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The Legends Orthopedics 5.5 mm Suture Anchors is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle, and knee.

Specific indications are as follows:

Shoulder: Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.

Wrist/Hand: Ulnar/Radial collateral ligament reconstruction, scapholunate ligament reconstruction.

Foot/Ankle: Achilles tendon repair/reconstruction, hallax valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.

Elbow: Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair.

Knee: a Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure.

The Legends Orthopedics 2.9 mm Suture Anchor is indicated for use in soft tissue reattachment procedures.

Specific indications are as follows:

Shoulder: Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.

Wrist/Hand: Scapholunate ligament reconstruction.

Elbow: Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction.

Knee: Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament tendon repair. iliotibial band tenodesis, joint capsule closure, extracapsular repair, vastus medialis obliquus (VMO) muscle advancement.

The Legends Orthopedics 5.5 mm Knotless Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee.

Specific indications are as follows:

Shoulder indications: - Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.

Wrist/Hand indications: - Ulnar/Radial collateral ligament reconstruction, scapholunate ligament reconstruction.

Foot/Ankle indications: - Achilles tendon repair/reconstruction, hallax valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.

Elbow indications: - Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair.

Knee indications: - Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure.

The Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor) are an internal fixation device intended to aid in arthroscopic and orthopedic reconstructive procedures needing soft tissue fixation. due to injury or degenerative disease.

The subject device(s) is screw-like in shape and composed exclusively of PEEK plastic. The 5.5mm (17.5mm length) is available in both standard "knotted" and "knotless" configurations. The implantable anchor devices are available in diameters of 5.5mm (17.5mm length) and 2.9mm diameter (10mm length) and provided in sterile condition.

They 5.5mm & 2.9 Suture Anchors are provided sterile and supplied with nonabsorbable polyethylene suture. The anchor is supplied with reusable taps and guides of corresponding size.

The 5.5 knotless Suture Anchors are provided sterile no suture. Components are available in a range of sizes to meet the needs of an individual patient.

The 5.5mm suture anchor is supplied in two designs:

with USP #2 high strength non-absorbable polyethylene suture(s) intended to be knotted and Knotless without any suture and suture attachment does not require knot tying.

The 2.9mm suture anchor is supplied in two designs:

• i. with USP #2 high strength non-absorbable polyethylene suture(s) and where the anchor must be attached to the inserter before use and
• ii. where the anchors are provided preloaded on single use inserters.

The anchors are composed of polyetheretherketone (PEEK). The high strength suture is made from non-absorbable Ultra High Molecular Weight Polyethylene (UHMWPE). The implants are ethylene oxide (ETO) sterilized. All implants are supplied in sterile condition.

This document is a 510(k) Premarket Notification for a medical device, which seeks to demonstrate substantial equivalence to a predicate device. It does not contain information about a study proving the device meets acceptance criteria in the way you might expect for a digital health or AI device. Instead, it relies on demonstrating that the new device is functionally and materially similar to an already approved device.

Here's an breakdown based on the provided text, addressing your points where applicable, and noting where information is not present for this type of submission:

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

The document does not present "acceptance criteria" and "reported device performance" in the typical format of a study for an AI or digital health device with specific metrics like sensitivity, specificity, etc. Instead, it justifies substantial equivalence by comparing technological characteristics and adherence to recognized standards.

Here's a table summarizing the comparison to the predicate device, which serves as the basis for performance acceptance in a 510(k) of this type:

The study that "proves the device meets the acceptance criteria" in this context is the non-clinical laboratory testing performed by "RoG Sports Medicine" (presumably to ensure consistency across batches as the predicate device manufacturer). The submission states: "Non-clinical laboratory testing was performed by RoG Sports Medicine to determine substantial equivalence. The results were reviewed and side by side comparisons were done with the identified predicate device and it demonstrated that there were no significant differences between the Legends Orthopedics Suture Anchors... and the predicate device. The results indicated that the devices were functional within their intended use."

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

This information is not provided in the document. The submission references "non-clinical laboratory testing" without specifying sample sizes for these tests, which typically involve mechanical or material characterization rather than patient data. Data provenance like country of origin or retrospective/prospective status is irrelevant for this type of submission focused on material and mechanical equivalence.

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 information is not applicable/not provided. For a device like a suture anchor, "ground truth" established by experts in the context of clinical image interpretation or AI output is not relevant. The "ground truth" for these devices revolves around material properties and mechanical performance.

