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The KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I 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. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The KLIMT Expandable LIF Cage System is a lumbar intervertebral fusion cage that is implanted in the disc space between the intervertebral bodies to obtain fusion and mechanical stability. The subject cage is vertically expandable i.e., it has a height adjustable feature for ease of implantation and final secure fit to a patient's anatomy. The cage's components are manufactured via Selective Laser Melting (SLM) 3D printing technology using a medical grade metal powder and/or by machining (CNC method) and assembled into a final cage unit. The cages are manufactured from titanium alloy powder per ASTM F3001 and titanium alloy per ASTM F136 and are provided both sterile and nonsterile to the end user. The patient contacting portion of all instruments is made from Stainless Steel per ASTM F899 and all instruments are provided non-sterile and intended to be sterilized by the end user prior to use.

The provided text describes a medical device, the KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System, and its clearance process with the FDA. It does not describe acceptance criteria for a software device or a study proving that a device meets such criteria.

The information provided is for a physical medical device (an intervertebral body fusion device), not a software or AI-driven system. Therefore, I cannot extract the requested information about acceptance criteria for a software device, test set details, ground truth establishment, MRMC studies, or training set specifics, as these concepts are not applicable to the document's content.

The document discusses non-clinical performance data for the physical cage system, primarily focusing on mechanical testing (e.g., static and dynamic compression bending, torsion, subsidence, expulsion) as per ASTM standards, to demonstrate substantial equivalence to predicate devices. There are no clinical tests reported ("O N/A").

The "Summary of Performance Data (Nonclinical and/or Clinical)" section explicitly states:

• Non-Clinical Tests:
  • Static Compression Bending (per ASTM F2077)
  • Dynamic Compression Bending (per ASTM F2077)
  • Static Compression Shear Bending (per ASTM F2077)
  • Dynamic Compression Shear Bending (per ASTM F2077)
  • Static Torsion (per ASTM F2077)
  • Subsidence (per ASTM F2267)
  • Expulsion
• Clinical Tests: "O N/A"

Therefore, I cannot provide the requested details because the document pertains to a physical medical device's engineering performance rather than a software device's analytical or clinical performance using AI.

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The MONDRIAN Lumbar Plate System is indicated as additional support during fusion in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

The MONDRIAN Anterior Lumbar Plate System is anterior lumbar fusion devices used to provide structural stability in skeletally mature individuals. The system consists of plates, screws, and instruments to facilitate the installation of the implants. Plates and screws are manufactured from Titanium Alloy per ASTM F136. The instruments are manufactured from Stainless Steel per ASTM F899. Implants and instruments will be provided in non-sterile configuration and will require steam sterilization prior to use.

Based on the provided FDA 510(k) Clearance Letter for the MONDRIAN™ Anterior Lumbar Plate System, here's an analysis of the acceptance criteria and the study that proves the device meets them:

Important Note: The provided document is a 510(k) clearance letter, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance data and comparison of technological characteristics. It is not a detailed study report for a novel medical device, especially an AI-powered one. Therefore, many of the requested items related to AI device performance evaluation (such as sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, and training set details) are not applicable or present in this type of document because the device in question is a physical surgical implant, not an AI/software device.

Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" for a physical implant device like the MONDRIAN™ Anterior Lumbar Plate System are primarily related to its mechanical strength, durability, material safety (biocompatibility), and functionality under simulated physiological loads. The reported device performance is that the non-clinical tests showed the device meets these requirements and performs within its intended uses, indicating no new safety or effectiveness concerns compared to the predicate device. Specific numerical acceptance thresholds are not detailed in this high-level summary but would be part of the full submission.

Study Details (Focusing on the provided document's context)

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

   • Sample Size: Not explicitly stated as a "sample size" in the context of clinical data or AI test sets, as this is a non-clinical bench testing submission for a physical implant. The "test set" for this device refers to the number of implants or test specimens subjected to the various mechanical tests. This information is typically found in the test reports themselves, not the 510(k) summary.
   • Data Provenance: Not applicable in the context of country of origin for clinical data, as no clinical studies were performed ("Clinical Tests: N/A"). The non-clinical tests would have been performed in a laboratory setting, likely within the manufacturing entity's or a contract testing facility's country.

