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Infinity™ OCT System

The Infinity™ OCT 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 craniocervical junction, 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 spine.
• 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 Infinity™ OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The Infinity™ OCT System may be used with PASS OCT Patient Specific UNiD OCT rods. In order to achieve additional levels of fixation, the Infinity™ OCT System may be connected to the CD Horizon™ Spinal System and Vertex™ Reconstruction System rods with the Infinity™ OCT System rod connectors. Transition rods with differing diameters may also be used to connect the Infinity™ OCT System to the CD Horizon™ Spinal System. Refer to the CD Horizon™ Spinal System package insert, Vertex™ Reconstruction System and PASS OCT Spinal System package insert for a list of the indications of use.

Note: The 3.0mm multi axial screw (MAS) requires the use of MAS CROSSLINK™ at each level in which the 3.0mm screw is intended to be used.

The lateral offset connectors and MAS extension connectors are intended to be used with 3.5mm and larger diameter multi axial screws. The lateral offset connectors and MAS extension connectors are not intended to be used with 3.0mm screws.

Note: Segmental fixation is recommended for these constructs.

Medtronic Navigated Reusable Instruments for use with StealthStation™ and IPC™ POWEREASE™ Systems

Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.

Infinity™ OCT System

The Infinity™ OCT System is a posterior occipitocervical-upper thoracic system, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case.

The Infinity™ OCT System is fabricated from medical grade titanium alloy and medical grade cobalt chromium.

Medtronic Navigated Reusable Instruments for use with StealthStation™ and IPC™ POWEREASE™ Systems

Medtronic Navigated Reusable Instruments are spine preparation instruments manufactured from high grade stainless steel. These instruments are specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. Placing Medtronic single-use sterile spheres on each of the NavLock™ Tracker passive stems allows a Medtronic computer assisted surgery system such as the StealthStation™ Image Guidance System to track the instruments in the surgical field. Medtronic Navigated Reusable Instruments are compatible with various Medtronic spinal implant systems. These instruments are also compatible with Medtronic's IPC™ POWEREASE™ System when connected to the POWEREASE™ Driver.

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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 (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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion. With the exception of DDD, CD Horizon™ Legacy™ 3.5mm 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, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 - S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.

The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-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: DDD (as previously defined), spondylolisthesis, trauma, and/or tumor.

To achieve additional levels of fixation, 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. Similar 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 and Spire™ plates. Screws used in pediatric cases are only cleared for use via a posterior approach. All 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, and washers; GDLH™ rods, hooks, and connectors; Crosslink™ bar and connectors and Medtronic multi-axial rods and screws.

Note that certain components are specifically designed to connect to specific rod diameters, while other components can connect to multiple rod diameters. Care should be taken so the correct components are used in the spinal construct.

CD Horizon™ hooks are intended for posterior use only. CD Horizon™ staples 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.

CD Horizon™ Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, medical grade cobalt-chromium-molybdenum alloy, or medical grade PEEK Optima-LT1. Certain CD Horizon™ Spinal System components may be coated with hydroxyapatite. No warranties, expressed or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.

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

Medical grade titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum 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.

PEEK Optima-LT1 implants may be used with titanium or cobalt-chromium-molybdenum alloy implants. CD Horizon™ PEEK rods are not to be used in pediatric patients. PEEK rods are only to be used with the associated pedicle screws as well as interbody fusion devices in the anterior spinal column.

To achieve best results, do not use CD Horizon™ Spinal System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document.

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The Rialto™ SI Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The subject RIALTO™ SI Fusion System consists of cannulated devices available in various lengths, used to provide stabilization when fusion of the sacroiliac joint is desired. Autograft and/or allograft may be placed in conjunction with the RIALTO™ SI Fusion System. The RIALTO Screws are made using Titanium Alloy and are 40mm- 60mm in length with a diameter of 12mm. This device may be implanted via a minimally invasive approach using fluoroscopy or navigated instruments compatible with Medtronic StealthStation® and IPC® POWEREASE®.

