Search Results

The Stable-C Interbody System is an anterior cervical interbody fusion system. The Stable-C Interbody System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Stable-C Interbody System is to be used with supplemental fixation cleared for use in the cervical spine. The system is intended to be used with autogenous or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The system is to be used in patients who have had six weeks of non-operative treatment.

The Stable-C Interbody System is an anterior cervical interbody device comprised of a cage (lordotic angles of 0 , 6°, and 12°) made from Ti-6Al-4V per ASTM F3001 and two fixation anchors made from Ti-6-Al-4V ELI per ASTM F136. The device is offered in a variety of sizes to accommodate patient anatomy. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.

The provided text is a 510(k) premarket notification FDA letter for a medical device called the "Stable-C Interbody System." This document primarily focuses on demonstrating substantial equivalence to pre-existing, legally marketed devices.

It does NOT describe a study involving an AI/Medical Device that uses machine learning, nor does it provide details about acceptance criteria and performance data in the context of an algorithm's accuracy or effectiveness.

The "Performance Data" section in the document refers to mechanical testing of the physical implant device to prove its structural integrity and safety, not the performance of an AI algorithm.

Therefore, I cannot extract the requested information (acceptance criteria, details of a study proving algorithm performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) from the provided text because it is not relevant to an AI/ML medical device.

To answer your request, I would need a document describing the validation and performance of an AI/ML-based medical device.

Ask a specific question about this device

The Captiva Spine TirboLOX-C™ Cervical IBFD is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one-disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Captiva Spine TirboLOX-C™ Cervical IBFD is used to facilitate fusion in the cervical spine and is placed via an anterior approach at the C3 to C7 disc levels with autograft bone and/or allogenic bone graft composed of cancellous bone graft. Patients should have at least six weeks of non-operative to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.

The Captiva Spine, Inc. TirboLOX-CTM Cervical IBFD is made from a titanium alloy and is created using 3D printing technologies. The implants are available in various footprints to accommodate a variety of patient anatomies and is provided sterile. The device has a window in the center of device to accept autogenous bone and/or allogenic bone graft. The implant is available in the following configurations: lordotic, anatomically correct and parallel

This is a 510(k) premarket notification for a medical device, not a study evaluating an AI algorithm. Therefore, the requested information about acceptance criteria, study data, ground truth, and AI performance metrics is not applicable here.

The document describes the Captiva Spine TirboLOX-C™ Cervical IBFD, an intervertebral body fusion device. It focuses on demonstrating the device's substantial equivalence to legally marketed predicate devices through a series of non-clinical mechanical tests.

Here's a breakdown of the relevant information present in the document:

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

The document does not provide a table with specific quantitative acceptance criteria alongside performance data. Instead, it states that "The results of this non-clinical testing show that the strength of the TirboLOX-C™ Cervical IBFD is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." This implies that the device's performance in the listed tests met predetermined criteria acceptable for demonstrating equivalence to the predicate devices, but the exact numerical thresholds are not disclosed.

Device Performance (as reported):

• ASTM F2077-14: Static Axial Compression, Static Shear, Static Torsion, Dynamic Axial Compression, Dynamic Shear, Dynamic Torsion
• ASTM 2267-04: Static Subsidence
• ASTM F1978-12: Abrasion Resistance
• ASTM F1877-16: Wear Debris
• Additionally: Expulsion testing was performed.

The reported performance is qualitative: the device's strength is sufficient for its intended use and substantially equivalent to predicate devices. Specific quantitative results are not provided in this summary document.

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

This information is not provided because it's a mechanical device testing, not a clinical study on human data. The "sample" would refer to the number of devices tested, which is not specified. Data provenance like country of origin or retrospective/prospective is not relevant for this type of non-clinical, in-vitro testing.

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 as typically defined for AI/medical imaging studies (e.g., expert consensus on diagnoses) is not relevant for mechanical device testing. The "ground truth" for these tests are the established standards and specifications of the ASTM methods.

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

Not applicable. Adjudication methods are used in clinical trials or expert reviews to resolve disagreements in interpretations, which is not part of mechanical testing.

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

Not applicable. This is a spinal implant, not an AI-powered diagnostic device. No human readers or AI assistance were involved in the testing described in this document.

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

Not applicable. This device is an implant, not an algorithm.

