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The Mecta-C Stand Alone is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms for one level or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the spacer component of the Mecta-C Stand Alone should be packed with autograft bone graft composed of cancellous, cortical and/or corticocancellous bone graft and implanted via an anterior approach.

The Mecta-C Stand Alone implants are the same of the predicate device, Mecta-C Stand Alone cleared within K192906. They are provided sterile in single-use packages, designed for long-term implantation inside the human body and intended to be used during cervical interbody fusion surgeries. The Mecta-C Stand Alone implants are composed of cages, plates, locking screws, lag screws and antibackout screws. The cages are to be inserted between two (2) cervical vertebral bodies to provide support and correction during cervical interbody fusion surgeries. They are made in PEEK uncoated or Titanium coated and they are available in various widths, heights, and lengths, with a fixed 7° of lordosis. The hollow geometry of the implants allows the cages to be packed with bone graft. The plates, designed with different shapes to promote a specific approach or to simplify the procedure in a specific area, are assembled in front of the cage and allow for mounting of a certain number of screws. The screws are placed through the plate and cage in order to fix the device to the vertebral bodies.

The provided text is a 510(k) summary for a medical device (Mecta-C Stand Alone Extension) and outlines its comparison to predicate devices, primarily focusing on materials, design, and mechanical testing. It explicitly states that no clinical studies were conducted for either the predicate device (K192906) or the subject device.

Therefore, the document does not contain information on the acceptance criteria for device performance in a clinical setting, nor does it describe a study involving human subjects or AI algorithms to prove the device meets such criteria.

The "Performance Data" section (VII) refers solely to mechanical and material testing as per ASTM and ISO standards for the predicate device, which are deemed applicable to the subject device because they are "the same." These tests evaluate aspects like static and dynamic compression, shear, torsion, subsidence, expulsion, plate removal, pull-out, insertion/removal torque, wear, imaging properties, and pyrogenicity.

Without explicit information on clinical acceptance criteria or studies from the provided document, I cannot fulfill the request to describe them.

To answer your specific points based only on the provided text, the following would be true or cannot be determined:

1. A table of acceptance criteria and the reported device performance: Not available. The document lists mechanical tests performed on the predicate, but not acceptance criteria for clinical performance or AI algorithm performance.
2. Sample sized used for the test set and the data provenance: Not applicable in the context of clinical/AI performance. The mechanical testing refers to "worst case device" but doesn't specify sample sizes for those tests or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No human experts were involved in establishing ground truth for clinical AI performance, as no clinical studies were performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set or human adjudication process is 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: No, explicitly states "No clinical studies were conducted." Therefore, no MRMC study with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, explicitly states "No clinical studies were conducted." The device is a physical implant, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to clinical or AI performance. For the mechanical tests, the ground truth would be the physical properties and behavior of the device as measured against established standards.
8. The sample size for the training set: Not applicable. No AI algorithm training set is mentioned as no AI component is described.
9. How the ground truth for the training set was established: Not applicable. No AI algorithm training set is mentioned.

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The Mecta-C Stand Alone is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the Mecta-C Stand Alone should be packed with autogenous bone graft and implanted via an anterior approach.

The Mecta-C Stand Alone implants are a line extension to Medacta's anterior cervical discectomy and fusion devices' portfolio. The Mecta-C Stand Alone implants are composed of Mecta-C Stand Alone PEEK and Mecta-C Stand Alone TiPEEK implants. The Mecta-C Stand Alone implants are intended to be used during cervical interbody fusion surgeries. The implants are characterized by different sizes of the PEEK body, in combination with different plate designs and screws. The PEEK body is available uncoated as well as with a Titanium coating. The Mecta-C Stand Alone implants are composed of cages, plates, locking screws, lag screws, and antibackout screws. The cages are available in various widths, heights, and lengths, with a fixed 7° of lordosis. The cages are to be inserted between two (2) cervical vertebral bodies to provide support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows the cages to be packed with bone graft. The plates are designed with different shapes to promote a specific approach or to simplify the procedure in a specific area. The plates are assembled in front of the cage and allow for mounting of a certain number of screws. The screws are placed through the plate and cage in order to fix the device to the vertebral bodies. The Mecta-C Stand Alone implants are designed for long-term implantation inside the human body. The implants are provided sterile in single-use packages.

This document is a 510(k) summary for the Medacta International SA Mecta-C Stand Alone intervertebral body fusion device. It details the device's characteristics, indications for use, and comparison to predicate devices, focusing on demonstrating substantial equivalence. The document primarily focuses on non-clinical testing.

