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The Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
spondylolisthesis,
trauma (i.e. fractures or dislocations),
tumors.
deformity (defined as kyphosis, lordosis, or scoliosis),
pseudarthrosis.
failed previous fusion,
spinal stenosis

The Osteomed Implantes Anterior Cervical Plate System is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping bone screws using an anterior approach. Plates are available in a variety of lengths (22 mm - 110mm), addressing multiple levels of fixation (one to six). The Osteomed plate incorporates holes or vision ports on the longitudinal center line for intraoperative visualization and for screw fixation of bone graft. Bone screws are available in two diameters (Ø3.85 mm and Ø4.25 mm) and a variety of lengths (8mm - 20mm).

The provided document describes the Osteomed Implantes Anterior Cervical Plate System and its 510(k) submission to the FDA. This document does not contain information about a study proving the device meets specific acceptance criteria related to software algorithm performance, human-in-the-loop studies, multi-reader multi-case studies, or the use of experts for ground truth establishment.

Instead, this document details regulatory information for a medical device (an Anterior Cervical Plate System) and its non-clinical testing for substantial equivalence to predicate devices. The "acceptance criteria" referred to in the document are primarily related to mechanical performance standards for spinal implants, not algorithmic performance.

Here's an analysis based on the available information, addressing what can be answered and clearly stating what is not present:

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size: Not specified for the mechanical tests. Typically, these are engineering bench tests, not clinical human-based studies.
• Data Provenance: The tests are non-clinical (bench tests) performed to ASTM F1717 standards. The country of origin of this specific test data is not detailed, but the manufacturer is Osteomed Implantes, LTDA from Brazil.

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

• This information is not applicable and not provided. The "ground truth" for mechanical testing is adherence to engineering standards and comparative performance against predicate devices, not expert consensus on medical images or patient outcomes.

4. Adjudication method for the test set:

• This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used for clinical or imaging studies where expert consensus is needed.

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 MRMC study was done. The document explicitly states: "No clinical studies were performed." This device is a physical implant, not an AI or imaging diagnostic tool.

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

• No standalone algorithm performance study was done. This device is a physical implant, not an algorithm.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" is adherence to the mechanical performance requirements and benchmarks set by the ASTM F1717 standard and the performance of the legally marketed predicate devices. It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

• Not applicable and not provided. This is not an AI/ML device requiring a training set.

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

• Not applicable and not provided. This is not an AI/ML device.

Conclusion based on the provided document:

The Osteomed Implantes Anterior Cervical Plate System underwent non-clinical mechanical testing (static and dynamic compression, static torsion per ASTM F1717) to demonstrate substantial equivalence to predicate devices. The study concluded that the device is equivalent based on similarities in principles of operation, technology, materials, and indications for use, and the results of these non-clinical evaluations. No clinical studies were performed, and no information regarding algorithmic performance, human reader studies, or expert-derived ground truth for such studies is present because the device is a physical implant, not a software or AI-based diagnostic tool.

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The Intersomatic Cervical Device - DICOM PEEK is intended for anterior interbody spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-C3 disc to the C7-T1 disc). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended for use with additional supplemental fixation systems and autogenous bone graft implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with intervertebral cage.

The Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK and Intersomatic Transforaminal - TLIF PEEK is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-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 I spondylolisthesis at the involved level(s). DIMEI and TLIF Spinal Implants are to be used with autogenous bone graft and implanted via an open posterior or transforaminal approach. The DIMEI and TLIF Spinal Implant is to be used with additional supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK and Intersomatic Transforaminal - TLIF PEEK were developed as implants for the stabilization of the cervical and lumbar spinal column. The implants have ridges on both their inferior and superior surfaces to prevent migration, and graft windows which help facilitate bony integration. X-ray markers are integrated for visualization of the implants during and after surgery.

Here's an analysis of the provided text regarding acceptance criteria and study information for the Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, and Intersomatic Transforaminal - TLIF PEEK devices.

Based on the provided FDA 510(k) summary, these devices are intervertebral body fusion devices, and the submission primarily relies on demonstrating substantial equivalence to predicate devices, rather than establishing performance against specific, quantifiable acceptance criteria from a clinical study for a novel AI/software function.

