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The Theken VU VBR SYSTEM is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture).

The Theken VU VBR SYSTEM is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absences of fusion for a prolonged period. Bone graft material is recommended to be packed into the interior openings of the device prior to implantation.

The Theken VU VBR SYSTEM is intended to be used with supplemental internal spinal fixation systems, such as the Theken BodyForm Thoracolumbar Fixation System (K983622), Approved 12/98) or the Theken Coral Pedicle Screw System (K041592, Approved 9/04).

The Theken VU VBR SYSTEM is comprised of rounded rectangular and rectangular cages with fenestrations and radii on all sides and toothed spikes which are used in combination with spacer components. The cages and spacer can be locked together into a variety of geometric configurations to fit each individual patient's pathology. The toothed spikes of the rounded rectangular and rectangular cages engage with the superior and inferior end plates of the neighboring vertebral bodies to resist rotation and migration. A single construct is sufficient to be used at all spinal levels and pathologies.

The provided document is a 510(k) summary for the Theken VU VBR SYSTEM, which is a vertebral body replacement device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to establish acceptance criteria for device performance in terms of accuracy, sensitivity, or specificity.

Therefore, the document does NOT contain the information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

The 510(k) summary explicitly states: "Establishment of equivalence is based on similarities of intended use, design, and physical characteristics. All implants are used to treat the same conditions, have essentially the same precautions and contradictions for use, and have equivalent potential for complications for the risk of use. In addition they all represent a basic design concept in terms of safety and effectiveness, and differ only in minor details. Based on the design concept, the use of established well known materials, feature comparisons, mechanical testing, indications for use, pre-production quality assurance planning and engineering analysis (adherence to GLP), Theken Surgical believes that sufficient evidence exists to reasonably conclude that the VU VBR SYSTEM is substantially equivalent to existing legally marketed devices."

The study that "proves the device meets the acceptance criteria" in this context refers to the comparison against predicate devices and mechanical testing, not a clinical study to establish diagnostic performance. The "acceptance criteria" are not reported as specific performance metrics like sensitivity/specificity but rather as conformity to the design, materials, and intended use of equivalent devices already on the market and adherence to good laboratory practices (GLP) for mechanical testing.

Since this is a medical device and not an AI/algorithm-based diagnostic tool, many of the requested fields are not applicable to this type of regulatory submission.

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The CPOD/LPOD is indicated for use in the thoracolumbar spine (i.c. T1 to L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (e.g. fracture).

The CPOD/LPOD is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. middle alle posterior upmar over and to be packed into the interior openings of the device prior to implantation.

The CPOD/LPOD is intended to be used with supplemental, internal spinal fixation The Cr OD/El OD is intended to or arm Thoracolumbar Fixation System (K983622) or the DePuy Acromed ISOLA System (K980485).

The Theken CPOD / LPOD VBR is comprised of Titanium rounded rectangular and rectangular frames with fenestrations and radii on all sides and toothed spikes which are used in combination with Titanium spacer components. The frames and spacer can be locked together into a variety of geometric configurations to fit each individual patient's pathology. The toothed spikes of the rounded rectangular and rectangular frames engage with the superior and inferior end plates of the neighboring vertebral bodies to resist rotation and migration. A single construct is sufficient to be used at all spinal levels and pathologies.

The Theken CPOD / LPOD VBR System is designed to be constructed using two cage components in conjunction with an appropriate single spacer component. This combination of components creates an implantable construct. The use of a single cage as an implant has not been tested or approved.

The provided text describes a 510(k) premarket notification for a medical device called the "Theken Surgical CPOD / LPOD Vertebral Body Replacement System (CPOD / LPOD VBR)". This document primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than presenting a standalone study with acceptance criteria and performance data in the typical sense of algorithm-based device evaluations.

Therefore, many of the requested categories for a study proving acceptance criteria (like sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable in this context, as this is a regulatory submission for a physical medical implant, not an AI/algorithm-based diagnostic or screening tool.

However, I can extract information related to the device's characteristics and the basis for its approval.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a table of specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) and corresponding reported performance metrics like one would find for a diagnostic algorithm. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices. The performance is therefore implicitly "equivalent" to that of the predicate devices.

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

• Not Applicable. This is a 510(k) for a physical implant, not a study involving a "test set" of patient data for performance evaluation in the typical sense. Equivalence is established through comparison of design, materials, intended use, and mechanical testing on the device itself.

