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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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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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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 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 Medronic drill guides. Some of the Medtronic Surgical Instruments are also compatible with the IPC™ 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. Medtronic cannulas may or may not be used with Midas Rex™ attachments and tools. Do not implant instruments.

The robotic graft delivery instruments are non-sterile re-usable instruments that may be used during the preparation and placement of various graft material during spinal surgery. The subject instruments are made of a medical grade stainless steel commonly used in orthopedic procedures, which meet available national or international standards specifications. The robotic graft delivery instruments are intended to be used when preparing and placing graft material during spinal surgery. To enable trajectory guidance compatibility of the surgical instruments with the MAZOR X Stealth™ Edition System, the instrument dimensions have been designed to work through the MAZOR X arm guides. The instruments will be provided non-sterile and reusable.

The provided document describes Medtronic's Robotic Graft Delivery Instruments and their 510(k) summary (K230716). However, it does not contain detailed information regarding acceptance criteria, the specific study design to prove acceptance, sample sizes for test/training sets, expert qualifications, or adjudication methods. The document primarily focuses on regulatory clearance by demonstrating substantial equivalence to predicate devices and lists general performance tests conducted.

Therefore, many of the requested fields cannot be filled from the provided text.

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

Acceptance Criteria and Device Performance

The document describes general performance tests, but explicit acceptance criteria with numerical targets are not provided. The 'Description' column of the performance test table gives an indication of what was confirmed, which implicitly suggests the desired performance.

Implicit Acceptance Criteria and Reported Device Performance

Additional Information on the Study:

• Sample size used for the test set and the data provenance:

  • Sample Size: Not specified in the document.
  • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing appears to be laboratory-based ("Anatomical Simulated Use," "Mechanical Guidance Accuracy," "Depth Control Analysis").

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

  • Not specified. The document refers to "expected use conditions" and engagement with "facet defect created by Mazor X Stealth Edition facet decortication tools," suggesting a simulated environment rather than human expert reads of clinical images or data for ground truth.

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

  • Not applicable/Not specified. The tests described are functional and mechanical in nature, not involving interpretation by multiple adjudicators.

• 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. The device is a surgical instrument, not an AI-assisted diagnostic tool. This type of study is not relevant to this device.

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

  • Not applicable. The device is a surgical instrument. The performance testing "confirmed instrument functionality under expected use conditions" and "mechanical guidance accuracy," implying standalone functional and mechanical testing of the instrument itself rather than an algorithm.

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

  • The "ground truth" for the performance tests appears to be objective, measurable mechanical and functional standards (e.g., "allowable surgical tool mechanical tolerance," "engage facet defect"). It is not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic device.

• The sample size for the training set:

  • Not applicable. This device is a mechanical surgical instrument, not an AI/machine learning model that requires a training set.

• How the ground truth for the training set was established:

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

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MASTERGRAFT® Matrix EXT 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, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.

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 ß-tricalcium phosphate formulation. MASTERGRAFT® Matrix EXT is supplied sterile in a premixed strip form for single patient use. The device 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.

This FDA 510(k) summary for Medtronic's MASTERGRAFT® Matrix EXT bone void filler does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML powered medical device.

Instead, this document is a Traditional 510(k) application focused on demonstrating substantial equivalence to previously cleared predicate devices. The primary purpose of this specific submission is the addition of a new contraindication to the Instructions for Use (IFU) for the MASTERGRAFT® Matrix EXT.

Therefore, many of the requested points regarding AI/ML device testing are not applicable to this document. The document describes a traditional medical device (bioresorbable collagen and calcium phosphate ceramic) and its non-clinical testing for substantial equivalence, not an AI/ML algorithm's performance.

Here's an analysis based on the provided text, highlighting what's available and what's not:

1. Table of acceptance criteria and the reported device performance

• Not Applicable. This document does not describe specific acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, or image analysis accuracy) for an AI/ML device. The "performance" mentioned refers to the general function and characteristics of the bone void filler, which are deemed "Identical" to the predicate devices.

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

• Not Applicable. No test set in the context of evaluating an AI/ML algorithm's performance is mentioned. The non-clinical testing refers to tests conducted on the physical device, not on data for algorithm evaluation.

