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The PULLUP® BTB, BT LOOP®, PULLUP® CLIP and PULLUP® TEX CLIP devices are designed to be used as cortical fixation for ACL reconstruction.

The device is proposed in the following variants:

• -PULLUP®: comprises a titanium button-plate, and an adjustable nonabsorbable braided loop. The system is preloaded with traction and flip threads, and is designed to be used with a soft tissue graft.
• PULLUP® BTB: comprises a titanium button-plate, and an adjustable nonabsorbable braided loop. The system is preloaded with traction and flip threads, as well as a temporary splice suture, and is designed to be used with a bone-tendon-bone graft.
• -BT LOOP®: comprises a titanium button-plate, and an adjustable nonabsorbable braided loop. The system is preloaded with traction and flip threads, as well as a temporary splice suture, and is designed to be used with a bone-tendon-bone graft. It is assembled on a holder that must be mounted on the GraftTech® preparation station.
• -PULLUP® CLIP: comprises a titanium button-plate only, is designed to be used with a soft tissue graft, and can either be connected to another PULLUP® CLIP button-plate by using the PULLUP® TEX CLIP nonabsorbable braided loop, or can be connected to another PULLUP® device.

Standard models are used for cortical tunnels with a diameter of 4.5 mm; XL models are used for cortical tunnels with a diameter between 5 and 10 mm.

The implants are supplied sterile, individually packaged, ready to use.

This is a 510(k) premarket notification for a medical device, not a study evaluating an AI algorithm. Therefore, the standard information requested for describing acceptance criteria and a study proving device performance for an AI algorithm is not applicable here.

Here's a breakdown of why the requested information cannot be provided from the given document:

• This is not an AI/Software as a Medical Device (SaMD) submission: The document describes PULLUP® BTB, PULLUP® CLIP, PULLUP® TEX CLIP adjustable fixation systems, and BT LOOP® for ligament reconstruction. These are physical implants, not AI algorithms.
• The document focuses on substantial equivalence to a predicate device: The purpose of a 510(k) submission is to demonstrate that a new device is as safe and effective as a legally marketed predicate device. It doesn't typically involve new clinical studies with acceptance criteria in the way AI algorithm validation does.
• "Device performance" refers to mechanical and biological properties: In this context, "device performance" refers to the biocompatibility, biological, and mechanical properties of the physical implant, not the diagnostic or predictive performance of an algorithm.

Based on the provided text, I can extract the following relevant information regarding non-clinical performance:

1. Acceptance Criteria and Reported Device Performance (Non-Clinical)

Explanation: The document states that "Non-clinical testing including biocompatibility, biological and mechanical performances were not impacted by the change. The results indicated that the devices were functional within their intended use and equivalent to the predicate devices. The proposed device has been determined to be non-pyrogenic." This indicates that the new variants met the established non-clinical performance and safety profiles, thus fulfilling the acceptance criteria for these aspects.

The following requested information is NOT APPLICABLE or NOT AVAILABLE in the provided document, as it pertains to AI/algorithm validation, not to the premarket notification of a physical medical device:

• Sample size used for the test set and the data provenance: Not applicable.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• 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.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

In summary, this document describes the substantial equivalence of a physical medical device (ligament fixation systems) through non-clinical testing, not the performance validation of an AI algorithm.

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The In2Bones Hercules™ Suture Anchors are intended for use in the following applications:

1. Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction.

2. Foot/Ankle: Lateral and Medial stabilization. Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction.

3. Knee: Medial collateral and Lateral ligament repair, Patellar tendon and Posterior oblique ligament repair.

4. Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction.

5. Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction.

The In2Bones Hercules™ Suture Anchor System is a bone implant device intended for the fixation of soft tissue to bone. This system consists of two anchor styles manufactured from ASTM F 2026 Poly Ether Ether Ketone (PEEK) - Fully threaded anchor and Knotless anchor - that are available in five sizes ranging from 2.0mm to 5.5mm and 4 sizes ranging from 2.5mm to 5.5mm respectively, for use in a range of fixation applications.

This document is a 510(k) summary for the Hercules™ Suture Anchor System. It details the device's indications for use, comparison to predicate devices, and performance testing conducted to demonstrate substantial equivalence.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for the mechanical performance tests in an easily digestible table format with reported performance. Instead, it states that "mechanical testing was done in accordance with ASTM F543-07 to evaluate the anchors and establish substantial equivalence." This implies that the acceptance criteria are met if the device's performance is comparable to or better than previously cleared predicate devices, as assessed against the standards of ASTM F543-07.

