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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 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 for all of the following indications regardless of the intended use: 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 Coral™ Spinal System consists of a variety of shapes and sizes of screws, rods, hooks, cross-connectors, and connecting components. Coral™ Spinal System components can be rigidly locked creating a rigid construct for promoting fusion. Coral™ Spinal System implant components are fabricated from medical grade titanium alloy described by such standards as ASTM F67, ASTM F136, ISO 5832-3, and ISO 5832-2. Alternatively, the entire system may be made out of medical grade stainless steel described by such standards as ASTM F138, ISO 5832-1, and ISO 5832-9. Caution use of dissimilar metals, i.e. stainless steel and titanium must not be used in combination, but must be used independently.

The provided document is a 510(k) summary for the Coral™ Spinal System. It describes the device, its intended use, and its substantial equivalence to predicate devices, focusing on mechanical testing. This document does not contain information typically found in a study proving a device meets acceptance criteria related to diagnostic accuracy or clinical performance.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving performance in the context of diagnostic or AI/ML device evaluation. The information provided is for a traditional medical device (spinal implant) where substantial equivalence is primarily demonstrated through mechanical testing and comparison to existing devices.

However, I can extract the information provided about the device's substantial equivalence and general description:

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

The document does not specify "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy that would be applicable to a diagnostic device or AI/ML system. Instead, it references substantial equivalence to predicate devices. For a spinal implant, this typically means demonstrating comparable mechanical properties and safety.

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 applicable and not provided in the document as it refers to mechanical testing data, not a clinical or diagnostic performance 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 applicable and not provided. Ground truth in the context of diagnostic accuracy, clinical outcomes, or AI labeling is not relevant for the type of substantial equivalence demonstrated here (mechanical testing of a spinal implant).

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

This information is not applicable and 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

This information is not applicable and not provided. This is for an orthopedic implant, not an AI/ML-assisted diagnostic device.

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

This information is not applicable and not provided. This is not an AI/ML device.

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

The closest concept to "ground truth" here would be the established standards for mechanical testing (e.g., ASTM F-1717) and the characteristics of the predicate devices. The "ground truth" for the device's safety and effectiveness is inferred through its mechanical equivalence to devices already on the market.

8. The sample size for the training set

This information is not applicable and not provided. This is not an AI/ML device.

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

This information is not applicable and not provided. This is not an AI/ML device.

Summary of why most fields are N/A:

The provided document is a 510(k) summary for a spinal surgical implant (Coral™ Spinal System). The primary method for demonstrating substantial equivalence for such devices is through mechanical testing against established standards (like ASTM F-1717) and comparison to legally marketed predicate devices. The request's questions are designed for evaluating diagnostic devices, particularly those that might use AI/ML, which involve clinical performance studies, ground truth establishment, expert review, and statistical measures like sensitivity and specificity. These concepts are not relevant to the information presented in this 510(k) filing for a spinal fixation system.

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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 Nonlinear Taper Lag Screw is intended for the fixation of long and small bone fractures.

The Nonlinear Taper Lag Screw is a cancellous lag screw with a nonlinear tapered shank for optimal strength-to-diameter properties. Screws are available in a range of sizes.

The provided text describes a 510(k) submission for a medical device called the "Nonlinear Taper Lag Screw." This is a bone fixation screw, and the information primarily focuses on its regulatory approval process, intended use, and substantial equivalence to a predicate device, rather than a study evaluating its performance against specific acceptance criteria in a clinical setting in the way an AI/ML device would be.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable to this type of device and submission. This is a traditional medical device, not an AI/ML device.

However, I can extract the relevant performance data and address the applicable points based on the provided text.

Acceptance Criteria and Device Performance for Nonlinear Taper Lag Screw

Given that the "Nonlinear Taper Lag Screw" is a traditional medical device (bone fixation screw) and not an AI/ML-based device, the concept of "acceptance criteria" and "device performance" in the context of the provided document primarily refers to the non-clinical engineering and mechanical properties required for FDA 510(k) clearance, rather than clinical performance metrics typically associated with AI/ML systems.

The FDA's 510(k) clearance process for such a device relies on demonstrating "substantial equivalence" to a legally marketed predicate device (Aesculap Titanium Alloy Bone Screws, K970549) based on similar intended use and technological characteristics, including, where appropriate, performance data.

Here's an interpretation based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

- Stiffness
- Strength
- Fatigue Life | "Properties of stiffness, strength, and fatigue life were characterized." |

| Overall Performance:
- Adequate for fixation of long and small bone fractures
- Comparable to predicate device (K970549) | Cleared as substantially equivalent for the intended use. |

Note: The document does not explicitly state numerical acceptance thresholds or detailed performance values. These are implied to have met the necessary standards for substantial equivalence to the predicate device as demonstrated in the non-clinical testing.

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

• Sample Size: Not specified in the provided text. This typically refers to the number of screws or test specimens used in the non-clinical mechanical testing.
• Data Provenance: Non-clinical (laboratory) testing was performed. The country of origin for the data is not specified, but the company (Theken Surgical) is based in Barberton, Ohio, USA, suggesting testing was likely conducted in the US or a facility compliant with US regulatory standards. The testing was retrospective in the sense that the data was generated prior to the 510(k) submission.

