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The Acumed Suture Anchor System is designed to be used for soft tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder.

The Acumed Suture Anchor System is intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, and shoulder.

Shoulder: Rotator Cuff Repair, Bankhart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular shift or Capsulolabral Reconstruction.

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

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

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

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

The Acumed Suture Anchor System is a system for anchoring soft tissue grafts), using #2 high-strength suture, back to the bone for reattachment. It is available in diameters of 4.5 mm & 5.5 mm in order to accommodate differing anatomic requirements.

The anchor is a screw designed to provide fixation to bone that comes with two, #2 high-strength suture (pre-attached) in order to secure soft tissue (or soft tissue grafts) to the anchor. The system includes Class 1 instruments.

The provided document describes a medical device, the Acumed Suture Anchor System, and its acceptance criteria for 510(k) clearance. However, the study supporting this clearance is a preclinical testing rather than a study involving human subjects or AI algorithms. As such, many of the requested categories related to AI performance, human expert involvement, and ground truth establishment are not applicable.

Here's the information derived from the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Size used for the test set and the data provenance:

   • Not applicable. The study involved preclinical testing of the modified suture anchor, not a test set of data or human subjects.

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

   • Not applicable. The ground truth was based on the physical properties and performance of the device in preclinical testing. No human experts were used to establish a ground truth for a test set.

3. Adjudication method for the test set:

   • Not applicable. This was preclinical testing, not a study requiring adjudication of a test set.

4. 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 was preclinical testing of a medical device, not an MRMC study involving human readers or AI.

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

   • Not applicable. This was preclinical testing of a physical medical device, not an algorithm.

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

   • Preclinical Testing Results: The ground truth was established through physical testing (static and dynamic tension tests) comparing the modified device's performance to the predicate device.

7. The sample size for the training set:

   • Not applicable. There was no training set, as this was preclinical testing of a physical device.

8. How the ground truth for the training set was established:

   • Not applicable. There was no training set. The "ground truth" for the preclinical performance was established via engineering and biomechanical testing standards.

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The Acumed Suture Anchor System is intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, and shoulder.

Shoulder: Rotator Cuff Repair, Bankhart 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 and Bunionectomy.

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

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

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

The Acumed Suture Anchor System is a system for anchoring soft tissue (or soft tissue grafts), using #2 high-strength suture, back to the bone for reattachment. It is available in diameters of 3.5mm & 4.5mm in order to accommodate differing anatomic requirements.

The anchor is a screw designed to provide fixation to bone that comes with two, #2 high-strength suture (pre-attached) in order to secure soft tissue (or soft tissue grafts) to the anchor.

The system includes Class 1 instruments.

The provided document describes the Acumed Suture Anchor System, a medical device for soft tissue fixation to bone. The information primarily focuses on the device's description, intended use, indications for use, technological characteristics, and a comparison to a predicate device for substantial equivalence.

However, the provided text does not contain information related to acceptance criteria or a study proving the device meets specific performance metrics in the way a diagnostic AI/ML device would. This document describes a traditional medical implant, where "performance data" refers to mechanical testing for strength and equivalence to an existing device, not diagnostic accuracy, sensitivity, or specificity.

Therefore, for your specific request that includes acceptance criteria, sample sizes for test sets, ground truth establishment, expert involvement, MRMC studies, or standalone algorithm performance, the provided document does not contain this information.

The "Performance Data" section states:

"The Acumed Suture Anchor System and the predicate were subjected to static and dynamic tension along the axis of the screw as well as static and dynamic tension normal to the axis of the screw. The results demonstrate that the subject components are substantially equivalent to the predicate."

This indicates engineering/mechanical testing to show the new device performs similarly to a previously approved device (the predicate). It does not involve a clinical study with human patients, diagnostic performance metrics, or the establishment of ground truth in a diagnostic sense.

To directly answer your numbered points based on the provided text:

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

   • Acceptance Criteria: Not explicitly stated as pass/fail thresholds for specific engineering metrics. Instead, the criterion for approval is "substantial equivalence" to the predicate device based on mechanical performance.
   • Reported Device Performance: "The results demonstrate that the subject components are substantially equivalent to the predicate."

   Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
   Mechanical Strength (Static and Dynamic Tension along/normal to screw axis)	Performance comparable to predicate device (Arthrex 3.7 mm Bio-Corkscrew (K061863))	Demonstrated substantial equivalence to the predicate.

2. Sample sized used for the test set and the data provenance: Not applicable. This was mechanical testing, not a clinical trial with a "test set" of patients or data provenance in the context of diagnostic AI.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for diagnostic AI (e.g., expert consensus on images, pathology reports) is not relevant for this mechanical testing.

4. Adjudication method: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, as it's not an algorithm/AI device.

7. The type of ground truth used: For mechanical testing, the "ground truth" would be the measured physical properties (e.g., tensile strength, fatigue resistance) of the devices under controlled conditions, compared against the known properties of the predicate device. This isn't "expert consensus" or "pathology" in the diagnostic sense.

