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The Scient'X Anterior Buttress Plate is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.

The Anterior Buttress Plate is a graft containment device that features a Ti plate fixed by a vertebral body screw. The Ti plate is connected to a PEEK buttress that extends over the adjacent intervertebral space maintaining the position of the bone graft.

The provided text is for a 510(k) summary for a medical device (Scient'X Anterior Buttress Plate), which falls under the category of spinal implants. These summaries are typically for demonstrating substantial equivalence to a predicate device, which often involves mechanical testing rather than clinical studies with human subjects or AI performance metrics.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, AI standalone performance, training set size) are not applicable to this type of regulatory submission and information will not be found in the provided document.

Here's the information that can be extracted or deduced from the provided text:

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

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

• Not Applicable. The submission focuses on substantial equivalence based on mechanical testing and comparison to predicate devices, not on a clinical test set with human data as would be relevant for AI/diagnostic devices. The document does not specify sample sizes for mechanical tests, nor details about data provenance in the context of clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. Ground truth, in the sense of expert consensus for diagnostic accuracy, is not relevant to this type of device submission. The primary "ground truth" for substantial equivalence would be the performance characteristics of the predicate devices.

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

• Not Applicable. Adjudication methods are typically used in clinical studies involving interpretation of results (e.g., imaging). This is a mechanical device submission.

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 a medical device (spinal implant), not an AI or diagnostic tool where MRMC studies would be conducted.

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

• Not Applicable. This is a physical spinal implant, not an algorithm or AI device.

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

• The "ground truth" for this submission is the performance characteristics and safety profiles of the legally marketed predicate devices. Substantial equivalence means the new device is as safe and effective as existing devices. This would be established through mechanical testing results compared to the predicate, and possibly design comparisons.

8. The sample size for the training set

• Not Applicable. This is not an AI or machine learning device requiring a training set.

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

• Not Applicable. This is not an AI or machine learning device.

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The Scient'x Tribeca™ Cage implants are indicated for use with autogenous bone graft as an intervertebral body fusion device at either one or two contiguous levels in the lumbosacral spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Tribeca™ Cage is to be used in skeletally mature patients who have had six months of non-operative care.

The Tribeca™ Cage is implanted using an anterior or posterior approach and is intended to be used single or in pairs with ISOBAR ø6.2mm Hemispherical Screws with Offset Clamps and ø5.5mm Rods.

The Tribeca™ Cage involves lumbar component spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Tribeca™ Cage is manufactured from PEEK-OPTIMA polymer and is provided nonsterile.

This 510(k) summary describes a spinal intervertebral fusion device, the Scient'x Tribeca™ Cage, and its substantial equivalence to a predicate device. However, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically seen for AI/ML-based medical devices or diagnostics.

The document primarily focuses on:

• Device description (Tribeca™ Cage made of PEEK-OPTIMA polymer)
• Intended use and indications for use (intervertebral body fusion in the lumbosacral spine for degenerative disc disease)
• Predicate device (Abbott Spine Ardis Spacer K073202)
• Performance standards met: ASTM F2077 and F2267. These are mechanical testing standards for intervertebral body fusion devices, not clinical performance metrics or acceptance criteria for an AI algorithm.
• FDA's substantial equivalence determination.

Therefore, most of the requested fields are not applicable or cannot be extracted from the provided text.

Here is a summary of what can be inferred or stated as N/A:

1. Table of acceptance criteria and the reported device performance:

   Acceptance Criteria	Reported Device Performance
   Compliance with ASTM F2077 (static and dynamic shear)	Testing indicates substantial equivalence to predicate device.
   Compliance with ASTM F2267 (fatigue testing)	Testing indicates substantial equivalence to predicate device.
   No specific numeric clinical acceptance criteria or performance metrics are provided in the document.

2. Sample size used for the test set and the data provenance: N/A. This document pertains to a physical implant and its mechanical testing, not a digital algorithm evaluated on 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: N/A. Ground truth as typically understood for AI models is not relevant here. The "ground truth" for this device's performance would be derived from mechanical testing results against ISO/ASTM standards.

4. Adjudication method for the test set: N/A.

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: N/A. This is not an AI-assisted device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: N/A. This is a physical implant.

7. The type of ground truth used: For the mechanical performance, the "ground truth" would be the specifications and performance characteristics defined by ASTM F2077 and F2267, and the comparative performance of the predicate device.