Here's an analysis of the provided text in relation to your questions, highlighting what is present and what is missing:

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

The document lists the types of performance tests conducted and the standards followed, but it does not provide a specific table of acceptance criteria and the reported device performance results. It states: "Testing was conducted according to written protocols with acceptance criteria that were based on standards." This implies that such a table or detailed results exist in the full submission to the FDA, but they are not included in this public summary.

The non-clinical performance tests mentioned are:

• Performance Tests per ASTM F2077-18:
  • Static compression
  • Static compression-shear
  • Static torsion
  • Dynamic compression
  • Dynamic compression-shear
  • Dynamic torsion
  • Plate removal
• Performance Tests per ASTM F2267-2004 (Reapproved 2018):
  • Subsidence
• Performance Tests per ASTM F543-17:
  • Pull-out
  • Insertion and removal torque
• Other performance tests:
  • Expulsion
  • Torsion (listed separately from ASTM F2077-18 torsion)
  • Wear testing
  • MRI evaluation
  • Implant imaging properties
• Pyrogenicity:
  • Bacterial Endotoxin Test (LAL test) per European Pharmacopoeia §2.6.14 (equivalent to USP chapter )
  • Pyrogen test per USP chapter

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: Not specified for any of the non-clinical tests. The phrase "worst-case implants" is used, suggesting a selection of samples, but not the quantity.
• Data Provenance: Not explicitly stated. The submitting company is Medacta International SA in Switzerland, and Medacta USA is also mentioned. However, the location where the testing was performed (country of origin of the data) is not given. The nature of these mechanical and biological tests (non-clinical) means "retrospective or prospective" doesn't strictly apply in the same way it would to clinical studies.

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 information is not applicable as the document explicitly states: "No clinical studies were conducted." The testing described is non-clinical (mechanical, material, and biocompatibility testing), which does not involve human subjects or expert clinical review for ground truth establishment.

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

This information is not applicable for the same reason as point 3. Adjudication methods are typically used in clinical studies involving human interpretation or consensus.

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 information is not applicable. The device is an intervertebral body fusion device, not an AI-powered diagnostic or assistive tool. No MRMC studies were conducted as there were no clinical studies at all.

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

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

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

For the non-clinical tests, the "ground truth" is established by adherence to pre-defined engineering standards and their associated acceptance criteria. For example, the "ground truth" for static compression is that the device must withstand a certain load as defined by ASTM F2077-18 without failing, or for pyrogenicity, that the bacterial endotoxin levels must be below a specified threshold. There are no clinical "ground truth" types (like pathology or outcomes data) mentioned because no clinical studies were performed.

8. The sample size for the training set

This information is not applicable. As a physical implant, this device does not have a "training set" in the context of machine learning or AI.

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

This information is not applicable for the same reason as point 8.

Summary of what is missing/not applicable for this device submission:

Since this 510(k) submission primarily relies on non-clinical performance testing and comparison to predicate devices, and explicitly states no clinical studies were conducted, many of your questions related to clinical trials, expert review, AI performance, and human reader studies are not relevant to this particular submission.

The critical missing information from the public summary, in relation to your questions about acceptance criteria and device performance, is the quantitative results of the non-clinical tests and the specific numerical acceptance criteria for each test. The document states these exist ("written protocols with acceptance criteria") but does not disclose them.

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The Mecta-C intervertebral body fusion device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with supplemental spinal fixation.

The Mecta-C device is intended for use at one level in the cervical spine, from C2-T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment prior to treatment with the device.

The purpose of this submission is to add the Mecta-C with titanium markers and the Mecta-C TiPEEK with titanium markers to Medacta's Mecta-C product offering. The Mecta-C with titanium markers and the Mecta-C TiPEEK with titanium markers are intervertebral body fusion devices intended for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the cervical spine. The Mecta-C and the Mecta-C TiPEEK intervertebral body fusion devices are indicated for the treatment of degenerative diseases of the cervical disc and can be used for cervical fusion from C2-T1.

The Mecta-C with titanium markers are intervertebral body fusion devices manufactured with an implant grade polyetheretherketone (PEEK) body and titanium markers. The Mecta-C TiPEEK with titanium markers are intervertebral body fusion devices manufactured with a PEEK body, commercially pure titanium (CPTi) coating, and titanium markers' material is changing from tantalum to titanium to reduce artefact during imaging scans.

The titanium marker's spikes are also being modified to reduce the conical edge from 90° to 50°. The purpose of the conical edge change is to create a sharper tip design which allows for better penetration of the titanium pin and a more uniform contact between the PEEK cage and vertebral body.

