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The Cayenne Medical, Inc. BioWick™ X Implant is intended to be used for the reattachment of soft tissue to bone in rotator cuff repairs.

The BioWick™ X Implant is a sterile, manually operated, single procedure implant device for reattachment of soft tissue to bone. The implant is preloaded with floating suture and loaded on a disposable driver. The BioWick™ X implant incorporates design features that facilitate implant placement under arthroscopic, open, or limited access conditions in soft tissue to bone reattachment procedures. The BioWick™ X implant is offered in two sizes, 5.5 mm and 6.5 mm. The implant is made out of PolyEtherEtherKetone (PEEK), L-lactide/glycolide copolymer (PLGA), and Ultra High Molecular Weight Polyethylene (UHMWPE). The floating sutures are size 2 non-absorbable Ultra High Molecular Weight Polyethylene (UHMWPE) surgical sutures. The implant is either preloaded with two or three surgical sutures. The disposable driver has a working shaft length (from handle to distal tip of anchor) of 6.24 in (158mm) with an outer shaft diameter of 0.159 in (4.0mm). The driver shaft is made out of surgical grade stainless steel and the handle is made out of ABS plastic. The driver facilitates the placement of the implant into a hole tapped in the bone.

The provided text is a 510(k) Summary for a medical device (BioWick™ X Implant with Driver) and does not contain information about a study proving the device meets specific acceptance criteria in the context of AI/ML or diagnostic performance. Instead, it details the substantial equivalence of the new device to a predicate device, which is a regulatory pathway for medical devices.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML or diagnostic study.

Based on the provided text, the following points can be extracted about the device's regulatory submission, but not in the format of AI/ML performance criteria:

• Acceptance Criteria and Reported Device Performance: This information is not presented as "acceptance criteria" and "reported device performance" in the context of a diagnostic study. Instead, the submission focuses on demonstrating "substantial equivalence" to a predicate device (K151068 SureLock W Suture Anchor). This equivalence is based on similarities in indications for use, intended use, design features, technology, and materials.

  • Indications for Use: The BioWick™ X Implant is intended to be used for the reattachment of soft tissue to bone in rotator cuff repairs. This is identical to the predicate device.
  • Technological Differences: The subject device differs from the predicate device in terms of design features (number of floating sutures) and the offered sizes.
  • Non-clinical Testing: The device underwent non-clinical testing including being assessed as non-pyrogenic, biocompatibility testing, sterility validation, and mechanical and cadaveric usability testing. The results of these tests are implied to have met sufficient standards to demonstrate substantial equivalence, but specific numerical acceptance criteria and performance data are not detailed in this summary.

• Sample Size for Test Set and Data Provenance: Not applicable. No diagnostic test set was used. Non-clinical testing was performed, but specific sample sizes for these tests are not provided in the summary.

• Number of Experts and Qualifications: Not applicable. This summary does not involve expert review for diagnostic ground truth.

• Adjudication Method: Not applicable.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study was done, as clinical testing was not used to establish substantial equivalence.

• Standalone Performance: Not applicable. This is not an AI/ML algorithm requiring standalone performance evaluation.

• Type of Ground Truth Used: Not applicable in the context of AI/ML. The "ground truth" for this device's regulatory review is its comparison to an already marketed predicate device based on its design, materials, and intended use, supported by non-clinical testing.

• Sample Size for Training Set: Not applicable. There is no training set for an AI/ML algorithm.

• How Ground Truth for Training Set Was Established: Not applicable.

In summary, the provided document is a regulatory submission for a medical implant, not a study evaluating the diagnostic performance of an AI/ML device. Therefore, the requested information cannot be extracted from the text.

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The AFX™ Femoral Implant with Inserter is intended for use in tenodesis procedures with soft tissue grafts, utilizing either arthroscopic or open techniques during Anterior Cruciate Ligament (ACL), Posterior Cruciate Ligament (PCL), Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), and Medial Patellofemoral Ligament (MPFL) reconstruction.

The AFX Femoral Implant with Inserter is a non-absorbable internal fixation device used in arthroscopic or open cruciate ligament reconstruction to anchor tendon grafts (such as the hamstring tendon) within a surgically created femoral tunnel to enable tissue ingrowth with the resultant formation of a permanent bony attachment.

Modifications to the predicate device, AperFix AM Femoral Implant with Inserter, that are the subject of this submission are confined solely to a line extension consisting of a metal free version of the original 24mm implant.