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

   • Not Applicable. This question typically pertains to studies involving human interpretation (e.g., radiologists, pathologists) to establish ground truth for AI algorithms. For a physical implant, "ground truth" is established by engineering specifications, material standards, and validated mechanical testing methodologies.

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

   • Not Applicable. Adjudication methods are used to resolve disagreements among human experts in establishing ground truth for clinical studies or AI performance evaluation. For mechanical testing, results are objective measurements against predefined engineering criteria, eliminating the need for adjudication.

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

   • No. An MRMC study is not relevant here as the MONDRIAN™ Anterior Lumbar Plate System is a physical surgical implant, not an AI software device intended to assist human readers.

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

   • No. This refers to the performance of an AI algorithm alone. The MONDRIAN™ Anterior Lumbar Plate System is a physical medical device; thus, this type of standalone performance evaluation is not relevant.

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

   • Engineering Specifications and Material Standards: For this device, the "ground truth" for evaluating its performance comes from established engineering principles, material science (e.g., ASTM F136 and ASTM F899 standards for Titanium Alloy and Stainless Steel), and validated mechanical testing protocols. The device's ability to withstand specified loads (static and dynamic) without failure or excessive deformation, and its material compliance, constitute the 'ground truth' it must meet.

7. The sample size for the training set:

   • Not Applicable. There is no "training set" in the context of machine learning or AI for this physical medical device.

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

   • Not Applicable. As there is no training set for this physical device, the concept of establishing ground truth for it does not apply.

In summary, the provided document details the 510(k) clearance for a physical implant device. The "study" proving it meets acceptance criteria consists of non-clinical mechanical bench testing demonstrating its equivalence in performance and characteristics to legally marketed predicate devices, rather than clinical trials or AI performance evaluations.

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When used as an Intervertebral Body Fusion device, the RODIN Expandable Lumbar Cage System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The RODIN Expandable Lumbar Cage System is intended for use with autograft and with supplemental spinal fixation systems and that have been cleared by the FDA.

When used as a Vertebral Body Replacement device, the RODIN Expandable Lumbar Caqe System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable partial or total vertebral body due to tumor or trauma (i.e. fracture). VBRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The RODIN Expandable Lumbar Cage System is intended for use with autograft and/or allograft and with supplemental spinal fixation systems and that have been cleared by the FDA.

The RODIN Expandable Lumbar Cage System is an intervertebral body fixation system and vertebral body replacement consisting of implants with various widths, heights, and lordosis to accommodate individual patient pathology. The devices are intended to deploy using CTL Medical instruments once placed into the spinal interbody space. System implants and instruments are manufactured from implant grade titanium (Ti-6AI-4V ELI per ASTM F136) and surgical grade stainless steel and silicone rubber respectively. The implants consist of tantalum markers (per ASTM F560) that enable viewing the implant position under imaging. These implants are intended for use with supplemental spinal fixation and bone graft. The implants are provided in both sterile and non-sterile configurations.

I am sorry. I cannot provide the acceptance criteria and study information based on the input text. The provided text is a 510(k) summary for a medical device (RODIN™ Expandable Lumbar Cage System) and does not contain details of specific performance criteria or a clinical study evaluating the device's performance against such criteria.

The document explicitly states: "No additional bench testing was deemed necessary for the subject device as there is no major change in design and technology as compared to the predicate device. The bench testing submitted in the predicate device 510(k) K160646 is still applicable to the subject device."

This indicates that the submission relies on the testing and performance data of its predicate device (K160646, XYcor Expandable Spinal Spacer System) to demonstrate substantial equivalence, rather than presenting a new study for the RODIN™ system itself.

Therefore, the requested information, such as a table of acceptance criteria and reported device performance, sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth type, and training set details, is not available within the provided text.

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"CERVICAL" NITRO Interbody Fusion Cage System Family (i.e., the MATISSE NITRO Anterior Cervical Interbody Fusion Cage System and the MONET NITRO Anterior Cervical Interbody Fusion Cage System) are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level or two contiguous levels.

DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radios. Cervical NITRO Interbody Fusion Cage System Family are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach from the C2-C3 disc space using autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

Cervical NITRO Interbody Fusion Cage System Family 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.