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

This information is not applicable/not provided. Adjudication methods are typically used in studies involving subjective interpretation (e.g., radiological reads) to establish a consensus ground truth. For mechanical testing of a suture anchor, such a method is not used.

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 information is not applicable/not provided. MRMC studies are used to evaluate AI systems in diagnostic imaging. This device is a physical surgical implant, not an AI or diagnostic imaging system.

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

This information is not applicable/not provided. This is not an algorithm-based device.

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

The "ground truth" for this device is based on established material specifications, mechanical testing standards, and performance characteristics of the legally marketed predicate device. In essence, the predicate device's proven safety and effectiveness, supported by its own non-clinical data and adherence to standards, serves as the "ground truth" for comparison.

8. The sample size for the training set

This information is not applicable/not provided. This device is not an AI/ML product that would require a 'training set'.

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

This information is not applicable/not provided. As above, no training set is relevant for this type of device.

In summary, this 510(k) submission for the Legends Orthopedics Suture Anchors demonstrates substantial equivalence by showing that the new device has identical intended use, indications for use, materials, design features, sterilization, and overall performance characteristics to a predicate device (RoG™ Sports Medicine Suture Anchor, K111590). The "study" that supports this is a series of non-clinical laboratory tests comparing the subject device to the predicate device and confirming adherence to relevant industry standards. Clinical trials were not conducted or deemed necessary for this type of submission, as the fundamental technology and performance are considered equivalent to an already approved device.

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Iconix® Knotless Anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. Specific indications are listed below.

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

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

Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Repair

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

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Medial Patellofemoral Ligament (MPFL) Repair/ Reconstruction, Quadriceps Tendon Repair

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

The Iconix® Knotless Anchors are soft-tissue fixation devices, provided preloaded on a disposable inserter. The device is composed of a braided polyester anchor body that contains one working suture, also referred to as the repair strand, and a shuttle strand that is used to shuttle the repair strand around tissue and through the braided anchor body.

Sutures supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. Suture dyes are FDA approved. The inserter is comprised of metallic shaft with over molded handle. The device is sterilized by ethylene oxide gas and is provided sterile for single use. The anchor size will be available in 1.4mm with working sutures in standard USP size 2. Iconix® Knotless Anchor will be sold sterile for single use with no components or accessories.

The provided document is a 510(k) summary for the Iconix® Knotless Anchor, a medical device used for soft-tissue to bone fixation. It describes the device, its intended use, and its equivalence to a predicate device (Stryker ICONIX Anchors).

However, this document does not contain any information about a study involving AI/algorithm performance or human-in-the-loop studies. It focuses solely on the mechanical and biological safety of the physical medical device (the knotless anchor itself) in comparison to a predicate device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of AI/algorithm performance. The document only discusses non-clinical mechanical testing (insertion, cyclic, and pullout testing) to demonstrate performance comparability of the physical anchor to a predicate device, and standard safety validations (sterilization, biocompatibility, stability, usability engineering).

In summary, there is no information in the provided text that relates to:

• Acceptance criteria for an AI/algorithm (e.g., sensitivity, specificity, AUC)
• Sample sizes for algorithm testing (test sets, training sets)
• Data provenance for AI/algorithm development or testing
• Number/qualifications of experts for AI ground truth
• Adjudication methods for AI ground truth
• MRMC comparative effectiveness studies
• Standalone algorithm performance
• Type of ground truth for AI (pathology, outcomes data, etc.)
• Training set size or ground truth establishment for an AI algorithm

The document focuses on the equivalency of a physical medical device (a bone anchor) and its mechanical properties.

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The Apollo Knotless Suture Anchors are intended for use in soft tissue to bone fixation in areas such as the shoulder, elbow, knee, hip, wrist, hand, foot, and ankle.

The Apollo Knotless Suture Anchors are made from PEEK (Zeniva ZA-500 and Zeniva ZA-600) per ASTM F2026. The Anchors are provided loaded on individual inserters with and without integrated sutures made of ultra-high molecular weight polyethylene (UHMWPE), sterile, for single use only.

This document is a 510(k) Summary for the Maruho Medical Apollo Knotless Suture Anchor. It details the device, its intended use, and a comparison to predicate devices, but it does not contain details about acceptance criteria or a study proving the device meets those criteria in the context of a diagnostic or AI/machine learning device.

