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The Sapphire X3 Anterior Cervical Plate System is intended fixation (C2-T1) in skeletally mature patients as an adjunct to fusion for the following indications:

· Degenerative Disc Disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)

• · Spondylolisthesis
• · Trauma (including fracture or dislocation)
• · Spinal stenosis
• · Deformities or Curvatures (kyphosis, lordosis or scoliosis)
• Tumor
• · Pseudoarthrosis
• · Failed previous fusion

The purpose of this submission is to seek clearance for additional implant sizes in the Sapphire X3 Anterior Cervical Plate System. The Spinal Elements' Sapphire X3 Anterior Cervical Plate System is comprised of plates and screws that are used for attachment to the anterior cervical spine. Both plates and screws are available in a variety of sizes to suit the individual pathology and anatomic conditions of the patient. Plates are pre-shaped with radial and lordotic curvature and have large windows for graft and end plate visualization. Plates range in length to accommodate one to five levels of fusion. Sapphire X3 plates accommodate larger angles for the distal screws in order to minimize plate overhang on the vertebral bodies.

All screws are equipped with an internal locking mechanism that is actuated by rotating a preassembled inset screw. Upon rotation, the insert screw interfaces with a clip in the head of the screw causing the clip to expand. The expansion of the clip prevents the screw from disassociating from the plate.

Screws are available in both fixed and variable angle designs. Fixed angle screws have a predetermined trajectory relative to the plate. The fixed angle screws have a neck diameter similar in size to the screw hole diameter of the plate.

Variable angle screws provide freedom in trajectory of the screws into the vertebral body. They allow 8° of angulation in any direction relative to the plate. The variable angle screws have a neck diameter that is smaller than the screw hole diameter of the plate. This difference in diameter allows the variable angle screws to be inserted at various angles relative to the plate.

The materials used for the system remain unchanged. The plates and screws are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3. The locking clips on the screws are manufactured from Nitinol conforming to ASTM F2063.

This document, K231593, describes the 510(k) premarket notification for the "Sapphire X3 Anterior Cervical Plate System". However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria for software or AI/ML-driven performance.

The document primarily focuses on:

• Regulatory Clearance: Announcing the FDA's decision to clear the device for market.
• Device Description: Details about the physical components, materials, and design of the Sapphire X3 Anterior Cervical Plate System (plates and screws for spinal fixation).
• Indications for Use: The medical conditions for which the device is intended (e.g., Degenerative Disc Disease, Trauma, Spinal Stenosis).
• Predicate Devices: Identifying previously cleared devices that are similar and establish substantial equivalence.
• Performance Data (Mechanical Testing): Mentioning that mechanical performance testing (static compression bending, static torsion, dynamic compression bending) was performed according to ASTM F1717, which is a standard for spinal implant constructs.

There is no mention of any AI/ML component, software performance, or a study involving human readers or ground truth for diagnostic purposes. The device is a physical spinal implant system, not a diagnostic AI tool.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment because this information is not present in the provided document. The questions posed are relevant for AI/ML medical devices, which this product is not.

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Ventana™ L intervertebral body fusion devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

These devices are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

This device is intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients must have undergone a regimen of at least six (6) months' non-operative treatment prior to being treated with this device.

The subject devices are intervertebral body fusion devices for use in lumbar spinal surgery. They may also be referred to as interbody fusion devices or interbody cages. The devices are generally box-shaped with various holes throughout their design to allow for the placement of autograft or allogenic bone graft. They include a lid which further facilitates installation of bone graft and which is shut prior to implantation. The exterior of the devices has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the devices from migrating once they are implanted.

The devices submitted herein are additively manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F3001.

The provided text describes the Ventana™ L Spinal System, an intervertebral body fusion device. However, it does not contain information about acceptance criteria for an AI/ML powered device, nor does it detail a study proving such a device meets acceptance criteria. The text focuses on the substantial equivalence of the Ventana™ L Spinal System to predicate devices based on design, indications for use, and mechanical performance testing (e.g., static and dynamic compression, shear, and subsidence tests).

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

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Ventana™ C devices are intended for spinal fusion at one or two contiguous levels in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Implanted via an open, anterior approach for the C2-C3 disc space to the C7-T1 disc space and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

The device is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine (i.e., anterior plate systems).