When the MONET Anterior Cervical Interbody Fusion Cage System is used with the Supplementary Fixation Plate assembly, the plate-spacer assembly is a stand-alone device intended for use at one disc level or two contiguous levels of the cervical spine (from the C2-C3 disc space to C7-T1 disc space).

"LUMBAR" NITRO Interbody Fusion Cage System Family (i.e.; the MONDRIAN NITRO Lumbar Interbody Fusion Cage System consisting of ALIF/OLIF, DLIF, PLIF, and TLIF) are indicated for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).

Lumbar NTRO Interbody Fusion Cage System Family are intended to be used with supplemental spinal fixation systems. Patients should be skeletally mature and have six months of non-operative therapy prior to treatment with an intervertebral cage.

Lumbar NTRO Interbody Fusion Cage System Family with hyperlordotic cage offerings (>20°) require the use of anterior fixation.

The NITRO Interbody Fusion Cage System Family (Cervical and Lumbar ) cages offer a complete line of interbody cages for the cervical levels C2-C7 and the lumbar levels L2-S1 to be used with supplemental fixation and bone graft material. The cages are made of silicon nitride material and are available in a variety of widths, lengths, and lordotic angles, (parallel angles to accommodate varying degrees of lordosis and varying patient anatomy). The NITRO Interbody Fusion Cage System Family consists of hollow intervertebral spacers with an axial void designed to hold bone graft material. The bone graft is packed into and around the cage to further facilitate fusion.

Each system includes a complete set of instruments to implant the devices properly. The NITRO Interbody Fusion Cage System Family consists of following systems:

• MATISSE NITRO Anterior Cervical Interbody Fusion Cage (ACIF) System.
• MONET NITRO Anterior Cervical Interbody Fusion Cage (ACIF) System with Supplemental fixation.
• MONDRIAN NITRO Lumbar Interbody Fusion Cage System:
  • о MONDRIAN NITRO ALIF/OLIF Cage System
  • MONDRIAN NITRO DLIF Cage System о
  • O MONDRIAN NITRO PLIF Cage System
  • о MONDRIAN NITRO TLIF Cage System

The NITRO Interbody Fusion Cage System Family includes implants and instruments. The subject system uses the same instruments and fundamental technology as do their functional counterparts in CTL Medical's already cleared MATISSE, MONET, and MONDRIAN surgical instruments. As with the predicates, the subject device is implanted using a combination of device-specific and universal instruments manufactured from stainless steel materials that conform to ASTM F899.

This document pertains to the 510(k) premarket notification for the NITRO Interbody Fusion Cage System Family. It describes a mechanical device, not an AI/software device. Therefore, the information requested in the prompt, which is typical for demonstrating the performance of an AI/software medical device, is not applicable to this submission.

The acceptance criteria and study described in the document relate to the physical and mechanical performance of the interbody fusion cage system, such as:

• Mechanical Testing: Axial Static Compression, Shear Static Compression, Static Torsion, Axial Dynamic Compression, Subsidence, and Expulsion.
• Specific Component Testing: Plate Pull-Off, Screw Push Out.
• Biocompatibility Testing: Pyrogenicity testing.

The document concludes that "The technological differences between the subject device and the predicate do not raise new questions of safety and effectiveness. Any minor differences in technological characteristics have been tested and documented." This indicates that the device met the performance criteria established for interbody fusion devices by demonstrating substantial equivalence to predicate devices through these physical and biocompatibility tests.

To directly answer the prompt's request for an AI/software device, based on the provided text, the following would be the response:

1. A table of acceptance criteria and the reported device performance: Not applicable (N/A). The document details mechanical and biocompatibility testing for an implantable cage, not software performance metrics.
2. Sample sizes used for the test set and the data provenance: N/A. The testing involved mechanical samples of the device, not a data set of patient cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth, in the context of AI, refers to expert-labeled data. This document describes physical device testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A. Adjudication methods are used for expert consensus on data labels, which is not relevant here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A. This is a mechanical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. Not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A. The "ground truth" for a mechanical device is its adherence to engineering standards and safety profiles through physical testing.
8. The sample size for the training set: N/A. No training set as this is not a learning algorithm.
9. How the ground truth for the training set was established: N/A. No training set.