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. Ground truth, in the AI/ML sense, is not established or discussed in this document.

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

• Not Applicable. Adjudication methods for test sets are not relevant to this type of device submission.

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. No MRMC study or AI assistance is mentioned.

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

• Not Applicable. This is not an AI/ML algorithm.

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

• Not Applicable. Ground truth in this context is not defined as there is no algorithm being evaluated against such a benchmark. The "ground truth" for this device would be its physical and chemical properties and its biological interaction with bone, evaluated through non-clinical (e.g., biocompatibility, dissolution rate) and potentially clinical studies (which are referenced as already having occurred for the predicate).

8. The sample size for the training set

• Not Applicable. No training set for an AI/ML algorithm is mentioned.

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

• Not Applicable.

Summary of Device and Substantial Equivalence Information Present in the Document:

The document describes the MASTERGRAFT® Matrix EXT, a resorbable calcium salt bone void filler device.

• Device Description:

  • Made from medical-grade purified collagen of bovine origin (Type I, >95%) and biphasic calcium phosphate ceramic (15% hydroxyapatite and 85% ß-tricalcium phosphate).
  • Supplied sterile in a premixed strip form for single patient use.
  • A biocompatible, osteoconductive, porous implant that supports bony ingrowth and resorbs at a rate consistent with bone healing.
  • Absorbs bone marrow aspirate.

• Indications for Use:

  • To be combined with autogenous bone marrow.
  • Indicated for bony voids or gaps not intrinsic to the stability of the bony structure.
  • Can be used as a bone graft extender.
  • Gently packed into bony voids or gaps of the skeletal system (posterolateral spine, pelvis, ilium, and/or extremities).
  • For surgically created osseous defects or those from traumatic injury.
  • Resorbs and is replaced with bone during healing.

• Predicate Devices:

  • MASTERGRAFT® UltraMatrix (K130335, S.E. 04/19/2013)
  • MASTERGRAFT® Strip and MASTERGRAFT® Putty (K140375, S.E. 04/18/2014)

• Basis for Substantial Equivalence (Non-Clinical Testing):

  • The submission relies on non-clinical testing performed in support of MASTERGRAFT® Strip (K082166, S.E. 06/02/2009), which is considered relevant and supportive of the cited predicate K130335.
  • No new non-clinical testing was performed or submitted for this specific 510(k) application.
  • Testing was conducted in accordance with FDA Recognized Consensus Standards and FDA Guidelines.
  • The subject device is deemed substantially equivalent to the predicate MASTERGRAFT® UltraMatrix due to identical:
    • Indication for Use
    • Fundamental Scientific Technology/Operating Principle/Mechanism of Action
    • Basic Design
    • Performance
    • Manufacturing principles
    • Sterilization
    • Shelf-Life
    • Packaging
    • Material Composition (collagen, granules)
    • Use of rigid fixation
    • Safety and Effectiveness profile
  • It is also substantially equivalent to K140375 (MASTERGRAFT® Strip and MASTERGRAFT® Putty) regarding the additional contraindication identified in the labeling (which was the primary purpose of this specific 510(k)).

In essence, this document is a regulatory submission for a material-based medical device, not a software-based or AI/ML device, and thus the requested AI/ML specific information is not available within this text.

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The DIVERGENCE™ anterior cervical plate and bone screw components are intended for anterior interbody screw fixation from C2-T1. The indications of spinal instrumentation systems should be well understood by the surgeon. The plate and bone screw components are in the temporary stabilization of the anterior spine during the development of spinal first with: 1) degenerative disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by paiient history and radios), 2) trauma (including fractures). 3) tunors, 4) defined as kyphosis, lordosis, or scoliosis). 5) pseudoarthrosis, and/or 6) failed previous fusions.

"The DIVERGENCE™ anterior cervical cage component is intended to be used for amerior cervical interbody fusion procedures in skeletally mature patients with cervical dise disease at one level from the C2-C3 disc . Cervical disc disease is defined as intractable radior myclopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symplomatic nerve root and/or spinal confirmed by radiographic studies. This cage is to be used in patients who have had six weeks of non-overative treatment. The DIVERGENCE™ cage must be used with supplemental fixation. The DIVERGENCE™ cage is also required to be used with antogenous bone graft and/or allogenic bone graft comprised of cancellous bone grafi and is to be implanted via an open, anterior approach.