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with these devices.

The Spinal Elements' Ventana C Interbody System is an intervertebral body fusion device for use in cervical spine surgery. The device is generally box-shaped with various holes throughout its geometry to allow for the placement of autograft or allogenic bone graft. It includes a lid which further facilitates installation of bone graft, and which is shut prior to implantation. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is implanted.

The devices submitted herein are additively manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F3001.

The provided text describes a medical device submission (K222833) for the Ventana™ C Spinal System, an intervertebral body fusion device. This document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than reporting on the clinical performance of a novel AI/software device.

Therefore, the requested information regarding acceptance criteria and the study that proves the device meets the acceptance criteria (specifically pertaining to AI/software performance) cannot be extracted from this document, as it does not describe an AI or software as a medical device.

The "Performance Data" section lists various mechanical tests (Static/Dynamic Compression, Static/Dynamic Torsion, Subsidence per ASTM standards) to demonstrate the physical characteristics and safety of the implant itself, comparing it to predicate devices. It does not mention any software-related performance criteria, test sets, ground truth establishment, or human reader studies.

In summary, this document is about the physical characteristics and substantial equivalence of a spinal implant, not about the performance of an AI/software device. Therefore, I cannot provide the requested table and details related to AI/software performance.

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The Mercury® II Spinal System is intended to provide immobilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (TI-S1). Screws may be placed from the thoracic spine through the sacral spine and into the ilium. This system is interior/anterolateral nonpedicle fixation, posterior non-pedicle fixation 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 Spinal Elements Mercury II Spinal System may be used in conjunction with the Spinal Elements Overwatch System. In order to achieve additional levels of fixation, the Mercury II or Overwatch Fixation Systems may be connected to the Lotus Posterior Cervical/Thoracic rod connectors. Transition rods with differing diameters may also be used to connect the Lotus Posterior Cervical/Thoracic Spinal System to the Mercury II or Overwatch Spinal Systems. Refer to the Lotus Posterior Cervical/Thoracic Spinal System package insert for a list of Lotus indications for use.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Mercury II and Overwatch implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediatic pedicle screw fixation is limited to a posterior approach.

Spinal Elements' fenestrated screws are intended to be used with saline or radiopaque dye.

These devices are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

Spinal Elements' Navigated Instruments are intended to be used during the preparation and placements' Mercury® II screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Spinal Elements' Mercury II Spinal System is comprised of a variety of screws and rods that are used for attachment to the non-cervical spine (the thoracic spine through the sacrum and in the ilium). A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient. Rods span the distance between screws and achieve fixation by the mechanical joining of the rods with screws.

Screws and rods are made from titanium alloy (Ti-6A1-4V) conforming to ASTM F136 or ISO 5832-3. Additionally, some rods may be manufactured from cobalt-chrome alloy (Co-Cr) conforming to ASTM F1537 or ISO 5832-12.

Navigated instruments are surgical instruments manufactured from stainless steel, as specified in ASTM F899 or ASTM A564. Navigated instruments are non-sterile and are intended to be used with the Medtronic StealthStation® S7 and S8 System.

The provided text is a 510(k) premarket notification summary for the "Mercury® II Spinal System," a medical device. It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving the device meets specific acceptance criteria through a clinical study or performance data related to an AI/Software as a Medical Device (SaMD).

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample size, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies that would be typical for an AI/SaMD product.

The performance data mentioned is related to mechanical testing of the spinal system (screws and rods), not to the performance of a diagnostic or interventional AI.

To answer your request, I must state that the provided text does not contain the necessary information. The document is a regulatory submission for a physical medical device (spinal system and instruments), not an AI/SaMD.

If you have a document describing an AI/SaMD for me to analyze, please provide it.

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Crystal® devices are intended for spinal fusion at one or two contiguous levels in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Implanted via an open, anterior approach for the C2-C3 disc space to the C7-T1 disc space and packed with autograft bone graft comprised of cancellous and/or corticocancellous bone graft.

The device is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine (i.e., anterior plate systems).

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with these devices.

Vertu® devices are stand-alone interbody fusion devices intended for spinal fusion procedures at one level from the C2/ C3 disc space to the C7/T1 disc space in skeletally mature patients with degenerative disc disease of the cervical spine. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Implants are to be implanted via an open, anterior approach and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.