The provided FDA 510(k) clearance letter for the Rialto™ SI Fusion System does not contain information about the acceptance criteria and study proving a device meets those criteria in the context of an AI/Software as a Medical Device (SaMD).

The document describes a medical implant (Rialto™ SI Fusion System) and its mechanical and MRI safety performance, not an AI or software device. The studies mentioned (ASTM F2182-19e2, F2052-21, F2213-17, F2119-24, F2503-23) are for evaluating the safety and compatibility of passive implants in the Magnetic Resonance (MR) Environment, which are standard non-clinical tests for physical medical devices.

Therefore, I cannot provide the requested information for acceptance criteria and study details related to an AI/SaMD, as the provided input does not pertain to such a device.

If you have a document describing the clearance of an AI/SaMD, I would be happy to analyze it for the requested information.

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Grafton™ DBM and Grafton Plus ™ DBM Paste are intended for use as a bone graft extender, bone graft substitute, and bone void filler in bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space (excluding Flex or Crunch), pelvis and extremities) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. When used in intervertebral body fusion procedures, Graft™ DBM (excluding Flex or Crunch) and Grafton Plus ™ DBM Paste must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Grafton™ DBM and Grafton Plus™ DBM Paste are absorbed/remodeled and replaced by host bone during the healing process.

Magnifuse™ Bone Graft is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space, pelvis and extremities) not intrinsic to the stability of the bony structure. Voids or gaps may be surgically created defects or defects created by traumatic injury to the bone.
Magnifuse™ Bone Graft may be used in a manner comparable to autogenous bone or allograft bone. Magnifuse™ Bone Graft may be mixed with fluid such as bone marrow aspirate, blood, sterile water, or sterile water in order to adjust consistency and handling of bone graft material.
When used in intervertebral body fusion procedures, Magnifuse™ Bone Graft must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Magnifuse™ Bone Graft is resorbed/remodeled and is replaced by host bone during the healing process.

The Grafton™ DBM, Grafton Plus™ DBM Paste, and Magnifuse™ Bone Graft devices in this submission are human bone products containing human demineralized bone matrix (DBM).

Grafton™ DBM is a human bone product that contains human DBM with an inert additive. Grafton™ DBM is produced in particular physical forms (Grafton™ DBM Gel, Grafton™ DBM Putty, Grafton™ DBM Matrix, Grafton™ DBM Orthoblend) and/or handling property. Grafton™ DBM is provided in ready-to-use form and is intended in single patient, single use containers. Grafton™ DBM is identical to the device cleared in K051195.

Grafton Plus™ DBM Paste is human demineralized bone matrix combined with an inert additive to yield a product having a particular physical form and/or handling property. Grafton Plus™ DBM Paste is identical to the device cleared in K043048.

Magnifuse™ Bone Graft is a human bone allograft product containing human DBM and surface demineralized cortical bone chips sealed in an absorbable mesh pouch for intraoperative handling. It is intended for use in filling bony voids or gaps or the skeletal system not intrinsic to the stability of the bony structure. Magnifuse™ Bone Graft is provided ready-to-use in various package sizes by volume or dimension and is intended for single patient use. Magnifuse™ Bone Graft is identical to the device cleared in K082615.

This FDA 510(k) clearance letter (K251193) is for bone graft materials (Grafton™ DBM, Grafton Plus™ DBM Paste, Magnifuse™ Bone Graft) and does not describe an AI/software device or a study with "acceptance criteria" based on AI performance metrics like sensitivity, specificity, or reader studies.

The document details the substantial equivalence of new product formulations/expanded indications for use to previously cleared predicate and reference devices. The "performance" section refers to pre-clinical testing and leveraging prior clearances for bone graft characteristics (e.g., DBM properties, viral inactivation, shelf-life, biocompatibility in animal models, etc.), not a clinical study involving human readers or AI algorithm performance.