The markers are placed in the implant on each end of the TiPEEK cages to allow easier radiological assessment of the position and orientation of the radiolucent TiPEEK cages.

The cages are offered in various widths, heights, footprint geometries, and lordosis which can be inserted between two cervical vertebra bodies 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.

This document describes the 510(k) submission for the Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers intervertebral body fusion devices. This submission aims to extend the existing Mecta-C product offering by changing the marker material from tantalum to titanium and modifying the conical edge of the marker spikes.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the performance testing of the predicate devices and states that engineering rationales determined that the proposed implants (with titanium markers) did not represent a new worst-case for mechanical testing. This implies that the acceptance criteria for the new devices are met if their performance is equivalent to or better than the predicate devices, especially considering the minor changes. Explicit quantitative acceptance criteria are not detailed for the new device variant within this summary; instead, reliance is placed on the existing predicate device testing.

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

The document does not explicitly state specific sample sizes for the performance tests conducted on the predicate devices. It refers to "verification activities, as identified through risk analysis, were previously conducted on the worst-case implants to written protocols with pre-defined acceptance criteria."

The data provenance is retrospective, as the performance data cited was generated for the predicate devices (K112862 and K142744) in previous submissions. The country of origin for the data is not specified, but Medacta International SA is based in Switzerland.

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

This information is not applicable to this submission. The device is a physical intervertebral body fusion device, not an AI/software device requiring ground truth established by medical experts for diagnostic or prognostic purposes. The "ground truth" here relies on established engineering and material science standards and mechanical testing results.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3.

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 information is not applicable as this is not an AI/software device.

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

This information is not applicable as this is not an AI/software device.

7. The Type of Ground Truth Used:

For this type of medical device, the "ground truth" is established through:

• Engineering Standards: Adherence to recognized national and international standards (e.g., ASTM F2026-16, ISO 5832-3:1996, ASTM F1580-12) for materials.
• Mechanical Testing Results: Quantitative measurements obtained from shear, tension, fatigue, and subsidence tests showing mechanical integrity and performance under simulated physiological conditions.
• Biocompatibility Standards: Compliance with established biocompatibility requirements for implantable devices.

8. The Sample Size for the Training Set:

This information is not applicable as this is not an AI/software device and thus does not have a "training set."

9. How the Ground Truth for the Training Set was Established:

This information is not applicable as this is not an AI/software device.

In summary: This 510(k) submission relies on demonstrating substantial equivalence to its predicate devices by providing an engineering rationale that minor changes (marker material and conical edge) do not negatively impact device performance, combined with existing performance data from the predicate devices. The "study" proving the device meets acceptance criteria refers to the previous performance tests conducted on the predicate devices, the adherence to material standards, and the engineering justification for the minor modifications.

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The Mecta-C intervertebral body fusion device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with supplemental spinal fixation.

The Mecta-C device is intended for use at one level in the cervical spine, from C2-T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment prior to treatment with the device.

The Mecta-C TiPEEK Intervertebral Body Fusion Devices are fusion devices intended for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the cervical spine. The Mecta-C TiPEEK intervertebral body fusion device is indicated for the treatment of degenerative diseases of the cervical disc and can be used for cervical fusion from C2-T1. The Mecta-C TiPEEK intervertebral body fusion device consists of a PEEK Implant Grade Polyetheretherketone (ASTM F 2026) body with a commercially pure titanium (CPTi, ASTM F 1580) coating and tantalum markers (ISO 13782 / ASTM F 560). The markers are placed in the implant on each end of the TiPEEK cages to allow easier radiological assessment of the position and orientation of the radiolucent TiPEEK cages. The cages are offered in various widths, heights, footprint geometries and lordosis which can be inserted between two cervical vertebra bodies 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.

The provided document is a 510(k) summary for a medical device called Mecta-C TiPEEK, an intervertebral body fusion device. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than describing a study to prove the device meets specific acceptance criteria based on clinical outcomes or standalone AI algorithm performance.

Therefore, the requested information elements related to AI/algorithm performance, ground truth establishment, expert adjudication, multi-reader multi-case studies, and training set details are not applicable or cannot be extracted from this document, as it concerns a physical implantable device, not an AI/software.

However, I can provide information regarding the performance testing conducted to demonstrate substantial equivalence for the physical device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are derived from relevant ASTM standards and FDA guidance documents for intervertebral body fusion devices and metallic plasma-sprayed coatings on orthopedic implants. The document states that the device "passed all requirements" of the testing performed, implying meeting the pass/fail criteria within those standards. However, specific numerical acceptance criteria (e.g., minimum load to failure, wear rates) and the exact reported performance values are not detailed in this summary. Instead, it makes a general statement of compliance and substantial equivalence to predicate devices.

