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The JuggerKnot™ Mini Soft Anchors are intended to be used for soft tissue to bone fixation with indications for use in:

Maxillofacial

For the repair, repositioning or reattachment of soft tissues, ligament and tendons to the mandible for surgical stabilization of the TMJ articular disc.

The JuggerKnot™ Mini Soft Anchors consist of a coreless sleeve structure and suture. The anchors are intended for use in soft tissue fixation by bunching against bone when deployed.

The JuggerKnot™ Mini Soft Anchors device underwent non-clinical testing to demonstrate substantial equivalence to its predicate devices.

1. Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the exact sample size used for the mechanical pullout testing. It mentions "comparison testing" was conducted, implying multiple samples of both the JuggerKnot™ Mini Soft Anchors and the Mitek Mini QUICKANCHOR® Plus were tested. The data provenance is not specified, but it's likely from a prospective laboratory setting given it's non-clinical testing. No country of origin for the data is provided.

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

Not applicable. This was non-clinical mechanical testing, not a study requiring expert clinical assessment for ground truth.

4. Adjudication Method for the Test Set:

Not applicable. This was non-clinical mechanical testing, not a study involving human interpretation. The "ground truth" was established by objective mechanical measurement of pullout strength.

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. This document describes a K140908 510(k) submission for a medical device (soft tissue anchors), not an AI/CAD device. Therefore, no MRMC comparative effectiveness study involving human readers or AI assistance was conducted.

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

No. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth used was objective mechanical measurement of pullout strength. This is determined by a testing machine that measures the force required to pull the anchor out of the bone material, rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device and not an AI algorithm requiring a training set.

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

Not applicable, as there was no training set.

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Soft tissue fixation to bone, specifically during ligament reconstructive procedures.

The WasherLoc™ and No-Profile Screw and Washer Systems include titanium alloy (Ti-6Al-4V) screws and washers in various lengths and sizes. Both 4.5mm and 6.0mm diameter screws in lengths from 30mm to 70mm are available, with washer sizes in 14mm, 16mm, and 18mm diameters with and without spikes.

The provided 510(k) summary describes a medical device, the WasherLoc™ and No-Profile Screw and Washer Systems, and its evaluation for MR compatibility. This summary does not contain information about an AI/ML powered device, therefore no information is available that could answer your questions.

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The JuqqerKnotless™ Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, elbow, knee, hand/wrist, and hip. Specific indications are as follows:

Shoulder
Acromio-clavicular Separation, Anterior Shoulder Instability Repair, Bankart lesion repair, Biceps tenodesis, Capsule Repair or Capsulolabral Reconstruction, Deltoid Repair, Rotator Cuff Repair, S.L.A.P Lesion Repairs

Foot and Ankle
Achilles Tendon Repair/Reconstruction, Hallux Valgus Reconstruction, Lateral/Medial Stabilization Repairs/Reconstruction, Midfoot/Forefoot Reconstruction/Repairs

Elbow
Biceps Tendon Reattachment, Biceps Tendon Reconstruction, Lateral/Medial Repairs, Lateral Epicondy/itis Repair (Tennis Elbow Repair), Ulnar & Radial Collateral Ligament Reconstruction

Knee
Iliotibial Band Tenodesis, Joint Capsule Closure, Lateral/Medial Collateral Liqament Repair, Patellar Ligament Repair, Patellar Tendon Repair, Patellar Realignment/Repair, Posterior Oblique Ligament Repair, VMO Advancement

Hand and Wrist
Collateral Ligament Repair (Gamekeeper's Thumb), Scapholunate Ligament Reconstruction, Tendon Transfers in Phalanx, Volar Plate Reconstruction

Hip
Labral

The JuggerKnotless™ Soft Anchors consist of a coreless sleeve structure and a knotless construct incorporating ZipLoop™ Technology. The anchors are intended for use in soft tissue fixation by bunching against bone when deployed.