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

The "ground truth" for the mechanical performance tests are the established ASTM (American Society for Testing and Materials) standards and test methodologies. These standards define the parameters, procedures, and conditions for evaluating the mechanical properties of medical implants to ensure their safety and effectiveness. The goal is to show the device performs within acceptable limits mandated by these standards and comparably to predicate devices.

8. The sample size for the training set

Not applicable. There is no AI algorithm being described, so there is no training set.

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

Not applicable, as there is no training set.

Ask a specific question about this device

The Genesys Spine AIS-C Cervical Anchored Interbody System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one-disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The system is designed for use with supplemental fixation (i.e. cleared cervical plating system) and with autograft to facilitate fusion. These patients should have had six weeks of non-operative treatment.

The Genesys Spine AIS-C Cervical Anchored Interbody System includes PEEK interbodies and titanium interbodies, which utilize an integrated titanium alloy locking mechanism. Both PEEK interbodies and titanium interbodies are to be anchored to patient anatomy via two (2) titanium allov bone anchors. The Cervical Anchored Interbody System (AIS-C) was designed to provide additional biomechanical strength to traditional ACDF procedures through integrated fixation combined with supplemental fixation.

The provided text describes a 510(k) premarket notification for a medical device, the Genesys Spine AIS-C Cervical Anchored Interbody System. This document focuses on demonstrating substantial equivalence to predicate devices primarily through non-clinical (mechanical) testing. It does not contain information about a study involving human-in-the-loop performance, AI assistance, or the establishment of ground truth by medical experts for a diagnostic or AI-powered device. Therefore, many of the requested items (e.g., sample size for test/training sets, expert qualifications, MRMC studies, standalone AI performance) are not applicable or cannot be extracted from this document.

However, I can extract information related to the acceptance criteria and the (mechanical) study that proves the device meets those criteria.

Here's a breakdown of the available information:

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

The acceptance criterion for the mechanical tests was set as follows:

2. Sample sized 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 as a numerical sample size. The document mentions "all possible configurations of the AIS-C System constructs were analyzed in order to determine the worst case to be used for testing." This implies a selection of specific configurations for mechanical testing rather than a statistical sample size in the context of human data.
• Data Provenance: The data is from non-clinical mechanical testing, not human or patient data. Therefore, country of origin or retrospective/prospective classification is not applicable in the typical sense. The testing was conducted to U.S. standards (ASTM).

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 document describes mechanical testing of a medical implant, not a diagnostic device or AI system that requires expert-established ground truth from medical images or patient data. The "ground truth" here is the physical performance against established industry standards and predicate device performance.

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

• Not Applicable. Pertains to human review of data, not mechanical testing.

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

• No. This was not an MRMC study and did not involve human readers or AI assistance.

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

• No. This device is a physical implant, not an algorithm.

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

• The "ground truth" for this device's performance is objective mechanical testing per established ASTM standards (F2077-11 for static and dynamic axial compression, compressive-shear, and torsion; F2267-04 for static subsidence; and ASTM draft standard F-04.25.02.02 for expulsion testing). The "truth" is whether the device meets or exceeds the mechanical performance of predicate devices.

8. The sample size for the training set:

• Not Applicable. This is not an AI or machine learning device.

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

• Not Applicable. This is not an AI or machine learning device.

Ask a specific question about this device

SAGICO IBF System - ARIA Lumbar implants are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

SAGICO IBF System - ARIA Lumbar are to be filled with autogenous bone graft material. The SAGICO IBF System -ARIA Lumbar implant is intended to be used with supplemental fixation cleared by the FDA to properly utilize this device.

The SAGICO IBF System - ARION Cervical implant is interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and at least six (6) weeks of non-operative treatment.

The SAGICO IBF System - ARION Cervical implant is to be filled with autogenous bone graft material and placed via open anterior approach. The SAGICO IBF System – ARION Cervical implant must be used with additional internal fixation (e.g. anterior plate or cervical pedicle screws) cleared by the FDA to properly utilize this device.

