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The OptiMesh Multiplanar Expandable Interbody Fusion System is indicated for use as an adjunct to fusion in an intervertebral body fusion at one level in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, physical examination, and radios. Eligible patients shall have undergone six (6) months of conservative (non-operative) care. The OptiMesh device with compatible allograft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion, is intended for use with supplemental posterior fixation systems intended for use in the lumbar spine.

AFT is intended for use as a bone void filler in the extremities, spine, intervertebral disc space, and pelvis for voids or gaps that are not intrinsic to the stability of the bony structure. AFT is indicated for use in the treatment of osseous defects caused by surgery or traumatic injury. When used in intervertebral body fusion procedures, AFT must be used on its own with an intervertebral body graff containment device cleared by FDA for use with a bone void filler.

The OptiMesh Multiplanar Expandable Interbody Fusion System is an intervertebral body graft containment device that is a non-rigid, implanted spinal device that is designed to contain bone graft within its internal cavity. The device is inserted into the intervertebral body space of the spine and is intended as an adjunct to intervertebral body fusion.

AFT Allograft Filler Tube is composed of human demineralized bone matrix, human nondemineralized bone, and sodium hyaluronate. All components of AFT are resorbable. AFT is aseptically processed and provided pre-loaded into a disposable delivery tube.

The provided text describes a 510(k) premarket notification for the "OptiMesh Multiplanar Expandable Interbody Fusion System" with the addition of "AFT Allograft Filler Tube" as a compatible allograft. It outlines the purpose of the submission, device descriptions, indications for use, technological characteristics, and non-clinical/clinical testing. However, the document does not provide specific acceptance criteria or detailed study results in the format requested.

The FDA 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving a device meets specific, quantifiable acceptance criteria with a detailed study report. The non-clinical and clinical data presented here are used to support this claim of substantial equivalence.

Based on the provided text, I can infer some aspects and highlight what is not present:

Inferred Information:

• Acceptance Criteria (Implied): The implied acceptance criteria revolve around demonstrating that the OptiMesh device with AFT performs comparably to the predicate device and the reference devices in terms of mechanical performance and biological impact, without introducing new safety or effectiveness concerns. This means that:
  • Mechanical performance of OptiMesh + AFT should be "as intended" and comparable to the reference device and ISO 23089-2 data.
  • Biological impact of AFT should be comparable to the reference bone graft.
  • Biocompatibility, pyrogenicity/endotoxin, sterilization, packaging, and shelf-life should be acceptable and comparable.
  • The risk profile should not be altered, and new safety/effectiveness issues should not arise.
• Study Proving Acceptance Criteria: The study used to demonstrate this is primarily a critical engineering and clinical comparison to a bone graft used in a prospective, multi-center, non-randomized, FDA and IRB approved performance goal clinical investigation.

Information NOT present explicitly in the document:

• Specific quantifications of acceptance criteria.
• A table of acceptance criteria and reported device performance with numerical values.
• Sample sizes used for the test set (e.g., number of patients/data points in the clinical investigation for comparison).
• Data provenance (country of origin, retrospective/prospective for the comparison study). While it mentions a "prospective" clinical investigation for the reference bone graft, it doesn't specify if the comparison itself involved new prospective data or a retrospective analysis of the existing investigation's data.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• MRMC comparative effectiveness study details (effect size, human reader improvement). This type of study is more common for diagnostic imaging AI than for interbody fusion systems.
• Standalone algorithm performance (algorithm only without human-in-the-loop). This is a physical device, so "standalone algorithm performance" is not applicable in the typical AI/software sense.
• Type of ground truth used (pathology, outcomes data, etc.) beyond "clinical data" and "performance goal clinical investigation."
• Sample size for the training set. There's no mention of a "training set" in the context of an AI/machine learning model. This submission is for a physical medical device.
• How the ground truth for the training set was established. (Not applicable for this type of device submission).