Therefore, I cannot provide the information requested in your prompt as it pertains to AI device acceptance criteria and performance studies. The document does not contain:

• A table of acceptance criteria and reported device performance for an AI system.
• Sample sizes for a test set, data provenance, or expert ground truth establishment for an AI study.
• Details on MRMC studies or human reader improvement with AI assistance.
• Standalone algorithm performance.
• Description of ground truth type for an AI system.
• Training set sample size or how ground truth for training was established for an AI system.

The "Performance" section explicitly states: "The devices' performance in the intervertebral body space was supported by a robust analysis of bone grafting materials in the prior posterolateral spine fusion studies." This refers to biological and mechanical performance of the bone graft materials themselves, not an AI software.

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The Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. The Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

These patients should be skeletally mature and have had six months of nonoperative treatment. The Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology is intended to be used with autograft bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate or a bone void filler cleared for use in intervertebral body fusion to facilitate fusion. These implants may be implanted via an open or a minimally invasive posterior approach and/or transforaminal approach.

The Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology consists of Additively Manufactured (AM) titanium spacers of various lengths, and heights to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The open geometry of the implants allows them to be packed with autograft bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate or a bone void filler cleared for use in intervertebral body fusion to facilitate fusion. The Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology in intended for use with supplemental fixation systems cleared for use in the lumbar spine.

The subject Adaptix™ Interbody System Fusion devices are available in a variety of lengths and heights for treatment in lumbar interbody fusion procedures. The subject device is designed with a large hollow region in the center to house autograft or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate or a bone void filler cleared for use in intervertebral body fusion to facilitate fusion. The design incorporates "honeycomb windows" through the interbody device to permit bone growth through the implant. The new bone formation through the Interbody Device is intended to provide long-term structural support and fusion at the implanted disc space. The Interbody Device incorporates Titan Surface Technologies™ including a macro-rough surface on the superior and inferior surfaces of the device along with the entire device being treated with nanoLOCK™ Surface Technology (MMN™) to improve fixation to the adjacent bone. The nanoLOCK™ Surface Technology (MMN™) provides a microscopic roughened surface with nano-scale features.

The subject device is manufactured from Titanium-6 Aluminum-4 Vanadium Extra Low Interstitial (Ti-6Al-4V ELI) powder in accordance with ASTM F3001: Standard specification for additive manufacturing titanium-6 aluminum-4 vanadium ELI (Extra Low Interstitial) with powder bed fusion.

This 510(k) clearance letter is for the Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology, which is an intervertebral body fusion device. This type of device is a physical implant designed to facilitate spinal fusion in patients with Degenerative Disc Disease (DDD).

Crucially, this document describes a medical device (an implant), not a software or AI-driven diagnostic/therapeutic device.

Therefore, most of the requested information regarding acceptance criteria and study design for AI/software devices (such as sample sizes for test/training sets, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment for AI models) is not applicable to this 510(k) submission.

The "performance data" section in this document refers to the data demonstrating the safety and effectiveness of the physical implant, which typically involves mechanical testing, biocompatibility testing, material characterization, and comparison to predicate devices, rather than clinical performance data from a diagnostic algorithm.

Here's how to interpret the provided document in the context of your request:

Key Takeaway from the Document:

The current 510(k) submission (K250669) is not for a new device design or new technology assessment, but rather to expand the indications for use of an already cleared physical implant (Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology, K201267) to include the use of bone void fillers as an additional graft option.

The core argument for clearance is substantial equivalence to existing predicate devices, arguing that the expanded use does not introduce new safety or effectiveness concerns, as bone void fillers are widely used and the primary predicate device is already cleared.