Here's an analysis of the provided text regarding the acceptance criteria and study for the JuggerKnotless™ Soft Anchors:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Acceptance Criteria" for this device:
The document does not explicitly list numerical "acceptance criteria" in the way one might see for diagnostic software (e.g., target specificity/sensitivity). Instead, for this type of medical implant, the primary "acceptance criterion" for non-clinical testing is typically demonstrated equivalence in performance (specifically, mechanical fixation strength) to an already legally marketed and accepted predicate device. This is a common approach for 510(k) submissions where substantial equivalence is claimed.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "mechanical pullout testing," but the number of anchors or tests performed is not specified.
• Data Provenance: The testing was "non-clinical laboratory testing," implying it was conducted in a controlled lab setting, likely in the USA where Biomet Sports Medicine is located. It is by definition retrospective in the context of device development, as it assesses the device's properties before market release.

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

This question is not applicable to the provided document. The "ground truth" for this type of device (medical implant fixation) is established through objective mechanical testing (fixation strength measurements) against a control, not through expert consensus or interpretation of images.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in studies involving human interpretation (e.g., radiologists reviewing images), not for objective mechanical testing of device performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• Was it done? No. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." MRMC studies typically involve human readers interpreting cases, often to compare AI-assisted performance with unassisted performance. This was a non-clinical, mechanical performance study.

• Effect size of human readers improving with AI vs without AI assistance: Not applicable, as no MRMC study or clinical study involving human-AI interaction was performed or reported.

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

• Was it done? Yes, in a sense. The mechanical testing performed on the JuggerKnotless™ Soft Anchors is a form of "standalone" evaluation of the device's physical performance, independent of human interaction during its assessment. The device itself is an implant, not an algorithm. The testing evaluated the device's intrinsic mechanical property (fixation strength) without human-in-the-loop performance assessment of that specific property.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth used was objective mechanical measurements of "fixation strength." This is determined through physical testing protocols that measure parameters like pullout force, displacement, or ultimate load to failure, compared against a predicate device.

8. The Sample Size for the Training Set

This question is not applicable. This device is a physical medical implant, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The device's design and manufacturing 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, as there is no training set for this device.

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The JuggerKnot™ Mini Soft Anchors are intended to be used for soft tissue to bone fixation with indications for use in:

Shoulder Bankart repair

Foot and Ankle Midfoot Reconstruction, Hallux valgus reconstruction

Hand and Wrist

Ulnar or lateral collateral ligament reconstruction, Repair/reconstruction of collateral ligaments, flexor and extensor tendon at the PIP (proximal interphalangeal, DIP (distal interphalangeal), and MCP (metacarpal interphalangeal) joints for all digits, Scapholunate ligament reconstruction.

The JuggerKnot™ Mini Soft Anchors consist of a coreless sleeve structure and suture. The anchors are intended for use in soft tissue fixation by bunching against bone when deployed.

Here's a breakdown of the acceptance criteria and the study information for the JuggerKnot™ Mini Soft Anchors, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Note: The document explicitly states "None provided as a basis for substantial equivalence" under "Clinical Testing." This indicates that biological safety and efficacy were demonstrated through non-clinical testing and comparison to predicate devices, rather than human trials.

Study Details

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

• Test Set Sample Size: Not explicitly stated. The summary mentions "mechanical pullout testing" where the JuggerKnot™ Mini Soft Anchors were compared to two predicate devices. This implies a sample size of anchors for each device type subjected to the pullout test, but the exact number isn't quantified.
• Data Provenance: The testing was "Non-clinical laboratory testing," indicating it was conducted in a controlled lab environment. The country of origin is not specified, but the applicant "Biomet Sports Medicine" is located in Warsaw, Indiana, USA, suggesting the testing likely occurred in the US or under US guidance. The testing is retrospective in the sense that it's performed on manufactured devices, not on living subjects over time.

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

This question is not applicable in the context of this device and study. The "ground truth" for non-clinical mechanical testing is typically established by engineering standards and validated testing protocols, not by expert consensus in the way clinical diagnostic image interpretation would be. The outcome (fixation strength) is objectively measured by testing equipment.

