Search Results

The X-Twist Biocomposite Suture Anchors are indicated for attachment of soft tissue to bone. These products are intended for the following indications:

Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromo-Clavicular Separation Repair, Deltoid Repair

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair, Meniscal Root Repair, Secondary or adjunct fixation for ACL/PCL reconstruction or repair, MPFL Repair/Reconstruction

Elbow: Ulnar/Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair

The X-Twist Biocomposite Suture Anchor consists of the implants (anchor and anchor tip) and the anchor driver assembly. The anchor and anchor tip are provided assembled to the driver and sterile. The X-Twist Biocomposite anchor is molded using a composite of beta-TCP (beta-tricalcium-phosphate) and PLGA (poly-lactic-co-glycolic acid). The anchor tip is molded using PEEK (polyetheretherketone). The anchor is fully threaded, double-helical, cannulated, and has inline fenestrations on each quarter-turn face. The anchor tip is retained on the driver via retention suture(s) or suture tape(s) that are passed through the driver cannulation, looped over the retention bridge within the tip, and returned out the proximal end of the driver handle and cleated. These devices are to be used with a drill, awl, and/or bone tap. The X-Twist Biocomposite Suture Anchors are provided sterile and in 4.75mm, 5.5mm, or 6.25mm diameters.

The X-Twist Biocomposite Suture Anchor, as described in this 510(k) summary, did not undergo a study to prove acceptance criteria in the traditional sense of a clinical or standalone performance study. Instead, the FDA determined substantial equivalence based on non-clinical testing and comparison to predicate devices.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For the specific non-clinical test reported, here are the acceptance criteria and results:

Ask a specific question about this device

The PEEK SINEFIX is intended for soft tissue to bone reattachment in rotator cuff repairs for tendon ruptures up to 2 cm.

The SINEFIX is a PEEK implant which can be used to re-attach a ruptured rotator cuff tendon to the humerus of the shoulder. The implant can be used to re-attach complete or partially ruptured tendons up to 2 cm to facilitate the healing of the natural bone-tendon interface. The implant consists of a baseplate with a lateral and a medial anchor. The baseplate is placed over the tendon and attached to the humerus with the anchors. The medial anchor goes through the tendon, while the lateral anchor goes directly into the bone, lateral of the tendon.

The provided document is a 510(k) summary for a medical device called SINEFIX, a PEEK implant for soft tissue to bone reattachment in rotator cuff repairs. This document does not describe a study involving an AI/Machine Learning device or a multi-reader multi-case (MRMC) comparative effectiveness study. It focuses on the non-clinical testing of a physical implant.

Therefore, many of the requested categories for AI/ML device studies cannot be answered from this document. However, I can provide information based on the non-clinical testing for the physical SINEFIX device.

Here's a breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for each test and then provide the exact performance results in a consolidated table. Instead, it lists the types of tests performed and concludes that the results demonstrate substantial equivalence.

Implied Acceptance Criteria (based on the type of tests performed and the conclusion of substantial equivalence):

• Mechanical Performance: The device must perform comparably to predicate devices in terms of mechanical strength, pullout strength, and response to cyclic loading. This would imply meeting or exceeding the mechanical properties of the predicate devices or relevant ASTM/ISO standards.
• Biocompatibility: The device must be biocompatible, meaning it does not cause adverse biological reactions. The acceptance criterion is compliance with ISO 10993-1.
• Sterilization: The device must be able to be effectively sterilized to a sterility assurance level (SAL) of 10^-6. Acceptance criterion is compliance with ISO 11137-1/2.
• Packaging: The packaging must maintain sterility and product integrity for the stated shelf life. Acceptance criterion is compliance with ISO 11607-1/2.
• Reprocessing (for reusable instruments): Reusable instruments (if any are associated with the implant) must be able to be reprocessed effectively. Acceptance criterion is compliance with the FDA guidance on reprocessing medical devices.

Reported Device Performance:

The document states: "Results of the performed tests demonstrate that the SINEFIX are substantially equivalent to legally marketed predicate devices." This is the overarching reported performance. Specific numerical results are not provided in this summary.

2. Sample size used for the test set and the data provenance

For the non-clinical tests (insertion, pullout, cyclic loading, static tensile, dynamic testing, pyrogenicity, endotoxins, packaging, biological evaluation, sterilization validation, reprocessing validation), the sample sizes are not specified in this 510(k) summary. These tests are performed in a laboratory setting (not on human data), so terms like "country of origin of the data" or "retrospective/prospective" are not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as the tests are non-clinical (mechanical, biological, sterility, etc.) and do not involve "ground truth" derived from expert interpretation of medical images or patient data. The interpretation of results would be done by laboratory personnel according to established scientific and engineering standards and protocols.

4. Adjudication method for the test set

Not applicable, as there is no "test set" in the context of human data or expert review. Non-clinical tests follow laboratory protocols and standards.

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. This is for a non-AI/ML physical implant, not a diagnostic or prognostic AI tool.

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

Not applicable. This is for a non-AI/ML physical implant.