Instead, this document describes a medical device (a suture anchor) and its substantial equivalence to previously cleared predicate devices. The "performance testing" mentioned is related to the physical characteristics of the suture anchor (e.g., pullout strength, fatigue) and material biocompatibility, not diagnostic performance metrics like sensitivity, specificity, or AUC as would be expected for an AI/ML-driven device.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance because this document is not about an AI/ML-enabled medical device or a diagnostic tool with performance metrics typically associated with such criteria.

The information provided is about a physical implantable medical device and its mechanical/physical performance.

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The Responsive Arthroscopy Mustang Knotless Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, hand/wrist, and elbow in the following procedures:

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

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

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

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicylitis Repair

The Mustang and Mustang Knotless Suture Anchors are modified versions of the RA Large Screw-in Suture Anchors and the Large Push-In Suture Anchors, respectively, that were previously cleared under K180951. The Mustang and Mustang Knotless Suture Anchors are families of suture anchors intended for the fixation of soft tissue to bone. Both Mustang systems include two diameter sizes of suture anchors made of polyether ether ketone (PEEK) per ASTM F2026 along with repair suture tape, inserters, awls, and taps.

Both the Mustang and Mustang Knotless device families include several configurations that differ in anchor diameter and suture offerings to accommodate various procedures and patient anatomies.

The Mustang Suture Anchors will be offered in two diameter sizes (4.5 and 5.5mm) and are provided with either two #2 sutures or one 1.5 mm suture tape (4.5mm anchor); or three #2 sutures or two 1.5mm suture tapes (5.5mm anchor).

The Mustang Knotless Suture Anchors will be offered in two diameter sizes (4.75 and 5.5mm) and are designed to accept up to six #2 suture tails or two 1.5mm suture tape tails (4.75mm anchor); or up to eight #2 suture tails or four 1.5mm suture tape tails (5.5mm anchor). The Mustang Knotless Suture Anchors also feature a suture pull tab and an auxiliary #0 suture that holds the anchor in place until use.

The Mustang and Mustang Knotless Suture Anchors are pre-loaded on disposable inserters and provided sterile via ethylene oxide (EO).

The only differences between the subject devices and the predicate devices are considered minor and include modified anchor body geometry, modified anchor body dimensions, increase in the number of sutures or suture tapes compatible with the implants, modified internal locking screw geometry and dimensions, and the addition of vent holes to the anchor bodies. In addition, the subject Mustang Knotless Suture Anchor inserter has been modified slightly to correspond with the anchor changes. No other changes are being made to the inserters or other instrumentation that may be used during a procedure.

Here's a breakdown of the acceptance criteria and study information for the Responsive Arthroscopy Mustang Knotless Suture Anchors, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document unfortunately does not list specific numerical acceptance criteria or detailed numerical results for each test. Instead, it makes a general statement that "All testing met acceptance criteria and demonstrated that the devices met design specifications and performed as intended."

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

• Sample Size for Test Set: Not specified. The document only mentions that "bench testing was performed on the subject devices" without detailing the number of units tested.
• Data Provenance: The studies were retrospective in the sense that they were conducted on the developed device. The data is internal to the manufacturer (Responsive Arthroscopy LLC) and generated through controlled bench testing rather than patient data. Country of origin for the data is implicitly the United States, given the company's location and FDA submission.

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

This section is not applicable as the studies conducted were bench testing (mechanical performance tests) on inert medical devices, not clinical studies involving patient data that would require interpretation by medical experts to establish a "ground truth." The ground truth for these tests is the physical measurement of force or torque.

4. Adjudication Method for the Test Set

This section is not applicable for the same reason as point 3. Bench testing results are objective measurements and do not typically involve adjudication by experts.

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 device is a physical medical implant (suture anchors), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and the concept of improving human reader performance with AI are irrelevant.

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

This section is not applicable as the device is a physical medical implant and does not involve any algorithms or AI for its function.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing mentioned in the document is the physical measurement of the mechanical properties of the suture anchors. This includes:

• Measurement of forces required for insertion.
• Measurement of torque generated during insertion.
• Measurement of resistance to cyclic pullout force.
• Measurement of force required for suture locking.

These are direct physical quantities measured using laboratory equipment, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This section is not applicable. The device is a physical medical implant, not a machine learning model. Therefore, there is no concept of a "training set." The design and materials are based on established engineering principles and prior predicate devices.

