(84 days)
The Black Diamond Pedicle Screw System, with or without MIS instrumentation, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.
When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Black Diamond Pedicle Screw System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Black Diamond Pedicle Screw System is intent patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatic pedicle screw fixation is limited to a posterior approach.
The Black Diamond Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, and cross links. All the components are available in a variety of sizes to match more closely the patient's anatomy
The provided text describes a 510(k) premarket notification for a medical device called the "Black Diamond Pedicle Screw System." This document focuses on demonstrating substantial equivalence to previously marketed predicate devices, primarily through non-clinical mechanical testing, rather than a clinical study involving human patients or complex AI algorithms. Therefore, much of the information requested about acceptance criteria for AI/ML performance, sample sizes for test sets, expert adjudication, MRMC studies, and ground truth establishment is not applicable to this specific submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The "acceptance criteria" presented in this submission are not expressed as specific performance metrics and thresholds (e.g., accuracy > X%, AUC > Y%) typical for AI/ML devices. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through various comparisons, primarily mechanical testing.
| Acceptance Criteria (Implied by Substantial Equivalence Claim) | Reported Device Performance (Summary) |
|---|---|
| Similar intended use | "similar intended uses" |
| Same materials | "fabricated from the same material as the predicate devices" |
| Similar design features/functions | "share similar basic design features and functions" |
| Dimensionally similar | "dimensionally similar to cited predicate devices" |
| Sterilization method (non-sterile) | "supplied non-sterile and cited predicate devices are non-sterile" |
| Non-inferior mechanical performance | "Showed as good or better performance to the cited predicate devices under the same test conditions." |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable in the context of human data or image data for AI/ML. The "test set" here refers to the Black Diamond Pedicle Screw System components themselves undergoing non-clinical mechanical testing. The specific number of physical components tested is not detailed, but standard mechanical testing involves multiple samples to ensure statistical validity.
- Data Provenance: Not applicable in the context of human data. The "data" comes from mechanical testing of the device components.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not human expert interpretation.
4. Adjudication Method:
Not applicable.
5. MRMC Comparative Effectiveness Study:
Not applicable. No clinical studies involving human readers or AI assistance were performed.
6. Standalone Performance Study:
Not applicable. This is a physical medical device, not an AI algorithm. The performance evaluation is based on mechanical testing of the device itself.
7. Type of Ground Truth Used:
Ground truth for this submission is based on engineering standards and direct physical measurements derived from non-clinical mechanical testing (e.g., static and dynamic compression per ASTM F1717, static torsion per ASTM F1717).
8. Sample Size for the Training Set:
Not applicable. This device is not an AI/ML model and does not have a "training set" in that context.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
§ 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.