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

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

In summary, the provided document is a 510(k) summary for a traditional medical device (a suture anchor), and the "performance data" described relates to mechanical testing for substantial equivalence, not the diagnostic performance criteria typically associated with AI/ML devices that would require the detailed information requested in your prompt.

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The Acu-Sinch Repair System is intended to be used in conjunction with a clavicle plate of the Congruent Bone Plate System to provide fixation during the healing of clavicle fractures.

The Acu-Sinch Repair System also may be used as a stand-alone system for treatment of acromioclavicular and/or coracoclavicular ligament disruption.

The Acumed Suture Anchor is intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow 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, Midfoot Reconstruction, Metatarsal Ligament Repair
• Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial Band Tenodesis
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Acumed's Locking Clavicle Plating System is designed to provide fixation during fractures, fusions, or osteotomies of the clavicle.

The Acu-Sinch Repair System consists of several components (Suture Anchor, Clavicle Fracture Plate, Acu-Sinch plate, Suture Retainer, Screws, and Suture) which can be combined to create various device constructs to treat the indications listed above. The Suture Anchor can be used for fixation of suture to bone in the anatomic locations listed above.

The acceptance criteria and study proving the device meets these criteria are described below:

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 exact "sample sizes" in terms of number of devices or iterations for the preclinical testing. The testing described is preclinical (laboratory-based mechanical testing), not a clinical study involving human or animal subjects, so data provenance such as "country of origin" or "retrospective/prospective" is not applicable in the typical sense. The testing was performed on the device components themselves.

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

This information is not applicable as the "ground truth" for the preclinical mechanical tests is based on the physical properties and performance of the device components compared to established predicate devices, rather than expert interpretation of medical data.

4. Adjudication Method for the Test Set

This information is not applicable as the preclinical tests involve objective mechanical measurements and comparison to predicate devices, not expert adjudication of clinical outcomes or images.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The study conducted was preclinical mechanical testing.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The device is a surgical repair system, not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for the preclinical testing was established by the performance of legally marketed predicate devices. The acceptance criterion for the Acu-Sinch Repair System was that its mechanical performance (load to failure, fatigue, pull-out strength, and general engineering analysis) was "substantially equivalent" to these predicates.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" as this is a medical device subject to preclinical mechanical testing, not an algorithm that requires training data.

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

This question is not applicable for the reasons stated above.

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This device is intended for anchoring soft tissue to bone in soft tissue repair of the foot and ankle and rotator cuff repair.

The Acumed Suture Anchor is a single use implantable device used with non-absorbable, noncoated white or green #2 or #0 braided polyester suture to anchor soft tissue to bone in rotator cuff repairs as cleared by 510(k) submission K980103 and soft tissue repairs of the foot and ankle. The suture anchor is manufactured from titanium 6AL 4V ELI per ASTM F136 and is provided non-sterile.

This document is a 510(k) summary for the Acumed Suture Anchor, a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results in the way one would for a novel AI/software medical device.

Therefore, many of the requested categories for AI/software device evaluation are not applicable or cannot be extracted from the provided text. The document describes a traditional hardware medical device (suture anchor), not a software or AI-driven device.

Here's an analysis based on the provided text, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This document is a 510(k) summary for a hardware device, not a performance study for an AI/software device. It doesn't present performance metrics like sensitivity, specificity, or accuracy against a defined acceptance criterion.

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

Not applicable. There is no "test set" in the context of evaluating an AI or software device. The document mentions "data on file at Acumed" regarding steam sterilization validation, but this is a manufacturing process validation, not clinical performance data for a diagnostic or therapeutic AI.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth, as understood in AI/software device evaluation, is not established or discussed for this hardware device.

4. Adjudication Method

Not applicable. There is no adjudication process described for a study evaluating AI or software performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. An MRMC study is relevant for evaluating the impact of AI on human readers, which is not the subject of this 510(k).

6. Standalone (Algorithm Only) Performance Study

Not applicable. The Acumed Suture Anchor is a physical implant, not an algorithm.

7. Type of Ground Truth Used

Not applicable. There is no "ground truth" established in the sense of clinical diagnoses or outcomes to validate an algorithm. The 510(k) process for this device relies on demonstrating substantial equivalence to existing legally marketed predicate devices in terms of indications for use, technological characteristics, and safety/effectiveness profiles.

8. Sample Size for the Training Set

Not applicable. There is no "training set" for a hardware medical device like this suture anchor.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set mentioned or relevant for this type of device submission.

Summary of Relevant Information from the Provided Text for a Hardware Medical Device:

The document focuses on demonstrating Substantial Equivalence to legally marketed predicate devices, which is the primary "study" for a 510(k) submission of this nature.