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 Acuitive CITREFIX™ Knotless Suture Anchor is intended for fixation of suture to bone in the shoulder foot/ankle, knee, hand/wrist and elbow in the following procedures:

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

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achiles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction. Metatarsal Ligament Repair/Tendon Repair

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

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

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

The CITREFIX Knotless Suture Anchor is comprised primarily of Acuitive Technologies' proprietary CITREGEN, citrate-based polymer / bioceramic composite material. An integral eyelet made of PEEK conforming to ASTM F2026 facilitates passage of the suture through the tip of the anchor. The CITREFIX device is offered in diameters between 2.9 and 5.5 mm and lengths ranging between 12.5 and 24.0 mm. The CITREFIX Knotless Suture Anchor is implanted with reusable instruments, which include size specific drill and awl options for preparing the bone and an insertion instrument for placement of the CITREFIX device. Suture is not provided with the CITREFIX device.

The CITREFIX Knotless Suture Anchor is made from CITREGEN biomaterial, a homogeneous biocomposite of 60 % unsintered hydroxyapatite (HA) and 40 % polyester. CITREGEN's polymer component is a citrate-based network of completely amorphous polymer chains crosslinked together to form an elastomeric material. As water penetrates the subject device, surface erosion of the polymer occurs through hydrolysis of ester bonds located between the monomers and at crosslink sites.

This document is a 510(k) summary for a medical device (The Acuitive Citrefix™ Knotless Suture Anchor). It does not present a study proving the device meets acceptance criteria in the way you've described (e.g., in the context of an AI/ML medical device with accuracy metrics).

Instead, this document focuses on demonstrating substantial equivalence to a predicate device for a physical medical implant. The "acceptance criteria" here are largely related to functional performance and safety testing compared to established standards and the predicate device, rather than diagnostic performance metrics like sensitivity or specificity.

Therefore, I cannot populate the table and answer all questions as requested because the provided input does not contain information about:

• Diagnostic performance metrics (e.g., sensitivity, specificity, AUC)
• Sample sizes for test sets in the context of diagnostic accuracy studies
• Data provenance (country of origin, retrospective/prospective) related to patient data for diagnostic evaluation
• Number of experts, qualifications, or adjudication methods for ground truth in diagnostic studies
• MRMC comparative effectiveness studies
• Standalone algorithm performance
• Training set information (size, ground truth establishment)

However, I can extract the information relevant to the performance testing described for this physical device:

1. Table of Acceptance Criteria and Reported Device Performance

• Pull-out strength at Time-Zero
• Pull-out strength after soaking in 37°C PBS
• Pull-out strength after 5,000 cycles of simulated physiological loading | Bench testing was performed for pull-out strength on the worst-case (2.9mm diameter) and intermediate size (4.5mm) subject CITREFIX devices, and a same-size predicate Arthrex PushLock device.

Results: "demonstrating substantial equivalence of the predicate and subject devices." (Specific numerical values for pull-out strength are not provided in this summary.) |
| Material/Biocompatibility:

• Biocompatibility per ISO 10993-1
• Elemental analysis per ASTM F2902
• Extractables & Leachables (E&L) testing
• Toxicological risk assessment | - Biocompatibility demonstrated by ISO 10993 testing for a permanent implant, including toxicological risk assessment through the lifecycle of the device.
• Biocompatibility studies performed with CITREGEN devices at various stages of life cycle through 90% demonstrated biocompatibility per ISO 10993-6.
• E&L testing performed, with biocompatibility and toxicological risk assessments concluding that CITREGEN material devices are safe for long-term implantation. |
  | Sterility & Shelf-Life:
• Sterility testing (including EO residuals)
• Bacterial endotoxin testing
• Packaging and shelf life testing (real and accelerated time aging) | - Meets set endotoxin limits (

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The Smith & Nephew HEALICOIL Knotless Suture Anchor is intended for use only for the reattachment of soft tissue to bone for the following indications:

Shoulder

• Biceps tenodesis

· Rotator cuff tear repair

The HEALICOIL Knotless Suture Anchor consists of an anchor on an inserter fitted with a suture passer. The anchor consists of the following components: a proximal implant (REGENESORB or PEEK), a non-absorbable distal implant (PEEK or Titanium), and a nonabsorbable PEEK plug. The anchor is preloaded on a stainless steel inserter. This device is to be used with Smith & Nephew ULTRABRAID, ULTRATAPE, and MINITAPE Sutures. This device is provided sterile, for single use only.

