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The T-PLATE ANTERIOR PLATE FIXATION SYSTEM is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures. When properly used this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 2) Pseudoarthrosis; 3) Spondylolysis; 4) Spondylolisthesis; 5) Fracture; 6) Neoplastic disease; 7) Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, lordosis, and / or kyphosis) associated with pelvic obliquity.

The modified T-PLATE Anterior Fixation System (The Translation Plate Phase 1 (T-1 plate) and The Translation Plate Phase 2 (T-2 plate)) is a temporary implant used for the correction and stabilization of the spine. The system is also intended to help provide temporary stabilization and to help augment the development of a solid spinal fusion. The modified T-PLATE Anterior Fixation System (The Translation Plate Phase 1 (T-1 plate) and the Translation Plate Phase 2 (T-2 plate)) is a supplemental fixation device consisting of a variety of sizes of plates, and screws, as well as ancillary products and instrument sets. The modified T-PLATE Anterior Fixation System (The Translation Plate Phase 1 (T-1 plate) and the Translation Plate Phase 2 (T-2 plate)) components can be locked into a variety of configurations, with each construct being tailor-made for the individual case. The implant components are made from medical grade titanium alloy. Stainless steel and titanium components must not be used together in a construct.

Here is an analysis of the provided information, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states that "Mechanical testing was performed" but does not specify the sample size used for this testing. It also does not provide any information regarding data provenance (e.g., country of origin, retrospective or prospective). Given that this is a 510(k) for a mechanical device, the "test set" would refer to the mechanical specimens tested, not patient data.

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

This information is not applicable to this submission. For a mechanical device, "ground truth" is established through engineering standards, test methods, and quantitative measurements of mechanical properties, not through expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable. Mechanical testing does not involve adjudication in the way clinical studies or expert reviews do. Standardized test methods (e.g., ASTM, ISO) typically dictate how results are measured and interpreted.

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 MRMC comparative effectiveness study was mentioned or performed. This submission is for a physical medical device (an anterior fixation system), not an AI-powered diagnostic or assistive tool. Therefore, the concepts of human readers or AI assistance are not relevant.

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

Not applicable. As stated above, this is for a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is based on mechanical engineering standards and quantitative measurements of the device's physical properties and performance under various loads and conditions (e.g., fatigue, static strength, stiffness). The comparison is made against the performance of the legally marketed predicate device.

8. The Sample Size for the Training Set

There is no concept of a "training set" in this type of 510(k) submission for a mechanical device. The device is designed, manufactured, and then tested, not "trained."

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

Not applicable. As there is no training set, there is no ground truth established for it.

Summary of Acceptance Criteria and Study for K072231:

The primary acceptance criterion for the T-PLATE Anterior Fixation System in this 510(k) submission (K072231) was demonstrating substantial equivalence to a previously cleared predicate device (K051764).

The study that proves the device meets this acceptance criterion was "mechanical testing." This testing compared the performance of the modified T-PLATE system (T-1 plate and T-2 plate) to the predicate device. The nature of this testing would involve evaluating properties like strength, fatigue resistance, and construct stability, ensuring that the modified device performs comparably to the predicate for its intended use as a spinal fixation system. While specific details of the tests (e.g., specific loads, cycles, failure modes) and the number of samples are not provided in this summary, the FDA's clearance indicates that these mechanical tests were sufficient to demonstrate substantial equivalence, thus meeting the regulatory acceptance criteria for market authorization.

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The T-PLATE ANTERIOR PLATE FIXATION SYSTEM is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures. When properly used this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 2) Pseudoarthrosis; 3) Spondylolysis; 4) Spondylolisthesis; 5) Fracture; 6) Neoplastic disease; 7) Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, lordosis, and / or kyphosis) associated with pelvic obliquity.

The T-PLATE Anterior Fixation System is a temporary implant used for the correction and stabilization of the spine. The system is also intended to help provide temporary stabilization and to help augment the development of a solid spinal fusion. The T-PLATE Anterior Fixation System is a supplemental fixation device consisting of a variety of sizes of plates, and screws, as well as ancillary products and instrument sets. The T-PLATE Anterior Fixation System components can be locked into a variety of configurations, with each construct being tailor-made for the individual case. The implant components are made from medical grad titanium alloy. Stainless steel and titanium components must not be used together in a construct.

The provided text describes a medical device, the T-PLATE Anterior Fixation System, and its regulatory approval process, specifically a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a full clinical study with acceptance criteria and performance metrics in the way one might for a novel AI device or a drug.

Therefore, many of the requested categories for a study proving device meets acceptance criteria are not applicable to this document. The "study" mentioned is mechanical testing to demonstrate substantial equivalence, not a clinical trial with human subjects, AI algorithms, or ground truth established by experts.

Here's an breakdown based on the provided text, indicating which information is available and which is not:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified (refers to mechanical testing, not a patient test set).
• Data Provenance: Not specified. It's mechanical testing of the device itself, not human data.

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. Ground truth in the context of expert consensus on medical images or diagnoses is not relevant for mechanical testing of a spinal fixation system. Substantial equivalence is based on engineering principles and comparison to a predicate device.

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

• Not applicable. There was no "test set" of patient data requiring adjudication in a clinical or diagnostic sense.

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 document describes a physical medical device (spinal implant), not an AI system.

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)

• Not applicable. The "ground truth" for substantial equivalence under 510(k) is the performance and characteristics of the legally marketed predicate device (PYRAMID™ ANTERIOR PLATE FIXATION SYSTEM). The new device is evaluated against engineering benchmarks to ensure it is similar enough to the predicate.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. There is no "training set" for this type of device.

Summary based on the document:

The T-PLATE Anterior Fixation System gained regulatory clearance through a 510(k) premarket notification. This process determines substantial equivalence to an existing legally marketed device (the PYRAMID™ ANTERIOR PLATE FIXATION SYSTEM, K013665). The evidence provided for this equivalence was mechanical testing of the device. The document does not describe clinical studies involving human subjects, AI performance, or ground truth established by medical experts for a diagnostic task.

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