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The devices are intended for soft tissue to bone suture fixation for the following indications: Shoulder - Bankart lesion repairs - S.L.A.P. lesion repairs - Acromio-clavicular Repairs - Capsular Shift/Capsulolabral Reconstruction - Deltoid Repair - Rotator cuff tear repairs - Biceps tenodesis; Foot and Ankle - Medial/lateral repairs, reconstructions 1 - Achilles tendon repairs - Midfoot and forefoot repairs - Hallux Valgus reconstruction; Elbow - Ulnar or radial collateral ligament reconstructions - Tennis elbow repair - Biceps tendon reattachment; Knee - Extra-capsular repairs: -Medial collateral ligament Lateral collateral ligament Posterior oblique ligament - Iliotibial band tenodesis - Patellar tendon repair - -VMO advancement - Joint capsule closure; Hand/Wrist - Collateral ligament repair (Gamekeeper's Thumb) - -Scapholunate ligament reconstruction - Tendon transfers in phalanx - Volar plate reconstruction

The anchor is cylindrical in shape and is preassembled threaded with USP size 2-0 I he anchor is cynnurear in shape and if production Device holds the anchor and through 2 braided poryester suture. The mass of the sutures can then be used to secure the soft tissue to the bone.

The provided document describes a 510(k) premarket notification for a medical device called the "Multitak Suture System." This type of submission focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than conducting new clinical studies to establish acceptance criteria and performance against those criteria.

Therefore, much of the requested information, specifically regarding detailed acceptance criteria, study methodologies (test set, ground truth, expert involvement, MRMC studies, standalone performance, training set details), and specific performance metrics in numerical terms, is not available in the provided text.

The document primarily focuses on:

• Identifying the device and its intended use.
• Listing predicate devices.
• Stating that performance data was collected (pullout testing).
• Concluding that the device is substantially equivalent to predicate devices based on this testing.

Here's an attempt to answer the questions based only on the provided text, highlighting what is missing:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only mentions "pullout testing," which implies laboratory or bench testing rather than human clinical data.

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

• Number of Experts: Not applicable, as this was likely bench testing, not an expert-driven ground truth assessment.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable, as this was likely bench testing.

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

• MRMC Study: No. This device is a surgical anchor, not an AI-assisted diagnostic tool, so an MRMC study is not relevant or described.

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

• Standalone Performance: No, this device is a physical surgical implant, not an algorithm.

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

• Type of Ground Truth: For the "pullout testing," the ground truth would inherently be against a quantitative measurement of the mechanical property (pullout strength) of the device itself and its predicate. It's not a clinical "ground truth" derived from patient outcomes or pathology.

8. The sample size for the training set

• Sample Size: Not applicable. This device is a physical medical device, not an AI model, and therefore does not have a "training set."

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

• Ground Truth Establishment: Not applicable, as there is no training set for this type of device.

Summary of the "Study" (Per the Document):

The document states that the Multitak Suture System underwent pullout testing. The "proof" that it meets acceptance criteria (which are implied to be "equal to or better than the predicate device's pullout strength") is the conclusion that the device "demonstrated pullout strength equal to or better than the predicate device(s)." This is a comparative biomechanical study, not a clinical trial with human subjects. The full details of this testing (e.g., specific test methods, number of samples, statistical analysis) are not provided in this summary.

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The Multitak Suture System is intended for soft tissue to bone suture fixation for the following indications: Knee Shoulder Extra-capsular repairs: Bankart lesion repairs Medial collateral ligament S.L.A.P. lesion repairs Lateral collateral ligament Acromio-clavicular repairs Posterior oblique ligament Capsular shift/capsulolabral reconstruction Iliotibial band tenodesis Deltoid repair Rotator cuff tear repairs Biceps tenodesis Foot and Ankle Medial/lateral repairs, reconstructions Achilles tendon repairs (Gamekeeper's Thumb) Midfoot and forefoot repairs Hallux valgus reconstruction Elbow Ulnar or radial collateral ligament reconstructions Tennis elbow repair Biceps tendon reattachment Patellar tendon repair VMO advancement Joint capsule closure Hand/Wrist Collateral ligament repair Scapholunate ligament reconstruction Tendon transfers in phalanx Volar plate reconstruction

The anchor is tubular in shape and is preassembled threaded with USP size 2-0 through 2 braided polyester suture. An Introduction Device holds the anchor and delivers it into the bone through a predrilled hole. The sutures can then be used to secure the soft tissue to the bone.

The provided text describes the "Multitak Suture System" and its intended use, but it does not contain acceptance criteria or a detailed study that proves the device meets specific performance criteria. The "Performance Data" section is very brief and general.

Here's an analysis of the information that is available, and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The study appears to be a laboratory-based biomechanical test.

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

• Not applicable. The "ground truth" here relates to biomechanical performance (pullout strength, insertion), not expert interpretation of medical images or clinical outcomes. The study was a laboratory-based mechanical test.

4. Adjudication Method for the Test Set

• Not applicable. This was a laboratory mechanical test, not a study requiring expert adjudication.

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

• No, a MRMC comparative effectiveness study was not done. The study described is a laboratory-based mechanical test comparing the device to a "suture only reattachment technique."

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

• Not applicable. This is a medical device (suture anchor), not an algorithm or AI system.

7. The Type of Ground Truth Used

• Biomechanical Measurements: The ground truth was established through direct physical measurements of pullout strength and verification of insertion and locking mechanisms in a laboratory setting. This is a form of engineered or physical ground truth, not pathology, expert consensus, or outcomes data.