When used together, the DIVERGENCE™M components can be used only to treat cervical dise disease.

The DIVERGENCE™ Anterior Cervical Fusion System consists of temporary implants (plates and bone screws) intended for anterior screw fixation, and fusion devices (interbody cages) intended to stabilize and promote bone fusion during the normal healing process following surgical correction of disorders of the spine. The DIVERGENCE™ anterior cervical plates and bone screws are available in broad range of size offerings that are intended for anterior screw fixation intended for stabilization use during the normal healing process following surgical correction of disorders of the spine. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The DIVERGENCE™ anterior cervical plate and bone screws are made from titanium allov and are provided sterile.

The DIVERGENCE™ anterior cervical cages available in various widths and heights can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These implants must be used with supplemental fixation. The device is made from medical grade polyetheretherketone (PEEK OPTIMA™), contains titanium alloy wire markers and is provided sterile.

The DIVERGENCE™ Anterior Cervical Fusion System is a medical device subject to regulatory review. The provided text is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to previously cleared predicate devices, rather than presenting a detailed study with specific acceptance criteria and performance data as might be found in a clinical trial report or a comprehensive engineering validation study. As such, the information you're requesting regarding quantitative acceptance criteria and detailed study outcomes (like sample sizes for test/training sets, expert qualifications, MRMC studies, and explicit ground truth definitions) is not explicitly available in this type of summary.

However, based on the text provided, here is how we can interpret and present the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Acceptance Criteria" in this context:

For a 510(k) submission, "acceptance criteria" are typically defined by the recognized consensus standards (like the ASTM standards cited) and the comparative performance to the predicate device. The device "met the pre-determined acceptance criteria for all tests," which implies that its mechanical performance (strength, stability, resistance to subsidence) was comparable to or better than that of the predicate devices and within the established safety and performance limits set by the standards. The exact quantitative values for these criteria are not disclosed in this summary but would be part of the full submission.

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

• Sample Size for Test Set: Not explicitly stated in the 510(k) summary. These tests are typically conducted on a representative number of physical devices according to the specified ASTM standards.
• Data Provenance: The tests are non-clinical (laboratory-based mechanical testing) performed to recognized consensus standards (ASTM). No human or animal data is described, so country of origin for clinical data or retrospective/prospective status is not applicable here.

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

This question is not applicable to this type of submission. The "ground truth" for the non-clinical tests is established by the specified ASTM standards and the measurements obtained during the mechanical testing of the physical devices. There are no human experts "establishing ground truth" in the way one would for image interpretation or diagnosis.

4. Adjudication Method for the Test Set

Not applicable. This refers to adjudication of discrepancies in human interpretation, which is not relevant for mechanical testing against standards.

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 510(k) for a physical medical implant (spinal fusion system), not a software or AI-powered diagnostic device. Therefore, MRMC studies involving human readers and AI assistance are not relevant to this submission.

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

Not applicable. As above, this is for a physical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation in this 510(k) is the mechanical performance measured against established ASTM consensus standards and the comparative performance to the predicate devices. The goal is to demonstrate that the device performs mechanically in a manner substantially equivalent to legally marketed devices and meets relevant safety standards.

8. The Sample Size for the Training Set

Not applicable. "Training set" refers to data used to train an algorithm. This is a physical device, and therefore, an algorithmic training set is not relevant.

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

Not applicable, as there is no training set for an algorithm.

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The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

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

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

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

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

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

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

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

The purpose of this submission is to modify Medtronic's CD HORIZON® Spinal System to add additional components to the system, specifically, modified Side Loading/Closed Domino Connectors.

The provided document is a 510(k) summary for the CD Horizon® Spinal System, a medical device for spinal fixation. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with acceptance criteria.

The document explicitly states: "No clinical testing was performed" (Section XI).

Therefore, it is not possible to provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as no such study was conducted for this specific 510(k) submission.

