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It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only. Vertebral staples are limited to use with 5.5mm and larger monoaxial screws only.

1. The ZODIAC™ Spinal Fixation System when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for:
   a. Patients having fractures of the thoracic and lumbar spine.
   b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
   c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis).
2. The ZODIAC™ Spinal Fixation System, when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
3. In addition, the ZODIAC™ Spinal Fixation System, when used as a pedicle screw fixation system is intended for:
   a. Patients receiving only autogenous bone graft.
   b. Patients having the device fixed or attached to the lumbar and sacral spine (L3-S1) and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
4. The ZODIAC™ Spinal Fixation System, when used as a laminar hook and bone screw system is intended for:
   a. Patients having fractures of thoracic and lumbar spine.
   b. Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scolliosis, or kyphoscoliosis with associated paralysis or spasticity).
   c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis).
5. When used as an anterior fixation system, the ZODIAC Spinal Fixation System intended for degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), fracture, pseudarthrosis, tumors and/or failed previous fusion.

The ZODIAC™ Spinal Fixation System is comprised of various types and sizes of implantable components that are assembled to create a rigid spinal construct. System components are manufactured from titanium alloy, Ti-6AI-4V ELI (ASTM F 136). System rods are available in titanium allov or commercially pure titanium, CP Grade 4 (ASTM G67). This submission seeks clearance for a line extension.

The provided document describes a medical device, the ZODIAC™ Spinal Fixation System, and its clearance through the 510(k) pathway. This pathway relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than explicit performance against predefined acceptance criteria from a clinical study.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable as this submission is for a spinal fixation system, which typically involves mechanical and biocompatibility testing, not diagnostic performance studies with human readers.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable for a 510(k) for a spinal fixation system that relies on mechanical testing and substantial equivalence. The "test set" in this context refers to the samples used in mechanical and dynamic testing of the device hardware, not a clinical data set. The document does not specify the number of individual implants or components tested.
• Data Provenance: The testing was presumably conducted by the manufacturer, Alphatec Manufacturing, Inc., or a contracted lab. The document does not specify the country of origin of this testing data. It is a retrospective summary of testing performed.

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

• Not Applicable. This is a hardware device (spinal fixation system), not a diagnostic algorithm where expert ground truth is established for a test set. The "ground truth" here would be the physical properties derived from mechanical testing specifications and comparison to predicate devices, which are assessed by engineers and regulatory bodies.

4. Adjudication Method for the Test Set

• Not Applicable. As there are no human readers or expert consensus involved in establishing a ground truth for a diagnostic test set in this context, there is no adjudication method.

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, an MRMC study was NOT done. This device is a spinal fixation hardware system, not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not relevant.

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

• No, a standalone (algorithm only) performance study was NOT done. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

• Engineering specifications and performance of predicate devices. For a device like the ZODIAC™ Spinal Fixation System, the "ground truth" for its performance evaluation in a 510(k) is based on:
  • Mechanical and Dynamic Testing Standards: The device's physical properties (e.g., strength, fatigue resistance) are tested against established engineering standards and specifications.
  • Predicate Device Performance: The central claim of a 510(k) is substantial equivalence. The "ground truth" for this claim is a comparison of the device's design, materials, and performance (including mechanical testing) to that of legally marketed predicate devices, which are already considered safe and effective for their intended use.

8. The Sample Size for the Training Set

• Not Applicable. This is a hardware device, not an AI/ML algorithm. There is no concept of a "training set" in the context of this 510(k) submission.

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

• Not Applicable. As there is no training set for this device, there is no ground truth established for it.

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It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only.

1. The ZODIAC™ Spinal Fixation System when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for:
   a. Patients having fractures of the thoracic and lumbar spine.
   b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
   c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).
2. The ZODIAC™ Spinal Fixation System, when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
3. In addition, the ZODIAC™ Spinal Fixation System, when used as a pedicle screw fixation system is intended for:
   a. Patients receiving only autogenous bone graft.
   b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
4. The ZODIAC™ Spinal Fixation System, when used as a laminar hook and bone screw system is intended for:
   a. Patients having fractures of thoracic and lumbar spine.
   b. Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
   c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).

The ZODIAC™ Spinal Fixation System is comprised of various types and sizes of implantable components that are assembled to create a rigid spinal construct. System components are offered in titanium alloy, Ti-6Al-4V ELI (ASTM F 136). System rods are also available in commercially pure titanium, CP Grade 4 (ASTM G67). This submission seeks clearance for stainless steel (ASTM F 138) system components.