8. The sample size for the training set: N/A. This is not an AI/ML device.

9. How the ground truth for the training set was established: N/A. This is not an AI/ML device.

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The ISOBAR Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion.

As a pedicle screw system, the ISOBAR Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of solid fusion.

The Semi-Rigid Rod and Dual Dampener Rod should only be used at levels (one and two levels, respectively) that will be fused.

The ISOBAR Spinal System consists of pedicle screws, rigid rods and crosslink members (K990118, K013444, K020245, K031290 and K051063), semi-rigid rods (K991326) and hooks (K013440 & 013447). The Isobar Semi-rigid Dual Dampener Rod is an addition to the ISOBAR Spinal System family. The semi-rigid rod allows a very small amount of compression, torsion and bending. The components in this submission are fabricated from Ti6A14V alloy, conforming to ASTM F136 and ISO 5832-3, which is known to be biocompatible.

The provided text is a 510(k) summary for the "ISOBAR Spinal System." It details the device's indications for use, description, and states its substantial equivalence to predicate devices. However, it does not contain the specific information required to answer your questions regarding acceptance criteria, study details, sample sizes, expert involvement, or grand truth establishment for performance evaluation.

Here's an explanation of why the requested information is not present in the given document:

• Acceptance Criteria and Reported Device Performance: The document only states that "Testing performed indicates the ISOBAR Spinal System is substantially equivalent to predicate devices." It does not provide specific acceptance criteria (e.g., specific thresholds for mechanical strength, fatigue life) or the quantitative results of the tests performed against such criteria.
• Sample Size for Test Set and Data Provenance: This document is a regulatory submission for a spinal implant system. Performance testing for such devices typically involves benchtop mechanical testing (e.g., fatigue, static strength), not studies on human data or medical images. Therefore, concepts like "test set," "data provenance," or "country of origin of the data" in the context of medical imaging or clinical study data do not apply here. The "sample size" would refer to the number of devices or components tested mechanically, which is not disclosed.
• Number of Experts and Qualifications: As the evaluation is based on mechanical performance and substantial equivalence to predicate devices, there isn't a need for medical experts to establish "ground truth" or to adjudicate observations in the way they would for, say, an AI-powered diagnostic device analyzing medical images.
• Adjudication Method: Not applicable for a mechanical device substantial equivalence submission.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is used for diagnostic devices, particularly those involving human interpretation of medical data, to assess how a new technology (like AI) affects reader performance.
• Standalone Performance: While the device is "standalone" in the sense that it's an implantable device, the concept of "algorithm only without human-in-the-loop performance" is typically relevant to AI/ML software devices.
• Type of Ground Truth: The "ground truth" for a spinal implant system's performance would generally be established by adherence to recognized ASTM or ISO standards for mechanical testing (e.g., fatigue strength, pull-out strength). The document only mentions conformity to ASTM F136 and ISO 5832-3 for material properties, but not specific performance test standards or their results.
• Sample Size for Training Set: Not applicable. This pertains to AI/ML models.
• How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided document is a 510(k) summary primarily focused on demonstrating substantial equivalence to predicate devices based on indications for use, design, function, and materials, rather than detailed performance study results against specific acceptance criteria. For mechanical devices like spinal implants, "performance standards" typically refer to adherence to recognized test methods and successful completion of those tests, rather than clinical studies with human participants. The document indicates that testing was performed to show substantial equivalence, but it does not elaborate on the specific tests, their results, or the acceptance criteria used.

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The Scient'x Spinal System is a posterior, noncervical pedicle and non-pedicle system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, disfocation, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The Scient'x Spinal System consists of monoaxial pedicle screws, rigid rods and crosslink members, semi-rigid rods, polyaxial screws, cross link and closed and open screws. It can be used for single or multiple level fixations. The modifications included in this submission is the addition of Polyaxial LP Screws, and additional sizes of Polyaxial TTL U Screws, Polyaxial TTL High U-screw, Monoaxial TTL U Screws, Polyaxial Hemispherical Screws, MX Polyaxial Screws, MX Monaxial Screws - Closed and MX Monaxial Screws - Open.

This a medical device, not an AI/ML powered device, so acceptance criteria and study data would differ from AI/ML device requirements.

Here's an analysis of the provided text in relation to your request about acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the mechanical properties of the pedicle screw systems as the focus of testing. It directly states that testing was performed following the protocol of ASTM F1717 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model."

