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The Response Spine System (Response 4.5/4.0 & Response 5.5/6.0 Spine Systems) is intended for immobilization and stabilization 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, pseudoarthrosis, and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Response Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Response Spine System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Response Spine System is a pedical screw spinal implant system consisting of longitudinal members (rods), anchors (hooks and screws), interconnection components (rod-to-rod and anchorto-rod connectors) and fasteners in a variety of sizes to accommodate differing anatomic requirements.

Here's an analysis of the provided text regarding the OrthoPediatrics Response Spine System's acceptance criteria and studies:

The provided FDA 510(k) clearance document for the Response Spine System does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/human-in-the-loop diagnostic device.

Instead, this document is for a medical implant (spinal system) and the "acceptance criteria" and "study" refer to mechanical bench testing to demonstrate performance compared to a predicate device. The information requested in your prompt (e.g., sample size for test sets, expert ground truth, MRMC studies, standalone algorithm performance) is typically relevant to AI/diagnostic imaging devices, not spinal implants.

Therefore, many of your requested fields cannot be filled based on this specific document. However, I will answer the fields that are addressed by the document, focusing on the mechanical testing context.

Acceptance Criteria and Device Performance for OrthoPediatrics Response Spine System (K181390)

The provided document details the clearance of the Response Spine System, a medical implant, primarily based on demonstrating substantial equivalence to a predicate device through mechanical bench testing. It does not involve AI or diagnostic performance.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact number of test samples or constructs used for the mechanical tests. It refers to "worst case line extension Response 4.5/5.0 Spinal System pedicle screw constructs."
• Data Provenance: The testing was bench-top mechanical testing performed by the manufacturer, OrthoPediatrics, Corp. This is not clinical data, so country of origin or retrospective/prospective distinctions are not applicable in the usual sense.

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

• Not Applicable. This is a mechanical device, not a diagnostic one requiring expert interpretation of images or clinical data to establish ground truth. "Ground truth" for mechanical testing is based on engineered specifications and comparison to predicate device performance.

4. Adjudication method for the test set:

• Not Applicable. As this involves mechanical testing of a medical implant, adjudication methods like 2+1 or 3+1 are not relevant. Performance is determined by physical measurements against established engineering standards and predicate device performance.

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. An MRMC study was not done. This is not an AI-assisted diagnostic device.

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

• No. This is not an AI algorithm.

7. The type of ground truth used:

• The ground truth for the mechanical testing was the established mechanical performance characteristics of the predicate device (Response 5.5/6.0 Spine System, K150600) and general industry standards for thoracolumbosacral pedicle screw systems, as well as the intrinsic mechanical properties measured during testing.

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning device that requires a training set.

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

• Not Applicable. No training set was used.

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