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The Cayenne Medical, Inc. Ventix™ Link Knotless Anchors are intended to be used for the reattachment of soft tissue to bone for the following indications:

Shoulder

• Acromioclavicular separation repairs ●
• Deltoid repairs
• Rotator cuff repairs
• Biceps tenodesis

Knee

• Extra-capsular repairs ●
• o Medial collateral ligament
• o Lateral collateral ligament
• Posterior oblique ligament O
• Patellar realignment and tendon repairs
• Illiotibial band tenodesis ●
• Supplementary fixation when used in conjunction with a primary fixation device in ACL repair and reconstruction surgical procedures requiring graft fixation.

Foot and Ankle

• Medial or lateral instability repairs/reconstructions
• Achilles tendon repairs/reconstructions

The Ventix™ Link Knotless Anchor is a sterile, manually operated, single procedure anchor device for reattachment of soft tissue to bone. The anchor is preloaded on a disposable inserter. The Ventix™ Link Knotless Anchor incorporates design features that facilitate anchor placement under arthroscopic, open or limited access conditions in soft tissue to bone reattachment procedures. The Ventix™ Link Knotless Anchor is offered in two sizes, 4.75mm and 5.5mm, and can receive up to six suture ends. The anchor is made out of PolyEtherEtherKetone (PEEK). Zimmer Biomet TRU-LINK™, MaxBraid™ and/or MaxBraid™ BroadBand™ Tape, or Force Fiber® USP #1 or #2 sutures are to be only used with the Ventix™ Link Knotless Anchors.

The disposable inserter has a working shaft length (from handle to distal tip of anchor) of 6.1 in (155 mm) with an outer shaft diameter of 0.1875 in (4.76 mm). The inserter shaft is made out of surgical grade stainless steel and the handle is made out of ABS plastic. The inserter facilitates the placement of the implant into a hole prepared in the bone.

This document is a 510(k) premarket notification for a medical device called the "Ventix Link Knotless Anchor with Inserter."

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving the device meets them:

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

Based on the provided text, there isn't a specific table of "acceptance criteria" from a performance study that directly compares against the reported device performance in a quantitative manner. The document states that "Non-clinical testing data...demonstrated that the functionality and safety of the Ventix™ Link Knotless Anchor are adequate for its intended use and determination of substantial equivalence to the predicate device."

The non-clinical testing performed included:

• Mechanical testing: Specifically, "pull-out strength."
• Biocompatibility assessment
• Pyrogenicity assessment
• Shelf-life assessment
• MRI safety assessment

While these are the types of tests conducted, the document does not report the specific quantitative acceptance criteria or the actual measured performance values for these tests. It only states that the results "demonstrated that the functionality and safety... are adequate."

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" for mechanical testing, biocompatibility, pyrogenicity, shelf-life, and MRI safety. However:

• Sample size: The specific sample sizes used for these non-clinical tests are not provided in this document.
• Data provenance: The country of origin of the data is not specified. Given that the manufacturer is "Cayenne Medical, Inc." based in "Scottsdale, Arizona," it's likely the testing was conducted in the US or by a lab contracted by a US company, but this is not explicitly stated. The tests are non-clinical, so the terms "retrospective" or "prospective" are not applicable in the same way they would be for clinical trials.

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 question is geared towards studies involving human interpretation or clinical expertise to establish a "ground truth" (e.g., in AI/diagnostic device studies).

• Not Applicable: The studies conducted for this device were non-clinical (mechanical, biocompatibility, etc.). Therefore, there were no human "experts" in the sense of clinicians establishing a "ground truth" for diagnostic or predictive purposes related to the device's function. The "ground truth" in these engineering and material science tests would be established by validated test methods and material specifications, interpreted by qualified engineers/scientists, but these are not explicitly identified as "experts" for ground truth establishment in this context.

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

• Not Applicable: As mentioned above, the studies were non-clinical and did not involve human interpretation requiring adjudication methods.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable: This device is a surgical implant (suture anchor). It is not an AI diagnostic or assistive device that would involve human "readers" or benefit from AI assistance in its direct use. Therefore, no MRMC comparative effectiveness study was done.

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

• Not Applicable: This device is a physical medical implant, not an algorithm or software. Therefore, the concept of "standalone (algorithm only)" performance is not relevant.

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

For the non-clinical tests:

• Mechanical Testing (Pull-out strength): The "ground truth" would be established by engineering standards and specifications (e.g., a certain force in Newtons/pounds the anchor must withstand) as determined by the device design and potentially industry standards. The test results would then be compared against these predefined physical requirements.
• Biocompatibility, Pyrogenicity, Shelf-life, MRI Safety: The "ground truth" for these tests is compliance with established international standards (e.g., ISO, ASTM) and regulatory guidelines for material safety, sterility, stability, and compatibility.