To extract acceptance criteria and reported performance, we infer from what is mentioned:

Note: The document focuses on demonstrating substantial equivalence rather than defining specific acceptance criteria for a new, novel product. Therefore, the "reported device performance" is often a statement that the relevant standard was met, implying that the performance was acceptable relative to the predicate devices.

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

• Sample Size for Test Set: The document does not specify the exact sample size (number of anchors) used for each mechanical test (Anchor Insertion Torque, Torque to Failure, Tensile Pullout, Cyclic Load, Post-Fatigue Pullout). It only mentions that "mechanical testing was done."
• Data Provenance: The studies were bench tests (non-clinical performance mechanical testing). This means the data is not from human subjects. The location where the tests were performed is not specified, but it would have been in a laboratory or testing facility. The data is prospective in the sense that these tests were conducted specifically for this submission, although they are based on established standards.

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

This section is not applicable as the studies are mechanical bench tests, not involving human interpretation or expert evaluation of data to establish a ground truth. The "ground truth" for these tests is defined by the physical properties and performance characteristics measured against industry standards (ASTM, ISO).

4. Adjudication Method for the Test Set

This section is not applicable as the studies are mechanical bench tests. Adjudication methods (like 2+1, 3+1) are typically used for studies involving multiple human readers assessing medical images or patient data where disagreements may arise.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study involves human readers, and the provided information pertains to the mechanical performance of a medical device (suture anchors), not an AI algorithm for diagnostic purposes.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

Not applicable. The device is a physical medical implant (suture anchor system), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used

The "ground truth" for the mechanical performance tests is based on established engineering standards and specifications (e.g., ASTM F543-07, ANSI/AAMI ST72, ISO 11135, ISO 11137-2, ISO 10993-1, ISO 11607-1). The device's performance is compared against these objective, quantifiable standards and against the performance of predicate devices as measured under these standards.

8. Sample Size for the Training Set

Not applicable. This submission is for a physical 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. As stated above, there is no training set for a physical medical device.

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Force Fiber® Non-absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopedic surgeries.

Force Fiber Suture - Black is a non-absorbable, sterile, surgical suture composed of Ultra High Molecular Weight Polyethylene (UHMWPE) dyed black using D&C Black #4 not to exceed 1.0% by weight. It is an uncoated braid offered in a variety of cut lengths, with or without needles, and provided sterile for single use only. Force Fiber Suture - Black is available in sizes 0, 1 and 2, and meets all surgical suture requirements established by the USP for non-absorbable surgical sutures except for oversize diameter.

This document is a 510(k) summary for a medical device called "Force Fiber® Suture - Black." It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study where specific performance criteria are measured against acceptance criteria. Therefore, much of the requested information regarding study design, sample sizes, expert involvement, and ground truth establishment is not present in this document.

However, I can extract the general acceptance criteria and what is reported about the device's performance based on the provided text.

Acceptance Criteria and Reported Device Performance

• Suture diameter
• Tensile strength
• Needle attachment | "Force Fiber Suture - Black is available in sizes 0, 1 and 2, and meets all surgical suture requirements established by the USP for non-absorbable surgical sutures except for oversize diameter."
  "Force Fiber Suture - Black is tested in accordance with USP - non-absorbable surgical sutures for suture diameter, tensile strength and needle attachment, and meet the requirements of the Class II Special Controls Guidance: Surgical Sutures; Guidance for Industry and FDA; June 3, 2003." |
  | Material Biocompatibility (ISO 10993-1:2018) | Evaluation through biological qualification safety tests as outlined in ISO 10993-1: 2018 --Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing. This implies meeting the safety requirements for medical devices in contact with the body. | "All materials used in the fabrication of the Force Fiber Suture - Black were evaluated through biological qualification safety tests as outlined in ISO 10993-1: 2018 --Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing." |
  | MRI Safety | "MR Safe" designation, meaning it poses no known hazards in MR environments. | "Force Fiber Suture - Black is tested to demonstrate it is "MR Safe" and poses no known hazards in MR environments." |
  | Substantial Equivalence | No differences in technological characteristics and performance characteristics compared to predicate devices, and the difference (addition of black dye) does not raise new questions of safety or efficacy, making it as safe and effective as currently marketed predicate devices. This is the primary "acceptance criterion" for a 510(k) pathway. | "Force Fiber Suture – Black is substantially equivalent to its predicate Force Fiber Suture devices because there are no differences in technological characteristics and performance characteristics between the proposed and predicate devices. The proposed sutures have the same fundamental design and intended use as the predicate devices. The difference between Force Fiber Suture - Black and its predicate Force Fiber Suture devices is the addition of black dye... This difference does not raise new questions of safety or efficacy. Therefore, Force Fiber Suture - Black is as safe and effective as its currently marketed predicate devices." |

