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The Instrument System for Endoscopic Spinal Surgery is intended for use in spinal surgical procedures such as: arthroplasty, nucleotomy, discectomy, and foraminotomy. These manual surgical instruments are hand-held devices intended to manipulate tissue in spinal surgery.

The rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the spinal column.

The Integra Spine Instrument System for Endoscopic Spinal Surgery is an assembled, comprehensive set of instruments for use in endoscopic decompression techniques. The instrument set includes guide wires, pituitaries, ronguers, trephines, trocar / dilators, cannulas, reamers, dural elevator, nerve hook, mallet, forceps, chisels, and associated handles. The instrument set will be used with an FDA cleared endoscope with a length of no more than 254mm and working channel of at least 4.1mm.

This document describes the acceptance criteria and study proving the device meets those criteria, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated as a numerical sample size. The testing involved verification of individual instrument functions and a cadaver study.
• Data Provenance: The cadaver study was performed with a cadaver (human cadaver), indicating a form of retrospective human anatomical testing in a controlled environment. The country of origin for the cadaver or the specific institution is not given.

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

• Number of Experts: One surgeon.
• Qualifications of Experts: The surgeon was described as "skilled in percutaneous and endoscopic spinal procedures." No further details on years of experience or specific board certifications are provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Implicitly, "none" in the traditional sense of multiple reviewers. The evaluation of instrument performance was conducted by a single "skilled surgeon" in the cadaver setting. There is no mention of a consensus process between multiple experts.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not performed. This device is a surgical instrument system, not an imaging or diagnostic device that typically undergoes MRMC studies.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Study: Yes, in a manner applicable to a surgical instrument. "Mechanical testing consisted of verification testing of the individual instrument functions." This can be considered a standalone evaluation of the instruments' physical properties and operational capabilities without direct human surgical interaction beyond the test setup. The cadaver study then integrated human users, but the mechanical testing itself was standalone.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth was based on the design specifications and intended functionality of the physical instruments. In the cadaver study, the ground truth was essentially the successful and satisfactory performance of the instruments during simulated surgical procedures as observed and judged by a skilled surgeon. It is a functional efficacy ground truth within a simulated surgical environment.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is a manual surgical instrument system, not an AI/ML-based device that would typically have a "training set" in the computational sense. The device's design is based on established surgical principles and predicate devices, refined through engineering and testing, not machine learning.

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

• Ground Truth for Training Set: Not applicable. As mentioned, there is no "training set" in the context of an AI/ML device. The "ground truth" for the development and design of these instruments would stem from anatomical and physiological knowledge, surgical best practices, and the performance characteristics of existing predicate devices. This would have been established through years of medical knowledge development and engineering experience, not through a specific formal "ground truth establishment" for a data set.

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The Vu c POD Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease (DDD) at one level from C2-C3 to C7-T1. Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. The Vu c POD implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The cervical device is to be used in patients who have had six weeks of non-operative treatment. The Vu c.POD Intervertebral Body Fusion Device is intended for use with supplemental internal fixation systems, such as the Theken Spine Manta Ray or the Theken Spine Tether systems.

The Vu c POD Intervertebral Body Fusion Device consists of cervical spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Vu c POD Intervertebral Body Fusion Device is manufactured from PEEK OPTIMA LT1 polymer. The Vu c·POD Intervertebral Body Fusion Device is for single level anterior spinal use from the C2-C3 to C7-T1 disc levels.

The provided text describes the Integra Spine Vu c-POD Intervertebral Body Fusion Device. It outlines its indications for use and states that preclinical testing was performed to demonstrate substantial equivalence to a predicate device. However, this document does not contain the specific acceptance criteria and detailed study that proves the device meets those criteria, as typically found in a clinical trial report or a performance goal document.

The information provided is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a previously marketed device rather than proving performance against detailed acceptance criteria from a new study.

Therefore, I cannot fulfill your request for the comprehensive table and detailed study information as it is not present in the provided text.

Here's what I can extract based on the information given, noting where data is absent:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test set sample size: Not specified. The testing mentioned is "preclinical testing" per ASTM standards, which typically involves a number of samples for mechanical tests, but the exact count is not provided.
• Data provenance (country of origin, retrospective/prospective): Not specified. Preclinical testing data is usually generated in laboratories, but the location is not mentioned.