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The MONET Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis. The MONET Anterior Cervical Plate System is intended to be used as an adjunct to fusion with either the MONET ACIF Cage System or structural allograft or any FDA-cleared Cervical Cage System.

The MONET Anterior Cervical Plate System is an anterior cervical fixation device used to provide structural stability in skeletally mature individuals. The system is comprised of plates, screws and instruments to facilitate the installation of the implants.The plates are available in various heights and widths to fit the anatomical needs of a wide variety of patients. The plates and screws are manufactured from Titanium Alloy per ASTM F136. The instruments are manufactured from Stainless Steel per ASTM F899. Implants and instruments will be provided in non-sterile configuration and will require steam sterilization prior to use.

The provided document is a 510(k) summary for the MONET Anterior Cervical Plate System. It describes the device, its intended use, and its substantial equivalence to predicate devices based on non-clinical testing. However, it does not provide specific acceptance criteria or an explicit study that proves the device meets detailed performance criteria in the format requested.

The document states: "Results of the non-clinical tests indicate that no new issues of safety and effectiveness have been raised." This is a general statement about the outcome of the comparison to predicate devices, rather than a detailed report of adherence to specific numerical acceptance criteria.

Therefore, I cannot provide the detailed information requested in the table and subsequent questions based on the provided text. The document focuses on demonstrating substantial equivalence through similar intended use, indications, materials, design features, and sterilization methods, supported by types of non-clinical tests rather than specific performance metrics and their corresponding acceptance thresholds.

Here's what I can extract regarding the performance testing, though it lacks the specific detail asked for:

Summary of Performance Data (Nonclinical and/or Clinical):

• Non-Clinical Tests:
  • Static Compression Bending (per ASTM F1717)
  • Static Torsion (per ASTM F1717)
  • Dynamic Compression Bending (per ASTM F1717)
• Clinical Tests:
  • N/A (No clinical tests were performed for this submission)

Regarding the specific questions asked, based only on the provided text:

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

   • Cannot be provided. The document lists the types of tests performed (Static Compression Bending, Static Torsion, Dynamic Compression Bending, all per ASTM F1717) but does not provide specific numerical acceptance criteria or the reported performance data for the MONET Anterior Cervical Plate System. It only states that the "results of the non-clinical tests indicate that no new issues of safety and effectiveness have been raised," implying it met the criteria for substantial equivalence to the predicate devices.

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

   • Cannot be provided. The document does not specify sample sizes for the non-clinical tests, nor does it provide data provenance details like country of origin or whether the data was retrospective or prospective.

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

   • N/A. This question is usually relevant for studies involving human interpretation (e.g., medical imaging). The tests performed were non-clinical mechanical tests, not involving expert interpretation of "ground truth" in that sense.

4. Adjudication method for the test set:

   • N/A. This is not applicable to the non-clinical mechanical tests 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:

   • N/A. This device is a physical spinal implant, not an AI-powered diagnostic tool. No MRMC study was conducted.

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

   • N/A. This device is a physical spinal implant, not an algorithm.

7. The type of ground truth used:

   • For the non-clinical mechanical tests, the "ground truth" would be established by the engineering specifications and requirements outlined in ASTM F1717, which dictate how mechanical properties should be measured and what performance characteristics are expected for such devices. The document does not specify these values.

8. The sample size for the training set:

   • N/A. This is not relevant for a physical medical device undergoing mechanical testing. There is no "training set" in the context of device approval for this type of product.

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

   • N/A. As no training set is relevant, this question is not applicable.

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The CASSATT™ SU Fixation System is intended for fixation of sacroiliac joint disruptions and intended for sacrolliac joint fusion for conditions including.

· Sacroiliac joint disruptions,

· Degenerative sacroiliitis,

· To augment immobilization and stabilization of the sacroillac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and

· Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

The CASSATT™ SIJ Fixation System is a cannulated screw system, including head washer. The system offers various sizes to accommodate a wide range of anatomies. These devices come in various sizes to accommodate patient anatomy, which are all manufactured from titanium alloy, as specified in ASTM F136.

