Search Results

The InTice™-C Porous Ti Cervical Interbody System is intended for spinal fusion procedures at one level (C2 - T1 inclusive) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autograft comprised of cancellous and/or corticocancellous bone graft. Patients should receive at least six (6) weeks non-operative treatment with the InTice™-C Porous Ti Cervical Interbody System.

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine (i.e. posterior cervical screw and rod systems and anterior cervical plate systems).

The InTice™-C Porous Ti Cervical Interbody System is an intervertebral fusion device, generally box or oval-shaped, and available in a variety of shapes and sizes to accommodate the individual patient anatomy. The implants are made from highly porous commercially pure titanium (CP-TI Grade 2) that complies with ASTM F67. The material is formed into an integrated titanium scaffold, OsteoSync™ Ti (manufactured by Sites Medical), which assists in securing the implant in the intervertebral space. The formed titanium material has a porosity created by a designed hole pattern, and the superior and inferior surfaces of the implant have a tooth pattern to help resist implant dislodgement or expulsion once placed in its desired location. The hollow center of the implant allows the device to be packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The single use implants are provided sterile, and should not be reused under any circumstances.

The system does not contain software/firmware or electrical equipment.

The provided text describes a 510(k) premarket notification for a medical device, the InTice™-C Porous Ti Cervical Interbody System. This type of submission aims to demonstrate that a new device is substantially equivalent to legally marketed predicate devices, rather than proving its safety and effectiveness through clinical trials designed to meet specific acceptance criteria for a novel technology.

Therefore, the document does not contain information about:

• Acceptance criteria in the context of clinical performance metrics for an AI/device (e.g., sensitivity, specificity, accuracy). The "acceptance criteria" here are related to proving substantial equivalence to a predicate device.
• A study that proves the device meets the acceptance criteria as would be done for a new device claiming improved clinical outcomes. Instead, it describes non-clinical testing to demonstrate performance equivalence to predicate devices.
• Sample size for a test set and data provenance: There is no "test set" in the sense of a clinical validation dataset. The "testing" refers to biomechanical and material tests.
• Number of experts and their qualifications, adjudication methods, MRMC studies, standalone performance, or type of ground truth used for a test set: These concepts are relevant to clinical or AI performance validation, which is not the focus of this 510(k) submission.
• Sample size for training set or how ground truth for training set was established: These concepts are relevant for AI/machine learning models which are not part of this device submission.

What the document does describe in terms of "acceptance":

The "acceptance" in this context refers to the FDA's acceptance of the 510(k) premarket notification and the determination of substantial equivalence. The criteria for this acceptance are primarily based on demonstrating that the new device has "substantially equivalent" technological characteristics and performs comparably to legally marketed predicate devices, without introducing new safety or effectiveness concerns.

Here's a breakdown of the relevant information provided in the document, framed against the requested points, highlighting what is not applicable:

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

• Acceptance Criteria (Implicit for 510(k) Substantial Equivalence): The implicit acceptance criteria for this 510(k) submission are that the device's technical characteristics and performance must be "substantially equivalent" to predicate devices and not raise new questions of safety or effectiveness. This is demonstrated through non-clinical testing.
• Reported Device Performance (Non-Clinical):

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

• Not Applicable: This is a 510(k) submission for a physical medical device (interbody system), not an AI algorithm or a clinical study dataset for performance evaluation. The "testing" refers to mechanical and material property testing, not clinical data sets.

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

• Not Applicable: Ground truth establishment by experts is relevant for clinical outcome or diagnostic accuracy studies, particularly for AI or image-based diagnostics. This is a submission for a spinal implant, relying on engineering and material standards for performance assessment relative to predicates.

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

• Not Applicable: Adjudication methods apply to studies involving human interpretation or clinical endpoint assessments, which are not detailed in this 510(k) for a physical implant.

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: MRMC studies are specific to evaluating diagnostic performance, often for AI-assisted image interpretation. This submission is for a physical orthopedic implant.

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

• Not Applicable: This criterion is for AI algorithms. The device described does not contain software/firmware or electrical equipment (Page extract 5).

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

• Not Applicable (in the clinical/AI sense): The "ground truth" for this device's performance is based on established engineering standards (ASTM and other biomechanical properties) and comparison to the known characteristics of predicate devices. There is no clinical "ground truth" established in this document, as it focuses on substantial equivalence through non-clinical means.

8. The sample size for the training set

• Not Applicable: There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable: There is no "training set" for this device.

