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The Moss Miami Spine System is a pedicle screw system 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 spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Moss Miami Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The Moss Miami Spine System is also a hook and sacral/illiac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The CrossOver Cross Connector is designed to transversely connect two rods used in spinal instrumentation constructs. The connector minimizes the torsional forces on the construct, thus reducing the micromotion and the probability of the construct shifting after placement.

The provided 510(k) summary for the Moss Miami Spinal System does not include information about acceptance criteria or a study proving the device meets said criteria in the way typically found for AI/ML-driven devices (e.g., performance metrics against a clinical standard).

Instead, the documentation describes a traditional medical device submission for a spinal implant system. The "performance data" mentioned refers to engineering tests to characterize the physical properties and functionality of the device components, rather than clinical efficacy measured against specific performance metrics like sensitivity or specificity.

Therefore, many of the requested bullet points, particularly those related to clinical performance, ground truth, expert review, and sample sizes for AI/ML models, are not applicable to this type of submission.

Here's a breakdown of the information that is available, and why other requested information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document in the format requested for AI/ML devices.

For this device (a spinal implant):

• Acceptance Criteria (Implied): The device (CrossOver Cross Connector) would need to meet biomechanical performance standards and demonstrate equivalence in design and materials to its predicate devices (MOSS MIAMI Spinal System Transverse Connector and EZ-Link Transverse Connector). This would involve tests for strength, fatigue, torsional forces, and material compatibility. These specific numerical criteria are not detailed in the summary.
• Reported Device Performance: The summary states: "Performance data were submitted to characterize the CrossOver Cross Connector." However, the actual results of these characterization tests (e.g., specific load capacities, fatigue cycles, torque resistance) are not reported in this summary document. The summary only confirms that such data "were submitted."

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

• Not Applicable in the traditional sense for a clinical performance study. For a mechanical device, "test set" refers to physical samples of the manufactured device components. The specific number of physical units tested is not mentioned in this summary.
• Data Provenance: Not applicable in the context of clinical data for AI/ML. The "performance data" would have been generated in engineering labs, likely within the manufacturer's facilities or accredited testing labs, characterizing the mechanical properties of device components.

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

• Not Applicable. "Ground truth" in this context refers to clinical diagnoses or outcomes, which is relevant for AI/ML devices analyzing medical images or data. For a spinal implant, "ground truth" might relate to established engineering standards or material science properties, which would be validated by engineers and metallurgists rather than clinical experts.

4. Adjudication method for the test set

• Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human reviewers (e.g., radiologists) when establishing ground truth for AI/ML performance studies. This is not relevant for the mechanical testing of a physical implant.

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 type of study specifically for AI/ML diagnostic or assistive devices, comparing human performance with and without AI aid. The Moss Miami Spinal System is a physical implant, not an AI/ML diagnostic tool.

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

• Not Applicable. This refers to the performance of an AI/ML algorithm independently. The Moss Miami Spinal System is a physical implant, not an algorithm.

7. The type of ground truth used

• Not Applicable in the clinical sense. For this device, "ground truth" would derive from established engineering principles, material science specifications (e.g., ASTM F-136 for titanium alloy), and biomechanical testing standards. This would not be "expert consensus, pathology, or outcomes data" in the clinical AI/ML context.

8. The sample size for the training set

• Not Applicable. There is no "training set" for a physical spinal implant device in the AI/ML context. The device design is based on engineering principles, predicate device designs, and material science, not machine learning from a dataset.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

Summary of what can be gleaned from the document regarding "performance":

• The submission included "Performance data... to characterize the CrossOver Cross Connector." This implies a series of mechanical and material tests.
• The device is "Manufactured from ASTM F-136 implant grade MATERIALS: titanium alloy," indicating adherence to a recognized standard for implant materials.
• The FDA's 510(k) clearance (K013296) indicates that the device was found "substantially equivalent" to predicate devices (K983583, K001372, K001470). This substantial equivalence is based on similar intended use, technological characteristics, and safety and effectiveness, which includes evaluation of the submitted performance data.

In conclusion, the provided document describes a much earlier and different type of device submission than one for an AI/ML medical device, and therefore the requested information categories are largely not applicable.

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When used as a posterior, noncervical screw fixation system or as an anterior, thoracic/lumbar screw fixation system, the MOSS Miami Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e. discogenic; back pain with degeneration of the disc confirmed by patient history and radiographic studies).

When used as a pedicle screw fixation system of the noncervical spine in skeletally matrue patients, the MOSS Miami System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The MOSS Miami Spinal System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.