Given these limitations, here is the best possible answer based only on the provided text, heavily inferring the "acceptance criteria" based on the substantial equivalence claims:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and data provenance:
* Sample Size: Not specified in the given text.
* Data Provenance: The clinical data for comparison comes from a "prospective, multi-center, non-randomized, FDA and IRB approved performance goal clinical investigation" involving a reference bone graft. The country of origin is not specified but it's an FDA-approved study, implying it was likely conducted in the US or under FDA oversight for data acceptability.

3. Number of experts used to establish the ground truth for the test set and their qualifications:
* Not specified. The clinical investigation mentioned for comparison would have medical professionals involved, but the text does not detail the "ground truth" establishment process by experts in the context of this submission.

4. Adjudication method for the test set:
* Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
* No, an MRMC study is not mentioned. This type of study is typically for evaluating diagnostic imaging systems where human readers interpret medical images. This submission is for a physical interbody fusion system.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* No, this concept is not applicable. The device is a physical medical implant, not an AI algorithm.

7. The type of ground truth used:
* The term "ground truth" is not explicitly used in the context of a dataset for algorithmic evaluation. However, for the clinical performance comparison, the "performance goal clinical investigation" likely established clinical outcomes (e.g., fusion rates, pain reduction, adverse events) as the de facto "truth" against which the subject device's performance (via comparison to a reference bone graft) was evaluated.

8. The sample size for the training set:
* Not applicable. This submission is for a physical medical device, not an AI/machine learning model that would require 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 model.

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The OptiMesh Multiplanar Expandable Interbody Fusion System is indicated for use as an adjunct to fusion in an intervertebral body fusion at one level in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, physical examination, and radios. Eligible patients shall have undergone six (6) months of conservative (non-operative) care. The OptiMesh device with compatible allograft is intended for use with supplemental posterior fixation systems intended for use in the lumbar spine.

The OptiMesh Multiplanar Expandable Interbody Fusion System is an intervertebral body graft containment device that is a non-rigid, implanted spinal device designed to contain bone graft within its internal cavity. The device is inserted into the intervertebral body space of the spine and is intended as an adjunct to intervertebral body fusion.

The OptiMesh Lordotic device incorporates an asymmetrical dual chamber mesh with a larger chamber in the anterior portion of the disc space than in the posterior. Due to the asymmetry of the two mesh chambers when filled, the implant is designed to result in a lordotic shape.

The provided document is a 510(k) summary for the OptiMesh Multiplanar Expandable Interbody Fusion System. This document does not describe a study involving an AI/CADe device, human readers, or a test set with ground truth established by experts.

Instead, this document describes a medical device (an intervertebral body fusion system) and its mechanical and design properties. The non-clinical testing performed focuses on benchtop performance ASTM testing and risk assessment to demonstrate equivalence to a predicate device.

Therefore, I cannot provide the requested information, such as acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, or adjudication methods, as these concepts are not applicable to the information presented in this 510(k) summary.

In summary, the provided document does not contain information about an AI/CADe device study to fulfill the prompt's requirements.

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Spineology Navigation Instruments are indicated for use during the preparation and placement of:

• Spineology's Fortress™, Threshold™, Threshold™ V2, and Palisade™ pedicle screws .
• Spineology's OptiMesh® Portal Assembly .

during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous orthopedic procedures.

These instruments are designed for use with the Medtronic StealthStation® Spine System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to images of the anatomy.

Spineology Navigation Instruments are non-sterile, reusable surgical instruments that are manufactured from stainless steel and operated manually.

Spineology Navigation Instruments for Pedicular Fixation include Awls, Bone Taps, Drills, and Screwdrivers. The navigable instruments are equipped with a dimensional feature that allows connection to Medtronic's NavLock Trackers. A Navigation Adapter is also available with dimensional features that allows the same instruments to Medtronic's SureTrak" II Universal Trackers. These instruments are compatible with Spineology's Fortress", Threshold" Threshold™ V2, and Palisade™ Pedicular Fixation Systems and Medtronic's StealthStation® S7 (v2.1.0) and S8 (v1.0.0) Spine System.

