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The RESPONSE 4.5/5.0 and 5.5/6.0 Spine Systems are intended for immobilization of the posterior, non-cervical spine 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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

When used for posterior non-cervical pediatic patients, the Response 4.5/5.0 and 5.5/6.0 Spine System implants are indicated as an adjunct to treat adolescent idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. The Response 4.5/5.0 and 5.5/6.0 Spine Systems are intended to be used with autograff and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The RESPONSE 4.5/5.0 Spine System and RESPONSE 5.5/6.0 Spine System (herein referred to as the RESPONSE Spine Systems) are pedicle screw spinal implant systems consisting of longitudinal members (rods), anchors (hooks and screws), interconnection components (rod-to-rod and anchor-to-rod connectors), and fasteners in a variety of sizes to accommodate differing anatomic requirements. All implant components are manufactured from titanium alloy (6Al-4V-ELI; ASTM F-136), commercially pure titanium (ASTM F67), and cobalt-chromiummolybdenum alloy (ASTM F-1537). All system components and instruments are provided nonsterile.

The longitudinal members (rods) are provided in straight and pre-bent configurations. The anchors include a variety of hooks and pedicle screws. The interconnection components include rod-to-rod and anchor-to-rod connectors. The fasteners include set screws for all the pedicle screws, hooks and connectors. The system is implanted using general (Class I, 510(k) exempt) and specific (Class II) surgical instruments.

This submission adds additional rods, pedicle screws, anchor-to-rod connectors, and Class II instruments to the RESPONSE Spine Systems.

The provided text is a 510(k) summary for the RESPONSE™ Spine System. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance, primarily through comparison of design, materials, and intended use, along with mechanical performance testing.

It does not contain information related to a study that establishes acceptance criteria for, or proves the device meets, performance characteristics typically measured for AI/ML-based medical devices (e.g., sensitivity, specificity, AUC). This type of device is a physical implant (pedicle screw system), and its "performance" is assessed through mechanical strength and durability testing, not through analysis of diagnostic accuracy or reader improvement.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance (in the context of diagnostic accuracy/AI performance).
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study or human reader improvement with AI assistance.
6. Standalone performance (algorithm only).
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

However, I can extract the information provided regarding the mechanical performance tests, which serve as the "study" proving the device's physical capabilities.

Study information related to the device's physical performance:

1. Acceptance Criteria and Reported Device Performance (as related to mechanical testing):

The document lists the types of mechanical performance testing conducted, implicitly indicating that meeting the standards of these tests would be the acceptance criteria for the physical device components. Specific numerical acceptance values or reported performance metrics (e.g., maximum force before failure) are not explicitly provided in this 510(k) summary, only that the tests were performed.

2. Sample size used for the test set and data provenance:
Not applicable as this is mechanical testing of physical implants, not data-driven testing. The "test set" would be the number of physical implants tested for mechanical properties. This specific number is not disclosed in the summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth in this context refers to the physical properties of the materials and constructs, established by engineering and material science standards (ASTM, ISO).

4. Adjudication method for the test set:
Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
No. This study type is for AI/human reader performance, not for physical implant performance.

6. If a standalone performance was done:
Not applicable in the context of AI/ML performance. Standalone performance here relates to the inherent mechanical properties of the devices themselves, which were tested.

7. The type of ground truth used:
Engineering and material science standards (e.g., ASTM, ISO guidelines for mechanical testing and biocompatibility).

8. The sample size for the training set:
Not applicable. The "training set" concept is for AI/ML models, not for physical device manufacturing.

9. How the ground truth for the training set was established:
Not applicable.

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