(81 days)
The Easy Rod is a variation of the Vincer ISOLA rod of the ISOLA Spine System. This rod offers the suggeon casier contourability and casior in-site bending compared with crising V inch disneter ISOLA System consists of two subsystems: The Posterior ISOLA system and the Anarior 1501:4 System. The Easy Rod is intended to be used with the Posterior ISOLAsystem at this time.
The ISQLA implants, when used with pedicte scews, are in Grade 3 or 4 spondylolisthesis at LS-S1 utilizing and logous bone graft, having the device to the lumbar and secral spinc and intended to be removed after solid fusion is amained.
When not used with redicle screws, the ISOLA System is intended for hook, wire, and or sacrabilias screw fixation from the T1 to the ilium/secum. The non pedicle screw indications are spondylolistesis, degate (defined as discogence back pain with degencration of the disc confirmed by history and radios), deformines (scolinsis, lordosis and kyphosis), buttor, forture and previous failed surgery.
As a whole, the Posterior ISOLA spinal system is intended for T !- secral fixation. Pedicle secon fixation is from 13-S1.
The Anterior ISOLA system is intended for use in correcing schiol deformities by establishing an scially and routionally rigid firstion bridge parallel to the soinc. The Anterior system is indicated in sincations where loss of correction is expected, where scollosis cass or where pelvic obliquity is present. Spinal levels for anterior instrumentation ac from TS-L4.
Properly used, the Posterior and Anterior ISOLA Systems will provide temporary stabilization as an adjunct to spinal bone grafing processes. Specific indications are:
- Idiopathic scoliosis.
- Neuromuscular scoliosis kyphoscoliosis with associated paralysis or spacisticity.
- Scollosis with deficient posterior elements such as that resulting from laminectomy or myelomeningoosle.
- Spinal fractures (acute reduction or late deformity).
- Degenerative disc disease (defined as discognic back pain with deperation of the discover and radiographic studies).
- Neoplastic discase.
- Revision surgery.
The Anterior ISOLA system is also used for the correction and stabilization of schiotic curves, for the prevence of undesired scoliotic curves, and for the stabilization of weskened trunks. Indications for these include:
- Collapsing and unstable paralytic deformity.
- Progressively increasing scoliosis.
- Decreasing cardio-respiratory function, secondary to spinst or rib deformity or collapse.
- Inability to maintain sitting balance, necessitating the use of the hands.
- Increasing pelvic obliquity coincident with beck pain or loss of sitting balance.
The stainless steel Easy Rod is offered in 1/4 inch (6.35 mm) outer diameter and 18" (457 mm) in length. Generally, two rods are required in the construct and are cut to the appropriate length during the surgical procedure. The Easy Rod is a variation of rods previously cleared for the ISOLA Spinal System under K884163 and K944737.
The provided text describes the 510(k) summary for the AcroMed Easy Rod, a component of the ISOLA Spinal System. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed performance data from a clinical study. Therefore, the information requested about acceptance criteria, device performance, and study methodology is largely not present in this regulatory filing as it would be for a clinical trial.
However, I can extract the relevant information that is available and note what is missing.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Consistency with previously cleared components | "Static and fatigue testing show the AcroMed Easy Rod to perform consistent with previously cleared components." |
| Equivalence to AcroMed's 1/2 inch diameter ISOLA rod (K944737) | "The AcroMed Easy Rod is equivalent to AcroMed's 1/2 inch diameter ISOLA rod as cleared under K944737..." |
| Equivalence to the Harrington System | "...and to the Harrington System, manufactured by Zimmer beginning in the 1960's." |
Missing Information:
- Specific quantitative acceptance criteria (e.g., minimum fatigue cycles, specific load limits).
- Detailed quantitative performance data for the Easy Rod (e.g., actual fatigue cycles achieved, load-to-failure values). The statement simply asserts consistency, not concrete numbers against criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The performance data section refers to "static and fatigue testing" which indicates mechanical testing, not a clinical test set with patient data.
- Data Provenance: Not applicable in the context of clinical data. This refers to mechanical testing conducted by the manufacturer, AcroMed Corporation, based in Cleveland, OH, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The "performance data" refers to mechanical testing, not clinical studies requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This pertains to clinical studies, not mechanical 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
- No. This is a medical device (spinal rod) and not an AI/imaging diagnostic device. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For mechanical testing, the "ground truth" would be established by engineering standards and validated testing protocols.
8. The sample size for the training set
- Not applicable. No training set is mentioned as this device is not an AI/machine learning system.
9. How the ground truth for the training set was established
- Not applicable. No training set is mentioned.
Summary of the Study:
The "study" described in the 510(k) summary is a series of mechanical static and fatigue tests. The purpose of these tests was to demonstrate substantial equivalence of the AcroMed Easy Rod to legally marketed predicate devices. The key finding was that the Easy Rod's performance was consistent with previously cleared components, specifically AcroMed's 1/2 inch diameter ISOLA rod (K944737) and the historical Harrington System. This is a common approach for spinal fixation device 510(k) clearances, where mechanical performance equivalence is used to establish safety and effectiveness without requiring new clinical trials, given the predicate device's established clinical history.
§ 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.