The provided text is a 510(k) Summary for the CASSATT™ SIJ Fixation System. This document outlines the rationale for the device's substantial equivalence to previously cleared devices. It does not describe an AI/ML powered medical device, therefore, the requested information about acceptance criteria, study that proves device meets acceptance criteria, sample sizes, experts, adjudication methods, MRMC studies, standalone performance, ground truth, and training set information is not applicable.

The document focuses on the mechanical performance of a medical implant and compares it to predicate devices based on established ASTM standards.

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The MONDRIAN ALIF Cage with Supplementary Fixation Plate System (MONDRIAN ALIF Cage) is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone.

The MONDRIAN ALIF Cage with Supplementary Fixation Plate System is intended for use with either two or four titanium alloy screws which are provided with the system. When used with screws and implants with lordotic angles ≤20°, the MONDRIAN ALIF Cage with Supplementary Fixation Plate System is a stand-alone interbody fusion device. If the physician chooses to use fewer than the number of screws compatible with the plate, then a supplemental spinal fixation system that is cleared for use in the lumbosacral spine must be used. Hyperlordotic cage offerings (>20°) require the use of a supplemental fixation system (e.g. facet screws or posterior fixation).

The MONDRIAN ALIF Cage with Supplemental Fixation Plate System are anterior lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals. The system is comprised of spacers, plates, screws and instruments to facilitate the installation of the implants. The spacers are manufactured from PEEK per ASTM F2026 and/or Titanium Alloy per ASTM F136, plates and screws are manufactured from Titanium Alloy per ASTM F136. The instruments are manufactured from Stainless Steel per ASTM F899. Implants and instruments will be provided in non-sterile configuration and will require steam sterilization prior to use.

The document describes the MONDRIAN ALIF Cage with Supplementary Fixation Plate System, an intervertebral body fusion device.

Acceptance Criteria and Reported Device Performance:

The document states that the rationale for substantial equivalence is based on the following general characteristics being similar to predicate devices:

• Axial Dynamic Compression (per ASTM F2077)
• Screw Push-Out Testing
• Plate-Cage Disassembly Testing
  Results indicate that the device will perform within the intended uses and no new issues of safety and effectiveness have been raised. |
  | Clinical Tests | No specific clinical tests are mentioned as being performed for this submission ("o" is listed under clinical tests with no further details). The document relies on substantial equivalence to predicate devices, implying that clinical performance is considered similar based on the similarities in the device's characteristics and the non-clinical test results. |

Study to Prove Device Meets Acceptance Criteria:

The document describes a non-clinical study to demonstrate substantial equivalence to previously cleared predicate devices (K192863 and K160597).

1. A table of acceptance criteria and the reported device performance: This is provided above.

2. Sample size used for the test set and the data provenance:
   The document does not explicitly state the sample sizes for the non-clinical tests (Axial Dynamic Compression, Screw Push-Out, Plate-Cage Disassembly Testing). It also does not mention data provenance as these are laboratory/bench tests, not patient data studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These were non-clinical, mechanical tests performed according to ASTM standards. Expert consensus would not be used to establish "ground truth" for these types of tests; rather, the results would be compared against predefined criteria from the standard or predicate device performance.

4. Adjudication method for the test set: Not applicable. This was a non-clinical, mechanical testing study, not a study requiring adjudication of expert interpretations.

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 an implantable medical device (ALIF cage), not an AI-assisted diagnostic or imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device. The non-clinical tests assess the mechanical performance of the physical device.

7. The type of ground truth used: For the non-clinical tests, the "ground truth" or reference for acceptance would be the performance criteria (e.g., strength, durability) specified by relevant ASTM standards (e.g., ASTM F2077) and/or comparison to the mechanical performance of the predicate device(s).

8. The sample size for the training set: Not applicable. This is a non-clinical performance study of a physical medical device, not a machine learning model.

9. How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device submission.

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The CTL Amedica Navigation Instrument System is intended to be used during the preparation and placement of CTL Amedica screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The CTL Amedica Navigation Instrument System is specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

The CTL Amedica Navigation Instrument System are manual surgical instruments for use with the Medtronic® StealthStation™ Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of this navigation system provides the surgeon access to real-time, multiplane 3D images (and 2D images) providing confirmation of hardware placement.

