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The XIA® 4.5 Spinal System is interior/anteriolateral and posterior, non-cervical pedicle and non-pedicle fixation for the following indications: • Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) - · Spondylolisthesis - · Trauma (i.e. fracture of dislocation) - · Spinal Stenosis - · Curvatures (i.e. scoliosis, kyphosis, and/or lordosis) - Tumor - Pseudarthrosis - · Failed Previous Fusion The Stryker Spine DIAPASON® Spinal System, Opus® Spinal System, and XIA® 4.5 Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector when used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. Except for the staples, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the XIA® 4.5 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the XIA® 4.5 Spinal System is intended to treat petients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The subject devices consist of a variety of multiple component spinal fixation systems intended for use as an adjunct to fusion. These devices have been previously cleared by FDA. The primary purpose of this submission is to establish an MR Conditional labeling claim for these implants.

The Stryker Spine Sierra Mertz family of spinal implant systems (referred to as "the subject devices" in the document) is seeking an MR Conditional labeling claim.

Here's an analysis of the acceptance criteria and study proving device conformance, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in the provided text. The document refers to "the subject devices" which is a family of 20 different spinal systems. It's implied that various components within these systems were subjected to testing.
• Data Provenance: The document does not specify the country of origin of the data. The study was a prospective test conducted to establish MR Conditional labeling for the devices.

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

This is not applicable as the study involved physical testing for MR compatibility according to a standard (ASTM F2503), not human expert evaluation of medical images or data.

4. Adjudication Method for the Test Set

This is not applicable for this type of physical device testing. The results are based on adherence to the parameters set by the ASTM F2503 standard.

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

This is not applicable. The submission is for spinal implants and their MR compatibility, not an AI-powered diagnostic or assistive tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable, as the device is a physical spinal implant system, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the test was compliance with the ASTM F2503 standard for MR compatibility. This standard defines specific parameters and limits for evaluating the safety and performance of medical devices in an MRI environment, such as magnetic field interactions, RF-induced heating, and image artifact.

8. The Sample Size for the Training Set

This is not applicable. This is a medical device clearance for physical implants, not a machine learning or AI model that requires a training set.

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

This is not applicable. As stated in point 8, there is no training set for this type of device submission.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study performed was a MR Compatibility testing per ASTM F2503. The FDA document states: "The test results demonstrate that the subject devices performance met the prescribed acceptance criteria and are substantially equivalent to the predicate devices." This indicates that the physical and electrical properties of the spinal implant systems, when subjected to MRI conditions outlined in the ASTM F2503 standard, did not pose unacceptable risks (e.g., excessive heating, dangerous magnetic force, or significant image artifacts) and thus were deemed MR Conditional. The purpose of this testing was to establish the MR Conditional labeling claim for the devices.

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The MANTIS Clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of:

1. Endoscopic marking
2. Hemostasis for:

• Mucosal/sub-mucosal defects

The MANTIS Clip is a sterile device consisting of a pre-loaded, radiopaque, singleuse, endoscopic clipping device consisting of two main components: the delivery system and the clip.
The delivery system consists of a handle assembly and delivery catheter. The deliverv system is constructed using stainless steel, and polyester materials. The delivery system will allow for the device to rotate at the distal end. The MANTIS Clip delivery system is offered in a 235cm working length. The clip consists of a stainlesssteel capsule and clip arms, a cobalt chrome yoke, and a styrene tension breaker. The clip is deployed from the delivery system during use. The MANTIS Clip jaws are engineered such that they can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. Re-opening, closing, and rotation capability may be limited by clinical circumstances and patient anatomy. There are no associated accessories included with this device. The clip jaw teeth are designed with smaller angle between the teeth and the clip arm body.

The MANTIS Clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of: endoscopic marking; hemostasis for mucosal/sub-mucosal defects

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The MANTIS® Spinal System and MANTIS® Redux Spinal System is intended for percutaneous, posterior, non-cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments 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; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthrosis; and Failed Previous Fusion.

The Radius® Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the Radius® Spinal system is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Degenerative Disc Disease (DDD) (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; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthorisis; and Failed Pervious Fusion. The Radius® Spinal System can also be linked to the XIA® Titanium Spinal System via the Ø5.5mm to Ø6.0mm Radius® rod-to-rod connector.