Information Not Available in the Document:

Because this document is a 510(k) summary demonstrating substantial equivalence for a surgical suture, not a clinical study report for an AI/imaging device, the following information is not provided:

2. Sample size used for the test set and the data provenance: Not applicable in this context. The testing mentioned refers to material properties and biocompatibility, not performance against a specific "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI algorithms (e.g., diagnostic accuracy) is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: 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: Not applicable. This device is a surgical suture, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For material properties, the "ground truth" would be established by validated testing methods and specifications (e.g., USP standards), not expert consensus on medical images or outcomes.
8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a medical device (surgical suture) and demonstrates its compliance with established regulatory standards (USP, ISO) and substantial equivalence to existing predicate devices. It does not involve AI or imaging diagnostics, and therefore, many of the requested data points related to those types of studies are not relevant or present.

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Pre-sutured allograft tendons are intended for use as a construct in anterior cruciate ligament and posterior cruciate ligament reconstruction.

This device consists of a combination of tendons that have been cleaned and disinfected using a proprietary process. The tendons are pre-sutured and terminally sterilized by low dose electron beam irradiation. The device may include anterior tibialis, posterior tibialis, peroneus longus, semitendinosus and/or gracilis tendons and is pre-sutured with Force Fiber UHWMPE nonabsorbable surgical suture. Through a contractual agreement with Teleflex Medical, AlloSource has the license rights to manufacture pre-sutured tendons using their UHMWPE non-absorbable surgical suture cleared 15-Sept-2009 under pre-market clearance K092533. All products are provided sterile and for single patient use.

The provided text describes a 510(k) premarket notification for a medical device called "ReConnex™ Pre-Sutured Tendon". It details the device's characteristics, intended use, and the justification for its substantial equivalence to a predicate device.

However, the provided document does not contain any information about an AI/ML device, nor does it discuss acceptance criteria and study results in the context of an AI/ML algorithm's performance.

The document primarily focuses on:

• The regulatory classification of the device (Class II, surgical suture).
• The components of the device (pre-sutured allograft tendons).
• Its intended use (ACL/PCL reconstruction).
• Comparison to a predicate device (Arthrex Suture Grafting Kit) and a reference device (Force Fiber UHWMPE Non-absorbable Surgical Suture).
• Biocompatibility requirements (donor eligibility, infectious disease screening).
• Performance testing related to physical properties of the tendon/suture construct (visual characteristics, tensile strength, suture pull-out, knot pull strength).
• A cadaver feasibility study demonstrating biomechanical equivalence to a surgeon-sutured construct and feasibility of implantation.
• Bacterial endotoxin testing.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML device based on the provided text. The prompt's requirements (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, AI assistance effect size, standalone algorithm performance, training set details) are all relevant to the validation of an AI/ML system, which is not what this document is describing.

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The Stryker Self-Punching ICONIX Anchors are intended to be used for soft-tissue to bone fixation in the elbow, shoulder, knee and hip. See indications below.

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

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

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

Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair

The Self-Punching ICONIX Anchors (herein referred to as the proposed device(s)) are all suture anchors with a push-in design, provided sterile and preloaded on a disposable inserter. The anchors consist of a polyester sheath interwoven over non-absorbable working sutures, which are folded over and mounted on the forked tip of the inserter. The anchor is inserted into the bone using a self-punching mechanism, and the polyester sheath bunches as the anchor is deployed to allow for fixation in bone. The anchor preloaded on the inserter is packaged in a single-use sterile barrier system (SBS).

The provided text is a 510(k) summary for the Stryker Self-Punching ICONIX, a medical device for soft-tissue to bone fixation. It does not describe a study involving acceptance criteria and a device's performance against them in the context of an AI/algorithm-based diagnostic or prognostic device.