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

• This information is not applicable and not provided. The "ground truth" concept is typically used in AI/diagnostic studies to assess human expert performance against a reference standard. Here, the "truth" is established by adherence to ASTM mechanical testing standards.

4. Adjudication method for the test set

• Not applicable and not provided. Adjudication methods are typically used in clinical studies or AI performance evaluations involving human readers.

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

• No MRMC study was done or mentioned. This device is an implant, not an AI diagnostic tool.

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

• For the preclinical testing, the "ground truth" would be the established methods and expected outcomes defined by the ASTM F2077 and ASTM F2267 standards for spinal intervertebral body fusion devices.

8. The sample size for the training set

• Not applicable/Not specified. This device did not involve machine learning or AI training datasets.

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

• Not applicable.

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The Cervical Standalone Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Cervical Standalone Intervertebral Body Fusion Device implants are to be used with autogenous bone graft and implanted via an anterior approach. The cervical device is to be used in patients who have had six weeks of non-operative treatment. The Cervical Standalone Intervertebral Body Fusion Device is to be used with two titanium alloy screws which accompany the implant.

The Cervical Standalone Intervertebral Body Fusion Device is comprised of PEEK-OPTIMA® LT cages which are available in a variety of sizes. The cages include toothed spikes on the top and bottom surfaces to engage with the superior and inferior end plates of neighboring vertebral bodies to resist rotation and migration. The cage shape and open center allow for bony in-growth in and around the implant. A single cage is sufficient to be used at each intervertebral level. Screws are inserted through the anterior titanium face and screwed into the vertebral bodies for bony fixation.

The acceptance criteria for the Cervical Standalone Intervertebral Body Fusion Device are based on demonstrating substantial equivalence to a predicate device, the COALITION™ Spacer Intervertebral Body Fusion Device (K083389). The study proving the device meets these criteria involved mechanical testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify a distinct "test set" in terms of patient data or
  clinical samples. The testing described is primarily mechanical and wear testing of the device itself.
• Data Provenance: Not applicable as the testing is non-clinical, mechanical testing of the device.

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

• Not applicable. The ground truth for this device's acceptance is based on adherence to engineering standards (ASTM F-2077 and F-2267) and comparison to a predicate device, not on expert clinical review of test data.

4. Adjudication method for the test set

• Not applicable. This was a non-clinical, mechanical testing study against established ASTM standards and
  predicate device equivalence.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a
  physical implant, not an AI-powered diagnostic or assistive tool.

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

• Not applicable. This device is a physical implant, not an algorithm. The "standalone" in the device name refers to its design as an intervertebral fusion device that does not require an anterior plate.

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

• For the mechanical testing, the ground truth was defined by established engineering standards (ASTM F-2077 and F-2267) and the performance specifications of the device itself, with the aim of demonstrating that the device performed "as designed" and met/exceeded these specifications.
• For substantial equivalence, the ground truth was based on the characteristics and performance of the legally marketed predicate device (K083389).

8. The sample size for the training set

• Not applicable. This is a physical medical device undergoing mechanical validation, not a machine
  learning model requiring a training set.

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

• Not applicable, as there was no training set for a machine learning model.

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When used with the bone screws, the Theken Spine Vu aPOD Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft material.

When used with the SpinPlate, the Theken Spine Vu aPOD Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft material. When used with the SpinPlate, the Theken Spine Vu aPOD Intervertebral Body Fusion Device is intended for use with supplemental fixation such as the Coral Spinal System or the BodyForm Thoracolumbar Fixation System.

The Theken Spine Vu aPOD Intervertebral Body Fusion Device, when used with bone screws, is a stand alone device. If the Theken Spine Vu aPod Intervertebral Body Fusion Device is used with the SpinPlate then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability. The SpinPlate and bone screws are not intended to be used together. This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

The Vu aPOD Intervertebral Body Fusion Device consists of lumbar spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Vu aPOD spacers are manufactured from PEEK OPTIMA LT1 polymer per ASTM F2026 while the bone screws and SpinMate are comprised of Titanium alloy (Ti-6Al-4V ELI) per ASTM F136. Radiographic markers present with the Vu aPOD spacers are comprised of tantalum per ASTM F560. The Vu aPOD Intervertebral Body Fusion Device is for lumbar spinal use at one or two contiguous levels from the L2-L3 to L5-S1 disc levels.