The implant is designed to accommodate two screws should be used to ensure adequate fixation of the implant.

Lucent® are intervertebral body fusion devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems).

This device is intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.

The Zeus® Lumbar Interbody Fusion Devices are indicated for intervertebral body spinal fusion procedures in sketally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level. The Zeus® Lumbar Interbody Fusion Devices are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The Ceres®-C Stand-Alone Cervical System is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Ceres@-C Stand-Alone Cervical implant is intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted with an anterior approach.

The Omega XP device is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. Omega XP device is intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fration. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Spinal Elements' Crystal Cervical Interbody System is an intervertebral body fusion device for use in cervical spine surgery. The device is generally box-shaped with various holes throughout its geometry to allow for the placement of bone graft material. The exterior of the device has teeth or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned.

Spinal Elements' Vertu Cervical Interbody System is composed of an implant body and fixation screws. The implant body is generally a box-shaped device with holes through its body for the placement of graft material. Additionally, it has teeth located on its superior and inferior external surfaces to help keep the device from migrating once placed in its desired location. There are also screw holes located in the implant body. Each screw hole is lined in its internal surface with a titanium ring insert. Screws pass through screw holes of the implant body and affix to bone to help prevent implant migration. When fully seated, the screw head rests on the titanium insert of the screw hole.

The Lucent device is an interbody fusion device for use in lumbar spine surgery. Because PEEK is translucent, tantalum pins are placed in various locations of the PEEK device to serve as markers for radiographic visualization of the device orientation. The Lucent devices are of various shapes, heights, width, length and lordosis to suit patient anatomy.

The Zeus Interbody Fusion Devices are comprised of implants designed to treat the cervical and lumbar spine. The implants are available in a range of sizes and shapes to accommodate variations in surgical approach and patient anatomy. Each cage has a hollow center to allow placement of autograft. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.

The Ceres-C Stand-Alone Cervical System includes a PEEK spacer with Tantalum markers, and a titanium interbody plate and screws. The spacer component is assembled to the interbody plate and implanted anteriorly. The endplate contacting surfaces of the spacer component include serrations, and the plate component includes two holes for inserting one bone screw in each vertebral body. The plate component also includes a screw lock at each hole. The bone screws are available in a variety of diameters and lengths. The interbody plate components are available in a variety of heights. The spacer components are available in a variety of depths, widths, and heights.

The Omega XP System devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion in the lumbar spine. They are designed to be used in conjunction with supplemental spinal fixation instrumentation. The series is comprised of cages of various sizes and are designed to expand in height intraoperatively to accommodate variations in surgical approach and patient anatomy. Each cage has a hollow center to allow placement of autograft inside of the cage. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.

This document is a 510(k) Premarket Notification from the FDA regarding several spinal intervertebral body fusion devices manufactured by Spinal Elements, Inc. The document states that the devices are substantially equivalent to previously marketed predicate devices and therefore do not require a premarket approval application.

Critically, this document is a regulatory approval notice based on the substantial equivalence principle, not a study evaluating the performance of an AI/ML powered medical device. It explicitly states under "Performance Data" that: "No changes were made to the existing devices nor were any new components were added to the systems. Therefore, no additional testing was required or performed."

As such, this document does not contain the information required to answer the prompt regarding acceptance criteria and a study that proves the device meets those criteria for an AI/ML powered medical device. The device described (intervertebral body fusion devices) is a physical implant, not a software-based AI/ML product.

Therefore, I cannot provide the requested information based on this document.

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Lucent® 3D intervertebral body fusion devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

These devices are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems).

This device is intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.

The subject devices are intervertebral body fusion devices for use in lumbar spinal surgery. They may also be referred to as interbody fusion devices or interbody cages. The devices are generally box-shaped with various holes throughout their design to allow for the placement of autograft or allogenic bone graft. They include a lid which further facilitates installation of bone graft and which is shut prior to implantation. The exterior of the devices has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the devices from migrating once they are implanted.

The devices submitted herein are additively manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F3001.

The provided text is a 510(k) summary for the Lucent® 3D Spinal System, a medical device for spinal fusion. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than proving the performance of an AI/ML-based device against specific acceptance criteria derived from a clinical study.

Therefore, the information required to answer your request (acceptance criteria for an AI/ML device, details of a study proving it meets them, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment) is not present in the provided text.

