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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 (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 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®-LP system is composed of rods fixed on the spine with pedicle screws. The Erisma®-LP includes monoaxial and polyaxial screws cannulated or not and monoaxial and polyaxial screws with or without breaking tabs, as well as a transverse link which connects two rods altogether.

The implants used in the Erisma®-LP system are made of ISO 5832-3 or ASTM F136 medical grade titanium alloy.

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. Those instruments are considered Class I, general purpose, manual orthopedic instruments encompassed within the regulation in 21CFR 888.4540.

This document is a 510(k) summary for the Erisma®-LP Spinal Fixation System. It describes a medical device, specifically a pedicle screw spinal system.

Based on the provided text, the Erisma®-LP Spinal Fixation System is a mechanical device, not an AI/software device. Therefore, a discussion of acceptance criteria and studies in the context of AI/software device performance, ground truth, and human reader studies is not applicable.

The document focuses on demonstrating substantial equivalence to predicate devices through a comparison of:

• Intended Use and Indications for Use: These are the same as the cleared Erisma®-LP system.
• Technological Characteristics: The modified device has small differences (addition of breaking tabs, improved polyaxial screw assembly fixation strength, change in screw threading) that are stated not to raise new safety or effectiveness concerns and are present in reference devices.
• Performance Data (Bench Testing):
  • Dynamic ASTM F1717-15 testing
  • Pull-Out ASTM F543 testing

The information typically requested for AI/software device performance (such as a table of acceptance criteria vs. reported performance, sample size for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance) is not part of this submission for a hardware medical device.

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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™ 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.

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.

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