SAGICO IBF System - ARIA Lumbar implants are interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. SAGICO IBF System - ARIA Lumbar implants are provided in different shapes to accommodate various surgical approaches to the lumbar spine (posterior, transforaminal [posterolateral] or lateral and can expand to the desired height. The SAGICO IBF System - ARIA Lumbar implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The SAGICO IBF System - ARIA Lumbar implants are to be filled with autogenous bone graft material. Protrusions are located on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

SAGICO IBF System - ARION Cervical implants are interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. SAGICO IBF System - ARION Cervical implant is intended to be used between two contiguous levels from C2 to T1 and placed via an open anterior surgical approach. The implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. SAGICO IBF System - ARION Cervical implants are comprised of PEEK Optima LT1 and include large central hollow window to be filled with autogenous bone graft material. SAGICO IBF System - ARION Cervical implants features protrusions located on the top and bottom surfaces of PEEK spacers to engage with superior and inferior endplates of the adjacent vertebrae to resist rotational and expulsion. SAGICO IBF System - ARION Cervical includes internal titanium spin blade offering internal fixation and expansion of 1mm in height allowing low profile insertion. SAGICO IBF System - ARION Cervical implant is intended to be used with FDA cleared supplemental fixation to properly utilize the device.

The SAGICO IBF System ARIA Lumbar and ARION Cervical implants are manufactured from medical Grade PEEK (Polyetheretherketone) OPTIMAT LT I (Invibio"") per ISO 10993-1 USP Class VI, and ASTM F2026, Titanium Alloy per ASTM F136 and Tantalum beads /rods to be Grade IINS R05200, IINS R05400 according to ASTM F560.

The SAGICO IBF System ARIA Lumbar and ARION Cervical implants are intervertebral body fusion devices to help restore integrity to the spine in the cervical and lumbar regions.

Here's a breakdown of the acceptance criteria and study information for the SAGICO IBF System - ARIA Lumbar and ARION Cervical devices, based on the provided document:

This document describes a 510(k) premarket notification for intervertebral body fusion devices, which means the approval process focuses on demonstrating substantial equivalence to already legally marketed devices, rather than establishing a completely new safety and effectiveness profile through extensive clinical trials. Therefore, the "study" referred to is a non-clinical performance study comparing the device to predicates, not a clinical trial with human subjects.

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: For a 510(k), explicit numerical acceptance criteria for each test are often not provided in the summary document but are implicitly understood to be meeting or exceeding the performance of the chosen predicate devices according to recognized standards. The "reported device performance" is essentially that the device performed substantially equivalently to the predicates in these tests.

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

• Sample Size: The document does not specify exact sample sizes for the non-clinical tests (e.g., how many devices were tested for compression, shear, etc.). It refers to "non-clinical performance data testing."
• Data Provenance: This is a non-clinical, in-vitro study. Therefore, there is no country of origin for patient data. The data is generated from laboratory testing of the devices.

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

• This question is not applicable in the context of this 510(k) submission. "Ground truth" usually refers to clinical diagnoses or outcomes established by medical experts for a diagnostic or AI-driven system. Here, the "truth" is established by adherence to engineering and biocompatibility standards.

4. Adjudication Method for the Test Set

• Not applicable. This is a non-clinical engineering study, not a clinical study requiring adjudication of expert opinions.

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. This is a mechanical intervertebral body fusion device, not a diagnostic or AI-driven imaging interpretation system. MRMC studies are not relevant here.

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

• Not applicable. This is a physical implant device, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for these types of devices is established by engineering standards and material specifications. The device's performance is compared against the requirements outlined in standards like ASTM F2077, F2267-04, F04.25.02.02, and material standards (ISO 10993-1, ASTM F2026, F136, F560). The "truth" is that the device meets these established performance and material safety benchmarks, demonstrating substantial equivalence to predicate devices that also meet these benchmarks.

8. The Sample Size for the Training Set

• Not applicable. There is no concept of a "training set" for a physical medical implant device in this context. This is not an AI/machine learning application.

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

• Not applicable, as there is no training set for a physical implant device.

Summary of the Study:

The study described is a non-clinical performance evaluation focusing on the mechanical and material characteristics of the SAGICO IBF System - ARIA Lumbar and ARION Cervical devices. The goal was to demonstrate substantial equivalence to legally marketed predicate devices, a requirement for 510(k) clearance by the FDA. The testing included:

• Mechanical Testing: According to ASTM F2077 (Static and Dynamic Compression, Compression Shear, Torsion) and ASTM F2267-04 (Subsidence), and ASTM F04.25.02.02 (Static Push-out Test).
• Material Biocompatibility: Assessed by the use of medical-grade materials (PEEK Optima LT1, Titanium Alloy, Tantalum beads/rods) that comply with established international and ASTM standards (ISO 10993-1 USP Class VI, ASTM F2026, ASTM F136, ASTM F560).

