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Pedicle Screw System: The MASADA Modular Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: 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, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the MASADA pedicle screw implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The MASADA pedicle screw is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Navigated Instrument System: The MASADA navigated instruments are intended to be used in the preparation and placement of MASADA screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Refer to the Astura Navigated Instrument system Instructions For Use (INS-00006) regarding the use of these instruments.

Sublaminar Band System: The MASADA sublaminar band is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: - Spinal trauma surgery, used in sublaminar or facet wiring techniques. - Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis. - Spinal degenerative surgery, as an adjunct to spinal fusions. The MASADA sublaminar band may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.

The MASADA Modular Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion. The system is composed of modular polyaxial screws, monoaxial screws, rods, cross connectors, rod connectors, sublaminar band cerclages, band connectors, and hooks. The system is supported by a comprehensive set of instruments to install the implants within the system. All implant components are manufactured from the materials listed in the table below.

The provided text is an FDA 510(k) clearance letter for a medical device called the "MASADA Modular Spinal Fixation System." This document is a regulatory approval, not a scientific study report describing the performance of an AI/ML device. Therefore, it does not contain the information requested regarding acceptance criteria, device performance metrics, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for an AI/ML system.

The "Non-clinical Test Summary" explicitly states: "An engineering analysis determined that no new worst case conditions have been introduced since the previously cleared submission (K231694)." and the "Clinical Test Summary" explicitly states: "No clinical studies were performed."

This means the clearance was based on substantial equivalence to predicate devices through design, materials, and engineering analysis, rather than new performance data from a clinical or AI/ML-specific study.

Therefore, I cannot provide the requested table and details about acceptance criteria and study findings for an AI/ML device based on the given input.

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Pedicle Screw System: The MASADA Modular Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: 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, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediative patients, the MASADA pedicle screw implants are indicated as an adjunct to fusion to treat adolessent idiopathic scoliosis. The MASADA pedicle screw is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Navigated Instrument System: The MASADA navigated instruments are intended to be used in the preparation and placement of MASADA screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Refer to the Astura Navigated Instrument system Instructions For Use (INS-00006) regarding the use of these instruments.
Sublaminar Band System: The MASADA sublaminar band is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

• Spinal trauma surgery, used in sublaminar or facet wiring techniques.
• Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis. - Spinal degenerative surgery, as an adjunct to spinal fusions.
  The MASADA sublaminar band may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.

The MASADA Modular Spinal Fixation System is a top loading thoracolumbar, sacral, and iliac fixation system designed to provide fixation during the fusion process. The system is composed of modular polyaxial screws, monoaxial screws, rods, cross connectors, rod connectors, sublaminar band cerclages, band connectors, and hooks. The system is supported by a comprehensive set of instruments to install the implants within the system. All implant components are manufactured from the materials listed in the table below.

This document is an FDA 510(k) clearance letter for the MASADA Modular Spinal Fixation System. It does not describe an AI medical device or any study proving a device meets acceptance criteria related to AI performance. Therefore, I cannot provide the requested information.

The document primarily focuses on:

• Device name: MASADA Modular Spinal Fixation System
• Regulatory classification: Class II, Thoracolumbosacral Pedicle Screw System, Spinal Interlaminar Fixation Orthosis, Bone Fixation Cerclage, Orthopedic Stereotaxic Instrument.
• Intended Use/Indications for Use: Immobilization and stabilization of the posterior, non-cervical spine, including an articulated "Navigated Instrument System" for guiding surgical placement using imaging (CT, MR, fluoroscopy). Also includes a Sublaminar Band System.
• Substantial Equivalence: Comparison to predicate devices (OLYMPIC Posterior Spinal Fixation System, OLYMPIC Navigated Instruments, OLYMPIC Deformity Band System, Globus CREO Stabilization System).
• Non-clinical testing: Static Compression Bending, Dynamic Compression Bending, Static Torsion, Tulip Dissociation (all mechanical tests according to ASTM standards).
• Clinical testing: Explicitly states "No clinical studies were performed."

The request asks for details specific to an AI/ML powered device, including:

1. Table of acceptance criteria and device performance (AI metrics).
2. Sample size and data provenance for a "test set" (implying data used for AI evaluation).
3. Number and qualification of experts for ground truth establishment.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details (human reader improvement with AI).
6. Standalone (algorithm only) performance.
7. Type of ground truth (e.g., pathology, outcomes data).
8. Training set sample size and ground truth establishment for training.