The document discusses:

• Device Description: Intervertebral body fusion devices, box-shaped with "teeth", made from titanium alloy.
• Indications for Use: Spinal fusion for degenerative disc disease (DDD) at L2-S1, with or without Grade 1 spondylolisthesis/retrolisthesis, requiring supplemental spinal fixation and bone graft.
• Substantial Equivalence: Comparison to predicate devices (Lucent® K150061, OmegaLIF K150395) based on indications, surgical technique, design, manufacturing, and materials.
• Performance Data: Lists various mechanical tests (Static Compression, Static Compression Shear, Dynamic Compression, Dynamic Compression Shear, Subsidence) performed according to ASTM standards, concluding that "All data indicates that the device will perform as intended."

In summary, the provided document does not contain the information requested about a study for an AI/ML device's acceptance criteria.

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Lucent® intervertebral body fusion devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

These devices are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems).

This device is intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.

The subject devices are intervertebral body fusion devices for use in lumbar spinal surgery. They may also be referred to as an interbody device or interbody cage. The devices are generally box-shaped with various holes throughout their design to allow for the placement of autograft or allogenic bone graft. The exterior of the devices have "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the devices from migrating once they are surgically positioned.

The devices submitted herein may be manufactured from polyetheretherketone (PEEK) materials and titanium alloy (Ti-6A1-4V conforming to ASTM F 136 and ISO 5832-3 or ASTM F 1472) or PEEK material conforming to ASTM F 2026 with a plasma sprayed coating of commercially pure titanium (per ASTM F 1580) on their superior and inferior surfaces and titanium alloy (Ti-6Al-4V conforming to ASTM F 136 and ISO 5832-3 or ASTM F 1472). Because PEEK is radiolucent, tantalum (per ASTM F 560) pins are placed in various locations of the PEEK devices to serve as markers for radiographic visualization of device orientation.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device called Lucent® XP Curved, an intervertebral body fusion device.

Based on the provided text, the device does not involve an AI/ML component or complex diagnostic performance. Therefore, a study demonstrating the device meets acceptance criteria related to AI/ML performance (e.g., accuracy, sensitivity, specificity, human-in-the-loop improvement, ground truth methodology) is NOT applicable here.

The acceptance criteria and supporting "study" are primarily focused on mechanical performance and material characteristics to demonstrate substantial equivalence to a previously cleared predicate device.

Here's a breakdown of the relevant information provided:

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

The document states: "All data indicates that the device will perform as intended." The "acceptance criteria" are implied by adherence to the referenced ASTM standards and the demonstration of "substantial equivalence" to the predicate. No numerical performance metrics are provided in a table format in this document, as the focus is on similarity to an already cleared device, not novel performance claims.

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

• Test Set Sample Size: Not explicitly stated as a number of 'cases' or 'patients'. The testing is mechanical (on the device itself) rather than clinical. The "sample" would refer to the number of devices or test coupons subjected to the specified ASTM mechanical tests. This information is typically detailed in the full test reports, not usually summarized in this 510(k) format.
• Data Provenance: The document does not specify country of origin for the mechanical testing data. It is inherently "retrospective" in the sense that the justification relies on the established performance of the predicate device.

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 mechanical device, not one requiring expert human interpretation of medical images or data for ground truth establishment. The "ground truth" for this device's performance is objective mechanical testing per engineering standards (ASTM F 2077-18).

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

• Not Applicable. As no expert review or human interpretation is involved in establishing performance, no adjudication method is necessary.

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 does not involve AI or human readers for diagnostic assistance.

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

• Not Applicable. This device does not have a software algorithm component.

7. The type of ground truth used:

• For mechanical performance: Objective engineering standards and test results from the ASTM F 2077-18 standards.
• For biocompatibility: Identity to previously cleared materials and manufacturing processes from predicate device K182584.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this device does not utilize machine learning or AI.

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

• Not Applicable. As there is no training set.

