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The MectaLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.

The MectaLIF 3D Metal are a line extension to the MectaLIF Oblique and Posterior PEEK implants (K110927, K131671, K181970 and K212831) and MectaLIF Oblique and Posterior TiPEEK implants (K133192, K181970 and K212831). Specifically, the purpose of this submission is to obtain the clearance of MectaLIF 3D Metal Posterior, Oblique and Oblique Dome additively manufactured from Ti6Al4V according to ASTM F2924-14. MectaLIF implants are used to replace a degenerative disc in order to restore the height of the spinal column structure. The devices are not intended to be coupled with other implants but are intended to be used with supplemental fixation and autogenous bone graft. The subject implants are provided individually packed, sterile and single-use.

This document is an FDA 510(k) clearance letter for a medical device called "MectaLIF 3D Metal." This type of document is a regulatory submission demonstrating that a new device is as safe and effective as a legally marketed predicate device. It does not generally contain acceptance criteria or detailed study results for AI/software-as-a-medical-device (SaMD), as it pertains to a physical implant.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details cannot be extracted from the provided text because it is not relevant to this type of device or submission.

The document details the following for a physical medical device (intervertebral body fusion device):

• Device Name: MectaLIF 3D Metal
• Regulation Number: 21 CFR 888.3080
• Regulation Name: Intervertebral Body Fusion Device
• Regulatory Class: Class II
• Product Code: MAX
• Indications for Use: The MectaLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion.
• Predicate Devices: MectaLIF Extension (K212831), MectaLIF Posterior Extension (K181970), MectaLIF TiPEEK (K133192), MectaLIF Extension (K131671), MectaLIF (K110927).
• References Devices: Mpact 3D Metal Implants – DMLS Technology (K202568), GMK 3D Metal Tibial Tray (K221850).
• Performance Data (Non-Clinical Studies): Mechanical standard tests (static and dynamic axial/shear compression, axial compressive subsidence), expulsion test, wear analysis, stereological evaluation, abrasion test, static tensile test, static shear test, pyrogenicity testing, biocompatibility assessment, and shelf-life evaluation. These tests are conducted according to various ASTM and ISO standards for intervertebral body fusion devices and implant materials.
• Clinical Studies: No clinical studies were conducted for this submission, as is often the case for 510(k) clearances when substantial equivalence can be demonstrated through non-clinical testing and comparison to predicates.

In summary, the provided text does not contain information about acceptance criteria or performance studies related to AI/software, as it describes the 510(k) clearance for a physical orthopedic implant.

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The GMK® knee prosthesis is designed for cemented application in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.

The GMK 3D Metal® Tibial Baseplate is indicated for cemented application if there is evidence of sufficient sound bone to seat and support the components.

This knee replacement system is indicated in the following cases:

• · Severely painful and/or disabled joint as a result of arthritis, rheumatoid arthritis or polyarthritis
• · Collagen disorders, and avascular necrosis of the femoral condyle
• · Post traumatic loss of joint configuration
• Primary implantation failure

Tibial wedges cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement. The screwed tibial augments are for screwed fixation to the tibial baseplate. In case a semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral components. In case a GMK Revision or GMK Sphere Revision tibial tray is used, an extension stem must be implanted.

It is not possible to implant tibial wedges and extens with the GMK 3D Metal® Tibial Baseplate.

Limitations for use for GMK SPHERE/GMK SPHERIKA used with kinematic alignment

GMK® Sphere and GMK® SpheriKA can be implanted in kinematic alignment. In this case, this knee replacement system is indicated for:

• · Severely painful and/or disabled joint as a result of arthritis, rheumatic arthritis or polyarthritis
• · Collagen disorders, and/or avascular necrosis of the femoral condyle
• · Moderate valgus, varus, or flexion deformities

The GMK 3D Metal Tibial Tray is a line extension to Medacta GMK Total Knee System.

The subject devices are sterile, individually packaged implants designed for cemented use in Total Knee Arthroplasty procedures.

The GMK 3D Metal Tibial Tray is available in eleven sizes plus two bridge versions with right and left configuration.

The subject devices are manufactured using a Direct Metal Laser Sintering (DMLS) process with titanium alloy powder (Ti-6Al-4V) according to ASTM F2924-14.

