(70 days)
The AcroMed Cable/Wire Pedicle Screw is designed to be utilized with the ISOLA Spine System (K951657). When used with pedicle screws, the ISOLA implants are intended for use in grade 3 or 4 spondylolisthesis at L5-S1 utilizing autologous bone graft and intended to be removed after solid fusion is attained. Levels of attachment for the indication range from L3 to the sacrum.
The ISOLA Spinal System, when not used with pedicle screws, is intended for hook, wire, and/or sacral/iliac screw fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture and previous failed surgery.
As a whole, the ISOLA Spinal System is intended for T1-sacral fixation. Screw fixation is from L3-S1.
The AcroMed Cable/Wire Pedicle Screw is a pedicle screw with a modified grooved head and hole through the base of the head. The ISOLA rod is placed on top of the screw so that the rod fits in the groove. The groove is sized to accommodate both the 4.75 mm and 6.35 mm diameter rods.
The AcroMed Cable/Wire Pedicle Screw is intended for use with 18 gauge wire (304.8 mm in length) (K895439), which adjoins the screw to the rod. Alternatively, stainless steel Songer cable (K935481) may be used in place of 18 gauge wire. The wire or cable is threaded through the hole at the base of the screw head and the wire is twisted or the cable is crimped over the top of the rod.
The screw is available in cancellous lengths of 25.0 mm, 30.0 mm, and 35.0 mm.
The AcroMed Cable/Wire Pedicle Screw is manufactured from implant grade stainless steel conforming to ASTM F1314 specifications. The wire is made from stainless steel conforming to ASTM F1350 specifications. Stainless steel Songer cables are manufactured from stainless steel conforming to ASTM F138 specifications.
This document describes a medical device, the AcroMed Cable/Wire Pedicle Screw, and its intended use with the ISOLA Spine System. The information provided is for regulatory clearance (510(k) summary) and focuses on demonstrating substantial equivalence to previously cleared devices rather than a study proving the device meets explicit acceptance criteria in the context of clinical performance or AI/software.
Therefore, many of the requested categories are not applicable to this type of document, which describes a physical medical implant and its mechanical testing.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance consistent with previously cleared components. | "Static and fatigue testing show the AcroMed Cable/Wire Pedicle Screw to perform consistent with previously cleared components." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for the static and fatigue testing.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This would typically be laboratory-based mechanical testing, not clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: This device is a mechanical implant. Performance is evaluated through laboratory testing (static and fatigue) against engineering standards or comparison to predicates, not through expert-established ground truth in a clinical or imaging context.
4. Adjudication method for the test set
- Not Applicable: See point 3. Testing is mechanical/laboratory, not based on expert adjudication.
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
- Not Applicable: This is a physical medical device (pedicle screw), not an AI or imaging-based diagnostic/software device. Therefore, MRMC studies and AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable: See point 5.
7. The type of ground truth used
- Implied Ground Truth: For mechanical testing, the "ground truth" would be established engineering standards for strength, fatigue life, and deformation, often compared against predicate devices. The document explicitly states "consistent with previously cleared components."
8. The sample size for the training set
- Not Applicable: There is no "training set" as this is not an AI/machine learning model.
9. How the ground truth for the training set was established
- Not Applicable: See point 8.
Summary of Study that Proves the Device Meets Acceptance Criteria:
The document states that "Static and fatigue testing show the AcroMed Cable/Wire Pedicle Screw to perform consistent with previously cleared components." This implies a series of mechanical tests (e.g., measuring ultimate tensile strength, yield strength, endurance limit under cyclic loading) conducted in a laboratory environment. The "acceptance criteria" appear to be that the device's mechanical performance should be equivalent to or better than that of predicate devices (other AcroMed pedicle screws cleared under K951657 and the Harrington Lag Screw). However, the specific protocols, loads, cycles, or results of these tests, including the specific quantitative acceptance criteria, are not detailed in this 510(k) summary. This summary serves as an attestation of such testing having been performed and the results being favorable for substantial equivalence.
§ 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.