However, the provided text does not explicitly list specific numerical acceptance criteria (e.g., minimum load to failure, maximum displacement) or the reported device performance metrics (the actual test results). It only states that the testing was undertaken and the standard followed.

To create the table you requested, we would need the actual test report which would detail:

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

• Sample Size: The document does not specify the sample size used for the mechanical testing. ASTM F1717 would typically specify a minimum number of samples for each test, but this information is not present in the 510(k) summary.
• Data Provenance: The testing was "undertaken to determine the mechanical properties of the pedicle screw systems." This is a pre-market, non-clinical study conducted by the device manufacturer (Scient'x) or a contracted lab. The country of origin for the data is implied to be France (where Scient'x is based) or where their testing facility is located, but not explicitly stated. It is entirely retrospective in the sense that it's laboratory testing, not patient data.

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

This question is not applicable to this type of device and study.

• Ground truth in the context of mechanical testing for a medical implant is established by validated engineering principles and standards (like ASTM F1717), not by expert consensus or medical diagnosis.
• The 'experts' involved would be bioengineers or mechanical engineers specializing in medical device testing, not radiologists or pathologists. Their qualifications would be in engineering and materials science, with experience in performing and interpreting mechanical tests according to international standards. The document does not specify who performed the tests or any qualifications.

4. Adjudication Method for the Test Set:

This question is also not applicable to this type of device and study. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in human expert interpretations (e.g., in medical image analysis or clinical trial endpoint assessment). Mechanical testing results are objective measurements that do not require such adjudication.

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 relevant for evaluating diagnostic or prognostic tools that involve human readers (e.g., radiologists interpreting images) and are designed to assess the impact of a new technology (like AI) on reader performance.
• This device is a spinal implant system, and its evaluation focuses on mechanical integrity and biocompatibility, not on diagnostic accuracy or human reader performance.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done:

No, a standalone performance study was not done.

• This question is relevant for AI/ML algorithms where "standalone" refers to the algorithm's performance without any human intervention or interpretation.
• Since the Scient'x Spinal System is a physical implant, this concept does not apply. The "performance" here refers to its mechanical response under simulated physiological loads.

7. The Type of Ground Truth Used:

The "ground truth" for this study is derived from:

• Engineering Standards and Specifications: Specifically, ASTM F1717 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model." This standard defines the parameters, loads, and methods for evaluating spinal implants, effectively setting the "truth" for what constitutes acceptable mechanical behavior.
• Material Specifications: Compliance with ASTM F136 and ISO 5832-3 for Ti6Al4V alloy is also a "ground truth" for material composition and quality.

8. The Sample Size for the Training Set:

This question is not applicable.

• A "training set" refers to data used to train a machine learning model.
• The Scient'x Spinal System is a physical medical device, not an AI/ML algorithm. Therefore, there is no training set involved in its evaluation.

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

This question is not applicable as there is no training set for a physical medical device.

In summary:

The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices primarily through non-clinical mechanical testing and material compliance. While it mentions the standard followed (ASTM F1717), it lacks the specific numerical acceptance criteria and the actual performance data that would typically be found in a detailed test report. The evaluation paradigm for a spinal implant is entirely different from that of an AI/ML diagnostic algorithm, rendering many of your specific questions regarding AI/ML irrelevant to this document.

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Davantis/Antelys Vertebral Body Replacements are vertebral body replacements for use in the lumbar and thoracic spine (T4-L5) to replace a damaged, collapsed or unstable vertebral body due to tumor or trauma (i.e. fracture). These are not stand-alone devices, ISOBAR 06.2 Hemispherical Screws with Offset Clamps and Ø5.5 Rods must be utilized to enhance the stability of the reconstruction in skeletally mature patients following full or partial corpectomy.

The DAVANTIS/ANTELYS Vertebral Body Replacements are oval shaped. The interior of the spacers has three compartments to provide space for bone graft. The implanted in the vertical position. These components are available in various heights (9mm-75mm). The superior and inferior surfaces of these components have ridges to interface with the vertebral endplates to resist rotation. The body has a multitude of holes to allow additional impaction of bone graft.