None of this information is present in the provided text because the MASADA Modular Spinal Fixation System is a physical surgical implant and instrument system, not an AI/ML-driven diagnostic or therapeutic device. The "Navigated Instrument System" component uses existing imaging modalities (CT, MR) and a Medtronic StealthStation® System for anatomical localization, which is a computer-assisted surgical navigation system, but not an AI-powered device that processes medical images for diagnostic or prognostic purposes to which AI-specific acceptance criteria and studies would apply.

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Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the presence of incomplete bone healing.

The Modular Spinal Fixation System, when properly used, is intended for posterior pedicle screw fixation of the noncervical posterior spine in skeletally mature patients to treat adolescent idiopathic scoliosis (4.75 systems only). It provides stabilization of spinal segments as an adjunct to fusion. Pediatric pediatric pediatic pedicle screw fixation is limited to a posterior approach.

When used as a posterior spine thoracic/lumbar system, the Modular Spinal Fixation System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (8) spondylolisthesis.

In order to achieve additional levels of fixation in skeletally mature patients, the Modular Spinal Fixation System may be connected to the Solstice OccipitoCervicoThoracic Fixation System's 3.5mm rod. The Modular Spinal Fixation System is intended to be used with autograft or allograft.

The Modular Spinal Fixation System consists of an assortment of rods, modular screws, modular tulips, cross connectors and offset connectors. The head and taper lock are assembled together during manufacturing to create the modular tulip assembly. The cross connectors are also assembled during manufacturing. The Modular Spinal Fixation System implant components are made from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136 and cobalt chrome (Co-28Cr-6Mo) per ASTM 1537.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Life Spine Modular Spinal Fixation System components with components from any other system or manufacturer.

The provided text (FDA 510(k) K183430 submission for the Modular Spinal Fixation System) describes the acceptance criteria and supporting studies for a spinal implant system, not an AI-powered medical device. Therefore, much of the requested information regarding AI device testing (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance, ground truth establishment) is not applicable or cannot be extracted from this document.

The document focuses on demonstrating the substantial equivalence of the new spinal fixation system to existing predicate devices based on design, materials, indications for use, and mechanical performance through bench testing.

Here's the information that can be extracted or deduced from the provided document, focused on the acceptance criteria and the study that proves the device meets them, insofar as they relate to a medical implant:

1. Table of Acceptance Criteria and Reported Device Performance

For a spinal implant system like this, "acceptance criteria" primarily revolve around meeting established mechanical performance standards for spinal implants and demonstrating material biocompatibility, as well as being substantially equivalent to legally marketed predicate devices.

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

• Sample Size for Test Set: This document does not specify exact sample sizes for the mechanical bench tests (e.g., number of implants tested). For mechanical tests per ASTM standards, a sufficient number of samples are typically tested to ensure statistical validity and representativeness of the product. The focus is on demonstrating "substantial equivalence" of the new device's mechanical properties to the predicate, rather than clinical performance on a "test set" of patient data.
• Data Provenance: The data is derived from bench testing (laboratory studies) of the physical implant components, not from patient data. Therefore, concepts like country of origin for data or retrospective/prospective studies are not applicable.

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

• This is not applicable as the "ground truth" for a mechanical implant is adherence to specified material and mechanical performance standards, not expert consensus on medical images or diagnoses. The "experts" involved would be engineers/technicians conducting the tests and interpreting the results against the ASTM standards.

4. Adjudication Method for the Test Set

• Not applicable for mechanical bench testing. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involve human interpretation of data where consensus is needed to establish a "ground truth" (e.g., reading medical images).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study is relevant for AI-powered diagnostic or assistive devices where human readers (e.g., radiologists) interpret medical images. This document pertains to a physical surgical implant, not an AI device.

6. If a Standalone (Algorithm Only Without Human-in-the-loop Performance) Was Done

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

7. The Type of Ground Truth Used

• The "ground truth" for this device's acceptance is based on adherence to standardized engineering specifications and mechanical performance criteria (e.g., ASTM F543, ASTM F1717) and the established material properties of the chosen medical-grade alloys (ASTM F136, ASTM F1537). This is a physical and engineering ground truth, not one derived from clinical outcomes, pathology, or expert consensus on patient data. The ultimate 'ground truth' for this submission is demonstrating substantial equivalence to existing, legally marketed predicate devices.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI device, so there is no "training set" in the machine learning sense.

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

• Not Applicable. As there is no training set for an AI model, this question is irrelevant to the device described.

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