(28 days)
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using allograft and/or autograft, the Erisma® Deformity Spinal System is indicated as an adjunct to fusion for the following indications:
Degenerative disc disease (Define as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Degenerative spondylolisthesis with objective evidence of neurologic impairment; Severe spondylolisthesis (Grades 3 and 4) of the fifth lumbarfirst sacral (L5-S1) vertebral joint; deformities (Scoliosis); spinal tumor; failed previous fusion (pseudarthrosis).
When used as a pedicle screw fixation system of the non- cervical posterior spine in skeletally mature patients using allograft and/or autograft, the Erisma® LP Spinal System is indicated as an adjunct to fusion for the following indications: Degenerative Disc Disease (discogenic pain with degeneration of the disc confirmed by history and radiographic studies); degenerative spondylolisthesis with objective evidence of neurologic impairment; severe spondylolisthesis (grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; fracture; dislocation; scoliosis; kyphosis; spinal tumor; failed previous fusion (pseudarthrosis)
The Erisma® Deformity Spinal System device is designed for use in the surgical treatment of spinal pathologies as outlined in the device's indications for use, which remains the same from the cleared Erisma® Lp Spinal Fixation System device (K170163). The treatment consists of the fusion of two or several vertebrae in order to restore spinal stability, with or without any other endocanalar concomitant surgical procedure. The Erisma® Deformity Spinal System device is an extension of the already cleared Erisma® Lp Spinal Fixation System.
The cleared Erisma® Lp Spinal Fixation System are composed of cannulated and non-cannulated monoaxial and polyaxial screws, crosslinks, rods, screw sets and associated instruments. Further, the implants used in both the cleared Erisma® Lp Spinal Fixation System device and Erisma® Deformity Spinal System are made of Ti6Al4V allov per ASTM F136.
The subject of this submission is the extend to the Erisma® Lp Spinal Fixation System, with the addition new components 'Closed Offset Connectors' and commercialization of the 'Open Offset Connectors' provided in the Erisma® Deformity Spinal System range.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:
Disclaimer: The provided FDA 510(k) clearance letter and its associated summary are for a spinal fixation system, which is a physical medical device. This document does not describe a software algorithm or AI device. Therefore, many of your requested points regarding AI/algorithm performance criteria, sample sizes for training/test sets, expert ground truth, MRMC studies, and standalone performance are not applicable to the information provided.
The document focuses on demonstrating substantial equivalence of a modified physical device (Erisma® Deformity Spinal System) to a legally marketed predicate device, primarily the Erisma® Lp Spinal Fixation System (K170163). This is achieved through engineering performance testing, not clinical studies involving patient data or AI analysis.
Analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Standard) | Device Performance (Test Type) |
|---|---|
| ASTM F1798 (Static axial load gripping) | Performed to characterize subject modification |
| ASTM F1798 (Static axial torque gripping) | Performed to characterize subject modification |
Explanation: The document states that "Static axial load gripping tests and static axial torque gripping tests per ASTM F1798 was performed to characterize the subject modification addressed in this notification." While specific numerical acceptance criteria and precise performance values are not detailed in this summary, the conclusion indicates that these tests were sufficient to demonstrate substantial equivalence in terms of safety and effectiveness. This implies that the device met the performance expectations set by the standard for these tests.
2. Sample size used for the test set and the data provenance
Not applicable. This is a physical device clearance based on mechanical testing, not a study involving patient data or an algorithm's performance on a dataset. The "test set" would refer to the physical units subjected to the mechanical tests, but the quantity is not specified in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of device performance, typically refers to expert interpretation of data for diagnostic or prognostic devices. For a spinal fixation system, "ground truth" relates to the fundamental mechanical properties and performance under stress, evaluated against established engineering standards (ASTM F1798). This does not involve clinical experts establishing ground truth in the way it would for an AI diagnostic tool.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth in image analysis, neither of which are described here. The evaluation is based on engineering test results against a standard.
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 clearance for a physical spinal implant, not an AI or software device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a clearance for a physical spinal implant, not an AI or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this physical device, the "ground truth" for demonstrating substantial equivalence is based on:
- Adherence to established international and national standards for medical device materials and mechanical testing (e.g., ASTM F136 for Ti6Al4V alloy, ASTM F1798 for static gripping tests).
- Demonstrating that the modified device's performance aligns with, or is equivalent to, the performance of the legally marketed predicate devices. The acceptance of the test results by the FDA is based on this engineering comparison.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
Summary of the K240872 Submission:
The K240872 submission is for the Erisma® Deformity Spinal System: Erisma® Lp Spinal Fixation System. It's classified as a Class II medical device (Thoracolumbosacral Pedicle Screw System, 21 CFR 888.3070).
The core of the submission is to demonstrate substantial equivalence to existing predicate devices, primarily the Erisma® LP Spinal Fixation System (K170163) manufactured by CLARIANCE SAS. The current submission extends the previously cleared system by adding new components: 'Closed Offset Connectors' and commercializing 'Open Offset Connectors'.
The study mentioned to prove the device meets acceptance criteria is the Performance Data section, which states:
- "Static axial load gripping tests and static axial torque gripping tests per ASTM F1798 was performed to characterize the subject modification addressed in this notification."
The conclusion then asserts:
- "Performance data demonstrate that the subject devices have a substantially equivalent safety and effectiveness profile compared to the Erisma® Lp Spinal Fixation System (K170163). Thus, the modified Erisma® Lp Spinal Fixation System and Erisma® Deformity Spinal System are substantially equivalent."
Therefore, the "acceptance criteria" were the performance requirements stipulated by the ASTM F1798 standard, and the "study" was the mechanical testing conducted according to that standard. The successful performance in these tests, demonstrating similarity to the predicate device, led to the conclusion of substantial equivalence and FDA clearance.
§ 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.