Therefore, most of the requested fields related to AI/software performance, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this particular device submission. The "acceptance criteria" here refer to the regulatory standards and testing required for this type of medical implant to demonstrate safety and effectiveness equivalent to existing devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. The testing described is non-clinical mechanical testing of the physical implant, not a study involving patient data or a "test set" in the context of AI/software performance.
• Data Provenance: Not applicable. The data comes from benchtop mechanical testing, not human subjects.

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

• Not applicable. Ground truth as typically defined for AI/software (e.g., diagnostic labels) is not relevant for this type of mechanical device testing. The "ground truth" for mechanical testing is established by adherence to ASTM standards and engineering principles.

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

• Not applicable. There was no clinical or expert-based adjudication in the context of this submission. The "adjudication" for mechanical testing is based on whether the device passed the specified ASTM standards.

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. No MRMC study was performed as these are physical medical implants, not AI/software for interpretation.

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

• Not applicable. No algorithm-only performance study was conducted.

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

• Not applicable. The "ground truth" for this submission are the established ASTM standards for mechanical testing of intervertebral body fusion devices.

8. The sample size for the training set

• Not applicable. There was no "training set" in the context of an AI/software algorithm.

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

• Not applicable. There was no "training set" or corresponding ground truth to establish.

Summary of the Study:

The provided document describes a 510(k) premarket notification for three intervertebral body fusion devices: Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, and Intersomatic Transforaminal - TLIF PEEK.

The study relied on non-clinical mechanical testing to demonstrate "substantial equivalence" to previously marketed predicate devices, as is common for Class II medical devices in the 510(k) pathway.

Specifically, the following analyses were conducted:

• Static and dynamic compression per ASTM F2077
• Static and dynamic torsion per ASTM F2077
• Subsidence per ASTM F2267

The manufacturer, Osteomed Implantes, LTDA, concluded that the DICOM PEEK, DIMEI PEEK, and TLIF PEEK devices are equivalent to the predicate devices based on similarities in principles of operation, technology, materials, and indications for use, supported by the results of these non-clinical evaluations.

No clinical studies were performed. The submission explicitly states this.

Ground Truth for Non-clinical Testing: The ground truth for this type of testing is adherence to the specified ASTM international standards (ASTM F2077 for compression/torsion and ASTM F2267 for subsidence), which are recognized benchmarks for evaluating the mechanical properties of intervertebral body fusion devices. The devices are expected to meet or exceed the performance of the predicate devices under these test conditions.

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The DPZ Pedicular Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e., scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

The DPZ Pedicular Fixation System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e., fracture or dislocation); spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudarthrosis and failed previous fusion.

The DPZ Pedicular Fixation System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to more closely match the patient's anatomy.

The provided text describes the DPZ Pedicular Fixation System, its intended use, and the non-clinical tests conducted to demonstrate its equivalence to predicate devices. However, it explicitly states: "No clinical studies were performed."

Therefore, I cannot provide information on acceptance criteria based on human performance or studies involving human readers/experts, as no such clinical data is presented in this document.

Here's the information that can be extracted from the provided text regarding the device's acceptance criteria and the study that proves it meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for the non-clinical tests. The document only mentions "The following analyses were conducted."
• Data Provenance: Not explicitly stated, but it refers to "non-clinical tests" which typically involve laboratory or bench testing of the device hardware.

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" for non-clinical mechanical testing is based on the specifications within the ASTM F1717 standard and the measured performance of the device compared to predicate devices. Human experts are not involved in establishing this ground truth for a mechanical test.

4. Adjudication method for the test set:

• Not applicable, as this refers to human reader review and consensus, which was not performed.

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 MRMC study was done, as "No clinical studies were performed."

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

• Not applicable. This is a medical device (pedicle fixation system), not an algorithm or AI. The standalone performance refers to the device's mechanical integrity under specified ASTM standards.

7. The type of ground truth used:

• The ground truth for the non-clinical tests was based on the performance requirements and methodologies outlined in the ASTM F1717 standard for spinal implant constructs. The device's performance was then compared to that of predicate devices to establish substantial equivalence.

8. The sample size for the training set:

• Not applicable. This is a non-AI/algorithm medical device. "Training set" refers to data used to train an AI model.

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

• Not applicable for the same reason as above.

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