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

Not applicable for a physical implant's mechanical or material performance. "Ground truth" for these types of tests refers to established physical properties, chemical composition, and performance against defined standards (e.g., maximum load at failure, sterility assurance level).

8. The sample size for the training set

Not applicable. This is for a non-AI/ML physical implant, so there is no "training set."

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

Not applicable. This is for a non-AI/ML physical implant, so there is no "training set" or "ground truth" in that context.

Ask a specific question about this device

The Arthrex Tenodesis PushLock Anchor is intended to provide soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, knee, foot/ankle, and hand/wrist. Specifically;

Shoulder: Rotator Cuff Repairs, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist

The Arthrex PushLock Tenodesis Anchor is a push-in anchor made of Polyetherether-ketone. This is the same material of the predicate device. The proposed anchor is designed with either a forked or closed eyelet and comes preloaded on a disposable inserter. These are similar features to the cleared Arthrex PushLock (K101679) and Arthrex SwiveLock (K101823) suture anchors. The proposed anchor is offered sterile.

The provided text describes a medical device, the Arthrex PushLock Tenodesis Anchor, and its substantial equivalence to a predicate device. However, it does not contain information regarding a study with acceptance criteria and device performance as typically understood for AI/software devices, nor does it provide details about sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

The "Performance Data" section solely refers to tensile testing and bacterial endotoxin testing, which are standard engineering and biocompatibility tests for physical medical implants, not performance metrics for an AI or digital health device.

Therefore, I cannot fulfill the request as the necessary information is not present in the provided document.

Here's a breakdown of why I cannot generate the requested table and study description based on the input:

• No AI/Software Device: The document describes a physical medical implant (a tenodesis anchor), not an AI/software device. Acceptance criteria and performance metrics for a physical implant are typically mechanical strength, biocompatibility, and sterility, not diagnostic accuracy, sensitivity, or specificity.
• No Clinical Study for Performance (as requested): The "Performance Data" section details physical and chemical tests (tensile testing and bacterial endotoxin testing), not a clinical study involving human subjects or data analysis for diagnostic or prognostic performance.
• Missing Information: All specific points requested (sample size for test set, data provenance, number of experts, adjudication, MRMC, standalone performance, type of ground truth, training set size, training set ground truth) are absent because they are relevant to AI/software validation, which is not what this document addresses.

In summary, the provided document is a 510(k) summary for a physical medical implant, not a study report for an AI-powered device. Therefore, the information requested in the prompt is not available in the given text.

Ask a specific question about this device

The KATOR Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:

Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.

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

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.

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

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

Hip: Capsular Repair, Acetabular Labral Repair.

The KATOR Suture Anchor is designed to attach soft tissues to bone. It consists of an anchor body that is placed within a bone tunnel and a suture locking pin that secures soft tissue repair suture tape within the implant.

The applicant is seeking 510(k) clearance for the KATOR Suture Anchor, a device designed to attach soft tissues to bone. The submission focuses on demonstrating substantial equivalence to predicate devices through technological characteristics comparison and nonclinical testing.

Here's an analysis of the provided information, structured to address your questions:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify sample sizes for the individual nonclinical tests (Insertion, Pullout Strength, Cyclic Displacement, Pyrogenicity). It only mentions that "All testing was performed on test units representative of finished devices."

Data provenance is not explicitly stated as retrospective or prospective, but considering it's nonclinical testing of a device, it would inherently be prospective testing performed in a controlled laboratory environment. There's no mention of country of origin for the data, but the manufacturer is based in Logan, Utah, USA, suggesting the testing was likely conducted in the US or by a US-affiliated lab.

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

This question is not applicable to this submission. The KATOR Suture Anchor is a physical medical device, and its performance is evaluated through mechanical and biocompatibility testing, not through interpretations requiring expert consensus or ground truth derived from expert opinions (as would be the case for AI/software devices or diagnostic tools). The "ground truth" here is defined by engineering and biological standards.

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons above. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among human experts when establishing ground truth, typically in the context of diagnostic or interpretive tasks. The nonclinical tests here have objective pass/fail criteria based on predefined specifications.

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

An MRMC study was not applicable and therefore not performed. This type of study is specifically designed for evaluating the impact of AI on human reader performance, typically in diagnostic imaging or similar fields where human interpretation is a key component. The KATOR Suture Anchor is a physically implanted medical device, and its safety and effectiveness are determined by objective mechanical and biocompatibility tests, not by human reader performance.

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

This question is not applicable. The KATOR Suture Anchor is a physical medical device, not an algorithm or software. Therefore, there is no "standalone algorithm performance" to evaluate.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the nonclinical tests conducted:

• Mechanical Tests (Insertion, Pullout Strength, Cyclic Displacement Testing): The ground truth is established by engineering specifications and industry standards. The device is subjected to forces and movements, and its response is measured against predefined thresholds for strength, displacement, and ease of insertion.
• Pyrogenicity (BET Test): The ground truth is established by biological safety standards for pyrogen limits. The test measures the presence of pyrogens, and the result is compared against a specified limit to determine if the device meets safety requirements.

