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Erisma®-LP Navigated Instruments are intended to be used in the preparation and placement of Erisma® Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Erisma®-LP Navigated Instruments are manual, non-sterile, reusable surgical instruments for use with the Medtronic StealthStation™ Navigation System to assist the surgeon in locating anatomical structures in either open, minimally invasive or percutaneous procedures for preparation and placement of the Clariance Erisma®-LP, Erisma®- MIS pedicle screw implants. The Erisma®-LP Navigated Instruments include the following instruments: Drivers, Tap, Bone Awl, Probes. The instrumentation is designed for use with the Medtronic StealthStation™ Navigation System hardware and software. These instruments are made of medical quality stainless steel according to the ASTM F899 and titanium alloy according to the ASTM F136.

The provided text is a 510(k) premarket notification for the Erisma®-LP Navigated Instruments. This document outlines the manufacturer's claim of "substantial equivalence" of their device to a legally marketed predicate device.

It's crucial to understand that a 510(k) submission primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive de novo clinical trials.

Unfortunately, the provided text does not contain the level of detail typically found in a clinical study report for AI-powered or diagnostic devices regarding acceptance criteria and performance data. The "Performance Data – Non-Clinical" section explicitly states that mechanical tests were performed, not a clinical study involving human patients or complex AI algorithms.

Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of AI or diagnostic performance (e.g., sensitivity, specificity, human reader improvement with AI) cannot be extracted from this document.

Here's an analysis of the provided information relative to your request:

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

Not applicable in the context of this 510(k) submission.
The document describes non-clinical performance data for mechanical and compatibility aspects of a surgical navigation instrument, not a diagnostic or AI-driven performance study with acceptance criteria like accuracy, sensitivity, or specificity. The "Performance Data – Non-Clinical" section mentions:

• Compatibility between Erisma®-LP Navigated Instruments and Medtronic Naclock Tracker.
• Ability of Erisma®-LP Navigated Instruments to be registered by Medtronic StealthStation™ System.
• Simulation of pedicle insertion.

The reported performance is that these tests "demonstrated the substantial equivalence of the system to legally marketed devices." No specific numerical "acceptance criteria" or "reported device performance" metrics (e.g., within X mm accuracy) are provided, as this is a general statement of equivalency for mechanical function.

2. Sample size used for the test set and the data provenance

Not applicable for a clinical test set.
The testing described is non-clinical/mechanical. There is no mention of a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable.
There was no clinical test set requiring expert ground truth.

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

Not applicable.
There was no clinical test set requiring adjudication.

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

No.
This device is a navigated surgical instrument, not an AI-powered diagnostic or interpretive device for human readers. Therefore, an MRMC study and AI assistance improvement are irrelevant to its nature.

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

No.
This is a physical surgical instrument system used in conjunction with "human-in-the-loop" (a surgeon) and the Medtronic StealthStation™ Navigation System. It is not a standalone algorithm.

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

Not applicable in a clinical sense.
For the mechanical tests, the "ground truth" would be engineering specifications and the performance of the predicate device.

8. The sample size for the training set

Not applicable.
This device likely does not use machine learning in a way that requires a "training set" of data in the common sense of AI/ML software. Its functionality relies on physical design and interface with the navigation system.

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

Not applicable.
As above, no training set data.

In summary: The provided document is a 510(k) for a navigated surgical instrument (Erisma®-LP Navigated Instruments) intended to assist surgeons in spine surgery by precisely locating anatomical structures when used with the Medtronic StealthStation® System. The regulatory pathway is based on substantial equivalence to an existing predicate device (Medtronic Navigated CD Horizon Solera Screwdriver/Taps).

The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical mechanical tests and compatibility assessments rather than clinical performance trials or AI/diagnostic performance studies. The document states these non-clinical tests "demonstrated the substantial equivalence of the system to legally marketed devices," which is the fundamental "acceptance criterion" for a 510(k) submission. No detailed quantitative acceptance criteria or clinical performance metrics (like accuracy, sensitivity, or human reader performance) are provided, nor would they typically be for this type of device and regulatory submission.

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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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