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The Su2ura® Approximation Device is indicated in endoscopic surgery for the placement of interrupted or running stitches in soft tissue.

The Anchora Su2ura® Approximation Device is a sterile single use device is indicated in endoscopic surgery for the placement of interrupted or running stitches in soft tissue. The device is a 5mm single-use endoscopic suturing device loaded with threaded anchors. It is designed to deploy up to 19 anchors by a trigger action of the handle of the delivery system. After deployment, each anchor is anchored within the tissue in which it was deployed. After deployment of 2 or more anchors, the suture that passes between the anchors can be tightened to pull the anchors toward each other and approximate the tissue. The delivery system consists of a plastic handle and a 36-cm stainless steel shaft. The handle includes a Trigger, a Knob, and a Toggle Button. A Cap can be added at the distal edge of the Shaft to advance extracorporeal suture knots. The anchors can be deployed in single-stitch or running- stitch configuration. The device deploys the anchors through a needle with an outer diameter of 2.1 mm, available in two lengths: 5 mm and 9 mm protrusion. The Anchor is advanced outside of the needle by a Pushrod. Each anchor, made of stainless steel, is threaded with an off-the-shelf UHMWPE suture manufactured by Teleflex Medical. The device provides the anchors already threaded on this suture. The device is sterile packaged and designed for single use only. The device is manufactured from medical grade materials (mainly plastics and stainless steels).

The Su2ura Approximation Device is a sterile, single-use endoscopic suturing device with the following acceptance criteria and reported performances:

1. Acceptance Criteria and Device Performance

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

• Biocompatibility: Not explicitly stated as a test set with a specific sample size of biological samples, but rather a set of material characterization studies (extractables and leachables) and toxicological risk assessments. The input does not provide information on the number of samples for these tests.
• Human Factors: 18 representative users. The provenance of the users (e.g., country of origin, whether they were clinicians or laypersons, etc.) is not specified. The study appears to be prospective.
• Pre-Clinical Performance (Animal Study): 8 pigs (5 for test items, 3 for control items). The provenance of the data is a GLP animal study. It is a prospective study.
• Mechanical Performance, MRI Safety, Packaging Integrity: These involved various bench tests. The sample sizes for each specific test (e.g., number of devices tested for tensile strength or deployment reliability) are not explicitly stated in the provided text. The data provenance is from laboratory/bench testing.

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

• Biocompatibility: No explicit external experts are mentioned for establishing ground truth. Compliance was based on ISO standards.
• Human Factors: The "representative users" assessed usability. It's not stated whether these were "experts" in the sense of clinicians or if their feedback constituted a "ground truth" to be adjudicated. Their feedback was used to confirm usability.
• Pre-Clinical Performance (Animal Study): Not explicitly stated how many experts were involved in evaluating the histopathological data, but it would typically involve veterinary pathologists. Their specific qualifications are not detailed.
• Mechanical Performance, MRI Safety, Packaging Integrity: Ground truth for these studies relies on recognized ASTM and USP standards and internal engineering measurements. No external "experts" were mentioned for ground truth establishment beyond standard scientific and engineering practices.

4. Adjudication Method for the Test Set

The document does not specify any formal adjudication method (like 2+1 or 3+1) for the various studies conducted as part of the regulatory submission.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a surgical tool, and its effectiveness is not assessed through human reader interpretation of images, but rather through direct use in surgery, performance in bench tests, and pre-clinical animal studies. Clinical testing was expressly stated as "not required to demonstrate substantial equivalence."

6. Standalone Performance Study

The studies described (bench testing, animal study, human factors) are essentially "standalone" in the sense that they evaluate the device itself. However, the term "standalone performance" often refers to the algorithm-only performance of AI devices without human-in-the-loop. This device is a mechanical surgical tool, not an AI or imaging diagnostic device, so this concept does not directly apply.

7. Type of Ground Truth Used

• Biocompatibility: Compliance with ISO 10993 standards (e.g., acceptable levels of extractables/leachables, lack of toxicological risk).
• Human Factors: User feedback and observed usability were used to confirm clarity of training and IFU, and the overall usability of the device. This is a form of self-reported or observed performance against predetermined usability goals.
• Pre-Clinical Performance (Animal Study): Histopathological data (from tissue analysis) and clinical monitoring of animals provided the ground truth for safety and performance (e.g., successful closure, similar long-term safety profile to controls).
• Mechanical Performance, MRI Safety, Packaging Integrity: These rely on objective measurements and adherence to established industry standards (ASTM, USP) and predefined product specifications.

8. Sample Size for the Training Set

This question is not applicable. The Su2ura® Approximation Device is a mechanical surgical device, not a machine learning or AI model, so there is no "training set" in the context of algorithm development.

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

This question is not applicable, as there is no training set for this type of 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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The FIXIT®/ ComposiTCP™ threaded anchor system is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, but not limited to, the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair; SLAP Lesion Repair; Biceps Tenodesis; Acromio-clavicular Separation Repair; Deltoid Repair; Capsule Shift or Capsulolabral Reconstruction;

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

Knee: Anterior Cruciate Ligament Repair; Medial Collateral Ligament Repair; Lateral Collateral Ligament Repair; Patellar Tendon Repair ; Posterior Oblique Ligament Repair; Iliotibial Band Tenodesis ;

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

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

FIXIT® / ComposiTCP™ Threaded Anchor System is composed of a bioabsorbable composite anchor (30% β-TCP/ 70%PLDL) pre-loaded on a disposable screwdriver and 2 sutures. Different variations of the product are available depending on the type of suture combination (2 flat sutures, or 1 round + 1 flat)

For each configuration, the implant is supplied sterile, ready to use.

