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MSFX MIKRON SPINAL FIXATION SYSTEM is intended for use in the noncervical spine. When used as a posterior, noncervical pedicle and non- pedicle fixation system, the MSFX MIKRON SPINAL FIXATION SYSTEM is intended to provide additional support during fusion using autograft in the treatment of 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

• -Curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
  -Tumor

-Pseudoarthrosis; and failed previous fusion

Msfx Mikron System is a top-loading, multiple component, posterior spinal fixation system consisting of polyaxial pedicle screws, monoaxial pedicle screws, cannulated and spondylolisthesis screws, rods (Straight and curved) , connectors , hooks and setscrews. It allows surgeons and functions to build a spinal implant construction to stabilize and promote spinal fusion. The System components are supplied non-sterile, for single use and fabricated from titanium alloy (Ti6Al4V-EL) that conforms to ASTM F136. Various sizes of these components are available.

The provided text is a 510(k) clearance letter from the FDA for a spinal fixation system (MSFX MIKRON SPINAL FIXATION SYSTEM). It does not describe the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The document primarily focuses on the regulatory aspects of a traditional medical device (spinal implants), including:

• Device Name: MSFX Mikron Spinal Fixation System
• Regulation Number/Name: 21 CFR 888.3070, Thoracolumbosacral Pedicle Screw System
• Regulatory Class: Class II
• Product Code: NKB, KWP
• Indications for Use: Provides support during fusion for various spinal conditions (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, failed previous fusion).
• Predicate Devices: K171497 (Mikron Spinal Fixation system), K212220 (Artfx Spinal Fixation System), K091445 (CD HORIZON SPINAL SYSTEM), K071373 (XIA 3 Spinal System).
• Device Description: Multi-component, posterior spinal fixation system made of titanium alloy.
• Testing: Biomechanical tests performed according to ASTM F2193 and ASTM F1717, demonstrating substantial equivalence to the predicate device.

Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, its performance, study details (sample size, data provenance, expert ground truth, adjudication), or MRMC/standalone studies, as this document is not about an AI/ML medical device.

To answer your request, I would need a document pertaining to an AI/ML medical device.

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The SAGICO OSI SPINAL SYSTEM by Osimplant is intended for use in the non-cervical spine.

When used for anterior/anterolateral and posterior, non-cervical pedicle fixation system, the SAGICO OSI SPINAL SYSTEM by Osimplant 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;
• · Curvatures (i.e. scoliosis, kyphosis, and/or lordosis);
• · Tumor:
• · Pseudoarthrosis; and
• Failed previous fusion

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the SAGICO OSI SPINAL SYSTEM by Osimplant implants are indicated as an adjunct to treat adolescent idiopathic scoliosis.

The SAGICO OSI SPINAL SYSTEM by Osimplant for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The SAGICO OSI SPINAL SYSTEM by Osimplant constructs of monoaxial screws, uniplanar screws, polyaxial screws, reduction screws, locking cap set screws, rods, hooks, monoaxial and muttiaxial transverse connectors and associated surgical instruments. The SACICO OSI SPINAL SYSTEM by Osimplants are available in a variety of sizes to accommodate individual patient anatomy and pathology conditions. SAGICO OSI SPINAL SYSTEM by Osimplant implants are designed to adapt 5.5mm diameter rods; the implants are manufactured from Ti6A14V alloy and offered in a sterile package option.

The provided text is a 510(k) summary for the SAGICO OSI SPINAL SYSTEM by Osimplant, a medical device for spinal fixation. It details the device's indications for use, technological characteristics, and performance data used to establish substantial equivalence to predicate devices. However, this document does not describe an AI/ML device or algorithm. It is a clearance for a traditional physical medical implant system consisting of screws, rods, and associated instruments.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies for an AI device cannot be extracted from this document, as it pertains to a mechanical spinal implant system.

The information below is a general template for response if the input data would contain information for an AI/ML powered device, as the prompt is not expecting the type of the device to be considered.

This document does not describe an AI/ML powered medical device. It describes a traditional, mechanical spinal implant system (SAGICO OSI SPINAL SYSTEM by Osimplant). Therefore, the specific details requested regarding AI/ML device performance, acceptance criteria, sample sizes for AI/ML models, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance are not available in this document.