The DAVANTIS!ANTELYS components are fabricated from pure poly(ether ether ketone) (PEEK). This material closely matches the modulus of elasticity of cortical bone, improving the biomechanical interface and reducing the stress shielding effect. They are fully radio-translucent, which enables optimum follow-up with diagnostic imaging, as the interbody fusion progresses. Two metal wires at the opposite ends of the spacers allow radiological confirmation of the cage position post operatively.

This document is a 510(k) summary for the DAVANTIS/ANTELYS Vertebral Body Replacement device, which describes its intended use, design, and equivalence to a previously cleared device. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The 510(k) process is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It typically relies on comparison to a predicate device and often involves bench testing, rather than clinical studies with quantifiable performance metrics against acceptance criteria.

Therefore, I cannot provide the requested information from the provided text, as it describes a regulatory submission (510(k)) that focuses on substantial equivalence, not on studies proving specific acceptance criteria.

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The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Stella Cervical Plate." This type of document does not contain any information about acceptance criteria or a study proving device performance against such criteria.

The purpose of a 510(k) clearance is to establish that a new medical device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics. This process typically relies on demonstrating equivalence in design, materials, and sometimes testing that compares the new device to the predicate device, but it does not involve clinical effectiveness studies or the establishment of specific acceptance criteria for a device's performance in the way implied by your request.

Therefore, I cannot provide the requested information based on the input text. The text does not describe:

1. A table of acceptance criteria and reported device performance: This is not present.
2. Sample size used for the test set and data provenance: No such test set is described.
3. Number of experts used to establish ground truth and qualifications: Not applicable, as no ground truth is established in this context.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted or mentioned.
6. Standalone (algorithm only) performance study: Not applicable, as this is a physical medical device, not an AI algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable (no AI training set).
9. How ground truth for the training set was established: Not applicable.

The letter simply states that the FDA reviewed the premarket notification and found the device substantially equivalent to a predicate device, thereby allowing it to be marketed.

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The Scient'x Cement Restrictor is intended as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.

This device is not intended for any spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.

The Scient'x Cement Restrictor is a hollow trapezoidal block with 1mm toothed serrations on opposite sides to prevent migration and has a threaded hole on the superior surface to attach an insertion tool. The parts are machined from PEEK that conforms to ASTM F2026-02. As peek is radiolucent gold wire radiographic markers inserted into small holes and serve as location and orientation markers for radiographs.

This document is a 510(k) summary for the Scient'x Cement Restrictor and does not contain information about acceptance criteria or a study proving the device meets those criteria. The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data against pre-defined acceptance criteria in the same way a clinical trial or a more rigorous performance study might for a novel device.

The information provided focuses on:

• Device Description: The physical characteristics of the cement restrictor.
• Intended Use: What the device is designed for.
• Predicate Devices: Other legally marketed devices to which the Scient'x Cement Restrictor is compared for substantial equivalence.
• Regulatory Classification: Its class and product code.
• Labeling Limitations: A warning regarding its use in spinal indications because safety and effectiveness in that context have not been established.

Therefore, I cannot extract the requested information (acceptance criteria, study summary, sample sizes, ground truth details, MRMC study, standalone performance) from the provided text as it is not present. This document is a regulatory submission, not a performance study report.

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CO Vertebral Body Replacements are vertebral body replacements for use in the lumbar and thoracic spine (T1-L5) to replace a damaged, collapsed or unstable vertebral body due to tumor or trauma (i.e. fracture). These are not stand-alone devices, ISOBAR Ø6.2 Hemispherical Screws with Offset Clamps and Ø5.5 Rods must be utilized to enhance the stability of the reconstruction in skeletally mature patients following full or partial corpectomy.

The CO Vertebral Body Replacements are rectangular shaped in pairs for full corpectomy or individually when only a portion of the vertebral body is resected. The interior of the spacers is open to provide space for bone graft. The implant is always implanted in the vertical position. These components are available in various heights (7mm-150mm) and cross sections to accommodate the variability of patient size, anatomic variation, and the size of the vertebral body defect. The superior and inferior surfaces of these components have ridges to interface with the vertebral endplates to resist rotation and migration. The body has a multitude of holes to allow additional impaction of bone graft.

The CO components are fabricated from pure poly(ether cther ketone) (PEEK). This material closely matches the modulus of elastical bone, improving the biomechanical interface and reducing the stress shielding effect. They are fully radio-translucent, which enables optimum follow-up with diagnostic imaging, as the interbody fusion progresses. I wo metal wires at the opposite cads of the spacers allow radiological confirmation of the cage position post operatively.

