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The Syzygy Stabilization System is intended to provide immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and/or sacral spine, specifically as follows:

• When intended for pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients the Syzygy Stabilization System is indicated for one of the following: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); fracture; dislocation; scoliosis; kyphosis; spinal tumor; and/or failed previous fusion (pseudarthrosis).

· In addition, when used as a pedicle screw fixation system, the Syzygy Stabilization System is indicated for skeletally mature patients having degenerative spondylolisthesis with objective evidence of neurologic impairment and/or severe spondylolisthesis (grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; who are receiving fusions using autogenous bone graft only; who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and who are having the device removed after the development of a solid fusion mass.

The Syzygy Stabilization System consists of posted screws, couplers, and associated surgical instruments. The system is used in conjunction with the Amendia Savannah-T pedicle screw and rod system. The Syzygy posted screws are self-tapping with a cancellous thread design. They are available in cannulated and non-cannulated configurations, in a variety of diameters and lengths. The Syzygy posted screws are attached to the pedicles via couplers (medial and cranial) which accept and secure the longitudinal rods to build a rigid construct. The screws and couplers are manufactured from Ti-6AI-4V (ASTM F136) and are provided non-sterile for singleuse.

This document is a 510(k) premarket notification for the Syzygy Stabilization System, a medical device for spinal stabilization. The document does not describe the acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-based device performance evaluation, but rather for a traditional medical device (pedicle screw system).

Therefore, I cannot provide the requested information regarding AI device acceptance criteria and study details. The document focuses on mechanical testing of spinal implants and a cadaveric validation study to demonstrate substantial equivalence to predicate devices, which is typical for a 510(k) submission for this type of hardware.

Specifically, the document states:

• Acceptance Criteria & Device Performance: The document refers to "requirements as established by the test protocol and applicable ASTM standards" for mechanical tests, and "substantially equivalent to the Predicate" for the cadaveric validation study. However, it does not provide a table of numeric acceptance criteria or specific device performance metrics in a way that would be applicable to an AI device.
• Study Types: The studies performed were:
  • Static Axial Compression Bending (ASTM F1717-14)
  • Static Axial Tension Bending (ASTM F1717-14)
  • Static Torsion (ASTM F1717-14)
  • Dynamic Axial Compression Bending (ASTM F1717-14)
  • Dynamic Axial Tension Bending (ASTM F1717-14)
  • A Cadaveric validation study.
• The document does not include information on:
  • Sample size used for a test set (in the context of AI data splits)
  • Data provenance (country of origin, retrospective/prospective)
  • Number or qualifications of experts for ground truth
  • Adjudication method
  • Multi-reader multi-case (MRMC) comparative effectiveness study
  • Standalone algorithm performance
  • Type of ground truth (expert consensus, pathology, outcomes data, etc. in an AI context)
  • Sample size for a training set
  • How ground truth for a training set was established

The information provided pertains to the mechanical and general performance characteristics of a physical spinal implant system, not the performance of an AI or algorithmic medical device.

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The Pagoda™ Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, noncervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (T) -S1/lleum) for the following indications:

1. Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
2. Degenerative Spondylolisthesis with objective evidence of neurologic impairment
3. Trauma (fracture or dislocation)
4. Spinal tumor
5. Failed previous fusion (pseudarthrosis)
6. Spinal stenosis
7. Spinal deformities or curvatures such as scoliosis, kyphosis, or lordosis

The Pagoda™ Pedicle Screw System consists of rods, polyaxial screws, reduction screws, monoaxial screws, set screws, transverse connectors, and offset connectors which can be variously assembled to provide immobilization of the thoracolumbar and lumbosacral spine. All components are made from Titanium Alloy (Ti6Al4V).

This document describes the acceptance criteria and study proving the device meets them for the Ortho Development® Pagoda™ Pedicle Screw System.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

For the Pagoda™ Pedicle Screw System, the acceptance criteria are based on compliance with established ASTM standards for spinal implant mechanical testing and demonstrating substantial equivalence to predicate devices. The reported performance is that the device meets these criteria.

Dynamic Compression Testing
- Performed according to ASTM F1717

Static Torsion Testing
- Performed according to ASTM F1717

Overall Substantial Equivalence
- Demonstrated equivalence in mechanical performance to predicate devices (Pangea K052123, Tiger K113058, Synergy Helical Flange Plug K041449, MOSS Miami K964024) based on the specified mechanical tests, ensuring the Pagoda™ system performs at least as safely and effectively as legally marketed predicate devices.