The document focuses on demonstrating substantial equivalence of the mechanical implant system to predicate devices based on:

• Indications for Use: The SAGICO OSI SPINAL SYSTEM is intended for use in the non-cervical spine for various conditions like degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, and failed previous fusion in skeletally mature patients. For pediatric patients, it's indicated for adolescent idiopathic scoliosis (posterior approach only).
• Technological Characteristics: The device consists of monoaxial screws, uniplanar screws, polyaxial screws, reduction screws, locking cap setscrews, rods, hooks, monoaxial and multiaxial transverse connectors, and associated surgical instruments. Implants are made from Ti6Al4V alloy and designed for 5.5mm diameter rods.
• Performance Data (Non-clinical):
  • ASTM F1717-04: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model (Static Compression Bending Test, Dynamic Compression Bending Test).
  • ASTM F1798-13: Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants (Axial Gripping Test, Axial Torsion Gripping Test, Flexion Extension Static Test).
• Basis of Substantial Equivalence: Comparable data drawn from design, labeling, indications for use, function, and implant materials compared to predicate devices (XIA® 3 Spinal System, USS Small Stature System, CD HORIZON Spinal System, TSRH Spinal System).

If this were an AI/ML device, the requested information would typically be presented as follows (this is a hypothetical example for illustrative purposes, not based on the provided document):

1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical for an AI/ML device)

2. Sample Size and Data Provenance for Test Set (Hypothetical)

• Sample Size: 500 spinal imaging studies (e.g., X-rays, CT scans)
• Data Provenance: Retrospective data collected from 3 hospitals in the United States and 2 hospitals in Germany.

3. Number and Qualifications of Experts for Ground Truth (Hypothetical)

• Number of Experts: 3 independent radiologists
• Qualifications: All board-certified radiologists with subspecialty training in musculoskeletal radiology and at least 10 years of experience interpreting spinal imaging.

4. Adjudication Method for Test Set (Hypothetical)

• Adjudication Method: 2+1. Initial assessment by two radiologists. Discrepancies were resolved by a third, senior radiologist.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study (Hypothetical)

• Was an MRMC study done? Yes.
• Effect Size: In the MRMC study, human readers (radiologists) demonstrated a statistically significant improvement in fracture detection accuracy (AUC increased by an average of 0.05, p < 0.001) when assisted by the AI device compared to reading without AI assistance. This translated to a 15% reduction in missed fractures among the assisted group.

6. Standalone Algorithm Performance (Hypothetical)

• Was a standalone study done? Yes. The performance metrics in the table above reflect the standalone performance of the algorithm on the test set.

7. Type of Ground Truth Used for Test Set (Hypothetical)

• Type of Ground Truth: Expert consensus (as established by the 2+1 adjudication method based on expert review of the imaging studies). In cases where available, pathology reports and follow-up clinical outcomes were used to corroborate expert diagnoses.

8. Sample Size for Training Set (Hypothetical)

• Sample Size: 5,000 spinal imaging studies (e.g., X-rays, CT scans).

9. How Ground Truth for Training Set was Established (Hypothetical)

• Ground Truth Establishment: Annotated by a team of trained radiology residents and fellows under the supervision of experienced attending radiologists. A subset of the annotations (10%) was independently reviewed by a senior radiologist for quality control, and discrepancies were resolved through discussion.

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The IMPLANET Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The IMPLANET Spine System is intended for posterior, non-cervical pedicle and non-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, spinal deformities (i.e., scoliosis, kyphosis and/or lordosis), turnor, pseudarthrosis, or revision of a failed fusion attempt.

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

The IMPLANET Spine System is a posterior instrumentation system. The polyaxial screws are made of Ti6Al4V titanium alloy compliant with ISO 5832-3. The polyaxial screw is comprised of three sections: the pedicle screw; the head; and a ring that connects the screw to the head. The polyaxial screws are offered in diameters ranging from 5.0 to 7.5 mm and in lengths ranging from 35 to 60 mm.

The monoaxial pedicle screws are made of Ti6A!4V titanium alloy compliant with ISO 583203 and are available in 5.0 mm, 6.0 mm, 7.0 mm, and 8.0 mm diameters. The screws range in length from 35 to 60 mm.

The system includes both straight and pre-bent rods made of Ti6Al4V titanium alloy.

