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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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The AcroMed Pedicle Screw is designed to be utilized with the ISOLA Spine System (K944737). The ISOLA Spinal System, when used with pedicle screws, is intended for use in grade 3 or 4 spondylolisthesis at L5-S1 utilizing autologous bone graft and intended to be removed after solid fusion is attained. The component that is the subject of this premarket notification, the 4.75 mm diameter pedicle screw, is a line extension version of AcroMed Pedicle Screws previously cleared under K951657 for the ISOLA system. It is intended for use in pediatric and other applications where anatomic considerations limit the size of the implants that can be used for internal fixation applications.

The AcroMed Pedicle Screw is composed of two sections: a long cancellous section with an integral fixed lower nut, and a machine threaded section topped with an hexagonal drive head. The integral nut serves two purposes: it creates a stronger bolt connection between the screw and rod and it eliminates the "claw hammer" effect associated with other screw designs. The AcroMed Pedicle Screw is supplied with an adjustable tapered nut and an optional lock nut, which enables a pedicle screw and a slotted connector to be adjoined utilizing a locking nut system. The junction point of the adjustable integral nut and machine thread portion of the pedicle screw is also rounded to reduce potential stress concentration. The screw is available in cancellous thread lengths from 25-50 mm, in 5 mm increments.

Here's an analysis of the provided text based on your request:

It's important to note that the provided text is a 510(k) summary for a medical device (AcroMed Pedicle Screw) seeking clearance from the FDA. These summaries typically focus on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical study data with detailed acceptance criteria and performance metrics in the way a clinical trial for a diagnostic AI device would.

Therefore, many of your requested points will either be "Not Applicable" (N/A) or have limited information available due to the nature of a 510(k) submission for a mechanical implant.

Acceptance Criteria and Device Performance (Based on available information)

Study Details:

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

   • Sample Size (Test Set): Not explicitly stated in terms of patient numbers or specific measurement counts. The "performance data" refers to "static and fatigue testing," which typically involves a specific number of mechanical test specimens (e.g., screws) tested under laboratory conditions. The exact number of screws tested is not provided.
   • Data Provenance: N/A for clinical data. The performance data relates to in vitro mechanical testing, not human patient data. There is no information on the country of origin of this in vitro testing.

2. 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):

   • N/A. This device is a mechanical implant, not a diagnostic tool requiring expert interpretation for ground truth establishment. The "ground truth" for its performance is its physical and mechanical properties measured by engineering tests.

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

   • N/A. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes. The performance data presented here refers to objective mechanical testing.

4. 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:

   • N/A. This study relates to the mechanical performance of a pedicle screw, not a diagnostic AI system or human reader performance.

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

   • N/A. This device is a mechanical implant, not an algorithm.

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

   • For the mechanical performance, the "ground truth" is defined by engineering standards and measurements. This includes ASTM F1314 for material composition and internal mechanical testing protocols for static and fatigue strength, with "consistency" to predicate device performance as the benchmark. For indications for use, the ground truth is established by clinical understanding of spinal conditions like spondylolisthesis.

7. The sample size for the training set:

   • N/A. This device is a mechanical implant, not an AI or machine learning model that requires a "training set."

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

   • N/A. (See point 7).

Summary for K963639 - AcroMed Pedicle Screw (4.75 mm):

This 510(k) summary focuses on demonstrating that the 4.75 mm AcroMed Pedicle Screw is substantially equivalent to previously cleared AcroMed pedicle screws. The "study" described is primarily mechanical performance testing (static and fatigue). The acceptance criteria for this testing is that the new screw performs "consistently with previously cleared components." The sample size for this mechanical testing is not specified, but it would involve a certain number of test specimens. Ground truth is established by engineering standards and comparative mechanical performance metrics. There are no elements related to human readers, AI, or large-scale clinical trials in the provided information.

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