The Navigation Instruments include the following:

• Drivers
• Taps
• Awls
• Probes

Use of the Navigated Instrument System is limited to Taps ranging in sizes from 4.5mm to 8.5mm in diameter. The Navigation Instruments are to be used with the following CTL Amedica Systems but not limited to:

• RAPHAELTM Pedicle Screw System Family
• PICASSO II™ MIS Spinal System Family
• TAURUS™ Pedicle Screw System Family

The CTL Amedica Navigation Instruments are designed for use only with the hardware and software of the Medtronic StealthStation Navigation System.

The CTL Amedica Navigation Instruments are manufactured from Stainless Steel and Aluminum. All of these materials conform to ASTM F899.

The provided text describes the CTL Amedica Navigation Instrument System, but it does not contain any specific numerical acceptance criteria or performance results from a study that proves the device meets those criteria.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices (K172115 and K153442) for 510(k) clearance. This means the manufacturer is asserting their device is as safe and effective as a legally marketed device, rather than providing new, independent performance metrics against specific acceptance thresholds.

Therefore, many of the requested sections regarding detailed study information cannot be answered from the provided document.

Here's a breakdown of what can be inferred or explicitly stated based on the text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Information (Based on the provided text):

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

• Sample Size: Not specified. The document mentions "all subject instruments" for compatibility testing and "both the predicate devices and subject devices" for dimensional analysis, but no specific count is given for the test set.
• Data Provenance: Not explicitly stated, but the testing was conducted as part of the regulatory submission process for the CTL Amedica Navigation Instrument System, implying it was conducted by or for the manufacturer. It is a non-clinical, controlled environment (simulated surgical navigation use environment) rather than clinical data.

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

• Not Applicable. The ground truth in this non-clinical testing appears to be based on engineering analysis, dimensional comparisons, and the successful registration and function with the predicate Medtronic StealthStation system. There is no mention of human experts establishing a 'ground truth' for specific anatomical localization or diagnostic outcomes.

4. Adjudication method for the test set

• Not Applicable/Not Specified. Since there's no mention of human experts establishing ground truth or evaluating outcomes in a subjective manner, an adjudication method like 2+1 or 3+1 is not relevant to the described 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. The document explicitly states "Clinical Tests: o N/A". This is a premarket notification for a medical instrument system, not an AI-powered diagnostic device, and therefore this type of study is not applicable or performed as part of this submission. The device is an instrument used with a navigation system.

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

• Partially. The testing described is primarily standalone device performance (how the instruments themselves function with the navigation system). It's "algorithm only" in the sense that the instruments interface with the "Medtronic StealthStation System" software, and their compatibility/accuracy with that system's function is assessed. However, this is not an "AI algorithm" in the typical sense of a diagnostic or predictive model. The assessment of "accuracy, function and performance in a simulated surgical navigation use environment" primarily focuses on the instrument's interaction with the navigation system.

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

• The "ground truth" for this non-clinical testing is based on:
  • Successful registration and compatibility with the Medtronic StealthStation system.
  • Dimensional measurements and geometrical comparisons against predicate devices (for dimensional comparison and rigidity).
  • Expected function and performance in a simulated environment as defined by the capabilities of the StealthStation system and the purpose of the surgical instruments.
  • Essentially, the ground truth is the expected engineering and functional performance when integrated with the existing, cleared navigation system.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that requires a training set in the conventional sense. The device is a set of physical surgical instruments.

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

• Not Applicable. (See point 8)

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The MONDRIAN™ Lumbar Interbody Fusion Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. The system is to be used with supplemental fixation cleared for use in the lumbar spine. Hyperlordotic cage offerings (>20°) require the use of anterior fixation. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The MONDRIAN™ Lumbar Interbody Fusion Cage system is intended for use as an interbody fusion cage device to maintain lumbar intervertebral spacing and must be used with supplemental fixation. The devices are available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The devices are made of PEEK-OPTIMA LT1 –or- PEEK VESTAKEEP i-Grade with Tantalum marker pins; titanium alloy; or a combination of PEEK, Titanium Alloy, or both.