The manufacturer is submitting for a modification to an already marketed device, adding "modified Side Loading/Closed Domino Connectors." The regulatory strategy relies on non-clinical testing and comparison to previously cleared predicate devices.

Here's a breakdown of why the requested information cannot be provided based on the given text:

1. A table of acceptance criteria and the reported device performance: Not available. Since no clinical testing was performed, there are no reported device performance metrics against acceptance criteria from a clinical study.
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. No clinical test set was used.
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. No clinical test set with ground truth established by experts was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a mechanical spinal system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a mechanical spinal system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No clinical study requiring ground truth was performed for this 510(k).
8. The sample size for the training set: Not applicable. This is a medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Instead of clinical testing, the submission relies on:

• Risk analysis: "A risk analysis of the device modifications was completed in accordance with Medtronic design control procedures. The risk analysis, which included an engineering rationale, demonstrated that the subject CD HORIZON® Spinal System does not introduce new issues of safety or effectiveness." (Section X)
• Substantial Equivalence to predicate devices: The modification is deemed substantially equivalent to "Medtronic's CD HORIZON® Spinal System K090390 (S.E. 05/15/2009) and CD HORIZON® Spinal System K101074 (S.E. 06/22/2010)." This means the new components are considered safe and effective because similar components already on the market have demonstrated safety and effectiveness.

For devices like the CD Horizon® Spinal System undergoing minor modifications, regulatory bodies often accept non-clinical evidence (like engineering rationale and comparison to predicate devices) if the changes do not introduce new safety or effectiveness concerns.

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The CLYDESDALE® 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® 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 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 may be implanted via a minimally invasive lateral approach.

The CLYDESDALE® Spinal System is intended to help provide support in the intervertebral body space during fusion of vertebral bodies in the lumbar spine. This system is intended to be used with supplemental fixation. The CLYDESDALE® Spinal System consists of PEEK cages of various widths and heights, which include tantalum markers. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allow them to be packed with autogenous bone graft. The purpose of this 510(k) submission includes additional implant sizes and trials for the CLYDESDALE® Spinal System. The subject implants will be offered in 18mm, 22mm, 26mm widths, 0°, 8°, 12°, 18° of lordosis and 8mm, 10mm, 12mm, 16mm. 18mm. 20mm heights, and in the same lengths as the predicate CLYDESDALE® Spinal System, K100175 (S.E. 06/02/2010).

The information provided pertains to the CLYDESDALE® Spinal System, which is an intervertebral body fusion device. The acceptance criteria and the study that proves the device meets those criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

The report states, "Based on the results, the subject implants demonstrated that they are as safe, as effective and perform as well as the predicate device(s)." This indicates that the acceptance criteria were met by showing equivalency to predicate devices in mechanical testing.

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

This submission did not involve clinical testing. The tests conducted were non-clinical mechanical tests on the device itself. Therefore, there is no "test set" in the context of patient data, nor is there data provenance in terms of country of origin or retrospective/prospective nature. The tests were performed on the medical devices (implants).

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

Not applicable. As this was a non-clinical mechanical study, no human experts were involved in establishing a "ground truth" for a test set of patient data. The ground truth was established by the specified mechanical testing standards.

4. Adjudication Method for the Test Set

Not applicable. No human readers or adjudication method were involved as this was a non-clinical mechanical study.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as this was a non-clinical mechanical study. No human readers or AI were involved in the evaluation of the device's performance.

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

Not applicable. This device is a physical implant, not an algorithm or AI system. Therefore, a standalone algorithm performance study was not performed.

7. Type of Ground Truth Used

The ground truth for this study was based on established mechanical testing standards and the performance of legally marketed predicate devices. Specifically, the device's performance was compared to the requirements outlined in the FDA's guidance document, "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device," and demonstrated substantial equivalence to predicate devices.

8. Sample Size for the Training Set

Not applicable. This submission concerns a physical medical device, not an AI or machine learning model. There is no concept of a "training set" in this context.

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

Not applicable. As there is no training set for a physical device, no ground truth needed to be established for it.

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The CRESCENT® Spinal System 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 devices are intended to be used with supplemental fixation instrumentation which has : been cleared by the FDA for use in the lumbar spine.

