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Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.

The PILOT® Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities.

When used as a posterior spine thoracic/lumbar system, the PILOT® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

The PILOT® Spinal System consists of an assortment of rods, screws, and bodies in various shapes ITIC I THE PILOT® Spinal System side loading bodies are designed to accept either a 5.5mm or 6.35mm diameter rod. The rods are either pre-lordosed or straight.

The proposed modification to the PILOT Spinal System enhances the ease of use of the system by increasing the force transfer efficiency.

The PILOT® Spinal System implant components are made from titanium alloy described by ASTM F 136. Stainless steel and titanium implant components must not be used together in a construct. Do r 150. Sameess steel and notes spinal System components with the components from any other system or manufacturer. The PILOT® Spinal System components should never be reused under any circumstances.

The provided document is a 510(k) summary for the PILOT® Spinal System, a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against acceptance criteria through a clinical study with real-world data and expert ground truth.

Therefore, many of the requested information points, such as sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types for AI/ML device studies, are not applicable to this document as it describes a physical hardware device validated through mechanical testing, not an AI/ML algorithm.

However, I can extract the relevant information regarding performance data.

1. Table of Acceptance Criteria and Reported Device Performance

This device is not an AI/ML device, so "acceptance criteria" here refers to the standards for mechanical performance.

Note: The document states that the performance data (static and fatigue testing per ASTM F1717) was presented to "demonstrate the substantial equivalency of the PILOT Spinal System" to its predicate devices. Specific numerical results for these tests are not provided in this summary but would have been part of the full 510(k) submission.

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

This is not applicable as the document describes mechanical testing of a spinal implant system, not an AI/ML algorithm evaluated on a dataset. The "test set" would refer to the physical devices tested.

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

This is not applicable. Ground truth, in the context of AI/ML, involves human interpretation or pathology. For mechanical device testing, the "ground truth" is established by the objective physical properties and behavior under defined loads, as measured by testing equipment according to established standards.

4. Adjudication method for the test set

This is not applicable. Adjudication methods are relevant for subjective human assessments in clinical or AI/ML ground truth establishment. Mechanical tests have objective pass/fail criteria based on 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

This is not applicable, as this is not an AI-assisted diagnostic device.

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

This is not applicable, as this is a physical medical device, not an algorithm.

7. The type of ground truth used

This is not applicable in the AI/ML sense. For this mechanical device, the "ground truth" for performance is based on established engineering standards and physical measurements (e.g., load-bearing capacity, fatigue life) according to ASTM F1717.

8. The sample size for the training set

This is not applicable, as this device does not involve a "training set" in the context of AI/ML.

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

This is not applicable, as this device does not involve a "training set" or "ground truth" in the context of AI/ML.

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Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.

The PILOT® Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities.

When used as a posterior spine thoracic/lumbar system, the PILOT® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

When implanted in the thoracic, lumbar, and/or sacral spine, the PILOT® Spinal System provides additional support during spinal fusion. The PILOT® Spinal System consists of screws and rods in a variety of shapes and sizes. The PILOT® Spinal System is manufactured from medical grade titanium alloy and will be sold non-sterile. Modifications to the PILOT® Spinal System that are the subject of this submission are confined to the modification of the tightening mechanism of the body component.

The document describes design modifications made to the PILOT® Spinal System and demonstrates its substantial equivalence to previously cleared devices. The acceptance criteria and the study proving the device meets these criteria are related to biomechanical performance.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states that "Biomechanical testing in accordance with ASTM F1717 was conducted." This implies that the 'test set' in this context refers to the samples of the PILOT® Spinal System components and constructs that were subjected to the specified biomechanical tests.

• Sample Size: Not explicitly stated in terms of a number of devices or constructs. ASTM F1717 generally specifies test setup and conditions, but the exact number of samples for each test type (e.g., static compression, static torsion, fatigue compression/torsion) is determined by the manufacturer to achieve statistically significant results.
• Data Provenance: The data is generated from laboratory biomechanical testing of the device itself. It is not patient data (retrospective or prospective). Therefore, there is no country of origin of data in the typical clinical study sense.

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

This question is not applicable in the context of this 510(k) submission. For mechanical devices like spinal systems, "ground truth" is established through standardized engineering and materials testing (e.g., ASTM F1717 for mechanical performance). The "experts" involved would be engineers and laboratory technicians experienced in biomechanical testing, rather than medical professionals establishing clinical ground truth.

4. Adjudication Method for the Test Set:

Not applicable. Biomechanical testing relies on objective measurements and established standards (ASTM F1717). There is no "adjudication" in the sense of multiple human evaluators reviewing results.

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 pedicle screw spinal system, a physical medical implant. It is not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.

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

Not applicable. This device is a physical medical implant, not an algorithm or software.

7. The Type of Ground Truth Used:

The "ground truth" for the device's performance is established by the results of biomechanical testing conducted in accordance with ASTM F1717. This standard defines the methods for mechanical testing of spinal implant constructs, and the results (e.g., stiffness, strength, fatigue life) are compared against the requirements and performance of legally marketed predicate devices to demonstrate substantial equivalence.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical implant, not a software or AI system that requires a "training set."

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

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

Ask a specific question about this device

Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.

The PILOT™ Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities.

When used as a posterior spine thoracic/lumbar system, the PILOT™ Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

When implanted in the thoracic, lumbar, and/or sacral spine, the PILOT™ Spinal System provides additional support during spinal fusion. The PILOT™ Spinal System consists of a screws and rods in a variety of shapes and sizes. The PILOT™ Spinal System is manufactured from medical grade titanium and will be sold non-sterile.

The provided text describes a medical device, the PILOT™ Spinal System, and its clearance process through a 510(k) submission. However, it does not contain the specific details required to fully answer your request regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/algorithm-based device.

Here's a breakdown of what can and cannot be extracted from the provided text based on your request:

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

• Acceptance Criteria: Not explicitly stated as pass/fail criteria with numerical targets.
• Reported Device Performance: The document states "Biomechanical testing in accordance with ASTM F1717 was conducted to demonstrate substantial equivalence." This implies that the device performed comparably to predicate devices under the conditions of ASTM F1717, but specific performance metrics or thresholds are not provided. The outcome of this testing was used to claim "substantial equivalence."

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

• This information is not available in the provided text. ASTM F1717 is a standard for spinal implant testing, which typically involves mechanical testing on simulated bone or cadaveric specimens, not a clinical "test set" of patient data.

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

• This information is not applicable/available as the provided text describes a mechanical implant, not an AI/algorithm for diagnosis or image interpretation that would require expert ground truth labeling.

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

• This information is not applicable/available for the same reason as point 3.

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

• This information is not applicable/available as the device is a physical pedicle screw spinal system, not an AI-assisted diagnostic tool.

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

• This information is not applicable/available as the device is a physical implant, not an algorithm.

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

• The "ground truth" for this type of device is typically established through engineering standards and biomechanical properties (e.g., strength, durability, fatigue resistance) as defined by ASTM F1717, rather than clinical outcomes or expert consensus on clinical data. The goal is to show it performs equivalently to existing cleared devices under these physical tests.

8. The sample size for the training set:

• This information is not applicable/available as the device is a physical implant and does not use a "training set" in the context of machine learning.

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

• This information is not applicable/available for the same reason as point 8.

In summary, the provided document describes a traditional medical device (spinal implant) undergoing 510(k) clearance based on substantial equivalence to predicate devices, primarily through biomechanical testing against an industry standard (ASTM F1717). It does not involve AI or algorithmic performance evaluation, hence most of your specific questions are not addressed by this type of submission.

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