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The SYNMESH™ Spacer is a vertebral body replacement device in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The SYNMESH Spacer is intended to be used with Synthes supplemental internal fixation of the SYNMESH Spacer can be packed with bone graft.

The SYNMESH™ System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The SYNMESH System spacer is a titanium vertebral body replacement device used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals following corpectomy/vertebrectomy. Different cross section sizes and heights are available to suit the individual pathology and anatomical conditions.

The SYNMESH System spacer consists of a cylindrical round or oblong mesh, end rings, standard rings and screws. The round mesh is used in pairs and is available in various diameters and heights. The oblong mesh is used individually and is also available in various cross-section sizes and heights.

The provided text is a 510(k) summary from the FDA for a medical device called the "SYNMESH™ System." It describes the device, its intended use, and claims substantial equivalence to a predicate device based on material and non-clinical performance testing.

However, the document DOES NOT contain information regarding the acceptance criteria or study details for an AI/algorithm-driven device.

Specifically, the device described is a spinal implant (vertebral body replacement device), which is a physical product, not a software or AI-driven diagnostic/treatment tool. As such, the concept of "acceptance criteria" related to AI performance metrics (like sensitivity, specificity, AUC) and studies involving expert readers, ground truth establishment, training/test sets, or MRMC studies are not applicable to this particular 510(k) submission.

The "performance data" mentioned (static/dynamic torsion, compression, expulsion, subsidence) refers to mechanical testing of the physical implant, not the performance of an AI algorithm.

Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and study proving an AI device meets them, as the provided document describes a physical medical implant.

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The T-PAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The T-PAL Spacer should be packed with autogenous bone graft (i.e. autograft).

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. These patients should be skeletally mature and have had six months of nonoperative treatment.

The T-PAL Spacer is intended to be used with DePuy Synthes supplemental fixation.

The T-PAL Spacer System is an interbody fusion device used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals following intervertebral discectomy. The T-PAL Applicator is used to insert the T-PAL Spacer into the disc space. The T-PAL Applicator is composed of an inner shaft and handle (outer shaft). The scope of this submission is to develop an additional T-PAL Applicator option for surgeons to facilitate insertion of the T-PAL Spacer and final positioning in the interbody disc space.

Here's an analysis of the provided text regarding the DePuy Synthes T-PAL Spacer System, focusing on the acceptance criteria and study information:

Based on the provided text, the device in question is the T-PAL Advanced Applicator which is a minor modification to the already cleared T-PAL Applicator. This submission (K181231) is for the modified applicator, not the T-PAL Spacer System itself, though the applicator is used with the spacer system.

The submission is a 510(k) for substantial equivalence. This means the device is being compared to a legally marketed predicate device (T-PAL Spacer System K100089 and DePuy Synthes T-PAL Ti Spacer System K151276) to demonstrate that it is as safe and effective.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated. The text mentions "mechanical testing simulated the insertion of the implant," but does not provide details on the number of tests, specific loads, cycles, or other parameters of the mechanical testing.
• Data Provenance: Not explicitly stated, but it is implied to be from internal lab testing conducted by the manufacturer, DePuy Synthes. There is no mention of country of origin for the data or whether it was retrospective or prospective. Given it's a 510(k) for a modified component, it's highly likely to be internal, prospective, laboratory-based testing.

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

• This information is not applicable and not provided in the document. The study described is mechanical testing, not a clinical study involving human assessment or expert review of images/data to establish ground truth.

4. Adjudication method for the test set

• This information is not applicable and not provided in the document. The study described is mechanical testing, which does not involve human adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• This information is not applicable and not provided in the document. The device is a surgical applicator (mechanical device), not an AI/software device that assists human readers in interpreting medical images or data.

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

• This information is not applicable and not provided in the document. The device is a mechanical surgical applicator, not an algorithm or AI.

7. The type of ground truth used

• The "ground truth" for the mechanical testing would be the engineering specifications and performance metrics defined by the manufacturer and relevant industry standards for surgical instruments. The device's performance was evaluated against these predefined mechanical acceptance criteria.

