(179 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™ Spinal System is indicated as an adjunct to fusion for one or more of the following:
- 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 (LS-S1) ◆ vertebral joint
- Fracture.
- Dislocation, ●
- . Scoliosis.
- Kyphosis, .
- Spinal tumor.
- Failed previous fusion (pseudarthrosis). .
The Erisma™ LP instrumentation is designed for the surgical treatment of spinal pathologies. 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 provided document, K120469, is a 510(k) summary for a medical device called CLARIANCE Erisma-LP, a Noncervical Pedicle Spine System. This type of device is a physical medical implant, meaning its performance is primarily evaluated through non-clinical testing (e.g., mechanical, material, and biocompatibility testing) rather than clinical studies involving human patients for effectiveness claims in the way a diagnostic algorithm or a drug would be.
Therefore, the requested information regarding acceptance criteria and studies that prove the device meets those criteria will be focused on the non-clinical testing performed rather than traditional clinical comparative effectiveness studies or standalone algorithm performance.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" for performance in the typical sense of metrics like sensitivity, specificity, or AUC, as these would apply to diagnostic or AI-driven devices. Instead, the "acceptance criteria" for a spinal implant are adherence to recognized industry standards for mechanical and material performance.
| Acceptance Criterion (Standard Adherence) | Reported Device Performance |
|---|---|
| ASTM F1717 - 01 | Conforms to the standard, indicating validated design |
| ASTM F1717 - 09 | Conforms to the standard, indicating validated design |
| ASTM F1798 - 97 (Reapproved 2008) | Conforms to the standard, indicating validated design |
| ISO 14971 (Risk Management) | Rigorous application of the standard, eliminating or mitigating known health hazards |
The "reported device performance" is a statement of conformance to these standards, implying that the device successfully met the test requirements outlined within them for aspects like static and fatigue properties of spinal implant constructs and interconnection mechanisms.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of clinical data for performance evaluation. Non-clinical testing involves specific numbers of physical test specimens (implants, constructs) as defined by the ASTM standards, but these details are not provided in this summary.
- Data Provenance (country of origin, retrospective/prospective): Not applicable, as this device's substantial equivalence was determined based on non-clinical testing against standards and comparison to predicate devices, not clinical data collection.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. Ground truth for non-clinical testing refers to the established standards themselves, which are developed by expert committees within organizations like ASTM. The specific number and qualifications of individuals involved in the testing itself are not detailed here.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies to resolve discrepancies in expert interpretations (e.g., image readings). For non-clinical device testing, results are objective measurements against predetermined physical criteria within the standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. MRMC studies are typically performed for diagnostic devices (especially those involving image interpretation by multiple readers) to assess the impact of software or AI on human performance. This device is a physical implant.
- Effect size of human readers improve with AI vs without AI assistance: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? No. This concept applies to diagnostic algorithms or AI systems, not physical implants. The "performance" of the Erisma-LP device is its mechanical integrity and biocompatibility, as demonstrated through non-clinical laboratory tests.
7. Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this device's performance evaluation lies in the established performance criteria and test methodologies within recognized industry standards (ASTM F1717-01, ASTM F1717-09, ASTM F1798-97) and the principles of risk management (ISO 14971). For a physical implant, demonstrating conformance to these standards is how "ground truth" of safety and basic effectiveness (e.g., mechanical stability) is established for 510(k) clearance.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is not an AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
- How Ground Truth for Training Set was Established: Not applicable. As there is no training set for an AI algorithm, this question does not apply.
§ 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.