The subject CRESCENT® Spinal System consists of a variety of hollow intervertebral body spacers featuring a bullet-nosed, anatomically shaped design with axial voids designed to hold bone graft material. The implants may be implanted via a posterior, transforaminal or lateral approach and the procedure may be open or minimally invasive. The subject devices are designed with diamond V teeth across both superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The devices range from 7mm to 15mm in height and 36mm in length. The devices are manufactured from medical grade PEEK-Optima LTI (polyetheretherketone). These devices also contain Tantalum markers used for imaging purposes.

This document describes a 510(k) premarket notification for the CRESCENT® Spinal System. This type of submission focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting new clinical study data with acceptance criteria and a detailed study proving performance. Therefore, many of the requested data points (like sample size for test/training sets, expert qualifications, MRMC studies, standalone performance, and detailed ground truth establishment) are not typically included in such a submission.

However, I can extract the relevant information regarding the "acceptance criteria" and the "study" that supports the substantial equivalence claim.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission seeking clearance for additional sizes of an existing device, the "acceptance criteria" revolve around demonstrating that the new size does not introduce new safety or effectiveness concerns and performs equivalently to the already cleared predicate.

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

• Sample Size: Not applicable in the context of a 510(k) for an incremental change like a new size. There isn't a "test set" of patients or images in a clinical efficacy study sense. The "test" here refers to non-clinical, engineering testing and comparison to predicate devices.
• Data Provenance: Not applicable. The "data" comes from engineering analysis and comparison to existing regulatory clearances.

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

• Not applicable. Ground truth for clinical performance is not established for this type of submission. The "ground truth" for substantial equivalence is based on regulatory standards and comparison to previously cleared devices, evaluated by FDA reviewers.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is not an AI/CAD device. It is a spinal implant.

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

• Not applicable. This is not an AI/CAD device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" in this context is the established safety and effectiveness profile of the predicate devices, as determined by previous FDA clearances. The current submission's "truth" is that the new device variant (14.5mm wide PEEK implant) is equivalent to these predicates and does not introduce new risks. This is supported by:
  • Engineering rationale and risk analysis: Demonstrating that the new size does not represent a "worst-case" scenario based on biomechanical principles and ASTM standards.
  • Material and design comparison: Verifying identical material and similar design features to the predicate devices.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of this 510(k) submission for a spinal implant.

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

• Not applicable.

Summary of the "Study" Proving Device Meets Acceptance Criteria:

The "study" to prove the device met acceptance criteria was a non-clinical engineering assessment and comparative analysis against legally marketed predicate devices.

• Objective: To demonstrate that the addition of a 14.5mm wide PEEK implant to the CRESCENT® Spinal System is substantially equivalent to previously cleared predicate devices and does not introduce new safety or effectiveness concerns.
• Methodology:
  1. Identification of Predicates: The subject device was compared to CRESCENT™ Spinal System (K094025) and CRESCENT® Spinal System Titanium (K110543).
  2. Material Comparison: Verification that the material (PEEK-Optima LTI) is identical to a PEEK predicate (K094025).
  3. Design Comparison: Analysis of design features of the new 14.5mm wide implant against existing cleared sizes.
  4. Mechanical Analysis (Worst-Case Assessment): According to the document, ASTM F2077 "Test Methods for Intervertebral Body Fusion Devices" defines a worst-case device. Medtronic argued that since the existing cleared PEEK implants had widths of 11mm, 12mm, and 12.5mm, and the 14.5mm wide Titanium implants were already cleared, the new 14.5mm wide PEEK implant does not introduce a new "worst-case scenario" regarding mechanical performance (as its footprint is not reducing).
  5. Engineering Rationale and Risk Analysis: A formal engineering justification and risk assessment were completed to support the claim that the new size does not present new risks.
• Conclusion: Based on the engineering rationale, risk analysis, and supporting documentation, Medtronic concluded that the subject system demonstrates substantial equivalence to the listed predicate devices. The FDA concurred, granting clearance.