Spineology Navigation Instruments for Portal Placement include a Dilator, Portal, Tightener, Wrench, and a Portal Surrogate. The navigable instruments are equipped with dimensional features that allow connection to Medtronic's SureTrak II Universal Trackers. These instruments are compatible with Spineology's OptiMesh Expandable Interbody Fusion System for Access Portal Placement and Medtronic's StealthStation® S8 (v1.2.0) Spine System.

Spineology Navigation Instruments are intended to be used during the preparation and placement of spinal implants in optically navigated procedures.

This document (K213876) is a 510(k) premarket notification for Spineology Navigation Instruments. While it describes non-clinical testing performed to establish substantial equivalence to a predicate device, it does not detail a clinical study with an AI component or the specific acceptance criteria and performance data for an AI-powered device.

The document discusses "Spineology Navigation Instruments" which are physical surgical tools used for navigation during spinal surgery. The testing described (mating, registration, accuracy) relates to the mechanical and optical tracking performance of these instruments when used with Medtronic's StealthStation system, not the performance of an AI algorithm.

Therefore, I cannot extract the information required to answer your prompt because the provided input does not describe an AI/ML-based medical device.

**To answer your prompt, I would need a document describing the clearance/approval of an AI/ML device, ideally one that includes: **

• Specific performance metrics (e.g., sensitivity, specificity, AUC) for the AI model.
• Details about the datasets used (training and test sets, including provenance and size).
• Information on ground truth establishment (expert review, pathology, etc.).
• If applicable, details of MRMC studies or human-in-the-loop performance.

Without such information, any attempt to answer would be speculative and not based on the provided document.

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The Duo™ Expandable Interbody Fusion System is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to L5 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Duo device is designed for use with autograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

The Duo Expandable Interbody Fusion System is an intervertebral implant designed to provide mechanical support of the intradiscal space as an adjunct to fusion. The device is made of PEEK-OPTIMA® LT-1, titanium alloy, polyethylene terephthalate (PET), and tantalum or OsteoSync™ titanium, titanium alloy, and PET. The Duo implant is available in varying lengths, widths, heights, lordotic angles and is provided sterile. The implant is designed with a porous central cavity for graft containment, a rounded nose to aid in implant insertion, and rigid teeth to resist migration.

This document (K210155) is a 510(k) premarket notification for a medical device called the "Duo™ Expandable Interbody Fusion System," specifically a line extension of implants and implant trials. It describes the device, its intended use, and non-clinical testing performed to demonstrate substantial equivalence to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria, device performance results against those criteria, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or multi-reader multi-case studies generally associated with AI/ML-based medical devices or diagnostic tools.

The document primarily focuses on demonstrating mechanical and performance equivalence through benchtop ASTM testing for an intervertebral body fusion device, which is a physical implant, not a software or AI/ML diagnostic tool. Therefore, the requested information about AI/ML performance metrics, expert reviews, and data provenance typical for software validation studies is not applicable to this submission.

Based on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria for an AI/ML device, as this device is a physical implant and the testing described is related to its mechanical and material properties.

If there's an assumption that this is an AI/ML device based on the prompt structure, that assumption is incorrect when applied to the provided content. The document describes a traditional medical device submission for a spinal implant.

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The Spineology Interbody Fusion System (SIFS) is indicated for use as an adjunct to fusion in an intervertebral body fusion at one level in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic studies. Eligible patients shall have undergone six (6) months of conservative (non-operative) care. SIFS with compatible allograft and autograft is intended for use with supplemental posterior fixation systems intended for use in the lumbar spine.

The Spineology Interbody Fusion System (SIFS) is a lumber intervertebral body fusion device comprised of a PET (polyethylene terephthalate) mesh bag designed to contain compatible allograft and autograft as an adjunct to fusion for the treatment of degenerative disc disease. The device is placed into the prepared intervertebral disc space and then is packed with bone graft. The resulting SIFS implant is used with posterior supplemental fixation systems forming the completed SIFS construct.