4. Adjudication Method for the Test Set

This question is not applicable. As the testing is mechanical and quantitative (fixation strength), there is no "adjudication" of expert opinions. The measurements from the mechanical tests are the primary data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical cases. This submission focuses on the mechanical performance of a soft tissue fixation device.

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

This question is not applicable. This is not an AI/algorithm-based diagnostic device. The "device" itself is a physical implant. The "standalone" performance here refers to the mechanical performance of the anchor itself when tested in a controlled laboratory setting. The non-clinical testing described is essentially demonstrating the "standalone" mechanical performance of the anchors.

7. The Type of Ground Truth Used

The ground truth used for the non-clinical testing was objective mechanical measurements of fixation strength, as determined by standardized laboratory pullout tests.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of this 510(k) submission for a mechanical device. The device's design is based on engineering principles and similarity to predicate devices, not on machine learning from a dataset.

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

This question is not applicable for the reasons stated in point 8.

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The Biomet Sports Medicine™ Maxfire™ MarXmen™ Meniscal Repair Device is indicated for the repair of vertical longitudinal full thickness tears (i.e. bucket-handle) in the red-red and redwhite zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus.

The Maxfire™ Meniscal Repair Device is a permanent fixation anchor composed of a size 2-0 polyethylene/polypropylene ZipLoop™ construct with two #5 polyester sleeves. The ZipLoop™ construct is an adjustable loop created with a single piece of fiber material. When the ZipLoop™ is pulled tight, the sleeves lock against the meniscal tissue, pulling the tear together. The sleeves control the size of the knot ensuring that the anchor does not become too small and pull through the meniscal tissue. The anchors are pre-loaded onto an insertion instrument. The inserter allows for single entry into the joint. Once in the joint, the inserter will pierce the meniscus at the desired location. The insertion device is available as an in-line inserter or a pistol-grip inserter, the MaxFire™ MarXmen™ Meniscal Repair Device. This allows separate deployment of the anchors, one on each side of the tear. After the second anchor has been deployed, the knotted end of the ZipLoop™ construct is gently pulled by the surgeon, allowing the meniscal tear to be compressed. The Maxfire™ anchor sits on the back side of the meniscus.

The medical device referenced is the "MaxFire™ and MaxFire™ MarXmen™ Meniscal Repair Devices".

Here's an analysis of the acceptance criteria and study proving the device meets them:

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 a separate "test set" in the context of clinical data. The performance data provided is from non-clinical (mechanical) testing. No information is given about the sample size (number of devices or tests performed) for the fixation strength testing. The provenance of the data is also not stated (e.g., country of origin, retrospective or prospective).

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

Not applicable. This device is a mechanical implant, and the assessment is based on physical performance (fixation strength) rather than expert interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication was required for mechanical testing results.

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

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "None provided as a basis for substantial equivalence" under the "SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION."

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

Not applicable. This is not an AI/algorithm-based device. It is a mechanical medical implant.

7. The Type of Ground Truth Used

The ground truth for evaluating the device's main performance characteristic (fixation strength) was based on mechanical test results comparing it to a legally marketed predicate device. The acceptance criteria were derived from the performance of the predicate device (Arthrotek® MaxFire™ Meniscal Repair Device - K061776).

8. The Sample Size for the Training Set

Not applicable. This is a mechanical device, not an AI/machine learning model, so there is no concept of a "training set" in the traditional sense.

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

Not applicable. As above, there is no training set for this type of device. The mechanical properties were evaluated against pre-defined acceptance criteria based on the predicate device's performance.

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The Biomet Sports Medicine Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures.

The Biomet Sternal Fixation Devices System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures to aid in the alignment and stabilization of bone. The Implants for this application include Clips and ZipLoop™ constructs packaged with single use instruments to assist in insertion and applying tension to close the ZipLoop™ construct to the desired size. The Biomet Sternal Fixation System Devices are single use.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Biomet Sports Medicine Sternal Closure System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical acceptance criteria in a quantitative format. Instead, it relies on a comparative statement against predicate devices.

