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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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Medtronic Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Surgical Instruments are specifically designed for use with the Mazor X Stealth™ Edition, which is indicated for medical conditions 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.

Medtronic Surgical Instruments can be navigated or non-navigated manual instruments that may or may not be guided through the Mazor X Stealth™ Edition Arm Guide. Medtronic surgical drills shall only be used through the Mazor X Stealth™ Edition arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Medtronic Surgical Instruments are also compatible with the IPCT™ Powerease™ System or AO* style quick connect drilling motors. An instrument may incorporate a measuring function which has uses as described on the label and the instrument.

The CD HORIZON™ Spinal System surgical instruments are non-sterile or sterile, single, or re-usable instruments that may be used during the preparation and placement of various Medtronic spinal implants during spinal surgery. The subject instruments are made of a variety of materials commonly used in orthopedic and neurological procedures which meet available national or international standards specifications. Single-use Medtronic Surgical instruments should never be reused under any circumstances.

The CD Horizon™ instruments are intended to be used when preparing and placing Medtronic screws during spinal surgery. To enable optical navigation compatibility of the surgical instruments with the MAZOR X Stealth™ Edition System, the proximal ends of the instrument shafts have been designed with a bushing that provides a connection site where the NavLock™ trackers (K171267, S.E. 07/03/2017; K182104, 11/02/2018; K201327, S.E. 06/18/2020) can be attached. To enable trajectory guidance compatibility of the surgical instruments with the Mazor X Stealth™ Edition, the instrument dimensions have been designed to work with the Mazor X arm guides. The subject RG FAS Drivers may also be operated under power when attached to the POWEREASE™ Driver (K111520, S.E. 10/26/2011).

The subject instruments are reusable and will be provided non-sterile.

The provided text is a 510(k) summary for a medical device (Medtronic Surgical Instruments for use with Mazor X Stealth™ Edition) and does not describe acceptance criteria for an AI/ML device or a study proving that an AI/ML device meets such criteria.

The document discusses:

• Device Name: CD Horizon™ Spinal System / Medtronic Surgical Instruments for use with Mazor X Stealth™ Edition
• Regulatory Information: 510(k) clearance, product codes, classification, predicate devices.
• Intended Use: Surgical instruments for preparing and placing Medtronic implants during spinal surgery, assisting in precisely locating anatomical structures, compatible with MAZOR X Stealth™ Edition.
• Technological Characteristics: Comparison with predicate devices, stating similar intended use, indications, material, fundamental technology, and sterilization method.
• Performance Data: This section briefly mentions verification/validation activities, but these are for the surgical instruments themselves and their compatibility with the navigation system, not for an AI/ML algorithm's performance. The activities listed are:
  • Design Validation and Anatomical Simulated Use
  • Navigation Simulated Use
  • Navigation Accuracy Analysis

Given this, I cannot provide the requested information about acceptance criteria and the study that proves an AI/ML device meets them because the provided text does not describe an AI/ML device or its evaluation. It focuses on traditional surgical instruments.

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The Catalyft™ PL Expandable Interbody System is indicated for use as an intervertebral body fusion device in sketetally 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). These DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. Additionally, the Catalyft™ PL Expandable Interbody System can be used with spinal deformities as an adjunct to fusion. 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 marrow aspirate. These implants are intended for use with supplemental internal fixation systems.

Medtronic Navigated Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic Navigated Reusable Instruments can be compatible with various Medtronic spinal implant systems. Navigated surgical 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. An instrument may incorporate a measuring function, which has uses as described on the label and the instruments.