The conclusion of this non-clinical testing was that the SAGICO IBF System devices demonstrated performance substantially equivalent to legally marketed predicate devices, thus supporting their clearance for market.

Ask a specific question about this device

The Foundation™ 3D Interbody Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Foundation™ Cervical implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autograft bone. Foundation™ 3D Interbody implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Foundation™ 3D Interbody Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Foundation™ implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Foundation™ 3D Interbody Cervical Series Interbody System is an additively manufactured implant comprising of cervical interbody spacers. They are designed to provide mechanical support to the cervical spine while arthrodesis occurs. The cervical line has a partially porous construction and an open architecture with a large variety of footprints and lordosis angles to help optimize implant fit.

The Foundation™ 3D Interbody Lumbar Series Interbody System is an additively manufactured implant comprising of lumbar interbody spacers. They are designed to provide mechanical support to the lumbar spine while arthrodesis occurs. The lumbar lines feature a wide variety of lordosis and footprint options with fully porous architectures and varying pore sizes to offer increased room for bone growth with mechanical stability.

The Foundation™ 3D series of intervertebral body fusion devices are made from the titanium alloy Ti-6AL-4V ELI conforming to the ASTM F-136 specifications.

This document is a marketing clearance (510(k)) for a medical device, specifically an intervertebral body fusion device. It primarily focuses on demonstrating substantial equivalence to previously cleared devices based on mechanical and material testing, rather than clinical performance or AI algorithm performance.

Therefore, the requested information regarding acceptance criteria, study design for AI algorithms, human-in-the-loop studies, multi-reader multi-case studies, and ground truth establishment for AI training/testing cannot be extracted from this document. This document describes engineering performance tests, not clinical or AI performance studies.

Here's what can be extracted related to the device and its testing:

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

The document lists performance tests conducted, but does not provide specific numerical acceptance criteria or the quantitative results of these tests. It only states that the results "show that the strength of the Foundation™ 3D Interbody is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

Regarding the other points, the document does not contain the required information:

• 2. Sample sized used for the test set and the data provenance: Not applicable for mechanical/material testing.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 4. Adjudication method for the test set: Not applicable.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is not an AI/software device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as this refers to physical/mechanical properties, not diagnostic accuracy.
• 8. The sample size for the training set: Not applicable (no AI training involved).
• 9. How the ground truth for the training set was established: Not applicable (no AI training involved).

In summary, this document is a 510(k) clearance for a physical medical implant, not an AI-powered diagnostic device, and therefore does not contain information about AI acceptance criteria, clinical study designs for AI, or ground truth establishment for patient data. The "performance data" section refers to mechanical engineering tests demonstrating the device's physical strength and equivalence to predicate devices, not its diagnostic or clinical efficacy in a patient population aided by an algorithm.

Ask a specific question about this device

A-CIFT™ SoloFuse™ is intended for stand-alone use for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The A-CIFT™ SoloFuseTM system must be used with the internal bone screws for fixation. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one level from the C2-C3 disc to the C7-T1 disc. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

Degenerative Disc Disease is defined as discogenic pain with degeneration of the disc confirmed by a history and radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to the treatment with an intervertebral spacer.

The A-CIFT™ SoloFuse™ consists of a PEEK OPTIMA LT1 spacer with titanium bone screws for intervertebral body fusion. Fixation is achieved by inserting bone screws through the openings in the spacer into the vertebral bodies of the cervical spine. The lordotic and nonlordotic PEEK-OPTIMA® LT1 spacers are provided in heights of 5mm to 12mm with a width of 17mm and depths of 13.5mm and 14mm. The lag and rigid screws are offered in diameters 4.2mm and 4.5mm and lengths of 12mm. The titanium bone screws traverse the PEEK-OPTIMA® LTI interbody device either through the body or a posterior/inferior flange to anchor into the patient's vertebral body, thereby securing the interbody into the final placement location. The cage has endplate teeth for additional fixation, ports for bone graft and an anti-screw backout.

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text describes non-clinical testing on the device itself (mechanical and material tests), not clinical studies involving human patients or data derived from them. Therefore, there is no "test set" in the sense of clinical data or patient samples.