The ZODIAC™ Spinal Fixation System is a medical device, and the provided text is a 510(k) summary for its clearance. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a clinical study with acceptance criteria and device performance metrics in the way a diagnostic AI device might.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable in this context. The "study" here is primarily a performance data study to characterize the physical properties of the device, specifically the stainless steel components, and show they are equivalent to the previously cleared titanium alloy version.

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 Data Provenance:

• Sample Size: Not specified in the summary. This would refer to the number of components or constructs tested in engineering bench studies, not patient data.
• Data Provenance: Not applicable in terms of country of origin for patient data. The "data" are results from mechanical and material testing conducted on the device components. This would typically be laboratory data.
• Retrospective or Prospective: Not applicable. This refers to engineering test data, not clinical patient data collection.

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

• Number of Experts: Not applicable. Ground truth in this context refers to established material science and biomechanical engineering standards used to evaluate device performance.
• Qualifications of Experts: Not applicable. Evaluation would be against established engineering standards and specifications.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. Decision-making is based on comparing test results against established engineering standards and specifications for substantial equivalence.

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

• MRMC Study: No. This is a medical device for spinal fixation, not a diagnostic imaging or AI-assisted interpretation device. The study type is focused on mechanical and material properties.
• Effect Size of Human Readers Improvement: Not applicable.

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

• Standalone Study: Not applicable. There is no algorithm or AI component to this physical medical device. The "performance data" refers to the mechanical and material testing of the physical components.

7. Type of Ground Truth Used:

• Ground Truth: Engineering and material science standards, biomechanical testing criteria, and established performance characteristics of the predicate titanium alloy ZODIAC™ Spinal Fixation System. The "ground truth" for the new stainless steel components is that their performance must meet or exceed the performance of the predicate device to ensure substantial equivalence.

8. Sample Size for the Training Set:

• Sample Size: Not applicable. There is no AI or machine learning component requiring a training set.

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

• How Ground Truth Was Established: Not applicable. No training set is involved.

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The NOVEL™ VBR Spinal System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Novel™ VBR System is intended for use with supplemental spinal fixation systems. Specifically, the Novel™ VBR System is to be used with the Alphatec Zodiac™ Polyaxial Pedicle Screw System or the Alphatec Mirage™ Top Tightening Spinal System. Furthermore, the Novel™ VBR System is intended for use with bone graft.

The NOVEL™ VBR Spinal System is a vertebral body replacement device that is implanted into the vertebral body space to improve stability of the spine. System components are offered in various shapes and sizes to meet individual patient anatomy. System components are manufactured from titanium alloy (ASTM F-136) or polyetheretherkeytone (PEEK) material (ASTM F 2026 and ISO 10993). A radiographic marker fabricated from titanium alloy (ASTM F-136) or tantalum (ASTM F-560) allows for easy radiographic identification.

This document, K050553 for the NOVEL™ VBR Spinal System, is a 510(k) premarket notification. It describes a medical device and its intended use, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

The document states:

• "Performance data were submitted to characterize the NOVEL™ VBR Spinal System manufactured from PEEK material." (Section VIII)
• It refers to "substantial equivalence" to a previously cleared device.
• It is a regulatory clearance document, not a performance study report.

Therefore,Based on the provided document, the following information about acceptance criteria and a study proving the device meets those criteria cannot be found or inferred:

1. A table of acceptance criteria and the reported device performance: This document does not specify any quantitative acceptance criteria for the device's performance, nor does it present device performance data in a table or any other format that would allow for comparison to such criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): No information regarding sample sizes for any test sets, data provenance, or study design (retrospective/prospective) is provided. The document mentions "Performance data were submitted to characterize," but does not detail the specifics of this data or the studies generating it.
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): Since no clinical performance study is described, there is no mention of experts, ground truth establishment, or their qualifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: No adjudication method is mentioned as no test set or clinical assessment is detailed.
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 a spinal surgical implant, not an AI-powered diagnostic device. Therefore, an MRMC study related to AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: As this is a physical medical implant and not an algorithm, the concept of standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth is discussed as no clinical performance study is detailed.
8. The sample size for the training set: There is no mention of a training set, as this is a physical device and not a machine learning model.
9. How the ground truth for the training set was established: Not applicable, as there is no training set for an algorithm.

In summary, this document is a 510(k) clearance letter confirming that the FDA found the NOVEL™ VBR Spinal System substantially equivalent to a predicate device. It does not contain the detailed performance study information with acceptance criteria that you are requesting.