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The PERIMETER® Interbody Fusion Device 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 may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

The PERIMETER® Interbody Fusion Device consists of cages of various widths and heights which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The PERIMETER® Interbody Device is to be used with supplemental instrumentation. The device is offered in Titanium Alloy (Titanium-6Aluminum-4Vanadium ELI) or PEEK Optima LT1 (Polyetheretherketone). This interbody device is offered in sterile (PEEK) or non-sterile (PEEK and Titanium Alloy) forms. The PERIMETER® Interbody Fusion Device is offered in a variety of sizes ranging from 8mm to 20mm in height, 21mm to 28mm in length and between 19mm and 38mm in width. An array of lordosis options are provided for this device spanning from 4 degrees to 15 degrees of angulation. Both the PEEK and Titanium Alloy (Titanium-6Aluminum-4 Vanadium EL.I) devices are designed with teeth across both the superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus providing expulsion resistance. Additionally, the Titanium Alloy (Titanium-6Aluminum-4 Vanadium ELI) version of this device offers lateral windows for visibility of the autogenous bone graft.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, though it's important to note that this document is a 510(k) summary for a medical device and not a detailed clinical study report for a device that relies on an AI algorithm.

This document describes a medical device (Interbody Fusion Device) that does not involve an AI algorithm. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation will not be applicable. The study performed here is a non-clinical validation for a labeling change.

Therefore, for aspects related to AI (e.g., sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies), the answer will be "Not applicable" or "No AI component in this device."

Acceptance Criteria and Device Performance for PERIMETER® Interbody Fusion Device (K132700)

1. Table of Acceptance Criteria and Reported Device Performance

Study Information (Pertaining to non-clinical validation for labeling change)

Since this document describes a conventional medical device (an interbody fusion implant) and not an AI/ML-driven device, many of the AI-specific questions are not applicable.

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

   • Test set sample size: Not explicitly stated as a number of "samples" in the context of an AI test set. The validation involved "surgeons performing the procedure on cadavers." The number of cadavers or procedures is not specified.
   • Data provenance: Cadaveric testing. The country of origin is not specified, but the applicant is based in Memphis, Tennessee, USA. This was a non-clinical, prospective evaluation of the labeling change using cadavers.

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

   • Number of experts: "Surgeons" (plural) were involved. The exact number is not specified.
   • Qualifications of experts: Implied to be medical professionals qualified to perform spinal fusion procedures. No specific years of experience or sub-specialty are explicitly stated in this summary.

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

   • Not applicable in the context of an AI-driven "test set" and ground truth adjudication. The validation appears to be a direct confirmation by surgeons that the modified labeling aligns with their practical experience during cadaveric procedures. There's no indication of a consensus-based adjudication process for a binary or categorical ground truth.

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:

   • No. This was not an AI-assisted device, and therefore no MRMC study comparing human readers with and without AI assistance was performed.

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

   • No. This device does not have an algorithm component.

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

   • The "ground truth" here is the practical confirmation by surgeons during cadaveric procedures that the modified labeling accurately reflects how the device is used and its features. It's a pragmatic validation against expert surgical practice rather than a diagnostic "truth" like pathology.

7. The sample size for the training set:

   • Not applicable. There is no AI algorithm being developed or trained for this device.

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

   • Not applicable. There is no AI algorithm being developed or trained for this device.

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The T2TM Spinal System is a vertebral body replacement system intended for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The T2TM components consist of end caps which must be attached to a T2 XVBR™ expanding centerpiece to form a complete construct. The final construct is to be used with supplemental fixation. The T2 SCEPTOR™ components also serve as a vertebral body replacement device for the same intended use in the thoracolumbar spine. The T2 SCEPTOR™ end caps and endcleats must be attached to a PYRAMESH-C® device to form a complete construct. Both constructs (T2 XVBR™ and T2 SCEPTOR™) must be used with supplemental fixation to form a final construct. Specifically, the construct is to be used with the Medtronic ZPLATE II™ Anterior Fixation System, the DYNA-LOK CLASSIC® Spinal System, the VANTAGE™ Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, or their successors. Additionally, the T2TM Spinal System construct is intended to be used with allograft and/or autograft.

The T2 ALTITUDE™ Expandable Corpectomy System is a vertebral body replacement system intended for use in the thoracolumbar spine (T)-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The T2 ALTITUDE™ Expandable Centerpiece may be used with or without optional modular endcaps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation. Specifically, the construct is to be used with the VANTAGE® Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, or their successors. Additionally, the T2 ALTITUDE™ Expandable Corpectomy System is intended to be used with allograft and/or autograft.