This 510(k) summary describes a spinal implant device (CO Vertebral Body Replacements) and therefore does not include information about acceptance criteria or a study proving that the device meets them in the context of device performance metrics like sensitivity, specificity, accuracy, etc., which are typically found for AI/ML-driven devices or diagnostic tools.

Instead, the documentation focuses on demonstrating substantial equivalence to a predicate device based on its design, materials, and intended use. The "study" mentioned is a non-clinical summary that compares the new device to a previously cleared one.

Therefore, many of the requested categories (e.g., sample size for test/training sets, experts, MRMC studies, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This is a mechanical device, and the "test set" in this context refers to the non-clinical comparative analysis against a predicate device, not empirical data from a study with patients.

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

• Not Applicable. Ground truth, in the sense of expert consensus on medical images or diagnoses, is not relevant for the regulatory clearance of this mechanical spinal implant based on substantial equivalence.

4. Adjudication method for the test set

• Not Applicable. See 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

• Not Applicable. This is a mechanical spinal implant, not an AI-driven diagnostic or assistive device.

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

• Not Applicable. This is a mechanical device.

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

• The ground truth for this submission is based on the previously cleared predicate device (Scient'x Ellys VBR, K033109). The "truth" is established by demonstrating that the new device shares fundamental technological characteristics with a device already deemed safe and effective.

8. The sample size for the training set

• Not Applicable. This is a mechanical device, and there is no "training set" in the computational sense.

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

• Not Applicable. See above.

In summary: The provided document is a 510(k) summary for a mechanical spinal implant. The regulatory pathway for such devices typically relies on demonstrating substantial equivalence to an existing, legally marketed predicate device, rather than extensive clinical trials or performance studies with acceptance criteria as would be seen for diagnostic software or AI/ML devices. The "study" mentioned is a non-clinical comparison focusing on design, materials, and intended use.

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The Polyaxial Hemispherical Spinal Screws are intended for posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease(DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

As a pedicle screw system the Polyaxial Hemispherical Spinal Screws are intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The ISOBAR Spinal System consists of monoaxial and polyaxial pedicle screws rods, nuts and cross link members. (K990118, K013447 and K031290) It can be used for single or multiple level fixation. It also includes single and double hooks (K013444 and K013440) used for posterior, nonpedicle screw fixation of the noncervical spine, hook and sacral/iliac screw fixation to the noncervical spine and hook and sacral screw fixation to the T1-S1 spine.

The modification included in this submission is the addition of polyaxial hemispherical screws. These screws function in the same manner as the previously cleared hemispherical screws by insertion into the pedicle then placing an offset clamp over the screw with a rod that has been loaded into the clamp. A nut is them placed on the screw and tightened to secure the assembly. The new polyaxial screw allows the proximal portion of the screw to angulate in order to ease the assembly of the rod loaded clamps onto multiple screws that may not be axially aligned.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Polyaxial Hemispherical Spinal Screws:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided summary does not explicitly state a sample size for the test set. It mentions "Testing was performed per ATM F1717," which is a standard for pedicle screw spinal systems. This implies that the tests outlined in ASTM F1717 would have been conducted on a sufficient number of devices to demonstrate equivalence.

The data provenance is commercial, with the submitter being Scient'x, located in France. The testing would have been conducted by the manufacturer or a contracted lab in support of U.S. market clearance. The submission is retrospective in the sense that the testing was performed before the 510(k) submission.

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

This information is not applicable to this type of device submission. For a mechanical device like a spinal screw, the "ground truth" is established by adherence to a recognized international standard (ASTM F1717) and the physical properties of the materials and design, not by expert interpretation of data like in medical imaging.

4. Adjudication Method for the Test Set

This is not applicable to this type of mechanical testing. Adjudication methods like 2+1 or 3+1 are used for expert review of subjective data (e.g., medical images). The results of ASTM F1717 are objective measurements.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic or screening devices, particularly those involving human interpretation of data, and how an AI system might improve that human performance. This is a mechanical implant device.

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

This question is not applicable as this is a mechanical spinal implant, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance of the Polyaxial Hemispherical Spinal Screws relies on engineering specifications and recognized international standards (ASTM F1717). The comparison is made against the performance of a previously cleared predicate device that presumably also met these standards.

8. The Sample Size for the Training Set

This question is not applicable. This is a mechanical device, not an AI/ML algorithm that requires a training set.