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

• Sample Size: Not explicitly stated. The document mentions "Non-clinical laboratory testing was performed" and "The efficacy of the Biomet Sports Medicine Sternal Closure System was compared to that of the Ethicon Surgical Stainless Steel Sutures," implying a test set was used, but the number of devices or iterations tested is not provided.
• Data Provenance: The testing was "Non-clinical laboratory testing," suggesting an in-vitro or bench-top study. The location or specific laboratory where this testing occurred is not detailed. The data is retrospective in the sense that it's a submission after the tests were conducted, but it's not clinical retrospective data from patients.

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

Not applicable. This was a non-clinical laboratory study involving mechanical testing, not a clinical study requiring expert assessment of images or patient data to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable, as this was a non-clinical mechanical test, not a study requiring human adjudication of results.

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. The provided document concerns a medical device (Sternal Closure System), not an AI-powered diagnostic or decision support system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

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

Not applicable. This is not an AI-powered device. The "standalone" performance refers to the device's mechanical properties without human interaction during its function (i.e., its ability to provide equivalent cyclic fatigue strength).

7. The Type of Ground Truth Used

The "ground truth" for this non-clinical study was the mechanical performance (cyclic fatigue strength) of the predicate devices. The Biomet system's performance was measured against the established performance of these legally marketed devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set. The "training" in this context would be the design and engineering process of the device, informed by existing knowledge of sternal closure mechanics and predicate devices.

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

Not applicable. As this is not an AI/machine learning device, there is no "training set." The understanding that informed the device's design would stem from engineering principles, material science, and the known performance characteristics of existing sternal closure systems (predicate devices), rather than a specific "ground truth" derived for a training set.

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To provide fixation of soft-tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.

The Biomet Sports Medicine TunneLoc™ Tibial Fixation Device is a non-resorbable intratunnel implant intended to aid in arthroscopic ACL and/or PCL reconstructions. The inserter instrument provides a means to apply and hold tension to the soft tissue, align and drive the PEEK implant. A nitinol quide wire instrument is provided to aid in implant placement. The TunneLoc™ Tibial Fixation Devices provide the surgeon with a means to aid in the management of soft tissue to bone reattachment procedures.

This document describes the TunneLoc™ Tibial Fixation Device, a non-resorbable intratunnel implant for ACL and/or PCL reconstructions. The device is intended for soft tissue fixation within the tibial tunnel.

Here is an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample size (number of devices, test repetitions) for the non-clinical pullout tests.

• Data Provenance: The tests were conducted using porcine tibia and bovine tendon test medium. This indicates an in vitro or ex vivo setting, not human data. The country of origin of the data is not specified, but the applicant is based in Indiana, USA. The testing is retrospective in the sense that it evaluates the device after its design, but not on human patients.

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

• This information is not provided. Non-clinical mechanical tests typically rely on established engineering standards and methodologies for "ground truth" (e.g., force transducers, load cells, material properties testing machines), rather than human expert consensus.

4. Adjudication Method for the Test Set

• This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation or subjective assessments. Mechanical testing follows predefined protocols and measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence."

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

• This question is not applicable. The TunneLoc™ Tibial Fixation Device is a medical implant, not an algorithm or AI system. Its performance is evaluated through mechanical testing, not algorithmic output.

7. The Type of Ground Truth Used

• The ground truth for the non-clinical testing was established through objective measurement of pullout strength using force testing equipment. This relies on the physical properties of the materials and the mechanical forces applied, rather than expert consensus, pathology, or outcomes data, which are relevant for clinical studies or diagnostic devices.

8. The Sample Size for the Training Set

• This question is not applicable. This is a medical device, not an AI or machine learning system that requires a "training set."

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

• This question is not applicable as there is no training set for this device.