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The Sapphire® Spinal System is intended for anterior (C2-T1) in skeletally mature patients as an adjunct to fusion for the following indications:
· Degenerative Disc Disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
· Spondylolisthesis
· Trauma (including fracture or dislocation)
· Spinal stenosis
· Deformities or Curvatures (kyphosis, lordosis or scoliosis)
Tumor
· Pseudoarthrosis
· Failed previous fusion

The Sapphire X Anterior Cervical Plate Spinal System is intended for anterior cervical fixation (C2-T1) in skettally mature patients as an adjunct to fusion for the following indications:
· Degenerative Disc Disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
· Spondylolisthesis
· Trauma (including fracture or dislocation)
· Spinal stenosis
· Deformities or Curvatures (kyphosis, lordosis or scoliosis)
Tumor
· Pseudoarthrosis
· Failed previous fusion

Elements' Spinal System System and System and Sapphire Sapphire S X S Anterior Spinal Cervical Plate Spinal System are comprised of plates and screws that are used for attachment to the anterior cervical spine. Both plates and screws are available in a variety of sizes to suit the individual pathology and anatomic conditions of the patient. Plates are pre-shaped with radial and lordotic curvature and have large windows for graft and end plate visualization. Plates range in length to accommodate one to five levels of fusion. Sapphire X Anterior Cervical Plates accommodate larger angles for the distal screws in order to minimize plate overhang on the vertebral bodies.

All screws are equipped with an internal locking mechanism that is actuated by rotating a preassembled inset screw. Upon rotation, the insert screw interfaces with a clip in the head of the screw causing the clip to expand. The expansion of the clip prevents the screw from disassociating from the plate. The same screws will be used for both the Sapphire® and Sapphire X Anterior Cervical Plate Systems.

Screws are available in both fixed and variable angle designs. Fixed angle screws have a predetermined trajectory relative to the plate. The fixed angle screws have a neck diameter similar in size to the screw hole diameter of the plate.

Variable angle screws provide freedom in trajectory of the screws into the vertebral body. They allow 8° of angulation in any direction relative to the plate. The variable angle screws have a neck diameter that is smaller than the screw hole diameter of the plate. This difference in diameters allows the variable angle screws to be inserted at various angles relative to the plate.

The materials used for the system remain unchanged. The plates and screws are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3. The locking clips on the screws are manufactured from Nitinol conforming to ASTM F2063.

This is a premarket notification for the Sapphire® Spinal System and Sapphire X Anterior Cervical Plate Spinal System. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results or acceptance criteria based on performance metrics like sensitivity, specificity, or F1-score for AI/ML devices.

Therefore, many of the requested fields cannot be answered directly from this document as they are not relevant to a 510(k) for a spinal fixation system. This document specifically covers mechanical performance testing, not AI/ML algorithm performance.

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

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

For a spinal fixation system, "acceptance criteria" are typically defined by recognized standards for mechanical testing to ensure the device's structural integrity and functionality. The document references ASTM F1717, which sets standards for such tests. The "reported device performance" is a qualitative statement of compliance.

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 in the document. For mechanical testing, sample size would refer to the number of devices tested. Data provenance is not typically specified in this context.

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 is not applicable as the device is a spinal fixation system undergoing mechanical performance testing, not an AI/ML diagnostic tool requiring expert-established ground truth.

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

This is not applicable as the device is a spinal fixation system undergoing mechanical performance 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 is not applicable as the device is a spinal fixation system, 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 as the device is a spinal fixation system, not an AI/ML algorithm.

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

This is not applicable. For mechanical testing, the "ground truth" is adherence to the specified engineering standards and successful completion of the tests without failure.

8. The sample size for the training set

This is not applicable as the device is a spinal fixation system, not an AI/ML algorithm that requires a training set.

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

This is not applicable as the device is a spinal fixation system, not an AI/ML algorithm.

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The Mercury® and Overwatch® Spinal Systems are intended to provide immobilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (TI -S1). Screws may be placed from the thoracic spine through the sacral spine and into the ilium. These systems are intended for anterior/ anterolateral non-pedicle fixation, posterior non-pedicle fixation, and posterior 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.

These systems are intended to be used with bone graft.

The Spinal Elements Mercury Fixation System may be used in conjunction with the Spinal Elements Overwatch System. In order to achieve additional levels of fixation, the Mercury or Overwatch Fixation Systems may be connected to the Lotus Posterior Cervical/Thoracic rod connectors. Transition rods with differing diameters may also be used to connect the Lotus Posterior Cervical/Thoracic Spinal System to the Mercury or Overwatch Spinal Systems. Refer to the Lotus Posterior Cervical/Thoracic Spinal System package insert for a list of Lotus indications for use.

