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HIP: Hip capsule repair, Acetabular labrum reattachment

SHOULDER: Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs Biceps tenodesis

FOOT & ANKLE: Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy

ELBOW, WRIST, & HAND: Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair

KNEE: Extra-capsular repairs (Medial collateral ligament, Lateral collateral ligament, Posterioroblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Iliotiblal band tenodesis

The CinchLock Flex Knotless Suture Anchor is a non-degradable PEEK suture anchor that is pre-assembled to a stainless steel inserter. Non-degradable Ultra High Molecular Weight Polyethylene (UHMWPE) suture is provided within the sterile package with the Knotless Suture Anchor and Inserter. The CinchLock Flex Knotless Suture Anchor with Inserter and Suture is provided as a sterile single use device.

The provided document is a 510(k) premarket notification for a medical device called the "CinchLock Flex Knotless Suture Anchor." This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the manner you've outlined for algorithms or diagnostic tools.

Therefore, much of the information you requested (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) is not applicable to this type of regulatory submission. This document describes the device, its intended use, and then asserts substantial equivalence based on non-clinical verification and validation testing.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of specific numerical acceptance criteria with corresponding performance data in the typical sense for algorithms. Instead, the performance is evaluated by "non-clinical verification and validation testing" demonstrating equivalence to the predicate device. The general acceptance criterion is that the subject device performs at least as well as or similarly to the predicate device for various mechanical properties and safety aspects.

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

• Sample Size: Not explicitly stated as "test set" in the context of an algorithm. The non-clinical verification and validation testing would have involved a sufficient number of device samples to ensure statistically sound results for mechanical and other tests. Specific numbers are not detailed in this summary document.
• Data Provenance: The tests are described as "non-clinical verification and validation testing." This typically means laboratory bench testing, simulations, and material characterization performed by the manufacturer (Pivot Medical). It's not human clinical data or retrospective/prospective patient data.

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

• Not Applicable. This is a mechanical device, not a diagnostic algorithm requiring expert interpretation to establish ground truth. The "ground truth" for the mechanical tests would be established by standardized testing methods and measurement instruments, comparing the results to established norms or the predicate device's performance.

4. Adjudication Method for the Test Set:

• Not Applicable. No human adjudication of results is mentioned or relevant for these types of non-clinical mechanical tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. This type of study is specifically for evaluating the effectiveness of diagnostic or screening tools, particularly with human readers. This device is a surgical implant; an MRMC study is not relevant.

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

• Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

• For the non-clinical tests, the "ground truth" would be objective measurements obtained through calibrated equipment and standardized test protocols. The primary comparison point (the "truth" for demonstrating equivalence) is the performance of the legally marketed predicate device (CinchLock Knotless Suture Anchor, K131769).

8. The Sample Size for the Training Set:

• Not Applicable. As a physical device, there isn't a "training set" in the computational or AI sense.

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

• Not Applicable. See point 8.

Summary based on the document:

The document describes the CinchLock Flex Knotless Suture Anchor as a line extension to an existing device. The study to prove the device meets acceptance criteria primarily involved non-clinical verification and validation testing. The core of this study was to demonstrate substantial equivalence to a previously cleared predicate device (CinchLock Knotless Suture Anchor, K131769). The modifications were to the inserter, handle, and anchor coupling, with no changes to the implantable material.

The testing covered aspects like:

• Insertion Strength
• Anchor Coupling Strength
• Ultimate Tensile Strength
• Anchor Cinch Force
• Inserter Moment Testing
• Design Validation
• Packaging Validation
• Sterilization Validation
• Shelf Life/Stability Validation
• Biological Safety Assessment

The results of this testing verified that the subject device is substantially equivalent to the predicate, and raises no new questions of safety or effectiveness. Clinical testing was explicitly stated as "not required to demonstrate substantial equivalence for this submission."

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The CinchLock Knotless Suture Anchor and the NanoTack Suture Anchor 1.4mm are intended for the fixation of soft tissue to bone in the hip, shoulder, foot/ankle, hand/wrist, elbow, and knee. Please see individual indications for use statements.

The NanoTack® Suture Anchor, previously cleared under 510(k) K110473 and K130351, is intended for fixation of soft tissue to bone in the hip, shoulder, foot/ankle, hand/wrist, elbow, and knee, in the following procedures: Hip capsule repair, Acetabular labrum reattachment, Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions), Acromilavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis, Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy, Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Extra-capsular repairs (Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Iliotibial band tenodesis.

The CinchLock™ Knotless Anchor, previously cleared under 510(k) K123651, is intended for fixation of soft tissue to bone in the hip, shoulder, foot/ankle, hand/wrist, elbow, and knee, in the following procedures: Hip capsule repair, Acetabular labrum reattachment, Capsular stabilization, Bankart repair, Anterior shoulder Instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions, Acromilavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis, Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy, Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Extra-capsular repairs, Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament, Patellar realignment and tendon repairs, Vastus medialis obliquous advancement, Iliotibial band tenodesis.