Given this understanding, here's an attempt to answer your questions based on the provided text, highlighting where the information is not applicable due to the nature of the device:

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

Acceptance Criteria (Implicit for this type of device and submission):
For an interbody fusion device, the acceptance criteria typically revolve around:

• Biocompatibility: The material (Ti-6Al-4V ELI) must be biocompatible and safe for long-term implantation.
• Mechanical Strength/Durability: Ability to withstand physiological loads, prevent subsidence, and maintain stability. This is typically demonstrated through static and fatigue testing.
• Pore Size/Osteoconductivity: The design (e.g., "honeycomb windows," macro-rough and nanoLOCK™ surfaces) should facilitate bone ingrowth and fusion.
• Substantial Equivalence: The device must be demonstrated to be as safe and effective as predicate devices. For this specific submission, the crucial acceptance criterion is that adding bone void fillers does not negatively impact the safety or effectiveness of the pre-existing device.

Reported Device Performance (as described in the 510(k) Summary):
The document explicitly states:
"The subject Adaptix™ Interbody System devices do not require any additional data to support their expanded use with bone void fillers to facilitate intervertebral body fusion. This submission does not contain any new or modified implants since the original 510(k) clearance (K201267, S.E. 08-26-2020)."

"The overall design and dimensions of the subject devices are within the established size range of the predicate devices, ensuring compatibility and consistency in performance."

"The inclusion of bone void fillers as an additional graft option does not introduce new safety or effectiveness concerns. Bone void fillers are widely used in spinal fusion procedures and have been demonstrated to be safe and effective promoting bone growth and fusion."

Therefore, the "performance" demonstrated for this specific submission is that the device, when used with bone void fillers, maintains its established safety and effectiveness profile, relying on the prior clearance of the device itself and the known safety/effectiveness of bone void fillers.

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

• Not Applicable: This is a physical implant device seeking expanded indications based on substantial equivalence, not an AI/software device requiring a clinical test set from patient data. The "test set" would have referred to mechanical testing and material characterization, which are not detailed here beyond stating the device is made from Ti-6Al-4V ELI in accordance with ASTM F3001.

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

• Not Applicable: No "ground truth" in the AI/ML sense (e.g., labeling of medical images) is established for an implant device. Clinical efficacy is ultimately determined by fusion rates and patient outcomes in clinical trials, but this 510(k) relies on substantial equivalence and previous data.

4. Adjudication method for the test set

• Not Applicable: No diagnostic interpretations requiring adjudication are involved.

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 refers to AI-assisted diagnostic studies, which are not relevant to this physical interbody fusion device.

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

• Not Applicable: This refers to the performance of an AI algorithm, not relevant to this physical implant.

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

• Not Applicable in the AI/ML sense. For a physical implant, "ground truth" relates to successful fusion (bone growth) and clinical outcomes (pain reduction, functional improvement). This is typically established through radiographic evidence (CT scans, X-rays to confirm fusion), clinical examinations, and patient-reported outcomes from clinical studies, often comparing to a control or predicate. However, in this specific 510(k), the "ground truth" for the expanded use with bone void fillers is the established safety and effectiveness of bone void fillers themselves, and the prior data supporting the device's original clearance.

8. The sample size for the training set

• Not Applicable: No AI/ML training set is involved.

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

• Not Applicable: No AI/ML training set is involved.

Summary for this specific 510(k) (K250669):

The submission is for an expanded indication for use of an already cleared spinal interbody fusion device (Adaptix™ Interbody System). The "acceptance criteria" and "study" are implicitly tied to demonstrating that the addition of bone void fillers as a graft option does not compromise the device's established safety and effectiveness.

The "study" that proves the device meets the "acceptance criteria" for this specific submission is a demonstration of substantial equivalence by:

• Asserting that no new or modified implants are introduced.
• Confirming the overall design and dimensions are consistent with predicate devices.
• Citing the widespread use and established safety/effectiveness of bone void fillers in spinal fusion.
• Pointing out that the language for bone void fillers mirrors that of other cleared predicate devices.

This 510(k) is a regulatory update based on existing knowledge and established practices, rather than the presentation of novel clinical study data for a new device or an AI algorithm.