The provided document is a 510(k) premarket notification for a medical device (FIXIT®/ComposiTCP™ Threaded Anchor System) and does not describe an AI/ML-based device. Therefore, the questions related to acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details), and ground truth establishment for AI/ML models cannot be answered from this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device for a suture anchor through non-clinical performance testing.

However, I can extract the acceptance criteria and reported device performance related to the mechanical properties as presented in the document:

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

The remaining questions cannot be answered from the provided text as they pertain to AI/ML device studies, which this document does not describe.

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The FIXIT® threaded anchor system is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, but not limited to, the following procedures:

Shoulder: Rotator Cuff Repair; Bankart Repair; Biceps Tenodesis; Acromio-clavicular Separation Repair; Deltoid Repair; Capsule Shift or Capsulolabral Reconstruction;

Ankle/Foot: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Knee: Anterior Cruciate Ligament Repair: Medial Collateral Ligament Repair: Lateral Collateral Ligament Repair: Patellar Tendon Repair ; Posterior Oblique Ligament Repair; Iliotibial Band Tenodesis ;

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

Elbow: Biceps Tendon Reattachment: Unar or Radial Collateral Ligament Reconstruction: Temis Elbow Repair and Lateral Epicondylitis Repair

FIXIT® is a threaded anchor system made of Duosorb® 30 (β-TCP 30%/ PLDLA 70%), a composite, bioabsorbable material.

The implant is available in 2 different configurations:

• · FIXIT®Knotless: supplied in a holder,
• FIXIT®: pre-loaded on a disposable screwdriver with 2 sutures.
  The implant is supplied sterile, ready to use.

The provided text describes a medical device submission (K170868) for the FIXIT® Threaded Anchor System. This device is a suture anchor, and the submission aims to demonstrate its substantial equivalence to a predicate device, the Arthrex Bio-Composite Corkscrew (K082810).

It is crucial to understand that this document describes a non-AI/ML medical device. Therefore, the concepts of "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size for the test set," "data provenance," "number of experts used to establish ground truth," "adjudication method," "multi reader multi case (MRMC) comparative effectiveness study," "standalone performance," "type of ground truth used," "sample size for the training set," and "how the ground truth for the training set was established" do not apply in the context of an AI/ML device validation study.

Instead, the acceptance criteria for this type of device (traditional medical device) are outlined by regulatory bodies such as the FDA. For a Class II medical device like the FIXIT® Threaded Anchor System, the primary acceptance criteria for market clearance via a 510(k) pathway revolve around demonstrating substantial equivalence to a legally marketed predicate device. This is achieved through comparisons of:

• Intended Use: Must be the same or very similar to the predicate.
• Technological Characteristics: Must be similar to the predicate.
• Performance Data: Non-clinical testing (e.g., mechanical, biocompatibility) must show that the new device performs as safely and effectively as the predicate, and any differences in technological characteristics do not raise new questions of safety or effectiveness.

Here's a breakdown based on the provided text, adapted for the context of a traditional medical device:

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

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

This information is not provided in the document as it pertains to AI/ML validation studies. For this traditional device, non-clinical tests typically involve:

• Mechanical testing: A certain number of samples (e.g., a statistically significant number of anchors) would be tested for properties like pull-out strength or fixation strength. The specific sample sizes are not detailed in this summary.
• Biocompatibility testing: This is typically performed under ISO standards (e.g., ISO 10993) using standardized biological models (e.g., cell cultures, animal models) with a defined number of replicates, but the specifics are not in this summary.
• Bacterial Endotoxin Testing: This involves testing samples of the final sterile device using established methods like the Limulus Amebocyte Lysate (LAL) assay, with specific sample numbers.

The data provenance is inherent to laboratory testing rather than clinical data sets. The testing would have been conducted by the manufacturer or contracted labs following established protocols.

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 concept is not applicable to this type of traditional device submission. "Ground truth" established by experts is relevant for AI/ML diagnostic or interpretative devices. For the FIXIT® Threaded Anchor System, the "ground truth" for performance is established by objective, quantifiable physical and chemical tests (e.g., measuring force, observing cell reaction, detecting endotoxins) against industry standards or predicate device performance.

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

This is not applicable for a traditional medical device like a suture anchor. Adjudication methods are typically employed in clinical trials or AI/ML evaluations to resolve disagreements among human readers or experts on ground truth.

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 is not applicable. MRMC studies are specific to evaluating diagnostic devices, especially those involving human interpretation, often in the context of AI assistance. The FIXIT® Threaded Anchor System is a surgical implant, not a diagnostic tool, and involves no "human readers" or "AI assistance" in its intended function.

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

This is not applicable. This refers to AI/ML algorithm performance without human intervention. The FIXIT® Threaded Anchor System is a physical implant; there is no algorithm involved.

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

The "ground truth" for this device's performance is based on objective measurements and adherence to established standards in non-clinical testing:

• Biocompatibility: Adherence to ISO 10993 series standards, using established biological models and endpoints.
• Mechanical Performance: Quantifiable physical measurements (e.g., pull-out strength, torque, fatigue life) compared against engineering specifications, predicate device performance, or relevant biomechanical literature. The "ground truth" here is the physical measurement itself.
• Bacterial Endotoxin: Quantitative measurement of endotoxin levels, compared against specified regulatory limits.

8. The sample size for the training set

This is not applicable as there is no AI/ML algorithm requiring a training set.

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

This is not applicable as there is no AI/ML algorithm requiring a training set or its associated ground truth establishment.

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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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