The Catalyft™ PL Expandable Interbody System consists of implants, instruments, and cases, trays, and lids. The subject implants are expandable lordotic Titanium Alloy (Ti-6Al-4V ELI) interbody fusion implants that are provided in either an inline straight tip, known as the “PL” implant, or a hockey stick-shaped tip, which is known as the “PL40” implant. The implants are expandable and have varying footprints, heights, and lengths that provide surgeons the ability to have better control of the restoration of lordosis in patients and allows more ability to appropriately size the interbody to match patient anatomy. The subject implants are designed with a hollow center region to house autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate. In addition to implants, navigated instruments compatible with the StealthStation™ system have been developed. The subject StealthStation™ System compatible instruments are specific to the subject implants, and there are no changes to the StealthStation™ software related to the stereotaxic instruments in this submission. Previously cleared Navigated Rotating Shavers (K150231, S.E. 06/16/2015, K163581, S.E. 04/14/2017; K201267, S.E. 08/26/2020) will be used as disc prep instruments and trials for the Catalyft™ PL system. Cases, trays, and lids have been developed for transportation of the subject instruments.

This document describes the Catalyft™ PL Expandable Interbody System and Navigated Instruments Compatible with StealthStation™ System. The document does not contain information about an AI/ML device. Therefore, it is not possible to describe acceptance criteria and associated studies for an AI/ML device based on this document.

The document discusses the substantial equivalence of the Catalyft™ PL Expandable Interbody System and its navigated instruments to predicate devices. It mentions performance data related to mechanical testing of the implants and verification/validation testing for the navigated instruments.

Here's a breakdown of the type of information presented, which is relevant for a medical device but not an AI/ML system:

• Acceptance Criteria & Device Performance: The document lists various ASTM standards (ASTM 2077, ASTM 2267, ASTM Draft Standard F-04.25.02.02) for mechanical testing (Compression Fatigue, Compression-Shear Fatigue, Static Compression, Static Compression-Shear, Subsidence, Expulsion) of the implants. It also states that testing was completed to ensure the functionality and compatibility of new/existing instruments, and that navigated instruments underwent verification and validation activities. However, specific acceptance criteria values or detailed performance results are not provided in this summary.

• Sample Size, Data Provenance, Ground Truth for Test Set, Adjudication Method, MRMC Study, Standalone Performance, Ground Truth Type (for Test Set), Training Set Sample Size, and Ground Truth for Training Set: These categories are typically associated with the evaluation of AI/ML algorithms and are not applicable to the information provided in this document, as it concerns a physical medical device and its instruments. The focus is on mechanical integrity and functional compatibility rather than algorithmic performance or diagnostic accuracy.

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CAPSTONE™ SPINAL SYSTEM
The CAPSTONE™ Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 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. These patients should be skeletally mature and have had six months of non-operative treatment. These implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

CLYDESDALE PTC™ SPINAL SYSTEM
The CLYDESDALE PTC™ Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CLYDESDALE PTC™ Spinal System is used for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a minimally invasive lateral approach.

CRESCENT™ SPINAL SYSTEM
The CRESCENT® Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 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. These patients should be skeletally mature of nonoperative treatment. These implants are to be used autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

CRESCENT™ SPINAL SYSTEM TITANIUM
The CRESCENT Spinal System Titanium is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These 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. These patients should be skeletally mature and have had six months of non-operative treatment. These implants are to be used with autogenous bone graft. These devices are intended to be used with Medronic supplemental fixation which has been cleared by the FDA for use in the lumbar spine.

DIVERGENCE-L™ ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System Interbody cage is intended for interbody fusion in skeletally mature patients and is to be used with supplementation cleared for use in the lumbar spine. The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System Interbody device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These 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. Additionally, the DIVERGENCE-L™ Anterior Oblique Lumbar Fusion System device is indicated for use in patients diagnosed with deformity conditions as an adjunct to fusion. These patients should have had six months of non- operative treatment. The DIVERGENCEL™ Anterior/ Oblique Lumbar Fusion System interbody device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System interbody cage is also required to be used with autogenous bone graft. These implanted via a variety of open or minimally invasive approaches. These approaches include anterior and oblique.

The Intervertebral Body Fusion Device Systems are intended for vertebral body fixation of the thoracic or lumbar spine during the development of a thoracic or lumbar spinal fusion. Lumbar interbody fusion devices are intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine.