8. The sample size for the training set

• This information is not applicable and not provided in the document. As this is mechanical testing for a physical device, there is no "training set" in the context of machine learning or AI.

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

• This information is not applicable and not provided in the document. There is no training set mentioned or implied.

Summary of Device Performance Study and Conclusion:

The study performed was mechanical testing that simulated the insertion of the implant into an intervertebral body using the subject T-PAL Advanced Applicator. The purpose was to demonstrate that modifications to the applicator did not negatively impact its mechanical performance.

Conclusion: "The performance acceptance criteria was met." and "The insertion testing further demonstrates that the modifications to the design do not introduce any new questions of safety and effectiveness." The submission concludes that the T-PAL Advanced Applicator is substantially equivalent to the predicate devices.

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The VEPTR/VEPTR II device is indicated for skeletally immature patients with severe, progressive spinal deformities and/or three dimensional deformity of the thorax associated with or at risk of Thoracic Insufficiency Syndrome (TIS). TIS is defined as the inability of the thorax to support normal respiration or lung growth. This would include patients with progressive congenital, neuromuscular, idiopathic, or syndromic scoliosis.

In children with or at risk of developing Thoracic Insufficiency Syndrome, the natural course of lung development is arrested due to constriction by the thorax. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.

The VEPTR devices are attached perpendicularly to the subject's natural ribs and lumbar vertebra or pelvis. This mechanically stabilizes the chest wall and enlarges the thorax to improve respiration and lung growth. Once the VEPTR/VEPTR II device is in place, its design allows for expansion, anatomic distraction, and replacement of component parts through less invasive surgery.

The VEPTR/VEPTR II devices allow assembly in a number of different configurations. All of these configurations are required to accommodate the wide variety of anatomical deformities encountered by the clinician in treating patients with or at risk of developing Thoracic Insufficiency Syndrome.

This document is a 510(k) Premarket Notification for the DePuy Synthes Spine Vertical Expandable Prosthetic Titanium Rib (VEPTR/VEPTR II) device. It is a medical device submission, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance in the way a diagnostic AI/ML device submission would.

Therefore, the requested information elements related to AI/ML device performance, ground truth, expert adjudication, sample sizes for training/test sets, and MRMC studies are not applicable to this document. This submission relates to a physical orthopedic implant, not a diagnostic algorithm.

Here's a breakdown of the applicable information:

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

Since this is a submission for a physical implant demonstrating substantial equivalence, "acceptance criteria" are not defined as specific performance metrics like sensitivity/specificity for an AI/ML diagnostic. Instead, the submission relies on comparison to predicate devices and mechanical testing standards.

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

• Test Set (for clinical evaluation of safety and effectiveness): The submission references the results of the HDE (H030009) post-market follow-up. The specific sample size for this HDE is not provided in this document summary.
• Data Provenance: The HDE (H030009) is a Humanitarian Device Exemption, typically involving devices for rare conditions. This indicates a clinical study with human subjects, likely multi-center, but the specific country of origin and retrospective/prospective nature are not detailed in this summary. HDEs are inherently prospective post-market follow-ups to gather data on probable benefit and safety.

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. This is not an AI/ML device where "ground truth" is established by experts for diagnostic performance. Clinical outcomes and safety were evaluated in the HDE study.

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

Not applicable. This is not an AI/ML device with a human-labeled test set requiring adjudication. Clinical trial data typically has pre-defined endpoints and evaluation criteria.

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 a physical orthopedic implant.

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

Not applicable. This is a physical orthopedic implant, not an algorithm.

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

The closest equivalent to "ground truth" here would be clinical outcomes data from the HDE post-market follow-up, which would involve patient data reflecting safety and probable benefit in treating Thoracic Insufficiency Syndrome.

8. The sample size for the training set:

Not applicable. This is a physical orthopedic implant, not an AI/ML model.

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

Not applicable. This is a physical orthopedic implant, not an AI/ML model.

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