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Xenco Medical CancelleX Cervical Interbody System devices are intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Devices are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should have had at least six weeks of nonoperative treatment prior to surgical treatment with the device is intended to be used with supplemental fixation (e.g. anterior plate system).

Xenco Medical CancelleX Cervical Interbody System devices are generally box shaped with surface teeth and a central channel for packing autogenous bone. These implants are available in a range of shapes and sizes to accommodate variations in patient anatomy. Spacers are manufactured from Titanium Alloy (TI-6AL-4V per ASTM F3001-14). The system also includes instruments manufactured using 6061 T6 Aluminum Alloy (per ASTM B211 / B221) and Stainless Steel (per ASTM F899). All system implants and instruments are provided sterile packaged and are intended for single use.

This document is a 510(k) premarket notification decision letter from the FDA regarding a medical device, the Xenco Medical CancelleX Cervical Interbody System. It is not a study report for an AI/ML medical device.

Therefore, the requested information about acceptance criteria, study design, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details for an AI/ML device is not present in this document.

The document focuses on demonstrating substantial equivalence of a physical medical device (an intervertebral body fusion device) to existing predicate devices. It discusses:

• Device Description: Generally box-shaped with surface teeth, a central channel for autogenous bone, available in various shapes and sizes, manufactured from Titanium Alloy.
• Indications for Use: Spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease, implanted via an open, anterior approach, packed with autogenous bone, used with supplemental fixation.
• Technological Comparison: Similar design and sizing to predicates, but 3D printed from titanium with porous latticed areas, similar to an additional predicate.
• Non-Clinical Test Summary & Conclusions: Benchtop mechanical testing was performed according to ASTM standards (F2077 for static/dynamic axial compression, compression shear, and torsion; F2267 for subsidence), and expulsion testing per lab protocol. The conclusion states that the subject device has at least equivalent mechanical strength as the predicates.
• Clinical Testing: The document explicitly states, "Clinical testing was not applicable for this submission."

Since this document pertains to a physical implantable device and not an AI/ML software device, none of the specific questions regarding AI/ML device performance, acceptance criteria, or study methodologies can be answered from the provided text.

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When used as an intervertebral fusion device with bone graft, cervical:

Xenco Medical InterAlign Cervical Interbody System devices are intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Devices are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should have had at least six weeks of nonoperative treatment prior to surgical treatment with the device is intended to be used with supplemental fixation (e.g. anterior plate system).

When used as an intervertebral fixsion, cervical (interbody spacer w/ provided plate, bone screws, and locking cover):

Xenco Medical InterAlign Cervical Interbody System constructs are stand-alone anterior cervical interbody fusion devices intended for use as an adjunct to fusion at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). Patients should have received at least six weeks of non-operative treatment with the device. Xeno Medical InterAlign Cervical Interbody System constructs are to be packed with autogenous bone graft and implanted via an open, anterior approach. Xenco Medical InterAlign Cervical Interbody System constructs are intended to be used with the plate, bone screws, and locking cover provided and require no additional fixation.

Xenco Medical IntelAlign Cervical Interbody System devices are generally box shaped with surface teeth and a central channel for packing autogenous bone. These implants are available in a range of shapes and sizes to accommodate variations in patient anatomy. Spacers are manufactured from PEEK polymer (Zeniva ZA-500 per ASTM F2026) and contain titanium (per ASTM F67), titanium alloy (per ASTM F1472), or tantalum (per ASTM F560) markers to assist with radiographic visualization. Stand-alone device constructs additionally utilize a fixation plate and bone screws manufactured from titanium alloy, and a PEEK locking cover. The system also includes instruments manufactured using anodized 6061 T6 aluminum alloy per ASTM B211 / B221. All system implants and instruments are provided sterile packaged and are intended for single use.

The provided text is a 510(k) summary for the Xenco Medical InterAlign Cervical Interbody System. This type of submission is for medical devices that demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance data as might be seen for novel devices or those requiring PMA.

Therefore, the document does not contain information on acceptance criteria for device performance in a clinical study, nor does it detail a study that proves the device meets such criteria in terms of clinical outcomes. Instead, it demonstrates equivalence to existing devices primarily through technological characteristics and non-clinical performance testing.

Here's a breakdown based on the provided text, addressing the points where information is available or relevant to a 510(k):

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not applicable in the context of a 510(k) summary for a cervical interbody system. The 510(k) process focuses on demonstrating substantial equivalence to a predicate device, not on meeting specific clinical performance acceptance criteria in a study. The "Performance Testing" section states: "As the implants are identical to those cleared in K160313 and no changes have been made to indications or claims, no new non-clinical performance testing was required for the subject device implants. The subject device instrumentation is manufactured identically to those described in the reference device (K112913). As such, no biocompatibility testing was required to support the change. A gamma sterilization validation was performed to support the change in device material."