Instead, this document describes and demonstrates the substantial equivalence of a new medical device (Stryker Self-Punching ICONIX Anchors) to existing predicate devices based on non-clinical benchtop testing. The performance data presented focuses on fixation strength and insertion effort, not on diagnostic accuracy, sensitivity, specificity, or reader performance in an AI context.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details for AI performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these concepts are not addressed in this document for the described device.

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Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction
Hip: Capsular Repair, Acetabular Labral Repair

The proposed device is a suture-anchor to be used for soft tissue fixation to bone. The Gryphon Anchor is a cannulated, ribbed anchor, made of either non-absorbable PEEK (Polyetheretherketone) or absorbable Biocryl® RapideTM (composite of β-TCP and PLGA copolymer). Size #1 blue Permacord™ suture (UHMWPE braided suture) is preloaded on the anchor. The suture incorporates a pre-tied sliding knot (ProKnot knot). The Permacord suture is a non-absorbable suture that conforms to USP except for oversized diameter. The device is provided as sterile; the device is for single patient use only.

The provided document describes a 510(k) submission for a medical device, the GRYPHON™ ANCHOR w/PROKNOT™ Technology. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets new acceptance criteria through a clinical or performance study with a test set, ground truth experts, and MRMC studies as typically seen in AI/Software as a Medical Device (SaMD) submissions.

The "study" in this context is the non-clinical testing performed to show the new device performs similarly to the predicate device.

Here's how to interpret the information based on the provided text, addressing your points where possible, and noting when the information is not applicable to this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (an orthopedic anchor), the "acceptance criteria" are typically related to mechanical performance characteristics that demonstrate equivalence to the predicate.

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

• Sample Size for Test Set: Not explicitly stated. For mechanical testing of medical devices like this, the "sample size" refers to the number of physical anchors and sutures tested. This is typically determined by engineering standards and statistical power calculations to demonstrate a certain level of confidence in the performance. The document only states "Fixation strength testing, suture knot strength testing and suture fray testing were conducted."
• Data Provenance: The testing was "conducted" by DePuy Mitek. The provenance of the "data" itself (e.g., patient data, country of origin, retrospective/prospective) is not applicable here as this is mechanical testing of the device itself, not clinical data from patients.

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

• This is not applicable for this type of device submission. Ground truth, in the context of expert review, is relevant for diagnostic devices or AI/SaMD where human interpretation or clinical outcomes are the gold standard. For an orthopedic anchor, the "truth" is established by physical measurements and engineering specifications, not expert consensus.

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

• Not applicable. Adjudication methods are used in studies involving human interpretation or clinical outcomes to resolve discrepancies in ground truth labeling. For mechanical testing, the "adjudication" is based on objective measurements and established thresholds.

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. MRMC studies are specific to diagnostic imaging devices, particularly those involving AI. This device is a surgical implant (an anchor), not an imaging or diagnostic tool.

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

• Not applicable. This device does not have an algorithm component.

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

• The "ground truth" for this device's performance relies on engineering specifications, standardized test methods (e.g., ASTM standards, USP for sutures), and direct physical measurements (e.g., force required for fixation failure, suture break strength, degree of fraying). The "truth" is objective, measurable, and compared against established performance criteria from the predicate devices.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of machine learning. The design and manufacturing processes are established through engineering principles, not data-driven training.

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

• Not applicable. As there is no training set, there is no ground truth to establish for it.

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The HEALIX ADVANCE Anchor is indicated for use in soft tissue to bone fixation in association with post-operative immobilization as follows:

Shoulder: Rotator Cuff Repair, 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;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction;
Hip: Capsular Repair, Acetabular Labral Repair.

The Healix Advance" Anchor with Permacord™ suture is a threaded suture anchor preloaded on a disposable inserter assembly intended for fixation soft tissue to bone. Healix Advance Anchors are available in absorbable BR and non-absorbable PEEK materials. Permacord suture is a non-absorbable suture that conforms to USP, except for oversized diameter. Healix Advance Anchors with Permacord are provided sterile and is for single use only.

The provided text describes the Healix Advance™ Anchor with Permacord™ suture and its substantial equivalence to predicate devices, but it does not detail specific acceptance criteria or a study proving the device meets those criteria in the typical format you've requested for AI/software-based medical devices.

Instead, the submission focuses on demonstrating safety and effectiveness through substantial equivalence to already legally marketed devices, which is a common pathway for predicate-based medical devices. The "study" here refers to non-clinical testing performed to show that the new device performs comparably to its predicates.