The provided text describes the 510(k) premarket notification for the "HEALICOIL Knotless Suture Anchor" device. It outlines the device's characteristics, intended use, and substantial equivalence to predicate devices, but it does not contain detailed information about acceptance criteria or specific study results that would typically be found in a comprehensive clinical or performance study report.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth
• Adjudication method
• Multi reader multi case (MRMC) comparative effectiveness study information
• Standalone (algorithm only) performance information
• Type of ground truth used
• Sample size for the training set
• How the ground truth for the training set was established

The document focuses on demonstrating substantial equivalence to already cleared predicate devices by comparing their intended use, technological characteristics, and performance data from bench testing (insertion strength, pull-out strength, cyclic loading, sterilization, shelf-life, biocompatibility, bacterial endotoxin testing).

Here's what the document does provide regarding performance data:

Summary Performance Data (as reported in the document):

Study Information (based on the provided text):

The document describes bench testing rather than a "study" in the traditional sense of a clinical trial or a study involving human readers or algorithms. The performance data summarized relates to the physical and biological characteristics of the device and its components, primarily to establish substantial equivalence with existing devices.

• Data Provenance: The studies are described as "performance data" and "bench testing." The specific location or retrospective/prospective nature of the data collection is not detailed, but it's implied to be laboratory-based testing conducted by the manufacturer or a contracted lab.
• Ground Truth / Experts / Adjudication / MRMC / Standalone / Training Set: These concepts are typically associated with studies evaluating diagnostic or AI-driven devices, neither of which applies to this submission for a surgical suture anchor. Therefore, the document does not contain information on these aspects. The "ground truth" for this type of device is usually established by objective engineering specifications, materials science standards (e.g., ISO for biocompatibility), and mechanical testing protocols.

In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence through comparison of the device's design, materials, and bench-level performance data against predicate devices, rather than a clinical study report with detailed acceptance criteria for diagnostic performance or AI effectiveness.

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The ICONN Revolution Knotless Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:

Shoulder: Rotator cuff repair, Bankart repair, Biceps Tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.

Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.

The ICONN Revolution Knotless Suture Anchor (P/N 350000) is a sterile (gamma irradiation), single use implantable device made from Solvay's Zeniva® ZA-500 polyetheretherketone (PEEK) material indicated for soft tissue reattachment procedures in the shoulder, foot, and ankle. The anchor is available in one size (Diameter x Length): 5mm x 23mm. The implants with attached disposable inserter are supplied sterile and the instrument is supplied Non-Sterile and is to be sterilized in the ICONN instrument tray prior to surgery. The disposable inserter is made out of 17-4 stainless steel and the reusable driver is made out of 17-4 stainless steel (shaft) and silicone (handle). All anchors are intended to be used with the supplied #2 sutures and/or 1.5mm ICONN TetherTape, both made from Ultra High Molecular Weight Polyethylene (UHMWPE). The sutures/tape are supplied sterile, are packaged individually, and are single strands measuring 36/38 inches in length.

The provided text is a 510(k) summary for the ICONN Revolution Knotless Suture Anchor, a medical device. It describes the device, its intended use, and comparative studies against a predicate device to establish substantial equivalence for FDA clearance. The summary does not provide information about an AI/algorithm-based device as requested in the original prompt. Therefore, I cannot extract the specific details you've asked for regarding acceptance criteria and an AI study.

However, I can provide the available information related to the device's performance testing and acceptance criteria as described in the document, which are related to its mechanical and biocompatibility properties, not AI performance.

Here's a breakdown of the information that is available in the provided text:

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

The document mentions performance testing but does not present a formal table of "acceptance criteria" with specific numerical targets alongside "reported device performance." Instead, it states the following regarding the outcomes of the performance tests:

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The Smith & Nephew MICRORAPTOR Knotless Suture Anchor is intended for use only for the reattachment of soft tissue to bone for the following indications:

Hip
• Acetabular labrum repair/reconstruction

Shoulder

• Capsular stabilization
• Bankart repair
• Anterior shoulder instability
• SLAP lesion repairs
• Capsular shift or capsulolabral reconstructions
• Biceps tenodesis
• · Rotator cuff tear repairs

The MICRORAPTOR Knotless Suture Anchor consists of an anchor on an inserter fitted with a suture passer, and two accessory drills. The anchor consists of the following components: a proximal anchor body (REGENESORB or PEEK), and a non-absorbable PEEK distal anchor tip. The anchor is preloaded on a stainless steel inserter. This device is provided sterile, for single use only.

