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The PERLA® TL Posterior Osteosynthesis System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; 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 Osteosynthesis System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PERLA® TL Posterior Osteosynthesis System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The PERLA® TL posterior osteosynthesis 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 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 osteosynthesis implants are delivered either non-sterile or 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 subject product line extension of the PERLA® TL Posterior Osteosynthesis System manufactured by Spineart (K193396; K203222; K203506) consists of addition of cannulated fenestrated sagittal screws in various sizes and designs to accommodate different patient anatomies or surgeon's techniques.

The provided text describes a 510(k) premarket notification for a medical device called the "PERLA® TL Posterior Osteosynthesis System." This document primarily discusses the substantial equivalence of the new components (cannulated fenestrated sagittal screws) to previously cleared predicate devices based on mechanical performance and design.

However, the provided text DOES NOT contain information regarding the acceptance criteria for an AI/ML powered medical device, nor does it describe a study involving human readers or AI performance metrics such as sensitivity, specificity, or AUC.

The document details the FDA's acknowledgement of the 510(k) submission, the indications for use of the device, and a summary of the technical characteristics and non-clinical performance testing (mechanical testing like static and dynamic compression bending) to demonstrate substantial equivalence to predicate devices. It states:

• "Static compression bending, static torsion and dynamic compression bending testing were conducted in conformance to ASTM F1717-18. Results demonstrated substantial equivalence between Cannulated Fenestrated Sagittal Screw added component to the PerlaⓇTL system and the identified predicate devices."
• "As was established in this submission, the PERLA® TL added components are substantially equivalent and have the same technological characteristics to predicate devices in areas including indications for use, function, material composition, design, range of sizes and mechanical performance."

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves an AI-powered device meets the acceptance criteria based on the provided text. The device described (PERLA® TL Posterior Osteosynthesis System) is a physical medical implant (pedicle screw system), not an AI/ML-powered software device.

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The PERLA® TL posterior osteosynthesis 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 non-cervical pedicle screw fixation in pediatric patients, the PERLA® TL posterior osteosynthesis system is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PERLA® TL posterior osteosynthesis system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The PERLA® TL posterior osteosynthesis 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 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 osteosynthesis implants are delivered either non sterile or 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 subject product line extension of the PERLA® TL Posterior Osteosynthesis System manufactured by Spineart (K193396) consists of addition of cannulated screws (various models), fenestrated screws (various models), percutaneous rods and associated surgical instruments.

This is a 510(k) premarket notification for a medical device (PERLA® TL posterior osteosynthesis system), not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, and data provenance related to AI/ML performance is not present in the provided document.

The document discusses the substantial equivalence of the PERLA® TL device to legally marketed predicate devices, focusing on:

• Indications for Use: The system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for various spinal conditions in skeletally mature patients and for adolescent idiopathic scoliosis in pediatric patients.
• Device Description: It consists of screws, rods, set screws, hooks, rod connectors, and cross-connectors made from medical-grade titanium alloy and cobalt chromium. The current submission is a product line extension adding cannulated and fenestrated screws, percutaneous rods, and associated instruments.
• Technological Characteristics: The added components share the same indications for use, function, material composition, design, range of sizes, and mechanical performance as predicate devices.
• Non-clinical Performance Testing: Static compression bending, static torsion, and dynamic compression bending tests were conducted according to ASTM F1717 to demonstrate comparable mechanical properties to predicate devices.

Therefore, the information regarding acceptance criteria, study design, and data specifics that would be relevant for an AI/ML-based device (e.g., sample size, expert consensus, ground truth, effect size) is not applicable to this submission.

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The PERLA® TL posterior osteosynthesis system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of 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 non-cervical pedicle screw fixation in pediatric patients, the PERLA® TL posterior osteosynthesis system is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PERLA® TL posterior osteosynthesis system is intended to be used with autograft and/or allograft.
Pediatric pedicle screw fixation is limited to a posterior approach.

The PERLA® TL posterior osteosynthesis 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 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 osteosynthesis implants are delivered either non sterile or sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable - provided non-sterile except for the drill supplied as sterile or not sterile). Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.

This document pertains to the PERLA® TL posterior osteosynthesis system, a medical device, not an AI/ML device. Therefore, the questions related to AI/ML specific aspects such as sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training sets are not applicable.

However, based on the provided text, I can extract information regarding the device's acceptance criteria and the study conducted to prove it meets these criteria, focusing on the mechanical aspects relevant to this type of medical device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each of the mechanical tests (Static Axial Gripping, Static Axial Torque Gripping, Static Compression Bending, Static Torsion, and Dynamic Compression Bending). These are typically bench tests conducted on a sufficient number of device samples to ensure statistical validity and demonstrate equivalence to the predicate device.
Data provenance: The tests were conducted according to ASTM standards, which are internationally recognized. The data is from non-clinical testing performed by Spineart to support the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as this is not an AI/ML diagnostic device requiring expert interpretation for ground truth. The "ground truth" here is the objective measurement of mechanical properties against established ASTM standards and comparison to a legally marketed predicate device.

4. Adjudication method for the test set
Not applicable. Mechanical testing governed by ASTM standards uses objective measurements and predefined pass/fail criteria, often through comparison to a predicate device, rather than expert 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
Not applicable, as this is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML device.

7. The type of ground truth used
For the mechanical tests, the ground truth is established by the specified ASTM standards (e.g., F1798, F1717) themselves, which define methodologies for measuring specific mechanical properties. The performance of the predicate device (ROMEO® 2 Posterior Osteosynthesis System) also serves as a benchmark for demonstrating substantial equivalence. For bacterial endotoxin, the USP standard defines the acceptable limit. A "cadaver lab trial" was also conducted, which provides real-world functional insights, but its "ground truth" would be observational and qualitative regarding surgical handling and fit rather than a strict quantitative measure against a "ground truth" in the diagnostic sense.

8. The sample size for the training set
Not applicable, as this is not an AI/ML device. There is no concept of a "training set" in the context of mechanical performance testing for this type of implant.

9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.

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