Ask a specific question about this device

The X-spine Cortical Bone Screw System is intended for posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine for the following indications:

• Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
• Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion
• Spondylolisthesis
• Trauma (i.e. fracture or dislocation)
• Spinal stenosis
• Deformities or curvatures (i.e. scoliosis, kyphosis)
• Spinal tumor
• Pseudoarthrosis, and/or
• Failed previous fusion

The X-spinesw Cortical Bone Screw System consists of pedicle screws, rods, cross connectors, and associated instruments. Various forms and sizes of these implants are available so that adaptations can be made to take into account the pathology and anatomy of an individual patient. The system implant components are manufactured from Ti6Al4V ELI, a titanium based alloy which complies with ASTM F136. Alternatively, rods are also offered manufactured from cobalt chromium alloy which complies with ASTM F1537. The single use only implants are provided non-sterile, and should not be reused under any circumstances.

The system does not contain software/firmware or electrical equipment.

This document is a 510(k) premarket notification for a medical device called the "X-spine Cortical Bone Screw System." It seeks to demonstrate that the new device is substantially equivalent to legally marketed predicate devices, rather than establishing new acceptance criteria or proving effectiveness through a traditional clinical study.

Therefore, many of the requested points regarding acceptance criteria and performance studies are not directly applicable or available in this type of submission. This 510(k) summary focuses on equivalence to existing devices.

Here's an analysis based on the provided text:

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

This document does not present specific acceptance criteria in the typical sense of a target performance metric (e.g., sensitivity, specificity, accuracy) for a diagnostic or therapeutic AI device. Instead, it describes mechanical testing to demonstrate substantial equivalence to predicate devices. The "acceptance criteria" here are implied to be meeting or exceeding the mechanical performance of the predicate device.

2. Sample size 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. The testing described is mechanical, not clinical, and typically involves a specific number of devices or components. Details on the number of samples tested are not included. Data provenance (country, retrospective/prospective) is not relevant for this type of mechanical 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. This is a submission for a spinal implant, not an AI device or a diagnostic tool requiring expert ground truth for a test set. The "ground truth" for mechanical testing is established by standard laboratory procedures and measurements.

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

Not applicable. This is not a 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

Not applicable. This is not an AI device or a diagnostic tool that would involve human readers or an MRMC study.

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 (expert consensus, pathology, outcomes data, etc)

For mechanical testing of devices like this, the "ground truth" is typically defined by standardized physical measurements and engineering specifications, often established by ASTM standards (e.g., ASTM F1717). There is no "expert consensus" or "pathology" in the context of mechanical performance.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model, 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, there is no ground truth for it.

Ask a specific question about this device

The Calix® Lumbar Spinal Implant System is intended for spinal fusion procedures at one or two contiguous levels (L2 – S1 inclusive) in skeletally mature patients with degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the lumbosacral spine. DDD patients may also have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved level(s). These implants are to be packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft, and implanted via an anterior, posterior, and/or transforaminal approach. Patients should receive at least six (6) months of non-operative treatment prior to treatment with a lumbosacral intervertebral fusion device.

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

The X-spine Calix® Lumbar Spinal Implant System is an intervertebral fusion device for use with bone graft, designed for surgical placement between adjacent vertebrae of the lumbar spine as an adjunct to fusion.

The X-spine Calix® Lumbar Spinal Implant System is a generally hollow box or oval shaped device manufactured from Invibio PEEK-Optima™ LT1 per ASTM F2026. The device contains an array of holes located throughout its geometry as well as teeth on the superior and inferior surfaces to help prevent implant dislodgement or expulsion once placed in its desired location. The implants are available with or without a medical grade commercially pure titanium (CP Ti) plasma coating (per ASTM F1580) on the superior and inferior surfaces of the device.

The hollow center of the implant allows the device to be packed with bone graft: autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft,

The single use implants are supplied in several width, height and lordosis options to accommodate variations in patient anatomy and differing pathologies. The devices contain radiographic markers made from tantalum per ASTM F560 to aid in final placement verification. Plasma coated implants are provided clean and sterile. Nonplasma coated implants and instruments are provided non-sterile. All implants are intended for single use only, and should not be reused under any circumstances.

The system does not contain software/firmware.

The provided text describes a 510(k) premarket notification for a medical device (Calix® Lumbar Spinal Implant System), which is a regulatory submission demonstrating substantial equivalence to a legally marketed predicate device. This type of submission primarily relies on non-clinical performance data (mechanical and material testing) to demonstrate that the new device performs as well as or better than the predicate, especially when modifications are made.

