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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.

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The ShurFit CpTi-HA Coated Anterior Cervical Interbody Fusion System 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 discogenic pain with degeneration of the disc confirmed by history and radiographic studies. ShurFit Anterior Cervical Interbody Fusion System implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have at least six weeks of non- operative treatment prior to treatment with an intervertebral fusion device. The device should be used with supplemental fixation.

The ShurFit Anterior Cervical Interbody Fusion (ACIF) System consists of implants with various widths, heights and lengths to accommodate individual patient anatomy and graft material size. It is implanted from the anterior approach and packed with autogenous bone graft to facilitate fusion. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved. All components are manufactured from medical grade polyetheretherketone as described by ASTM F2026, specifically PEEK Optima LT1. The cages are included without a coating (already cleared K083118) or with a CpTi-HA (Commercially Pure Titanium -Hydroxyapatite) coating (this submission).

I am sorry, but the provided text is a 510(k) summary for a medical device (ShurFit CpTi-HA ACIF Interbody Fusion System). It describes the device, its indications for use, and a comparison to predicate devices, including a brief summary of non-clinical tests performed.

However, this document does not contain information about:

• Acceptance criteria
• A study that proves the device meets acceptance criteria.
• Reported device performance values against specific criteria.
• Sample sizes used for test sets.
• Data provenance (country of origin, retrospective/prospective).
• Number and qualifications of experts for ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size and ground truth establishment for the training set.

The document primarily focuses on demonstrating substantial equivalence to existing predicate devices based on technological characteristics and mechanical testing according to established ASTM standards for interbody fusion devices and coatings. It details what tests were performed on the device and its coating (e.g., Static Axial Compression, Static Tensile Bond Strength), but not the specific quantitative results or how those results compare to pre-defined acceptance criteria for a "study that proves the device meets the acceptance criteria."

Therefore, I cannot fulfill your request for the specific details you've asked for based on the provided text. This document is a regulatory submission for device marketing clearance, not a clinical study report or a detailed performance validation study report.

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The Octane® Straight Intervertebral Fusion Device, Ti Coated is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD,) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature, and have had at least 6 months of non-operative treatment. The device is intended for use with autogenous graft, and with supplemental fixation systems cleared for use in the lumbosacral spine.

The Exactech® Octane® Straight Spinal Implant is an implant constructed of medical grade Polyetheretherketone, (PEEK-OPTIMA® LT1). The implant incorporates ridges on the superior and inferior surfaces to resist expulsion. The device is open in the transverse plane to allow insertion of bone graft prior to placement, and fenestrated along the sides. The radiolucent PEEK-OPTIMA® material allows visualization of the defect site on radiography to assess bone growth, and incorporates tantalum markers to permit verification of position. The device is plasma coated with commercially pure titanium. The Octane Straight Spinal Implant is provided sterile for single use.

The purpose of this submission is the addition of a CP-Ti coating on a previously cleared lumbar intervertebral fusion device.

This document is a 510(k) premarket notification for the Octane® Straight Intervertebral Fusion Device, Ti Coated. The purpose of this submission is not for a medical imaging AI device, but for an intervertebral fusion device (a spinal implant). Therefore, many of the requested categories related to acceptance criteria, AI performance, ground truth, and expert evaluation are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding the performance data and the conclusion of substantial equivalence.

Here's the breakdown of the information that can be extracted:

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

   This document does not specify quantitative acceptance criteria in a table format with corresponding performance metrics. Instead, it lists the types of non-clinical tests performed and states a general conclusion.

   Acceptance Criteria Category	Reported Device Performance
   Mechanical Strength	"sufficient for its intended use"
   Substantial Equivalence	"substantially equivalent to legally marketed predicate devices"

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

   Not applicable. The tests performed are non-clinical (mechanical/material tests on the device itself), not studies on patient data.

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

   Not applicable. This is not an AI/diagnostic device that requires expert ground truth.

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. This is not an AI device.

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

   Not applicable. This is not an AI device.

