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The PERLA® TL Posterior Thoraco-lumbar Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used for posterior noncervical pedicle screw fixation in pediatric patients, the PERLA® TL Posterior Thoraco-lumbar Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PERLA® TL Posterior Thoraco-lumbar Fixation System is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The PERLA® TL Posterior Thoraco-lumbar Fixation System consists of a range of screws, rods, set screws, hooks, rod connectors and cross-connectors. These connecting components can be rigidly locked to the rod in a variety of configurations to be adapted for the individual case. The PERLA® TL Posterior Thoraco-lumbar Fixation System is manufactured from medical grade titanium alloy and medical grade cobalt chromium conforming respectively to standards ASTM F136 and ASTM F1537. The PERLA® TL Posterior Thoraco-lumbar Fixation System implants are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments. Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.

The provided text describes a 510(k) premarket notification for the PERLA® TL Posterior Thoraco-lumbar Fixation System. This submission is an "Extension of the range" and an "MRI update" for an already cleared device.

Crucially, the document explicitly states that this is an extension of an existing device and focuses on mechanical testing of new components (rods, rod connectors) and MRI safety evaluations. It does NOT describe a study evaluating the clinical performance or diagnostic accuracy of an AI or software device. Therefore, many of the requested points related to AI performance, such as sample sizes for test and training sets, expert ground truth, adjudication methods, and MRMC studies, are not applicable to this submission.

However, I can extract the relevant information regarding the acceptance criteria and the studies performed for this specific device extension.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The acceptance criteria for this device extension are primarily focused on the safety and performance of the added mechanical components and their compatibility with MRI environments, as well as adherence to material and manufacturing standards.

Regarding the points not applicable to this specific submission (as it's a hardware extension and MRI update, not an AI/software performance study):

• 2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. This document describes mechanical and MRI safety testing, not clinical data analysis. For mechanical testing, samples are typically physical devices.
• 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. No expert ground truth was established as this is not a diagnostic AI device.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudication method was used as this is not a diagnostic AI device.
• 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 not an AI-assisted diagnostic device.
• 6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. This is a medical implant, not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. Ground truth for diagnostic accuracy is not relevant here. The "ground truth" for mechanical testing is adherence to established engineering standards (ASTM).
• 8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
• 9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device requiring a training set.

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The Mariner Cap System is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.

The indications for use include the following applications:

• 1. Spinal trauma surgery, used in sublaminar or facet wiring techniques;
• 2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
• 3. Spinal degenerative surgery, as an adjunct to spinal fusions.

The Mariner Cap System shall be used in conjunction with the SeaSpine Mariner Pedicle Screw System whenever "wiring" may help secure the attachment of other implants.

The Mariner Cap is composed of three components: the Mariner Cap SP Connector, the Mariner Cap SP Locking Base, and the Locking Insert. The cap is designed to mate with the Mariner Pedicle Screw System screws. The Mariner Cap is added to the proximal end of the Mariner Screw and provides for an alternate method to attach the JAZZ Band and JAZZ Passer Band to skeletal structures as compared to the current method using a JAZZ connector (K171881).

The provided FDA 510(k) summary (K201240) describes the Mariner Cap System, a device intended for temporary stabilization as a bone anchor. However, this document does not contain the detailed information required to describe the acceptance criteria and a study that proves the device meets those criteria in the context of device performance as typically understood for AI/ML devices.

The document is a regulatory submission for a medical device (a physical implant), not a software or AI/ML device. Therefore, the "acceptance criteria" and "study" mentioned primarily refer to non-clinical mechanical testing to demonstrate substantial equivalence to a predicate device, rather than performance metrics like sensitivity, specificity, or reader improvement, which are common for AI/ML studies.

Here's a breakdown based on the information available and why certain aspects of your request cannot be fulfilled:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the "acceptance criteria" and "reported device performance" are related to mechanical testing for equivalence to a predicate device.

Note: This is a very different type of "performance" than what would be reported for an AI/ML device. There are no accuracy, sensitivity, or specificity metrics.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable in the context of mechanical testing. The testing would involve a certain number of manufactured devices for various mechanical tests, but this isn't a "test set" of patient data. The document does not specify the number of Mariner Cap Systems or components tested.
• Data Provenance: Not applicable. The "data" refers to the results of mechanical tests performed on the physical device components, not patient data from a specific country or collected retrospectively/prospectively.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable. Ground truth as typically understood for diagnostic AI/ML (e.g., radiologist reads) is not relevant for this type of mechanical device testing. The "ground truth" here would be the physical properties and mechanical behavior of the device under specific test conditions, as measured by standard engineering methods.
• Qualifications of Experts: Not applicable. Engineering and quality assurance personnel would perform and analyze these tests, following recognized standards (like ASTM 1717).

4. Adjudication Method

• Adjudication Method: Not applicable. This concept is relevant for disagreements among human readers or algorithm outputs in diagnostic studies. For mechanical testing, results are quantitative and compared against established benchmarks or predicate device performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No. This type of study is specifically for evaluating the impact of an AI algorithm on human reader performance. The Mariner Cap System is a physical implant, not an AI/ML diagnostic tool.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: No. The device is a physical implant, not an algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: For the mechanical testing, the "ground truth" would be the physical and mechanical properties of the device and its components, determined through standardized engineering tests (e.g., measuring forces, displacements, structural integrity, material properties) and compared against a predicate device.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. There is no training set as the device is not an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set Established: Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

In summary, the provided document describes a regulatory clearance for a physical medical implant (the Mariner Cap System) based on non-clinical mechanical testing demonstrating substantial equivalence to a predicate device. The questions posed in your request are largely tailored towards evaluating AI/ML-based medical devices, and thus many are not applicable to the context of this 510(k) submission.

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