Search Results

The MENIX® / MENIX® DUO Meniscal Suture Systems are indicated for use as suture retention devices to facilitate percutaneous or endoscopic soft tissue procedures. The MENIX® DUO systems are indicated for use in meniscal repairs and allograft transplant procedures. The MENIX® / MENIX® DUO systems are intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures. The MENIX ® / MENIX® DUO devices are intended for single use only.

The MENIX® / MENIX® DUO devices are intended to be used for all-inside meniscal repair:

• The MENIX® system consists of a single-use launcher which deploys a nonabsorbable implant composed of one anchor pre-tied with a suture.
• MENIX® DUO system consists of a single-use launcher which deploys a nonabsorbable implant composed of two anchors connected by a suture.
  Each anchor is pre-mounted on a needle to allow its deployment through the meniscus by pressing on the associated button. A transparent sheath acts as a penetration depth limiter and as a protection for users. As the MENIX® meniscal suture system consists of only one anchor associated with a suture, this suture must be tied to another MENIX® / MENIX® DUO meniscal suture system. The devices are supplied sterile, individually packaged and ready to use

The provided text is a 510(k) summary for the Menix®/Menix® Duo Meniscal Suture Systems. It describes a medical device and its equivalence to a predicate device, based on non-clinical performance data. This document does NOT describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it establish ground truth with human experts.

Therefore, I cannot provide information for most of the requested points, as they are not relevant to the content of this 510(k) summary. I can only provide details on the acceptance criteria and performance as they relate to the mechanical and biological testing for this specific type of medical device (surgical suture system).

Here's what can be extracted and what cannot:

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

The document states:

• "The mechanical performance data demonstrates that MENIX ® / MENIX® DUO meniscal suture system met performance specifications for traction strength and fatigue displacement traction strength through Dynamic then static tensile tests based on established acceptance criteria taken from the state of the art (Baraber's studies) and in comparison to the predicate device FAST-FIX 360 Meniscal Repair System (K121861)."
• "All acceptance criteria were met and MENIX ® / MENIX® DUO meniscal suture system were deemed biologically safe."

However, specific numerical acceptance criteria or the reported performance values (e.g., actual traction strength in Newtons or displacement in mm) are not provided in this summary. The table below reflects the general statements made.

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 in the document for any of the tests (biocompatibility or mechanical performance).
• Data Provenance: The device manufacturer (S.B.M. SAS) is located in Lourdes, France. The studies are non-clinical, likely laboratory-based. No mention of retrospective or prospective data.

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)

• Not applicable. This relates to human expert review for AI/ML ground truth, which is not described in this document. The "ground truth" for this device's performance is established via standardized laboratory mechanical and biological testing.

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

• Not applicable. This relates to human expert review for AI/ML ground truth, which is not described in this document.

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, an MRMC study was not done. This document describes a medical device, not an AI/ML diagnostic or assistive tool. The comparison is between the new device's mechanical properties and those of a predicate device, using non-clinical testing.

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

• Not applicable. This is not an AI algorithm.

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

• The "ground truth" for this device's safety and effectiveness relies on results from standardized mechanical performance tests (traction strength, fatigue displacement traction strength) and biocompatibility tests (per ISO 10993-1), compared against established specifications and a predicate device. It is not based on expert consensus, pathology, or outcomes data in the traditional sense for diagnostic tools.

8. The sample size for the training set

• Not applicable. This document does not describe an AI/ML device that requires a training set.

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

• Not applicable. This document does not describe an AI/ML device that requires a training set.

Ask a specific question about this device

The PULLUP® BTB, BT LOOP®, PULLUP® CLIP and PULLUP® TEX CLIP devices are designed to be used as cortical fixation for ACL reconstruction.

The device is proposed in the following variants:

• -PULLUP®: comprises a titanium button-plate, and an adjustable nonabsorbable braided loop. The system is preloaded with traction and flip threads, and is designed to be used with a soft tissue graft.
• PULLUP® BTB: comprises a titanium button-plate, and an adjustable nonabsorbable braided loop. The system is preloaded with traction and flip threads, as well as a temporary splice suture, and is designed to be used with a bone-tendon-bone graft.
• -BT LOOP®: comprises a titanium button-plate, and an adjustable nonabsorbable braided loop. The system is preloaded with traction and flip threads, as well as a temporary splice suture, and is designed to be used with a bone-tendon-bone graft. It is assembled on a holder that must be mounted on the GraftTech® preparation station.
• -PULLUP® CLIP: comprises a titanium button-plate only, is designed to be used with a soft tissue graft, and can either be connected to another PULLUP® CLIP button-plate by using the PULLUP® TEX CLIP nonabsorbable braided loop, or can be connected to another PULLUP® device.

