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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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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 5.5/6.0 Spine System is intended for immobilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to 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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

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

The Response 5.5/6.0 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 to accommodate differing anatomic requirements.

No accessories are offered with the system.

The provided document is a 510(k) Pre-Market Notification for a medical device called the "Response 5.5/6.0 Spine System." This document focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical testing and a review of material biocompatibility. It is not a study proving the device meets acceptance criteria related to AI or algorithmic performance, as the device itself is a physical spinal implant system, not a software algorithm.

Therefore, the requested information about AI/algorithmic performance, sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types and establishment are not applicable to this document. These questions are designed for evaluating AI/software as a medical device (SaMD), which this spinal system is not.

However, I can extract information regarding the device's mechanical acceptance criteria and the study (testing) performed to meet them.

Here's the relevant information paraphrased from the document:

1. Table of Acceptance Criteria and Reported Device Performance (Mechanical Testing)

The document states that the acceptance criteria for all mechanical tests were pre-determined. While the specific numerical acceptance values are not provided in this summary, the document explicitly states:

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

• Sample Size for Test Set: Not explicitly stated in terms of number of implants tested, but testing was performed on "subject devices" as per ASTM F1717 and ASTM F1798.
• Data Provenance: Not applicable in the context of clinical data provenance (e.g., country of origin, retrospective/prospective clinical study) as this refers to mechanical performance testing of the device itself, not clinical data from patients. The testing was conducted by OrthoPediatrics Corp.

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

• This question is not applicable as there is no "ground truth" established by human experts for mechanical testing of a physical medical device in the way it would be for an AI algorithm evaluating medical images. The "ground truth" for mechanical testing is defined by the standardized test methods (ASTM F1717 and ASTM F1798) and their associated performance specifications.

4. Adjudication method for the test set

• This question is not applicable for mechanical testing. Performance is evaluated against objective, pre-defined engineering standards established by ASTM.

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 question is not applicable. This is a physical spinal implant, not an AI software.

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

• This question is not applicable. This is a physical spinal implant, not an AI software.

7. The type of ground truth used

• For mechanical performance: The "ground truth" (or standard of performance) is defined by the requirements of the recognized industry standards: ASTM F1717 - "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model" and ASTM F1798 - "Standard Guide to Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants."

8. The sample size for the training set

• This question is not applicable. There is no "training set" for a physical medical device. The design, materials, and manufacturing processes are developed based on engineering principles and prior knowledge, not machine learning training.

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

• This question is not applicable for the same reasons as above.

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