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The ANATOMIC PEEK™ PTC Cervical Fusion System 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 or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The ANATOMIC PEEK™ PTC Cervical Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is 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. The ANATOMIC PEEK™ PTC Cervical Fusion System is to be used with supplemental fixation. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral cage.

The ANATOMIC PEEK™ PTC Cervical Fusion System is designed for use as a cervical interbody fusion device. These devices are manufactured from polyetheretherketone (PEEK OPTIMA™) each containing a commercially pure titanium coating along with tantalum markers. This device is to be used with autogenous and/or allogenic bone graft material (cancellous and/or corticocancellous bone chips). The ANATOMIC™ PEEK PTC Cervical Fusion System consists of hemi-cylindrical cages of various widths, heights and depths. The hollow geometry of the implants allows them to be packed with autogenous or allogenic bone graft (cancellous and/or corticocancellous bone chips) material.

This document is a 510(k) premarket notification for the ANATOMIC PEEK™ PTC Cervical Fusion System. It is a medical device for orthopedic use, specifically an intervertebral body fusion device.

Here's an analysis based on the provided text:

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

The document does not explicitly present a table of acceptance criteria nor specific quantitative device performance metrics (e.g., accuracy, sensitivity, specificity, or specific mechanical thresholds) in the way one might expect for a digital health device or a device with measurable "performance" in a clinical trial sense (like an AI algorithm's score).

Instead, the "performance data" for this device revolves around demonstrating substantial equivalence to existing predicate devices. This means that the device aims to perform similarly to devices already approved for market.

The acceptance criteria for a 510(k) submission for a device like this are generally focused on demonstrating:

• Similar Indications for Use: The new device treats the same condition in the same patient population.
• Similar Technological Characteristics: The device is made of similar materials, uses a similar design principle, and is intended to be used in a similar surgical approach.
• Performance (Bench Testing & Biocompatibility): The device meets established mechanical and material safety standards. For fusion devices, this typically includes:
  • Mechanical strength/stability testing (e.g., compression, shear, torsion, fatigue)
  • Expulsion resistance
  • Subsidence testing
  • Biocompatibility testing (ISO 10993 standards)
• Clinical Performance (often indirect for 510(k)): For devices where clinical performance can be inferred from predicate devices, a comprehensive literature review or comparative analysis is often sufficient. If the device has significant differences, clinical trials might be required, but this is less common for typical 510(k)s.

Reported Device Performance (as inferred from the document):

• Materials: Manufactured from polyetheretherketone (PEEK OPTIMA™) with a commercially pure titanium coating and tantalum markers. (Similar to predicate devices).
• Design: Hemi-cylindrical cages of various widths, heights, and depths, with hollow geometry for bone graft material. (Similar to predicate devices).
• Function: Facilitates intervertebral body fusion, provides correction and stabilization. (Similar to predicate devices).
• Biocompatibility: Implied to be acceptable based on the use of standard materials like PEEK and titanium, which have established biocompatibility for implantable devices.
• Mechanical Performance: Not explicitly stated with values, but the "performance data" section mentions "comprehensive literature review" for support of substantial equivalence, which would encompass the mechanical properties of similar PEEK/titanium fusion devices. The FDA's clearance implies that relevant bench testing data (which is part of such a review or submitted separately) was found acceptable and demonstrated similar performance to the 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)

The document states: "Clinical data in the form of a comprehensive literature review was provided in support of substantial equivalence of the subject device."

• Sample Size: Not applicable in the sense of a clinical test set with human patients enrolled specifically for this device. The "data" comes from published literature on similar devices and potentially from bench testing data for the current device. Therefore, no direct "sample size" of patients is reported for a specific test set.
• Data Provenance: The "comprehensive literature review" would draw from various sources, likely international, academic, and clinical publications. Specific countries or study designs (retrospective/prospective) are not detailed within this summary, as it covers a broad range of existing evidence. Bench testing data, if conducted for this specific device, would be generated by the manufacturer.

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 device is not an AI/diagnostic device that requires expert adjudication for ground truth establishing. The "ground truth" for a fusion device centers on its mechanical stability, biocompatibility, and ability to facilitate fusion, which are assessed through engineering tests, material science, and clinical outcomes studies (often from literature for 510(k)s), rather than expert interpretation of images or patient conditions.

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

Not applicable. There's no "test set" in the context of expert adjudication for diagnostic accuracy.

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 a diagnostic device or an AI-assisted device. MRMC studies are used to evaluate diagnostic performance.

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

Not applicable. This is a physical intervertebral body fusion device, not a software algorithm.

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

For this type of device, the "ground truth" for demonstrating substantial equivalence is multifaceted and includes:

• Mechanical Bench Testing Data: Demonstrating that the device meets predefined mechanical performance standards (e.g., static and dynamic compression, shear, torsion strength, resistance to expulsion, subsidence). This forms a critical part of the safety and effectiveness profile.
• Material Characterization: Verifying the composition and properties of the PEEK, titanium coating, and tantalum markers.
• Biocompatibility Data: Demonstrating that the materials are safe for implantation and do not elicit adverse biological responses (e.g., cytotoxicity, sensitization, irritation).
• Comparison to Predicate Devices: Showing that the materials, design, and intended use are sufficiently similar to legally marketed devices with a known safety and effectiveness profile.
• Literature Review Outcomes Data: The "clinical data in the form of a comprehensive literature review" would analyze existing clinical outcomes (e.g., fusion rates, complication rates, pain reduction) of predicate or substantially similar devices to support the expected clinical performance of the new device.

8. The sample size for the training set

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

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

Not applicable.

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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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