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

   Not applicable directly as "ground truth" for a diagnostic finding. The "ground truth" for this device's performance would be the specifications and requirements defined by the ASTM standards and the predicate device's performance, against which the subject device's mechanical and material properties are compared.

8. The sample size for the training set

   Not applicable. This is not an AI device.

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

   Not applicable. This is not an AI device.

Study that proves the device meets the acceptance criteria:

The study proving the device meets the acceptance criteria essentially refers to the performance data from the non-clinical testing. The document states:

• Tests Performed:

  • Static axial compression per ASTM F2077
  • Static compressive shear per ASTM F2077
  • Dynamic axial compression per ASTM F2077
  • Dynamic compressive shear per ASTM F2077
  • Percent Porosity per ASTM F1854-09
  • Coating Thickness per ASTM F1854-09
  • Static Shear per ASTM F1044-05
  • Static Tensile per ASTM F1147-05
  • Shear Fatigue per ASTM F1160-05
  • Abrasion per ASTM F1978-00

• Conclusion: "The results of this non-clinical testing show that the strength of the Octane® Straight Intervertebral Fusion Device, Ti Coated is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

The predicate devices used for comparison are:

• Primary Predicate: Octane® Straight Intervertebral Fusion Device, Manufacturer: Exactech, Inc. (K130434) - Note: This suggests the current device is an iteration (addition of Ti coating) of a previously cleared device from the same manufacturer.
• Reference Predicate: Calix™ PC Spinal Implant System, Manufacturer: X-Spine (K112036)

In summary, for this particular medical device (a spinal implant), the "study" consists of a series of non-clinical, bench-top mechanical and material property tests conducted according to recognized ASTM standards. The "acceptance criteria" are implied by these standards and the equivalence to the predicate devices, ensuring the device has "sufficient" strength for its intended use. There are no elements related to AI performance, human reader studies, or diagnostic accuracy in this submission.

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Crystal®:
The Crystal® device is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implanted via an open, anterior approach and packed with autogenous bone.

The Crystal® device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine (i.e., anterior plate systems).

Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.

Mosaic®:
The Mosaic® device is an interbody fusion device intended for spinal fusion procedures at one level (C3-C7) in sketally mature patients with degenerative disc disease (defined as neck pain 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 autogenous bone.

Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.

The implant is designed to accommodate two, three, or four screws. The maximum number of screws should be used to ensure adequate fixation of the implant.

Vertu®:
The Vertu® device is a stand-alone interbody fusion device intended for spinal fusion procedures at one level ( C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implanted via an open, anterior approach and packed with autogenous bone.

Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.

The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.

Crystal:
Crystal is an intervertebral body fusion device for use in cervical spinal surgery. The device is generally box-shaped with various holes throughout its geometry to allow for the placement of autograft. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned.

Mosaic:
The Mosaic Spinal Implant System is composed of a device body and fixation screws. The body is a generally box-shaped device with various holes located throughout its geometry for the placement of graft material. Additionally, it has teeth on its superior and inferior external surfaces to keep the device from migrating once placed in its desired location. The box-shaped body has projections (or flanges) that encompass screw holes. Screws pass through screw holes and affix to bone to help prevent implant migration.

Vertu:
The Vertu Cervical Intervertebral Body Fusion System is composed of an implant body and fixation screws. The implant body is a generally box-shaped device with holes through its body for the placement of graft material. Additionally, it has teeth located on its superior and inferior external surfaces to help keep the device from migrating once placed in its desired location. There are also screw holes located in the implant body. Screws pass through screw holes of the implant body and affix to bone to help prevent implant migration.

Here's a breakdown of the acceptance criteria and study information for the Crystal®, Mosaic®, and Vertu® intervertebral body fusion devices, based on the provided FDA 510(k) summary:

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the same way a de novo or PMA application might. Therefore, the "acceptance criteria" here are essentially the performance metrics of the legally marketed predicate devices, and the "study" is the non-clinical testing performed to show equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for substantial equivalence, the "acceptance criteria" are implied to be the performance of the predicate devices. The "reported device performance" demonstrates that the subject devices perform comparably to these predicates.