This document [K191788](https://510k.innolitics.com/search/K191788) is a 510(k) premarket notification for Medtronic Intervertebral Body Fusion Device Systems (specifically, the CAPSTONE™ Spinal System, CLYDESDALE PTC™ Spinal System, CRESCENT™ Spinal System, CRESCENT™ Spinal System Titanium, and DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System).

The submission is primarily focused on an MRI Update for these existing devices, meaning the purpose is to provide data demonstrating their safety and compatibility within the Magnetic Resonance (MR) environment. This is a common type of submission for established medical devices when new safety information or a change in labeling regarding MR compatibility needs to be supported.

Based on the provided text, there is no AI/ML component to this specific submission. The "device" in question refers to intervertebral body fusion implants, which are passive mechanical implants, not software algorithms or AI-driven systems. Therefore, most of the requested information regarding acceptance criteria and studies for an AI/ML device is not applicable to this document.

Here's a breakdown based on the information provided, highlighting the absence of AI/ML-specific details:

1. Table of Acceptance Criteria and 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)

• Not Applicable (N/A) for an AI/ML test set.
• The performance data provided is for MR safety testing of physical implants, not an AI/ML algorithm. The "test set" would consist of the physical devices themselves and the materials they are made from, subjected to various MR field conditions in a lab environment.
• Data provenance is typically from controlled laboratory testing environments, not patient data in the context of AI/ML.

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

• Not Applicable (N/A). This is a question relevant to AI/ML model evaluation involving human expert interpretation. For physical device MR safety testing, ground truth is established by physical measurements and compliance with ASTM standards, not expert consensus on interpretations.

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

• Not Applicable (N/A). Adjudication methods are for human interpretation of data, often in AI/ML performance studies. MR safety testing involves physical measurements and engineering evaluations.

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 (N/A). There is no AI/ML component or human-in-the-loop scenario described in this submission. This is a K-number for physical intervertebral body fusion devices and their MR compatibility, not an AI/ML software.

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

• Not Applicable (N/A). This document concerns physical intervertebral body fusion implants, not a standalone AI/ML algorithm.

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

• Not Applicable (N/A) in the context of AI/ML.
• For the MR safety testing, the "ground truth" (or reference standard) is defined by the ASTM test methods and their specified thresholds/parameters. For example, a certain level of magnetically induced displacement is acceptable, and exceeding that is considered unsafe.

8. The sample size for the training set

• Not Applicable (N/A). There is no AI/ML algorithm in this submission, and therefore no training set.

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

• Not Applicable (N/A). There is no AI/ML algorithm or training set discussed in this document.

Summary of Document K191788:

This 510(k) premarket notification is for intervertebral body fusion device systems (implants used in spinal surgery). The core of this particular submission is an MRI Update, which means the manufacturer is providing data to demonstrate the safety and compatibility of these existing physical implants when subjected to Magnetic Resonance (MR) imaging environments. The document details the various predicate devices and the indications for use of the Medtronic systems. The "performance data" section explicitly lists MR safety testing conducted according to recognized ASTM standards. The conclusion states that based on this data, the devices are "as safe and effective as the following predicates" and have been appropriately labeled for MR safety. The document does not involve any artificial intelligence, machine learning, or software algorithm performance evaluation.

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The CD Horizon™ Astute™ Spinal System is intended to provide for posterior, supplemental fixation when used with an interbody fusion cage for patients diagnosed with degenerative disc disease (DDD- defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). 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™ Astute™ Spinal System consists of a variety of sizes of rods, as well as set screws, which are used with bone screws from the CD Horizon™ Solera™ Spinal System, to create a variety of rigidly locked configurations, with each construct being tailored to the individual case. The CD Horizon™ Astute™ Spinal System implant components are fabricated from medical grade titanium alloy, tantalum, or polyetheretherketone (PEEK).

This document describes the premarket notification (K191066) for the CD Horizon™ Astute™ Spinal System. However, it does not contain information related to an AI/ML powered device, nor does it present acceptance criteria or a study that proves a device meets those criteria in the context of AI/ML performance metrics.