The transverse connectors are composed of Ti6Al4V titanium alloy compliant with ISO 5832-3. These connectors are used to build a transverse connection between two union rods.

The hooks are made of Ti6AI4V titanium alloy and are provided in multiple configurations.

The IMPLANET Spine System has principles of operation substantially similar to other pedicle screw-based systems for the indications listed.

The IMPLANET Spine System components may be used for posterior pedicle screw fixation in pediatric cases: polyaxial and monoaxial screws, rods, transverse connectors and rods.

The purpose of the subject 510(k) notice is the addition of new indications and the inclusion of intermediate screw sizes to the company's cleared system.

The provided text describes the Implanet S.A.'s IMPLANET Spine System, a spinal fixation device. However, it does not contain information related to software or AI/ML performance, acceptance criteria, or studies for such, as the device is a physical implant. The document is a 510(k) summary for a medical device (spinal fixation system) that primarily focuses on mechanical and material properties, biocompatibility, and manufacturing standards.

Therefore, I cannot provide the requested information about acceptance criteria and studies for a digital health device. The document describes:

1. Device Description: Physical components like polyaxial and monoaxial pedicle screws, rods, transverse connectors, and hooks, all made of Ti6Al4V titanium alloy.
2. Technological Characteristics: Substantially similar to other pedicle screw-based systems.
3. Performance Data: This section only refers to bench testing (static and dynamic mechanical tests), sterility validation, shelf life validation, and biocompatibility testing. It specifically states that these tests were performed on the previous version of the device (Calypso System) and some biocompatibility tests were reperformed on the current version.
4. Substantial Equivalence: Concludes that the device is substantially equivalent to predicate devices based on intended use, indications, technological characteristics, and principles of operation, with minor differences raising no new safety or effectiveness issues.

Conclusion:

The provided text does not contain any information about:

• Acceptance criteria related to AI/ML performance.
• Reported device performance for AI/ML.
• Sample size for test sets in an AI/ML context.
• Data provenance for AI/ML training/testing.
• Number or qualifications of experts for AI/ML ground truth.
• Adjudication methods for AI/ML ground truth.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies with AI assistance.
• Standalone algorithm-only performance studies.
• Type of ground truth used (expert consensus, pathology, outcomes data) in an AI/ML context.
• Sample size or establishment of ground truth for a training set in an AI/ML context.

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The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle, and nonpedicle fixation (T1-S2/Ilium). Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications:

• . degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
• . spondy lolisthesis,
• . trauma (i.e., fracture or dislocation),
• . spinal stenosis,
• . deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
• . tumor;
• . pseudoarthrosis, and
• failed previous fusion .
  When used for fixation to the ilium, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.
  The Phoenix MIS Fixation System when used with the Firebird Spinal Fixation System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
  The Firebird Spinal Fixation System components are used with certain components of the Orthofix Spinal Fixation System, including rods, rod connectors and cross-connectors.
  When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Firebird Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Firebird Spinal Fixation System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Firebird Spinal Fixation System is a temporary, titanium alloy, multiple component system comprised of a variety of non-sterile, single use components, made of titanium alloy or cobalt chrome alloy, that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body and ilium by means of screw or hook fixation to the non-cervical spine. The Firebird Spinal Fixation System consists of an assortment of rods, multi-axial and mono-axial pedicle screws, set screws, lateral offsets, bone screws, screw bodies, hooks and iliac connectors. The expansion of indications for the Firebird Spinal Fixation System is proposed for the inclusion of adolescent idiopathic scoliosis alone, and not other indications for a pediatric population.
A subset of the Firebird Spinal Fixation System and Phoenix MIS System components may be used in pediatric patients. These components consist of a variety of screws ranging in diameters from 4.5mm to 7.5mm and lengths ranging from 25mm to 60mm.

The provided document is a 510(k) summary for the Orthofix Firebird Spinal Fixation System. This type of regulatory submission (510(k)) is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria as you might see for a novel device or a PMA.

Therefore, the document does not contain information about acceptance criteria and a study proving a device meets them in the way a diagnostic AI device or a novel therapeutic device would. Instead, it focuses on demonstrating equivalence to existing devices based on design, materials, indications for use, and mechanical performance.

I will attempt to extract the closest equivalents to your requested information where possible, based on the context of a 510(k) submission.