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

The document describes performance testing on physical devices, not a clinical study with human subjects.

• Sample size: Not explicitly stated for each test, but standard engineering tests typically involve a relevant number of samples (e.g., n=5 or more) to achieve statistical significance according to the ASTM standards.
• Data provenance: Not applicable in the context of clinical data provenance. The testing was conducted in accordance with international and US standards (ASTM, FDA Guidance).

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 question is not applicable. The "ground truth" here is objective physical performance data obtained through standardized mechanical and wear testing, not expert interpretation of medical images or clinical outcomes.

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

Not applicable, as this refers to a human-involved process for establishing ground truth in clinical or imaging studies. The tests are objective per 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. This is a physical intervertebral body fusion device, not an AI-assisted diagnostic tool or imaging software.

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 an AI algorithm.

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

The "ground truth" in this context is the objective mechanical and material properties and performance of the device as measured against established engineering standards (e.g., ASTM F2077, ASTM F1877, ASTM F1580, ASTM F2267) and FDA guidance documents.

8. The sample size for the training set

Not applicable. There is no AI model or "training set" for this physical device.

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

Not applicable. There is no AI model or "training set" for this physical device.

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The Mecta-C intervertebral body fusion device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with supplemental spinal fixation.

The Mecta-C device is intended for use at one level in the cervical spine, from C2-T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment prior to treatment with the device.

The Mecta-C Intervertebral Body Fusion Devices are fusion devices intended for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the cervical spine. The Mecta-C body fusion device is indicated for the treatment of degenerative diseases of the cervical disc and can be used for cervical fusion from C2-T1. The Mecta-C intervertebral body fusion devices consist of a PEEK (Polyetheretherketone) body and tantalum markers. The markers are placed in the implant on each end of the PEEK cages to allow easier radiological assessment of the position and orientation of the radiolucent PEEK cages. The cages are offered in various widths, heights, footprint geometries and lordosis which can be inserted between two cervical vertebra bodies 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.

The provided text describes a 510(k) premarket notification for the Mecta-C Intervertebral Body Fusion Device. This type of submission relies on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing, rather than clinical studies with human participants or AI performance metrics. Therefore, many of the requested criteria related to studies involving AI, human readers, ground truth establishment for clinical data, and specific sample sizes for training/test sets are not applicable to this document.

However, I can extract information related to the performance testing conducted to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are implied by the performance of the predicate devices. The Mecta-C device aims to demonstrate "similar" or "substantially equivalent" mechanical performance according to specific ASTM standards.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a series of mechanical performance tests conducted according to established ASTM standards. These tests compare the Mecta-C Intervertebral Body Fusion Device to identified predicate devices (Vu cPOD and Bengal Cage).

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

• Sample Size for Test Set: The document does not specify the exact number of Mecta-C devices or predicate devices used in each mechanical test. Mechanical testing typically involves multiple samples (e.g., 5-10 per test condition) to ensure statistical significance, but these details are not provided in this 510(k) summary.
• Data Provenance: The data provenance is from mechanical laboratory testing, not human or clinical data. The tests were performed to ASTM standards, which are international standards. The country where the testing took place is not explicitly stated, but Medacta International SA is based in Switzerland and Medacta USA is in California.

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

• Not Applicable. For mechanical testing of medical devices, "ground truth" is established by the physical properties and performance characteristics of the predicate devices and the specifications of the ASTM standards. There are no human experts "establishing ground truth" in the way clinical studies would.

4. Adjudication Method for the Test Set:

• Not Applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies when there's ambiguity in human interpretation of data. For mechanical tests, the results are quantitative measurements against predefined criteria in the ASTM standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

• No. This is a mechanical device submission, not an AI or imaging diagnostic device. MRMC studies analyze human reader performance, often in conjunction with AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• No. This refers to AI algorithm performance. This submission is for a physical implantable device.

7. The Type of Ground Truth Used:

• Objective Mechanical Performance Data: The "ground truth" in this context is the quantitative mechanical performance data obtained from testing both the Mecta-C device and the predicate devices according to established ASTM standards (ASTM F2077 for various compression/shear/torsion tests and ASTM F2267 for subsidence). The FDA's acceptance of "substantial equivalence" relies on the Mecta-C device's performance falling within acceptable limits relative to these predicate devices.

8. The Sample Size for the Training Set:

• Not Applicable. There is no "training set" in the context of mechanical performance testing for substantial equivalence. This concept applies to machine learning algorithms.

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

• Not Applicable. See point 8.

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