The document does not describe an AI/ML-driven device or diagnostic tool that would require a study involving human readers, ground truth establishment through expert consensus (radiologists), or MRMC/standalone performance metrics typical of AI models. Therefore, many of the requested elements (sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this type of device submission.

The acceptance criteria and proof of performance for this particular device (a spinal implant) are based on mechanical and material testing as per established ASTM standards and FDA recommendations for intervertebral body fusion devices.

Here's a breakdown of the relevant information from the provided text, addressing the points where applicable and noting when information is not present or relevant:

Acceptance Criteria and Device Performance (for a spinal implant)

The acceptance criteria for this medical device are primarily based on demonstrating mechanical equivalence and safety to predicate devices, adhering to recognized standards. The "performance" here refers to the physical and functional integrity of the implant, not diagnostic accuracy.

Table of Acceptance Criteria and Reported Device Performance

Detailed Information as per Request (with applicability notes):

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

   • See table above. The acceptance criteria are largely adherence to specified ASTM standards and demonstrating that the modifications (titanium coating, allograft use) do not negatively impact performance compared to the predicate.

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

   • N/A. For this type of device (spinal implant), "sample size" refers to the number of physical devices or material samples tested in a lab, not a population of patients or images. The document does not specify the exact number of implants tested for each mechanical test, which is common for 510(k) summaries where the methodology typically follows established engineering test standards.
   • Data Provenance: The data originates from the manufacturer's (X-spine Systems, Inc.) internal testing, conducted in their facilities or contracted labs. This is not clinical data, so terms like "retrospective" or "prospective" are not applicable.

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. "Ground truth" in the context of this spinal implant device is established through physical mechanical testing and material characterization according to validated engineering standards (ASTM). It does not involve expert clinical assessment or image interpretation for establishing a "ground truth" diagnosis.

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

   • N/A. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in human-reader studies (e.g., in diagnostic imaging). This regulatory submission is for a physical implant, not a diagnostic AI device.

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. An MRMC study is designed to evaluate the performance of diagnostic devices, particularly AI-assisted ones, by comparing human reader performance with and without AI assistance. This submission is for an orthopedic implant and does not involve AI or human readers for diagnosis.

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

   • N/A. This refers to the standalone performance of an AI algorithm. The device is a physical implant, not an algorithm.

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

   • The "ground truth" for this device's performance is based on engineering standards and established physical properties. For example, the acceptable load-bearing capacity, expulsion resistance, and material characteristics determined by industry-standard mechanical testing are the "ground truth" for its functional performance.
   • For the Indications for Use, the "ground truth" for degenerative disc disease (DDD) is defined clinically: "back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies." This is a clinical definition for patient selection, not a ground truth for testing the device itself.

8. The sample size for the training set

   • N/A. There is no "training set" as this is not an AI/ML device.

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

   • N/A. No training set exists for this device.

Summary of Acceptance and Performance:

The Calix® Lumbar Spinal Implant System's acceptance and demonstrated performance hinge on its ability to meet or exceed the performance characteristics of its predicate device, the Calix® Lumbar Spinal Implant System (K131350), and other reference devices. The key elements of its "proof" are:

• Mechanical Testing: Demonstrating compliance with ASTM F2077 (for static/dynamic compression/shear) and ASTM F2267 (for subsidence) and FDA-recommended expulsion testing. The critical finding is that the new titanium plasma coating "does not present a new worst case, and does not impact the performance of the implants."
• Material Characterization: Showing the properties of the new CP Ti plasma coating via ASTM F1877.
• Indications for Use Expansion: Justifying that the addition of allograft use "does not impact the mechanical performance" and "does not introduce new risks," citing that allograft has been cleared for many other spinal implants.
• Substantial Equivalence: Ultimately, the study (mechanical and material testing) served to prove that the modified device is substantially equivalent to legally marketed predicate devices in terms of safety and effectiveness, despite the added coating and expanded graft options.

Ask a specific question about this device

The IRIX-A™ Lumbar Integrated Fusion System is a stand-alone intervertebral body fusion device intended for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1 inclusive). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have had a previous non-fusion spinal surgery at the involved level(s) and may have had up to a Grade I spondylolisthesis or retrolisthesis at the involved level(s). The IRIX-A™ System is intended to be used with autograft and/or allograft comprised of cancellous bone graft material, and is to be used with three titanium alloy screws included as part of the system.

Hyperlordotic implants >20° are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).