The screws of the modified 24mm implant differ from that of the original 24mm implant in that the combination of two PEEK screws, compression and deployment, in the modified 24mm implant play the role of the metal central screw in the original 24mm implant. In both the original 24mm and modified 24mm versions of the implant, lateral deflection of the body occurs as the implant is secured in position, however, in the original 24mm implant this occurrence is caused by advancing the head of the metal central screw and in modified 24mm implant this occurrence is caused by advancing the compression screw. In the subject 24 mm device, the unibody engages the wall of the femoral tunnel upon deploying the deployment screw. In the predicate 24 mm device the wings engage the wall of the femoral tunnel upon deploying the central screw.

This document describes a 510(k) premarket notification for a medical device called the "AFX™ Femoral Implant with Inserter." The submission focuses on a modification to an existing device, creating a metal-free version.

Here's an analysis of the provided text in relation to your request about acceptance criteria and supporting studies:

The document explicitly states: "Clinical testing was not used to establish substantial equivalence to predicate device." This means that many of your requested points, which pertain to clinical studies involving human patients, expert ground truth, and reader studies, are not applicable to this submission.

The primary method for demonstrating substantial equivalence in this 510(k) was through non-clinical testing.

Here's a breakdown of the available information:

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

The document doesn't provide a specific table with numerical acceptance criteria and a direct comparison of reported performance against those criteria. Instead, it offers a summary statement regarding the non-clinical testing.

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

• Sample Size: Not specified in the document.
• Data Provenance: The testing was non-clinical (mechanical, biocompatibility). While the manufacturer (Cayenne Medical, Inc.) is based in Scottsdale, Arizona, USA, the specific location and retrospective/prospective nature of the non-clinical testing are not detailed.

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

• Not applicable as clinical testing with human subjects and expert ground truth was not performed or used for substantial equivalence. The "ground truth" for non-clinical tests would be the established engineering/material science standards and predicate device performance.

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

• Not applicable as clinical testing was not performed.

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 physical implant, not an AI-assisted diagnostic tool.

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

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

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

• The "ground truth" for the non-clinical tests would be:
  • Engineering specifications: For cyclic and pull-out testing, specific thresholds or performance ranges would have been set based on relevant standards and the functional requirements of the device.
  • Predicate device performance: For ultimate pull-out strength, the performance of the legally marketed predicate device (AperFix® AM Femoral Implant with Inserter) served as a benchmark for comparison.
  • Biocompatibility standards: For biocompatibility, established ISO standards (e.g., ISO 10993 series) would define the acceptable criteria.

8. The sample size for the training set:

• Not applicable. This device does not involve machine learning or a "training set."

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

• Not applicable.

In summary, the provided document explicitly emphasizes that clinical testing was not used for this 510(k) submission. The substantial equivalence was established through non-clinical testing (biocompatibility and mechanical testing) comparing the modified device to its predicate.

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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. Quattro™ Link Knotless Anchors are intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder

• Capsular stabilization
• o Bankart repair
• o Anterior shoulder instability
• o SLAP lesion repairs
• o Capsular shift or capsulolabral reconstructions
• Acromioclavicular separation repairs t
• Deltoid repairs
• -Rotator cuff repairs
• Bicep tenodesis |

Elbow, Wrist, and Hand

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

Knee

• Extra-capsular repairs ।
• o Medial collateral ligament
• o Lateral collateral ligament
• o Posterior oblique ligament
• । Patellar realignment and tendon repairs
• o 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 l
• Metatarsal ligament/tendon repairs/reconstructions 1
• l Bunionectomy

The Quattro™ Link Knotless Anchor is a sterile, manually operated, single procedure suture anchor device for reattachment of soft tissue to bone in shoulder, elbow, wrist, hand, knee, foot, and ankle procedures. The anchor is mounted on an inserter. The Quattro Link Knotless Anchor incorporates design features that facilitate suture anchor placement under arthroscopic or open, limited access conditions in soft tissue to bone reattachment procedures. The anchor is offered in two different configurations, with or without a self-punching (SP) metal tip (PEEK anchor body and titanium alloy tip and PEEK only). The all PEEK anchor is offered in three different sizes, 2.9mm, 4.5mm. The PEEK and titanium alloy tip anchor is offered in one size, 4.5mm.

Here's a breakdown of the acceptance criteria and study information for the Quattro™ Link Knotless Anchor, based on the provided document:

The document states that a non-clinical study for the device was performed but does not explicitly provide information such as acceptance criteria beyond establishing that the "maximum suture slip force (ultimate pull-out strength) is significantly higher than that of the predicate devices." It also states that "product dimensional analysis met the components and product specifications."