Analysis of the Provided Document Regarding Acceptance Criteria and Device Performance

The Orthofix Firebird Spinal Fixation System is a Class III Preamendment Device (Pedicle screw spinal system) for which the manufacturer is seeking 510(k) clearance. A 510(k) clearance means the device is "substantially equivalent" to predicate devices. This type of submission generally relies on demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as a legally marketed device. It typically does not involve traditional clinical studies with acceptance criteria for device classification as one would expect for a novel device or an AI/diagnostic product.

Therefore, many of the requested points below are not directly applicable or quantifiable from this document.

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

   Not applicable in the context of this 510(k) submission. The performance assessment is focused on "substantial equivalence" to predicate devices, primarily through mechanical testing and engineering analysis rather than specific clinical acceptance criteria.

   The document states:
   "Previous mechanical testing of the system included static and dynamic compression bending testing and static torsion testing per ASTM F1717-04 and finite element analysis."

   While these tests have criteria for compliance with the standard, the document does not present a table of these criteria alongside specific device performance data. The conclusion drawn is that the device is substantially equivalent based on these results.

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

   Not explicitly stated for the mechanical testing mentioned. When mechanical testing is performed, the "sample size" refers to the number of physical devices or components tested. The data provenance is not specified.

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. Mechanical testing does not involve "experts" establishing ground truth in the way a diagnostic study would. The standards for mechanical testing (e.g., ASTM F1717-04) define the methods and parameters.

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

   Not applicable. Mechanical testing does not involve adjudication.

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 spinal fixation system, not a diagnostic or AI-powered device.

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

   Not applicable. This is a spinal fixation system, not an algorithm.

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

   For mechanical testing, the "ground truth" is defined by the physical properties and performance limits set by engineering standards (e.g., ASTM F1717-04). For the expansion of indications (specifically for adolescent idiopathic scoliosis), the document mentions: "Published clinical results and engineering analysis supported expansion of indications." This implies that existing clinical literature for similar predicate devices, combined with engineering analysis (which would include the mechanical testing), served as the basis for justifying the expanded indications. Outcomes data or expert consensus from previously published studies might have indirectly informed this, but no new study for this submission is detailed.

8. The sample size for the training set

   Not applicable. This is a spinal fixation system, not a machine learning model requiring a training set.

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

   Not applicable. This is a spinal fixation system, not a machine learning model.

Summary regarding the Firebird Spinal Fixation System and 510(k) process:

The K130932 submission for the Firebird Spinal Fixation System is a 510(k) premarket notification. The core of this submission is to demonstrate substantial equivalence to existing predicate devices. This is achieved by showing that the device:

• Has the same intended use.
• Has the same basic technological characteristics (design, materials: titanium alloy per ASTM F136 and cobalt chrome per ASTM F1537, as with predicates).
• Performs as safely and effectively as the predicate devices.

The "proof" the device meets acceptance criteria in this context relies on:

• Mechanical Testing: Static and dynamic compression bending, and static torsion testing per ASTM F1717-04.
• Finite Element Analysis (FEA).
• Comparison to existing predicate devices: K081684, K082797, K100044, K093926, K122901 (Orthofix Inc.), K113666 (Stryker Spine), K091445 (Medtronic Sofamor Danek USA), K994121 (Synthes Spine), K121630 (K2M, Inc.), K111492 (Medtronic Sofamor Danek USA).

The document states: "Previous testing performed on this device indicates that the Firebird Spinal Fixation System is substantially equivalent to predicate devices." and "Published clinical results and engineering analysis supported expansion of indications." This means the mechanical performance met relevant engineering standards, and the safety and efficacy for the expanded indications (specifically pediatric adolescent idiopathic scoliosis) were supported by existing clinical literature and the device's engineering characteristics being similar to already approved predicate devices.

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The Axle Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1 inclusive). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: 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); and/or tumor. The Axle Interspinous Fusion System is intended for use with bone graft material, and not for stand-alone use.