This indicates that equivalence was established through material, design, and manufacturing comparisons, along with sterilization validation. There are no clinical performance metrics or acceptance criteria presented.

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

This information is not applicable as there was no clinical "test set" in the context of device performance testing for this 510(k). The evaluation was based on design and material comparisons to predicate devices and non-clinical testing for material changes (sterilization validation).

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

This information is not applicable. Ground truth establishment for a clinical test set is not part of this 510(k) submission.

4. Adjudication Method for the Test Set:

This information is not applicable. No clinical test set adjudication method is mentioned.

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

This information is not applicable. An MRMC comparative effectiveness study is a clinical study involving human readers (e.g., radiologists interpreting images affected by an AI device) and is not relevant to this 510(k) for an interbody fusion device.

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

This information is not applicable. This device is a physical implant, not an algorithm, and therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used:

This information is not applicable for clinical performance. The "ground truth" in this 510(k) context relates to the established safety and effectiveness of the predicate devices based on their prior clearances and the technical specifications/materials of the subject device matching or being equivalent to those predicates.

8. The Sample Size for the Training Set:

This information is not applicable, as there is no "training set" in the context of an algorithm or AI.

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

This information is not applicable, as there is no "training set" for this device.

In summary, for the Xenco Medical InterAlign Cervical Interbody System as described in this 510(k) submission (K223059):

The device gained clearance by demonstrating substantial equivalence to previously cleared predicate devices (K160313, K140786) and a reference device (K112913). The primary arguments for equivalence are:

• Identical Implants: The implants of the subject device are identical to those cleared in K160313.
• No Change in Indications/Claims: The indications for use and claims are unchanged from the predicate.
• Material Equivalence: The instrumentation material is identical to the reference device (K112913).
• Non-clinical Performance Testing: A gamma sterilization validation was performed to support the change in instrument material. No new non-clinical performance testing was required for the implants because they are identical to the predicate. No biocompatibility testing was required for the instrument material change due to its similarity to the reference device.

The 510(k) process explicitly relies on the premise that if a new device is substantially equivalent to a legally marketed predicate device (in terms of intended use, technological characteristics, and safety/effectiveness), then it does not raise new questions of safety and effectiveness and does not require a full clinical trial to establish performance criteria.

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The Xenco Medical Multilevel CerviKit is interior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) spondylolisthesis, 3) trauma (including fractures or dislocations), 4) tumors, 5) deformity (defined as kyphosis, or scoliosis), 6) pseudarthrosis, 7) failed previous fusions and/or 8) spinal stenosis.

The Xenco Medical Multilevel CerviKit is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with bone screws using an anterior approach. Plates are available in a variety of lengths addressing multiple levels of fixation. The Xenco Medical Multilevel CerviKit plate incorporates graft windows on the longitudinal center line for intraoperative visualization and for screw fixation of bone graft. Fixed or variable bone screws are available in two diameters and a variety of lengths.

This document is a 510(k) premarket notification for the Xenco Medical Multilevel CerviKit, a spinal intervertebral body fixation orthosis. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Here's an analysis of the provided text regarding acceptance criteria and performance study:

The provided document does not describe a study involving an AI/Machine Learning device or a diagnostic device. Instead, it describes a medical device (a spinal implant) whose acceptance is based on demonstrating substantial equivalence to existing predicate devices through non-clinical mechanical testing.

Therefore, many of the typical questions for an AI/ML device's acceptance criteria and study design (e.g., sample size for test set with data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this submission.

However, I can extract the relevant information regarding the acceptance criteria and the "study" (non-clinical testing) as described in this specific 510(k) submission.

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing for Substantial Equivalence)

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

For this device, the "acceptance criteria" are implied by the performance of the predicate devices. The "reported device performance" is that the Xenco Medical Multilevel CerviKit performed "equivalently" to the predicates in the specified non-clinical tests. The specific numerical thresholds for "equivalence" are not detailed in this summary but would be part of the full test reports referenced.

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: Not explicitly stated in this 510(k) summary for the non-clinical tests. Typically, in mechanical testing for a spinal implant, a certain number of samples (e.g., n=5 or more) per test group would be used to establish statistical significance or demonstrate compliance with a standard.
• Data Provenance: Not applicable in the sense of patient data. This refers to laboratory-generated mechanical test data.
• Retrospective or Prospective: Not applicable. These are in vitro mechanical tests.