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 the exact sample size used for the mechanical testing or dimensional analysis test sets. It only mentions that "Mechanical testing was performed" and "Dimensional analysis was performed."

The data provenance is not explicitly stated in terms of country of origin. The study is a non-clinical study, specifically mechanical testing, and therefore doesn't involve human subject data (retrospective or prospective).

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

This question is not applicable as the study described is a non-clinical, mechanical testing study. "Ground truth" in the context of expert consensus is typically relevant for studies involving image interpretation, diagnosis, or clinical outcomes, not for the physical properties of a medical device.

4. Adjudication Method for the Test Set

This question is not applicable as the study described is a non-clinical, mechanical testing study. Adjudication methods (like 2+1 or 3+1) are used for resolving disagreements among human experts, which is not relevant here.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The described study is a non-clinical mechanical performance test, not a clinical study involving human readers or cases.

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

No, a standalone study (in the context of an algorithm or AI) was not done. This device is a physical surgical anchor, not a software algorithm.

7. The Type of Ground Truth Used

For the mechanical testing, the "ground truth" would be the measured physical properties of the device (ultimate pull-out strength, dimensions) obtained through standardized engineering tests, not a clinical "ground truth" like pathology or expert consensus.

8. The Sample Size for the Training Set

This question is not applicable as the described study is a non-clinical, mechanical testing study of a physical device. There is no "training set" in the context of machine learning.

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

This question is not applicable for the same reasons as #8.

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The AperFix AM Femoral Implant is intended for use in tenodesis procedures with soft tissue grafts, utilizing either arthroscopic or open techniques during Anterior Cruciate Ligament (ACL), Posterior Cruciate Ligament (PCL), Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), and Medial Patellofemoral Ligament (MPFL) reconstruction.

The AperFix AM Femoral Implant with Inserter is a non-absorbable internal fixation device used in arthroscopic or open cruciate ligament reconstruction to anchor tendon grafts (such as the hamstring tendon) within a surgically created femoral tunnel to enable tissue ingrowth with the resultant formation of a permanent bony attachment. Modifications to the device that are the subject of this submission are confined solely to limited to a line extension consisting of a 24 mm (shortened) version of the original 29 mm implant to enable greater flexibility in tendon graft placement within the femur when clinical conditions (i.e. anatomy and/or deformity) preclude use of the original 29 mm device. The body wedge and wings of the modified 24 mm device differ from those of the original 29 mm device in that the wings are one piece (as opposed to using an assembly of a wedge, two arms, and two pins). In both the 24 mm and 29 mm versions of the AperFix device, the advancing head of the central screw causes lateral deflection of the body as the implant is secured in position. In the subject 24 mm device, the wings engage the wall of the femoral tunnel upon tightening the central screw. In the predicate 29 mm device the arms engage the wall of the femoral tunnel upon tightening the central screw and wedge.

Here's a breakdown of the acceptance criteria and study information for the AperFix® AM Femoral Implant with Inserter, based on the provided 510(k) summary:

The provided document is a 510(k) Summary for a device modification, specifically a line extension (a shortened version of an existing implant). The primary focus of this type of submission is to demonstrate substantial equivalence to a predicate device, rather than proving initial safety and efficacy for a novel device through extensive clinical trials. Therefore, the "acceptance criteria" and "study" described herein relate to demonstrating equivalence for the modification, not necessarily proving full clinical utility from scratch.

Here is the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

   Acceptance Criteria	Reported Device Performance
   Pull-out strength comparable to predicate device	"It was shown that pull-out strength is comparable to the predicate device."
   Product dimensional analysis met component and product specifications	"Product dimensional analysis met the components and product specifications."

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

   • Sample Size for Test Set: Not explicitly stated. The document mentions "Mechanical testing was performed" and "Dimensional analysis was performed," but does not provide specific sample quantities for these tests.
   • Data Provenance: The document does not specify country of origin for the data or whether the tests were retrospective or prospective. Given the nature of mechanical and dimensional testing, these are typically prospective laboratory tests conducted by the manufacturer.

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

   • Not applicable. Ground truth for mechanical and dimensional testing is established by technical specifications, engineering standards, and direct measurement, not by human expert interpretation.

4. Adjudication Method for the Test Set

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical or image-based studies. Mechanical and dimensional tests have objective pass/fail criteria based on predefined specifications.

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

   • No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical data (e.g., images) and the AI's impact on their performance is being evaluated. This submission is for an orthopedic implant.

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

   • Not applicable. This is an orthopedic implant, not an algorithm or software device. Performance is based on mechanical properties and dimensions, not algorithmic output.