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The Sleeve with ZipLoop™ Fixation Devices are intended for fixation for the following indications:

Shoulder
Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps tenodesis

Foot and Ankle
Medial/lateral repair and reconstruction, Mid- and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair

Elbow
Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment

Knee
Extra-capsular repair: MCL, LCL, and posterior oblique ligament Iliotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure

Hand and Wrist
Collateral ligament repair, Scapholunate reconstruction, Tendon transfers in phalanx, Volar plate reconstruction

Hip
Acetabular labral repair

The Sleeve with ZipLoop™ Fixation Devices are a three component assembly consisting of two sleeves and a ZipLoop™ construct. The ZipLoop™ construct is an adjustable loop created with a single piece of fiber material. When the ZipLoop is pulled tight, the sleeve locks against the bone fixating the soft tissue. The Sleeve with ZipLoop™ Fixation Devices provide the surgeon with a means to aid in the management of soft tissue to bone reattachment procedures.

The provided text describes a 510(k) summary for the "Sleeve with ZipLoop™ Fixation Devices". This document focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against acceptance criteria through a clinical study. Therefore, much of the requested information (like acceptance criteria, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not applicable or not provided in this type of submission.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document explicitly states that non-clinical laboratory testing was performed to verify the fixation strength and functionality. The acceptance criterion was implicitly equivalence in pullout strength to the predicate devices.

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

• Sample Size: Not specified. The document only mentions "non-clinical laboratory testing" without detailing the number of samples or tests performed.
• Data Provenance: Not applicable, as this was non-clinical laboratory testing, not human data. The testing was performed by Biomet Sports Medicine.

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 clinical studies and expert review for AI devices, is not relevant here. The evaluation was based on physical property testing (pullout strength).

4. Adjudication method for the test set

• Not Applicable. Adjudication methods are used in clinical studies or expert reviews to resolve disagreements, not for mechanical 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

• No. An MRMC study was not done. This device is a surgical fixation device, not an AI-powered diagnostic or decision support tool. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence."

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

• Not Applicable. This is a physical medical device, not an algorithm. Standalone performance refers to AI algorithms.

7. The type of ground truth used

• Mechanical Test Results (Pullout Strength): The "ground truth" for the non-clinical testing was the objective measurement of pullout strength, compared against the pullout strength of predicate devices.

8. The sample size for the training set

• Not Applicable. This device did not involve machine learning or AI, so there was no training set. The "training" for such devices would typically involve design and engineering processes, material selection, and iterative physical testing, which don't have "training sets" in the AI sense.

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

• Not Applicable. No training set as it's not an AI/ML device.

In summary, this 510(k) submission primarily relies on non-clinical laboratory testing to demonstrate mechanical equivalence to existing predicate devices, rather than clinical efficacy or AI performance metrics.

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The ToggleLoc™ System Devices are intended for soft tissue to bone fixation for the following indications:

Shoulder: Bankart lesion repairs Acromio-clavicular repair, Capsular shift/capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps Tenodesis

Foot and Ankle: Medial/lateral repair and reconstruction, Mid- and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair, Ankle Syndesmosis fixation (Syndesmosis disruptions) and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures (only for ToggleLoc™ with Tophat)

Elbow: Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment

Knee: ACL/PCL repair / reconstruction, ACL/PCL patellar bone-tendon-bone grafts, Double-Tunnel ACL reconstruction, Extracapsular repair: MCL, LCL, and posterior oblique ligament, Illiotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure

Hand and Wrist: Collateral ligament repair, Scapholunate ligament reconstruction, Tendon transfers in phalanx. Volar plate reconstruction

Hip: Acetabular labral repair

The ToggleLoc™ System contains toggle buttons and a Tophat suture button preloaded with sutures and/or fiber constructs. The suture button has multiple eyelets for attachment of fiber constructs and/or sutures. The fiber constructs and/or sutures are preloaded for the convenience of the surgeon for soft tissue attachment.

This 510(k) summary for the ToggleLoc™ System describes a medical device seeking clearance based on substantial equivalence to previously marketed devices. It does not contain information about a study proving device performance against specific acceptance criteria.

The submission states that:

• Non-Clinical Testing: "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use."
• Clinical Testing: "None provided as a basis for substantial equivalence."