The document is a 510(k) summary for a spinal implant system. The "Performance Data" section (VII) discusses mechanical testing of the device and reference to clinical literature and a retrospective study of the predicate device to support its clinical use.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves an AI device meets acceptance criteria, as this document is not about an AI device.

To directly answer the prompt's request given the content of this specific document:

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

• Acceptance Criteria: "The subject devices met the pre-determined acceptance criteria for all tests." (Page 5)
• Reported Device Performance:
  • Mechanical Testing (ASTM F1717 & F1798): The subject devices met the pre-determined acceptance criteria for static and dynamic compression bending, static torsion, static axial grip, static torsional grip, and static and dynamic flexion/extension.

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

• Sample Size (Test Set): Not specified for mechanical testing. For clinical performance, it refers to data from the predicate device's unspecified "retrospective study," so the sample size is unknown.
• Data Provenance: Unspecified for mechanical testing. For clinical performance, implies data from a retrospective study, country of origin is not mentioned.

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 a mechanical device, not an AI diagnostic/prognostic device requiring expert-established ground truth.

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

• Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC study was not done as this is not an AI device.

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

• Not applicable. This is a mechanical device.

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

• Mechanical Testing: Ground truth is based on the specifications and performance limits defined by ASTM F1717 and F1798 standards.
• Clinical Performance: Ground truth for clinical claims is supported by the outcomes of the predicate device's retrospective study and clinical literature, implying patient outcomes data.

8. The sample size for the training set

• Not applicable. This is not an AI device with a training set.

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

• Not applicable. This is not an AI device.

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When used without cement, CD Horizon™ Fenestrated Screws (with or without Sextant™ or Longitude™ instrumentation) are 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, tumor and/or trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis), pseudarthrosis, and/or failed previous fusion.

When used in conjunction with Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Coment, CD Horizon™ Fenestrated Screws are 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 thoracic, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion™ Fenestrated Screws augmented with Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

Kyphon™ Xpede™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer includes multiple myeloma and metastatic lesions, including those arrsing from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathological fracture may include a symptomatic microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.

When used in conjunction with CD Horizon™ Fenestrated Screws, Kyphon™ Xpede™ Bone Cement is 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 thoracic, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CD Horizon™ Fenestrated Screws augmented with Kyphon™ Xpede™ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

When used in conjunction with CD Horizon™ Fenestrated Screws, Medtronic HV-R™ Fenestrated Screw Cement is 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 thoracic, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion. Medronic HV-R™ Fenestrated Screw Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.

The CD Horizon™ Fenestrated Screw Set consists of a variety of cannulated screws. These screws contain a series of fenestrations which allows polymethylmethacrylate (PMMA) bone cement (Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement) to be injected into the treated site. This cement is used to augment screw fixation into the pedicle in patients whose life expectancy is of insufficient duration to permit achievement of fusion. These implants may also serve as traditional pedicle screws when used without bone cement in patients with non-compromised bone quality. CD Horizon™ Fenestrated Screws are specifically designed to connect to appropriate rods and associated connecting components contained within the CD Horizon™ Spinal System. CD Horizon™ Fenestrated Screw Set implant components are fabricated from medical grade titanium and/or medical grade titanium alloy and/or medical grade cobalt-chromiummolybdenum allov.

Kyphon™ Xpede™ Bone Cement is a polymethylmethacrylate (PMMA) that contains approximately 30% barium sulfate. It is designed for delivery in a highly viscous state. Kyphon™ Xpede™ Bone Cement is provided sterile in two components: 20 grams of powder and nine grams of liquid. The powder contains methylmethacrylate-styrene copolymer, barium sulfate and benzoyl peroxide. The liquid contains methylmethacrylate (monomer), hydroquinone and N, N dimethyl-p-toluidine.