The Axle Interspinous Fusion System consists of plates and inserts of various sizes that are used to provide supplemental stabilization of the spinous processes to support fusion. The svstem components can be assembled in a variety of configurations so that adaptations can be made to take into account pathology and individual patient anatomy. The systems components are manufactured using standard manufacturing processes of medical grade Titanium alloy (Ti6Al4V) that complies with ASTM F136 - Standard Specifications for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and Invibio PEEK Optima LT-1 in accordance with ASTM F2026 -Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications. The implant components are provided clean and non-sterile. These devices are supplied in a rigid sterilization tray and are to be sterilized by a healthcare professional using a Steam Autoclaye in accordance with the instructions for use provided by X-spine Systems Inc., as well as the instructions provided by the Autoclave manufacturer.

The provided text describes a 510(k) premarket notification for the Axle™ Interspinous Fusion System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies to establish novel performance criteria. Therefore, the information requested in your prompt regarding acceptance criteria, study details, and AI-specific metrics is largely not applicable to this document.

Here's an breakdown of why and what information can be extracted based on the provided text:

General Context of the Document:

This is a 510(k) submission, specifically a "Special 510(k): Device Modification." This means X-spine Systems, Inc. is seeking to market a modified version of an already cleared device. The primary goal of a 510(k) is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective. This is typically achieved through comparison of design, materials, manufacturing processes, and sometimes non-clinical performance testing (bench testing), rather than large-scale clinical trials.

Missing Information (and why):

Most of the requested information (sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone AI performance, type of ground truth, etc.) is relevant for studies conducted to establish the de novo efficacy or safety of a new and novel device, particularly those involving AI/ML components for diagnostic or prognostic purposes. The Axle Interspinous Fusion System is a mechanical implant, and its 510(k) submission does not involve AI or these types of clinical study methodologies.

Information Extracted from the Document:

Despite the above, I can provide a limited answer based on the provided text, focusing on what is relevant to a 510(k) for a mechanical device:

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

For a mechanical implant like the Axle Interspinous Fusion System, "acceptance criteria" and "reported device performance" are typically defined by engineering standards and successful completion of specified mechanical tests, demonstrating equivalence to the predicate device. The document states:

Self-correction/Clarification: The document doesn't explicitly list numerical "acceptance criteria" (e.g., "must withstand X N of compression"). Instead, it states that the device was tested using specific ASTM standards and additional tests. The acceptance for a 510(k) is that the device performs comparably to the predicate device under these tests, thereby demonstrating "substantial equivalence." The document concludes that the modified device "substantially meet[s] the performance criteria established by the cleared parent device," implying it met the unstated performance thresholds benchmarked against the predicates.

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

• This information is not provided as the device is a mechanical implant primarily evaluated through bench testing. The "test set" here refers to the physical samples of the device undergoing mechanical scrutiny, not a clinical data set. There is no mention of country of origin or retrospective/prospective data collection as it's not a clinical study in that sense.

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)

• This information is not applicable/provided. "Ground truth" in the context of mechanical testing refers to the physical properties and performance characteristics of the materials and device components. Experts in this field would be engineers and material scientists interpreting the results of mechanical tests, but their number and specific qualifications are not detailed in this 510(k) summary.

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

• This information is not applicable/provided. Adjudication methods are typically for subjective clinical assessments or image interpretations, not for objective mechanical testing.

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 information is not applicable. The Axle Interspinous Fusion System is a surgical implant, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted, nor is AI involved.

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

• This information is not applicable. As stated, this is a mechanical implant with no AI component.

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

• The "ground truth" for this device's evaluation is primarily engineering specifications and measurements from mechanical (bench) testing against established ASTM standards and comparable performance to the predicate devices.

8. The sample size for the training set

• This information is not applicable/provided. The concept of a "training set" is relevant for machine learning models, which are not involved here.

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

• This information is not applicable/provided for the same reasons as #8.

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When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using allograft and/or autograft, the TSRH® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients using allograft and/or autograft: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint: (2) who are receiving fusions using autogenous bone graft only: (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) pseudarthrosis, (7) tumor resection, and/or (8) unsuccessful previous attempts at spinal fusion.

When used as a unilateral supplemental fixation device in the antero-lateral thoracic/lumbar region, the TSRH® L-Plate and VANTAGE™ screws are intended for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

For anterior use only the TSRH® Spinal System has the additional indication of: spondylolysis.

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

The TSRH® Spinal System is intended to help provide immobilization and stabilization of solnal segments as an adjunct to fusion of the thoracic. Iumbar. and/or sacral spine.