When used for posterior non-cervical pedicle screw fixation in pediatic patients the Mercury and Overwatch 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.

Spinal Elements' Mercury Spinal System is comprised of a variety of screws, hooks, rods, connectors, and staples that are used for attachment to the non-cervical spine (the thoracic spine through the sacrum and in the ilium). A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient. Rods span the distance between screws and hooks and achieve fixation by the mechanical joining of the rods with the screws or hooks. Connectors are used to mechanically join one rod to another. Staples (when used) are placed under the screws to help distribute loads placed against the bone.

Screws, hooks, rods, connectors, and staples are made from titanium alloy (Ti-6A1-4V) conforming to ASTM F 136 and ISO 5832-3 or ASTM F 1472. Additionally, some rods may be manufactured from cobalt chromium alloy (Co-Cr) conforming to ASTM F 1537 and ISO 5832-12.

The Overwatch Spine System consists of spinal implants for fixation of the thoracolumbar and/or sacral spine. The system includes rods, screws, set screws, transverse crosslinks, rod connectors, and hooks. The Overwatch screws are self-tapping and are available with either a cancellous or a dualfix thread design. They are available in cannulated and noncannulated configurations, in a variety of diameters and lengths. The system implants are manufactured from Ti-6A1-4V (ASTM F136).

The Overwatch Spine System is a multiple component system comprised of spinal implants for fixation of the thoracolumbar and/or sacral spine. The system includes rods, pedicle screws, set screws, transverse crosslinks, rod connectors, and hooks. When assembled, the components create a rigid structure to provide stabilization and promote spinal fusion. The systems screws are self-tapping and are available with either a cancellous or cortical cancellous dualfix thread design. The tulips are offered in low top, extended tab and tower configurations. All implant components of the Overwatch Spine System are manufactured from Ti-6Al-4V (ASTM F136) and are provided non-sterile for single-use. The system is to be used with bone graft material to facilitate spinal fusion.

This document is a 510(k) Premarket Notification from the FDA for the Mercury® and Overwatch® Spinal Systems. It establishes the substantial equivalence of these devices to previously cleared predicate devices. The information provided outlines the device description, indications for use, and performance data, but it does not describe a study meant to prove the device meets specific acceptance criteria in the way one might for a diagnostic AI device.

Instead, the "acceptance criteria" here refer to the criteria for demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance by the FDA. The study described is a series of performance tests.

Here's the breakdown of the requested information based on the provided document:

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

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

This document describes performance testing for a medical implant (spinal system), not a diagnostic algorithm. Therefore, the concept of "test set" and "data provenance" for patient data is not directly applicable in the same way.

• Sample Size: Not specified in terms of patient numbers. The "sample size" would refer to the number of devices or components tested in the mechanical performance tests. This information is typically detailed in the full test reports, which are not included here.
• Data Provenance: Not applicable in the context of patient data. The performance tests are laboratory-based mechanical tests.

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 is not applicable. The "ground truth" for this type of device is established through engineering and biomechanical standards (e.g., ASTM standards) and laboratory testing, not through expert consensus on medical images or clinical outcomes in the same way an AI diagnostic device would.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical evaluations, particularly for image-based diagnostics. This document is about mechanical performance 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

Not applicable. MRMC studies are for evaluating diagnostic accuracy, particularly in imaging, with and without AI assistance. This document describes the mechanical performance of a spinal implant.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" for the performance claims for this device is based on accepted engineering standards (ASTM) for the mechanical and material properties of spinal implants. The device components are manufactured from materials conforming to specific ASTM and ISO standards (e.g., Ti-6A1-4V conforming to ASTM F 136 and ISO 5832-3). The performance tests (Static Axial Grip, Dynamic Compression Bending, etc.) are conducted according to these established standards.

8. The sample size for the training set

Not applicable. This device is not an AI model that requires a training set.

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

Not applicable. This device is not an AI model that requires a training set.

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The Spinal Elements Lotus Posterior Cervical/Thoracic Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Lotus Posterior Cervical/Thoracic Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Lotus Posterior Cervical/Thoracic Spinal System may be connected to the Mercury® Spinal System with the Lotus Posterior Cervical/Thoracic rod connectors. Transition rods with differing diameters may also be used to connect the Lotus Posterior Cervical/Thoracic Spinal System to the Mercury Spinal System. Refer to the Mercury Spinal System package insert for a list of the Mercury Spinal System indications for use.

