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The Premier is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T1-S1): 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; and failed previous fusion (pseudoarthrosis).

The purpose of this 510(k) is to make modifications to the previously cleared Premier Spinal System (K160320). The changes include modifications to the implants, surgical instruments, indications and labeling. The Premier consists of fixed-angle screws, fix-angle reduction screws, multi-axial screws, multi-axial reduction screws, rods, crosslink plates, set screws, planar screw, iliac screw, domino connector, lateral connector and hooks.

It is made of Titanium Alloy (Ti6Al4V), which meets ASTM F136-13, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium (Extra Low Interstitial) Allov for Surgical Implant Applications, which are widely used for surgical implants with wellknown biocompatibility.

The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 106 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

The provided text does not describe an AI medical device or a study proving its acceptance criteria. Instead, it is an FDA 510(k) clearance letter for a Premier Thoracolumbosacral pedicle screw system, which is a physical orthopedic device used in spinal surgeries.

Therefore, I cannot extract the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth related to an AI device. The document focuses on regulatory clearance for a medical implant and mentions conformance to ASTM standards and ISO guidelines for sterilization, not AI performance metrics.

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The Premier is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization of the spine as an adjunct to fusion with bone graft.

The premier consists of fixed-angle screws, fix-angle reduction screws, multi-axial screws, multi-axial reduction screws, rods, crosslink plates, set screws, planar screw, domino connector, lateral connector and hooks. It is made of Titanium Alloy (Ti6Al4V), which meets ASTM F136-13, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 10^-6 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

This document is a 510(k) summary for the "Premier" pedicle screw spinal system. It does not describe an AI/ML powered medical device or a study involving human readers or AI assistance. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technical characteristics.

Therefore, the requested information regarding acceptance criteria for an AI device, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document.

The document indicates "No clinical study is included in this submission" (Page 6). The acceptance criteria and the study that proves the device meets them are based on non-clinical tests verifying design specifications and compliance with ASTM F 1717-13 as detailed in the "Non-Clinical Test Conclusion" section (Page 6).

Here's the relevant information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not applicable. This document refers to non-clinical mechanical testing, not a test set for an AI device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on the performance according to established ASTM standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is for mechanical testing, not clinical data 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: No, an MRMC study was not done. The device is not an AI/ML device.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: No, this is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the mechanical tests, the "ground truth" is defined by the performance parameters and failure criteria established within the ASTM F 1717-13 standard. For material, it's compliance with ASTM F136-13. For sterilization, it's compliance with ISO 17665-1: 2006.

8. The sample size for the training set: Not applicable. There is no training set for this type of device (spinal implant).

9. How the ground truth for the training set was established: Not applicable. There is no training set.

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The Milestone™ Spinal System is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved level. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via transforaminal approach. These implants are to be used with autogenous bone graft.

DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.

These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

The Milestone Spinal System consists of INVIBIO PEEK-OPTIMA LT1 lumbar cages of various lengths and heights, which can be inserted between two lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. They are designed with angular teeth to allow the implant to grip the superior and inferior end plates. The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The cages contain radiographic tantalum markers used for both intra and post-operative positioning and visualization. The cages are provided sterile. The Milestone Spinal System also includes various device specific instruments which are provided non-sterile.

Here's an analysis of the provided 510(k) summary, specifically addressing the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a non-clinical testing program. The summary explicitly states:

"Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:" (followed by a list of standards).

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

The document does not specify sample sizes for non-clinical tests (e.g., how many devices were tested for seal strength or ASTM F2077-03). Non-clinical tests typically refer to laboratory testing of physical and mechanical properties, not patient data. Therefore, the concept of "country of origin of the data" and "retrospective or prospective" is not applicable here as no patient data was used.

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

This information is not applicable as there was no clinical study or patient data involved in establishing ground truth. The "ground truth" for the non-clinical tests was established by adherence to recognized international and national standards (e.g., ISO, USP, ASTM) and comparison to a legally marketed predicate device.

4. Adjudication Method for the Test Set

This information is not applicable as there was no clinical study or patient data requiring expert adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission."

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

This question is not applicable as the device is an intervertebral body fusion device (an implant), not a software algorithm or AI-based diagnostic tool.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating the device meets the acceptance criteria (and is substantially equivalent) relies on physical and mechanical performance data obtained from non-clinical testing against recognized industry standards (e.g., ASTM F2077-03) and direct comparison of specifications (materials, dimensions, intended use) to an existing predicate device.

8. The Sample Size for the Training Set

This information is not applicable. The device is an orthopedic implant, not an AI or machine learning model that requires a "training set."

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

This information is not applicable as there is no training set for this type of device.

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The General Spinal System is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.

The spinal system consists of screws, rods, crosslink plates, set screws and hooks.

It is made of Titanium Alloy (Ti6Al4VELI), which meets ASTM F136-02a, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well known biocompatibility.