The IRIX-A™ Lumbar Integrated Fusion System is a stand-alone intervertebral fusion device to restore biomechanical height and act as an aid in fusion of the lumbar spine in anterior discectomy procedures. The device is generally boxed shaped with teeth on the superior and inferior faces of the device. The IRIX-A™ implant is manufactured from both titanium alloy (Ti6AI4V) in accordance with ASTM F136 and Invibio PEEK Optima LT1 in accordance with ASTM F2026, or from Ti6Al4V titanium alloy alone. The device will be supplied with the option of having the superior and inferior surfaces of the device plasma coated with medical-grade commercially pure titanium (CP Ti) per ASTM F1580.

The device is secured in location through the use of bone screws, also manufactured from titanium alloy (Ti6Al4V) per ASTM F136. The devices are provided in various sizes, and screws are offered in multiple lengths to adjust for variations in patient anatomy. The spacers of the IRIX-A™ System are supplied clean and STERILE. The screws and accompanying instruments of the IRIX™-A System are provided clean and non-sterile.

The system does not contain software/firmware or electrical equipment.

The provided document is a 510(k) Pre-market Notification from the FDA for a medical device called the IRIX-A™ Lumbar Integrated Fusion System. This submission focuses on establishing substantial equivalence to existing predicate devices, rather than a clinical study evaluating the device's diagnostic performance against specific acceptance criteria for AI/software-based devices. Therefore, much of the requested information regarding acceptance criteria for device performance in a clinical context, sample sizes for test and training sets, expert qualifications, and ground truth establishment, is not applicable or not present in this type of regulatory document.

However, I can extract information related to the performance data provided within this 510(k) summary for non-clinical testing.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states the device "meets or exceeds the performance of the predicate device" for these tests, implying that the acceptance criteria are based on the performance of the predicate device as established through the same ASTM standards and FDA recommendations.

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

• Test set sample size: Not applicable. This document describes non-clinical mechanical testing, not a clinical study involving a test set of data.
• Data provenance: Not applicable. The testing is described as "Nonclinical testing" and performed on the device itself.

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

• Not applicable. Ground truth for clinical data is not relevant to this non-clinical mechanical testing.

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:

• Not applicable. This is not an AI/software-based diagnostic device, nor a comparative effectiveness study involving human readers.

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

• Not applicable. This is not an algorithm-only device.

7. The type of ground truth used:

• For the non-clinical performance data: The "ground truth" or reference for performance is the established performance characteristics of the predicate device under the specified ASTM standards and FDA recommendations for static and dynamic compression, subsidence, and expulsion.

8. The sample size for the training set:

• Not applicable. This product does not involve machine learning or a "training set."

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

• Not applicable.

Summary based on the provided document:

The IRIX-A™ Lumbar Integrated Fusion System is a physical medical device (intervertebral body fusion device), not an AI/software-based diagnostic tool. The regulatory submission (510(k)) aims to demonstrate substantial equivalence to legally marketed predicate devices. This is achieved through non-clinical performance testing (mechanical/physical tests) rather than clinical studies involving patient data and diagnostic performance metrics like sensitivity, specificity, or reader studies.

The performance data supplied focuses on:

• ASTM F2077: Static and dynamic compression testing
• ASTM F2267: Subsidence
• Expulsion testing as recommended by FDA

The conclusion is that the subject device "meets or exceeds the performance of the predicate device" for these tests, indicating that its mechanical integrity and function are comparable or superior, and it "does not introduce any new risks." The predicate device itself acts as the benchmark for establishing acceptable performance under these tests.

Ask a specific question about this device

The Calix-C™ Cervical Interbody Spacer is intended for spinal fusion procedures at one level (C2 - T1 inclusive) in skeletally mature patients with degenerative disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Patients should receive at least six (6) weeks of non-operative treatment with the Calix-CTM Cervical Interbody Spacer.

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine (i.e., posterior cervical screw and rod systems and anterior cervical plate systems).

The Calix-C™ Cervical Interbody Spacer is an intervertebral fusion device, generally box or oval-shaped, that has various holes throughout its geometry. The device body is made from Invibio PEEK-Optima™ (polyetheretherketone) per ASTM F2026, with radiographic markers made from tantalum per ASTM F560. Superior and inferior surfaces of the device have teeth to help prevent implant dislodgement or expulsion once placed in its desired location. The implants are available with or without titanium plasma coating on the superior and inferior surfaces of the device. The plasma coating is made from medicalgrade titanium per ASTM F1580. The hollow center of the implant allows the device to be packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

The system does not contain software/firmware.

The given document is a 510(k) premarket notification for a medical device (Calix-C™ Cervical Interbody Spacer). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through clinical studies or detailed human-AI comparative effectiveness.

Therefore, the requested information regarding acceptance criteria, study design details like sample size for test sets and training sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment cannot be found within this document.

