Search Results

The MectaLock PEEK Suture anchors (size 4.5, 5.5 & 6.5 mm) are intended for use in arthroscopic or open surgical approaches:
· soft tissue refixation within the shoulder joint (i.e .: rotator cuff repair)

The MectaLock Suture Anchor Extension includes implantable devices used for soft tissue re-fixation (e.g. muscles, tendons, ligaments) composed of a PEEK anchoring component and an Ultra High Molecular Weight PolyEthylene (UHMWPE) non-absorbable braided suture.
Specifically, the devices subject of this submission are MectaLock PEEK Suture Anchors Ø4.5, Ø5.5 and 06.5 mm with short driver; a range extension of the already cleared MectaLock PEEK Suture Anchor (K190474).
Identically to the reference device cleared within K190474, the MectaLock Suture Anchor Extension implants are knotless devices 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 anchor with the provided non-absorbable suture, packaged and included in the whole product's blister. The driver can be disposed immediately after the implant has been placed.

The provided text describes a 510(k) premarket notification for a medical device called the "MectaLock Suture Anchor Extension." This document, issued by the FDA, determines the device's substantial equivalence to legally marketed predicate devices.

However, the information you're asking for, which pertains to the acceptance criteria and the study proving a device meets those criteria (specifically for AI/Software-as-a-Medical-Device performance), is not present in this regulatory document.

This FDA letter is for a physical medical device (suture anchors) and focuses on non-clinical performance and biocompatibility. It explicitly states: "No clinical studies were conducted." The performance data section lists:

• Design Validation: MectaLock Suture Anchor Extension Design Validation Report.
• Performance Testing: MR Safety evaluation, Cyclic and load-to-failure properties of suture anchors.
• Pyrogenicity: Bacterial endotoxin test, Pyrogen test.
• Biocompatibility: Assessment as per ISO 10993 series and FDA Biocompatibility Guidance Document.

Therefore, I cannot fulfill your request for the following information based on the provided text:

• A table of acceptance criteria and reported device performance related to AI/software.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study results.
• Standalone (algorithm-only) performance results.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for AI/software.
• Sample size for the training set for AI/software.
• How ground truth for the training set was established for AI/software.

The document is about a different type of medical device and does not involve AI or software performance evaluation.

Ask a specific question about this device

The SnugFit All-Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue to bone in the hip and shoulder in the following procedures:

• Hip: acetabular labral repair
• Shoulder: glenoid labrum repair; rotator cuff repair, biceps tendon repair

The SnugFit All-Suture Anchor is an implantable device indicated for the treatment of hip and shoulder instability (Size 1) and shoulder rotator cuff repair and biceps tenodesis (Size 2).
The SnugFit All-Suture Anchor is a knotted device composed entirely of sutures, made of ultra-high molecular weight polyethylene (UHMWPE) and polyester (PET) specifically arranged and braided to create an anchoring point within the bone after its deployment. The sutures that compose the anchor, are also used to secure soft tissues to a supporting structure (i.e. bone).
The SnugFit All-Suture Anchors are provided EtO sterile with a 5 years shelf life. The sterile, individually packaged, devices consist of the all-suture anchor and a disposable stainless steel driver with a plastic handle. The all-suture anchor is provided pre-loaded on the disposable driver.
The SnugFit All-Suture Anchors are available in six (6) different configurations depending on anchor size (size 1 and size 2), driver length (long and short), and typology of preloaded sutures.

The provided FDA 510(k) summary for the Medacta International SA SnugFit All-Suture Anchor does not contain information regarding acceptance criteria or a study proving the device meets said criteria in the context of diagnostic accuracy or AI performance.

This document is a premarket notification for a medical device (an all-suture anchor for soft tissue fixation to bone), not a diagnostic algorithm or AI-powered device that would typically involve acceptance criteria related to sensitivity, specificity, accuracy, or human reader performance.

The "Performance Data" section lists non-clinical studies related to the physical performance and safety of the implantable device. These studies are mechanical evaluations, biocompatibility tests, and sterilization validations, which are standard for orthopedic implants.

Here's why the requested information cannot be extracted from this document:

• Type of Device: The SnugFit All-Suture Anchor is a physical implant used in surgery, not a diagnostic imaging tool, AI algorithm, or device that performs an analytical function.
• Performance Data focus: The performance data described (design validation, cyclic and load-to-failure properties, pyrogenicity, biocompatibility) are all related to the mechanical properties, material safety, and physical integrity of the anchor, not diagnostic accuracy.
• Absence of AI/Diagnostic Context: There is no mention of AI, diagnostic imaging, disease detection, or human reader studies.

Therefore, I cannot provide a table of acceptance criteria and device performance, nor details about sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the information contained in the provided FDA submission for this particular device.

Ask a specific question about this device

The MectaLock All-Suture Anchor is in arthroscopic or open surgical approaches for fixation of suture (soft tissue) to bone in the hip and shoulder in the following procedures:

• · Hip: acetabular labral repair
• Shoulder: glenoid labrum repair; cuff rotator repair

The MectaLock All-Suture Anchors are implantable, knotted, devices composed entirely of ultrahigh molecular weight polyethylene (UHMWPE) specifically arranged and braided to create an anchoring point within the bone after deployment. The sutures that compose the anchor are also used to secure soft tissues to a supporting structure (i.e., bone).
The sterile, individually packaged, devices consist of the all-suture anchor and a disposable stainless steel driver with a plastic handle. The all-suture anchor is pre-loaded on the disposable driver.
MectaLock All-Suture Anchors are available in six (6) different configurations depending on anchor size (size 1 and size 2), driver length (long and short), and typology of preloaded floating sutures (standard or tape sutures).

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for the "MectaLock All-Suture Anchors" and outlines the device's characteristics, indications for use, comparison to a predicate device, and summarily lists non-clinical studies conducted (design validation, MR compatibility, characterization testing, pyrogenicity, biocompatibility, sterilization, shelf-life). It explicitly states that "No clinical studies were conducted."

Therefore, I cannot provide the requested information regarding acceptance criteria, reported performance, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or ground truth details for training sets.

Ask a specific question about this device