The Pivot Suture Anchors which are part of this expanded indications submission are as follows: Pivot CinchLock Knotless Suture Anchor, Pivot NanoTack Suture Anchor 1.4mm. These anchors are non-degradable suture anchors manufactured from PEEK-OPTIMA® LT1 polymer. The CinchLock and NanoTack Anchors are attached to / pre-assembled to a stainless steel Inserter. Non-degradable ultra-high molecular weight polyethylene (UHMWPE) blue co-braid #1 suture is provided in the sterile package with the CinchLock Knotless Suture Anchor and Inserter. The Pivot NanoTack Suture Anchor incorporates a non-degradable ultra high molecular weight polyethylene (UHMWPE) blue co-braid #1 suture. The CinchLock Knotless Suture Anchor and NanoTack Suture Anchor 1.4mm devices are provided as a single use sterile devices.

I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets those criteria, as it focuses on a medical device clearance (510(k) for suture anchors) rather than an AI/ML device.

Specifically, the document discusses:

• Device Names: CinchLock Knotless Suture Anchor, NanoTack Suture Anchor 1.4mm
• Classification: Bone Anchor, Class II, Product Code MBI
• Predicate Device: Smith and Nephew BioRaptor 2.3PK Suture Anchor - K071586
• Device Description: Non-degradable suture anchors made from PEEK-OPTIMA® LT1 polymer, pre-assembled to a stainless steel Inserter, with UHMWPE suture.
• Intended Use: Fixation of soft tissue to bone in various anatomical regions (hip, shoulder, foot/ankle, hand/wrist, elbow, and knee) for specified procedures.
• Technological Characteristics: Identical to previous submissions; the current submission is for expanded indications.
• Performance Testing: Mentions "insertion strength, anchor strength, suture strength, and biocompatibility testing" demonstrating substantial equivalence to the predicate device.
• Substantial Equivalence: Claimed based on indications for use, technological characteristics, and comparison to the predicate device.
• FDA Clearance: A letter from the FDA confirming substantial equivalence and providing clearance.
• Expanded Indications for Use: Detailed lists of procedures for the NanoTack and CinchLock anchors across various joints.

This information pertains to a traditional medical device (suture anchors) and its mechanical and biological performance, not an AI/ML diagnostic or prognostic device. Therefore, the questions regarding acceptance criteria in terms of performance metrics like sensitivity, specificity, AUC, sample sizes for test/training sets, ground truth establishment, expert consensus, MRMC studies, or standalone algorithm performance are not applicable to this document.

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The NanoTack Suture Anchor is intended for the fixation of soft tissue to bone in the hip, and is indicated for the reattachment of hip labrum to the acetabulum.

The Pivot NanoTack Suture Anchor 1.4mm is a non-degradable suture anchor manufactured from PEEK-OPTIMA® polymer attached to a non-degradable ultra high molecular weight polyethylene (UHMWPE) blue co-braid #1 suture that is pre-assembled to a Flex stainless steel Inserter. The NanoTack Suture Anchor 1.4mm with Flex Inserter is provided as a single use sterile device.

The Pivot Medical NanoTack Suture Anchor 1.4mm with Flex Inserter is a medical device designed for the fixation of soft tissue to bone in the hip, specifically for the reattachment of the hip labrum to the acetabulum. The device is a "Special 510(k)" submission, meaning it is substantially equivalent to a previously cleared device (NanoTack Suture Anchor 1.4mm - K110473) with minor modifications.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states that "Pre-clinical testing includes insertion strength and anchor strength." However, it does not specify the sample size used for these tests. The data provenance is also not explicitly mentioned, but "pre-clinical testing" typically implies laboratory or cadaveric studies, not human clinical trials, and would likely be conducted in the country of origin of the manufacturer (USA, given the FDA submission). It is a prospective study as it evaluates the device performance for regulatory submission.

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

This information is not provided in the document. The testing described (insertion strength and anchor strength) are biomechanical performance tests, not subjective evaluations requiring expert clinicians to establish ground truth in the same way as, for example, image interpretation. Therefore, "ground truth" would be established by the objective measurements obtained during the mechanical testing.

4. Adjudication Method for the Test Set:

This information is not applicable and is not provided. The performance testing involves objective measurements rather than subjective assessments that would require an adjudication method.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret images or data, and the AI's impact on their performance is evaluated. The NanoTack Suture Anchor is a surgical implant, and its evaluation focuses on mechanical performance, not diagnostic accuracy.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone (algorithm only) performance study was not done. The NanoTack Suture Anchor is a physical medical device, not an algorithm. Its performance is assessed through mechanical and material testing.

7. Type of Ground Truth Used:

The ground truth for the performance testing (insertion strength and anchor strength) was established through objective mechanical and material property measurements. For example, force gauges would be used to measure insertion force, and load cells would measure anchor pull-out strength.

8. Sample Size for the Training Set:

This information is not applicable and is not provided. The NanoTack Suture Anchor is not an AI/ML device that requires a training set. Its design and performance are based on engineering principles and materials science.

