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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 (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 lumbar-first sacral (L5-S1) vertebral joint; fracture; dislocation; scoliosis; kyphosis; spinal tumor; failed previous fusion (pseudarthrosis)

The Erisma® LP MIS components are intended for percutaneous, posterior, non-cervical pedicle fixation of the spine to provide immobilization of spinal segments in skeletally mature patients 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 lumbar-first sacral (L5-S1) vertebral joint,
• · Fracture,
• · Dislocation,
• · Scoliosis,
• · Kyphosis,
• · Spinal tumor,
• · Failed previous fusion (pseudarthrosis).

The modified Erisma® Lp Spinal Fixation 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® Deformity Spinal System; Erisma® Lp Spinal Fixation System device (K240872). 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 cleared Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System is composed of cannulated and non-cannulated monoaxial and polyaxial screws, crosslinks, rods, Offset Connectors, screw sets and associated instruments. Further, the implants used in the cleared Erisma® Lp Spinal Fixation System device and modified Erisma® Lp Spinal Fixation System are both made of Ti6Al4V alloy per ASTM F136.

The modified Erisma® LP MIS 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 MIS device (K162367). The Erisma® LP MIS device is indicated for the surgical treatment of spinal pathologies by percutaneous access. The treatment consists of the stabilization of two or several vertebrae in order to restore spinal stability, with or without any other endocanalar concomitant surgical procedure.

The Erisma® LP MIS consists of cannulated extended pedicle screws and straight or pre-bent rods that can be used via posterior percutaneous surgical approach to provide the immobilization and the stabilization of spinal segments in mature patients as an adjunct to fusion in the treatment of instabilities or deformities of the thoracic, lumbar and sacral spine. The components are available in a variety of diameters and lengths to accommodate patient anatomy and are made from ISO 5832-3 or ASTM F136 medical grade Titanium alloy.

The subject of this submission is the extend to the Erisma® Lp Spinal Fixation System and the Erisma® LP MIS, with the addition of new components: 'Uniplanar Screws'

The provided text describes a 510(k) premarket notification for a spinal fixation system, not an AI/ML powered device. Therefore, it does not contain the specific information requested about acceptance criteria and studies related to AI/ML device performance.

The document focuses on demonstrating substantial equivalence to predicate devices for a modified Erisma® Lp Spinal Fixation System and Erisma® LP MIS. The performance data presented are for mechanical tests, not clinical studies involving AI or human interpretation.

Therefore, I cannot provide the requested information for acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this submission is not for an AI/ML powered medical device.

The "Performance Data" section explicitly states: "Dynamic compression bending test and Static torsion mechanical verification test according to ASTM F1717 and static torsional grip test according to ASTM F1798 were performed to characterize the subject modification addressed in this notification." These are mechanical tests for a physical implant, not a study of an AI algorithm's diagnostic or predictive capabilities.

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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.

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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 Fixation System is indicated as an adjunct to fusion for the following indications:

• Deqenerative 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® LP instrumentation is designed for the surgical treatment of spinal pathologies. The treatment consists in the fusion of two or several vertebrae in order to restore spinal stability, with or without any other endocanalar concomitant surgical procedure.

The Erisma® LP spinal system is composed of rods (straight or pre-bent) fixed on the spine with pedicle screws. The Erisma® LP includes monoaxial and polyaxial pedicle screws (cannulated or not), monoaxial and polyaxial pedicle screws with breaking tabs, as well as transverse link which connects two rods altogether.

The implants used in the Erisma® LP system are available in a variety of diameters and lengths to accommodate patient anatomy and are made of medical grade titanium alloy per ASTM F136 or cobalt-chromium allov per ASTM F1537.

The Erisma® LP procedures are performed using a set of surgical instruments common for posterior spinal fixation approach. Most of the instruments provided are common surgical tools used in these types of posterior fixation of the spine.

This document describes the Clariance SAS Erisma® LP Spinal Fixation System, a medical device for spinal surgery. The information provided is from an FDA 510(k) summary. I will extract the requested information based on the provided text.

Based on the provided text, the Erisma® LP Spinal Fixation System is a mechanical device (spinal fixation system), not an AI/ML-driven diagnostic or assistive device. Therefore, many of the typical acceptance criteria and study characteristics for AI/ML devices (like human reader performance, ground truth establishment, training sets, etc.) are not applicable to this submission.

The acceptance criteria and study described here relate to the mechanical performance and material characteristics of the spinal fixation system.

Here's the breakdown of the requested information, adapted for a mechanical device:

1. A table of acceptance criteria and the reported device performance

   Acceptance Criterion	Reported Device Performance
   Dynamic Axial Compression per ASTM F1717	Performed and characterized the modification. The submission indicates the performance demonstrates the modified device is as safe and effective as the predicate device. Specific numerical results are not provided in this summary.
   Substantial Equivalence to predicate devices (K153326 and K130877)	Achieved. The modified device has the same intended use, similar indications, principles of operation, and technological characteristics. Performance data supports that it is as safe and effective.
   Material Composition	Cobalt-chromium alloy per ASTM F1537 (for new rods); medical grade titanium alloy per ASTM F136 (for other components).
   Dimensions and Design	Rods have similar dimensions and design as those already cleared under K153326 for the Erisma® LP predicate device.

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: Specific numbers are not provided in this summary. Mechanical testing typically involves a set number of samples required by the standard (ASTM F1717).
   • Data Provenance: Not explicitly stated, but mechanical testing is typically performed in a laboratory setting. There is no indication of country of origin for the test data or whether it was retrospective or prospective, as these terms are usually applied to clinical studies.

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. For mechanical testing of a spinal fixation system, "ground truth" is established by the test standard (e.g., ASTM F1717) and the physical properties of the materials and design, not by expert consensus in the typical sense of clinical image review. The acceptance is based on meeting the performance requirements defined by the standard.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discordant expert opinions in clinical studies (e.g., image interpretation). This is a mechanical device performance study, where acceptance is based on objective measurements 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 mechanical device, not an AI/ML device, so MRMC studies involving human readers are not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

   • Not Applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

   • Mechanical Standard Compliance/Predicate Equivalence: The "ground truth" for this device's performance is its compliance with recognized mechanical testing standards (e.g., ASTM F1717) and demonstrating substantial equivalence in performance and characteristics to legally marketed predicate devices.

8. The sample size for the training set

   • Not Applicable. This is a mechanical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

   • Not Applicable. As there is no training set for a mechanical device, this question is not relevant.

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