8. The Sample Size for the Training Set

This question is not applicable. The KATOR Suture Anchor is a physical medical device, and its development and testing do not involve "training sets" in the context of machine learning. The design and manufacturing processes are based on engineering principles and material science, not data training.

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

This question is not applicable for the same reasons as #8. There is no training set for a physical medical device.

Ask a specific question about this device

FiberTak DR is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below:
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

FiberTak DR is an "all-suture" soft-tissue fixation device with an expandable push-in design. The anchor and connected sutures are impacted into a pilot hole. The sutures are then manually tensioned to set the anchor by "bulging" the suture sleeve within the pilot hole. Once the anchor is set, the suture is passed around or though soft tissue and tied in a knot; or the repair can be completed in a knotless fashion when used in combination with Arthrex SwiveLock Anchors (K101823). FiberTak DR is constructed from a hollow braid of polyester with a suture component combination assembled through the hollow braid. The suture component can be made from either UHWMPE or a polyblend of UHMWPE and Polyester. The anchor configuration of FiberTak DR is similar to the predicate device, except that it combines suture and tape within the same anchor. FiberTak DR is available in three models with combinations in the color of its suture components. FiberTak DR comes preloaded on a disposable inserter made from stainless steel (ASTM F899) whereas the predicate inserter is made of nitinol. The handle of the inserters is made of ABS plastic. FiberTak DR may be sold separately or in a kit with implantation instrumentation. The proposed FiberTak DR is provided sterile for single use.

The provided document is a 510(k) premarket notification for the FiberTak DR device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through clinical studies or extensive performance testing with pre-defined thresholds.

Therefore, the document does not contain the following information typically associated with acceptance criteria and a study proving a device meets them:

• A table of acceptance criteria and the reported device performance: While mechanical testing is mentioned, specific acceptance criteria and detailed performance results are not provided in this summary.
• Sample sized used for the test set and the data provenance: Not explicitly stated for performance testing.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is a device performance submission, not a diagnostic accuracy study.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable as this is a device performance submission, not a diagnostic accuracy study or an AI-assisted interpretation study.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: Not applicable in the context of this device's performance testing.
• The sample size for the training set: Not applicable (no AI/algorithm training set).
• How the ground truth for the training set was established: Not applicable.

What is stated in the document regarding how the device meets regulatory requirements:

The submission focuses on demonstrating substantial equivalence to a predicate device (K151230: Arthrex FiberTak Anchors) based on:

1. Similar basic design features (all-suture anchor).
2. Similar materials.
3. Similar intended use.
4. Mechanical testing: "The submitted mechanical testing demonstrates that the pull-out strength of the proposed FiberTak DR exceeds the pull out strength of the predicate device. In addition, the pull out displacements recorded meet the criteria established by the predicate devices and therefore of no clinical relevance."
5. Biocompatibility and packaging/shelf life: Determined acceptable due to similarities in material and packaging with the predicate device.

In summary, the FDA's clearance is based on the finding that the FiberTak DR is substantially equivalent to existing devices, primarily supported by comparative mechanical testing showing its performance is at least equivalent to, if not exceeding, that of the predicate device. The document does not detail specific acceptance numeric thresholds, but rather implies that performance equivalent to a previously cleared device is the "acceptance criterion" for this type of submission.

Ask a specific question about this device

The MedShape PEEK Interference Screw is intended for soft tissue to bone reattachment in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. Specifically;

Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valqus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfers in the Foot and Ankle

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal Joint Arthroplasty (Basal Thumb Joint Arthroplasty), Carpal Ligament Reconstructions and Repairs, Tendon Transfer in the Hand/Wrist

The proposed Helical Ridge Bone Anchor is a sterile, single use, orthopedic implant intended to be used for fixation of soft tissue to bone.

The Helical Ridge Bone Anchor is comprised of PEEK. The anchor is provided sterile and pre-loaded on a disposable driver handle.

The provided document is a 510(k) premarket notification for the MedShape Helical Ridge Bone Anchor (also referred to as MedShape PEEK Interference Screw). This type of submission is for medical devices and does not typically involve AI/ML components or software. Therefore, the questions related to AI/ML study design, such as sample size for test and training sets, data provenance, ground truth establishment, expert adjudication, MRMC studies, and standalone performance, are not applicable to this document.

However, I can extract information related to the device's acceptance criteria and the studies performed to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance: Not applicable. The studies mentioned are primarily bench testing (e.g., in Sawbone® models) rather than clinical studies with human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in the context of AI/ML or clinical expert review is not relevant here. The "ground truth" for this device's performance would be the physical properties and mechanical strength of the anchor, measured objectively.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used in clinical trials or expert review for AI/ML performance, not for bench testing of physical devices.

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. This device is a physical bone anchor, not an AI/ML diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical bone anchor.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance testing (e.g., monotonic soft tissue fixation strength, dimensional verification, material safety), the "ground truth" refers to objective measurements and established standards for mechanical properties and material safety.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Ask a specific question about this device