The document does not explicitly detail these "ground truths" but implies that the tests confirmed "adequacy" against such standards.

8. The sample size for the training set

• Not Applicable: This device is not an AI/machine learning product and therefore does not have a "training set" in that context. The "training" for a physical device happens during its design and manufacturing process, using engineering principles and material science.

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

• Not Applicable: As per point 8, there is no "training set" in the context of an AI/machine learning device. The design and manufacturing processes are validated against engineering and regulatory standards, but this isn't analogous to establishing "ground truth" for a training set in AI.

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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™ W Suture Anchors is intended to be used for the reattachment of soft tissue to bone in rotator cuff repairs.

The SureLock™ W Suture Anchor is a sterile, manually operated, single procedure suture anchor device for reattachment of soft tissue to bone. The suture anchor is preloaded with floating suture and loaded on a disposable inserter. The SureLock™ W 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™ W Suture Anchor is offered in one size, 2.5mm. The anchors are made out of non-absorbable Ultra High Molecular Weight Polyethylene (UHMWPE) surgical suture, PolyEtherEtherKetone (PEEK), and L-lactide/glycolide copolymer (PLGA). The floating sutures are made out of size 2 non-absorbable UHMWPE surgical sutures. The suture anchor is pre-loaded with two floating sutures.

The disposable inserter has a working shaft length of 22.2 cm with an outer shaft diameter of 4.6mm. 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 into a hole drilled in the bone. The knob on the inserter handle is rotated to apply tension to the floating sutures to expand and deploy the anchor in the bone tunnel. When the knob is fully rotated, the floating suture limbs are released from the inserter and the inserter is removed.

I am sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) premarket notification for a medical device (SureLock™ W Suture Anchor) and details its administrative information, device description, intended use, and comparison to a predicate device.

It explicitly states:

• "Clinical testing was not used to establish substantial equivalence to predicate device."
• It focuses on non-clinical testing (biocompatibility and mechanical testing) to demonstrate functionality and safety.

Therefore, the document does not include:

• A table of acceptance criteria and reported device performance related to a study proving acceptance criteria.
• Details about sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth for test or training sets.

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

Foot and Ankle

• । Hallux valgus reconstruction
• । Midfoot reconstruction

Hand and Wrist

• -Ulnar or lateral collateral ligament reconstruction
• Repair/reconstruction of collateral ligaments
• Flexor and extensor tendon at the PIP, DIP, and MCP joints for all digits —
• -Scapholunate ligament reconstruction

The Short 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 with needles and loaded on a disposable inserter. Short 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 Short SureLock™ All-Suture Anchor is offered in two configurations, 1.4mm anchor with one size 0 Ultra High Molecular Weight Polyethylene (UHMWPE) suture strand with attached needles and 1.4mm anchor with one size 2-0 UHMWPE suture strand with attached needles. The anchors and floating sutures are made out of non-absorbable Ultra High Molecular Weight Polyethylene (UHMWPE) surgical sutures. The needles attached to the floating suture are made out of medical grade stainless steel.

The 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 disposable inserter has a working shaft length of 4.14 cm with an outer shaft diameter of 4.0 mm. 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 to the floating suture limbs to expand and deploy the anchor in the bone tunnel. The floating suture limbs with needles are then released from the inserter and the inserter is removed.

The provided text is a 510(k) Summary for a medical device (Short SureLock™ All-Suture Anchor) and a corresponding FDA letter. This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device rather than establishing acceptance criteria and proving performance through a clinical study in the way a new drug or high-risk device might.

Therefore, many of the requested elements (e.g., acceptance criteria, detailed study design with sample sizes, expert ground truth, MRMC study, training set) typically associated with AI/ML device performance or clinical trials are not applicable to this 510(k) submission.

Here's an analysis based on the information available:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds in the traditional sense for a clinical or AI performance study. Instead, the acceptance criteria for a 510(k) are implicitly:
  • Demonstrate that the new device is as safe and effective as a legally marketed predicate device.
  • Show that differences in technological characteristics do not raise different questions of safety and effectiveness.
  • For mechanical properties, demonstrate "comparable" performance to the predicate device.
• Reported Device Performance:

  Performance Metric	Acceptance Criteria (Implicit)	Reported Performance
  Pull-out strength	Comparable to predicate device	"Testing showed that the Short SureLock™ Anchor ultimate pull-out strength was comparable to that of the predicate device."
  Biocompatibility	Biocompatible for intended use	(Implied by use of medical grade stainless steel and UHMWPE, common in medical devices; no specific results given for this device, but usually relies on material characterization and ISO standards)
  Sterility	Sterile	"...sterile (using ethylene oxide sterilization method)..."
  Indications for Use	Broader indications for use should not raise different questions of safety and effectiveness.	"The subject device has a broader indication for use... The two added indications for use do not raise different questions of safety and effectiveness."