The provided text is a 510(k) Summary for the MICRORAPTOR Knotless Suture Anchor, a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a clinical or AI-based study.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The "Summary Performance Data" section mentions that the device met "performance specifications for insertion strength and pullout strength" and "met performance specifications for cyclic loading based on the predicate." However, it does not explicitly state what those specifications (acceptance criteria) were or provide numeric results of the testing. It implies that these were mechanical engineering tests, not studies involving human readers or AI.

This document is for a physical medical device (suture anchor), not software or an AI device. The questions in the prompt are more relevant to AI/software device submissions, particularly those involving image analysis or diagnostic support.

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The CrossFT™ Knotless Suture Anchor with Disposable Driver is intended to reattach soft tissue to bone in orthopedic surgical procedures. The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may 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 CrossFT™ Knotless Suture Anchors with Disposable Driver are sterile, single use devices. The CrossFT™ Knotless Suture Anchors are manufactured from PolyEtherEtherKetone (PEEK™). The anchors are provided sterile, single use and preloaded on a disposable driver. The anchors are available in three sizes and nine configurations.

The provided document describes the "CrossFT™ Knotless Suture Anchor with Disposable Driver" and its substantial equivalence to a predicate device (K091549). This is a medical device, not an AI/ML device, and therefore the concepts of acceptance criteria related to algorithmic performance (like sensitivity, specificity, MRMC studies, standalone performance, ground truth establishment by experts, training/test set sizes, and data provenance) are not applicable in this context.

The document focuses on demonstrating substantial equivalence for a medical device through engineering and biological performance testing.

Here's an interpretation of the relevant information provided, focusing on what is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a table format with corresponding reported performance values for each criterion. It broadly mentions completed performance testing to demonstrate the device performs as intended and is substantially equivalent.

However, based on the types of testing listed, we can infer general areas of acceptance. The "Reported Device Performance" is stated generally as having "met the endotoxin limits" and that the testing "demonstrates that the CrossFT™ Knotless Suture Anchor with Disposable Driver performs as intended and is substantially equivalent to the predicate device."

2. Sample Size for Test Set and Data Provenance

This information is not provided in the document. For a physical medical device, "test set" typically refers to the number of units or samples subjected to each performance test. The document also does not specify the country of origin of data or whether tests were retrospective/prospective.

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

This information is not applicable for this type of medical device submission. "Ground truth" established by experts is a concept central to evaluating diagnostic or AI/ML device performance. For this physical device, "ground truth" relates to engineering specifications, material properties, and biological safety standards.

4. Adjudication Method for the Test Set

This information is not applicable for this type of medical device submission. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human readers/experts when establishing ground truth for diagnostic or AI/ML performance.

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

This is not applicable. MRMC studies are used to evaluate the comparative effectiveness of diagnostic methods (e.g., human readers with and without AI assistance) on a set of cases. This document describes a physical surgical implant.

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

This is not applicable. This refers to algorithmic performance without human intervention, which is relevant for AI/ML devices.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance would be defined by engineering specifications, material science standards, and established biological safety standards. For example, the "ultimate fixation strength" would have a specific quantifiable standard that the device must meet, derived from biomechanical requirements. The "met the endotoxin limits" is an example of meeting a specific biological safety standard, which acts as a "ground truth" for endotoxin levels.

8. The Sample Size for the Training Set

This is not applicable. "Training set" refers to data used to train an AI/ML algorithm. This document describes a physical medical device.

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

This is not applicable for the reasons stated above.

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This device (PeBA Series and Cinch Series Anchor/Suture Combination) is intended for use only for the fixation of nonabsorbable synthetic sutures.

The Cinch Series Anchor/Suture Combination is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspensions for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.

The PeBA Series Anchor/Suture Combination is intended for the fixation of surgical suture material for the following indications:

Shoulder:

• 1. Bankart lesion repairs
• 2. SLAP lesion repairs
• 3. Acromio-clavicular separation repairs
• 4. Rotator cuff tear repairs
• 5. Capsular shift or capsulolabral reconstructions
• 6. Biceps tenodesis
• 7. Deltoid repairs

Foot and Ankle:

• 1. Hallux Valgus repairs
• 2. Medial or lateral instability repairs
• 3. Achilles tendon repairs/reconstructions
• 4. Midfoot reconstructions
• 5. Metatarsal ligament/tendon repairs/reconstructions Elbow, Wrist, and Hand:
• 1. Scapholunate ligament reconstructions
• 2. Ulnar or radial collateral ligament reconstructions
• 3. Tennis elbow repair
• 4. Biceps tendon reattachment