For the mechanical tests, the sample size is not explicitly stated, but it refers to the A-CIFT™ SoloFuse™ device itself undergoing various mechanical tests. The provenance is not explicitly stated as a country of origin for data; however, the testing standards (e.g., ASTM) are international standards often adopted globally. This was not a retrospective or prospective human data 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)

This information is not applicable as the studies described are non-clinical mechanical and material tests of the device, not studies requiring expert interpretation of diagnostic images or clinical outcomes to establish ground truth.

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

This information is not applicable as the studies described are non-clinical mechanical and material tests, which do not involve subjective interpretation or adjudication by multiple experts in the context of clinical ground truth.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a physical medical device (intervertebral fusion device), not an AI-assisted diagnostic or treatment planning tool. Therefore, there is no mention of human readers or AI assistance effect size.

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

No, a standalone algorithm-only performance study was not done. This submission is for a physical medical device, not an algorithm.

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

For the mechanical tests, the "ground truth" is established by the specified ASTM standards and material specifications. The device's performance is compared against the requirements and benchmarks set by these established engineering and material standards, rather than clinical ground truth (like pathology or outcomes data).

8. The sample size for the training set

This information is not applicable as the studies described are non-clinical mechanical and material tests of a physical device, and not machine learning or AI models that require training sets.

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

This information is not applicable since there is no training set for an AI model.

Ask a specific question about this device

The Pro-Link Cervical Spacer System is intended to be used with the screws provided and requires no additional supplementary fixation.

The Pro-Link System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. It is to be used in patients who have had at least six weeks of non-operative treatment. This device is intended to be used with autogenous bone graft.

The PRO-LINK Cervical Spacer System is intended to serve as a stand-alone intervertebral body fusion device. The system is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. The implant is hollow to permit packing with autogenous bone graft to help promote fusion. It includes two pockets to permit placement of titanium bone screws (Ti 6Al-4V ELI) to provide internal fixation while a titanium lock plate (Ti 6Al-4V ELI) prevents screw back out.

The provided document is a 510(k) summary for the Pro-Link Cervical Spacer System, a medical device for spinal fusion. It focuses on demonstrating substantial equivalence to previously cleared devices rather than direct clinical performance studies against specific acceptance criteria. Therefore, several of the requested sections are not applicable or cannot be extracted directly from this type of regulatory submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not contain a table of acceptance criteria or reported device performance in the context of clinical outcomes or diagnostic accuracy. Instead, it demonstrates "substantial equivalence" to predicate devices through technical characteristics and a specific type of performance testing related to the device's physical properties.

Explanation of "Acceptance Criteria" in this context: For a 510(k) submission, "acceptance criteria" are generally met by demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is often done through performance testing (like the mechanical testing mentioned) that shows the new device meets established standards or performs comparably to the predicate, and by showing similar materials, design, and intended use. Specific quantitative clinical performance metrics with pre-defined thresholds (e.g., sensitivity/specificity for a diagnostic device) are typically not included in this type of submission for an intervertebral body fusion device unless a new indication or technology is being introduced that requires clinical trials.

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

• Sample Size for Test Set: Not applicable / Not mentioned. The document describes mechanical testing of the device itself, not a clinical study with a "test set" of patients or data. The testing mentioned (ASTM F2077) would involve a sample of the manufactured devices. The specific number of devices tested is not provided.
• Data Provenance: Not applicable. The "performance data" refers to in-vitro mechanical testing of the device. There is no mention of country of origin for clinical data, as no clinical data from patients is referenced. The testing type is in-vitro, not retrospective or prospective clinical data.

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

Not applicable. This device is an intervertebral body fusion system, not a diagnostic device requiring expert interpretation for ground truth establishment. The "performance data" section focuses on mechanical testing, which would be evaluated by engineers and regulatory bodies based on compliance with standards.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication method is relevant to the mechanical testing described.

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 surgical implant, not an AI-assisted diagnostic or decision support tool that would involve human readers or MRMC studies.

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

Not applicable. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

• For Mechanical Testing: The "ground truth" for the mechanical performance testing lies in the established ASTM standards (ASTM F2077, ASTM F2026, ASTM F560, ASTM F136). The device's performance is compared against these engineering standards and to the performance of predicate devices to establish substantial equivalence.
• For Substantial Equivalence: The ultimate "ground truth" for a 510(k) is the legal determination by the FDA that the new device is as safe and effective as a predicate device already on the market. This is a regulatory "truth" based on the submitted evidence.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not a machine learning or AI-based device.

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

Not applicable. This device does not involve a training set.

Ask a specific question about this device