Clinical Equivalence
- Demonstrated equivalence in intended use, design, materials, manufacturing methods, and packaging to predicate devices. This implies that the device is expected to perform similarly in clinical applications for the stated indications. | Met Criteria:
- The Pagoda™ Pedicle Screw System underwent and successfully passed static and dynamic compression testing per ASTM F1717.
- The Pagoda™ Pedicle Screw System underwent and successfully passed static torsion testing per ASTM F1717.
- Conclusion: "Mechanical test results demonstrate that the proposed Pagoda™ Pedicle Screw System is substantially equivalent to the predicate devices."
- Conclusion: "Based on similarities in intended use, design, materials, manufacturing methods, and packaging, Pagoda™ Pedicle Screw System has demonstrated that it is substantially equivalent to the previously cleared predicate devices."

The FDA's 510(k) clearance (K131785) confirms that the device has met the criteria for substantial equivalence to its predicates. |

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

This submission is for a medical device (pedicle screw system), not a software or AI algorithm. Therefore, the concept of a "test set" in the context of data used for an algorithm's performance evaluation is not applicable here.

• Sample Size for Test Set: Not applicable. The "test set" here refers to physical devices undergoing mechanical stress tests, not data. The document does not specify the number of individual components or systems tested, but it is implied that a sufficient number were tested to meet the requirements of the ASTM standards.
• Data Provenance: Not applicable in the context of patient data. The provenance for the testing is "non-clinical tests" conducted on the device itself.

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

Not applicable. "Ground truth" in this context would refer to material science and mechanical engineering standards established by organizations like ASTM, interpreted and applied by qualified engineers and technicians, not medical experts establishing truth from patient data. The document does not specify the number or qualifications of the individuals who performed or supervised the mechanical testing.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation of medical images or data requiring adjudication. The "adjudication" is determined by whether the physical device passes or fails the specified mechanical tests according to ASTM F1717.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for diagnostic devices or AI algorithms where human readers interpret medical images. The Pagoda™ Pedicle Screw System is a physical implant, and its evaluation focuses on mechanical integrity and substantial equivalence to predicate devices, not human reader performance.

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

Not applicable. The Pagoda™ Pedicle Screw System is a physical medical implant, not an algorithm or AI software. Therefore, there is no "standalone algorithm" performance to evaluate.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation comes from:

• ASTM Standard Specifications: The established mechanical performance requirements and methodologies outlined in ASTM F1717 for static and dynamic compression, and static torsion. These standards define what constitutes acceptable mechanical device performance.
• Predicate Device Performance: The mechanical and functional characteristics of the legally marketed predicate devices (Pangea, Tiger, Synergy Helical Flange Plug, MOSS Miami). The "ground truth" for substantial equivalence is that the new device performs at least as well as these established devices.

8. The Sample Size for the Training Set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The product development process involves design, engineering, and manufacturing, followed by non-clinical testing.

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

Not applicable, as there is no "training set." The engineering validation process for physical devices relies on design specifications, material properties, manufacturing controls, and adherence to recognized industry standards (like ASTM) to ensure safety and effectiveness.

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The Mont Blanc Pedicle Screw System is intended for noncervical pedicle fixation from the T1 to S1 vertebrae in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (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, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.

The Mont Blanc Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle screws and rods. The rods are provided straight and intended to interface with the screws, which are traditional saddle design. This device is intended to be used with bone graft to provide immobilization and stabilization of a spinal segment as an adjunct to fusion. The Mont Blanc Pedicle Screw System is fabricated from wrought Ti-6Al-4V (ISO 5832-3).

The provided text is a 510(k) summary for a medical device called the "Mont Blanc Pedicle Screw System." It describes the device, its intended use, and the basis for its substantial equivalence to previously cleared devices.

However, the questions you've asked are about "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of device performance, sample sizes for test and training sets, expert review, and ground truth establishment.

Based on the provided document, the device described is a pedicle screw system, which is an orthopedic implant. For this type of device, "performance testing" typically refers to mechanical testing to ensure the device's structural integrity and durability, rather than a clinical study evaluating diagnostic accuracy or algorithmic performance as would be the case for an AI/ML device.