Standard models are used for cortical tunnels with a diameter of 4.5 mm; XL models are used for cortical tunnels with a diameter between 5 and 10 mm.

The implants are supplied sterile, individually packaged, ready to use.

This is a 510(k) premarket notification for a medical device, not a study evaluating an AI algorithm. Therefore, the standard information requested for describing acceptance criteria and a study proving device performance for an AI algorithm is not applicable here.

Here's a breakdown of why the requested information cannot be provided from the given document:

• This is not an AI/Software as a Medical Device (SaMD) submission: The document describes PULLUP® BTB, PULLUP® CLIP, PULLUP® TEX CLIP adjustable fixation systems, and BT LOOP® for ligament reconstruction. These are physical implants, not AI algorithms.
• The document focuses on substantial equivalence to a predicate device: The purpose of a 510(k) submission is to demonstrate that a new device is as safe and effective as a legally marketed predicate device. It doesn't typically involve new clinical studies with acceptance criteria in the way AI algorithm validation does.
• "Device performance" refers to mechanical and biological properties: In this context, "device performance" refers to the biocompatibility, biological, and mechanical properties of the physical implant, not the diagnostic or predictive performance of an algorithm.

Based on the provided text, I can extract the following relevant information regarding non-clinical performance:

1. Acceptance Criteria and Reported Device Performance (Non-Clinical)

Explanation: The document states that "Non-clinical testing including biocompatibility, biological and mechanical performances were not impacted by the change. The results indicated that the devices were functional within their intended use and equivalent to the predicate devices. The proposed device has been determined to be non-pyrogenic." This indicates that the new variants met the established non-clinical performance and safety profiles, thus fulfilling the acceptance criteria for these aspects.

The following requested information is NOT APPLICABLE or NOT AVAILABLE in the provided document, as it pertains to AI/algorithm validation, not to the premarket notification of a physical medical device:

• Sample size used for the test set and the data provenance: Not applicable.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• 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.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

In summary, this document describes the substantial equivalence of a physical medical device (ligament fixation systems) through non-clinical testing, not the performance validation of an AI algorithm.

Ask a specific question about this device

The FIXIT®/ ComposiTCP™ threaded anchor system is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, but not limited to, the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair; SLAP Lesion Repair; Biceps Tenodesis; Acromio-clavicular Separation Repair; Deltoid Repair; Capsule Shift or Capsulolabral Reconstruction;

Ankle/Foot: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy

Knee: Anterior Cruciate Ligament Repair; Medial Collateral Ligament Repair; Lateral Collateral Ligament Repair; Patellar Tendon Repair ; Posterior Oblique Ligament Repair; Iliotibial Band Tenodesis ;

Wrist/Hand: Scapholunate Ligament Reconstruction; Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.

Elbow: Biceps Tendon Reattachment; Ulnar or Radial Collateral Ligament Reconstruction; Tennis Elbow Repair and Lateral Epicondylitis Repair.

FIXIT® / ComposiTCP™ Threaded Anchor System is composed of a bioabsorbable composite anchor (30% β-TCP/ 70%PLDL) pre-loaded on a disposable screwdriver and 2 sutures. Different variations of the product are available depending on the type of suture combination (2 flat sutures, or 1 round + 1 flat)

For each configuration, the implant is supplied sterile, ready to use.

The provided document is a 510(k) premarket notification for a medical device (FIXIT®/ComposiTCP™ Threaded Anchor System) and does not describe an AI/ML-based device. Therefore, the questions related to acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details), and ground truth establishment for AI/ML models cannot be answered from this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device for a suture anchor through non-clinical performance testing.

However, I can extract the acceptance criteria and reported device performance related to the mechanical properties as presented in the document:

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

The remaining questions cannot be answered from the provided text as they pertain to AI/ML device studies, which this document does not describe.

Ask a specific question about this device

The FIXIT® threaded anchor system is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, but not limited to, the following procedures:

Shoulder: Rotator Cuff Repair; Bankart Repair; Biceps Tenodesis; Acromio-clavicular Separation Repair; Deltoid Repair; Capsule Shift or Capsulolabral Reconstruction;

Ankle/Foot: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Knee: Anterior Cruciate Ligament Repair: Medial Collateral Ligament Repair: Lateral Collateral Ligament Repair: Patellar Tendon Repair ; Posterior Oblique Ligament Repair; Iliotibial Band Tenodesis ;

Wrist/Hand: Scapholunate Ligament Reconstruction: Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.