7. The Type of Ground Truth Used

   • Engineering Specifications and Standards: For mechanical testing (pull-out strength), the ground truth would be defined by established engineering principles for fixation strength in bone, relevant ASTM standards (if applicable), and the performance characteristics of the predicate device. For dimensional analysis, the ground truth is the engineering design specifications and drawings for the implant components.

8. The Sample Size for the Training Set

   • Not applicable. There is no "training set" in the context of mechanical and dimensional testing for a physical implant. The device's design is validated against specifications, not trained on data.

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

   • Not applicable. As there's no training set, there's no ground truth for it. The "ground truth" for the device's design and performance validation (as mentioned in point 7) is established through engineering design, material science principles, and comparison to the predicate device.

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The CrossFix® II Meniscal Repair Device is intended for approximation of soft tissue in meniscal repair procedures.

The CrossFix® II Meniscal Repair device is a sterile hand-held, manually operated, single procedure suture placement system for meniscus soft tissue approximation procedures.

The provided text describes the CrossFix® II Meniscal Repair Device, its intended use, and a summary of performance tests conducted. However, it does not contain a detailed study proving the device meets specific acceptance criteria with the level of detail requested in the prompt. The text references "predetermined acceptance criteria" for bench testing but does not list them or provide quantitative results in the form of a table.

Therefore, the following information is extracted from the document, and where specific details are not available, it is noted.

Acceptance Criteria and Device Performance Study for CrossFix® II Meniscal Repair Device

The CrossFix® II Meniscal Repair Device underwent performance tests in a simulated use environment and bench testing to demonstrate its functionality and strength.

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 the sample sizes used for the simulated use environment testing or bench testing (e.g., number of devices, number of sutures tested). The data provenance is implied to be from in-vitro bench testing and simulated use, without information on country of origin or whether it's retrospective/prospective.

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

This information is not provided in the document. The "ground truth" for the performance tests would be the established engineering and functional specifications for the device.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The performance tests appear to be quantitative measurements against engineering specifications rather than expert adjudication.

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

No MRMC comparative effectiveness study was mentioned. The document focuses on the device's functional performance and equivalence to predicate devices, not on human reader performance with or without AI assistance.

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

This is not applicable to a mechanical medical device like the CrossFix® II Meniscal Repair Device, which is a suture placement system. There is no algorithm involved in its direct operation.

7. Type of Ground Truth Used

The "ground truth" for the device's performance is based on engineering specifications and predetermined acceptance criteria for mechanical properties (suture knot pull out force, tensile strength, diameter, handle deployment force) and functional operation (insertion, deployment, removal).

8. Sample Size for the Training Set

This is not applicable, as there is no "training set" in the context of this mechanical device's performance validation. The device doesn't involve machine learning or AI that would require a training set.

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

This is not applicable for the reasons stated above.

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The Cayenne Medical, Inc. CuffLink™ Suture Anchors are intended for use for the reattachment of soft tissue to bone for Rotator Cuff Repairs.

The CuffLink™ Suture Anchor is a sterile, manually operated, single procedure suture anchor device for reattachment of soft tissue to bone in procedures such as shoulder rotator cuff repair. There are two sutures loaded through the center of the anchor around, an eyelet at the distal tip of the anchor and back through the center. The suture anchor is mounted on a driver. The CuffLink Suture Anchor incorporates design features that facilitate suture anchor placement under arthroscopic or open, limited access conditions in soft tissue to bone reattachment procedures such as shoulder rotator cuff repair.

The CuffLink Suture Anchor is offered in two different sizes with four suture color options. The anchor sizes are 5.5 x 16 mm and 6.5 x 16 mm. Sutures used in the anchor are size # 2 nonabsorbable surgical sutures. The CuffLink driver has a working length of 14 cm with an outer shaft diameter of 3 mm.

This document is a 510(k) Summary for the Cayenne Medical, Inc. CuffLink™ Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with acceptance criteria for device performance.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not explicitly provided in this type of submission document.

However, based on the provided text, here's what can be inferred or directly stated:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of acceptance criteria with specific numerical targets. Instead, it states that "Mechanical testing was performed on the CuffLink Suture Anchor and a predicate device. Testing showed ultimate pull-out strength was equivalent to the predicate device."

2. Sample Size and Data Provenance for Test Set

• Sample Size: Not specified for the mechanical testing. The document only mentions "mechanical testing was performed."
• Data Provenance: Not specified. It's likely that the testing was conducted in a laboratory setting by the manufacturer, but the location or whether it involved patient data (retrospective or prospective) is not applicable for this type of mechanical comparison testing.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. Mechanical testing for pull-out strength does not involve human experts establishing ground truth in the same way clinical or diagnostic studies do. The "ground truth" would be the objective measurement of pull-out strength.