This document pertains to the 510(k) summary for the Theken Spine Vu aPOD Intervertebral Body Fusion Device, a spinal implant, not an AI/ML powered device. As such, concepts like "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (e.g., sensitivity, specificity, F1 score) are not directly applicable.

The document describes the preclinical testing performed to demonstrate the device's substantial equivalence to predicate devices, focusing on mechanical performance.

Here's an interpretation of the requested information based on the provided text, re-framing "acceptance criteria" to refer to the mechanical performance standards:

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

Explanation: The document states that "Preclinical testing has been performed per ASTM F2077 (static axial compression, static compression-shear, static torsion, dynamic axial compression, dynamic compression-shear, expulsion) and ASTM F2267 (static subsidence) indicating that the Vu aPOD Intervertebral Body Fusion Device is substantially equivalent to predicate devices." This implies that the device successfully met the performance requirements outlined in these ASTM standards, thus proving its mechanical integrity and equivalence to existing, cleared devices.

Regarding the remaining points (2-9), these are relevant to AI/ML device evaluations and are not applicable to this physical medical device. The document does not contain information on:

• Sample size used for a test set (as there is no "test set" in the AI/ML sense)
• Data provenance for a test set
• Number of experts used to establish ground truth or their qualifications
• Adjudication method for a test set
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone (algorithm only) performance
• Type of ground truth (e.g., pathology, outcomes data) for an AI/ML model
• Sample size for a training set
• How ground truth for a training set was established

This 510(k) summary focuses on demonstrating mechanical and material equivalence of a surgical implant to previously cleared devices through preclinical bench testing, rather than evaluating the performance of an AI/ML algorithm.

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The Stainless Steel Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), a posterior non-pedicle screw fixation system (T1-L5), or as an anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Stainless Steel Spinal System consists of a variety of shapes and sizes of screws, rods, hooks, and cross-connectors. The Stainless Steel Spinal System components can be rigidly locked together creating a rigid construct for promoting fusion. The individual implant components are fabricated from medical grade stainless steel alloy 316 LVM described by such standards as ASTM F-138 and ISO 5832-1.

Here's a summary of the acceptance criteria and study information for the Stainless Steel Spinal System (K100970) based on the provided text, formatted to address your specific points:

Since the provided text describes a spinal implant system and its mechanical testing, not a diagnostic AI device, many of the requested fields (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable. I will specify "N/A" for these fields.

Acceptance Criteria and Device Performance for Stainless Steel Spinal System (K100970)

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "The construct performed as designed and met or exceeded all product specifications." This implies that the specific numerical criteria were met, but the exact numerical thresholds for "product specifications" and the measured performance values 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. (The study involves mechanical testing of device constructs, not data from human subjects or images.)
• Data Provenance: N/A (Mechanical tests are conducted on manufactured devices, not patient data.)

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

• Number of Experts: N/A (Ground truth for mechanical performance is established by engineering standards and test results, not expert consensus.)
• Qualifications of Experts: N/A

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

• Adjudication Method: N/A (Not relevant for mechanical testing.)

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

• MRMC Study: No, this is not an AI/diagnostic device.

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

• Standalone Performance: No, this is not an AI/diagnostic device.

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

• Type of Ground Truth: Engineering standards and design specifications as defined by ASTM F-1717.

8. The sample size for the training set

• Sample Size for Training Set: N/A (This is not an AI/machine learning device that requires a training set.)

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

• Ground Truth for Training Set: N/A

Study Summary:

The study conducted for the Stainless Steel Spinal System involved mechanical testing to demonstrate its performance and substantial equivalence to predicate devices. The tests performed were:

• Static axial compression
• Static torsion
• Dynamic axial compression

These tests were performed in accordance with ASTM F-1717. The results indicated that the device performed as designed and met or exceeded all specified product requirements, supporting its substantial equivalence to the predicate devices.

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The Coral™ Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The purpose of this submission is the addition of cobalt chrome rods to the Coral™ Spinal System. The Coral™ Spinal System components can be rigidly locked together in a variety of configurations to promote fusion for a wide variety of patient anatomies.