Medtronic HV-RTM Fenestrated Screw Cement is a polymethylmethacrylate (PMMA) that contains approximately 30% barium sulfate. It is designed for delivery in a highly viscous state. Medtronic HV-RTM Fenestrated Screw Cement is provided sterile in two components: 20 grams of powder and nine grams of liquid. The powder contains methylmethacrylate-styrene co-polymer, barium sulfate, and benzovl peroxide. The liguid contains methylmethacrylate (monomer), hydroquinone and N. N dimethyl-p-toluidine.

This FDA 510(k) summary does not contain any information regarding clinical performance studies, AI algorithms, or human-in-the-loop performance.

The document is a premarket notification for medical devices (bone cement and fenestrated screws), not an AI/ML-driven diagnostic device. The application focuses on demonstrating substantial equivalence to previously cleared predicate devices based on technological characteristics and existing performance data for those predicates.

Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies, as these types of studies were not conducted or reported in this submission for these specific medical devices.

The document explicitly states:

"Medtronic believes that testing is not warranted for the subject devices as they do not present a new worst case when compared to the predicate devices. All existing predicate data previously provided in the predicate 510(k)s are still applicable."

This indicates that the submission relies on the performance data of the predicate devices rather than new performance studies for the subject devices themselves.

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Cervical and Thoracolumbar
The T2 Stratosphere™ Expandable Corpectomy System is a vertebral body replacement device intended for use in the thoracic and lumbar spine (TI-L5) and cervical spine (C2-C7). The T2 Stratosphere™ Expandable Corpectomy System is intended for use in skeletally mature patients.

When used in the cervical spine, the T2 Stratosphere™ Expandable Corpectorny System is used to replace a collapsed, damaged, or unstable vertebral body caused by tumor, trauma (i.e. fracture), or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. When used in the cervical spine. the T2 Stratosphere™ Expandable Corpectomy System may not be used with optional modular end caps. When used in the cervical spine at single or two levels, the T2 Stratosphere™ Expandable Corpectomy System is intended to be used with supplemental fixation for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation cleared for use in the cervical spine. When used in the thoracic and lumbar spine, the T2 Stratosphere™ Expandable Corpectomy System is used to replace a collabsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The T2 Stratoshere™ Expandable Corpectorny centerpiece may be used with or without optional modular end caps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation cleared for use in the thoracic and lumbar spine. When used in the cervical spine, the T2 Stratosphere™ Expandable Corpectomy System is intended for use with autograft or allogenic bone graft comprised of cancellous bone graft as an adjunct to fusion. When used in the thoracic and lumbar spine, the 72 Stratosphere™ Expandable Corpectomy System is intended for use with autograft or allograft as an adjunct to fusion. The T2 Stratosphere™ Expandable Corpectory 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 and/or thoracolumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

Thoracolumbar
The T2 Stratosphere™ Expandable Corpectory System is a vertebral body replacement device intended for use in the thoracic and lumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The T2 Stratosphere™ Expandable Centerpiece may be used with or without optional modular end caps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation cleared for use in the thoracic and lumbar spine.

The T2 Stratosphere™ Expandable Corpectory System is intended for use with autograft or allograft, as an adjunct to fusion. The T2 Stratosphere™ Expandable Corpectomy 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 thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The T2 STRATOSPHERE™ Expandable Corpectomy System is an adjustable vertebral body replacement device and features a self-adjusting end cap which provides continuous angulation between 0-8° in any direction to accommodate the patient's anatomical requirements.

The T2 STRATOSPHERE™ Expandable Corpectomy may be used in the thoracolumbar and cervical spine. The T2 STRATOSPHERE™ Expandable Corpectomy devices for use in the cervical spine are restricted to 13mm diameter centerpieces. Only the 13mm devices are cleared for both cervical and thoracolumbar region of the spine.

The device is inserted between two vertebral bodies in the thoracolumbar or cervical spine and is expanded to aid in the surgical correction and stabilization of the spine. The device may be implanted through a lateral, oblique, or posterior approach using a minimally invasive technique or implanted through a lateral, oblique, posterior, or anterior approach through a traditional open technique.