The provided text describes the acceptance criteria and the study that proves the Spineology Interbody Fusion System (SIFS) meets these criteria. It does not describe an AI/ML device but rather a medical implant. Therefore, the questions related to AI/ML specific aspects (e.g., test set ground truth, MRMC study, standalone algorithm performance, training set) are not applicable to this document. The focus below will be on the information provided regarding the device's clinical and non-clinical performance and acceptance criteria.

Acceptance Criteria and Device Performance for Spineology Interbody Fusion System

This document outlines the evaluation of the Spineology Interbody Fusion System (SIFS), an intervertebral body graft containment device, for De Novo classification. The acceptance criteria are derived from both non-clinical/bench testing and a clinical study designed to demonstrate the device's safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are established through a combination of non-clinical performance benchmarks (where applicable) and primary clinical endpoints.

2. Sample Sizes and Data Provenance

• Clinical Study Sample Size:
  • Test Set (Clinical Study Cohort): 102 subjects were enrolled and treated across 10 clinical sites.
  • Follow-up at 24 Months: 96 subjects provided complete data in-window (95.0% follow-up rate). Fusion assessment was conducted on 97 subjects (considering 12- and 24-month assessments).
• Data Provenance: The data is from a 24-month, prospective, single-arm, multi-center clinical study (G140140). The location of the clinical sites is not specified beyond "multi-center," but typically for FDA De Novo, such studies are conducted in the US or with data acceptable to the FDA. The study was based on a previously conducted prospective, randomized, multi-center study (G030106) for the same device. Given the context of a US FDA De Novo submission, it is highly likely that the centers were primarily in the United States, and the data is prospective.

3. Number of Experts and Qualifications for Ground Truth (Clinical Study)

• Ground Truth for Fusion: "Fusion was assessed by independent radiologists at the 12-month time point, and again at 24 months for those subjects who had not fused."
• Number of Experts: Not explicitly stated how many independent radiologists assessed each case, nor is their specific qualification (e.g., years of experience) mentioned. However, "independent radiologists" implies qualified medical professionals specialized in interpreting spinal imaging.

4. Adjudication Method (Clinical Study Test Set)

• The document implies that "independent radiologists" assessed fusion, but it does not specify an adjudication method (e.g., 2+1, 3+1 consensus process) for discrepancies between readers if multiple readers were used per case. It states fusion was "assessed by independent radiologists," which could mean one radiologist per case or multiple without a defined consensus process in the provided text.

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

• No MRMC study was conducted. This was a single-arm study evaluating the device's performance, not a comparative effectiveness study involving human readers with/without AI assistance. The device is an implant, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance

• Not Applicable. This is a medical implant, not an algorithm. Therefore, "standalone (i.e., algorithm only without human-in-the-loop performance)" is not relevant.

7. Type of Ground Truth Used (Clinical Study)

• Combination of Clinical Outcome Measures and Radiographic Assessment:
  • Pain and Function: Ground truth derived from patient-reported outcomes (Visual Analog Scale for pain, Oswestry Disability Index for function).
  • Fusion: Ground truth established through "bridging bone demonstrated on CT Scan," assessed by independent radiologists. This is a radiographic ground truth.
  • Safety: Ground truth based on the occurrence and classification of adverse events, assessed by a Clinical Events Committee (CEC). This involves medical record review and expert medical judgment.

8. Sample Size for the Training Set

• Not Applicable. This is a human-implanted medical device, not an AI/ML algorithm. There is no concept of a "training set" in the context of device development as described here. The clinical study served as the primary evidence to demonstrate safety and effectiveness for regulatory approval.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant. The clinical study's data, as described in point 7, formed the basis of the evidence for the device's performance.

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The standard and oblique Rampart One devices are integrated intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months non-operative treatment. The standard and oblique Rampart One devices are designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

The standard Rampart One devices with 8° and 12° lordotic angles may be used with or without supplemental fixation using a fixation system cleared by FDA for use in the lumbar spine. When used without supplemental fration, the standard Rampart One devices with 8° and 12° lordotic angles must be used with four (4) screws. The standard Rampart One devices with 16° and 20° lordotic angles must be used with four (4) screws and a supplemental fixation system cleared by FDA for use in the lumbar spine.