Here's an interpretation based on the provided text, formatted to align with your request where possible, but with clear indications where the information is not present in the document.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document states "Verification activities were performed on the implant and / or its predicates" and "Testing assessments include pull out testing, insertion and failure torque, in-vitro testing and suture testing per USP." This implies engineering bench testing, which would involve a certain number of samples, but the exact count is not provided.
• Data Provenance: The testing appears to be internal lab testing ("Verification activities were performed"), not necessarily in a country of origin context. It is non-clinical/bench testing. It is retrospective in the sense that it's evaluating a final design against pre-defined performance metrics, but the data itself is generated prospectively for the submission.

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

• Not applicable. This is a medical device for physical implantation, not an AI/software device that requires human expert review for "ground truth" labels. The "ground truth" for this device's performance is established by engineering specifications and material standards (like USP) as well as the performance of predicate devices.

4. Adjudication Method for the Test Set

• Not applicable. As this is not an AI/software device requiring human judgment for data labeling, there is no adjudication method in the context described. Performance is measured against engineering and material specifications.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

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

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

• Not applicable. This is a physical medical device.

7. The type of ground truth used

• For this type of device, the "ground truth" is defined by:
  • Engineering Specifications: Specific quantifiable values for pull-out strength, torque, etc.
  • Material Specifications: Adherence to established standards such as USP (United States Pharmacopeia) for sutures.
  • Predicate Device Performance: The demonstrated safe and effective performance of the predicate devices. The new device is shown to be substantially equivalent to these devices.

8. The Sample Size for the Training Set

• Not applicable. This product is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. This product is a physical medical device, not an AI/ML algorithm that requires a training set and associated ground truth establishment.

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The Cayenne Medical, Inc. SureLock™ All- Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system may be used in either arthroscopic or open surgical procedures. After the anchor is deployed in the bone, the floating sutures can be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The Cayenne Medical, Inc. SureLock™ All-Suture Anchors are intended to be used for the reattachment of soft tissue to bone for the following indications:

Shoulder

• Capsular stabilization
• Bankart repair
• Anterior shoulder instability
• SLAP lesion repairs
• Capsular shift or capsulolabral reconstructions
• Acromioclavicular separation repairs
• Deltoid repairs
• Rotator cuff repairs
• Biceps tenodesis

Foot and Ankle

• Hallux valgus repairs
• Medial or lateral instability repairs/reconstructions
• Achilles tendon repairs/reconstructions
• Mid and forefoot reconstructions
• Metatarsal ligament/tendon repairs/reconstructions
• Bunionectomy

Elbow

• Ulnar or radial collateral ligament reconstruction
• Lateral epicondylitis repair
• Biceps tendon repair

Hand and Wrist

• Collateral ligament repair
• Scapholunate ligament reconstruction
• Volar plate reconstruction
• Tendon transfers in phalanx

Hip

• Acetabular labral repair

Knee

• Extra-capsular repairs
• Medial collateral ligament
• Lateral collateral ligament
• Posterior oblique ligament
• Patellar realignment and tendon repairs
• Illiotibial band tenodesis
• VMO advancement
• Joint capsule closure

The SureLock™ All-Suture Anchor is a sterile (using ethylene oxide sterilization method), manually operated, single procedure all suture anchor device for reattachment of soft tissue to bone. The all-suture anchor is preloaded with floating suture and loaded on a disposable inserter. SureLock™ All-Suture Anchor incorporates design features that facilitate suture anchor placement under arthroscopic, open, or limited access conditions in soft tissue to bone reattachment procedures.

The SureLock™ All-Suture Anchor is offered in two different sizes, 1.4mm and 2.2mm. The anchors and floating sutures are made out of non-absorbable Ultra High Molecular Weight Polyethylene (UHMWPE) surgical sutures.

The 1.4mm anchor is formed by passing one end of a length of suture perpendicularly back through itself in alternating directions a number of times. This results in a construct resembling a ladder. The four suture tails are cut and trimmed. A floating suture is passed through the loops in the anchor to form the anchor construct.

The 2.2mm anchor is formed by passing the end of a first length of suture through the core of a second length. Then, one end of the second length is passed through the core of the first length, creating a loop with four suture tails. The loop is twisted alternately a number of times with the floating sutures weaved through each twist to form the anchor construct.

The 1.4mm anchor is pre-loaded with one floating suture and the 2.2mm size is preloaded with two floating sutures.