I am sorry, but the provided text from K091266 does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, or study methodologies that are typically found in a clinical study report.

The document is a 510(k) summary for the Coral™ Spinal System, which focuses on demonstrating substantial equivalence to previously cleared predicate devices for the addition of cobalt chrome rods to the system. It primarily discusses:

• Device Description: The components and their materials.
• Intended Use: The medical conditions the device is designed to treat.
• Predicate Devices: Previously cleared devices it is similar to.
• Substantial Equivalence Argument: How the new components are similar to existing ones in terms of indications for use, operating principle, biocompatible materials, surgical techniques, manufacturing, sterilization, and packaging.
• Regulatory Information: Classification and product codes.

The key phrase "sufficient evidence exists to reasonably conclude that the additional components are substantially equivalent to the predicate device...This is based on the design concept, the use of established, known materials, feature comparisons, mechanical testing, indications for use, preproduction quality assurance planning and engineering analysis" indicates that the evaluation was based on bench testing (mechanical testing) and a comparison of design and materials, rather than clinical efficacy studies with patient data.

Therefore, I cannot provide the requested table or answer the questions related to clinical study design, acceptance criteria, sample sizes, ground truth establishment, or human reader performance. This type of information is not typically part of a 510(k) submission focused on substantial equivalence for a device modification where prior clinical data on the predicate device is assumed to be sufficient.

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The Atoll OCT Spinal System is indicated to promote fusion of the occipito-cervico-thoracic regions of the spine (Occiput - T3). The intended indications are as follows:

• Degenerative Disc Disease (as identified by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis
• Spinal Stenosis
• Fracture/Dislocation
• Tumors
• Pseudoarthrosis
• Atlanto/axial fracture with instability
• Occipitocervical dislocation
• Revision of previous cervical and upper thoracic spine surgery
  The occipital bone screws are limited to occipital fixation only. The use of the polyaxial and standard screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. Screws are not intended for use in the cervical spine.
  The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
  The Atoll OCT Spinal System can also be linked to the Theken Coral Spinal System with the use of transitional rods and rod connectors.

The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, occipital plates and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient physiology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F136 and ISO 5832-3. To achieve the best results. unless otherwise specifically described in another Theken Spine document, do not use the Atoll OCT Spinal System components in conjunction with components from any other manufacturer. The purpose of this submission is the addition of an occipital plate.

This document is a 510(k) Summary for a medical device called the "Atoll™ OCT Spinal System." It is a premarket notification to the FDA to demonstrate substantial equivalence to previously cleared devices.

Based on the provided text, a detailed study proving the device meets specific acceptance criteria is NOT present. The document primarily focuses on establishing "substantial equivalence" to predicate devices rather than providing detailed performance studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies.

Therefore, many of the requested details cannot be extracted directly from this specific 510(k) summary. I can, however, extrapolate some information based on the nature of a 510(k) submission for spinal implants.

Here's an attempt to answer as much as possible:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is typically found in detailed design validation and verification reports, which are summarized in a 510(k) but not fully reproduced in the public summary. For spinal implants, acceptance criteria would generally be related to:

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

• Test Set Sample Size: Not specified in the provided text. For mechanical testing of medical devices like spinal implants, sample sizes are often determined by statistical power requirements to detect differences between designs or to demonstrate compliance with standards. It typically involves multiple samples for each component and construct configuration.
• Data Provenance: Not specified. For mechanical testing, this data would generally be generated in a laboratory setting (in-vitro testing), potentially conducted by the manufacturer or an independent testing facility. It is not typically human clinical data (prospective or retrospective) for a 510(k) of this device type, unless a device has novel features requiring clinical data, which is not indicated here.

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

This is not applicable as the "ground truth" concept, in the way it's usually applied to AI or diagnostic devices (e.g., expert consensus on images), does not apply to the mechanical testing required for spinal implants in a 510(k). The "ground truth" for these devices is derived from engineering and scientific principles, validated testing methodologies, and compliance with recognized standards.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are typically for clinical outcome assessment or image interpretation, not for mechanical device testing. Results from mechanical testing are typically objective measurements against predefined acceptance criteria.