The MOSS MIAMI System is available in either Stainless Steel or Titanium. The following components are available in Stainless Steel: longitudinal rods, monoaxial screws, polyaxial screws, reduction screws, hooks, reduction hooks, transverse connectors, axial connectors, staple washers and sacral extenders. The following components are available in Titanium: longitudinal rods, monoaxial screws, polyaxial screws, hooks, transverse connectors, axial connectors, washers, staple washers, and sacral extenders. The design, intended use, and material of these components have been cleared in previous 510(k) submissions.

The provided text is a 510(k) summary for the DePuy AcroMed MOSS Miami Spinal System, a medical device for spinal fixation. It describes the device, its intended use, and its substantial equivalence to previously cleared devices.

However, this document does not contain any information about acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth, expert review, sample sizes, or comparative effectiveness for an AI/algorithm-based device. The entire document pertains to a physical spinal fixation system and its regulatory clearance based on substantial equivalence to existing predicate devices, not on the performance of a software algorithm.

Therefore, I cannot answer your request with the input provided. The requested information is not present in the document.

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The MOSS Miami Spinal System is intended for non-cervical use in the spine.

When used with ante ior screw fixation or posterior hook, non-pedicle screw fixation the MOSS Miami Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to turnor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e. discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).

When used with pedicle screw fixation, the MOSS Miami Spinal System is intended for use in patients with severe spondylolisthesis (Grades 3 and 4) at the US-S1 vertebral joint, having fusions with antogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.

The MOSS MIAMI System is available in cither Stainless Steel or Titanium. The screws, polygial corect are available in Stainless Steel or Titanum. The screws, polyaxial screws, reduction screws, hooks, reduction hooks, transverse connectors, axial conrectors, staple washers and sacral extenders. The following screws, books, transwice organium: longitudinal rods, monoaxial screws, polyaxial screws, hooks, transverse connectors, axial connectors, washers, staple washers, and sacral extenders. The resign, intended use, and material of these components have been cleared in previous 51 3(k) submissions.

The line extension covered in this submission are additional screw components to the existing 5mm Stainless Steel and 5.5mm Titanium alloy versions of the MOSS Miami Spinal System. The additional screws consist of Stainless Steel and Titanium 5-7mm diameter polyaxial and monoaxial screws in 5mm increments to provide screws lengths from 25mm to 90mm The additional screws also consist of Titanium 8mm diameter monoaxial screws in imm increments to provide screws lengths from 25mm to 90mm, and the addition of Stainless Steel 8mm monoaxial and polyaxial and of Titanium 8mm polyaxial screws in 1-1 lengths from 25mm to 90mm in 5mm increments. Additionally, the intended uses of the 7mm monoaxial and polyaxial screws, which were previously cleared as part of the 5mm stainless steel version of this system, were expanded to include anterior use.

The provided text does not contain information about acceptance criteria, device performance, or a study specifically designed for the DePuy Motech MOSS Miami Spinal System. The document is a 510(k) summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting detailed performance study results against specific acceptance criteria.

Therefore, I cannot provide the requested table and study details.

Here's why and what information is available:

• Nature of the Document: This is a regulatory submission for premarket notification (510(k)), not a clinical trial report or a detailed engineering performance study. The 510(k) process in the US allows a manufacturer to market a device by demonstrating that it is "substantially equivalent" to a legally marketed predicate device, without requiring extensive new clinical studies if the equivalence is clear.
• Focus on Substantial Equivalence: The document explicitly states, "Based on the information provided, DePuy believes that the subject additional screws in the MOSS Miami Spinal Systems and the additional indication of non-cervical anterior use of the Stainless Striel 7mm monoaxial and polyaxial screws are substantially equivalent to other currently legally marketed spinal systems' screws."
• Device Description: The "DEVICE DESCRIPTION AND INTENDED USE" sections detail the components, materials (Stainless Steel or Titanium), available sizes (diameters 5-8mm, lengths 25-90mm), and indications for use.
• Predicate Devices: The document lists several "SUBSTANTIALLY EQUIVALENT DEVICES" (e.g., DePuy Motech MOSS Miami Spinal Systems K933881, K950697, etc., and AcroMed VSP & ISOLA). The equivalence is largely based on similar design, intended use, and materials to these cleared devices, as well as the addition of different screw lengths and diameter.
• FDA Response: The FDA letter confirms the substantial equivalence with specific limitations and warnings regarding pedicle screw use, particularly for severe spondylolisthesis at L5-S1 and the requirement for device removal after fusion. This indicates that while the device was cleared, the FDA imposed strict conditions based on the existing evidence and regulatory framework for pedicle screws at the time.

In summary, the document serves to establish regulatory clearance by demonstrating equivalence, not to present novel performance data against specific acceptance criteria for a new device.

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