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

• Not Applicable. See point 2. The "ground truth" here relates to engineering principles, material science, and clinical practice for spinal implants. Regulatory bodies (FDA) and potentially design engineers at Theken Surgical/consultants would be the "experts" in this context, evaluating compliance with standards and equivalence.

4. Adjudication Method:

• Not Applicable. See point 2.

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

• No. This is not a diagnostic device or an AI assistant for human readers. Therefore, an MRMC study is not relevant.

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

• Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

• The "ground truth" for the device's acceptability is based on:
  • Regulatory Standards: Compliance with FDA regulations (e.g., 21 CFR 878.3060 for Vertebral Body Replacement Devices).
  • Material Standards: Use of ASTM F-136 compliant Titanium Ti-6Al-4V (ELI).
  • Biomechanical Engineering Principles: The design's ability to restore biomechanical integrity.
  • Clinical Precedent: The established safety and effectiveness of the predicate devices.
  • Mechanical Testing: Though not detailed in the provided text, the document mentions "mechanical testing" as a basis for equivalence. This typically involves in-vitro biomechanical tests simulating physiological loads on the implant.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/machine learning model.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable. This is not an AI/machine learning model.

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The Theken Large Cement Restrictor is designed to occlude the medullary canal before the introduction of acrylic cement during surgeries such as total hip arthroplasty, as well as prevent cement from flowing down the diaphysis thereby facilitating cement pressurization. The Theken Large Cement Restrictor is NOT intended for any spinal indications.

The Theken Large Cement Restrictor is titanium, hollow, rectangular frame with The Thelions and radii on all sides and toothed spikes on opposite sides. The device is intended to be used in conjunction with standard PMMA cement.

The provided text is a 510(k) summary for the Theken Large Cement Restrictor, an orthopedic surgical device. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The document primarily focuses on establishing substantial equivalence to previously marketed predicate devices (Signus Medizintechnik GmbH Rabea™ Cement Restrictor Device and Medtronic Sofamor Danek Titanium Cement Restrictor Device) for regulatory approval.

Here's a breakdown of why the requested information is absent based on the provided text:

1. Acceptance Criteria and Reported Device Performance:

   • The document states "Static evaluation was performed and the strength of the device was characterized." However, it does not provide specific quantitative acceptance criteria for strength, nor does it present the numerical results ("reported device performance") from this characterization.

2. Sample Size for Test Set and Data Provenance:

   • No information about a "test set" in the context of device performance testing is provided. The static evaluation mentioned is a non-clinical test, not a clinical study on a patient sample.

3. Number of Experts and Qualifications:

   • This information is relevant for studies involving human interpretation (e.g., image-based diagnostics) or clinical ground truth establishment. This device's evaluation did not involve such expert review.

4. Adjudication Method:

   • Not applicable as there's no expert-based ground truth establishment mentioned.

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

   • Not applicable. This is an orthopedic implant, not an AI-assisted diagnostic tool.

6. Standalone Performance:

   • The "Static evaluation" is a standalone test of the device's physical properties. However, as noted in point 1, the specific performance metrics and acceptance criteria are not detailed.

7. Type of Ground Truth Used:

   • For the static evaluation, the "ground truth" would be the engineering specifications and test standards for material strength and mechanical properties. These are not explicitly detailed in the summary.

8. Sample Size for Training Set:

   • Not applicable. This is not an AI/ML device that requires a training set.

9. How Ground Truth for Training Set was Established:

   • Not applicable.

In summary, the provided 510(k) document is a regulatory submission for a physical medical device, not an AI/ML-based diagnostic or prognostic tool. Therefore, much of the requested information, which pertains to clinical studies, human expert involvement, and AI model evaluation, is not present in this type of document. The only performance data mentioned is a non-clinical "static evaluation," but the specifics of that evaluation (criteria and results) are not elaborated.

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The Theken Small Cement Restrictor is intended for use as a cement restrictor in orthopaedic surgeries such as those involving the tibial plateau in total knee replacement. The Theken Small Cement Restrictor is NOT intended for any spinal indications.

The Theken Small Cement Restrictor is a hollow, titanium, and rounded rectangular frame with fenestrations on all sides and toothed spikes on opposite sides. The device is intended to be used in conjunction with standard PMMA cement.

The provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria, as it is a 510(k) summary for a medical device (Theken Small Cement Restrictor) that primarily focuses on demonstrating substantial equivalence to a predicate device.

