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The MANTIS® Spinal System and MANTIS® Redux Spinal System is intended for percutaneous, posterior, non-cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications:

• Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
• Spondylolisthesis;
• Trauma (i.e., fracture or dislocation);
• Spinal stenosis;
• Curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
• Tumor:
• Pseudoarthrosis; and
• Failed previous fusion.
  The Titanium and Vitallium® rods from the Stryker Spine RADIUS® Spinal System are intended to be used with the other components of MANTIS® Spinal System and MANTIS® Redux Spinal System.

This 510(k) is intended to introduce a line extension to the existing MANTIS® Redux Spinal System. The line extension consists of additional sizes of the MANTIS® Redux Long Arm Polyaxial Screws. The additional sizes include the 7.5 mm and 8.5 screw diameter, ranging 30 - 90 mm in length for the MANTIS Redux Spinal System. No modifications were made to the MANTIS Spinal System.

The provided text is a 510(k) summary for a medical device (Stryker Spine MANTIS® Spinal System and MANTIS® Redux Spinal System). It focuses on demonstrating substantial equivalence to predicate devices for a line extension. It does not contain information on acceptance criteria, a study proving device performance against acceptance criteria, or any of the detailed study parameters you've requested (sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth types, or training set details).

This type of submission typically relies on non-clinical (bench) testing to show that the new components meet established performance standards and are comparable to existing, legally marketed devices. It does not involve clinical studies with human participants or the assessment of AI algorithm performance as described in your prompt.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study proving device performance because that information is not present in the provided document.

The document discusses:

• Device Modification: Additional sizes (7.5 mm and 8.5 mm diameter, 30-90 mm length) for MANTIS® Redux Long Arm Polyaxial Screws.
• Intended Use: Percutaneous, posterior, non-cervical pedicle and non-pedicle fixation of the spine for immobilization and stabilization as an adjunct to fusion in skeletally mature patients for various indications (e.g., DDD, spondylolisthesis, trauma).
• Technological Characteristics: Substantial equivalence in terms of material, design, and indications for use to predicate devices.
• Testing: Static Compression Bending testing, Static Torsion testing, and Fatigue Compression Bending testing per ASTM F1717 were conducted on the subject components and compared to a predicate system to demonstrate substantial equivalence.

In summary, the provided text describes a regulatory submission for a medical device line extension, not a study evaluating AI performance or clinical efficacy against specific acceptance criteria for diagnostic or therapeutic accuracy.

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The MANTIS® Spinal System is intended for posterior, non-cervical pedicle fixation 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, pseudoarthrosis and failed previous fusion.

This Special 510(k) submission is intended to introduce a line extension to the MANTIS Spinal System, which entails additional diameter size cannulated polyaxial screw components as well as additional straight rod components in a variety of lengths. Modifications were made to the existing MANTIS Spinal System (K061813) to render the new components. The MANTIS Spinal System will include cannulated polyaxial screw, pre-bent rod and straight rod components that can be used via either a percutaneous surgical approach or a standard open approach.

The provided text does not describe the acceptance criteria or a study that proves a device meets such criteria. Instead, it is a 510(k) summary for a spinal fixation system, focusing on its substantial equivalence to predicate devices and its intended use.

Therefore, I cannot provide the requested information in the format specified because the necessary details are not present in the given input.

The document discusses:

• Proprietary Name: MANTIS® Spinal System
• Common Name: Spinal Fixation Appliances
• Regulatory Class: Class III
• Device Product Code: 87 MNH, 87 MNI, 87 NKB
• Predicate Devices: Stryker Spine MANTIS Spinal System (K061813), Stryker Spine Xia® Titanium Spinal System (K013823, K043473, K002858, K060361), and Stryker Spine Osteonics Spinal System (K951725).
• Description of Device Modification: Line extension including additional diameter size cannulated polyaxial screw components and additional straight rod components.
• Intended Use: Posterior, non-cervical pedicle fixation for indications such as degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, and failed previous fusion.
• Technological Comparison: States that the additional screw and rod components have equivalent mechanical properties to the predicate devices and are made from the same materials.

Missing Information:

The document does not contain any information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or data provenance.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method for a test set.
5. Multi-reader, multi-case (MRMC) comparative effectiveness study or effect size.
6. Standalone (algorithm only) performance study.
7. Type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

This is a regulatory submission aimed at demonstrating substantial equivalence based on material and mechanical properties compared to already cleared devices, not a study evaluating performance against specific acceptance criteria for a new feature or algorithm.

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The MANTIS™ Spinal System is intended for percutaneous, posterior, non-cervical pedicle fixation 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, pseudoarthrosis and failed previous fusion.

The MANTIS™ Spinal System includes cannulated polyaxial screw and straight or pre-bent rod components that can be used via a percutaneous surgical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy. The implants will be provided non-sterile.

The provided text is a 510(k) Summary for the MANTIS™ Spinal System, a medical device for spinal fixation. It details the device's description, intended use, and substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria or a study proving device performance against such criteria in the context of the requested AI/algorithm evaluation.

The 510(k) process for this type of medical device (spinal fixation system) typically involves demonstrating substantial equivalence to a legally marketed predicate device through engineering tests (e.g., mechanical strength, fatigue, biocompatibility) rather than clinical studies of "acceptance criteria" or "device performance" as understood in algorithm evaluation (like sensitivity, specificity, or reader studies).

Therefore, I cannot provide the requested information from the provided document.

To be explicit, the following information is not available in the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The 510(k) focuses on substantial equivalence to predicate devices, not specific performance metrics against pre-defined acceptance criteria, especially not in an AI/algorithm context.
2. Sample sized used for the test set and the data provenance: Not applicable/not present. No "test set" for an algorithm is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not present.
4. Adjudication method: Not applicable/not present.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This document describes a physical medical device, not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No.
7. The type of ground truth used: Not applicable/not present.
8. The sample size for the training set: Not applicable/not present.
9. How the ground truth for the training set was established: Not applicable/not present.

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