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The MectaLIF Anterior is an interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The interior of the MectaLIF Anterior can be packed with autograft or autologous bone graft. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six months of non-operative treatment. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The MectaLIF Anterior Stand-Alone system is intended to be used with bone screws provided and requires no additional supplementary fixation. The MectaLIF Anterior Simple requires additional supplementary fixation such as pedicle screws and rods or lumbar anterior plate system.

The subject MectaLIF Anterior Extension implants are a line extension designed to provide a larger product offering in Medacta MectaLIF Anterior portfolio. The MectaLIF Anterior is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. The family of MectaLIF Anterior system features two designs: MectaLIF Anterior Stand-Alone Fusion Device System, which is a system consisting of cages, plates and is intended to be used with bone screws provided and requires no additional supplementary fixation. MectaLIF Anterior Simple, which is a cage/plate system requiring additional supplementary fixation. The purpose of this submission is to introduce new cages footprints as well as new plates and screws designs. Identically to already cleared MectaLIF Anterior implants, the subject MectaLIF Anterior Extension implants consists of disc spacers made of PEEK Implant Grade Polyetheretherketone (ASTM F2026) body coated with commercially pure titanium (CPT), ASTM F1580). The spacers contain tantalum markers (ISO 13782 / ASTM F560) and include a flush plate secured to the vertebral body with 4 bone screws. Both the plates and the screws are made of Ti6A14V ELI (ISO 5832-3/ASTM F136). The flush plate is secured to the disc spacer via an interlocking mechanism and it is available in two designs lock and lag where an additional anti-back-out cover plate is used to reduce the risk of screw migration after the implantation. The interior of the disc spacer can be packed with autograft or autologous bone graft.

The provided text describes the MectaLIF Anterior Extension, an interbody fusion device. However, it does not include acceptance criteria or the specifics of a study proving the device meets said criteria as would be present for an AI/ML powered device. This document is a 510(k) summary for a medical device that appears to be a physical implant, not an AI or software-based medical device. Therefore, the requested information regarding AI/ML device performance, such as sample sizes for test and training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, is not applicable or available in this document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data (e.g., mechanical testing, biocompatibility).

Key Points from the document:

• Device Type: The MectaLIF Anterior Extension is a physical interbody fusion device (implants, plates, and screws).
• Approval Basis: The approval is based on demonstrating substantial equivalence to legally marketed predicate devices, not on proving new clinical effectiveness or AI/ML performance.
• No Clinical Studies: The document explicitly states: "No clinical studies were conducted."
• No AI/ML Component: There is no mention of any AI or machine learning component in the device description or performance data.

Therefore, I cannot provide the requested table or information because it is not within the scope of the provided document. The questions about AI/ML performance metrics are not relevant to this specific device.

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The MectaLock PEEK Suture anchors are intended for use in arthroscopic or open surgical approaches for fixation of suture (soft tissue) to bone in the shoulder and hip in the following procedures:

· Hip: acetabular labral repair; and

· Shoulder: glenoid labrum repair.

The MectaLock PEEK® Suture Anchor is an implantable device used for soft tissue re-fixation (i.e.: muscles, tendons, ligaments...) composed of an anchoring component (PEEK® anchor) and an Ultra High Molecular Weight PolyEthylene non-absorbable braided suture. The MectaLock PEEK® Suture Anchor is a knotless device provided mounted on the tip of a dedicated disposable driver which allows the surgeon to insert the anchor into a pilot hole, previously drilled in the desired position into the patient's bone. The surgeon must combine the MectaLock PEEK® Suture Anchor with the provided non-absorbable UHMWPE suture, packaged and included in the whole product's blister. The driver can be disposed immediately after the implant has been placed. The MectaLock PEEK® Suture Anchor portfolio is composed of three anchor sizes: ø2.4, ø2.9, and ø3.4mm combined with two driver lengths: short and long.

The provided text is a 510(k) summary for the MectaLock PEEK Suture Anchor. It is a regulatory submission for a medical device that does not involve an AI/ML algorithm.