The Stryker Spine TRIO® Plate System is intended for posterior, noncervical (T10-S1) pedical and nonpedical fixation of the spine for the following indications: Degenerative Disc Disease (DDD) (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; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthorisis; and Failed Pervious Fusion.

The Stryker Spine TRIO® Spinal Fixation System is intended for posterior, noncervical pedicle and non-pedicle fixation of the spine. The Stryker Spine TRIO® Spinal Fixation System is indicated for: Degenerative Disc Disease (DDD) (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; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthorisis; and Failed Pervious Fusion. The TRIO® Spinal Fixation Sytem is intended to be used in conjunction with the OSS Diapason Rods, Opus Spinal System Rods, and the Multi-Axis Cross Connectors.

The Stryker Spine TRIO® Spinal System is intended for posterior, noncervical pedicle and nonpedicle fixation of the spine to provide immobilization and stabilization of spinal segements in skeletally mature patients as an adjunct to fusion for the following indications: Degenerative Disc Disease (DDD) (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; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthorisis; and Failed Pervious Fusion. The TRIO® + Spinal System is intended to be used in conjunction with the OSS/Diapason Rods or Opus Rods, XIA® Pre-bent Rods, and the Multi-Axis Cross Connectors.

The Stryker Spine TRIO® TRAUMA Spinal System is intended for percutaneous, posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: Degenerative Disc Disease (DD) (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; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthorisis; and Failed Pervious Fusion.

The XIA® Spinal System and XIA® 4.5 Spinal System are intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: Degenerative Disc Disease (DDD) (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, and/or Lordosis); Tumor; Pseudoarthrosis and; Failed previous fusion. The 6mm diameter rods from the DIAPASON® Spinal System and OPUS® Spinal System are intended to be used with the other components of the XIA® Titanium Spinal System. The Titanium Multi-Axial Cross Connector are intended to be used with the other components of the XIA® Titanium Spinal System.

The XIA® 3 Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle fixation system, the XIA® 3 Spinal System is intended to provide additional support during autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Degenerative Disc Disease (DDD) (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; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor, Pseudoarthorisis; and Failed Pervious Fusion. The Ø5.5mm rods from the Stryker Spine Radius® Spinal System and the Ø6.0mm Vitallium Rods from the XIA® Spinal System are intended to be used with the other components of the XIA® 3 Spinal System. When used for posterior noncervical pedicle screw fixation in pediatric patients, the XIA® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scollosis. The XIA® 3 Spinal System for pediatic use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The XIA® 4.5 Spinal System is intended for anterior/anteriolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: Degenerative Disc Disease (DD) (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; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthorisis; and Failed Pervious Fusion. The Stryker Spine DIAPASON® Spinal System, OPUS® Spinal System and XIA® 4.5 Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector when used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. Except for the staples, the XIA® 4.5 Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical pedicle screw fixation in pediatric patients. The XIA® 4.5 Spinal System for pediatric use in intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The STRYKER Spine thoraco-lumbar spinal fixation systems, subject of this 510(k), are non-cervical, pedicle and non-pedicle fixation systems comprised of screws, rods, plates, hooks, connectors, washers and staples. The components are manufactured from either Titanium (Titanium Alloy and CP Titanium), Stainless Steel or Cobalt-Chromium-Molybdenum Alloy (Vitallium®). This Special 510(k) submission seeks clearance for sterile labeling of the listed STRYKER Spine thoraco-lumbar spinal fixation systems. All of the components of the subject devices will be sterilized by gamma radiation, a traditional sterilization method as per FDA guidance document, Updated 510(k) Sterility Review Guidance K90-1; Guidance for Industry and FDA.

This is a 510(k) Premarket Notification for sterile packaging of a range of spinal systems. The key claim is substantial equivalence to previously cleared non-sterile versions of the same devices. Therefore, the "device" in question for this submission is specifically the sterile packaging and the sterilization process, not the spinal implant itself as a medical device performing a physiological function. The "performance" being evaluated is the ability to maintain sterility and the structural integrity of the device within its packaging over its shelf life.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

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

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

The document primarily discusses the sterilization process and packaging rather than clinical performance of the implant itself. Therefore, typical "test set" in the context of clinical or diagnostic AI/software devices (e.g., patient data) is not applicable here.