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 explicitly stated. The document mentions "Mechanical testing (pull-out strength) was performed" and implicitly implies a sufficient number of devices for the tests to be considered statistically valid and comparable.
• Data Provenance: Not applicable. The testing described is in vitro mechanical testing, not human data.

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)

• Not applicable. This device is a physical medical implant. Ground truth is established through physical and material science testing, not expert consensus on interpretations of data (like in an AI/ML context).

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

• Not applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This is not an AI/ML device. It's a surgical implant.

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

• No. Not an AI/ML device.

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

• The "ground truth" for the mechanical testing would be the physical measurements of pull-out strength obtained from standardized mechanical testing equipment, following established test methods (e.g., ASTM standards). The comparison is against the predicate device's performance under similar testing conditions.

8. The sample size for the training set

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

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

• Not applicable. See point 8.

In summary: The provided document is a 510(k) premarket notification for a Class II medical device (suture anchor). The "study" proving it meets "acceptance criteria" is a non-clinical mechanical testing comparison against a legally marketed predicate device, demonstrating substantial equivalence in terms of safety and effectiveness for its intended use, rather than a clinical trial or AI performance study with detailed clinical metrics and ground truth establishment.

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The Cayenne Medical, Inc. Quattro® Bolt Tenodesis Screws are intended to be used for the reattachment of soft tissue to bone for the following indications:

Shoulder

• 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
• 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

The Quattro® Bolt Tenodesis Screw is a sterile (using gamma radiation method), manually operated, single procedure device for reattachment of soft tissue to bone. The Quattro® Bolt screw is preloaded on a disposable driver. Quattro® Bolt device incorporates design features that facilitate screw placement under arthroscopic, open, or limited access conditions in soft tissue to bone reattachment procedures.

The Quattro® Bolt tenodesis screw is offered in 5 different sizes, 5mm×10mm, 6mm×12mm×14mm, 8mm×16mm, 9mm×16mm. The screws are made out of PolyEtherEtherKetone (PEEK).

The disposable driver has a working shaft length of 14cm with an outer shaft diameter of 3.0 mm. The driver shaft is made out of surgical grade stainless steel and the handle is made out of ABS plastic.

The provided text is a 510(k) summary for the Cayenne Medical, Inc. Quattro® Bolt Tenodesis Screw. It describes the device, its intended use, and claims substantial equivalence to a predicate device based on non-clinical testing.

However, the document does not contain the detailed information necessary to answer your request about acceptance criteria and a study that proves the device meets those criteria, specifically:

• Acceptance criteria table: No such table is present.
• Reported device performance: While pull-out strength is mentioned as "comparable," no specific performance metrics or thresholds (e.g., in a table) are provided.
• Sample size for the test set: Not mentioned.
• Data provenance: Not mentioned.
• Number of experts and their qualifications: Not applicable, as this is non-clinical mechanical testing, not a study involving expert assessment of images or clinical outcomes.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted; this is a non-clinical mechanical test.
• Standalone algorithm performance: Not applicable; this is a physical medical device, not an AI algorithm.
• Type of ground truth: For mechanical testing, the "ground truth" would be the measured physical properties, but the document doesn't detail how these were established beyond stating "mechanical testing (pull-out strength) was performed."
• Sample size for the training set: Not applicable as there is no AI or ML training set.
• How ground truth for the training set was established: Not applicable.

The document states:

• "Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence is included. Mechanical testing (pull-out strength) was performed on the Quattro® Bolt tenodesis screw and the predicate device. Testing showed that the Quattro® Bolt tenodesis screw ultimate pull-out strength was comparable to that of the predicate device."

This indicates that a non-clinical mechanical testing study was performed, specifically measuring pull-out strength. The acceptance criterion for this test appears to be "comparable to that of the predicate device" in terms of ultimate pull-out strength. However, the specific numerical thresholds or target values for "comparable" are not provided in this summary.

In summary, based on the provided document, I cannot fulfill your request for a detailed table of acceptance criteria and associated study information because the document primarily focuses on demonstrating substantial equivalence through non-clinical mechanical testing, without providing the specific quantitative details you're asking for.

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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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