Therefore, the information you are requesting about

1. Acceptance criteria and reported device performance (in terms of sensitivity, specificity, etc.)
2. Sample sizes for test set and data provenance
3. Number of experts and qualifications for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study
6. Standalone algorithm performance
7. Type of ground truth (pathology, outcomes data, etc.)
8. Sample size for training set
9. How training set ground truth was established

is not present in the provided 510(k) summary.

The document states:

• Performance Testing: "Testing performed indicates the Mont Blanc Pedicle Screw System is substantially equivalent to predicate devices. Testing included mechanical testing per ASTM F1717, including static and dynamic compression bending and static torsion." This refers to laboratory-based mechanical tests, not clinical studies.
• Acceptance Criteria: These would be defined by the ASTM F1717 standard for pedicle screw systems (e.g., minimum loads for static and dynamic failure, or deformation limits) but are not explicitly detailed in the summary.
• Device Performance: The documented performance is that it met the requirements of ASTM F1717, showing it is "substantially equivalent" to predicate devices. Specific numerical results from these tests (e.g., actual breaking strength values) are not provided in this summary.

In summary, this document does not contain the type of information you are asking for, which is typically found in submissions for AI/ML-driven diagnostic devices or devices that rely on complex data analysis and expert interpretation. It describes a traditional, passive mechanical implant.

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When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the Mahe Perfect Spine - Pedicle Screw 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 the thoracic. Iumbar and sacral spine: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), (5) tumor, and (6) failed previous fusion (i.e. pseudarthrosis). In addition, when used as a pedicle screw system placed between L3 and S1, the Mahe Perfect Spine - Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) in skeletally mature patients receiving fusion with autologous bone graft and with removal of the device after solid fusion is established.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the Mahe Perfect Spine - Pedicle Screw System is intended for use in skeletally mature patients and pediatric patients for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) tumor resection, and/or (7) unsuccessful previous attempts at spinal fusion (pseudoarthrosis).

When intended for anterolateral fixation of the T6-L5 spine the Mahe Perfect Spine - Pedicle Screw System is indicated for: (1) degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) spondylolisthesis, (3) trauma (i.e. fracture or dislocation), (4) spinal stenosis, (5) deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis}, (6) tumor and (7) failed previous fusion.

The Mahe Perfect Spine - Pedicle Screw System consists of a variety of shapes and sizes of rods, hooks, monoaxial and polyaxial screws, cross connectors, as well as appropriate instrumentation.

The Mahe Perfect Spine - Pedicle Screw System components are fabricated from titanium alloy per ASTM F136.

The system is sold non-sterile, the products have to be sterilized prior to use.

The provided text details a 510(k) submission for the Mahe Perfect Spine - Pedicle Screw System. This is a medical device for spinal fixation, not an AI/ML powered device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as it relates to AI/ML device performance (e.g., accuracy, sensitivity, specificity, F1-score) is not applicable here.

Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices based on non-clinical performance data and technological characteristics.

Here's how the information provided relates to the typical framework for medical device clearance in this context:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is not an AI/ML device, there are no "acceptance criteria" for metrics like sensitivity or accuracy. The "acceptance criteria" here are implicit in demonstrating substantial equivalence through mechanical testing, material specifications, and intended use.

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

• Test Set: The "test set" in this context refers to the samples of the device components that underwent mechanical testing. The specific number of samples for each test (static compression bending, static torsion, dynamic compression bending, etc.) is not explicitly stated in the provided text.
• Data Provenance: The data comes from non-clinical laboratory testing performed on the device itself ("the worst case construct"). There is no mention of country of origin for the data or whether it's retrospective or prospective, as it's a materials/mechanical engineering study, not a clinical trial.

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

• This question is not applicable to this type of device submission. "Ground truth" in the context of expert consensus is relevant for diagnostic AI/ML devices where experts annotate data for algorithm training and evaluation. For a spinal fixation system, the "ground truth" for its performance is derived from standardized mechanical testing against established engineering benchmarks and comparison to predicate devices, not expert human assessment of images or clinical outcomes in a test set.

4. Adjudication Method:

• Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human experts in establishing ground truth for diagnostic AI/ML systems. This is a mechanical device, not an AI/ML diagnostic.

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

• No. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks. This device is a surgical implant, not a diagnostic tool that assists human readers.