The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 10 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development. validation, and routine control of a sterilization process for medical devices

The provided text describes a 510(k) submission for a spinal system and focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing. It does not contain information about the use of AI, human readers, or clinical study data for device performance as would be relevant for acceptance criteria in the context of an AI-powered diagnostic device.

Therefore, the following information regarding acceptance criteria and a study proving device performance as typically applied to AI devices (especially those involving diagnostic accuracy) cannot be extracted from the given text:

1. A table of acceptance criteria and the reported device performance: Not available. The document refers to "design specifications" being met, but these are not defined in terms of specific performance metrics suitable for a table.
2. Sample size used for the test set and the data provenance: Not applicable, as no test set beyond bench testing materials is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no expert evaluation for ground truth is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as clinical ground truth establishment is not mentioned for this type of device. The studies are bench tests.
8. The sample size for the training set: Not applicable, as this is not an AI device.
9. How the ground truth for the training set was established: Not applicable.

However, based on the provided text, here's what can be extracted regarding the device's "acceptance criteria" (in the context of a 510(k) submission for a physical implant) and the study that proves it meets them:

Acceptance Criteria and Device Performance for the General Spinal System (K122994)

Study Details:

• Type of Study: Non-clinical bench tests.
• Sample Size for Test Set: Not explicitly stated, typical for bench testing where a representative number of samples are tested according to defined standards.
• Data Provenance: Not applicable, as these are laboratory bench tests, not clinical data.
• Ground Truth Establishment: For bench tests, the "ground truth" is defined by the specified performance limits and methodologies outlined in the ASTM and ISO standards used. The device's physical properties and performance are verified against these objective criteria.
• Training Set: Not applicable as this is not an AI device.
• Adjudication Method: Not applicable for bench testing against established engineering standards.
• MRMC Comparative Effectiveness Study: Not applicable.
• Standalone Performance: The non-clinical bench tests evaluate the device's standalone physical performance parameters. The "algorithm only" concept does not apply here.

The core of the submission relies on demonstrating that the proposed device, the General Spinal System, performs similarly to a legally marketed predicate device (CD HORIZON® Spinal System, K042790) by meeting the same widely accepted industry standards for spinal implants.

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Locking Bone Plates and Screws are intended for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.

The proposed products, Locking Bone Plates and Screws, contain (1) locking plats with various specifications, (2) locking screws with various specifications and (3) Various specific instruments.

The bone plates are used for internal fixation of bones, screws are used for fix the plates on the bones, and instruments are used for completing the surgery.

Locking Screws are available in two kinds, which are self-dapping and self-drilling. Both of them share the same dimensions and materials.

These devices are provided un-sterilized, but shall be sterilized via autoclave method to achieve Sterility Assurance Level of 10th by hospital prior to use.

The requested information is detailed below, based on the provided text:

Acceptance Criteria and Device Performance Study

The submission focuses on establishing substantial equivalence for medical implants (Locking Bone Plates and Screws) rather than a diagnostic AI device. Therefore, the "acceptance criteria" and "device performance" are related to mechanical and material specifications, and regulatory standards, rather than diagnostic metrics like accuracy, sensitivity, or specificity. The study confirming these criteria is a series of bench tests.

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 as a number of individual plates/screws, but rather through the scope of the specifications (e.g., bone plate lengths from 26-312mm). The testing was conducted on samples representative of the proposed device's various specifications.
• Data Provenance: The tests were "Bench tests" conducted by the manufacturer, Weigao Orthopaedic Device Co., Ltd. in Weihai, Shandong, China. The data is retrospective in the sense that it's a pre-market submission based on completed testing, but it's not clinical data; it's engineering test data.

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

This section is not applicable as the submission describes a medical device (bone plates and screws), not an AI/diagnostic device that would require expert consensus for ground truth on disease states. The "ground truth" here is defined by established engineering and material standards (ASTM and ISO).

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods are typically for clinical or AI performance studies involving interpretations, not for engineering bench tests where outcomes are measured against predefined specifications.

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. No MRMC study was conducted as this is a submission for a medical implant, not an AI-assisted diagnostic tool.

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

This is not applicable. This submission is for a physical medical device, not a standalone AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device type is based on established industry standards and specifications:

• ASTM F382-99 (Reapproved 2008), Standard Specification and Test Method for Metallic Bone Plates.
• ASTM F543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws.
• ANSI/AAMI/ISO17665-1: 2006 for sterilization.
• Material specifications: ASTM F67-06 for Titanium and ASTM F136 for Ti6Al4V ELI.

The performance of the proposed device was compared against the specifications and mechanical performance of the predicate devices, which are also compliant with these standards.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is a submission for a physical medical device, not an AI/machine learning model.

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

This is not applicable for the same reason as point 8.

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The Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metatstatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.

The Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metatstatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.