The document specifically states under "X. PERFORMANCE DATA" that:

• "Mechanical testing is recommended in the FDA special controls guidance document, 'Class II Special Controls Guidance: Intervertebral Body Fusion Device'."
• "X-spine has previously submitted to the FDA results of performance testing for Calix cervical implants: K112036 and K083637, according to the following standards:" (lists ASTM standards for mechanical testing).
• "Therefore, no new nonclinical testing was performed for the purpose of this submission."

This indicates that the "performance data" for this device relates to mechanical (non-clinical) testing, not clinical performance data involving human readers or AI. The product is a physical implant, not a software or AI-driven diagnostic device.

To directly answer your request based solely on the provided text, without making assumptions:

Acceptance Criteria and Study for Calix-C™ Cervical Interbody Spacer

Based on the provided FDA 510(k) submission document for the Calix-C™ Cervical Interbody Spacer, the "study" conducted for this submission primarily involved demonstrating substantial equivalence to predicate devices and relying on previously conducted nonclinical (mechanical) performance testing. The device is an intervertebral body fusion device, not an AI or software-based diagnostic tool. Therefore, the types of acceptance criteria and study methodologies typically associated with AI/software performance (e.g., sensitivity, specificity, reader studies, ground truth establishment by experts) are not applicable or described in this document.

The "performance data" mentioned in the document refers to mechanical testing to ensure the structural integrity and functional performance of the physical implant.

Key points from the document regarding "performance":

• No new nonclinical testing was performed for the purpose of this submission (K171075).
• The manufacturer (X-spine) had previously submitted results of performance testing for earlier versions of Calix cervical implants (K112036 and K083637).
• These previous tests were conducted according to established ASTM standards for intervertebral body fusion devices, focusing on:
  • Static and dynamic torsion testing
  • Static and dynamic axial compression and compression shear testing
  • Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
  • Expulsion testing
  • Performance Qualification of Commercially Pure Titanium Plasma Spray (CP Ti)

Given that the device is a physical implant and this submission is an update to an existing device (adding sizes and expanding indications), the performance evaluation relies on the known biomechanical properties and the established equivalence to predicate devices, rather than a new human-reader or AI-driven study.

Therefore, the following information cannot be extracted or inferred from the provided text, as it pertains to methodologies not described or applicable to this type of device submission:

1. Table of acceptance criteria and reported device performance (for AI/diagnostic): Not applicable for a physical implant. The "acceptance criteria" here relate to mechanical properties and substantial equivalence to predicates.
2. Sample size for test set and data provenance: Not applicable for AI/diagnostic performance. Mechanical testing would have specific samples, but details not provided for this submission.
3. Number of experts and qualifications for ground truth: Not applicable.
4. Adjudication method for test set: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for training set: Not applicable.
9. How ground truth for training set was established: Not applicable.

Ask a specific question about this device

The Spider® Cervical Plating System is intended for anterior fixation of the cervical spine. The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with the following: degenerative disc disease (as identified by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal tumors, deformity (e.g., kyphosis, lordosis, scoliosis), pseudarthrosis, and/or failed previous fusion.

The Spider® Cervical Plating System consists of titanium alloy (Ti 6Al 4V ELI) anterior cervical plates and bone screws, allowing for fixation between one and four intervertebral segments. The plates attach to the anterior portion of the vertebral body of the cervical spine, levels C2 to C7. The titanium alloy conforms with ASTM F136, Standard Specification Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) alloy for Surgical Implant Applications (UNS R56401).

The system does not contain software/firmware.

The provided text is a 510(k) summary for the Spider® Cervical Plating System. This document describes a medical device, specifically an implant for spinal fixation, and compares it to previously cleared predicate devices to demonstrate substantial equivalence.

The content focuses on mechanical and material properties of the device (e.g., titanium alloy, screw lengths, pullout testing) to support its safety and effectiveness for its intended surgical purpose. It does not contain information related to AI/ML or software-based medical devices, nor does it describe clinical studies for such devices.

Therefore, I cannot extract the information requested about acceptance criteria and a study proving device performance in the context of AI/ML devices, including:

1. A table of acceptance criteria and the reported device performance: This document reports mechanical test results for a physical implant, not performance metrics like sensitivity, specificity, or AUC for an AI/ML algorithm.
2. Sample sizes used for the test set and the data provenance: Not applicable, as there's no test set of image data or patient data referenced in the context of AI/ML evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML device would involve expert annotations or clinical outcomes, which are not described here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as 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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI/ML context. The "ground truth" for this device's performance would be engineering specifications and biomechanical test results.
8. The sample size for the training set: Not applicable, as there is no AI/ML training set.
9. How the ground truth for the training set was established: Not applicable, as there is no AI/ML training set.