The disposable inserter has a working shaft length of 22,2 cm with an outer shaft diameter of 2.0 mm for the 1.4mm SureLock anchor and 2.4mm for the 2.2mm SureLock anchor. The inserter shaft is made out of surgical grade stainless steel and the handle and knob are made out of ABS plastic. The inserter pushes the suture anchor construct into a hole drilled in the bone. The knob on the inserter handle is rotated to apply tension on the floating suture(s) to expand and deploy the anchor in the bone tunnel. The floating suture limbs are then released from the inserter and the inserter is removed.

The Cayenne Medical, Inc. SureLock™ All-Suture Anchor is a medical device designed to reattach soft tissue to bone in orthopedic surgical procedures. The device comes in two sizes, 1.4mm and 2.2mm, and is pre-loaded with non-absorbable Ultra High Molecular Weight Polyethylene (UHMWPE) surgical sutures.

Here's an analysis of its acceptance criteria and the study that proves its performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state numerical acceptance criteria in a dedicated table format. However, it indicates that the key performance metric for proving substantial equivalence to predicate devices is ultimate pull-out strength.

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

• Sample Size: The document does not explicitly state the numerical sample size used for the mechanical testing (pull-out strength). It mentions testing "both predicate and subject devices for the range of the subject device indications using three bone block densities." This implies multiple tests across different densities, but the exact number of samples per device or density is not provided.
• Data Provenance: Not specified, but likely from laboratory testing conducted by Cayenne Medical, Inc. The data is retrospective in the sense that it's reported after the testing was performed for the 510(k) submission. There is no information regarding country of origin for the data.

3. Number of Experts and their Qualifications for Ground Truth:

Not applicable. This device is not an AI/ML medical device, and therefore, a ground truth established by human experts for image interpretation or diagnosis is not relevant for this type of mechanical device. The "ground truth" here is the objective measurement of pull-out strength in a laboratory setting.

4. Adjudication Method for the Test Set:

Not applicable, as this is laboratory mechanical testing against a predicate device, not involving human interpretation or consensus. The comparison is based on quantitative measurements.

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

Not applicable. This is not an AI/ML medical device requiring human-in-the-loop performance evaluation or MRMC studies.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This is not an AI/ML general purpose medical device.

7. Type of Ground Truth Used:

The ground truth for the performance claim (comparable pull-out strength) is derived from mechanical testing data (objective measurements of ultimate pull-out strength) rather than expert consensus, pathology, or outcomes data. The comparison is made against a legally marketed predicate device.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML medical device. There is no "training set" in the context of device development for a mechanical suture anchor.

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

Not applicable, as there is no training set for this type of mechanical device.

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The Cayenne Medical, Inc. Quattro® GL Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:

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 repairs
• Biceps tenodesis

Elbow, Wrist, and Hand

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

Knee

• Extra-capsular repairs
• Medial collateral ligament
• Lateral collateral ligament
• Posterior oblique ligament
• Patellar realignment and tendon repairs
• Vastus medials obliquous advancement
• Illiotibial band tenodesis

Foot and Ankle

• Hallux valgus repairs
• Medial or Lateral instability repairs/reconstructions
• Achilles tendon repairs/reconstructions
• Midfoot reconstructions
• Metatarsal ligament/tendon repairs/reconstructions
• Bunionectomy

This traditional 501(k) premarket notification is to expand the indications for use for Cayenne Medical Quattro GL Suture Anchor. The Quattro GL (LabraLink) Suture Anchor was cleared per premarket notification K112960. Cayenne seeks to expand the existing indications for use for the subject device to include the indications listed above.

The Quattro® GL Suture Anchor is a sterile, manually operated, single procedure suture anchor. The anchor has two suture eyelets allowing for one or two sutures to be loaded through the eyelets. The suture anchor is mounted on an inserter. The Quattro GL Suture Anchor incorporates design features that facilitate suture anchor placement under arthroscopic, open, or limited access conditions in soft tissue to bone reattachment procedures. The Quattro GL Suture Anchor is only offered in one size, 2.9mm with four suture color options. The anchors are offered in two configurations, single loaded or double loaded sutures. Suture(s) used on the anchor are size # 2 non-absorbable surgical sutures. The Quattro GL inserter has a working length of 25.8 cm with an outer shaft diameter of 3.2 mm. Since the market clearance of this device, the length of the Suture Anchor was decreased from 15mm to 11.4mm. The technological characteristics of the Quattro GL Suture Anchor have not changed.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Quattro® GL Suture Anchor:

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

The provided 510(k) summary does not explicitly state specific acceptance criteria in a quantitative or qualitative manner that would be typically found for performance metrics like sensitivity, specificity, accuracy, etc., for a diagnostic device.

Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices based on:

Key takeaway: The primary "acceptance criterion" for this 510(k) appears to be demonstrating that the device is substantially equivalent to legally marketed predicate devices, particularly in terms of its mechanical properties and that the expanded indications for use do not introduce new safety or effectiveness concerns. The specific numerical values for "pull-out strength" that define "comparable" 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)

The document mentions "Non-clinical testing data submitted, referenced, or relied upon" including "Mechanical testing (pull-out strength)."

• Sample Size: The specific sample size used for the pull-out strength testing is not specified in the provided summary.
• Data Provenance: The document does not provide details on the country of origin of the data or whether the testing was retrospective or prospective. Given it's mechanical testing of physical anchors, it's inherently prospective in nature for a new batch of tested devices.

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 section is not applicable to the provided document. The Quattro® GL Suture Anchor is a medical device (suture anchor) for surgical reattachment, not a diagnostic device that requires expert interpretation for establishing ground truth on a test set (e.g., for image analysis). The "ground truth" for this device lies in its physical and mechanical properties (e.g., strength, biocompatibility), which are evaluated through non-clinical laboratory testing.

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

This section is not applicable for the same reasons as point 3. Adjudication methods like 2+1 (two readers agree, third is tie-breaker) are used in diagnostic studies to resolve discrepancies in expert interpretation of medical images or data. The testing described for the suture anchor is mechanical in nature and does not involve human interpretation requiring adjudication.

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

This section is not applicable. The Quattro® GL Suture Anchor is a surgical implant, not an AI-powered diagnostic tool or system designed to assist human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.

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

This section is not applicable. The device is a physical surgical implant. There is no algorithm or AI component to this device that would have standalone performance.

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

For the mechanical testing (pull-out strength), the "ground truth" would be the objective, empirically measured physical properties of the suture anchors under controlled laboratory conditions, typically using standardized testing methods (e.g., ASTM standards) on a material testing machine. This is not "expert consensus" or "pathology" in the diagnostic sense, but rather a direct measurement of physical performance.

8. The sample size for the training set

This section is not applicable. This device is a physical medical implant, not an AI or machine learning model that requires a "training set" of data.

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

This section is not applicable for the same reason as point 8.

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The Cayenne Medical, Inc. LabraLink™ Suture Anchor is intended for the reattachment of soft tissue to bone for shoulder procedures such as Bankart repair and SLAP lesion repair.

The LabraLink™ Suture Anchor is a sterile, manually operated, single procedure suture anchor device for reattachment of soft tissue to bone for shoulder procedures such as Bankart repair and SLAP lesion repair. The anchor has two suture eyelets allowing for one or two sutures to be loaded through the eyelets. The suture anchor is mounted on an inserter. The LabraLink Suture Anchor incorporates design features that facilitate suture anchor placement under arthroscopic, open, or limited access conditions in soft tissue to bone for shoulder procedures such as Bankart repair and SLAP lesion repair.

The LabraLink Suture Anchor is offered in one size, 2.9 x 15 mm with four suture color options. The anchors are offered in two configurations, single loaded or double loaded sutures. Suture(s) used on the anchor are size # 2 non-absorbable surgical sutures. The LabraLink inserter has a working length of 25.8 cm with an outer shaft diameter of 3.2 mm.

Mechanical testing was performed on the LabraLink Suture Anchor and a predicate device. Testing showed ultimate pull-out strength was significantly higher than the predicate device.

The provided text is a 510(k) summary for the LabraLink™ Suture Anchor, a medical device. It does not describe acceptance criteria for a study, nor does it present results from a clinical study to prove the device meets such criteria. Instead, it details the device's technical specifications, intended use, and substantial equivalence to previously marketed predicate devices, which is the basis for its FDA clearance.

Therefore, I cannot extract the requested information as it is not present in the provided document. The document focuses on regulatory clearance based on substantial equivalence, primarily through mechanical testing comparisons with predicate devices, rather than a clinical study with detailed acceptance criteria and performance metrics against human expert ground truth.

If you have a different document that describes such a study, please provide it.

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