(112 days)
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
| Acceptance Criteria (Bench Testing) | Reported Device Performance (Response 4.5/5.0 Spinal System) |
|---|---|
| Static yield (comparable to cleared, predicate systems) | Has static yield comparable to cleared, predicate systems. |
| Stiffness (comparable to cleared, predicate systems) | Has static stiffness comparable to cleared, predicate systems. |
| Dynamic compression bending runout properties (comparable to cleared, predicate systems) | Has dynamic compression bending runout properties comparable to cleared, predicate systems. |
| Overall properties (comparable to or better than other commercially available, adult-indicated posterior pedicle screw devices) | Overall, the results show the Response 4.5/5.0 Spinal System to have properties comparable to or better than other commercially available, adult-indicated posterior pedicle screw devices. |
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.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.