The T2 STRATOSPHERE™ Expandable Corpectomy System is intended to be used with supplemental fixation cleared for use in the cervical and thoracolumbar spine. The device is not intended to be used as a stand-alone implant.

The T2 STRATOSPHERE™ Expandable Corpectomy System is made of titanium alloy (TI6A14V) in accordance with ASTM F136 Standard Specification for Wrought Titanium- Aluminium-4 Vanadium ELI Alloy for Surgical Implant Applications. The centerpieces are available in multiple diameters and heights. The system also features modular end caps which are available in various angles and geometries.

The medical device in question is the Medtronic T2 STRATOSPHERE™ Expandable Corpectomy System. It's a vertebral body replacement device used in the thoracic, lumbar, and cervical spine. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing detailed acceptance criteria and a study to prove performance as would be expected for a novel device or a PMA submission with clinical trials.

The assessment of the acceptance criteria and study proving the device meets them is based on the information provided in the 510(k) summary, which mainly references non-clinical testing performed on predicate devices and biocompatibility testing on the subject device.

Here's the breakdown of the information requested:

Acceptance Criteria and Reported Device Performance

Study Information

The 510(k) summary for the T2 STRATOSPHERE™ Expandable Corpectomy System primarily relies on a demonstration of substantial equivalence to predicate devices, rather than a standalone clinical study with a test set of patients. Therefore, many of the typical clinical study parameters (sample size for test set, expert qualifications, adjudication, MRMC study, standalone performance) are not directly applicable in the way they would be for a de novo or PMA submission.

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

   • Test Set Sample Size: Not applicable in the context of a clinical test set. The performance data presented are primarily non-clinical (biocompatibility, mechanical, pyrogenicity).
   • Data Provenance: The biocompatibility and pyrogenicity tests were performed on "worst-case subject implants." The mechanical testing data is "provided in the Predicate 2 (K173125, S.E 12/20/2017) submission" and "testing conducted on the predicate implants satisfies testing requirements for the subject devices." This means the mechanical data is retrospective from previous submissions. Specific country of origin for the studies is not mentioned but is implied to be in compliance with U.S. standards.

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

   • Not applicable as there was no clinical test set requiring expert ground truth establishment for this 510(k) summary. The regulatory review is based on non-clinical data and comparison to predicates.

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

   • Not applicable as there was no clinical test set requiring adjudication.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This device is a surgical implant, not an AI-powered diagnostic tool.

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

   • Not applicable. This device is a surgical implant. The performance assessed is mechanical strength, material compatibility, and sterility, which are inherent properties of the device, not an algorithm's output.

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

   • For biocompatibility: Standardized material specifications (ASTM F136) and biological evaluation guidelines (FDA's Draft Guidance for ISO-10993).
   • For mechanical properties: Standardized test methods (ASTM F2077, ASTM Draft Standard F-04.25.02.02) that define acceptable mechanical performance for intervertebral body fusion devices.
   • For pyrogenicity: Standardized limits for bacterial endotoxin (20 EU/device) as per ANSI/AAMI ST72 and USP <161>.

7. The sample size for the training set:

   • Not applicable in the context of a clinical training set for this device submission. The device design and manufacturing processes are based on established knowledge and previous predicate devices.

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

   • Not applicable. The design and manufacturing are based on engineering principles, materials science, and established regulatory standards for similar devices, rather than a "training set" with ground truth in the AI/clinical study sense.

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The T2 STRATOSPHERE™ Expandable Corpectomy System is a vertebral body replacement system intended for use in the thoracolumbar spine (T1-L5) and cervical spine (C2-C7). The T2 STRATOSPHERE™ Expandable Corpectomy System is intended for use in skeletally mature patients.