Therefore, the requested information about acceptance criteria and study data for an AI/ML device (e.g., sample size for test/training sets, experts for ground truth, MRMC studies) is not present in this document. The document describes the device, its intended use, comparison to predicate devices, and non-clinical performance testing (e.g., design validation, characterization testing, pyrogenicity, sterilization) to establish substantial equivalence to a legally marketed predicate device. It explicitly states: "No clinical studies were conducted."

Because this document is not about an AI/ML device, I cannot fulfill the request for information specific to AI/ML device studies.

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The Mectal IF Anterior Stand Alone system is an anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The interior of the MectaLIF Anterior Stand Alone can be packed with autograft or autologous bone graft. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be sketally mature and have had six months of non-operative treatment. The MectaLIF Anterior Stand-Alone system is a system intended to be used with bone screws provided and requires no additional supplementary fixation. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

The MectaLIF Anterior Stand Alone devices are stand-alone anterior interbody fusion devices indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. MectaLIF Anterior Stand Alone is intended to be used with the provided bone screws and requires no additional supplementary fixation.

MectaLIF Anterior Stand Alone consists of disc spacers made of PEEK Implant Grade Polyetheretherketone. The spacers are provided uncoated or coated with a commercially pure titanium (CPTi). Both uncoated and coated spacers contain tantalum markers, and include titanium bone screws and a titanium plate.

The interior of the disc spacer can be packed with autograft or autologous bone graft. The plate comes in four different designs (Flush, Long, L5-S1, and Hybrid) and is secured to the disc spacer via an interlocking mechanism. The disc spacer and attached plate are secured to the vertebral body with the bone screws. The Flush, Long, and Hybrid plates are used with four bone screws while the L5-S1 plate is used with three bone screws.

The subject MectaLIF Anterior Stand Alone Extension introduces Long Head Screw implants that are line extension to the previously cleared Medacta International MectaLIF Anterior Stand Alone -K160605.

The MectaLIF Anterior Long Head Screw implants have been designed with the same or similar shape, dimensions and materials as the previously cleared MectaLIF Anterior Stand Alone screws (K160605): they share the lengths, the diameters, the material and the body shape, the only difference is the longer screw head (compared to current Medacta MectaLIF Anterior screws already on the market) and the tighter coupling dimensions (Torx interface) developed to allow better stability between the screw and the screwdriver during screw implantation.

The MectaLIF Anterior Long Head Screw implants are manufactured with the same material as the Medacta predicate device MectaLIF Anterior Stand Alone screws [cleared through K160605]: Ti-6Al-4V ELI (ISO 5832-3 Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy + ASTM F136 Standard Specification for Wrought Titanium-6Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)).

The provided text is a 510(k) summary for a medical device (MectaLIF Anterior Stand Alone Extension) and outlines the regulatory submission process, device description, and a comparison to a predicate device. It does not describe an AI/ML-driven medical device, nor does it contain information about clinical studies with human participants, expert ground truth establishment, or typical performance metrics like accuracy, sensitivity, or specificity.

Therefore, the requested details regarding acceptance criteria, study design for AI/ML devices, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance are not available in this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on material, design, and biomechanical testing of an intervertebral body fusion device.

Here's what can be extracted from the document, though it doesn't fit the typical AI/ML study structure you described:

Acceptance Criteria and Reported Device Performance (as per a medical device submission, not AI)

The acceptance criteria here refer to meeting established standards for intervertebral body fusion devices, rather than a statistical threshold for AI performance. The "performance" is demonstrated through adherence to these standards.

Since this is not an AI/ML device, the following points are not applicable and cannot be answered from the provided text:

2. Sample size used for the test set and the data provenance: Not an AI/ML device; no test set of patient data described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not an AI/ML device; ground truth in this context refers to physical testing standards.
4. Adjudication method for the test set: Not an AI/ML device; no human review process for a 'test set' of data.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance, often with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm to evaluate.
7. The type of ground truth used: In the context of a physical medical device, "ground truth" is established by adherence to biomechanical and material standards. For the purpose of this 510(k), testing against ASTM and ISO standards serves as the "ground truth" to demonstrate physical performance.
8. The sample size for the training set: Not applicable. No AI/ML model for training.
9. How the ground truth for the training set was established: Not applicable. No AI/ML model for training.

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