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The TAMARACK™ Anterior Thoracolumbar Plating System is intended for fixation to the anterolateral vertebral bodies (T10 to L5). This system is intended for implantation on one side only for the treatment of thoracic and lumbar spine instability as a result of fracture, including dislocation and subluxation, tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous fusion surgery.

The TAMARACK™ Anterior Thoracolumbar Plating System facilitates the surgical correction of spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. Device implants include a range of sizes of plates, screws, bolts and a locking nut. All system components are made from titanium alloy (Ti 6Al-4V) meeting ASTM F-136.

The provided text describes a medical device, the TAMARACK™ Anterior Thoracolumbar Plating System, and its 510(k) summary for FDA clearance. However, it does not contain information about specific acceptance criteria, a study proving device performance against those criteria in a clinical or AI context, or details about the development and validation of an AI algorithm.

The document focuses on:

• Device Description: What the device is, its components, and materials.
• Classification: Its regulatory classification.
• Indications for Use: The medical conditions and anatomical locations for which the device is intended.
• Substantial Equivalence: It claims substantial equivalence to a predicate device (Z-Plate by Medtronic Sofamor Danek, K991460). This is a common pathway for FDA clearance for Class II medical devices, where clinical trial data proving safety and effectiveness is not typically required if the device is sufficiently similar to an already cleared device.
• Performance Data: It briefly states that "Static and dynamic testing of the TAMARACK™ Anterior Thoracolumbar Plating System was performed and submitted in this application." This refers to mechanical testing of the physical hardware, not a clinical study involving human patients or an AI performance study.

Therefore, based on the provided text, I cannot complete the requested information, particularly regarding acceptance criteria, AI performance, sample sizes for training/test sets, ground truth establishment, or expert involvement. The device is a physical implant, not an AI/software device.

If you were expecting information about an AI-powered device, this document is not relevant to that type of inquiry.

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It is intended that this device, in any system configuration, be removed after the development of solid fusion mass. The ROC™ Lumbar Plating when intended to arovide 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 lumbosacral spine: severe spondylolisthesis (grades 3 and 4), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis). The ROC Lumbar Plating System is indicated for placement in L3 – S1.

The ROC™ Lumbar Plating System is a spinal fixation system intended to improve stability of the lumbosacral spine. There are a variety of implants that can be used for this procedure including; lumbar plates, botts, offset links and locking nuts. All components are made from titanium alloy, Ti 6Al 4V meeting specifications of ASTM F136.

This 510(k) summary is for a spinal implant system, not an AI/ML powered device. Therefore, much of the requested information regarding AI/ML device studies (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, ground truth establishment) is not applicable.

However, I can extract the relevant information about the non-clinical performance testing that was performed for this device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not explicitly stated in the 510(k) summary for mechanical testing. Standard testing typically involves multiple samples to achieve statistical significance.
• Data provenance: The performance data was generated through physical testing of the device components/system. This is laboratory-based testing, not human or clinical data.

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 mechanical performance is established by engineering standards (e.g., ASTM F136 for material, and other mechanical testing standards for static and dynamic performance) and the results obtained from the tests themselves. It does not involve expert clinicians establishing a "ground truth" in the way it would for AI diagnostic algorithms.

4. Adjudication method for the test set

• Not applicable. This refers to consensus reaching among experts for AI/ML ground truth, which is not relevant for physical device testing 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 device is a physical implant, not an AI/ML diagnostic 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 AI/ML algorithm.

7. The type of ground truth used

• The "ground truth" for the device's performance is established by:
  • Engineering Standards: Adherence to material specifications (ASTM F136).
  • Mechanical Testing Results: The quantitative and qualitative outcomes of static and dynamic load testing.
  • Predicate Device Performance: The established safety and effectiveness profile of existing, legally marketed predicate devices to which this device demonstrated substantial equivalence.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device; there is no training set.

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

• Not applicable. This is not an AI/ML device; there is no training set.

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1. When used as a hemi-hip replacement system, it is intended for osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal involvement of the corresponding acetabulum, femoral head or neck fractures, aseptic necrosis of the femoral head, previous failed hip arthroplasty where there is evidence of sufficient bone quality to adequately set the implant.
2. When used as a total hip replacement system, it is intended for osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal involvement of the corresponding acetabulum, femoral head or neck fractures, aseptic necrosis of the femoral head, previous failed hip arthroplasty where there is evidence of sufficient bone quality to adequately set the implant.
3. In addition, the SIERRA™ hip stem is intended for cases where alternative modes of trealment appear less preferable and the associated risks of a total hip replacement are thought to be acceptable. It is intended for severely disabled joints, which could result from arthritis or late stages of avascular necrosis and revisions of unsuccessful acetabular cup arthroplasty and/or femoral procedure.