The oblique Rampart One devices must be used with two (2) screws and a supplemental fixation system cleared by FDA for use in the lumbar spine.

Rampart One implants are intervertebral body fusion devices for use with bone graft in the intervertebral disc space to stabilize spinal segments as an adjunct to fusion. These devices are manufactured from PEEK-OPTIMA HA Enhanced (spacer), titanium alloy (face plate), and tantalum (radiopaque markers) materials. Rampart One devices incorporate integrated fixation in the form of titanium alloy screws. Rampart One devices are provided in standard and oblique configurations. The standard device accommodates four screws and the oblique device accommodates two screws. In each device, the screws are inserted through the anteriorly-located face plate into the adjacent vertebral bodies. Rampart One devices are provided in various heights and lordotic angles and contain a hollow core to receive autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Placement is achieved with an insertion instrument that allows for manipulation of the implant in the intervertebral disc space.

The provided text is a 510(k) Premarket Notification from the FDA regarding the Spineology Rampart One Lumbar Interbody Fusion System. This documentation is for a medical device (lumbar interbody fusion system), not an AI software/device. Therefore, the content does not discuss acceptance criteria or studies related to AI device performance.

The document details the device's classification, indications for use, comparison to predicate devices, and non-clinical (benchtop mechanical) testing conducted to demonstrate substantial equivalence. It does not contain information about clinical studies with human subjects, ground truth establishment, expert adjudication, or MRMC studies that would be relevant for an AI/software device.

As such, I cannot extract the information required by your prompt, as it is designed for AI/software device evaluation, and the provided document pertains to a physical medical implant.

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The standard and oblique Rampart One devices are integrated intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months non-operative treatment. The standard and oblique Rampart One devices are designed for use with autograft and/or allograft comprised of carcellous and/or corticocancellous bone graft.

The standard Rampart One device may be used with or without supplemental fixation systems cleared by FDA for use in the lumbar spine. When used without supplemental fixation, the standard Rampart One device must be used with four (4) screws.

The oblique Rampart One device must be used with two (2) screws and with supplemental fixation systems cleared by FDA for use in the lumbar spine.

Rampart One implants are intervertebral body fusion devices for use with bone graft in the intervertebral disc space to stabilize spinal segments as an adjunct to fusion. These devices are manufactured from PEEK-OPTIMA HA Enhanced (spacer), titanium alloy (face plate), and tantalum (radiopaque markers) materials. Rampart One devices incorporate integrated fixation in the form of titanium alloy screws. Rampart One devices are provided in standard and oblique configurations. The standard device accommodates four screws and the oblique device accommodates two screws. In each device, the screws are inserted through the anteriorly-located face plate into the adjacent vertebral bodies. Rampart One devices are provided in various heights and lordotic angles and contain a hollow core to receive autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Placement is achieved with an insertion instrument that allows for manipulation of the implant in the intervertebral disc space.

This document, K191091, is a 510(k) premarket notification for the Rampart™ One Lumbar Interbody Fusion System, specifically concerning the addition of a new Implant Inserter and modified Inserter Guides. It asserts substantial equivalence to a predicate device.

Crucially, this submission does not describe an AI/ML-driven device or diagnostic software that would typically have acceptance criteria related to classification metrics (e.g., sensitivity, specificity, AUC). Instead, it pertains to a physical medical device (intervertebral body fusion system) and its associated surgical instruments. The "acceptance criteria" and "study" described in the document are engineering and non-clinical performance tests for these physical instruments, not clinical performance metrics for an AI algorithm.

Therefore, many of the requested items in the prompt (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this type of device submission.

However, I can extract the relevant "acceptance criteria" and "proof" as described for this mechanical device:

Acceptance Criteria and Study for the Rampart™ One Lumbar Interbody Fusion System (Focus on Inserter and Guides)

Device Under Review: New Implant Inserter and modified Inserter Guides for the Rampart™ One Lumbar Interbody Fusion System.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Engineering Focus):

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

• Not Applicable in the context of clinical AI/ML studies. This submission refers to "design verification testing" and "simulated use" for physical instruments. The sample size would refer to the number of tests/cycles performed on the instruments, which is not detailed in this summary.
• Data Provenance: Not specified as clinical data. It refers to internal engineering tests.