Elbow: Biceps Tendon Reattachment: Unar or Radial Collateral Ligament Reconstruction: Temis Elbow Repair and Lateral Epicondylitis Repair

FIXIT® is a threaded anchor system made of Duosorb® 30 (β-TCP 30%/ PLDLA 70%), a composite, bioabsorbable material.

The implant is available in 2 different configurations:

• · FIXIT®Knotless: supplied in a holder,
• FIXIT®: pre-loaded on a disposable screwdriver with 2 sutures.
  The implant is supplied sterile, ready to use.

The provided text describes a medical device submission (K170868) for the FIXIT® Threaded Anchor System. This device is a suture anchor, and the submission aims to demonstrate its substantial equivalence to a predicate device, the Arthrex Bio-Composite Corkscrew (K082810).

It is crucial to understand that this document describes a non-AI/ML medical device. Therefore, the concepts of "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size for the test set," "data provenance," "number of experts used to establish ground truth," "adjudication method," "multi reader multi case (MRMC) comparative effectiveness study," "standalone performance," "type of ground truth used," "sample size for the training set," and "how the ground truth for the training set was established" do not apply in the context of an AI/ML device validation study.

Instead, the acceptance criteria for this type of device (traditional medical device) are outlined by regulatory bodies such as the FDA. For a Class II medical device like the FIXIT® Threaded Anchor System, the primary acceptance criteria for market clearance via a 510(k) pathway revolve around demonstrating substantial equivalence to a legally marketed predicate device. This is achieved through comparisons of:

• Intended Use: Must be the same or very similar to the predicate.
• Technological Characteristics: Must be similar to the predicate.
• Performance Data: Non-clinical testing (e.g., mechanical, biocompatibility) must show that the new device performs as safely and effectively as the predicate, and any differences in technological characteristics do not raise new questions of safety or effectiveness.

Here's a breakdown based on the provided text, adapted for the context of a traditional medical device:

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

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

This information is not provided in the document as it pertains to AI/ML validation studies. For this traditional device, non-clinical tests typically involve:

• Mechanical testing: A certain number of samples (e.g., a statistically significant number of anchors) would be tested for properties like pull-out strength or fixation strength. The specific sample sizes are not detailed in this summary.
• Biocompatibility testing: This is typically performed under ISO standards (e.g., ISO 10993) using standardized biological models (e.g., cell cultures, animal models) with a defined number of replicates, but the specifics are not in this summary.
• Bacterial Endotoxin Testing: This involves testing samples of the final sterile device using established methods like the Limulus Amebocyte Lysate (LAL) assay, with specific sample numbers.

The data provenance is inherent to laboratory testing rather than clinical data sets. The testing would have been conducted by the manufacturer or contracted labs following established protocols.

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 concept is not applicable to this type of traditional device submission. "Ground truth" established by experts is relevant for AI/ML diagnostic or interpretative devices. For the FIXIT® Threaded Anchor System, the "ground truth" for performance is established by objective, quantifiable physical and chemical tests (e.g., measuring force, observing cell reaction, detecting endotoxins) against industry standards or predicate device performance.

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

This is not applicable for a traditional medical device like a suture anchor. Adjudication methods are typically employed in clinical trials or AI/ML evaluations to resolve disagreements among human readers or experts on ground truth.

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 is not applicable. MRMC studies are specific to evaluating diagnostic devices, especially those involving human interpretation, often in the context of AI assistance. The FIXIT® Threaded Anchor System is a surgical implant, not a diagnostic tool, and involves no "human readers" or "AI assistance" in its intended function.

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

This is not applicable. This refers to AI/ML algorithm performance without human intervention. The FIXIT® Threaded Anchor System is a physical implant; there is no algorithm involved.

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

The "ground truth" for this device's performance is based on objective measurements and adherence to established standards in non-clinical testing:

• Biocompatibility: Adherence to ISO 10993 series standards, using established biological models and endpoints.
• Mechanical Performance: Quantifiable physical measurements (e.g., pull-out strength, torque, fatigue life) compared against engineering specifications, predicate device performance, or relevant biomechanical literature. The "ground truth" here is the physical measurement itself.
• Bacterial Endotoxin: Quantitative measurement of endotoxin levels, compared against specified regulatory limits.

8. The sample size for the training set

This is not applicable as there is no AI/ML algorithm requiring a training set.

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

This is not applicable as there is no AI/ML algorithm requiring a training set or its associated ground truth establishment.

Ask a specific question about this device