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

No, an MRMC comparative effectiveness study was not done. MRMC studies are used to assess the performance of diagnostic imaging devices or AI algorithms interpreted by human readers. This document is for a spinal implant, which does not involve human readers interpreting data in this context.

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

No, a standalone (algorithm-only) study was not done. This is not an AI or algorithm-based device.

7. The Type of Ground Truth Used:

As explained in point 3, the concept of "ground truth" in the context of expert consensus, pathology, or outcomes data is not directly applicable here. For a spinal implant, the "ground truth" for performance is based on:

• Engineering Specifications: Conformance to design blueprints and material specifications.
• Standardized Mechanical Testing: Results from tests conducted according to recognized ASTM/ISO standards (e.g., for static compression, torsion, fatigue). These standards define the "truth" of what constitutes acceptable mechanical performance.
• Biocompatibility Testing: Results from tests conforming to ISO 10993.
• Comparison to Predicate Devices: Demonstrating that the new device performs at least as well as, or is equivalent to, legally marketed predicate devices, as evaluated through these objective tests.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device, so there is no "training set" in the computational sense.

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

Not applicable, as there is no training set for this type of device.

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The Atoll Cervico-Thoracic System is indicated to promote fusion of the cervico-thoracic regions of the spine (C1 - T3). The intended indications are as follows:

• Degenerative Disc Disease (as identified by neck or back pain of discogenic origin with t degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis .
• Spinal Stenosis .
• Fracture/Dislocation .
• Tumors .
• Pseudoarthrosis .
• Revision of previous cervical and upper thoracic spine surgery .

The use of the screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The screws are not intended for use in the cervical spine,

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

The Atoll Cervico-Thoracic System can also be linked to the Theken Coral Spinal System with the use of transitional rods and rod connectors.

The Atoll Cervico-Thoracic System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient pathology. The Atoll Cervico-Thoracic System components are manufactured from medical implant grade titanium alloy Ti-6A1-4V (ELI) per ASTM F136 and ISO 5832-3. To achieve the best results, unless otherwise specifically described in another Theken Spine document, do not use Atoll Cervico-Thoracic System components in conjunction with components for any other system or manufacturer. The purpose of this submission is the addition of a head to head cross connector.

This is a 510(k) summary for a medical device called the Atoll™ Cervico-Thoracic System. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of the device's clinical performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not available in the provided text.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The provided text does not contain a table of acceptance criteria or reported device performance in the sense of clinical effectiveness or accuracy studies. This 510(k) submission is primarily focused on demonstrating substantial equivalence based on similarities in intended use, design, and physical characteristics to previously cleared predicate devices.

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

This information is not provided. The submission focuses on device characteristics, not clinical study data for a "test set."

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 information is not provided. There is no mention of a "test set" or ground truth establishment by experts in the context of clinical performance.

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

This information is not provided for the reason mentioned 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 information is not provided. The device is a spinal fixation system, not an AI-assisted diagnostic tool, so an MRMC study is not relevant here.

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

This information is not provided and is not applicable as the device is a physical implant, not an algorithm.

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

This information is not provided, as the submission does not detail a clinical study with "ground truth."

8. The sample size for the training set

This information is not provided. There is no mention of a "training set" as this is not a machine learning device.

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

This information is not provided for the reason mentioned above.

Summary of available information relevant to acceptance criteria (interpreted as basis for clearance):

The "acceptance criteria" in the context of this 510(k) submission are the demonstrations that the device is substantially equivalent to legally marketed predicate devices.

• Acceptance Criteria (for 510(k) clearance): The Atoll™ Cervico-Thoracic System must demonstrate substantial equivalence to predicate devices in terms of:

  • Intended Use
  • Design
  • Physical Characteristics
  • Material Composition

• Study/Evidence that proves the device meets perceived "acceptance criteria":

  The submission asserts that the "Equivalence for the Atoll Cervico-Thoracic System is based on similarities of intended use, design, and physical characteristics when compared to the predicate devices."