The TSRH® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, staples, plates and connecting components as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tallor-made for the individual case.

A subset of TSRH® Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, and connecting components as well as CD HORIZON® Spinal System components cleared for pediatric use. Similarly to the TSRH® implants used in adult case, these components can be rigidly locked into a variety of configurations, with each construct being tailored-made for the individual case. All screws used in pediatric cases are only cleared for use via a posterior approach. All of the components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy and medical grade cobalt -chromium-molybdenum alloy.

TSRH® Spinal System staples are specifically excluded for use in pediatric patients.

Certain implant components from other Medtronic spinal systems can be used with the TSRH® Spinal System. These components include GDLH® rods, rod/bolt connectors, Variable Angle T-bolts, set screws and locking screws; DYNALOK® PLUS bolts, and Vantage™ Anterior Fixation System screws.

The hooks are intended for posterior use only. The staples are for anterior use only. The TSRH-3D® and TSRH® 3Dx™ connectors, and TSRH-3D® and TSRH® 3Dx™ screws are intended for posterior use only. Within the TSRH® family, the cobalt chromium rods should only be used with TSRH® 3Dx™ Spinal System. All CROSSLINK® Plates are for posterior use and the CROSSLINK® Axial and Offset Plates may be used anteriorly as well.

The TSRH® Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium or titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy. Medical grade titanium, titanium alloy, and/or cobalt-chromium-molybdenum alloy may be used together. Certain TSRH® Spinal System components may be coated with hydroxyapatite. Never use titanium, titanium alloy, and/or cobalt-chromium-molybdenum alloy with stainless steel in the same construct.

The purpose of this 510(k) submission is to expand the indications of use to allow for use of pedicle screw based constructs to treat pediatric patients.

The provided document describes the Medtronic TSRH® Spinal System, a medical device for spinal fixation, and its 510(k) submission for an expanded indication for use in pediatric patients.

Here's an analysis of the acceptance criteria and study information contained within the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in the traditional sense (e.g., specific thresholds for success, failure rates, or statistical significance levels). Instead, the performance is demonstrated through the concept of "substantial equivalence" to a predicate device and positive clinical data.

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

• Sample Size:
  • 40 pediatric patients treated with TSRH® pedicle screws only.
  • 105 pediatric patients treated with a hybrid of TSRH® hooks and pedicle screws.
  • Total patients in the reported clinical data = 145 patients.
• Data Provenance:
  • Country of origin: Not explicitly stated.
  • Retrospective or Prospective: "Published retrospective clinical data" indicates it was a retrospective study.

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

The document does not mention the use of experts to establish a "ground truth" for the clinical data in the context of a specific reader study or algorithm evaluation. Instead, the "truth" is based on the clinical outcome of the patients as documented in the retrospective data. It is implied that the diagnoses (adolescent idiopathic scoliosis) and treatment outcomes were established by the treating physicians and documented in patient medical records.

4. Adjudication Method for the Test Set

Not applicable. The document does not describe a process for adjudicating interpretations or measurements in the clinical data. The clinical data appears to be a record of patient treatments and outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document discusses a spinal system (an implantable device), not an imaging or diagnostic AI algorithm that would typically involve human readers. Therefore, there is no mention of human readers improving with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone performance study in the context of an algorithm or AI without human intervention was not conducted. This document describes a physical medical device (spinal system), not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for the clinical data used to support the expanded indication is based on clinical outcomes data and patient diagnoses. Specifically:

• Diagnosis of "adolescent idiopathic scoliosis."
• Treatment with TSRH® Spinal System (pedicle screws or hybrid).
• Presumably, the success or failure of the fusion and correction of scoliosis as observed in the clinical follow-up of these patients.

8. Sample Size for the Training Set

Not applicable. This is a 510(k) submission for a physical medical device, not an AI/ML algorithm that requires a training set. The clinical data mentioned is for validating the device's expanded indication, not for training a model.

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

Not applicable, as there is no training set for an AI/ML algorithm in this context.

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The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation 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); tumor; pseudarthrosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.

With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.

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

The CD HORIZON SPIRE™ Plate is a posterior, single level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (TI-SI) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined); spondylolisthesis; trauma; and/or tumor.

In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.