The Lotus Posterior Cervical/Thoracic Spinal System consists of a variety of fixation devices manufactured from Ti-6Al-4V that are attached to the spine. Screws may be placed from a posterior approach into the cervical and/or thoracic spine. Hooks may be placed on the posterior elements of the various vertebrae. Rods span the distance between the screws/hooks, and various other connectors may be used between rods or between rods and screws/hooks. The system achieves fixation by the mechanical joining of the rods, screws, hooks and connectors. A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient.

The provided text is a 510(k) premarket notification for a medical device called the "Lotus® Posterior Cervical/Thoracic Spinal System." This document primarily focuses on demonstrating the substantial equivalence of the device to legally marketed predicate devices, rather than presenting a study that establishes acceptance criteria and then proves the device meets them through clinical or standalone performance studies against a ground truth.

Therefore, many of the requested elements (acceptance criteria, device performance, sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study details, standalone performance, type of ground truth, training set size, and training set ground truth establishment) are not present in the provided text.

The document discusses performance testing but these are typically mechanical tests to ensure structural integrity and safety, not clinical performance against acceptance criteria for diagnostic or therapeutic efficacy as would be seen in AI or drug approval processes.

Here's a breakdown of what can be extracted and what is missing:

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

• Not found. This document doesn't define clinical acceptance criteria (e.g., sensitivity, specificity, accuracy, or a specific clinical outcome measure) for the device. The "performance data" mentioned refers to mechanical testing.

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

• Not found. This section is not applicable as there is no test set for clinical performance, only mechanical testing of components.

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 found. This section is not applicable as there is no test set or ground truth established in the context of clinical performance.

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

• Not found. This is 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 found. This device is a surgical implant, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant to this device.

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

• Not found. This device is a physical surgical implant, not an algorithm.

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

• Not found. Not applicable for this type of device and submission. The "ground truth" for mechanical testing would be the engineering specifications and material properties, against which the physical tests are performed.

8. The sample size for the training set

• Not found. Not applicable, as this device does not involve a training set for an algorithm.

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

• Not found. Not applicable, as this device does not involve a training set for an algorithm.

What is provided regarding "Performance Data":

The document states under "Performance Data":
"Published literature and performance testing support substantial equivalence. Tests included:

• Interconnection testing per ASTM F 1798
• Dynamic Compression Bending per ASTM F 1717
  All data indicates that the device will perform as intended."

Interpretation for your request:

• Acceptance Criteria (Mechanical): The acceptance criteria for these tests would be the specifications outlined in the ASTM F 1798 (Standard Guide for Spinal Implant Material Selection) and ASTM F 1717 (Standard Test Methods for Spinal Implant Constructs in a Corpectomy Model) standards. These standards define methods for testing the mechanical properties and fatigue life of spinal implant constructs. The device "meets" these acceptance criteria if it passes the specified tests according to the standard's requirements (e.g., withstands certain forces, lasts for a specified number of cycles without failure).
• Reported Device Performance (Mechanical): The document generally states, "All data indicates that the device will perform as intended," implying it met the criteria of the ASTM standards. Specific numerical performance values (e.g., ultimate tensile strength, bending modulus, fatigue life in cycles) are not provided in this summary.
• Study That Proves the Device Meets Acceptance Criteria: The study referred to is the "performance testing" based on the ASTM F 1798 and ASTM F 1717 standards. These are in vitro mechanical engineering studies, not clinical trials.
• Sample Size for Test Set: For mechanical testing, this refers to the number of device constructs tested. This information is not specified in the document (e.g., "n=5 constructs were tested").
• Data Provenance: The tests are in vitro laboratory tests, not human data.
• Ground Truth: For mechanical testing, the "ground truth" would be the engineering specifications and material science principles, and the expectation that the device should not fail under conditions prescribed by the ASTM standards.

In summary, the provided document is a regulatory submission for a physical medical device (spinal system) focusing on substantial equivalence based on prior clearances and mechanical performance testing, not on clinical performance against a diagnostic or therapeutic ground truth as your questions imply for something like an AI device.

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