• Acceptance Criteria: The implicit acceptance criterion for a 510(k) is that the new device is "substantially equivalent" to predicate devices in terms of:
  • Indications for use.
  • Technological characteristics (e.g., material, design, sterilization).
  • Safety and effectiveness.
• Study That Proves Device Meets Acceptance Criteria (in this context): The "study" is the comparison to predicate devices.
  • Predicate Devices: Mitek GII Anchor, SuperAnchor, Linvatec Revo, and Zimmer Statak.
  • Demonstration of Equivalence:
    • Indications: The Acumed Suture Anchor has the "same indications" as the predicates (anchoring soft tissue to bone in rotator cuff repairs, and soft tissue repairs of the foot and ankle).
    • Materials: Manufactured from titanium 6AL 4V ELI per ASTM F136, similar to predicates.
    • Design: Screw-based design is "similar to the Linvatec Revo and the Zimmer Statak."
    • Surgical Techniques: "Similar surgical techniques" to the Mitek GII Anchor and SuperAnchor.
    • Sterilization: The document mentions "Acumed has identified a set of process parameters for steam sterilization which provide an SAL of 10 as validated by data on file at Acumed." This is a validation of the sterilization process itself, not a comparative performance study in a clinical setting.
  • Conclusion: "Based on the similarities between the Acumed Suture Anchor and the predicate devices studied, the safety and effectiveness of the Acumed Suture Anchor is expected to be similar to the predicate devices mentioned above."

Essentially, the "study" for this 510(k) is a detailed comparison and justification, rather than a clinical trial or a performance evaluation against specific numerical thresholds in a test set. This is typical for Class II hardware devices seeking market clearance via the 510(k) pathway.

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This device is intended for anchoring soft tissue to bone in rotator cuff repairs of the shoulder and soft tissue repair of the foot and ankle.

The Acumed Suture Anchor is a single use implantable device used with non-absorbable, non-coated white or green #2 or #0 braided polyester suture to anchor soft tissue to bone in rotator cuff repairs and soft tissue repairs of the foot and ankle. The suture anchor is manufactured from titanium 6AL 4V ELI per ASTM F 136 and is provided non-sterile.

The provided text is a 510(k) summary for the Acumed Suture Anchor, a medical device. This type of regulatory submission focuses on demonstrating "substantial equivalence" to existing, legally marketed predicate devices, rather than establishing de novo performance criteria through a study with specific acceptance criteria as would be done for novel devices or those undergoing extensive clinical trials.

Therefore, the document does not contain information regarding a study designed to establish acceptance criteria and prove the device meets them in the way described in the request. Instead, the core argument for clearance is based on the similarity to predicate devices.

Here's how to address the requested information based on the provided text, and where it falls short:

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

• Information Not Found: The document does not define specific performance acceptance criteria (e.g., tensile strength, pull-out force) for the Acumed Suture Anchor, nor does it report specific performance values from a dedicated study against such criteria. The submission relies on the assumption that its performance will be "similar" to predicate devices.

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

• Information Not Found: No test set sample size or data provenance is mentioned because no performance study, in the sense of testing against acceptance criteria, is described for the Acumed Suture Anchor. The "data on file at Acumed" regarding sterilization mentions an SAL, but this is a process validation, not a device performance study.

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

• Information Not Found: This information is not applicable as no test set or expert-established ground truth is described for the device's functional performance.

4. Adjudication method for the test set

• Information Not Found: This is 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

• Information Not Found: This is not applicable. The device is a physical bone anchor, not an AI-assisted diagnostic tool.

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

• Information Not Found: This is not applicable. The device is a physical bone anchor, not an algorithm.

7. The type of ground truth used

• Information Not Found: This is not applicable to a device clearance based on substantial equivalence to predicate devices for its functional performance. The "ground truth" here is essentially the regulatory acceptance of the predicate devices.

8. The sample size for the training set

• Information Not Found: This is not applicable. There is no mention of a "training set" as this is not a machine learning or diagnostic device.

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

• Information Not Found: This is not applicable.

Summary of Device Acceptance Criteria and Study as per the Provided Text:

The Acumed Suture Anchor's acceptance and market clearance are not based on meeting new, device-specific performance acceptance criteria established through a dedicated study. Instead, its acceptance is based on demonstrating substantial equivalence to existing predicate devices.

The arguments for substantial equivalence are:

• Identical Indications For Use: "This device is identical in indication to the Mitek GII and SuperAnchor (K953877), the Zimmer Statak (K926384), and the Linvatec Revo (K941691)." Specifically, "This device is intended for anchoring soft tissue to bone in rotator cuff repairs of the shoulder and soft tissue repair of the foot and ankle."
• Similar Design and Manufacturing Material: "This device is most similar in design to the Zimmer Statak and the Linvatec Revo devices in that all three are based on screw designs and are manufactured from titanium alloys. The Acumed Suture Anchor is manufactured from titanium 6AL 4V ELI per ASTM F 136."
• Similar Surgical Techniques: "The Acumed Suture Anchor and the Mitek GII Anchor and SuperAnchor have similar surgical techniques."
• Sterilization Validation: Acumed has identified process parameters for steam sterilization providing an SAL of 10^-6, "as validated by data on file at Acumed." (This is a process validation, not a performance study of the anchor itself).

In essence, the "study" demonstrating this device meets "acceptance criteria" is the comprehensive review by the FDA (K980103) concluding that the Acumed Suture Anchor is substantially equivalent to legally marketed predicate devices, thereby assuming similar safety and effectiveness. No specific performance study to quantify device performance (e.g., pull-out strength in tissue) against predefined numerical acceptance criteria is detailed in this 510(k) summary.

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