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

• Not Applicable. Ground truth, in the AI/ML sense, is not relevant here. The "ground truth" for a mechanical device is simply its physical performance against engineering specifications, likely established by internal engineers and quality control personnel.

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

• Not Applicable. Adjudication methods are for human interpretation of clinical data, not for engineering tests of physical instruments.

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-assisted diagnostic device.

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.):

• Not Applicable in the AI/ML sense. The "ground truth" is the engineering specifications and functional requirements of the device's mechanical performance.

8. The sample size for the training set:

• Not Applicable. No training set for an AI/ML model is involved.

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

• Not Applicable. No training set for an AI/ML model is involved.

Summary of the Study Proving Acceptance (for this specific device and its modifications):

The "study" cited in this 510(k) summary is comprised of non-clinical engineering design verification tests and a risk assessment.

• Methodology: The submission states "Design verification testing was conducted to support the new Implant Inserter and modified Inserter Guides confirming function and performance in simulated use." This would typically involve mechanical tests, durability tests, dimensional checks, and functional tests to ensure the instruments properly hold, insert, and release the interbody fusion device.
• Proof: The success of these tests, combined with a review of design changes and a risk assessment, led the manufacturer (Spineology) to conclude that the modified components maintained the same intended use, technological characteristics, principle of operation, and risk profile as the predicate device. This forms the basis for their claim of substantial equivalence, which is the primary "acceptance criterion" for a 510(k) submission of this type. The FDA's clearance letter indicates their agreement with this conclusion.

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The Duo™ Lumbar Interbody Fusion Device is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to L5 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Duo device is designed for use with autograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

The Duo Lumbar Interbody Fusion Device is an intervertebral implant designed to provide mechanical support of the intradiscal space as an adjunct to fusion. The device is made of PEEK-OPTIMA® LT-1, titanium alloy, polyethylene terephthalate (PET), and tantalum. The Duo implant is available in varying lengths and heights with two lordotic configurations and is provided sterile. The device is designed with a porous central cavity for graft containment, a rounded nose to aid implant insertion, and ridged teeth to resist migration.

The provided text is a 510(k) Summary for a medical device (Duo Lumbar Interbody Fusion Device) and does not contain information about acceptance criteria, study methodologies, or performance metrics typically associated with AI/ML-based medical devices. This document is related to a traditional medical device and focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use, rather than algorithmic performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving a device meets them for an AI/ML product from the given text. The provided document concerns a spinal implant and its surgical instruments, not an AI/ML device.

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The Duo™ Lumbar Interbody Fusion Device is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to L5 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and six months of non-operative treatment. The Duo device is designed for use with autograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

The Duo Lumbar Interbody Fusion Device is an intervertebral implant designed to provide mechanical support of the intradiscal space as an adjunct to fusion. The device is made of PEEK-OPTIMA® LT-1, titanium alloy, polyethylene terephthalate (PET), and tantalum. The Duo implant is available in varying lengths and heights with three lordotic configurations and is provided sterile. The device is designed with a porous central cavity for graft containment, a rounded nose to aid implant insertion, and ridged teeth to resist migration.

This document is an FDA 510(k) clearance letter for a medical device called the "Duo™ Lumbar Interbody Fusion Device." It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically seen for AI/ML-based medical devices or diagnostics.

The document pertains to a physical intervertebral body fusion device and focuses on establishing its substantial equivalence to a previously cleared predicate device. The "Non-Clinical Testing" section mentions mechanical testing (static and dynamic axial compression, compression-shear, subsidence, and expulsion) conducted on the primary predicate device and "engineering analysis and verification testing (expulsion testing)" that supported this implant line extension. This suggests the testing was for the physical properties and performance of the implant, not about a software device meeting specific performance metrics based on data.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving a device meets those criteria, as this document does not describe such a study or performance metrics relevant to AI/ML or diagnostic devices.