• Sterilization and Packaging Validation Data: The document mentions "accelerated aging data" for validating the 5-year shelf life. It does not specify the sample size for this testing, nor the country of origin or whether it was retrospective or prospective. However, these types of tests are typically prospective laboratory studies conducted in controlled environments.

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 submission is about the sterility and packaging of medical implants, not a diagnostic or clinical performance study that would require expert ground truth labeling. The "ground truth" here is the scientific validation of sterilization methods and shelf life according to recognized standards and FDA guidance.

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

Not applicable. Adjudication methods are typically used in clinical studies for establishing ground truth, which is not relevant to this submission on sterile packaging.

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 not an AI/software device and no MRMC study was conducted.

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

Not applicable. This is not an AI/software device.

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

The "ground truth" for this submission relies on:

• Scientific Validation of Sterilization: Adherence to established scientific principles and FDA guidance for sterilization (gamma radiation), demonstrating a Sterility Assurance Level (SAL).
• Accelerated Aging Data: Laboratory testing to simulate real-time aging and demonstrate that the sterile barrier packaging system maintains sterility for the stated shelf life.
• Material and Design Specification Conformity: Confirmation that the components are manufactured from specified materials and that their design, technical requirements, and intended use are identical to the non-sterile predicate devices.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. As this is not a machine learning or AI device, there is no training set and therefore no ground truth establishment for a training set.

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The Zip'r Mantis powered wheelchair is intended for an indoor/outdoor power wheelchair that provides transportation for disabled or elderly persons limited to a seated position.
To provide mobility to disabled or elderly persons limited to a seated position.

The Zip'r Mantis powered wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The design of this wheelchair is basically similar to other powered wheelchairs that are already on the market. By providing a powered wheelchair that breaks down into three manageable components (seat set, body frame with motors and battery pack), a user can have a more practical alternative when traveling long distances by bus, train, etc.

Here's a breakdown of the acceptance criteria and study information for the Zip'r Mantis powered wheelchair, based on the provided 510(k) summary:

This device is a physical product (a powered wheelchair), not an AI/software device. Therefore, the questions related to AI/software performance metrics, ground truth, expert adjudication, MRMC studies, and training/test set details are not applicable in this context. The study performed is engineering and safety testing against recognized standards.

Acceptance Criteria and Reported Device Performance

The Zip'r Mantis powered wheelchair's acceptance criteria are based on compliance with several international and national standards for wheelchairs. The study performed was a summary of non-clinical testing demonstrating this compliance.

Explanation of the Study and Why Other Information is Not Applicable:

The provided document is a 510(k) summary for a physical medical device (a powered wheelchair). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through engineering and safety testing. It is not an AI/Software as a Medical Device (SaMD) submission.

Therefore, the following points are not applicable and cannot be answered from the provided text:

• Sample size used for the test set and data provenance: This refers to data used for AI model evaluation. For a physical device, testing involves physical prototypes or production units against specified standards. The document doesn't detail the number of wheelchairs tested, but it does state they "complied with the requirements."
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: "Ground truth" and "experts" in this context typically refer to clinical or diagnostic interpretation for AI/software. For a wheelchair, ground truth is defined by the objective pass/fail criteria of the engineering standards.
• Adjudication method for the test set: Not applicable to engineering compliance testing.
• 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: MRMC studies are specific to evaluating human reader performance with and without AI assistance in interpretation tasks. This is not relevant for a powered wheelchair.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no algorithm being evaluated in a "standalone" fashion.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, the "ground truth" is defined by the objective, quantifiable requirements outlined in the cited engineering and safety standards.
• The sample size for the training set: Not applicable, as there is no AI model requiring a training set.
• How the ground truth for the training set was established: Not applicable, as there is no AI model requiring a training set.

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The MANTIS® Spinal System and MANTIS® Redux Spinal System is intended for percutaneous, posterior, non-cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications:

• Degenerative disc disease (DDD) (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, and/or lordosis);
• Tumor:
• Pseudoarthrosis; and
• Failed previous fusion.
  The Titanium and Vitallium® rods from the Stryker Spine RADIUS® Spinal System are intended to be used with the other components of MANTIS® Spinal System and MANTIS® Redux Spinal System.

