(150 days)
The Kentrospine PSS Pedicle Screw System is intended for posterior, non-cervical fixation as an adjunct to fusion for skeletally mature patients for rigid fixation and stability with 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 stenoss; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthritis; and/or failed previous fusion.
The Kentrospine PSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation system which consists of PSS Pedicle Screws (Monoaxial, polyaxial), PSS Rods, PSS Locking Cap, and a PSS Crosslink Connectors.
The Kentrospine PSS Pedicle Screw System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. Kentrospine PSS Pedicle Screw System components are supplied non-sterile, single use and are made from medical grade. biocompatible Titanium alloy (Ti6Al4V ELI) conforming to ASTM F136-13(2021)- Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. Various sizes of these implants are available.
The PSS Pedicle Screws are available in diameters from Ø4.50mm to Ø7.00mm and in lengths of 25mm to 55mm. PSS Rods are straight, made from titanium and available in 05.50mm diameter with length from 45mm, 55mm, 65mm, 75mm, 85mm, 100mm, 125mm, 200mm, 250mm, 300mm, 350mm, 450mm and 500mm.
Specialized instruments are available for the application and removal of the Kentrospine PSS Pedicle Screw System. The instruments are made from SAE 316L stainless steel which is complied with ASTM F899 - 20 Standard Specification for Wrought Stainless Steels for Surgical Instruments.
The provided document, an FDA 510(k) summary for the Kentrospine PSS Pedicle Screw System, describes the device's technical specifications, indications for use, and a comparison to a predicate device. However, it explicitly states, "No clinical studies were performed." This means there is no data presented in this document regarding the device's performance in a clinical setting with human subjects, nor any studies that address the performance of an AI algorithm or human-AI teaming.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets those criteria, as this document relates to a physical medical implant (pedicle screw system) and not an AI/software as a medical device (SaMD).
Specifically, the document states:
- "No clinical studies were performed." (Page 6, section "2. Clinical Performance Data/Information")
- The "Performance data" section (Page 6) focuses solely on non-clinical performance, referring to mechanical testing like static compression bending, static torsional testing, static tension bending, and fatigue compression testing against ASTM standards. These tests are relevant for the structural integrity and durability of a physical implant, not the performance of a diagnostic or assistive AI.
To directly answer your prompt based on the provided text, the answer to most of your questions is "Not applicable" or "No information provided" because the document is about a physical medical device (spinal implant) and explicitly states that no clinical studies were performed.
Here's a breakdown of why each specific point cannot be addressed from the given text:
- A table of acceptance criteria and the reported device performance: Not applicable. The "performance data" provided is for mechanical properties of the screw system (e.g., strength, durability), not diagnostic accuracy or AI performance. There are no acceptance criteria for an AI algorithm presented.
- Sample size used for the test set and the data provenance: Not applicable. No test set for an AI algorithm is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for an AI algorithm is established.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. No MRMC study or AI assistance is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI context. For the physical device, the "ground truth" for its performance is its compliance with mechanical test standards.
- The sample size for the training set: Not applicable. No training set for an AI algorithm is mentioned.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document does not contain information relevant to AI device acceptance criteria or performance studies. It is a 510(k) summary for a physical orthopedic implant.
§ 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.