The document states: "The system does not contain software/firmware." This explicitly confirms that the device described is a purely mechanical implant and not a software/AI/ML device.

Ask a specific question about this device

The Butrex® Lumbar Buttress Plating System is intervertebral body screw fixation/attachment to the L1-S1 spine over one vertebral body extending onto the adjacent intervertebral space. Due to variations in the anatomy, the plate is designed for applications caudal to the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one motion segment following anterior structural reconstruction for degenerative disc disease (DDD). DDD is defined as follows: back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies.

The Butrex® Lumbar Buttress Plating System consists of a variety of shapes and sizes of bone plates and screws. The Butrex plates contain two sockets for screw placement on one end and a buttressing surface on the other end. The system is intended for anterior screw fixation to the L1 to S1 spine. The components are manufactured from titanium alloy (Ti 6Al 4V ELI). The titanium conforms with ASTM F136, Standard Specification Wrouqht Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) alloy for Surqical Implant Applications (UNS R56401). A separate intervertebral fixation construct, such as posterior pedicle screws, must be used for proper stabilization to be achieved.

The system does not contain software/firmware.

This FDA 510(k) K170530 is for a spinal intervertebral body fixation orthosis, the Butrex® Lumbar Buttress Plating System. This device is a physical medical device, not an AI/ML powered device. As such, the standard acceptance criteria, study methodologies, and performance metrics typically associated with AI/ML devices (like sensitivity, specificity, AUC, sample sizes for training/test sets, ground truth establishment with expert consensus, MRMC studies, standalone performance, etc.) are not applicable to this document. The document describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence based on technological characteristics and design.

Therefore, I cannot provide the requested information for acceptance criteria and study details as they pertain to AI/ML device evaluations. The document focuses on material, design, and indications for use equivalence for a traditional implantable medical device.

Ask a specific question about this device

The Xsert™ Lumbar Expandable Interbody System is intended for spinal fusion procedures at one or two contiguous levels (L2 - S1 inclusive) in skeletally mature patients with degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the lumbosacral spine. DDD patients may also have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved level(s). These implants are to be packed with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via a posterior, and/or transforaminal approach. Patients should receive at least six (6) months of non-operative treatment prior to treatment with a lumbosacral intervertebral fusion device.

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

The Xsert™ Lumbar Expandable Interbody System of X-spine Systems, Inc. is an expandable interbody system used to provide structural stability in skeletally mature individuals following discectomy. The Xsert™ Lumbar Expandable Interbody System will consist of spacers offered in various shapes and sizes, and their heights can be intra-operatively expanded to fit the anatomical needs of a wide variety of patients. These spacers are intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft material and have features on the superior and inferior surfaces of each device to grip the endplates of the adjacent vertebrae to resist expulsion.

The implant components of the system are manufactured from medical grade Titanium alloy (Ti6Al4V) that complies with ASTM F-136. All implants will be provided clean and sterile, are intended for single use only, and should not be reused under any circumstances.

A series of manual surgical instruments intended to assist with the insertion and placement of the implants is included in an instrument tray, which is used for instrument sterilization and storage.

Here's the information regarding the acceptance criteria and study for the Xsert™ Lumbar Expandable Interbody System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K160959 510(k) Summary) does not explicitly list specific numerical acceptance criteria (e.g., minimum compression strength in Newtons) and corresponding numerical performance results for the device. Instead, it refers to industry standards that implicitly contain performance requirements for such devices. Therefore, the table below reflects what is stated:

Explanation of "Acceptance Criteria" in this context: For medical devices, particularly those seeking 510(k) clearance, the "acceptance criteria" are often implicitly met by demonstrating compliance with recognized consensus standards (like ASTM standards) and FDA guidance documents. The submission argues that by meeting these standards and guidance, the device's performance is "substantially equivalent" to legally marketed predicate devices, implying it meets the necessary safety and effectiveness thresholds defined by those standards.

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

• Sample Size for Mechanical Testing: The document does not specify the exact number of devices tested for each mechanical test (Static/Dynamic Compression, Subsidence, Expulsion). It only states that "Mechanical testing was performed."
• Sample Size for Simulated Use: The document mentions "surgeons in a cadaveric laboratory evaluation" but does not specify the number of cadavers or the number of device placements performed during this simulated use.
• Data Provenance: The data appears to be prospective as it involves laboratory testing and cadaveric evaluations of the specific Xsert™ Lumbar Expandable Interbody System. The country of origin of the data is not explicitly stated but is implied to be from the manufacturer's testing facilities (X-spine Systems, Inc.) in the USA.