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

This information is not applicable, as there is no training set for this type of medical device.

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The Pivot Knotless Suture Anchor is indicated for the reattachment of hip labrum to the acetabulum.

The Pivot Knotless Suture Anchor is a non-degradable suture anchor manufactured from PEEK-OPTIMA® LT1 polymer attached to / pre-assembled to a stainless steel Inserter. Non-degradable ultra-high molecular weight polyethylene (UHMWPE) blue co-braid #1 suture is provided in the sterile package with the Knotless Suture Anchor and Inserter. The Knotless Suture Anchor with Inserter and Suture is provided as a single use sterile device.

This document is a 510(k) premarket notification for a medical device (Knotless Suture Anchor). It does not contain acceptance criteria or a study proving device performance against acceptance criteria in the typical sense of a diagnostic or AI device. This type of submission relies on demonstrating "substantial equivalence" to a predicate device already on the market, rather than specific performance metrics against pre-defined acceptance criteria through a clinical trial.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from this document, as they pertain to a different type of device evaluation.

However, I can provide the information that is present and relevant to the "substantial equivalence" claim:

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

Instead of formal acceptance criteria and quantitative performance metrics like sensitivity/specificity for a diagnostic device, the "acceptance criteria" here is the demonstration of "substantial equivalence" to predicate devices based on technological characteristics and performance testing.

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

• Sample Size: Not applicable. This document refers to "pre-clinical testing" for insertion strength, suture strength, and biocompatibility, but does not provide details on sample sizes for these tests. There is no "test set" in the context of diagnostic performance evaluation.
• Data Provenance: Not applicable in the context of a retrospective/prospective study for device clinical performance. The pre-clinical testing would have been conducted in a lab setting.

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

• Not applicable. There is no "ground truth" to be established by experts as this is not a diagnostic device and no clinical efficacy study is detailed in this 510(k) summary. The evaluation focuses on material properties and mechanical performance compared to predicate devices.

4. Adjudication method for the test set:

• Not applicable. See point 3.

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 not an AI device or a diagnostic device where human reader performance would be a factor.

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

• Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

• Mechanical and Biocompatibility Standards / Predicate Device Performance. The "ground truth" for this type of submission is the established safety and effectiveness of the legally marketed predicate devices, and the demonstration that the new device meets similar performance benchmarks (e.g., strength, biocompatibility).

8. The sample size for the training set:

• Not applicable. There is no "training set" for an AI model or a device of this nature.

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

• Not applicable. See point 8.

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The NanoTack Suture Anchor is intended for the fixation of soft tissue to bone in the hip, and is indicated for the reattachment of hip labrum to the acetabulum.

The Pivot NanoTack Suture Anchor is a non-degradable suture anchor manufactured from PEEK-OPTIMA® polymer attached to a non-degradable ultra high molecular weight polyethylene (UHMWPE) blue co-braid #1 suture that is pre-assembled to a stainless steel Inserter. The NanoTack Suture Anchor with Inserter is provided as a single-use sterile device.

Based on the provided text, the device in question is the NanoTack Suture Anchor 1.4mm, a non-degradable suture anchor intended for the fixation of soft tissue to bone in the hip, specifically for the reattachment of the hip labrum to the acetabulum.

However, the provided document does not contain the details necessary to answer all parts of your request. The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed study report with specific acceptance criteria, performance metrics, or ground truth establishment.

Here's an attempt to answer as much as possible based on the given text, with explicit notes for missing information:

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

Missing Information: Specific quantifiable acceptance criteria (e.g., minimum pull-out strength, insertion torque, etc.) and the detailed numerical results from the performance testing are not provided in this summary.

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

Missing Information: The document does not specify the sample size for any test set (e.g., how many anchors were tested, how many times). It also doesn't mention the data provenance (country of origin, retrospective/prospective).

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 is not applicable to this type of device and study. The "ground truth" concept usually applies to diagnostic or prognostic devices where a true clinical state needs to be determined by human experts. For a mechanical device like a suture anchor, "ground truth" would relate to its physical properties and mechanical performance, which are measured using engineering tests, not expert consensus.

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

Not applicable for the reasons stated above (mechanical device, not diagnostic).

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 surgical implant, not an AI-assisted diagnostic tool or a device that involves human "readers" interpreting images. Therefore, an MRMC study and AI improvement effect size are not relevant.

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

Not applicable. This device is a physical surgical implant, not an algorithm.

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

As explained, "ground truth" in the diagnostic sense is not directly applicable. For performance testing of a mechanical device like this, the "ground truth" would be established by standardized engineering and mechanical test methods to measure properties like pull-out strength, ultimate tensile strength, fatigue life, etc., comparing them against the known performance of the predicate devices. The document states "performance testing conducted demonstrates that the insertion and fixation properties... are substantially equivalent." This implies that standard mechanical tests were performed.

8. The sample size for the training set

There is no mention of a training set. This is a physical medical device, not a machine learning model, so the concept of a "training set" is not applicable in this context.

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

Not applicable as there is no training set mentioned or relevant for this device.

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