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

• Not applicable. This submission is for a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used:

• The "ground truth" for this device's performance is derived from objective, standardized mechanical testing results (e.g., measurements of bending strength, torsion resistance, fatigue life) compared against established performance characteristics of legally marketed predicate devices and relevant industry standards (ASTM F1717-10, ASTM F2193-02, ASTM F1798).

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" in the context of a mechanical medical device submission. Training sets are for machine learning algorithms.

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

• Not applicable. As there is no training set, this question is not relevant.

In summary: The provided document is for a traditional medical device (spinal fixation system) seeking 510(k) clearance based on substantial equivalence to predicate devices, primarily supported by non-clinical mechanical performance data and material specifications. The questions concerning AI/ML evaluation metrics, expert consensus, and ground truth establishment for algorithms are outside the scope of this submission.

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The APEX Spine 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 the thoracic. Iumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudoarthrosis).

The APEX Spine System is also indicated for pedicle screw fixation 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, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 to S1), and for whom the device is intended to be removed after solid fusion is attained.

The APEX Spine System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with deqeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis).

When used in a percutaneous, posterior approach with AIM Spine MIS instrumentation, the APEX Spine System is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, and/or lordosis), turnor, pseudoarthrosis, and failed prvious fusion in skeletally mature patients . Levels of fixation are for the thoracic. lumbar and sacral spine.

The purpose of this submission is to add cannulated screws to the APEX Spine System and add indications for use of the APEX Spine System in a posterior percutaneous approach and product code NKB. The APEX Spine System Cannulated Screws have exactly the same geometry of the APEX screws with the addition of a cannulation. The screws are available in a variety of diameters and lengths and can be used with the components of the previously cleared APEX Spine System.

Materials: Titanium alloy per ASTM F136

Function: The APEX Spine System is indicated for 1)non-cervical spinal fixation devices intended for posterior, non-pedicle fixation, 2)for non-cervical pedicle screw fixation and 3)hook fixation systems of the non-cervical spine, 4)for degenerative disc disease.

The APEX Spine System is a pedicle screw spinal system. The submission (K110906) addresses the addition of cannulated screws to the system and new indications for use in a posterior percutaneous approach.

1. Table of Acceptance Criteria and Reported Device Performance

• Static Compression Bending
• Static Torsion
• Dynamic Compression Bending | Met: Results were "equal or higher than the predicate systems" for all tests (ASTM F1717-09). |
  | Material Composition:
• Titanium alloy per ASTM F136 | Met: The device utilizes Titanium alloy per ASTM F136. |
  | Biocompatibility: (Implicitly covered by substantial equivalence to predicates) | Met: Substantially equivalent to predicate devices with established biocompatibility. |
  | Sterility:
• Non-sterile, steam sterilized at hospital | Met: Device is non-sterile and intended for steam sterilization at the hospital. |

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

• Sample Size: Not explicitly stated for specific tests. The document refers to "testing" and "results," implying a sufficient number of samples were tested to generate comparative data.
• Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted by the manufacturer or a contracted testing facility, following ASTM standards. This is a retrospective analysis in the context of device design and comparison to predicates.

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

• Not applicable. This submission focuses on the mechanical and material equivalence of a spinal implant system to predicate devices, not on diagnostic accuracy requiring expert interpretation or ground truth establishment in a clinical sense.

4. Adjudication Method for the Test Set

• Not applicable. As noted above, this submission does not involve human readers or clinical interpretation that would require an adjudication method. The "adjudication" here is the comparison of mechanical test results against established predicate device performance and ASTM standards.

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

• No. This type of study is not applicable to a spinal implant system focused on mechanical performance and material composition.

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

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

7. The Type of Ground Truth Used

• Engineering/Performance Standards: The "ground truth" used for testing was primarily based on:
  • ASTM F1717-09: "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model."
  • Predicate Device Performance: The performance of previously cleared spinal systems (e.g., APEX Spine System (K062513), Viper Spine System (K090648), Polaris Spinal System (K103393), Synthes Pangea System (K052123)).
  • Material Specifications: ASTM F136 for Titanium alloy.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of this kinesiologic and material equivalence submission for a physical medical device. The device's design is based on established engineering principles and prior device knowledge, not a data-driven training process.

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

• Not applicable. As there is no training set, this question is not relevant. The "ground truth" in development of such a device is rooted in biomechanical principles, material science, and the established safety and effectiveness of predicate devices.

