(247 days)
The General System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, kyphosis, and/or lordoss), (3) spinal tumor, (4) failed previous fusion, (6) spinal stenosus. It is not intended for pedicle screw fixation above T8. This device may be used with autograft and/or allograft.
The General Spinal System consists of Fixed-Angle Reduction Screws. Rods, Cross Link and set screws. It is made of Titanium Alloy (Ti6Al4VELI), which meets ASTM F136-02a, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well known biocompatibility. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 10 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
The provided document is a 510(k) summary for the "General Spinal System," a pedicle screw spinal system. It describes the device, its intended use, and states that non-clinical tests were conducted to demonstrate substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, reported device performance metrics, detailed study designs (such as sample sizes, ground truth establishment, or expert qualifications), or the results of comparative effectiveness studies (MRMC) or standalone algorithm performance studies that would be necessary to answer the questions thoroughly.
Therefore, I can only provide information based on what is available in the document.
Detailed Breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in terms of specific performance metrics (e.g., specific load endurance values, displacement limits) that a device must meet, nor does it report specific numerical performance results for the device against such criteria.
Instead, the document states: "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standard: ASTM F1717-04, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, including the following items: Static compression bending test; Dynamic compression bending test; Static torsion test."
This implies that the acceptance criteria are adherence to the ASTM F1717-04 standard's methodologies and achieving comparable performance to the predicate device(s) within the scope of these tests. Without specific data, a table cannot be constructed with numerical values.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Compliance with ASTM F1717-04 for Spinal Implant Constructs in a Vertebrectomy Model | The device's non-clinical tests demonstrated compliance with ASTM F1717-04 for static compression bending, dynamic compression bending, and static torsion tests. The device was deemed Substantially Equivalent (SE) to predicate devices based on these tests. |
2. Sample size used for the test set and the data provenance
The document describes non-clinical mechanical tests. It does not involve human data or test sets in the context of clinical trials. Therefore, "sample size used for the test set" and "data provenance (e.g. country of origin of the data, retrospective or prospective)" are not applicable in the context of this device's testing as described. The testing was likely conducted in a laboratory setting.
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 the document describes non-clinical mechanical testing, not a study involving ground truth established by experts (e.g., radiologists, pathologists). The "ground truth" for mechanical testing is typically defined by the test standard (e.g., ASTM F1717-04) and the physical properties observed.
4. Adjudication method for the test set
This question is not applicable for the same reason as points 2 and 3. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert consensus scenarios, not for mechanical bench testing.
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. The device is a "General Spinal System" (a pedicle screw spinal system), which is a physical implant, not an AI or imaging diagnostic device. Therefore, MRMC studies and AI assistance are irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical medical implant, not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests described, the "ground truth" refers to the established performance characteristics and requirements outlined in the ASTM F1717-04 standard for spinal implant constructs, as well as the observed mechanical properties (e.g., strength, stiffness, fatigue life) of the tested device and its predicate(s). It is purely objective mechanical measurement, not a subjective "truth" established by experts or clinical outcomes.
8. The sample size for the training set
This question is not applicable. The document describes the testing of a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
§ 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.