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Mastergraft™ Matrix EXT is to be combined with autogenous bone marrow and is indicated for bony voids or gaps not intrinsic to the stability of the bony structure and can be used as a bone graft extender. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the posterolateral spine, intervertebral disc space, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process. When used in intervertebral body fusion procedures, Mastergraft™ Matrix EXT must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

Mastergraft™ Strip is to be combined with autogenous bone marrow and is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure and can be used as a bone graft extender.

The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the posterolateral spine, intervertebral disc space, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process. When used in intervertebral body fusion procedures, Mastergraft™ Strip must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

Mastergraft™ Putty combined with either autogenous bone marrow, and/or sterile water, and/or autograft is indicated as a bone void filler for bony voids or gaps not intrinsic to the stability of the bony structure. Additionally, Mastergraft™ Putty can be used with autograft as a bone graft extender.

Mastergraft™ Putty is to be gently packed into bony voids or gaps of the skeletal system (e.g., the posterolateral spine, intervertebral disc space, pelvis, ileum, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Mastergraft™ Putty resorbs and is replaced with bone during the healing process. When used in intervertebral body fusion procedures, Mastergraft™ Putty must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

Mastergraft™ Granules is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Additionally, Mastergraff™ Granules can be used with autograft as a bone graft extender. Mastergraft™ Granules is to be gently packed into bony voids or gaps of the skeletal system (e.g., the posterolateral spine, intervertebral disc space, pelvis, ilium and/or extremities). These defects may be surgically created osseous defects created from traumatic injury to the bone. Mastergraft™ Granules provides a bone void filler that resorbs and is replaced with bone during the healing process. When used in intervertebral body fusion procedures, Mastergraft™ Granules must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

The Mastergraft™ Family of bone grafts in this submission includes Mastergraff™ Matrix EXT, Mastergraft™ Strip, Mastergraft™ Putty, and Mastergraft™ Granules. The devices all include osteoconductive biphasic calcium phosphate ceramic granules in different biocompatible physical forms supplied sterile for single patient use.

Mastergraft™ Matrix EXT is made from a combination of medical grade purified collagen of bovine origin and biphasic calcium phosphate ceramic. In the devices, the collagen is a highly purified (>95%) Type I bioresorbable lyophilized collagen. The biphasic ceramic portion of the device is provided in a 15 percent hydroxyapatite and 85 percent B-tricalcium phosphate formulation. Mastergraft™ Matrix EXT is supplied sterile in a premixed strip form for single patient use. Mastergrafi™ Matrix EXT is a biocompatible, osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The device readily absorbs bone marrow aspirate. Mastergraft™ Matrix EXT is identical to the device cleared in K141824.

Mastergraff™ Strip is made from a combination of medical grade purified collagen of bovine origin and biphasic calcium phosphate ceramic. In the Mastergraft™ Strip device, the collagen is a highly purified (>95%) Type I bioresorbable Iyophilized collagen. The biphasic ceramic portion of the device is provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation. Mastergraft™ Strip is supplied sterile in a premixed strip form for single patient use. Mastergrafi™ Strip is a biocompatible, osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The device readily absorbs bone marrow aspirate and has been shown to heal bone defects. Mastergraft™ Strip is identical to the device cleared in K082166.

Mastergraff™ Putty is made from a combination of medical grade purified collagen of bovine origin and biphasic calcium phosphate ceramic. The collagen component in the Mastergraft™ Putty device is Type I bovine collagen. The biphasic ceramic portion of Mastergraft™ Putty is provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation. Mastergraft™ Putty is supplied as a sterile, dry, solid, construct hydrated for single patient use and is a moldable form of bone void filler. Mastergraft™ Putty is an osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. Mastergraft™ Putty is biocompatible. Mastergraft™ Putty readily absorbs bone marrow aspirate and was shown to heal bone defects. Mastergraff™ Putty is identical to the device cleared in K071813.