The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, staples and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

A subset of CD HORIZON® Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5mm to 6.35mm), hooks, screws, CROSSLINK® Plates, and connecting components. Similarly to the CD HORIZON® implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

Certain components within the CD HORIZON® Spinal System are specifically excluded for use in pediatric patients. These include PEEK rods, CD HORIZON® SPIRE spinous process plate device, Shape Memory Alloy Staples, DYNALOK® bolts, and TSRH® screws and washers. All screws used in pediatric cases are only cleared for use via a posterior approach. All of the components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, and medical grade cobalt-chromium-molybdenum allov.

Certain implant components from other Medtronic spinal systems can be used with the CD HORIZON® Spinal System in non-pediatric cases. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples, washers, GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors: LIBERTY® rods and screws; DYNALOK® PLUS and DYNALOK CLASSIC® bolts along with rod/bolt connectors; and Medtronic Multi-Axial rods and screws. Please note that certain components are specifically designed to connect to 03.5mm, 04.5mm, 05.5mm rods or 06.35mm rods, while other components can connect to both Ø5.5mm rods and Ø6.35mm rods. Care should be taken so that the correct components are used in the spinal construct.

CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE® rods and associated screws are intended for anterior use only. However, for patients of sinaller stature and pediatric patients, CD HORIZON® 4.5mm rods and associated components may be used posteriorly.

The CD HORIZON® Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, medical grade cobaltchromium-molybdenum alloy, or medical grade PEEK OPTIMA-LT1. Certain CD HORIZON® Spinal System components may be coated with hydroxyapatite.

Never use stainless steel and titanium implant components in the same construct.

Medical grade titanium, titanium alloy, and/or medical grade cobalt-chromiummolybdenum alloy may be used together. Never use titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct.

The CD HORIZON® Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium. titanium alloy, and cobalt-chromium-molybdenum alloy. Do not use with stainless steel. These staples are not to be used in pediatric patients.

PEEK OPTIMA-LT1 implants may be used with stainless steel, titanium, or cobaltchromium-molybdenum alloy implants. CD HORIZON® PEEK Rods are not to be used with CROSSLINK® Plates or in pediatric patients.

The purpose of this 510(k) was to add SEXTANT® 4.75mm diameter rods manufactured out of cobalt chrome and modified SEXTANT® and SEXTANT® reduction instruments to the CD HORIZON® Spinal System.

This is a 510(k) premarket notification for a medical device, the CD HORIZON® Spinal System. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific performance acceptance criteria through clinical studies in the same way an AI/ML-driven diagnostic device would.

Therefore, many of the requested sections related to acceptance criteria, study design, ground truth, and AI/ML performance metrics are not applicable to this document. The document focuses on demonstrating substantial equivalence through design features, materials, and non-clinical testing.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in terms of performance metrics for the device. The "performance" demonstrated is substantial equivalence to predicate devices, primarily through design verification and validation activities.

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

• Sample size for test set: Not applicable in the context of this 510(k). The non-clinical testing mentioned involves "tolerance stacks and cadaver lab" (for instruments) and a rationale for not requiring mechanical testing for the rods due to minor design changes. These are not explicitly quantified as "sample sizes" in the way one would for a clinical study or an AI model’s test set.
• Data provenance: Not applicable. The "testing" referred to is internal design verification and validation, not data collected from patients or a specific geographical region.

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 the context of clinical outcomes or diagnostic accuracy, is not established for this type of device submission. The substantial equivalence relies on engineering and design principles, and comparison to already cleared predicate devices.

4. Adjudication method for the test set

Not applicable. There is no "test set" in the sense of patient data requiring adjudication.

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/ML-driven device.

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

Not applicable. This is not an AI/ML-driven device.

7. The type of ground truth used

Not applicable. No "ground truth" (expert consensus, pathology, outcomes data) in the context of diagnostic accuracy or clinical effectiveness is used or presented in this 510(k). The "truth" for this submission is that the modifications to the device (new rod material/size, modified instruments) do not alter its fundamental performance or safety compared to the predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/ML-driven device.

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

Not applicable. This is not an AI/ML-driven device.

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The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation 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 and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.

With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.

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

The CD HORIZON SPIRE™ Plate is a posterior, single level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (TI-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined); spondylolisthesis; trauma; and/or tumor.

In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.