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Spineology Navigation Instruments are intended to be used during the preparation and placement of Spineology's Fortress, Threshold V2, and Palisade pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitalized landmarks of the anatomy.

Spineology Navigation Instruments are non-sterile, reusable instruments; including awls, bone taps, drills, and screwdrivers that are operated manually. These instruments are manufactured from stainless steel in accordance with ASTM F899 and are intended to be used within the context and limitations of the indications for use for Spineology's FDA-cleared Fortress™, Threshold™, Threshold™ V2, and Palisade™ Pedicular Fixation Systems and the Medtronic Synergy Experience StealthStation® System S7 (v2.1.0).

The provided text describes a 510(k) premarket notification for Spineology Navigation Instruments, specifically concerning the addition of an Adapter to an existing cleared instrument set.

Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

This document does NOT describe the performance of an AI-powered device or a study with specific performance metrics (like sensitivity, specificity, AUC, etc.) typically associated with AI/ML systems. Instead, it describes a medical device (surgical instruments) cleared under the 510(k) pathway, where the primary demonstration of safety and effectiveness relies on "substantial equivalence" to a predicate device.

Therefore, many of the requested items (e.g., sample size for test set, expert ground truth, MRMC study, standalone performance, training set details) are not applicable in the context of this specific regulatory submission. The "study" described is primarily non-clinical testing focused on design verification and risk assessment for the adapter, rather than clinical performance of an AI algorithm.

Here's a breakdown based on the provided text, indicating where information is not applicable (N/A) for this type of device clearance:

Acceptance Criteria and Device Performance (as demonstrated for this type of device):

The "acceptance criteria" for a 510(k) submission for a non-AI medical device like this are primarily demonstrating substantial equivalence to a legally marketed predicate device in terms of intended use, technological characteristics, and safety/effectiveness.

Detailed Study Information (largely N/A for this 510(k) submission):

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

   • N/A. This clearance is for surgical instruments, not an AI model evaluated on a "test set" of patient data. The "testing" involved non-clinical design verification (e.g., instrument mating, performance confirmation) for the adapter. The exact sample size for these non-clinical tests is not specified in the summary, but it would typically involve a sufficient number of units to demonstrate design integrity, not a patient data sample.
   • Data Provenance: N/A. No patient data provenance specified as clinical data was not required.

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

   • N/A. Ground truth establishment by experts for a test set of patient data is not relevant to this submission, as no clinical study evaluating interpretation or diagnosis was performed.

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

   • N/A. Not applicable, as there was no test set requiring expert adjudication.

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

   • N/A. This device is a set of surgical instruments, not an AI or imaging diagnostic aid. No MRMC study was performed.

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

   • N/A. Not applicable, as this is not an algorithm.

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

   • N/A. No ground truth from patient data was established or used, as no clinical performance study was conducted. The "ground truth" for the non-clinical testing was based on design specifications and engineering requirements.

7. The sample size for the training set:

   • N/A. This device does not involve a "training set" in the context of machine learning or artificial intelligence.

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

   • N/A. Not applicable.

Summary of the "Study" (Non-Clinical Testing for Substantial Equivalence):

The "study" conducted for this 510(k) submission was a series of non-clinical design verification activities focused on the newly added Adapter to the Spineology Navigation Instruments.

• Purpose: To demonstrate that the design outputs of the subject Spineology Navigation Instruments (with the adapter) met the design input requirements and that the adapter did not introduce new issues of safety or effectiveness.
• Methods:
  • Assessment of instrument mating (how the adapter fits with other instruments).
  • Confirmation that the performance of Spineology Navigation Instruments is unaffected by the use of the Adapter.
  • A risk assessment to confirm no new safety or effectiveness issues.
• Conclusion: Spineology demonstrated substantial equivalence to the predicate device, confirming the same intended use and that any differences in technological characteristics (specifically the addition of the adapter) did not raise new issues of safety and effectiveness.
• Clinical Testing: Explicitly stated as "Clinical testing was not performed or required to establish the substantial equivalence of Spineology Navigation Instruments to the predicate device."

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