Search Results

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

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.

Ask a specific question about this device