Mastergraft™ Granules is made of medical grade combination of hydroxyapatite and ßtricalcium phosphate. MASTERGRAFT® Granules is provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation. The product is supplied sterile for single patient use. MASTERGRAFT® Granules is an osteoconductive porous implant. Mastergraft™ Granules is identical to the device cleared in K082918.

The provided text is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating substantial equivalence of a new medical device to existing predicate devices. It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the context of an AI/ML medical device.

The document discusses bone void filler devices (Mastergraft™ family) and their indications for use, stating that the current submission expands their use to include intervertebral disc space. The core of the notification is to establish that these devices are substantially equivalent to previously cleared devices. This is a regulatory pathway for medical devices that does not typically involve the kind of detailed performance studies with acceptance criteria, test sets, ground truth establishment, or clinical outcome measures that would be expected for a novel AI/ML diagnostic or prognostic tool.

Therefore, I cannot fulfill your request using the provided text because it does not describe:

1. Acceptance criteria for device performance (in the context of an AI/ML device).
2. A study proving the device meets acceptance criteria. The document references prior clearances and robust analysis from previous studies, but it doesn't detail a new study design, methodology, or results related to specific performance metrics for the current submission.
3. Details about sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. These are all concepts relevant to the validation of AI/ML models, which are not discussed in this medical device submission.

The "Performance" section explicitly states: "The subject devices have been previously cleared under K141824, K082166, K071813, and K082918, which serve as Reference Devices. These submissions are leveraged to support the device's sterility, shelf-life, endotoxin, pyrogenicity, biocompatibility, and characterizations/bench performance as recommended in FDA's Class II Special Controls Guidance Document for Resorbable Calcium Salt Bone Void Filler Devices. The device's performance in intervertebral spine was supported by a robust analysis of bone grafting materials in the prior posterolateral spine fusion studies." This indicates reliance on previous data and general guidelines, not a new, specific performance study with the requested AI/ML validation metrics.

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The Catalyft™ LS Expandable Interbody System device, including those with or without micro- and nano-roughened surface textures, is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the Catalyft™ LS Expandable Interbody System can be used with patients diagnosed with multilevel degenerative scoliosis and sagittal deformities as an adjunct to fusion. When used in patients as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditions, additional supplemental fixation (e.g. posterior fixation) must be used. These patients should be skeletally mature and have undergone 6 months of non-operative treatment prior to surgery. Implants are used to facilitate fusion in the lumbar spine using autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.

These implants may be implanted via a variety of open or minimally invasive anterior or oblique approaches.

The Catalyft™ LS Expandable Interbody System device may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Catalyft™ LS Expandable Interbody System device is intended to be used with 4 titanium alloy screws. If the physician chooses to use less than 4 or none of the provided screws, additional supplemental fixation in the lumbar spine must be used to augment stability. Implants with lordosis angles greater than 20° are intended to be used with 4 screws and supplemental fixation.

The Catalyft™ LS Expandable Interbody System is an expandable titanium alloy interbody device consisting of expandable interbodies of various widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.

The interbody devices incorporate Titan Surface Technologies™, where exterior surfaces include nanoLOCK™ surface treatments designed to improve bone fixation to adjacent bone. nanoLOCK™ surface technology provides a microscopic, roughened surface with nano-scale features. nanoLOCK surface technology is specifically engineered to have nano textured features at a nanometer (10-9) level, which has demonstrated the ability to elicit an endogenous cellular and biochemical response attributed to these nanotextured features in vitro. nanoLOCK surface technology demonstrates elements to be considered nanotechnology as outlined in the FDA nanotechnology guidance document.

The provided document is a 510(k) Premarket Notification for a medical device called the Catalyft™ LS Expandable Interbody System. It details the device's characteristics, indications for use, and a comparison to predicate devices, along with performance data.

However, this document does not describe acceptance criteria for an AI/ML powered device, nor does it detail a study proving such a device meets acceptance criteria.

