Search Results

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.

Ask a specific question about this device

The Stable-C Interbody System is an anterior cervical interbody fusion system. The Stable-C Interbody System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Stable-C Interbody System is to be used with supplemental fixation cleared for use in the cervical spine. The system is intended to be used with autogenous or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The system is to be used in patients who have had six weeks of non-operative treatment.

The Stable-C Interbody System is an anterior cervical interbody device comprised of a cage (lordotic angles of 0 , 6°, and 12°) made from Ti-6Al-4V per ASTM F3001 and two fixation anchors made from Ti-6-Al-4V ELI per ASTM F136. The device is offered in a variety of sizes to accommodate patient anatomy. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.

The provided text is a 510(k) premarket notification FDA letter for a medical device called the "Stable-C Interbody System." This document primarily focuses on demonstrating substantial equivalence to pre-existing, legally marketed devices.

It does NOT describe a study involving an AI/Medical Device that uses machine learning, nor does it provide details about acceptance criteria and performance data in the context of an algorithm's accuracy or effectiveness.

The "Performance Data" section in the document refers to mechanical testing of the physical implant device to prove its structural integrity and safety, not the performance of an AI algorithm.

Therefore, I cannot extract the requested information (acceptance criteria, details of a study proving algorithm performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) from the provided text because it is not relevant to an AI/ML medical device.

To answer your request, I would need a document describing the validation and performance of an AI/ML-based medical device.

Ask a specific question about this device

The STALIF C® is intended to be used as an intervertebral body fusion cage as a standalone system used with bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to T1 for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone to facilitate fusion. STALIF C® is intended to be used at one level.

The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage.

STALIF C® is a radiolucent intervertebral body fusion cage with unicortical cancellous bone screws. It is intended to be used as an IBF cage without supplementary fixation. The cross section profile of the STALIF C® is similar to that of the vertebral body endplate with central cavity that can be packed with autograft. STALIF C® is manufactured from PEEK-OPTIMA® LTI with titanium alloy screws and X-ray marker wires manufactured from unalloyed Tantalum (ASTM F-560). The purpose of this 510(k) was to include a titanium coating (ASTM F1580) on both endplates.

Acceptance Criteria and Study for STALIF C®

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes for each mechanical test. It mentions that "Testing performed indicate that the STALIF C® is as mechanically sound as predicate devices," suggesting the tests were performed on the device itself.

The data provenance is from laboratory testing (mechanical testing), not from patient data, and is therefore neither retrospective nor prospective in the clinical sense.

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

Not applicable. The ground truth for this device is based on mechanical engineering standards (ASTM F2077 and F2267) and the device's ability to meet those established criteria, not on expert clinical interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. The "adjudication" is determined by whether the device's performance meets the defined mechanical standards, rather than expert consensus on a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No, an MRMC comparative effectiveness study was not conducted as this is a medical device (intervertebral body fusion cage), not an AI algorithm or diagnostic tool that relies on human interpretation.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used is based on established mechanical engineering standards (ASTM F2077 and F2267) for intervertebral body fusion devices. The device's performance was compared against these universally recognized standards for mechanical soundness.

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not an AI model, so there is no "training set." The device itself underwent the mechanical tests.

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

Not applicable. As there is no training set for an AI model, there is no ground truth to establish for it. The standards (ASTM F2077 and F2267) that define the "ground truth" for mechanical performance were established by industry experts and regulatory bodies.

Ask a specific question about this device