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FIX-L PEEK PLIF and T-PLIF System is an intervertebral body fusion devices intended for use to skeletally mature patients with Degenerative Disk Disease (DDD) of the lumbar spine with up to Grade 1 Spondylolisthesis at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. FIX-L PEEK PLIF and T-PLIF System is indicated to be used with autologous bone graft to facilitate fusion and are intended to be used with supplemental fixation. The device is to be used in patients who have had six months of nonoperative treatment.

FIX-L PEEK PLIF and T-PLIF System intended for use as an interbody fusion cage device and must be used with supplemental fixation. The device is available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The configurations are designed pursuant to a specific surgical approach and consist of the following: 1) Posterior Lumbar Approach (PLIF) and 2) Transforaminal Posterior Lumbar Approach (T-PLIF). FIX-L PEEK PLIF and T-PLIF System is made of PEEK VESTAKEEP i4R body (ASTM F2026) and tantalum markers (ASTM F560) for ease of visualization on radiographs. FIX-L PEEK PLIF and T-PLIF System is a non-sterile device, and it is required to be sterilized via autoclave method by the hospital prior to surgery.

The provided document is an FDA 510(k) clearance letter for an intervertebral body fusion device (FIX-L PEEK PLIF and T-PLIF System), which is a physical implant used in spinal surgery. This type of device is cleared based on non-clinical testing (bench tests) demonstrating substantial equivalence to a predicate device, not on clinical studies involving AI or human-in-the-loop performance.

Therefore, many of the questions related to AI device performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, and stand-alone algorithm performance are not applicable to this specific medical device clearance. The document explicitly states: "No clinical studies were considered necessary and performed."

However, I can extract information relevant to the non-clinical acceptance criteria and the study that proves the device meets them based on the provided text.

Acceptance Criteria and Device Performance for FIX-L PEEK PLIF and T-PLIF System

This device is an intervertebral body fusion device (an implant). Acceptance criteria and performance are established through bench testing to demonstrate mechanical safety and substantial equivalence to a predicate device, not through clinical or AI performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

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

For non-clinical bench testing of an implantable device, the "test set" refers to the physical samples of the device undergoing mechanical testing. The document does not specify the exact number of device samples tested for each criterion (e.g., number of implants subjected to axial compression).

• Sample Size: Not explicitly stated (typically, a statistically representative number of physical samples are used for each bench test, as defined by the ASTM standards).
• Data Provenance: Not applicable in the context of clinical or image data. The "data" comes from controlled laboratory bench tests of the manufactured physical device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable: For this type of device (physical implant), "ground truth" is established by adherence to recognized ASTM mechanical testing standards and comparison to a predicate device's established performance, not by expert human interpretation of data like in AI/imaging studies.

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods (e.g., 2+1, 3+1) are common in clinical trials or AI performance evaluations involving subjective human interpretation. For mechanical bench testing, the results are quantitative and objective, measured against the specified ASTM standard thresholds.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No: The document explicitly states: "No clinical studies were considered necessary and performed." MRMC studies are clinical studies typically used to evaluate the diagnostic performance of imaging systems or AI algorithms with human readers.

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

• No: This is a physical, implantable medical device, not an AI algorithm. Standalone performance studies are for AI systems.

7. The Type of Ground Truth Used

• Bench Test Standards and Predicate Device Equivalence: The "ground truth" for this device is based on its ability to meet the acceptance criteria outlined in recognized ASTM mechanical testing standards (e.g., ASTM F2077, ASTM F2267) and to demonstrate mechanical characteristics that are substantially equivalent to a legally marketed predicate device (K190563 - 4CIS® PEEK PLIF Cage). The physical and material properties (e.g., PEEK VESTAKEEP i4R body, tantalum markers) also contribute to the basis for "truth" in terms of biocompatibility and radiolucency.

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." The device design and manufacturing process are based on established engineering principles, material science, and the performance characteristics of the predicate device.

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ARIX Femur Nail System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric, subtrochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone).

ARIX Femur Nail System (Nail, Lag Screw, Interlocking Screw, Set Screw, and End Cap) is made of Titanium Alloy which meets ASTM F136. ARIX Femur Nail System is provided Sterile or Non-Sterile.

The provided text is an FDA 510(k) Clearance Letter for the ARIX Femur Nail System. This type of document is for a physical medical device (an intramedullary fixation rod), not a software or AI-powered device. Therefore, the questions regarding acceptance criteria, study details, expert involvement, and AI-specific metrics (like human improvement with AI assistance) are not applicable to the information given in this document.

For medical devices like the ARIX Femur Nail System, "acceptance criteria" are generally tied to meeting established industry standards for performance, material properties, and biocompatibility, rather than diagnostic accuracy or algorithmic performance. The "study that proves the device meets the acceptance criteria" refers to bench testing to demonstrate compliance with these standards and substantial equivalence to a predicate device.

Here's a breakdown of the information that is available based on your request, with an explanation of why other points are not applicable:

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

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

This information is not provided in a 510(k) summary for bench testing. The "test set" in this context refers to the physical samples of the device components manufactured for the specified mechanical and material tests. The document does not specify the number of samples tested for each benchmark. There is no patient data involved, as no clinical studies were performed.

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

Not applicable. "Ground truth" in this context would refer to the established pass/fail criteria for mechanical and material tests, which are defined by the ASTM standards themselves. These are engineering specifications, not expert interpretations of clinical data.

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

Not applicable. This refers to methods for reconciling discordant expert opinions in clinical studies, which were not 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 is not an AI-powered device, and no MRMC studies or clinical studies were performed.