The SIERRA™ Femoral Hip Stem is a sterile component used to help restore patient range of motion and aid in the treatment of other deformities as listed in the Indications for Use. The SIERRA™ Femoral Hip Stem has a tapered distal stem design and is available in a variety of options including cemented, porous coated or porous coated with hydroxylapatite (HA) coating. They are also available with standard or high offset necks, as well as collared and non-collared designs. This submission seeks clearance for the SIERRA™ Femoral Hip Stem, which is a line extension to the NexFlex™ Total Hip System. The SIERRA™ Femoral Hip Stem is manufactured from titanium alloy (Ti 6Al-4V, ASTM F136) or cobalt chrome (CoCrMo, ASTM F75). Cobalt chrome stems are intended for cemented use. The porous coated and HA/porous coated stems are intended for uncemented use.

The provided text describes the Sierra Femoral Hip Stem, a medical device, and its 510(k) clearance. However, it does not contain information about acceptance criteria, device performance, or a study that evaluates the device against such criteria.

The document is a 510(k) summary and an FDA clearance letter. These documents typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria in the way a clinical trial or a validation study for a new AI/software device would.

Specifically, the "Performance Data" section (VIII) only states: "Mechanical and dynamic testing of the SIERRA™ Femoral Hip Stem was performed." It does not provide any results, acceptance criteria, or details of these tests.

Therefore, I cannot answer the questions based on the provided text. The requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not present in this document.

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It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only.

1. The ZODIAC™ Polyaxial Spinal Fixation System when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for:
   a. Patients having fractures of the thoracic and lumbar spine.
   b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
   c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).
2. The ZODIAC™ Polyaxial Spinal Fixation System, when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
3. In addition, the ZODIAC™ Polyaxial Spinal Fixation System, when used as a pedicle screw fixation system is intended for:
   a. Patients receiving only autogenous bone graft.
   b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
4. The ZODIAC™ Polyaxial Spinal Fixation System, when used as a laminar hook and bone screw system is intended for:
   a. Patients having fractures of thoracic and lumbar spine.
   b. Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
   c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).

The ZODIAC™ Polyaxial Spinal Fixation System is comprised of various types and sizes of implantable components that are assembled to create a rigid spinal construct. System components are manufactured from titanium alloy, Ti-6AI-4V ELI (ASTM F 136). System rods are available in titanium alloy or commercially pure titanium, CP Grade 4 (ASTM G67). This submission seeks clearance for a line extension.

The ZODIAC™ Polyaxial Spinal Fixation System is a device used in spinal surgeries. The provided text describes its substantial equivalence to other pedicle screw systems already on the market, rather than presenting a performance study with acceptance criteria and detailed results from a clinical trial or algorithm evaluation.

Here's a breakdown of the information that can be extracted, and what is not present based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "Documentation was provided that demonstrates that the ZODIAC™ Polyaxial Spinal Fixation System is substantially equivalent to other pedicle screw systems currently on the market." This implies that the acceptance criteria for the mechanical and dynamic testing were based on demonstrating equivalence, or superiority, to established predicate devices in those specific performance metrics, rather than pre-defined absolute thresholds.

2. Sample Size and Data Provenance for Test Set

• Sample Size (Test Set): Not specified. The document only mentions "Mechanical and dynamic testing was performed." It does not detail the number of constructs, materials, or specific test configurations used.
• Data Provenance: Not specified. It's likely that the testing was conducted internally by Alphatec Manufacturing, Inc. or by a contract testing laboratory, but the country of origin or whether it was retrospective/prospective is not mentioned. This is typical for 510(k) submissions focusing on physical device performance testing.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

• Not applicable. This submission focuses on the mechanical and dynamic performance of the device itself, not on the interpretation of medical data by human experts to establish ground truth for a diagnostic or AI device.

4. Adjudication Method for Test Set

• Not applicable. As the "test set" refers to mechanical and dynamic testing of the device, there is no expert adjudication process involved. The results would be objective measurements from testing equipment.

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

• No. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This submission is for a spinal fixation system, not a diagnostic or AI device.

6. Standalone (Algorithm Only) Performance Study

• No. This is not an AI/algorithm-based device. "Standalone performance" in this context would refer to the mechanical and dynamic performance of the implant itself, which was evaluated as described in #1.

