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The SurgTech Thoracolumbosacral (TLS) Posterior Fixation System is intended to provide pedicle and non-pedicle immobilization and stabilization of the posterior non-cervical spine (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

The SurgTech Thoracolumbosacral (TLS) Posterior Fixation System consists of longitudinal members (rods), anchors (hooks and screws), interconnections (cross connector) and fasteners in a variety of sizes to accommodate differing anatomic requirements.

This document describes a 510(k) premarket notification for the "SurgTech Thoracolumbosacral (TLS) Posterior Fixation System," a spinal implant, not an AI/ML powered device.

Therefore, the requested information about acceptance criteria and study design relevant to AI/ML device performance (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) is not applicable and cannot be found within the provided text.

The document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing and comparison of technological characteristics.

Here’s the information that is present regarding the device's performance and testing:

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

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

• Not Applicable. The testing performed was mechanical testing of the device itself, not a clinical study on human subjects in the context of an AI/ML model's performance. The "test set" here refers to the device constructs subjected to mechanical stress. The number of constructs tested is not specified, but it's stated they were "worst-case" constructs.
• Provenance: Not specified beyond the tests being conducted on physical device constructs.

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

• Not Applicable. This is not an AI/ML diagnostic or predictive device requiring expert ground truth for its performance evaluation in that context. The "ground truth" for mechanical testing is based on established engineering standards (ASTM F1717) and the ability to withstand specified loads without failure, usually validated by engineers.

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

• Not Applicable. Adjudication methods are relevant for clinical assessments, particularly in AI studies where expert consensus on image interpretation or diagnoses is needed. This was mechanical testing.

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 device is a spine implant, not an AI-assisted diagnostic tool. No MRMC study was performed.

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

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

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

• For mechanical testing, the "ground truth" is defined by the acceptance criteria specified in the ASTM F1717 standard (mechanical performance thresholds and failure modes). The device's performance was compared to that of legally marketed predicate devices, implying that their performance under the same standard serves as a comparative benchmark.

8. The sample size for the training set:

• Not Applicable. There is no AI/ML model, hence no training set.

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

• Not Applicable. There is no AI/ML model, hence no training set ground truth.

In summary, the provided document describes a medical device (spinal fixation system) that received 510(k) clearance based on substantial equivalence demonstrated through mechanical testing against established standards and comparison to predicate devices, not through performance evaluation of an AI-powered diagnostic or therapeutic algorithm.

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The SurgTech Trauma System plates and screws are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions appropriate for the size and design of the device.
The large plate set components are indicated for the use including the femur and tibia. The small plate set is indicated for use in various bones including the clavicle, scapula, humerus, radius, ulna, pelvis, tibia and fibula. The mini plate set is indicated for use in various small bones including the metacsals, phalanges, calcaneus and those of the ankle.
In addition, the SurgTech Trauma System cancellous, cannulated lag, headless compression and non-locking cortical screws are indicated for use in bone reconstruction, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device.

The SurgTech Trauma System is a plate and screw fixation system. Plates are offered in "mini," "small" and "large" set sizes in a variety of shapes based upon the anatomical fixation required. Screws are also offered in "mini" "small" and "large" sets and, in addition, in locking cortical, non-locking cortical, cancellous and headless versions. Screws can also be used for fixation without the plates.

The provided text describes a 510(k) premarket notification for the "SurgTech Trauma System," which consists of bone plates and screws. This document is a regulatory submission to the FDA demonstrating substantial equivalence to existing legally marketed devices.

Crucially, the provided text DOES NOT contain information about an AI/ML-based medical device study.

Instead, the "Performance Data" section explicitly states that the device's performance was evaluated through mechanical testing of the plates and screws according to ASTM standards (ASTM F382 for bending, and other standards for torsion, insertion/removal, and pullout for screws).

Therefore, I cannot fulfill your request for information related to AI/ML acceptance criteria or a study proving its performance, as this document pertains to a traditional orthopedic implant, not an AI-powered diagnostic or therapeutic device.

To reiterate, the document details:

• Device: SurgTech Trauma System (bone plates and screws)
• Purpose of Submission: 510(k) premarket notification for substantial equivalence.
• Performance Evaluation Method: Mechanical testing (e.g., static and dynamic bending, torsion, insertion/removal, pullout) against ASTM standards.

It does not mention any AI/ML components, ground truth establishment by experts, MRMC studies, or any other elements relevant to AI/ML device performance evaluation.

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The SurgTech Interbody System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These patients may have had a previous non-fusion spinal surgery and may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). These devices are intended to be used with supplemental fixation which has been cleared for use in the lumbar spine.

The SurgTech Interbody System is a system of intervertebral body fusion devices. The Posterior Lumbar device is a structural column in a generally rectangular shape having a rounded nose. Teeth are integral to the inferior and superior surfaces and there is a central cavity to be filled with autograft. The implants are available in an assortment of footprint, height and angulation combinations to accommodate a variety of anatomic requirements.

The provided text describes a 510(k) premarket notification for a medical device called the "SurgTech Interbody System." This document is focused on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific clinical acceptance criteria through a study with performance metrics.

Therefore, many of the requested details about acceptance criteria, study sample sizes, expert ground truth, adjudication methods, and MRMC studies are not applicable or available within this type of regulatory submission.

However, I can extract information regarding the performance testing that was conducted:

1. Table of acceptance criteria and reported device performance:
   The document does not specify quantitative acceptance criteria. Instead, it states that the device's performance was compared to predicate devices.

   Acceptance Criteria (Quantitative)	Reported Device Performance (Quantitative)
   Not specified (Qualitative: Substantially equivalent to predicate)	Not specified (Qualitative: Demonstrated substantial equivalence to predicate)

   Performance Testing Details Provided:

   • Mechanical Testing: Performed on the "worst case" SurgTech Interbody System device according to ASTM F2077. This included static and dynamic compression.
   • Subsidence Testing: Performed on the "worst case" SIS PL device according to ASTM F2267.
   • Conclusion: "The mechanical test results demonstrate that the SurgTech Interbody System performance is substantially equivalent to the predicate devices."

2. Sample size used for the test set and the data provenance: Not applicable. This was mechanical testing, not a clinical study on a patient test set. The provenance is internal testing by SurgTech Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was mechanical engineering testing, not clinical evaluation requiring expert ground truth.

4. Adjudication method for the test set: Not applicable.

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-enabled device and no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-enabled device.

7. The type of ground truth used: For the mechanical tests, the "ground truth" was established by adherence to and successful completion of specified ASTM standards (ASTM F2077 for static/dynamic compression and ASTM F2267 for subsidence). The "substantial equivalence" claim is relative to the performance of predicate devices under similar testing.

8. The sample size for the training set: Not applicable. There is no mention of a training set as this is not an AI/ML device. The testing was physical mechanical testing.

9. How the ground truth for the training set was established: Not applicable.

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