8. The Sample Size for the Training Set

• Not applicable. This is a medical device, not an AI or machine learning model that requires a training set.

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

• Not applicable.

Summary of What's Missing and Why:

The provided document is a 510(k) summary for a medical device (a suture anchor system). These summaries typically focus on demonstrating substantial equivalence to predicate devices, rather than providing the detailed technical and statistical results of comprehensive clinical or AI performance studies.

Specifically, for the "Performance Data" section:

• It states that the device was "compared in pullout testing to the predicate device" and "found to demonstrate pullout strengths superior to those of a suture only reattachment technique." However, it does not provide:
  • Specific quantitative pullout strength values for the device or the comparator.
  • Statistical significance testing details (e.g., p-values, confidence intervals).
  • The type of material used for testing (e.g., cadaver bone, synthetic bone).
  • The number of samples tested (sample size).
• It states "Insertion testing was performed to verify insertion and locking at all indicated sites." Again, no specific data, methodology, or acceptance criteria are given.

Therefore, while the document confirms performance testing was done, it lacks the detailed information required to fully answer many of your questions, particularly regarding specific numerical acceptance criteria, sample sizes, and detailed performance metrics.

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The devices are intended for soft tissue to bone suture fixation for the following indications: Shoulder - Rotator cuff tear repairs । - Biceps tenodesis . Foot and Ankle - Lateral instability repairs/reconstructions - Elbow - Ulnar or radial collateral ligament reconstructions - - Tennis elbow repair - - Biceps tendon reattachment - Knee 1 - Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament

The anchor is tubular in shape and is preassembled threaded with USP size 2-0 through 2 braided polyester suture. An Introduction Device holds the anchor and delivers it into the bone through a predrilled hole. The sutures can then be used to secure the soft tissue to the bone.

The provided document describes a medical device, the Multitak Suture System™, but it does not contain the type of AI/ML-related performance data (e.g., accuracy, sensitivity, specificity) requested in the prompt. Instead, it describes a physical medical device and its mechanical performance testing.

Therefore, I cannot provide the information requested in the format of AI/ML acceptance criteria and study details. The document is primarily a summary of safety and effectiveness for a physical surgical anchor system, focusing on its intended use and mechanical pullout strength compared to a predicate device.

Here's an overview of what is available in the given text, rephrased to fit the context of device performance, even though it's not AI/ML performance:

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)

• Sample Size: Not specified. The document only mentions "cadaver bone". No specific number of samples or cadavers is provided.
• Data Provenance: The test was performed on "cadaver bone." The country of origin is not specified. It is an experimental, prospective test of the device's mechanical properties.

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 is a mechanical performance test, not a diagnostic or interpretation study. "Ground truth" would be the measured pullout strength.

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

• Not applicable. This is a mechanical performance test, not a study requiring adjudication of expert opinions. The ground truth is directly measured physical force.

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 a physical device; there are no "human readers" or "AI assistance" involved in its direct mechanical performance testing.

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

• Not applicable. This device is not an algorithm. Its performance is entirely "standalone" in the sense that its mechanical properties are inherent to the device itself.

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

• The "ground truth" for the performance test was the measured pullout tension (force) in cadaver bone, compared against established values or performance of a predicate device.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. There is no "training set."

In summary: The provided text details a physical medical device and its mechanical performance testing against a predicate device, not an AI/ML system, thus it lacks the specific AI/ML and diagnostic study details requested in the prompt.

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The devices are intended for soft tissue to bone suture fixation for the following indications: Shoulder - Rotator cuff tear repairs - Biceps tenodesis - Foot and Ankle - Lateral instability repairs/reconstructions - Elbow, Wrist and Hand - Ulnar or radial collateral ligament reconstructions - Tennis elbow repair - Biceps tendon reattachment - Knee - Extra-capsular repairs: -Medial collateral ligament Lateral collateral ligament

The anchor is tubular in shape and is preassembled threaded with USP size 2-0 through 2 braided polyester suture. An Introduction Device holds the anchor and delivers it into the bone through a predrilled hole. The sutures can then be used to secure the soft tissue to the bone.

This document, K964324 for the Multitak Suture System™, is a 510(k) submission to the FDA. It does not include performance data from a clinical study to demonstrate the device meets acceptance criteria.

The document explicitly states: "The nature of device changes do not necessitate performance data testing." This indicates that the submission is for a modification to a previously cleared device (Multitak SS Suture System, K934183) and, based on the FDA's guidance for 510(k) submissions, the changes were deemed not significant enough to require new clinical performance data to prove substantial equivalence. Therefore, there is no acceptance criteria or study outlined in this document.

To answer your specific questions in the format requested, I must state that the information is "Not Applicable" or "Not Provided" as no performance study or acceptance criteria are detailed in this particular document.

Here's how I would structure the response given the provided text:

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)

Not Applicable. No test set or performance data is presented in this submission.

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. No test set or ground truth establishment is described in this submission.

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

Not Applicable. No test set or adjudication method is described in this submission.

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. No MRMC study was conducted or described in this submission. This device is a surgical suture system, not an AI-assisted diagnostic tool.

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

Not Applicable. This device is a surgical suture system, not an algorithm.

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

Not Applicable. No ground truth is described as no performance study was conducted.

8. The sample size for the training set

Not Applicable. No training set is described as no performance study was conducted.

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

Not Applicable. No ground truth for a training set is described as no performance study was conducted.

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