The MONDRIAN™ Lumbar Interbody Fusion Cage System consists of cages made out of PEEK with marker pins made of Tantalum or Titanium alloy, both of which are identical to its predicate device. All of the heights, lengths, and widths are similar and/or within ranges covered by its predicate devices.

This document describes the MONDRIAN™ Lumbar Interbody Fusion Cage System and its substantial equivalence to predicate devices, not an AI/ML powered medical device. Therefore, much of the requested information (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable.

However, I can extract information related to the device's performance and the studies conducted to demonstrate its safety and effectiveness.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MONDRIAN™ Lumbar Interbody Fusion Cage System are based on demonstrating equivalent mechanical performance to predicate devices under the same test conditions. The "reported device performance" is that it met these criteria.

Study Details (as applicable to a physical medical device submission):

• Sample sized used for the test set and the data provenance: Not explicitly stated as a separate "test set" in the context of an AI/ML device. The "test set" here refers to the actual physical devices (MONDRIAN™ Lumbar Interbody Fusion Cage System) subjected to mechanical testing. The provenance of these devices would be their manufacturing origin (CTL Medical Corporation). The studies are in vitro mechanical tests.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for mechanical testing is established by engineering standards and measurements, not expert consensus.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Mechanical testing results are objective measurements against established standards and predicate device performance.
• 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 physical interbody fusion cage, not an AI/ML diagnostic or assistive device.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is defined by established engineering and material standards (e.g., ASTM F2026, ASTM F136, ASTM F560, ASTM F899, ASTM B211, ASTM B221) and the demonstrated performance of the predicate devices.
• The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML algorithm.
• How the ground truth for the training set was established: Not applicable.

Summary of the Device's Basis for Clearance:

The MONDRIAN™ Lumbar Interbody Fusion Cage System received FDA clearance (K192863) based on substantial equivalence to existing predicate devices (primarily CEZANNE™ and CEZANNE-II™ Lumbar Interbody Fusion Cage Systems). This means its safety and effectiveness were demonstrated by showing it has:

• The same intended uses.
• Similar indications, technological characteristics, and principles of operation.
• No new issues of safety or effectiveness raised by its technological differences.
• Demonstrated equivalent mechanical performance to the cited predicate devices under the same test conditions in the types of tests listed (Static Axial Compression, Static Compression Shear, Dynamic Axial & Compression Shear, Expulsion, Subsidence).

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MONET™ Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate assembly 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. The MONET™ Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate assembly is used to facilitate intervertebral body fusion in the cervical spine at the C2 to C7 disc levels using autograft bone. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. If the MONET Anterior Cervical Interbody Fusion Cage System is used without the Supplementary Fixation Plate assembly, note that supplementary fixation is still required.

The subject device consists of a plate and bone anchoring screws which are made of titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136. The anterior fixation plates can only be assembled with the predicate K172788 cage prior to final use. The final assembly constructs are implanted using a combination of device specific and universal instruments manufactured from stainless steel materials that conform to ASTM F899.

MONET™ Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate is considered an enhanced and modular line-extension to already cleared MONET™ Anterior Cervical Interbody Fusion Cage System (K172788).

The MONET™ Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate have the same risk classification, intended use, and generic designation, as the predicate system the MONET™ Anterior Cervical Interbody Fusion Cage System (K172788). The system is offered in various sizes and configurations to accommodate anatomical variation in the cervical vertebral levels and/or patient anatomy.

The provided text is a 510(k) summary for the MONET™ Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate. It describes the device, its intended use, and its substantial equivalence to predicate devices based on performance data.

However, the document does not contain information related to software or AI-based devices. Therefore, it does not include details about acceptance criteria, reported device performance in a clinical study involving AI, sample sizes for AI model validation, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, ground truth establishment, or training set details.

The performance data mentioned in the document refers to biomechanical tests performed on the physical medical device (in-vitro mechanical tests), not a study of an AI algorithm or software. The tests performed are:

• Static Compression
• Static Compression Shear
• Static Torsion
• Dynamic Axial Compression
• Dynamic Torsion
• Plate Pull-Off
• Screw Push out

These tests were performed according to ASTM F2077 and assess the mechanical integrity and stability of the intervertebral fusion cage system.

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