  • Intended Use: The provided "Indications for Use" for the Atoll™ Cervico-Thoracic System (C1-T3 fusion for various conditions like DDD, Spondylolisthesis, Spinal Stenosis, Fracture/Dislocation, Tumors, Pseudoarthrosis, Revision surgery) are implicitly considered substantially equivalent to the indications of the predicate devices.
  • Design: The device is described as "consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes." The specific modification in this submission is "the addition of a head to head cross connector." The design is deemed similar to the predicates.
  • Physical Characteristics: Not explicitly detailed in comparative tables, but implied by the device description and comparison to predicates.
  • Material Composition: "Implant Grade Titanium Alloy (Ti-6Al-4V) per ASTM F136 and ISO 5832-3" which is a common and accepted material for such implants, likely matching or being equivalent to the predicate devices.

  The study itself is the 510(k) submission process, where the sponsor provides documentation and justifications for these similarities to the FDA. The FDA's review and subsequent clearance (as indicated by the letter from MAR 13 2009) signify that the agency accepted the sponsor's demonstration of substantial equivalence. No specific clinical trial, as would be conducted for a novel device or one requiring PMA, is described or referenced.

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When used as an intervertebral body fusion device, the Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices are indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is indicated for use with autograft only. The Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices are intended for use with supplemental fixation such as the Coral Spinal System or the BodyForm Thoracolumbar Fixation System.

Degenerative disc disease (DDD) is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

When used as a vertebral body replacement (VBR) the Vu ePOD and Vu LPOD VBR System is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (ie. fracture).

The Vu ePOD and Vu LPOD VBR System 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. The device is indicated for use with autograft or allograft only.

The Vu ePOD and LPOD VBR System is intended for use with supplemental internal spinal fixation such as the BodyForm Thoracolumbar Fixation System or the Coral Spinal System.

The Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices are comprised of PEEK OPTIMA-LT cages with fenestrations and radii on all sides and toothed ridges. The toothed ridges of the concave cages engage with the superior and inferior end plates of the neighboring vertebral bodies to resist rotation and migration. The Vu ePOD is a straight shaped cage while the Vu LPOD has a curved shape. The Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices may be used individually or in a pair depending on the surgical need.

The provided document is a 510(k) Summary for the Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through engineering and mechanical testing, rather than extensive clinical studies on human subjects.

Therefore, many of the typical acceptance criteria and study design elements found in a clinical study for a medical image analysis AI device (like human reader performance, expert consensus on ground truth for AI training/testing, MRMC studies, etc.) are not applicable to this submission.

Here's a breakdown based on the information available:

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)

• Test Set Sample Size: Not explicitly stated as a number of devices. The "Summary of Test Data" indicates that "Mechanical testing of the subject device consisted of static axial compression, static compression shear, dynamic axial compression, dynamic compression shear, subsidence and expulsion." This implies that a sufficient number of device samples were manufactured and tested according to the specified ASTM standards.
• Data Provenance: The device manufacturer is Theken Spine, LLC, located in Akron, Ohio, USA. The testing was conducted in accordance with ASTM (American Society for Testing and Materials) standards. The data is from prospective mechanical testing conducted on manufactured devices, not from human subjects or retrospective clinical data.

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

This is not applicable. The ground truth for this device's performance is established through objective mechanical engineering tests against defined performance specifications and ASTM standards, not through expert human assessment of images or clinical outcomes.

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

This is not applicable. Mechanical test results are quantitative and objective. There is no need for human adjudication of the test results themselves, only for the interpretation and comparison against pre-defined engineering specifications.

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. This is a device for intervertebral body fusion and vertebral body replacement, not an AI device or a diagnostic imaging tool. Therefore, no MRMC study involving human readers and AI assistance was conducted or is relevant.

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

This is not applicable. There is no algorithm or AI component in this medical device.

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

The "ground truth" for this device's performance is the pre-defined engineering specifications derived from relevant ASTM standards (ASTM F-2077, ASTM F-2267) and the device's design requirements. The mechanical tests verify that the device meets these objective, quantifiable standards for strength, stability, and durability.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of an AI/algorithm for this device. The development of the device's design and manufacturing processes is informed by engineering principles and materials science, not machine learning training data.

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

This is not applicable. As there is no training set for an AI/algorithm, there is no ground truth established in this context. The design and performance requirements (analogous to "ground truth" for traditional medical devices) are based on biomechanical principles, clinical needs, and regulatory standards.

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