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

Not applicable. This is not an AI-powered device.

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

The "ground truth" for the device's performance is established by the specified ASTM (American Society for Testing and Materials) standards. These are internationally recognized engineering standards that define the methods and criteria for evaluating the mechanical properties and performance of medical implants.

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the context of machine learning.

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

Not applicable. This device does not involve machine learning or a training set.

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ARTFX MEDICAL Cervical PEEK Cages are made to be implanted into the appropriate vertebral section to help provide stability for spinal fusion after a diseased cervical disc producing neck and/or arm pain is removed during spinal decompression for patients who have had six weeks of nonoperative treatment.

Cervical PEEK Cages 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 (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.

Cervical PEEK Cages facilitate intervertebral body fusion in the cervical spine and are placed via the anterior approach and packed with autogenous bone. ARTFX MEDICAL Cervical PEEK Cages are to be used with supplemental fixation.

"Cervical Peek Cage" refers to a type of intervertebral cage used in spine surgery in the cervical (neck) region. ARTFX Cervical Cages cervical intervertebral devices made from PEEK Optima (per ASTM F2026) are created to be implanted into appropriate vertebral sections to help provide stability for spinal fusion after a diseased cervical disc-producing neck and/or arm pain is removed during spinal decompression for patients who have had six weeks of non-operative treatment. Cervical peek cages are often used in spinal fusion surqeries.

Fusion surgeries are designed to fuse two vertebrae.

The single-use implant devices feature an open cavity in the interior geometry to accommodate autogenous bone graft and maximize bone growth, with anti-migration teeth to engage the vertebral end plates and prevent expulsion.

The ARTFX Cervical Cages are supplied sterile, single-use, and are fabricated from PEEK that conforms to ASTM F2026 for cages, and with markers and pins that are titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136.

ARTFX En Vivo Spinal Cervical Peek Cage has a peek cage body.

Components of the ARTFX En Vivo Spinal cage have two pins, which assist in the positive anchorage of the implant between the superior and inferior vertebral bodies, and three radiographic markers.

ARTFX Simplex Spinal XI Cervical Locking Peek Cage has a peek cage body. Components of ARTFX Simplex Spinal XI Cervical Locking Peek Cage has two titanium screws which the system is attached to the cervical spine and a titanium locking screw.

Cervical cages consist of 3 models: En Vivo Anatomical Surface, En Vivo Straight Structure, and Simplex.

This document (K240893) is a 510(k) premarket notification for a medical device called ARTFX MEDICAL Cervical PEEK Cages. It focuses on demonstrating that the new device is substantially equivalent to existing, legally marketed predicate devices.

Crucially, this document describes a physical medical implant (intervertebral cage) and its mechanical properties, not a software-based medical device that relies on algorithms for diagnostic or prognostic purposes. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of algorithms (e.g., sensitivity, specificity, human reader performance with/without AI assistance, ground truth establishment) are not applicable to this submission.

The "study" mentioned in the document refers to non-clinical mechanical testing to ensure the physical properties of the implant are comparable to the predicates, not a clinical study involving data analysis from patients or images.

Here's how the provided information relates to your questions, highlighting why most are not applicable for this type of device:

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

• Not Applicable in the traditional sense for an AI/algorithm-driven device.
• The "acceptance criteria" here relate to mechanical performance standards (e.g., load-bearing capacity, fatigue resistance) as defined by ASTM standards. The document states:
  • "Non-clinical testing including subsidence per ASTM F2267 and static and dynamic axial compression, compression-shear, and torsion per ASTM F2077 was conducted."
  • "The results showed that the performance of the proposed devices is substantially equivalent."
• A table would typically show specific force values or deformation limits from these ASTM standards, and the corresponding measured values for the ARTFX MEDICAL Cervical PEEK Cages, demonstrating they fall within the acceptable range or perform comparably to the predicate. This specific data table is not included in the provided FDA letter/summary, but the statement confirms the testing was done and met the criteria for substantial equivalence.

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 refers to mechanical testing of physical implants, not data samples for an algorithm. The "sample size" would refer to the number of physical cages tested in the lab. Data provenance is irrelevant for 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. Ground truth, in the context of AI/algorithms, refers to the definitive correct answer for a diagnosis or measurement derived from expert consensus, pathology, or clinical outcome. For a physical implant, "ground truth" relates to the physical properties meeting engineering specifications, which is verified through standardized mechanical tests, not expert interpretation of data.

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

• Not Applicable. Adjudication is used for conflicting expert interpretations in clinical data for algorithms. Mechanical testing results are objective measurements from instruments.

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

• Not Applicable. This is specific to AI-assisted diagnostic devices. This submission concerns a physical implant.

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

• Not Applicable. This is specific to AI/algorithms. No algorithm is being submitted here.

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

• Not Applicable. As explained in point 3, ground truth for this device is established by adherence to engineering standards and mechanical test results (e.g., ASTM F2267, ASTM F2077), not by clinical expert consensus or pathology data.

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. No training set exists for this type of device.

In summary, the provided document is a 510(k) clearance letter for a physical medical implant, not a software-as-a-medical-device (SaMD) or AI-powered diagnostic tool. Therefore, the questions posed, which are tailored for AI/algorithm-based medical devices, are largely not relevant to the information contained in this specific FDA submission. The "proof" of meeting acceptance criteria for this device rests on successful non-clinical mechanical testing that demonstrated substantial equivalence to predicate devices in terms of material properties, design, and function.

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