• Data Provenance: Not applicable in the typical sense. The information comes from the design specifications, materials, and intended uses of the predicate devices already cleared by the FDA, and a comparison of the new device to these. This is analogous to a retrospective review of existing product data.

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

Not applicable. "Ground truth" in this context refers to the established safety, effectiveness, and regulatory status of the predicate devices. The "experts" are the FDA reviewers who previously cleared the predicate devices and who are reviewing this 510(k) submission. The document doesn't specify the number or qualifications of the FDA reviewers, but they are regulatory experts within the Office of Device Evaluation.

4. Adjudication Method for the Test Set

Not applicable. There's no "adjudication method" described for a test set. Substantial equivalence is determined by the FDA based on the provided comparison to predicate devices, material specifications, and design.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This document does not describe an MRMC study. These studies are typically for diagnostic AI devices assessing human reader performance.

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

No. This document describes a physical medical implant, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" is the established regulatory clearance and perceived safety/effectiveness of the predicate devices based on their prior 510(k) submissions. The "truth" is that these predicate devices are legally marketed, and the new device is sufficiently similar to them.

8. The Sample Size for the Training Set

No "training set" is mentioned as this is not an AI/machine learning device.

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

Not applicable. There is no training set mentioned.

Ask a specific question about this device