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The Spine-Tech Silhouette Spinal Fixation System, when used as a pedicle screw fixation system, is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the LS-S1 joint; b) who are receiving fusion using autogenous graft only; c) who are having the device fixed or attached to the lumbar or sacral spine; and d) who are having the device removed after the development of a solid fusion mass. When used for this indication, the fusion mass may not go above the L5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum.

When used as a hook and sacral screw system, the Spine-Tech Silhouette Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for sacral/iliac attachment only, screws of the Spin-Tech Silhouette Spinal Fixation System are intended for sacral/iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

The Spine-Tech Silhouette™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and facilitates the biological process of the spine. This system is intended for posterior use in the thoracic, lumbar and sacral regions of the spine. Implants of this system consist of hooks and/or screws, polyaxial screws of varying diameters and lengths, fixed screws of varying diameters and lengths, rods in varying lengths, hooks in varying designs, and transverse connectors, both fixed and variable. All implants in this system are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6A1-4V), conforming to ASTM F-136.

The implants of this system are for single use only. An implant should never be reused after being removed from the body or sterilized after coming into contact with body fluids or tissues.

The provided document is a 510(k) summary for the Spine-Tech Silhouette™ Spinal Fixation System. It describes the device, its intended use, and the basis for its substantial equivalence to predicate devices. However, it does not contain information regarding specific acceptance criteria, a formal study demonstrating the device meets those criteria, or details about a test set, ground truth, or expert involvement typically associated with AI/software device evaluations.

Instead, this document focuses on a medical device (spinal implant system) rather than a software or AI-based diagnostic/predictive device. The "testing" mentioned refers to biomechanical testing of the physical implants.

Therefore, many of the requested categories are not applicable to the content provided.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document does not specify quantitative acceptance criteria in terms of performance metrics commonly associated with software/AI (e.g., sensitivity, specificity, AUC). The performance reported is that the physical device components showed "equivalent mechanical performance" to predicate devices.

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

• Sample Size for Test Set: Not applicable. The "testing" refers to biomechanical tests on device components, not a clinical test set from human data for an AI/software.
• Data Provenance: Not applicable. The biomechanical testing would have been conducted in a lab setting, not using human data from a specific country or in a retrospective/prospective manner.

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

• Number of Experts: Not applicable. Ground truth, in the context of AI/software, refers to clinically verified labels or outcomes. For biomechanical testing, the "ground truth" would be established by engineering standards and measurements, not clinical experts.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable, as there is no clinical test set or ground truth adjudication process described.

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

• MRMC Study: No, this type of study is typically conducted for diagnostic imaging devices where human readers interpret medical images, often with AI assistance. This document describes a physical spinal implant system.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable, as this is a physical medical device.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the biomechanical testing, the "ground truth" would be the established engineering and materials science standards for spinal implants (e.g., ASTM F-136 for titanium alloy, specifications for load-bearing, fatigue, etc.). This is a physical or engineering "ground truth," not a clinical ground truth.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document is not about an AI/ML model, so there is no training set in that sense. The design and manufacturing processes are informed by engineering principles and possibly prior iterations, but not a "training set" of data.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML model. The design and manufacturing of the physical device components are based on established engineering and medical device standards.

Summary of Document's Focus:

The K980288 document is a premarket notification for a physical medical device. Its purpose is to demonstrate substantial equivalence to legally marketed predicate devices, primarily through comparison of materials, design, function, and biomechanical testing. It does not involve software or artificial intelligence, and therefore, the requested information pertaining to AI/software validation studies is not present.

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The Spine-Tech Bone Harvester is indicated for the cutting and collection of morselized autogenous bone graft from the anterior or posterior iliac crest, tibia or femur.

This device is intended to cut and collect finely morselized autogenous bone graft for any surgical procedure requiring bone graft to facilitate fusion and/or fill bone defects. These procedures include; spinal fusion, joint arthrodesis, total joint replacement, fracture repair, maxillofacial reconstruction and tumor removal.

All components of the Spine-Tech Bone Harvested are intended for single use only.

The Spine-Tech Bone Harvester consists of two cutting head/collection tube sizes, Hudson or Hall fitting adapter for power use, trocar and plunger. The cutting heads and trocar are constructed from stainless steel. The collection tube and adapter are constructed from medical grade polycarbonate. The plunger is constructed from acetal copolymer.

After cutting and collection of morselized bone graft, the cutting head is removed from the collection tube with the trocar and bone is pushed out of the collection tube with the plunger.

Here's an analysis of the provided 510(k) summary, aiming to extract the requested information about acceptance criteria and study details.

Based only on the provided text, it's immediately clear that the device is a physical medical instrument (bone harvester), not a software or AI-driven diagnostic device. Therefore, many of the requested points, such as those related to AI assistance, ground truth establishment for AI models, and sample sizes for training sets, are not applicable to this type of submission.

The 510(k) summary for a Class I device like the Spine-Tech Bone Harvester focuses on demonstrating substantial equivalence to predicate devices and verifying basic safety and performance, rather than complex clinical efficacy studies typically seen for higher-risk devices or novel technologies.

Acceptance Criteria and Study Details for Spine-Tech Bone Harvester

Given the nature of the device (a Class I surgical instrument), the "acceptance criteria" discussed in the 510(k) are related to materials, design, and basic functional performance, rather than diagnostic accuracy metrics like sensitivity or specificity. Similarly, the "study" referred to is primarily bench testing and internal quality assurance, not clinical trials with patient populations or expert reviews.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes used for the test set and the data provenance:

• Sample Size for Test Set: Not explicitly stated. The "test set" here refers to the actual devices or components tested during bench and quality assurance. This would typically involve a sample from manufacturing lots. The specific number of units tested is not provided in this summary.
• Data Provenance: The "testing" described is internal bench testing and quality inspection. Therefore, the data would be internally generated by Spine-Tech, Inc. There is no mention of specific country of origin for this testing data, nor whether it was retrospective or prospective (as these terms usually apply to clinical data, not manufacturing verification).

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 to this type of device and submission. "Ground truth" and "experts to establish ground truth" are concepts relevant to diagnostic devices, particularly those involving image interpretation or clinical judgment. For a bone harvester, "ground truth" would relate to its ability to physically cut and collect bone, which is verified through engineering tests, not expert consensus on diagnoses.

4. Adjudication method for the test set:

This information is Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve disagreements among multiple experts interpreting data, typically in diagnostic studies. For mechanical device testing, the results are objectively measured (e.g., dimensions, cutting efficiency, material strength) against pre-defined specifications, not subject to subjective expert interpretation requiring adjudication.

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. An MRMC study and discussions of AI assistance are relevant for AI/ML-driven diagnostic devices, not for a manual surgical instrument like a bone harvester.

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

This information is Not Applicable. This concept applies to AI/ML software. The Spine-Tech Bone Harvester is a physical instrument requiring user operation.

7. The type of ground truth used:

The "ground truth" for this device's performance would be:

• Engineering Specifications: Successful completion of bench tests (e.g., material strength, cutting efficiency, dimensional accuracy) against pre-defined engineering and design specifications.
• Adherence to Standards: Compliance with relevant material and biocompatibility standards (e.g., ASTM standards mentioned).
• Substantial Equivalence: Demonstrated equivalence in material, design, and function to legally marketed predicate devices, implying that if the predicate is safe and effective, the new device, being equivalent, also is.

8. The sample size for the training set:

This information is Not Applicable. "Training set" refers to data used to train AI/ML models. This device is a manual surgical instrument; there is no AI model involved.

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

This information is Not Applicable, for the same reason as point 8.

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