The plates with lowest profile are available several configurations, including different levels and lengths. It accommodates both semi-constrained constructs in which the variable screws are used for fixation, and constrained applications in which the fixed screws are rigidly locked to the plate attach to the anterior cervical spine with a minimum of four screws per plate.

The screws are also available in several configurations, including types (screw and self-tapping screw), locking methods (fixed locking and variable locking), diameters and various lengths.

All implants of Anterior Cervical Plate System are manufactured from Titanium alloy that meets the requirements of ASTM F136-11, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The materials are wildly used in the industry with well-known biocompatibility. No new materials are used in the development of this implant.

This system is provided non-sterile.

The provided text describes a medical device submission (K123578) for an Anterior Cervical Plate System. The document focuses on establishing the substantial equivalence of the proposed device to a predicate device based on non-clinical bench tests. It does not contain information about studies involving human subjects, AI algorithms, or detailed performance metrics that would typically address the requested criteria.

Therefore, many of the requested items cannot be answered from the provided text.

Here's a breakdown of what can and cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified for the bench tests.
• Data Provenance: The tests are "bench tests," meaning they were conducted in a laboratory setting, not with patient data. The manufacturer is Weigao Orthopaedic Device Co., Ltd. in Weihai, Shandong, China.

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

• Not Applicable. This is a bench test study, not a clinical study involving experts establishing ground truth for patient outcomes or image interpretation.

4. Adjudication Method for the Test Set:

• Not Applicable. This is a bench test study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done (with or without AI assistance):

• No. This is a mechanical device, and the study described is a bench test, not an MRMC study. There is no mention of AI.

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

• No. This is a mechanical device, and there is no mention of an algorithm or AI.

7. The Type of Ground Truth Used:

• For the bench tests, the "ground truth" would be the specifications outlined in the ASTM F1717-04 standard and the material properties defined by ASTM F136-11. The device's performance was compared against these predefined physical and mechanical criteria.

8. The Sample Size for the Training Set:

• Not Applicable. This is a bench test for a physical medical device, not a machine learning model, so there is no "training set."

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

• Not Applicable. As there is no training set, this question is not relevant.

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• · Simple, compound first- and second-degree tibial shaft fractures
• · Pseudarthrosis and delayed union

The Intramedullary Nail System is a temporary fixation intramedullary nail designed for fracture fixation and stabilization of the tibia. It consists of Intramedullary nail, Locking screw and End cap.
The Intramedullary nail is available in a variety of lengths and diameters to meet assorted anatomical needs. Each of the nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail. The Locking screw passes through the holes at the proximal distal sections of intramedullary nail for preventing rotation and axial compression. The End cap which screws into the threaded end of the intramedullary nail provides intraoperative lengths adjustment and prevents tissues growth into nail threads.
All implants of Intramedullary Nail System are manufactured from Ti-6AI-4V alloy that meets the requirements of ASTM F-136. The materials are wildly used in the industry with well known biocompatibility. No new materials are used in the development of this implant.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Intramedullary Nail System:

This device (Intramedullary Nail System) is a medical device for fracture fixation, and as such, its acceptance criteria and supporting studies are centered on its mechanical performance and biocompatibility rather than diagnostic accuracy or human interpretation. Therefore, many of the requested categories related to AI performance, expert consensus, and ground truth in a diagnostic context are not applicable here.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes (e.g., number of nails, screws) used for the bench tests. The tests were conducted to verify that the proposed device met design specifications and was substantially equivalent to the predicate device. The provenance is not explicitly stated beyond the manufacturing location of the device being China. The tests are de novo mechanical bench tests, not data derived from patients (retrospective or prospective).

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

Not applicable. This is a medical device for fracture fixation and stabilization, not a diagnostic device requiring expert interpretation for ground truth establishment. The ground truth for mechanical performance is established by standardized testing protocols (ASTM standards) and engineering principles.

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

Not applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which is not the case for these mechanical bench tests.

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 device is an intramedullary nail system, a physical implant for fracture fixation. It is not an AI-powered diagnostic or assistive tool, so an MRMC study is irrelevant.

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

Not applicable. This refers to an AI algorithm's performance, which is not relevant for this physical medical device. The "standalone" performance here relates to the device's mechanical performance in bench tests, independent of human interaction during its function as an implant.

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

The ground truth for the performance of this device is based on established engineering standards and material specifications from ASTM (American Society for Testing and Materials). Specifically:

• ASTM F1264-03 (Reapproved 2007): Standard Specification and Test Methods for Intramedullary Fixation Devices (for static bending, static torsion, and dynamic bending).
• ASTM F 543-07: Standard Specification and Test Methods for Metallic Medical Bone Screws (for pull-out strength).
• ASTM F-136: Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (for material biocompatibility).

8. The sample size for the training set

Not applicable. There is no "training set" in the context of mechanical bench testing for a physical implant. The device design is informed by engineering principles and existing predicate devices, not machine learning training from a dataset.

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

Not applicable, as there is no training set for this type of device submission.

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