7. Type of Ground Truth Used

• For the mechanical and dynamic testing, the "ground truth" would be the objective measurements obtained from laboratory testing (e.g., stiffness, fatigue limits, pull-out strength). These are compared against established industry standards or the performance of predicate devices. There is no biological or clinical "ground truth" established from patients or pathology in this type of submission for a spinal implant's physical performance.

8. Sample Size for Training Set

• Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

9. How Ground Truth for Training Set Was Established

• Not applicable. As there is no training set.

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The Alphatec Femoral Trochanteric Nail (FTN) System is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures.

The Femoral Trochanteric Nail (FTN) System consists of an intramedullary nail, lag screw, distal static or dynamic screws. The proximal cap screw, optional and routers offered in diameters of 10, 12, or 14 mm. The diameter is 10 mm with distal diameters one for a lag screw and one for an anti-rotational proximal portion of the nail having the neck angle of 135°, 130° or 135°. All implants are manufactured from titanium alloy (Ti-6Al-4V ELI).

The provided text describes a 510(k) summary for the Femoral Trochanteric Nail (FTN) System. Here's an analysis of the requested information based on the text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that the device is substantially equivalent to predicate devices. For mechanical performance, the acceptance criteria is implicitly set as being "at least comparable to, if not better than" the predicate devices.

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

The document does not specify sample sizes for mechanical testing or the provenance of the data (e.g., country of origin, retrospective or prospective). It simply states that "Mechanical and dynamic testing... was performed."

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

This information is not provided in the document. The study described is mechanical and dynamic testing, not a clinical study involving human experts establishing ground truth for patient outcomes.

4. Adjudication Method for the Test Set

This is not applicable as the described study is mechanical and dynamic testing, not a study requiring human adjudication for diagnostic accuracy or similar endpoints.

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

No, an MRMC comparative effectiveness study was not conducted. The performance data presented relates to mechanical and dynamic testing of the device itself, not human reader performance with or without AI assistance.

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

This question is not applicable as the device is a physical medical implant (Femoral Trochanteric Nail System), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the mechanical and dynamic testing would refer to recognized engineering standards and specifications for intramedullary nails, and comparative data from the predicate devices. The testing aims to demonstrate the device's physical properties meet or exceed established benchmarks.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical implant, not an AI algorithm that requires a training set. The mechanical testing itself doesn't involve a 'training set' in the machine learning sense.

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

This is not applicable for the reasons stated above.

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The Novel™ VBR Spinal System is intended for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Novel™ VBR Spinal System is intended for use with supplemental spinal fixation systems. Specifically, the Novel™ VBR Spinal System is to be used with the Alphatec Zodiac™ Polyaxial Pedicle Screw System or the Alphatec Mirage™ Top Tightening Spinal System. Additionally, the Novel™ VBR Spinal System is intended for use with bone graft.

The NOVEL™ VBR Spinal System is a vertebral body replacement device that is implanted into the vertebral body space to improve stability of the spine. System components are offered in three footprints of varying lengths, widths and heights to meet individual patient anatomy. System components are manufactured from titanium alloy (ASTM F136).

The provided text is a 510(k) summary for the NOVEL™ VBR Spinal System, which is a vertebral body replacement device. This document describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain the specific information required to answer your questions regarding acceptance criteria and a study proving device performance using AI/ML methodologies.

Here's a breakdown of why the information is missing and what it does provide:

• No AI/ML Component: The NOVEL™ VBR Spinal System is a physical medical device (an implant). The 510(k) summary describes standard mechanical testing (Static and dynamic testing) for comparing its physical properties to predicate devices, not AI/ML performance.
• Approval Date: The 510(k) was cleared in 2004, well before the widespread application of AI/ML in medical device performance evaluation as you've described in your questions.
• Focus of the Document: A 510(k) summary primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, not necessarily extensive novel performance studies in the way you've outlined for AI/ML systems.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, sample sizes, expert ground truth, MRMC studies, or standalone performance for an AI/ML device because this document does not pertain to such a device or study.

What the document does provide regarding performance:

VIII. Performance Data:

Static and dynamic testing of the NOVEL™ VBR Spinal System was performed. The test results demonstrated that the NOVEL™ VBR Spinal System is at least comparable to, if not better than those of the predicate devices.

Based on the available document, I cannot complete your request. It describes a physical medical device (a spinal implant) and its mechanical testing, not an AI/ML diagnostic or assistive device that would have acceptance criteria for algorithms, ground truth creation by experts, or MRMC studies.

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