4. Adjudication Method for Test Set

Not applicable. No expert adjudication method (like 2+1 or 3+1) is mentioned or relevant for mechanical pull-out strength testing.

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

Not applicable. This device is a mechanical suture anchor, not a diagnostic or imaging device that would typically involve human readers interpreting results with or without AI assistance. The submission focuses on the mechanical properties of the anchor.

6. Standalone Performance Study

Yes, in a sense. The mentioned "Mechanical testing" on the CuffLink Suture Anchor, comparing its ultimate pull-out strength to a predicate device, is a form of standalone performance evaluation for the device's physical properties. It's algorithm-only performance is not applicable since there is no algorithm involved.

7. Type of Ground Truth Used

The ground truth used for the mechanical testing was objective mechanical test measurements of ultimate pull-out strength. This is not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

Not applicable. This is a medical device (suture anchor), not an AI/ML algorithm that requires a training set.

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

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

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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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The Cayenne Medical, Inc. CuffLink Knotless Anchors are intended for use for the reattachment of soft tissue to bone for shoulder procedures such as Rotator Cuff Repairs.

The CuffLink™ Knotless Anchor is a sterile, manually operated, single procedure suture anchor device for reattachment of soft tissue to bone in procedures such as shoulder rotator cuff repair. The anchor is mounted on an inserter. The CuffLink Knotless Anchor incorporates design features that facilitate suture anchor placement under arthroscopic or open, limited access conditions in soft tissue to bone reattachment procedures such as shoulder rotator cuff repair. The anchor is offered in two different configurations, with or without a self-punching (SP) metal tip (PEEK anchor body and titanium alloy tip and PEEK anchor is offered in two different sizes. 4.5mm and 5.5mm. The PEEK and titanium alloy anchor is offered in one size, 4.5mm.

The provided text is a 510(k) summary for the Cayenne Medical, Inc. CuffLink™ Knotless Anchor. This document describes a medical device, its intended use, and its substantial equivalence to previously marketed products. However, it does not include information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically discussed for AI/ML device evaluations.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance. This means showing that the new device is as safe and effective as a legally marketed device, not necessarily that it meets specific performance thresholds against a predefined acceptance criterion in a clinical study setting.

Here's a breakdown based on the provided text, addressing your questions where possible and noting where information is absent:

1. Table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic or AI device. The "acceptance criteria" here is implicitly "demonstrate substantial equivalence to predicate devices."
   • Device Performance: The document states, "Mechanical testing was performed on the CuffLink Knotless Anchor and Inserter. It was shown that ultimate pull-out strength is significantly higher than that of a predicate device." This is a mechanical performance claim, not an AI/ML performance claim.

   Since this is a physical medical device (suture anchor) and not an AI/ML diagnostic tool, the typical "acceptance criteria" for AI/ML are not relevant here. The "performance" described is related to mechanical strength, not diagnostic accuracy.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
   Not applicable (N/A). The document refers to "mechanical testing," not a clinical "test set" for diagnostic performance. No details on the sample size for this mechanical testing or data provenance are provided beyond the general statement.

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):
   N/A. This concept of expert-established ground truth for a test set is not relevant for the mechanical testing of a suture anchor.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   N/A. This is relevant for AI/ML diagnostic studies, not for the mechanical testing of a physical device.

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:
   N/A. This is a physical device, not an AI system. No human readers or AI assistance are involved in its primary function.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   N/A. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   N/A. For the described mechanical testing, the "ground truth" would be the direct measurement of physical properties like pull-out strength, as determined by engineering standards and validated testing methods. It's not a diagnostic "ground truth."

8. The sample size for the training set:
   N/A. This device is not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established:
   N/A. This device is not an AI/ML model.

In summary:

The provided 510(k) summary focuses on demonstrating "substantial equivalence" of a physical medical device (a suture anchor) to existing predicate devices based on its intended use, design principles, and mechanical properties. It explicitly states that "Mechanical testing was performed... [and] ultimate pull-out strength is significantly higher than that of a predicate device."

The questions posed are primarily relevant for the evaluation of Artificial Intelligence (AI) or Machine Learning (ML) medical devices, which involve diagnostic performance, ground truth establishment, expert reviews, and reader studies. The CuffLink™ Knotless Anchor is not an AI/ML device, and thus, most of the requested information (related to AI acceptance criteria, test sets, ground truth for AI, MRMC studies, etc.) is not present in this document.

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