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

• N/A. This question is relevant for AI/ML performance evaluation where human experts determine the ground truth for image or data interpretation. For a mechanical device, ground truth is established by objective physical measurements and engineering standards (e.g., ASTM standards for mechanical properties). The "experts" would be the engineers and technicians conducting the mechanical tests and interpreting the results against established engineering specifications.

4. Adjudication Method for the Test Set

• N/A. Adjudication methods (e.g., 2+1, 3+1 consensus) are used for resolving disagreements among human experts in AI/ML performance studies. For mechanical testing, the "adjudication" is typically through adherence to standardized testing protocols and quality control measures.

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

• No. An MRMC study is not applicable as this is not an AI/ML diagnostic or interpretive device.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

• Yes, but not an "algorithm." The "Performance Data" section describes "Non-clinical: Static and fatigue cantilever beam testing" which was performed on the device itself. This is a standalone performance evaluation of the physical device's mechanical properties without human intervention impacting its intrinsic material or structural performance.

7. Type of Ground Truth Used

• Mechanical Measurement Standards. The "ground truth" for the non-clinical testing would be derived from established engineering standards and specifications for stiffness, strength, and fatigue life of bone fixation screws, often defined by organizations like ASTM or ISO. The tests measure objective physical properties of the screw.

8. Sample Size for the Training Set

• N/A. This concept is for AI/ML models. For a physical device, there is a design and manufacturing process, but not a "training set" in the AI sense.

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

• N/A. (See point 8).

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The Dogbone ACFS is indicated for trauma, deformity (lordosis and kyphosis), pseudoarthrosis, previously failed cervical spine fusion, tumor, degenerative disk disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.), and spinal canal stenosis.

The Dogbone ACFS is indicated for stabilizing the spine from C2 to C7. Unicortical or bicortical fixation from the anterior face of the vertebral bodies may be employed using either the variable angle or fixed angle screws. This product may be employed as an internal fixation device during the time interval required for arthrodesis.

The Dogbone ACFS is a titanium alloy anterior cervical plate fixation system. Plates are pre-contoured in two planes, and come in a variety of lengths. Screws arc available in two diameters, several lengths, and two different styles; fixed angle and variable angle. Fixed angle screws are used to build a rigid fixation construct. Variable angle screws are used to build a non-rigid construct. Hybrid constructs combining elements of fixed and variable angle screws may be built also. Eight locking tingers circumferentially disposed around the rim of each screw hole engage the screw heads to provide mechanical resistance against screw back-out.

The provided text describes a medical device called the "Dogbone ACFS," a spinal intervertebral body fixation orthosis. However, the document is a 510(k) summary for regulatory clearance and does not contain information about acceptance criteria, a study demonstrating the device meets those criteria, or any of the detailed data provenance, expert involvement, or statistical analyses typically associated with such studies for AI/software-as-a-medical-device (SaMD) products.

The "Performance Data" section specifically states: "Non-clinical: Static and fatigue cantilever axial compression testing was performed. Properties of stiffness, strength, and fatigue life were characterized. Static torsion was also examined." This indicates engineering performance testing for a mechanical device, not a study evaluating an algorithm's performance.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered:

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

• Cannot be provided. The document describes non-clinical engineering tests (stiffness, strength, fatigue life, static torsion) but does not define specific "acceptance criteria" (e.g., minimum stiffness values, maximum fatigue cycles) or quantitative "reported device performance" against those criteria. It only states that these properties were "characterized."

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

• Cannot be provided. This information is relevant for studies involving data-driven algorithms (like AI/ML). The document describes mechanical testing, not a study involving a test set of 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)

• Cannot be provided. This is relevant for studies involving human interpretation or labeling of data for ground truth. The device is a physical implant, and its performance is assessed via mechanical testing, not expert consensus on data.

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

• Cannot be provided. This is relevant for resolving discrepancies in expert labeling of ground truth in data-driven studies.

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

• Cannot be provided. This type of study is specific to AI/software that assists human readers/clinicians, which is not what the Dogbone ACFS is.

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

• Cannot be provided. This is relevant for AI-only devices. The Dogbone ACFS is a physical medical implant.

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

• Cannot be provided. No "ground truth" in the context of data labeling is mentioned. For mechanical devices, testing against engineering standards or established physical properties would be the equivalent.

8. The sample size for the training set

• Cannot be provided. No training set exists for this physical device.

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

• Cannot be provided. No training set or associated ground truth is relevant here.

Summary of available information from the document that relates to performance:

The document describes non-clinical performance data for a physical spinal implant.

• Type of tests performed:

  • Static cantilever axial compression testing
  • Fatigue cantilever axial compression testing
  • Static torsion testing

• Properties characterized:

  • Stiffness
  • Strength
  • Fatigue life

• Study proving device meets acceptance criteria:

  • No specific "study" in the sense of a clinical trial or AI performance validation is described. The "Performance Data" section indicates that these mechanical tests were performed and properties characterized. The implication for regulatory clearance (510(k)) is that these tests demonstrated the device's performance is substantially equivalent to a predicate device (Synthes (USA) Titanium Locking Plate System (TILPS) (K970048)) and meets general safety and effectiveness requirements for its intended use. The 510(k) summary does not detail the specific test results or the acceptance criteria established for these mechanical properties.

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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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