The T2 XVBR™ Spinal System is a distractible system. This construct is inserted between two vertebral bodies in the thoracic and/or lumbar spine and is expanded to aid in the surgical correction and stabilization of the spine. The construct is not intended to be used as a standalone device. The construct is intended to be used with either anterior and/or posterior supplemental spinal fixation systems already cleared for thoracic and lumbar spine stabilization. The T2 XVBR™ expandable centerpiece is made of titanium alloy. cobalt chrome, and nitinol. The T2 XVBR™ Titanium Alloy end caps are attached to the T2 XVBR™ expandable centerpiece to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy. The T2 XVBR™ Spinal System is available in multiple diameters and heights to accommodate the patient's anatomical requirements.

The T2 ALTITUDE™ Expandable Corpectomy System is a distractible system. This device is inserted between two vertebral bodies in the thoracic and lumbar spine and is expanded to aid in the surgical correction and stabilization of the spine. The device may be implanted through a lateral or posterior approach using a minimally invasive technique or implanted through a lateral, posterior or anterior approach through a traditional open technique. The device is not intended to be used as a stand-alone implant. The T2 ALTITUDE™ Expandable Corpectomy System is made of titanium alloy, cobalt chrome, and nitinol. The optional T2 ALTITUDE™ angled end caps may be attached to the T2 ALTITUDE™ expanding centerpiece to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy. The T2 ALTITUDE™ Expandable Corpectomy System is available in multiple diameters and heights to accommodate the patient's anatomical requirements.

This 510(k) summary describes an MRI update for the Medtronic Sofamor Danek T2 XVBR™ Spinal System & T2 ALTITUDE™ Expandable Corpectomy Systems. The submission's purpose is to provide appropriate MRI safety labeling for the devices and instructions for MRI technologists. The devices themselves have not undergone changes in design or specifications.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by adherence to specific ASTM standards for MR Conditional labeling. The "reported device performance" is the conclusion that the devices are "MR Conditional" based on testing against these standards.

Overall Conclusion: Non-clinical testing in accordance with the listed standards and a risk analysis led to the conclusion that the devices are MR Conditional in 1.5 Tesla and 3.0 Tesla MR environments.

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

The document does not specify a "sample size" in terms of patients or implanted devices for the test set. Instead, the testing was conducted on device components or constructs in a laboratory setting to evaluate their MR compatibility. The provenance of this data is non-clinical laboratory testing as described by the ASTM standards, not patient data (retrospective or prospective). The country of origin for the testing facilities is not explicitly stated, but Medtronic Sofamor Danek, USA Inc. is based in Memphis, Tennessee.

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

This type of submission (MRI compatibility) typically does not involve human expert adjudication of images or diagnoses to establish "ground truth." The "ground truth" for MR compatibility is established by adherence to physical measurement standards and engineering principles, as defined by the ASTM guidelines. Therefore, no medical experts (e.g., radiologists) were used in this capacity. The "experts" involved would be engineers and physicists performing the standardized tests.

4. Adjudication Method for the Test Set

No human adjudication method (e.g., 2+1, 3+1, none) was used for the test set, as the testing involves objective physical measurements against established ASTM standards, not subjective interpretation.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to a submission focused on device MRI compatibility. These studies are used to assess the diagnostic performance of a new imaging modality or AI algorithm, often comparing human reader performance with and without AI assistance. This submission deals with the physical safety requirements of an implant in an MRI environment.

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

No. This submission is for the MRI compatibility of physical spinal implants, not for an AI algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The Type of Ground Truth Used

The ground truth used is based on:

• Established engineering standards and physical measurements: Specifically, the ASTM standards (F2052, F2182, F2213, F2119, F2503) define the metrics and acceptable limits for magnetic displacement, heating, torque, and artifact generation.
• Risk analysis: A safety assessment is conducted based on these objective measurements to determine if the device poses an acceptable risk in the MR environment.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in this context as this is not an AI/machine learning device. The testing involved physical device samples (implants) and components.

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

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

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