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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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The Response Spine System is intended for posterior, non-cervical fixation (pedicle screw fixation T1-S2/ilium and hook fixation (T1-L5)) in pediatric patients is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and/or allograft.

The Response Spine System consists 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, including fixed angled screws, to accommodate differing anatomic requirements.

The OrthoPediatrics Response Spine System (K130655) relies on substantial equivalence to predicate devices rather than a standalone clinical study to demonstrate its safety and effectiveness. The acceptance criteria and the "study" proving it meets those criteria are articulated through mechanical testing designed to show equivalence.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific numerical acceptance values for these tests are not provided in the summary but would be detailed in the full test report, confirming that the Response Spine System's results fell within acceptable ranges or were comparable to the predicate devices.

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

• Sample Size for Test Set: Not explicitly stated as the evaluation focuses on mechanical testing of devices rather than patient data. The "sample" here refers to the number of devices (rods, screws, hooks, connectors) tested under various mechanical loads.
• Data Provenance: Not applicable in the traditional sense of patient data. The testing would have been conducted in a laboratory setting, likely in the US, by the manufacturer or a contracted testing facility. This is a retrospective comparison to existing predicate device data and established ASTM standards.

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

• Number of Experts: Not applicable in the context of mechanical testing. "Ground truth" for mechanical testing is established by the ASTM F1717 standard itself, which is developed by a consensus of engineering and medical experts in the field of spinal implants. The results are physical measurements.
• Qualifications of Experts: The "experts" in this context are the engineers and material scientists who designed and conducted the tests, and those who developed the ASTM F1717 standard.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Mechanical testing results are objective measurements against a standard. There is no human adjudication of "truth" in the way there is for clinical interpretations. The results either meet the standard/equivalence or they don't.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No. This device is a surgical implant undergoing mechanical performance testing, not an imaging or diagnostic device requiring human interpretation of results. Therefore, an MRMC study is not relevant.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

• Standalone Performance: Not applicable. This is a physical medical device, not a software algorithm. Its "performance" is its mechanical integrity under specified loads, which is evaluated directly in a lab.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this evaluation is based on:
  • Established ASTM F1717 Standard: This standard dictates the methodology and acceptable criteria for static and dynamic testing of spinal implant constructs.
  • Performance of Predicate Devices: The measured mechanical properties (e.g., stiffness, fatigue life) of the Response Spine System are compared to those of the legally marketed predicate devices (OrthoPediatrics' OP Spine System and Medtronic CD Horizon) to establish substantial equivalence.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is a physical device being evaluated for mechanical equivalence, not a machine learning model requiring a training set.

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 this type of device evaluation.

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