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

• Not Applicable. This is not a diagnostic device or an AI/ML algorithm that relies on expert human interpretation of medical images. The "ground truth" for mechanical testing is established by adherence to recognized ASTM standards and engineering principles. The experts involved would be mechanical engineers and biomedical engineers overseeing and conducting the tests.

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

• Not Applicable. As this is mechanical testing, there is no human interpretation or adjudication in the medical imaging sense. The test results are quantitative measurements against predefined criteria in the ASTM 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

• No MRMC study was done. This device is a physical implant, not an AI or imaging diagnostic tool.

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

• Not Applicable. This is not an algorithm.

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

• Ground Truth for Mechanical Performance: The "ground truth" for demonstrating substantial equivalence is based on established engineering and biomechanical principles captured in ASTM standards (e.g., ASTM F1717) and the established performance characteristics of the predicate devices. The physical properties and mechanical behavior of the device under simulated physiological loads are the "truth" being assessed.

8. The sample size for the training set

• Not Applicable. This device does not involve machine learning or a "training set."

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

• Not Applicable. As there is no training set for an AI/ML model.

Summary Specific to this Device Submission:

The Xenco Medical Multilevel CerviKit is a Class II medical device. Its acceptance and clearance are based on demonstrating substantial equivalence to legally marketed predicate devices. This equivalence is primarily supported by:

• Non-clinical (mechanical) testing: Static and dynamic compression testing (per ASTM F1717), static torsion testing (per ASTM F1717), and push-out testing for screws.
• Comparison of design, materials (Titanium alloy - Ti-6Al-4V ELI), and indications for use to predicate devices (K160702 Astura Medical ZION Anterior Cervical Fixation System and K080646 Biomet C-TekV MaxAnrm Anterior Cervical Plate).
• No clinical studies were performed.

The "study" that proves the device meets "acceptance criteria" here refers to the in-vitro mechanical testing, where the "acceptance criteria" are implied to be performance results comparable or superior to the predicate devices as per relevant ASTM standards.

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Sorrento Bone Graft Substitute is intended for use as a bone void filler to fill voids or gaps of the skeletal system not intrinsic to the stability of the bony structure (extremities, pelvis, posterior lateral spine). Sorrento Bone Graft Substitute is also indicated for use in the treatment of surgically created osseous defects created from traumatic injury to the bone. Sorrento Bone Graft Substitute must be wetted with bone marrow aspirate or, when used in the posterolateral spine, autologous bone must also be added (50/50 ratio by volume). Following placement in the bony void or gap (defect), Sorrento Bone Graft Substitutes are resorbed with bone during the healing process

Sorrento Bone Graft Substitute is a resorbable bone void filler made from a matrix of highly purified collagen (ASTM F2212) that has high porosity beta tricalcium phosphate (TCP) granules (ASTM F1088) dispersed throughout. The implant is provided as sterile, for single-use in double peel packages.

The provided document ([K191074](https://510k.innolitics.com/search/K191074)) is a 510(k) premarket notification for a medical device called Sorrento™ Bone Graft Substitute. It details the device's characteristics, indications for use, and a comparison to predicate devices to establish substantial equivalence.

Crucially, this document is a 510(k) premarket notification for a bone graft substitute, which is a physical device, and not an AI/ML-driven device. Therefore, the concepts of acceptance criteria, test sets, training sets, ground truth establishment by experts, MRMC studies, or standalone algorithm performance are not applicable to this document. The document describes a traditional medical device approval process based on biocompatibility, bench testing, and an animal study, not an AI/ML software validation study.

Therefore, I cannot extract the requested information about acceptance criteria and study that proves an AI/ML device meets them from this document. The document does not contain information about an AI/ML device.

If you intended to provide a document related to an AI/ML medical device, please provide that document.

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CancelleX Porous Titanium Lumbar Interbody System devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non- fusion spinal surgery at the involved spinal level(s). The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbrosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation. The device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the CancelleX device.

CancelleX Porous Titanium Lumbar Interbody System devices are being added to the Lumbar Interbody System. The CancelleX Porous Titanium Interbody devices are generally box shaped with surface teeth and a central channel for packing autogenous bone. These implants are available in a range of shapes and sizes to accommodate variations in patient anatomy. The devices are manufactured from Commercially Pure (Unalloyed) Titanium (ASTM F1580). The system also includes instruments manufactured using polyacrylamide (PARA-IXEF-GY51) polymer and stainless steel per ASTM F899.