This 510(k) is intended to introduce a line extension to the existing MANTIS® Redux Spinal System. The line extension consists of additional sizes of the MANTIS® Redux Long Arm Polyaxial Screws. The additional sizes include the 7.5 mm and 8.5 screw diameter, ranging 30 - 90 mm in length for the MANTIS Redux Spinal System. No modifications were made to the MANTIS Spinal System.

The provided text is a 510(k) summary for a medical device (Stryker Spine MANTIS® Spinal System and MANTIS® Redux Spinal System). It focuses on demonstrating substantial equivalence to predicate devices for a line extension. It does not contain information on acceptance criteria, a study proving device performance against acceptance criteria, or any of the detailed study parameters you've requested (sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth types, or training set details).

This type of submission typically relies on non-clinical (bench) testing to show that the new components meet established performance standards and are comparable to existing, legally marketed devices. It does not involve clinical studies with human participants or the assessment of AI algorithm performance as described in your prompt.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study proving device performance because that information is not present in the provided document.

The document discusses:

• Device Modification: Additional sizes (7.5 mm and 8.5 mm diameter, 30-90 mm length) for MANTIS® Redux Long Arm Polyaxial Screws.
• Intended Use: Percutaneous, posterior, non-cervical pedicle and non-pedicle fixation of the spine for immobilization and stabilization as an adjunct to fusion in skeletally mature patients for various indications (e.g., DDD, spondylolisthesis, trauma).
• Technological Characteristics: Substantial equivalence in terms of material, design, and indications for use to predicate devices.
• Testing: Static Compression Bending testing, Static Torsion testing, and Fatigue Compression Bending testing per ASTM F1717 were conducted on the subject components and compared to a predicate system to demonstrate substantial equivalence.

In summary, the provided text describes a regulatory submission for a medical device line extension, not a study evaluating AI performance or clinical efficacy against specific acceptance criteria for diagnostic or therapeutic accuracy.

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The MANTIS® Spinal System and MANTIS® Redux Spinal System is intended for posterior, non-cervical pedicle fixation 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), spondvlolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

The Titanium and Vitallium rods from the Stryker Spine RADIUS® Spinal System are also intended to be used with other components of MANTIS® Spinal System and MANTIS® Redux Spinal System.

This 510(k) is intended to introduce an extension to the existing MANTIS® Spinal System. The proposed line extension includes the addition of titanium Reduction Screws, and use of Stryker Spine Radius titanium and Vitallium® rods with other components of the MANTIS® and MANTIS® Redux Spinal Systems.

This is a 510(k) premarket notification for a medical device (MANTIS® Spinal System and MANTIS® Redux Spinal System) and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the way a clinical trial for a new drug or a novel AI diagnostic might.

Therefore, many of the requested fields cannot be directly extracted from this document as they are not relevant to a 510(k) for a spinal fixation system line extension. The information provided is primarily about mechanical testing and conformity to existing standards, showing the new components perform similarly to the predicate devices.

Here's an attempt to answer the questions based on the provided text, with explanations where information is not applicable or available:

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

The document states that "Engineering analysis and testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 were completed for the systems." This implies that the acceptance criteria are generally established by this FDA guidance and relevant consensus standards (e.g., relating to mechanical strength, fatigue, etc. for spinal fixation devices). However, specific quantitative acceptance criteria and reported performance values are not detailed in this summary.

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

The document mentions "Engineering analysis and testing." For mechanical devices, this typically involves testing a sample number of components and assemblies. The specific sample size for the mechanical testing is not provided in this summary.

• Test Set Sample Size: Not specified.
• Data Provenance: The testing would have been conducted by the manufacturer (Stryker Spine) or a contracted lab, likely in the US (Allendale, NJ is mentioned). It is a prospective generation of data for regulatory submission.