Summary of the Study Proving Acceptance Criteria:

The study summarized in K110906 is a non-clinical bench testing study designed to demonstrate the substantial equivalence of the modified APEX Spine System (with added cannulated screws and percutaneous approach indication) to its predicate devices.

• Study Name: Non-clinical Test Summary
• Study Type: Bench Testing, Mechanical Performance Comparison.
• Methodology:
  • Tests were conducted according to ASTM F1717-09, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model."
  • Specific tests included: Static Compression Bending, Static Torsion, and Dynamic Compression Bending.
  • The "acceptance criteria" here were that the results of these tests for the new device configuration should be "equal or higher" than those of the predicate devices.
• Results: The new device configuration for the APEX Spine System with cannulated pedicle screws met these performance criteria, with results reported as "equal or higher than the predicate systems."
• Conclusion: Based on these non-clinical tests, the manufacturer concluded that the APEX Spine System with the added cannulated pedicle screws is substantially equivalent to the predicate devices in terms of intended use, design, materials, performance, and function. No clinical studies were performed for this submission, as substantial equivalence was demonstrated through non-clinical testing and comparison to legally marketed predicate devices.

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When used as a pedicle screw fixation system in skeletally mature patients, the NGarde System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment and kyphosis.

In addition, when used as a pedicle screw fixation system, the NGarde System is indicated in patients:
Who are receiving fusions with autogenous graft only; Who are having the device fixed or attached to the lumbar or sacral spine; Who are having the device removed after the development of a solid fusion mass.

The NGarde System is a posterior, non-cervical instrumentation system consisting of both pedicle screws and connecting rods. Screws are of polyaxial top-loading design, are composed of titanium 6Al-4V alloy or titanium 6A1-7Nb, and are available in a range of diameters and lengths to accommodate physiological requirements. The rods are composed of titanium 6A104V alloy and synthetic polycarbonate urethane (PCU) polymer, are 6.0mm in diameter, and are also available in a range of lengths, from 40mm to 200mm.

The modification which is the subject of this Special 510(k) consists of the addition to the NGarde System of two alternate pedicle screws, offered in commercial distribution, which may be used at the physician's discretion as an alternative to the NGarde Systems screws. These alternative pedicle screws are similar and comparable to the NGarde screws and are available in a range of diameters and lengths.

The provided document describes the NGarde System, a pedicle screw system, and its 510(k) summary for a modification. The document explicitly states that no clinical testing was conducted to support this submission. Therefore, it does not contain the detailed information requested regarding device performance, sample sizes, expert involvement, or comparative effectiveness studies.

However, it does provide some information about non-clinical performance and a general statement about acceptance criteria.

Here's the breakdown of what can be extracted based on the provided text:

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

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

• Sample Size: Not specified. The document only mentions "verification and validation tests."
• Data Provenance: Not specified, as no clinical testing was conducted.

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

• This information is not applicable as no clinical testing was performed, and thus no "ground truth" was established in a clinical context for a test set. The validation was based on non-clinical performance data.

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

• Not applicable as no clinical testing was performed.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC study was done. The device is a physical pedicle screw system, not an AI-powered diagnostic or assistive tool for human readers.

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 (expert consensus, pathology, outcomes data, etc)

• Not applicable for clinical ground truth. For the non-clinical verification and validation, the "ground truth" would be defined by engineering specifications, material properties, and biomechanical standards against which the device performance was measured.

8. The sample size for the training set

• Not applicable as this is a physical medical device, not an AI/ML algorithm requiring a training set.

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

• Not applicable.

Summary of the Study:

The study referenced for the NGarde System's modification (a Special 510(k)) was primarily a non-clinical performance evaluation. The document states:

• "Non-Clinical Performance and Conclusions: Such verification and validation tests were identified as appropriate to address the results of a risk analysis for the subject Modification were completed, and met all acceptance criteria."
• "Clinical Performance: No clinical testing was conducted to support this submission."

Therefore, the "study" demonstrating that the device meets acceptance criteria was a series of non-clinical verification and validation tests. These tests were designed to address potential risks associated with the modification (addition of two alternate pedicle screws) and ensure that the modified system performed comparably to its predicate devices in terms of mechanical and material properties, as defined by "rigorous design control and risk analysis procedures." The specific acceptance criteria and detailed test results are not provided in this summary but were presumably part of the comprehensive submission to the FDA.

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