The provided text describes the regulatory clearance of the CancelleX Porous Titanium Lumbar Interbody Device. It does not contain information about the acceptance criteria or a study proving the device meets said criteria in the context of AI/ML device performance.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data (bench testing and biocompatibility). It explicitly states that animal and clinical performance data were not required to determine substantial equivalence.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI/ML or answer most of the requested questions.

Here's what can be extracted based on the provided document:

1. Table of Acceptance Criteria and the Reported Device Performance (as much as applicable):

The following questions cannot be answered based on the provided document as they relate to AI/ML device performance, which is not discussed:

• 2. Sample sized used for the test set and the data provenance
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• 4. Adjudication method for the test set
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• 7. The type of ground truth used
• 8. The sample size for the training set
• 9. How the ground truth for the training set was established

Summary of what the document does indicate:

The device's clearance was based on its substantial equivalence to previously cleared predicate devices, supported by non-clinical (biocompatibility and bench) testing. No AI/ML components or associated studies are mentioned.

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Sorrento Bone Graft Substitutes are intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities and pelvis not intrinsic to the bony structure. Sorrento Bone Graft Substitutes are also indicated for use in the treatment of surgically created osseous defects created from traumatic injury to the bone. Sorrento Bone Graft Substitutes must be wetted with bone marrow aspirate. Following placement in the bony void or gap (defect), Sorrento Bone Graft Substitutes are resorbed and replaced with bone during the healing process

Sorrento BioGlass Bone Graft Substitute is a resorbable bone void filler made from a matrix of highly purified collagen (ASTM F2212) that has high porosity beta tricalcium phosphate (TCP) granules (ASTM F1088) and Bioglass 45S5 (ASTM F1538) dispersed throughout. The implant is provided as sterile, for single-use in double peel packages.

The document is a 510(k) summary for the Sorrento™ Bioglass Bone Graft Substitute. It does NOT describe an AI/ML powered device, nor does it detail an AI/ML study.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving an AI device meets acceptance criteria. The document focuses on demonstrating substantial equivalence of a bone graft substitute to predicate devices through biocompatibility, bench testing, and animal studies.

Here's an analysis of what the document does provide, structured to address your points, though many will be flagged as "Not Applicable (N/A)" for an AI device:

1. Table of Acceptance Criteria and Reported Device Performance

As this is not an AI/ML device, the acceptance criteria and performance are related to the material properties and biological response of the bone graft substitute, not AI model metrics.

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

• Test Set Sample Size: For the animal study, the document mentions "rabbits" but does not specify the exact number of animals used.
• Data Provenance: The animal study was conducted to compare the device with predicate and reference devices. No country of origin is specified. It is a prospective animal study.

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)

• N/A. This device does not involve expert-established ground truth in the context of AI/ML. The evaluation involved radiographic and histomorphometric analysis in an animal model, which would typically be performed by trained veterinary pathologists or researchers, but no specific number or qualifications are provided in this regulatory summary.

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

• N/A. This is not relevant for the type of study described (biocompatibility, bench testing, animal study for a bone graft).

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

• N/A. This document describes a bone graft substitute, not an AI device. No MRMC study was conducted.

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

• N/A. This document describes a bone graft substitute, not an AI algorithm.

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

• For the animal study, "performance was evaluated radiographically and histomorphometrically." Histopathological and radiographic findings in animal models serve as the "ground truth" to assess bone regeneration and material integration.

8. The sample size for the training set

• N/A. This document describes a bone graft substitute. There is no AI model, and therefore no training set.

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

• N/A. This document describes a bone graft substitute. There is no AI model, and therefore no training set or ground truth establishment method for it.

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CancelleX Porous Titanium Lumbar Interbody System devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non- fusion spinal surgery at the involved spinal level(s). The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbrosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordoric interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation. The device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six months of non-operative treated with the CancelleX device.

CancelleX Porous Titanium Lumbar Interbody devices are being added to the Lumbar Interbody System. The CancelleX Porous Titanium Interbody devices are generally box shaped with surface teeth and a central channel for packing autogenous bone. These implants are available in a range of shapes and sizes to accommodate variations in patient anatomy. The devices are manufactured from Commercially Pure Titanium (ASTM F67). The system also includes instruments manufactured using polyacrylamide (PARA-IXEF-GY51) polymer and stainless steel per ASTM F899.

This document is a 510(k) Premarket Notification from Xenco Medical, LLC. for their CancelleX Porous Titanium Lumbar Interbody Device. It outlines the regulatory submission process and the data provided to demonstrate substantial equivalence to legally marketed predicate devices.

The document does not describe a study involving an AI/Machine Learning device or a study comparing device performance to human readers with or without AI assistance. It focuses on a medical implant (an intervertebral body fusion device) and demonstrates its substantial equivalence through biocompatibility testing and bench testing, as typically required for physical medical devices of this type.