The "Performance Data" section of the 510(k) summary states: "Non-clinical: Static evaluation was performed and the strength of the device was characterized." This indicates that some testing was performed to characterize the device's strength, but it does not provide specific acceptance criteria, detailed study design, or results in a format that would allow for the completion of the requested table and information.

Therefore, I cannot complete the requested information based on the provided text.

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The Tether™ ACFS is indicated for trauma, deformity (lordosis, kyphosis and scoliosis), pseudoarthrosis, previously failed cervical spine fusion, tumor, scollosis); pocudour.hrools; provised as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.), spondylolisthesis, and spinal stenosis.

The Tether™ ACFS is indicated for temporary stabilization of the spine from C2 to C7 during the time interval required for arthrodesis.

The Tether ACFS is a titanium alloy anterior cervical plate fixation system. The Tether AOTO 13 a titaniam anoy and come in a variety of lengths. Screws Prates are pre-contoured in two planos, and two different styles; fixed and variable in two diametors, cororal rengine are used to build a rigid fixation angle and variable angle screws are used to build a non-rigid construct. Hybrid constructs are possible by combining fixed and variable angle screws. A locking constructs are possible by comemages the plate hole upon entry into the plate and provides a mechanical lock against screw back-out.

The provided 510(k) summary for the Theken Surgical Company's Tether™ ACFS (Anterior Cervical Plate Fixation System) is for a medical device (spinal implant) and does not contain information related to software or AI performance. Therefore, many of the requested fields about AI-specific acceptance criteria, study design, and ground truth establishment cannot be answered from this document.

However, I can extract the general "performance data" provided for this medical device and present it.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states, "Static and fatigue testing was performed. Properties of stiffness, strength, and fatigue life were characterized." This implies that the device met pre-defined acceptance criteria for these mechanical properties, which are standard for spinal implants, allowing it to be considered substantially equivalent to the predicate device. However, the specific quantitative values for these criteria or the test results are not detailed in this summary.

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

• Sample Size for Test Set: Not specified. Testing would have involved a number of manufactured devices or prototypes.
• Data Provenance: Not specified, but generally, such non-clinical performance testing is conducted in a laboratory setting by the manufacturer or a contracted testing facility.

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

• Not applicable. This is a mechanical device, and "ground truth" for performance is established through engineering and biomechanical testing standards, not expert medical opinion.

4. Adjudication method for the test set

• Not applicable. Performance is based on objective measurements against engineering standards.

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/software device.

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

• Not applicable. This is not an AI/software device.

7. The type of ground truth used

• Ground Truth: Engineering standards and biomechanical testing protocols for spinal implants (e.g., ASTM standards for static and fatigue testing).

8. The sample size for the training set

• Not applicable. This is not an AI/software device. The concept of a "training set" is not relevant here.

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

• Not applicable. This is not an AI/software device.

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The BodyForm Thoraco-Lumbar Fixation System is intended for treatment of anterior thoraco-lumbar spinal instability caused by:

1. Trauma.
2. Tumor.
3. Degenerative Disc Disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
4. Anterior fusion following multiple failed posterior fusion operations, including pseudoarthrosis.
   The instrumentation is designed for levels of fixation from T10 to L4.

The BodyForm™ Thoraco-Lumbar Fixation System is a construct which consists of one plate, contoured to match the lateral profile of the thoraco-lumbar vertebral bodies, four Morse taper headed screws, and two locking set screws. Plates are designed specifically to particular graft heights, with anatomic limitations in mind.

The provided text describes the "BodyForm™ Thoraco-Lumbar Fixation System," a medical device for spinal instability. However, it does not contain any information about acceptance criteria, device performance metrics, or any specific studies related to clinical or AI/algorithm performance.

The document is a 510(k) summary for regulatory clearance, which primarily focuses on substantial equivalence to predicate devices and describes non-clinical testing for mechanical properties.

Therefore, I cannot provide the requested information. The following points would be "Not Applicable" or "Not Provided in the text":

1. A table of acceptance criteria and the reported device performance: Not provided. The text mentions "Properties of stiffness, strength, and fatigue life were characterized" according to ASTM F-1717-96, but no specific criteria or reported values are given.
2. Sample size used for the test set and the data provenance: Not provided. This typically refers to clinical or algorithmic test sets, which are not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method for the test set: 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 provided. This is a mechanical device, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided. This is a mechanical device, not an AI diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
8. The sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not provided.

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