This is a 510(k) premarket notification for a medical device, specifically a knee replacement component. The provided text outlines the device, its indications for use, and a comparison to predicate devices, along with performance data. However, it does not contain a study that proves the device meets specific acceptance criteria in the way an AI/ML device submission would.

The document states: "No clinical studies were conducted." and focuses on non-clinical performance data for the mechanical properties and biocompatibility of the implant. Therefore, I cannot provide the requested information regarding acceptance criteria and studies in the context of AI/ML device performance.

Here's why the prompt's request for acceptance criteria and a study to prove device performance (as would be applicable to an AI/ML device) cannot be fully answered from this document:

• No AI/ML Component: The GMK 3D Metal Tibial Tray is a physical implant (a knee prosthesis component). It is not an AI/ML-powered diagnostic, prognostic, or treatment guidance device.
• Performance Metrics Differ: The performance data provided is related to the material properties and mechanical integrity of the implant (e.g., stereological evaluation, tension tests, shear tests, fatigue tests, cementation studies, biocompatibility, shelf-life, pyrogenicity). These are not metrics like sensitivity, specificity, AUC, or reader performance improvement, which would be relevant for AI/ML devices.
• No Ground Truth or Human Expert Review: Since it's a physical implant, there's no "ground truth" derived from expert consensus or pathology in the AI/ML sense, nor a need for human experts to interpret AI output. The "ground truth" for an implant is its mechanical integrity, biocompatibility, and intended function within the body.

Therefore, for this specific submission, the categories requested (e.g., sample size for test set, number of experts, adjudication, MRMC study, standalone performance, ground truth type for test/training sets) are not relevant or applicable, as they pertain to the evaluation of AI/ML algorithms.

If this were an AI/ML device submission, the acceptance criteria would typically involve performance metrics related to its intended use (e.g., accuracy for image interpretation, specificity, sensitivity). The "study" would be a clinical or retrospective validation study comparing the device's output to a ground truth established by experts or pathology.

Summary of what can be extracted related to "performance" for this physical device:

The "acceptance criteria" and "study" are implicit in the Non-Clinical Studies section, demonstrating that the device meets engineering and safety standards for an orthopedic implant.

1. Table of Acceptance Criteria and Reported Device Performance: This document does not provide a formal table of "acceptance criteria" against "reported device performance" in the format typically seen for AI/ML devices with specific metrics like sensitivity or specificity. Instead, the submission relies on demonstrating compliance with ASTM standards and biocompatibility evaluations. The "performance" is the fact that the device passed these tests.

   Acceptance Criteria (Implied)	Reported Device Performance
   Compliance with ASTM F1854-15 (Stereological evaluation)	Studied/Evaluated
   Compliance with ASTM F1147-05(2017)e1 (Tension test)	Studied/Evaluated
   Compliance with ASTM F1044-05(2017)e1 (Static shear test)	Studied/Evaluated
   Compliance with ASTM F1160-14(2017)e1 (Dynamic shear test)	Studied/Evaluated
   Compliance with ASTM F1978-18 (Taber abrasion resistance test)	Studied/Evaluated
   Cementation study (implied mechanical stability with cement)	Studied/Evaluated
   Compliance with ASTM F1800-19e1 (Dynamic endurance fatigue test)	Studied/Evaluated
   Compliance with European Pharmacopoeia §2.6.14/USP (LAL)	Studied/Evaluated
   Compliance with USP (Pyrogen test)	Studied/Evaluated
   Biocompatibility	Evaluated
   Shelf-life	Evaluated

   Note: "Studied/Evaluated" implies the device met the requirements of these tests, as the submission states this data supports substantial equivalence.

2. Sample size used for the test set and data provenance: Not applicable in the AI/ML sense. Test "samples" would be physical devices or materials undergoing mechanical and biological testing. There is no "data set" of patient images or records. The provenance is from Medacta International S.A. internal testing.

3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. Ground truth for an implant is established by engineering standards and biological safety assessments, not expert consensus on interpretations.

4. Adjudication method for the test set: Not applicable.

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, as this is not an AI/ML device. "No clinical studies were conducted."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.

7. The type of ground truth used: Material properties, mechanical integrity, biocompatibility, and absence of pyrogens per established ASTM and Pharmacopoeia standards.

8. The sample size for the training set: Not applicable. This refers to the training of an AI model.

9. How the ground truth for the training set was established: Not applicable.

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