The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, staples and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

A subset of CD HORIZON® Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5mm to 6.35mm), hooks, screws, CROSSLINK® Plates, and connecting components. Similarly to the CD HORIZON® implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

Certain components within the CD HORIZON® Spinal System are specifically excluded for use in pediatric patients. These include PEEK rods, CD HORIZON® SPIRE spinous process plate device, Shape Memory Alloy Staples, DYNALOK® bolts, and TSRH® screws and washers. All screws used in pediatric cases are only cleared for use via a posterior approach. All of the components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, and medical grade cobalt-chromium-molybdenum alloy.

Certain implant components from other Medtronic spinal systems can be used with the CD HORIZON® Spinal System in non-pediatric cases. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples, washers, GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors; LIBERTY® rods and screws; DYNALOK® PLUS and DYNALOK CLASSIC® bolts along with rod/bolt connectors; and Medtronic Multi-Axial rods and screws. Please note that certain components are specifically designed to connect to ~ 3.5mm, ~ 4.5mm, ~ 5.5mm rods or ~ 6.35mm rods, while other components can connect to both ~ 5.5mm rods and ~ 6.35mm rods. Care should be taken so that the correct components are used in the spinal construct.

CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE® rods and associated screws are intended for anterior use only. However, for patients of smaller stature and pediatric patients. CD HORIZON® 4.5mm rods and associated components may be used posteriorly.

The CD HORIZON® Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, medical grade cobaltchromium-molybdenum alloy, or medical grade PEEK OPTIMA-LT1. Certain CD HORIZON® Spinal System components may be coated with hydroxyapatite.

Never use stainless steel and titanium implant components in the same construct.

Medical grade titanium, titanium alloy, and/or medical grade cobalt-chromiummolybdenum alloy may be used together. Never use titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct.

The CD HORIZON® Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol - NiTì). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt-chromium-molybdenum alloy. Do not use with stainless steel. These staples are not to be used in pediatric patients.

PEEK OPTIMA-LT1 implants may be used with stainless steel, titanium, or cobaltchromium-molybdenum alloy implants. CD HORIZON® PEEK Rods are not to be used with CROSSLINK® Plates or in pediatric patients.

The purpose of this 510(k) was to add modified setscrews manufactured out of medical grade titanium alloy to the CD HORIZON® Spinal System for use with 4.75mm diameter rods.

The provided 510(k) summary for the CD HORIZON® Spinal System (K102555) describes the acceptance criteria and the study that proves the device meets those criteria. The study focuses on the mechanical performance of modified setscrews added to the system, demonstrating their substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document states, "The subject devices met the pre-determined acceptance criteria for all test methods." However, the specific quantitative values for these criteria are not provided in this summary. It is implied that these criteria were established based on the performance of the legally marketed predicate devices, which the new setscrews needed to meet or exceed for substantial equivalence. The relevant standard for testing was ASTM F1798.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "the subject setscrews were subjected to interconnection testing" and "test methods included the following," suggesting that samples of the new setscrews were tested.
• Data Provenance: The testing was non-clinical mechanical testing, performed in accordance with ASTM F1798. It originates from the manufacturer's (Medtronic Sofamor Danek USA, Inc.) internal testing or contracted lab testing. The country of origin for the data is not specified, but the company is based in Memphis, Tennessee, USA. The data is prospective in the sense that new tests were conducted on the modified setscrews.

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

This is not applicable to this submission. The "ground truth" here is mechanical performance, established through standardized engineering tests (ASTM F1798), not through human expert assessment of clinical data or images.

4. Adjudication Method for the Test Set

This is not applicable. Mechanical test results are objective measurements and do not require expert adjudication in the same way clinical interpretations might.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This submission is for mechanical components (setscrews) of a spinal system and focuses on their physical performance rather than human interpretive performance with or without AI assistance.

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

This is not applicable. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used

The "ground truth" in this context is the objective mechanical performance of the setscrews as measured by standardized tests (Axial Grip, Static Flexion/Extension, Flexion/Extension Fatigue) against pre-determined acceptance criteria, which are implicitly derived from the performance of legally marketed predicate devices. This is a type of objective physical performance data or engineering test data.

8. The Sample Size for the Training Set

This is not applicable. There is no concept of a "training set" for this type of mechanical device submission.

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

This is not applicable as there is no training set mentioned in the context of this device submission.

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