Therefore, I cannot populate the requested table and information as a study proving device meets acceptance criteria, an acceptance criteria table with reported performance, sample sizes, expert qualifications, or ground truth details were not provided in this document.

In summary:

1. Table of acceptance criteria and reported device performance: Not provided. The submission states non-clinical testing was performed, but no specific acceptance criteria or performance metrics are detailed.
2. Sample size used for the test set and data provenance: Not applicable as no clinical or specific non-clinical test set details are provided.
3. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable, as no ground truth establishment for a test set is described.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study was mentioned.
6. Standalone (algorithm-only) performance: Not applicable, as this is a physical medical device, not an algorithm.
7. Type of ground truth used: Not applicable, as no specific ground truth for performance evaluation is described.
8. Sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

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Harpoon® and Mini-Harpoon® Suture Anchors are indicated for use in soft tissue reattachment procedures. Specific Indications are:

Shoulder - Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair, and anterior shoulder instability repair

Wrist - Scapholunate ligament reconstruction

Elbow - Biceps tendon reattachment, Ulnar or radial collateral ligament reconstruction, and lateral epicondylitis repair

Knee - Extracapsular Repair (Medial collateral ligament repair, lateral ligament repair, and posterior oblique ligament repair), joint capsule closure, iliotibial band tenodesis reconstruction, patellar realignment and tendon repair, and vastus medialis obliquus (VMO) muscle advancement

Foot and Ankle - Hallux valgus repairs, medial or lateral instability repair/reconstruction, Achilles tendon repair/reconstruction, midfoot reconstruction, and metatarsal ligament/tendon repair/reconstruction

Hip - Capsular Repair (acetabular labral repair)

The Harpoon® Suture Anchor is comprised of either stainless steel or titanium material designed with a collar that provides resistance to pullout of the device. It is preloaded with a polyethylene suture and available in two sizes.

The provided text is a 510(k) Summary for the Harpoon® Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in the way typically seen for diagnostic or AI-driven medical devices.

Therefore, most of the requested information cannot be extracted from this document.

Here's an assessment based on the available text:

Acceptance Criteria and Device Performance

The document does not specify quantitative acceptance criteria or a reported device performance table as would be expected for a diagnostic or AI device. Instead, it states:

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

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

A test set was not used in the context of performance evaluation against acceptance criteria, as no clinical testing or specific non-clinical performance evaluation against predefined criteria is detailed.

• Sample Size (Test Set): Not applicable, as no dedicated "test set" for performance evaluation is described.
• Data Provenance: Not applicable.

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

Not applicable, as no ground truth was established from expert review for a test set in this 510(k) submission.

4. Adjudication method for the test set

Not applicable, as no test set requiring adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence."

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

This concept is not relevant to the Harpoon® Suture Anchor, which is a physical medical device (suture anchor), not an algorithm or a software device.

7. The type of ground truth used

Not applicable. The "ground truth" concept (e.g., pathology, expert consensus) is typically associated with the evaluation of diagnostic or prognostic devices/algorithms. For a physical device like a suture anchor, "ground truth" would refer to its physical properties and mechanical performance, which were assessed via non-clinical testing. However, the details of how this was established are not provided other than: "Non-clinical laboratory testing was performed to determine substantial equivalence."

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is not an AI/ML algorithm that requires a training set.

Summary of what the document does provide regarding "proof" of meeting criteria:

The document leverages the concept of substantial equivalence to predicate devices. The "study" that proves the device meets (implicitly, rather than explicitly stated) acceptance criteria is the non-clinical laboratory testing that compared the Harpoon® Suture Anchor to its predicates.

"Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use."

This implies that the non-clinical tests (e.g., mechanical strength, pull-out force, material biocompatibility, etc. – although not detailed in this summary) demonstrated performance comparable to the predicate devices, thereby supporting the claim that it is "functional within its intended use" and "substantially equivalent." No specific quantitative acceptance criteria or detailed results from these non-clinical tests are included in this 510(k) Summary.

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