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

This question is not applicable to a 510(k) for a spinal fixation system line extension. "Ground truth" in the context of clinical expert review is relevant for diagnostic devices or AI algorithms evaluating patient data. For a mechanical device, performance is established through physical and engineering tests, not expert consensus on clinical cases.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert opinions, typically in clinical studies or AI algorithm validation. Mechanical tests have objective outputs.

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 mechanical device, not an AI diagnostic or assistance system. MRMC studies are for evaluating the performance of human readers, sometimes aided by AI, on clinical cases.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

For mechanical testing, the "ground truth" is typically the physical properties and performance characteristics of the materials and device components, measured against established engineering standards (e.g., tensile strength, fatigue limits, compression strength, etc.).

8. The sample size for the training set

Not applicable. This concept applies to AI/ML models. For mechanical testing, there is no "training set" in this sense.

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

Not applicable.

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The MANTIS® Spinal System is intended for posterior, non-cervical pedicle fixation 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, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

This Special 510(k) submission is intended to introduce a line extension to the MANTIS Spinal System, which entails additional diameter size cannulated polyaxial screw components as well as additional straight rod components in a variety of lengths. Modifications were made to the existing MANTIS Spinal System (K061813) to render the new components. The MANTIS Spinal System will include cannulated polyaxial screw, pre-bent rod and straight rod components that can be used via either a percutaneous surgical approach or a standard open approach.

The provided text does not describe the acceptance criteria or a study that proves a device meets such criteria. Instead, it is a 510(k) summary for a spinal fixation system, focusing on its substantial equivalence to predicate devices and its intended use.

Therefore, I cannot provide the requested information in the format specified because the necessary details are not present in the given input.

The document discusses:

• Proprietary Name: MANTIS® Spinal System
• Common Name: Spinal Fixation Appliances
• Regulatory Class: Class III
• Device Product Code: 87 MNH, 87 MNI, 87 NKB
• Predicate Devices: Stryker Spine MANTIS Spinal System (K061813), Stryker Spine Xia® Titanium Spinal System (K013823, K043473, K002858, K060361), and Stryker Spine Osteonics Spinal System (K951725).
• Description of Device Modification: Line extension including additional diameter size cannulated polyaxial screw components and additional straight rod components.
• Intended Use: Posterior, non-cervical pedicle fixation for indications such as degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, and failed previous fusion.
• Technological Comparison: States that the additional screw and rod components have equivalent mechanical properties to the predicate devices and are made from the same materials.

Missing Information:

The document does not contain any information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or data provenance.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method for a test set.
5. Multi-reader, multi-case (MRMC) comparative effectiveness study or effect size.
6. Standalone (algorithm only) performance study.
7. Type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

This is a regulatory submission aimed at demonstrating substantial equivalence based on material and mechanical properties compared to already cleared devices, not a study evaluating performance against specific acceptance criteria for a new feature or algorithm.

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The MANTIS™ Spinal System is intended for percutaneous, posterior, non-cervical pedicle fixation 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, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

The MANTIS™ Spinal System includes cannulated polyaxial screw and straight or pre-bent rod components that can be used via a percutaneous surgical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy. The implants will be provided non-sterile.

The provided text is a 510(k) Summary for the MANTIS™ Spinal System, a medical device for spinal fixation. It details the device's description, intended use, and substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria or a study proving device performance against such criteria in the context of the requested AI/algorithm evaluation.

The 510(k) process for this type of medical device (spinal fixation system) typically involves demonstrating substantial equivalence to a legally marketed predicate device through engineering tests (e.g., mechanical strength, fatigue, biocompatibility) rather than clinical studies of "acceptance criteria" or "device performance" as understood in algorithm evaluation (like sensitivity, specificity, or reader studies).

Therefore, I cannot provide the requested information from the provided document.

To be explicit, the following information is not available in the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The 510(k) focuses on substantial equivalence to predicate devices, not specific performance metrics against pre-defined acceptance criteria, especially not in an AI/algorithm context.
2. Sample sized used for the test set and the data provenance: Not applicable/not present. No "test set" for an algorithm is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not present.
4. Adjudication method: Not applicable/not present.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This document describes a physical medical device, not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No.
7. The type of ground truth used: Not applicable/not present.
8. The sample size for the training set: Not applicable/not present.
9. How the ground truth for the training set was established: Not applicable/not present.

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