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

• Mechanical Testing: Not applicable in the sense of human experts establishing ground truth for mechanical test results. The "ground truth" for mechanical testing is based on the objective measurements against the specified ASTM standards and FDA guidance.
• Simulated Use: The document mentions "surgeons" performing a cadaveric laboratory evaluation. It does not specify the number of surgeons involved or their specific qualifications (e.g., years of experience, subspecialty). These surgeons acted as "experts" for the human factors/usability aspect during simulated use, assessing device handling and surgical technique.

4. Adjudication Method for the Test Set

• Mechanical Testing: Not applicable. Performance is measured objectively according to standard protocols.
• Simulated Use: The document does not describe a formal adjudication method. It states that "Design validation... was performed with surgeons," implying their assessment of the device's usability and performance during the simulation serves as the validation. There's no mention of multiple reviewers or a consensus process for the simulated use results.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with AI/imaging diagnostics where human readers interpret medical images. The Xsert™ Lumbar Expandable Interbody System is a physical implant, and its evaluation consists of mechanical testing and simulated surgical use, not image interpretation.

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

This question is not applicable to the Xsert™ Lumbar Expandable Interbody System. This device is a physical implant, not an algorithm or software. Its performance is inherent to its mechanical properties and design, not an algorithm that can operate standalone.

7. The Type of Ground Truth Used

• Mechanical Testing: The ground truth is defined by the objective pass/fail criteria and performance thresholds established within the referenced ASTM standards (ASTM F2077, ASTM F2267) and FDA Guidance for Intervertebral Body Fusion Devices.
• Simulated Use: The ground truth for the simulated use in a cadaveric laboratory evaluation is the effectiveness and ease of use in a simulated surgical environment, as assessed by the participating surgeons. This is functionally a form of "expert assessment" or subjective feedback regarding the device's practical application.

8. The Sample Size for the Training Set

Not applicable. This device is a physical interbody fusion system, not an artificial intelligence or machine learning model that requires a "training set" of data.

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

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

Ask a specific question about this device

The Irix-C Cervical Integrated Fusion System is a stand-alone cervical fusion device intended for spinal fusion procedures at one level (C2 – T1 inclusive) in skeletally mature patients for treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radies).

Implants are to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

Patients should receive at least six (6) weeks of non-operative treatment with a cervical intervertebral fusion device.

The Irix-C Cervical Integrated Fusion System is a stand-alone intervertebral fusion device designed to restore biomechanical height and act as an aid in fusion of the cervical spine in anterior discectomy procedures. The device is generally boxed shaped with teeth on the superior and inferior faces of the device. The Irix-C implant will be manufactured in either a composite construction of titanium alloy (Ti6AI4V) in accordance with ASTM F136 and Invibio PEEK Optima LT1 in accordance with ASTM F2026, or from Ti6Al4V titanium alloy alone. The device will be supplied with the option of having the superior and inferior surfaces of the device plasma coated with medical-grade commercially pure titanium (CP Ti) per ASTM F1580.

The intervertebral fusion device is intended to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The device is then secured in location through the use of bone screws, also manufactured from titanium alloy (Ti6AI4V) per ASTM F136.

The devices are available in various sizes, and screws are offered in multiple lengths to adjust for variations in patient anatomy. The single-use implants are provided clean and non-sterile. These devices are intended to be sterilized by a healthcare professional using a steam autoclave in accordance with the instructions for use provided by X-spine Systems Inc., as well as the instructions provided by the manufacturer of the autoclave.

A series of manual surgical instruments, provided clean and non-sterile, intended to assist with the insertion and placement of the implants, is included in an instrument tray, which is used for instrument sterilization and storage.

The system does not contain software/firmware.

This document is a 510(k) premarket notification for a medical device called the "Irix-C Cervical Integrated Fusion System." It is a submission to the FDA seeking clearance to market the device.

Based on the provided text, the device is an intervertebral body fusion device intended for spinal fusion procedures. It is classified as a Class II device with product code OVE.

Crucially, this document states: "No substantial technological changes were made to the existing Irix-C System, nor were any new components added to the Irix-C System. The only change is the expanded Indications for Use. Therefore, no additional testing was required or performed."

This means there is NO EVIDENCE OF A STUDY to prove the device meets acceptance criteria related to its performance for this particular 510(k) submission. Instead, the submission relies on the substantial equivalence principle, arguing that the device is equivalent to previously cleared predicate devices for its expanded indications for use.