When used in the cervical spine, the T2 STRATOSPHERE® Expandable System is used to replace a collapsed, damaged, or unstable vertebral body caused by tumor, trauma (i.e. fracture), or for reconstruction following corpectorned to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. When used in the cervical spine, the T2 STRATOSPHERE™ Expandable Corpectomy System may not be used with optional modular end caps. When used in the cervical spine at one or two levels, the T2 STRATOSPHERE™ Expandable Corpectomy System is intended to be used with supplemental fixation for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation cleared for use in the cervical spine.

When used in the thoracolumbar spine, the T2 STRATOSPHERE® Expandable System is used to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The T2 STRATOSPHERE™ Expandable Corpectomy System may be used with or without optional modular end caps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation cleared for use in the thoracolumbar spine.

When used in the cervical spine, the T2 STRATOSPHERE™ Expandable Corpectomy System is intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. When used in the thoracolumbar spine, the T2 STRATOSPHERE™ Expandable Corpectomy System is intended for use with autograft or allograft as an adjunct to fusion. The T2 STRATOSPHERE™ Expandable Corpectomy 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 and/or thoracolumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The T2 STRATOSPHERE™ Expandable Corpectomy System is an adjustable vertebral body replacement device and features a self-adjusting end cap which provides continuous angulation between 0-8° in any direction to accommodate the patient's anatomical requirements. The T2 STRATOSPHERE™ Expandable Corpectomy devices for use in the cervical spine are restricted to 13mm diameter centerpieces. The T2 STRATOSPHERE™ Expandable Corpectomy System is made of titanium alloy. This device is inserted between two vertebral bodies in the thoracolumbar or cervical spine and is expanded to aid in the surgical correction and stabilization of the spine. The centerpieces are available in multiple heights.

The system also features modular end caps which are available in various angles and diameters that are only for use in the thoracolumbar spine.

The device is not intended to be used as a stand-alone implant.

The provided text describes the T2 STRATOSPHERE™ Expandable Corpectomy System, a vertebral body replacement device. The document is a 510(k) summary submitted to the FDA, demonstrating substantial equivalence to predicate devices, rather than a study evaluating an AI device or algorithm in the context of diagnostic accuracy. Therefore, many of the requested categories (e.g., sample size for AI test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable to this submission.

However, I can extract information related to the device's performance testing which serves as the "study that proves the device meets the acceptance criteria" in this context.

Here's a breakdown of the relevant information:

Acceptance Criteria and Reported Device Performance

Details on the "Study" (Device Performance Testing)

1. Sample size used for the test set and the data provenance: Not explicitly stated as a "sample size" in the context of patients or images, but rather the number of devices or components tested. The provenance is internal testing by Medtronic Sofamor Danek, USA Inc.

   • Test methods and materials: The testing involved mechanical and MRI evaluations of the T2 STRATOSPHERE™ Expandable Corpectomy System devices and components (specifically Ø13mm centerpieces for MRI).
   • Mechanical Tests: Static Compression, Compression Fatigue, Static Torsion, Torsion Fatigue, Expulsion.
   • MRI Testing: Evaluated according to FDA guidance for passive implants.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth here refers to engineering specifications and regulatory standards (ASTM standards and FDA guidance documents).

3. Adjudication method for the test set: Not applicable in the traditional sense of clinical adjudication. The assessment of meeting acceptance criteria is based on direct measurement against defined engineering and regulatory standards.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a surgical implant, not an AI diagnostic tool.

5. 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.

6. The type of ground truth used:

   • Mechanical Testing: Engineering specifications and performance requirements derived from ASTM F2077 and ASTM Draft Standard F-04.25.02.02.
   • MRI Compatibility: FDA guidance document "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment."
   • Clinical Literature Review (for cervical use): Existing published clinical literature regarding the safety and performance of similar devices.

7. The sample size for the training set: Not applicable. This device does not use an AI algorithm that requires a training set.

8. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) submission for a physical medical device, not an AI/ML powered medical device. Therefore, the "study" described focuses on engineering validation (mechanical and MRI testing) and a literature review to demonstrate substantial equivalence to previously cleared predicate devices, rather than clinical efficacy through traditional comparative studies involving human readers or AI algorithms.

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