The device described, an intervertebral body fusion device, is a physical implant, not an AI/ML software device. The "Performance Data" section specifically lists mechanical tests (e.g., Static and Dynamic Compression, Subsidence, Expulsion, Wear Debris, Bone screw push out, MRI Safety Evaluation) that are relevant to the physical and biomechanical characteristics of an implantable device, not to the performance of an AI/ML algorithm.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving an AI/ML device meets them based on the provided input, as the input concerns a traditional medical implant.

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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 (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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion.
With the exception of DDD, CD Horizon™ Legacy™ 3.5mm 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, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.
The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-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: DDD (as previously defined), spondylolisthesis, trauma, and/or tumor.
To achieve additional levels of fixation, CD HorizonTM Spinal System rods may be connected to the VertexTM Reconstruction System with the VertexTM rod connector. Refer to the VertexTM Reconstruction System package insert for a list of the VertexTM indications of use.

Not Found

This document describes a spinal system, not an AI/ML powered device. Therefore, the requested information pertaining to AI/ML device performance, such as acceptance criteria for AI models, human expert adjudication, MRMC studies, standalone algorithm performance, and training/test set details are not applicable.

The provided text focuses on the substantial equivalence of the Medtronic CD Horizon™ Spinal System to predicate devices, supported by mechanical testing and rationales.

Here's an analysis of the provided text based on the request's categories, indicating where information is present and where it is not applicable for this type of device:

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

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

• Sample Size: Not explicitly stated in this summary. Mechanical testing usually involves a specific number of samples per test type (e.g., 5-10 samples per group).
• Data Provenance: Not applicable in the context of "data provenance" for patient data, as this is a mechanical device. The testing was conducted by Medtronic to demonstrate substantial equivalence to existing predicate devices.

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 an AI/ML diagnostic or therapeutic device that relies on expert interpretation for ground truth. Ground truth for mechanical performance is established through 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 relevant for subjective interpretations, typically in clinical studies or AI model evaluations. For mechanical testing, the results are quantitative and directly measured against engineering 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

• Not Applicable: This is a mechanical device. MRMC studies are specific to evaluating diagnostic accuracy of imaging systems, often in the context of human reader performance with or without AI assistance.

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

• Not Applicable: This is a mechanical device. "Standalone" performance refers to AI algorithm performance without human intervention.

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

• Engineering Specifications and Standardized Test Methods: The "ground truth" for this device's performance is established by the specified mechanical properties (e.g., strength, durability, fatigue resistance) defined by relevant ASTM (American Society for Testing and Materials) standards (F1717, F1798, F2503). Compliance with these standards indicates the device performs as intended for its mechanical application.

8. The sample size for the training set

• Not Applicable: "Training set" refers to data used to train AI/ML models. This is a mechanical device, not an AI model.

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

• Not Applicable: As no AI training set exists, no ground truth establishment for it is relevant.

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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 (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, 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 titanium, cobalt chrome, and stainless-steel implants may also be used for the same indications as an adjunct to fusion. With the exception of DDD, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted. When used for posterior non-cervical pedicle screw fixation in pediatric patients, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless-steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. Devices are intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use. The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-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: DDD, spondylolisthesis, trauma, and/or tumor. To achieve additional levels of fixation, 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 Vertex™ indications.

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 3.5 to 6.35mm), hooks, screws, Crosslink™ plates and connecting components. Similar 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, Shape Memory Alloy Staples, Spire™ plates, and Dynalok™ bolts. Screws used in pediatric cases are only cleared for use via a posterior approach. 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, and 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. Note: certain components are specifically designed to connect to specific rod diameters, while other components can connect to multiple rod diameters. Care should be taken so 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. CD Horizon™ Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium titanium alloy medical grade cobalt-chromium- molybdenum alloy, or medical grade PEEK Optima-LT1. Certain CD Horizon™ Spinal System components may be coated with hydroxyapatite.