Knee:

• 1. Extra-capsular repairs
• a. medial collateral ligament
• b. lateral collateral ligament
• c. posterior oblique ligament
• 2. Iliotibial band tenodesis
• 3. Patellar realignment and tendon repairs, including vastus medialis obliquous advancement

The OBL Preloaded Series Anchor is intended for use only for the fixation of non-absorbable synthetic suture material for the following indications:

Shoulder:

• 1. Bankart lesion repairs
• 2. SLAP lesion repairs
• 3. Acromio-clavicular separation repairs
• 4. Rotator cuff tear repairs
• 5. Capsular shift or capsulolabral reconstructions
• 6. Biceps tenodesis
• 7. Deltoid repairs

Foot and Ankle:

• 1. Hallux Valgus repairs
• 2. Medial or lateral instability repairs/reconstructions
• 3. Achilles tendon repairs/reconstructions
• 4. Midfoot reconstructions
• 5. Metatarsal ligament/tendon repairs/reconstructions

Elbow, Wrist, and Hand:

• 1. Scapholunate ligament reconstructions
• 2. Ulnar or radial collateral ligament reconstructions
• 3. Lateral epicondylitis repair
• 4. Biceps tendon reattachment

Knee:

• 1. Extra-capsular repairs:
• a, medial collateral ligament
• b. lateral collateral ligament
• c. posterior oblique ligament
• 2. Iliotibial band tenodesis

3. Patellar realignment and tendon repairs, including vastus medialis obliquous advancement

*Pelvis:

• 2. Bladder neck suspension procedures

• This indication is marketed separately from the orthopedic indications under the trade name Cinch®

The Smith & Nephew TwinFix Ti Quick T is indicated for use as a suture anchor to facilitate percutaneous or endoscopic soft tissue procedures. The Smith & Nephew Suture Anchor is indicated for shoulder, foot, ankle, elbow, knee, wrist, and hand. Examples of such procedures include:

Shoulder:
Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tendonesis, and deltoid repairs.

Foot and Ankle:
Hallux Valqus repairs, medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, midfoot reconstructions, and metatarsal ligament/tendon repairs/reconstructions.

Elbow, Wrist and Hand:
Scapholunate ligament reconstructions, unler or radial collateral ligament reconstructions, tennis elbow repair, and biceps tendon reattachment.

Knee:
Extra-capsular repairs: medial collateral ligament, lateral ligament, and posterior oblique ligament. Iliotibial band tendonesis, and patellar realignment and tendon repairs, including vastus medialis obliquous advancement.

The Smith & Nephew TWINFIX FT PK suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder: Bankhart Repair SLAP lesion repairs Capsular shift or capsulolabral Reconstructions Acomioclavicular separation repairs Deltoid Repairs Rotator Cuff tear repairs Biceps tenodesis

Foot and Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions

Elbow: Ulnar or radial liqament reconstructions Lateral epicondylitis repair Biceps tendon reattachment

Knee: Extra-capsular repairs: - Medial collateral liqament - Lateral collateral ligament - Posterior oblique ligament Patellar realignment and tendon repairs: - Vastus medialis obliquous advancement Iliotibial band tenodesis

The Smith & Nephew BIORAPTOR Curved 2.3 PK Suture Anchor is intended 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 tear repairs Biceps 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

Elbow, Wrist, and Hand: Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair

Knee: Extra-capsular repairs: - -Medial collateral ligament - Lateral collateral ligament - - Posterior oblique ligament - Patellar realignment and tendon repairs - Vastus medialis obliquous - advancement Iliotibial band tenodesis

The Smith & Nephew TWINFIX Ultra Ti, PK, HA suture anchor families are intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder: Bankart lesion repairs SLAP lesion repairs Acromioclavicular separation repairs Rotator cuff tear repairs Capsular shift or capsulolabral reconstructions Biceps tenodesis Deltoid repairs

Foot and Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions

Elbow: Ulnar or radial liqament reconstructions Lateral epicondylitis repair Biceps tendon reattachment

Knee: Extra-capsular repairs: - Medial collateral ligament । - Lateral collateral ligament । - Posterior oblique ligament - Iliotibial band tenodesis Patellar realignment and tendon repairs: - Vastus medialis obliquous advancement

Hip: Abductor tendon repair

The Smith & Nephew FOOTPRINT Ultra PK suture anchor family is intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder: Rotator cuff repair, Bankart repair, Slap lesion repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.

Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.

Knee: Medial collateral ligament repair, Lateral collateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, Iliotibial band tenodesis.

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

Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction.

Hip: Distal row abductor tendon repair.

The HEALICOIL PK Suture Anchor (formerly Smith & Nephew Next Generation Fully Threaded PEEK Suture Anchor) is intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder: Bankart lesion repairs Slap lesion repairs Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis

Foot and Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstruction Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions

Knee: Extra-capsular repairs: - Medial collateral ligament । - Lateral collateral ligament i - । Posterior oblique ligament Patellar realignment and tendon repairs: - Vastus medialis obliquous advancement Iliotibial band tenodesis

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

Hip: Gluteal tendon repairs - -Gluteus medius and gluteus minimus repair

The Smith & Nephew Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications:

Hip Hip capsule repair · Acetabular labrum . reattachment/reconstruction

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 Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy

Elbow, Wrist, and Hand Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair

Knee Extra-capsular repairs - Medial collateral ligament ● - Lateral collateral ligament ● - Posterior oblique ligament Patellar realignment and tendon repairs - Vastus medialis obliquous ● advancement Iliotibial band tenodesis

Smith & Nephew Non-Absorbable Suture Anchors are provided in various non-absorbable materials. All of the Smith & Nephew Non-Absorbable Suture Anchors are provided sterile, for single use only. All Smith & Nephew Non-Absorbable Suture Anchors are preassembled onto an inserter, sized appropriately to accommodate the indicated procedures. Smith & Nephew Non-Absorbable Suture Anchors come in various configurations, including: with attached non-absorbable suture(s). In certain configurations, the Non-Absorbable Suture Anchors are packaged with a quide and awl. All configurations of the Non-Absorbable Suture Anchors are identical to the identified predicate devices.

The provided text is a 510(k) Premarket Notification from the FDA for several suture anchors manufactured by Smith & Nephew. It predominantly focuses on establishing substantial equivalence to existing predicate devices, rather than detailing a study that proves a device meets specific acceptance criteria.

The document lists the product names, their intended uses (which are identical to those of the predicate devices), and states that the substantial equivalence is based on identical indications for use, design features, operational principles, material composition, and performance to the predicate devices. It also mentions "Ship Testing and Post-Shipment mechanical functional testing for insertion and pullout (fixation) force demonstrates that the Non-Absorbable Suture Anchors are substantially equivalent to the currently marketed predicate devices."

However, the document does not contain the detailed information required to answer the specific questions about acceptance criteria and a study design that proves a device meets those criteria. The provided text is a regulatory clearance document, not a clinical study report or a detailed engineering test report.

Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and the reported device performance: The document states that the anchors "are substantially equivalent" in performance, but it doesn't provide a table of quantitative acceptance criteria (e.g., minimum pullout strength in Newtons) or the specific measured performance values for the new devices and predicates.
• Sample size used for the test set and the data provenance: While "Ship Testing and Post-Shipment mechanical functional testing" is mentioned, the sample sizes, type of data (e.g., in-vitro, ex-vivo), or provenance (country of origin, retrospective/prospective) are not detailed.
• Number of experts used to establish the ground truth for the test set and their qualifications: This type of information is typically related to clinical image interpretation or diagnosis studies, not mechanical testing of implants. There's no mention of experts establishing a "ground truth" in this context.
• Adjudication method for the test set: Not applicable as there's no mention of expert review or clinical assessment.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is for AI-assisted image interpretation studies, not mechanical device clearance.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): In the context of mechanical testing mentioned, the "ground truth" would be the measured physical properties (e.g., force, displacement), but the document does not specify the methods or a reference standard in detail.
• The sample size for the training set: Not applicable, as there's no machine learning algorithm involved.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory approval letter for a medical device based on substantial equivalence to predicate devices, and as such, it does not contain the detailed study design and results (acceptance criteria, sample sizes, ground truth establishment, expert involvement, etc.) typically found in a clinical or performance study report. The statement "Ship Testing and Post-Shipment mechanical functional testing for insertion and pullout (fixation) force demonstrates that the Non-Absorbable Suture Anchors are substantially equivalent to the currently marketed predicate devices" is the extent of the performance data provided, without specific numerical detail or study methodology.

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