Therefore, I cannot provide the information requested in your prompt because it is designed for studies of AI/ML-driven diagnostic or assistive devices, and this document pertains to a physical medical implant.

The document specifically states:

• "Animal performance data was not required to determine substantial equivalence."
• "Clinical performance data was not required to determine substantial equivalence."

It concludes that "Conclusions drawn from the non-clinical tests demonstrated that the subject device possessed at least equivalent performance characteristics as the predicate device, and that overall the subject device is substantially equivalent."

Since the information you requested (acceptance criteria, sample sizes, expert involvement, MRMC studies, standalone performance, ground truth types, and training set details for AI/ML) is not present in this document, I cannot generate a response that fulfills those specific points based on the provided text.

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The SETx Pedicle Screw System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion. The SETx Pedicle Screw System is intended for posterior, non-cervical pedicle fixation or anterolateral fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); curvatures (i.e., scoliosis, kyphosis, or lordosis); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; and failed previous fusion.

Not Found

This document is a 510(k) premarket notification decision letter for the SETx Pedicle Screw System. It declares that the device is substantially equivalent to legally marketed predicate devices. This type of document does not contain information about acceptance criteria or specific study results proving the device meets those criteria.

The information you are requesting (acceptance criteria, performance data, sample sizes, expert qualifications, ground truth establishment, etc.) for an AI/software-as-a-medical-device (SaMD) study is typically found in:

• Clinical study reports: Detailed documents submitted to regulators describing the design, conduct, results, and analysis of clinical trials.
• 510(k) Summary: A public summary provided by the manufacturer outlining the key information about the device and its substantial equivalence claims, which sometimes includes a high-level summary of performance data, especially for AI/ML devices.
• PMA (Premarket Approval) applications: For higher-risk devices, these applications require more extensive clinical evidence and detail.
• Publications in peer-reviewed journals: Manufacturers may publish their study results.
• FDA Premarket Submissions (PMA/510k) databases: While limited, some information might be accessible.

Therefore, based solely on the provided text, I cannot answer your request. The document is a regulatory approval letter for a mechanical pedicle screw system, not an AI/ML diagnostic or therapeutic device. It pertains to spinal implants, not software performance.

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When used as an intervertebral fusion device with bone graft, cervical:

Xenco Medical Cervical Interbody System devices are intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Devices are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should have had at least six weeks of non-operative treatment prior to surgical treatment with the device is intended to be used with supplemental fixation (e.g. anterior plate system).

When used as an intervertebral fusion device w/ integrated fixation, cervical (interbody spacer w/ provided plate, bone screws, and locking cover):

Xenco Medical Cervical Interbody System constructs are stand-alone anterior cervical interbody fusion devices intended for use as an adjunct to fusion at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). Patients should have received at least six weeks of non-operative treatment with the device. Xenco Medical Cervical Interbody System constructs are to be packed with autogenous bone graft and implanted via an open, anterior approach. Xenco Medical Cervical Interbody System constructs are intended to be used with the plate, bone screws, and locking cover provided and require no additional fixation.

Not Found

I am sorry, but since the document you provided is a 510(k) premarket notification letter from the FDA, it outlines the regulatory approval for a medical device (Xenco Medical Cervical Interbody System), but it does not contain any information about acceptance criteria, device performance studies, sample sizes, or ground truth establishment for an AI or software device.

Therefore, I cannot provide the requested information based on the given text.

The document primarily focuses on:

• Confirming substantial equivalence to predicate devices.
• Outlining regulatory requirements for the manufacturer.
• Stating the intended use/indications for use of the cervical interbody system.

It does not discuss the kind of performance studies or validation details that would be found in a submission for an AI-powered diagnostic device, for instance.

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

Not Found

I am sorry, but based on the provided document, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for the "Xenco Medical Posterior Cervical System," which primarily focuses on regulatory approval and indications for use. It does not contain details about specific acceptance criteria for device performance or any studies conducted to demonstrate that the device meets such criteria.

The information I can provide from the document includes:

• Device Name: Xenco Medical Posterior Cervical System
• Regulatory Class: Unclassified
• Product Code: NKG, KWP
• Indications for Use: To provide immobilization of spinal segments as an adjunct to fusion for acute and chronic instabilities of the cervical spine (C1 to C7) and thoracic spine (T1-T3), including traumatic fractures/dislocations, instability/deformity, failed previous fusions, tumors, and degenerative disease. Also, to restore spinal column integrity for a limited time in patients with advanced stage tumors where life expectancy is short.

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