This document, K233951, is a 510(k) premarket notification for the CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw). It is a notification demonstrating substantial equivalence to previously cleared predicate devices, not a study for a new device with new acceptance criteria and a detailed clinical trial. Therefore, most of the requested information regarding acceptance criteria, study details, and AI performance is not applicable to this type of submission.

Here's a breakdown of the relevant information provided and why other requested details are absent:

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

   • Acceptance Criteria (General): The acceptance criteria for this type of submission are typically that the new device does not present a "new worst case" compared to the predicate devices and meets established ASTM standards for spinal implants. The document explicitly states: "For the tested subject devices, the pre-determined acceptance criteria was met for all tests."
   • Reported Device Performance: The performance data reported is primarily through engineering bench testing according to existing ASTM standards for spinal implants. The document indicates that for tested devices, acceptance criteria were met. For rationalized devices (those where new testing was deemed unnecessary because they do not present a new worst case), the existing predicate data applies.

   Acceptance Criteria (Type)	Reported Device Performance
   ASTM F1717: Static Compression, Static Torsion, Compression Fatigue (Relevant for spinal system components)	Met pre-determined acceptance criteria for all tested devices.
   ASTM F1798: Axial Grip, Axial Torsion, Flexion Extension Static, Flexion Extension Fatigue Screw Reduction to Failure Testing (Relevant for pedicle screw systems)	Met pre-determined acceptance criteria for all tested devices.
   ASTM F2503: MRI Compatibility Evaluation	Met pre-determined acceptance criteria for all tested devices.
   Device does not present a "new worst case" compared to predicate devices (for rationalized devices). This implies that the performance characteristics (mechanical strength, material compatibility, etc.) are equivalent to or better than the predicate devices, as demonstrated by the existing predicate data or engineering analysis. The subject devices have the same intended use, indications for use, materials, similar overall design, fundamental technology, sterilization, and surgical technique as the predicate devices. The subject and predicate implants have the same function and fundamental scientific technology.	Applicable (existing predicate data is applicable).

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 refers to bench testing (mechanical, material, MRI compatibility). The "sample size" for such testing is generally a number of physical specimens tested to meet statistical power for engineering analysis, not a patient-based test set as in clinical studies. The document does not specify the exact number of physical samples for each test (e.g., how many screws were tested for axial grip).
   • Data Provenance: This is engineering test data, not patient data. Therefore, concepts like "country of origin of the data," "retrospective," or "prospective" are not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not applicable. This is an engineering test of spinal implant components, not an AI or diagnostic device requiring expert interpretation of medical images or patient data to establish ground truth.

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

   • Not applicable. Adjudication methods are used in clinical studies or performance studies where multiple readers or experts assess outcomes. This is bench 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. This is a spinal implant device, not an AI or diagnostic software. Therefore, an MRMC study or AI assistance is not relevant to this submission.

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

   • Not applicable. This is a physical medical device, not an algorithm or AI.

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

   • Not applicable in the clinical sense. For mechanical testing, the "ground truth" is defined by the physical limits and standards outlined in the ASTM protocols (e.g., a screw must withstand a certain load without failure, or a material must not show adverse reactions in an MRI environment).

8. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set.

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

   • Not applicable. As above, no training set for an AI/ML model is involved.

Summary of the 510(k) Submission:

This 510(k) submission for the CD Horizon ModuLeX Spinal System focuses on demonstrating substantial equivalence to existing predicate devices already on the market. The primary "study" involved is a series of bench tests (mechanical and MRI compatibility) conducted according to established ASTM standards (F1717, F1798, F2503) for spinal implants. The key "acceptance criterion" for these tests is simply meeting the pre-determined specifications of these standards, and the document states that these criteria were met for all tested devices. For components not subjected to new testing, the justification ("rationalization") relies on the fact that they do not present a "new worst case" compared to previously cleared predicate devices, implying their performance aligns with the existing, cleared data. This type of submission does not involve clinical studies or AI performance evaluations.

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