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

This question is not applicable. As explained above, there is no "training set" for this type of device.

Summary of the Study:

The "study" or rather, the non-clinical testing, performed to demonstrate the device meets acceptance criteria was based on ASTM F1717, a standard specification for spinal pedicle screw systems. The crucial aspect of the study was to show that the modified device (Polyaxial Hemispherical Spinal Screws) performed comparably to its predicate device (Scient'x ISOBAR Hemispherical Screw system). The specific performance metrics would have included various mechanical tests such as static and dynamic compression bending, torsion, axial pullout, implant-to-implant connection strength, corrosion resistance, and fatigue strength, as described in ASTM F1717. The acceptance criteria essentially were to meet or exceed the performance characteristics of the predicate device under these standardized conditions. The FDA's clearance (K051063) indicates that the agency found the results of this testing sufficient to establish substantial equivalence.

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The MX Polvaxial Pedicle Screw is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system the MX Polyaxial Pedicle Screws are indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The MX Polyaxial Pedicle Screw consists of pedicle screws and rods. Pedicle screws are inserted into the pedicles of the vertebrae and are available in three diameters (Ø6.2, Ø7.0 and Ø8.0mm) and in lengths ranging from 35mm to 70mm. A rod is then inserted through an opening in the side of the head of the screw. A set screw is inserted through the top of the screw head. As the set screw is tightened the rod is secured in the screw head and the polyaxial mechanism is fixed in place. The rods are available in lengths ranging from 45-600mm.

The MX is fabricated from material that conforms to ASTM F136 (Ti-6Al-4V alloy).

The provided 510(k) summary for the MX Polyaxial Pedicle Screw describes a medical device, but it does not contain information about acceptance criteria or a study proving device performance in the context of clinical or diagnostic efficacy, which is typically the focus of such questions.

Instead, the document details:

• Device Description: What the device is made of and how it functions mechanically.
• Intended Use: The medical conditions and patient population for which the device is designed.
• Summary of Nonclinical Tests: This explicitly states "Testing was performed per ASTM F1717." ASTM F1717 is a standard for mechanical testing of spinal implants, specifically for spinal implant constructs in a dynamic compression testing environment. This type of testing assesses the structural integrity, fatigue life, and mechanical properties of the device itself, not its clinical performance in patients or a comparison against a diagnostic standard.

Therefore, many of the requested details, such as sample size for test sets, data provenance, expert qualifications, ground truth establishment for a diagnostic study, MRMC studies, or standalone algorithm performance, are not applicable and not present in this document.

Here’s a description of the acceptance criteria and the study as much as can be extracted from the provided text, focusing on the mechanical testing aspect:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in the document. For mechanical testing per ASTM F1717, the sample size would refer to the number of device constructs tested, not human patient data.
• Data Provenance: Not applicable in the context of clinical or diagnostic data. For mechanical testing, the data would be generated in a laboratory setting.
• Retrospective or Prospective: Not applicable as this relates to clinical studies.

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

• Not applicable. For mechanical testing, ground truth is established by applying the test standard (ASTM F1717) and measuring physical properties, not by expert consensus on clinical findings.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication relates to resolving discrepancies in expert interpretations of clinical data.

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

• No. This type of study assesses human reader performance, often with and without AI assistance, for diagnostic tasks. The provided document concerns mechanical performance of a spinal implant.

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

• No. Standalone performance usually refers to the accuracy of an AI algorithm on its own. This document describes a physical medical device.

7. The Type of Ground Truth Used

• Mechanical Test Standards and Measurements: For the "Summary of Nonclinical Tests," the ground truth is adherence to the specifications and performance requirements outlined in ASTM F1717. This standard provides methodologies and criteria for evaluating the mechanical properties of spinal implant constructs. The device's performance is measured against these established engineering and biomechanical benchmarks.

8. The Sample Size for the Training Set

• Not applicable. Training sets are used for machine learning algorithms. The device is a physical pedicle screw system.

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

• Not applicable.

In summary, the provided text focuses on the mechanical and material safety/performance of the MX Polyaxial Pedicle Screw, demonstrating its substantial equivalence to predicate devices through compliance with ASTM F1717. It does not contain information related to clinical efficacy studies, diagnostic performance, or AI/software analysis that would involve human subjects, expert review, or machine learning methodologies.

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