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

The document does not explicitly state the sample sizes (e.g., number of units tested) for each mechanical test. The data provenance is derived from non-clinical bench testing conducted to support the substantial equivalence claim. There is no mention of country of origin for this testing, but it is typically conducted by the manufacturer or a contract research organization.

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

Not applicable. This submission relies on non-clinical bench testing and comparison to predicate device performance, not on expert-established ground truth from clinical data.

4. Adjudication Method for the Test Set

Not applicable for non-clinical bench testing focused on mechanical properties.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical Studies No clinical studies were performed."

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

This is not applicable as the device (intervertebral body fusion device) is a physical implant, not a software algorithm. The document explicitly states: "Software Verification and Validation Testing The device does not contain software. Therefore no software verification and validation testing were performed."

7. The Type of Ground Truth Used

The ground truth used is based on the established performance characteristics and safety profile of the predicate devices and recognized consensus standards (e.g., ASTM, ISO) for material and mechanical testing. For the wear debris, the ground truth for comparison was specifically the predicate Calix PC (K112036).

8. The Sample Size for the Training Set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI.

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

Not applicable. There is no training set.

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The ANATOMIC PEEK PTC Cervical Fusion System is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The ANATOMIC PEEK PTC device is to be used with supplemental fixation. The ANATOMIC PEEK PTC Cervical Fusion System is also required to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open anterior approach.

The ANATOMIC PEEK PTC Cervical Fusion System consists of PEEK cages of various widths and heights, which can be inserted between two cervical discs to give support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone. The ANATOMIC PEEK PTC Cervical Fusion System will be available in all the same sizes as the predicate system. The only difference between the subject and predicate devices is the subject devices also have a commercially pure titanium (CP Ti) coating.

The provided text describes a 510(k) premarket notification for the ANATOMIC PEEK PTC Cervical Fusion System. The primary purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to prove clinical effectiveness through a study with acceptance criteria in the typical sense of a diagnostic or treatment efficacy study.

Therefore, the requested information categories concerning acceptance criteria, device performance, sample size, ground truth, experts, and comparative effectiveness studies are not fully applicable in the context of this 510(k) summary. Instead, the document focuses on non-clinical (mechanical and material) testing to show that the new device (with a titanium coating) is as safe and effective as its predicate.

Here's an analysis of the provided text in relation to your request:

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

The document does not present a table of specific acceptance criteria with quantitative performance metrics for clinical efficacy. Instead, it details non-clinical testing performed to demonstrate substantial equivalence to a predicate device. The acceptance criterion for a 510(k) submission like this is primarily that the device performs as well as or similarly to the predicate device in its intended use, based on the non-clinical tests.

Summary of "Acceptance Criteria" (Implicit) and Reported "Device Performance" (Non-Clinical Testing):

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 for Test Set: Not explicitly stated for each test, but standard ASTM methods typically define sample sizes (e.g., number of specimens for mechanical testing). These are laboratory tests, not human trials.
• Data Provenance: The tests are non-clinical, conducted in a laboratory setting according to ASTM standards. Country of origin for data is not specified but would typically be the company's testing facilities or contract labs. This is not retrospective or prospective in the clinical sense.

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 is not applicable. For non-clinical, mechanical testing, "ground truth" is established by adherence to recognized ASTM standards and the measurements obtained during testing. There are no human experts "establishing ground truth" in the clinical sense for this type of submission.

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

This is not applicable for non-clinical mechanical testing directly. The ASTM standards themselves often include criteria for valid test runs and data interpretation.

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 applicable. This 510(k) submission is for a medical implant (fusion system), not a diagnostic device or an AI-assisted system. No MRMC study was conducted or is relevant here.

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

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

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

For the non-clinical tests described, the "ground truth" is defined by the physical and mechanical properties measured according to established ASTM standards. For example, for "shear fatigue," the ground truth is the material's failure point under specified cyclical loading as determined by the test method. For animal testing, the "ground truth" would be the observed biological response to the implant in the canine model.

8. The sample size for the training set

This is not applicable. This is a medical implant, not a machine learning algorithm that requires a "training set."

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

This is not applicable, as there is no "training set" for an implant.

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