Therefore, I cannot provide a table of acceptance criteria or details of a study proving the device meets those criteria, as no such study is described in this document for the current submission.

However, I can extract the proposed Indications for Use (the acceptance criteria in terms of clinical application) for the device and clarify why no performance study was conducted.

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

As stated above, this 510(k) submission did not involve new performance testing. The "acceptance criteria" for this submission are essentially the expanded "Indications for Use," which are compared to predicate devices for substantial equivalence, rather than being demonstrated through new performance data.

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

• Not applicable. No new performance study (test set) was conducted for this 510(k) submission.

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

• Not applicable. No new performance study requiring expert ground truth establishment was conducted.

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

• Not applicable. No new performance study requiring adjudication was conducted.

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 physical implant, not an AI/software device. The submission explicitly states "The system does not contain software/firmware."

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 AI/software device.

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

• Not applicable. No new performance study requiring ground truth was conducted. The ground for substantial equivalence is based on comparisons of design, materials, and established indications for use of predicate devices.

8. The sample size for the training set

• Not applicable. No new performance study (training set) was conducted as there is no algorithm or AI component.

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

• Not applicable. No new performance study (training set) was conducted.

Summary of the document's approach:

The manufacturer, X-Spine Systems, Inc., submitted a 510(k) for their Irix-C Cervical Integrated Fusion System. The core of this submission is substantial equivalence to existing predicate devices. They are seeking to expand the device's "Indications for Use" to include:

• The use of allograft (in addition to autograft) as bone graft material.
• An expanded anatomical region for use, specifically including level C2 (whereas the previous clearance was for C3-T1 inclusive).

The document explicitly states that no new performance data or testing was required or performed because "No substantial technological changes were made to the existing Irix-C System, nor were any new components added to the Irix-C System. The only change is the expanded Indications for Use."

They argue that the expanded indications are not "unique" and are already covered by other legally marketed devices, thus demonstrating substantial equivalence.

Ask a specific question about this device

The intended use of the Certex Spinal Fixation System is to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3):

• · Traumatic spinal fractures and/or traumatic dislocations;
• Instability or deformity;
• · Failed previous fusions (e.g., pseudoarthrosis);
• · Tumors involving the cervical/thoracic spine; and

· Degenerative disease, including intractable radiculopathy and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The X-spine Certex Spinal Fixation 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.

The X-spine Certex Spinal Fixation System can be linked to X-spine Fortex® Pedicle Screw System and X-spine Xpress™ Minimally Invasive Pedicle Screw System with rod-to-rod connectors and transition rods.

The Certex Spinal Fixation System consists of polyaxial screws, hooks, rods, occipital plates, occipital bone screws, cross bar connectors, lateral offset connectors and rod-to-rod connectors. System components can be connected and locked together to promote fusion of the occipitocervico-thoracic spine (Occiput-T3). System components are offered in various sizes and configurations to accommodate variations in pathology and individual patient anatomy. All Certex Spinal Fixation System components are manufactured from Titanium alloy (Ti6AI4V) in accordance with ASTM F136.

The purpose of this submission is to expand the indications of the Certex Spinal Fixation System to include cervical pedicle screw indications.

The provided document is a 510(k) premarket notification for the "Certex Spinal Fixation System." It focuses on demonstrating substantial equivalence to predicate devices, rather than providing a detailed study proving the device meets specific acceptance criteria in the manner typically seen for new AI/medical software devices.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance for an AI/software device cannot be extracted from this document, as it is for a mechanical spinal fixation system.

However, I can extract the information related to the performance testing that was conducted for this mechanical device:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not applicable. This document describes mechanical testing of a physical device, not a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineered standards and measurements, not expert consensus on medical images or outcomes.

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: Not applicable. 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. This is not an AI/software device.

7. The type of ground truth used: For mechanical testing, the "ground truth" would be the established engineering standards (ASTM F1717, ASTM F2706, ASTM F1798) and the performance characteristics of the predicate devices.

8. The sample size for the training set: Not applicable. This document does not describe a training set in the context of an AI/software device.

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

Additional Information from the document regarding the mechanical testing:

• Performance Testing: "Performance testing and a detailed literature search indicates the Certex Spinal Fixation System is as mechanically sound as predicate devices. Testing included static compression, static torsion, dynamic compression, and dynamic torsion per a modified version of ASTM F1717, ASTM F2706 and sub-assembly testing in ASTM F1798. The results demonstrate that the acceptance criteria defined by predicate device performance were met."

Ask a specific question about this device