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The Shadow Knotless All-Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:

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

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

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

Hand/Wrist: Scapholunate Ligament Reconstruction of Collateral Ligaments, Carpal Ligament Reconstruction, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP Joints for all Digits, Digital Tendon Repairs.

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

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

The Shadow Knotless All-Suture Anchor is a modified version of the Responsive Arthroscopy (RA) Mini Stealth All-Suture Anchors that were previously cleared under K230094. The subject Shadow Knotless device is a suture anchor intended for the fixation of soft tissue to bone. The Shadow device features a knotless, push-in design and is comprised entirely of suture material configured to provide an anchor in bone. The anchor creates a secure fixation point for the reattachment of soft tissue to bone when it is inserted through a pilot hole and deployed against the inserter tip below cortical bone in the desired anatomy. The subject device four longitudinally arranged round bundles that bunch together and expand radially when deployed to achieve fixation. The provided suture passing loop allows the integrated repair suture to be passed through the anchor body when securing the desired soft tissue, while the knotless feature allows the repair suture to be locked in place without tying a knot. The anchors may be delivered arthroscopically using inserters and reusable surgical instruments such as drills, guide tubes, and probes, which are identical to those provided with the predicate Mini Stealth All-Suture Anchors (K230094). The subject Shadow anchors are pre-loaded on disposable inserters and provided sterile via ethylene oxide (EO), while the reusable instruments are non-sterile and are intended to be sterilized by the end user.

The subject Shadow device is designed for a 2.1mm diameter pilot hole and is comprised of braided nonabsorbable ultra-high molecular weight polyethylene (UHMWPE). It is provided with an attached USP #1 UHMWPE nonabsorbable repair suture tail and a UHMWPE suture passing loop that are used to facilitate a repair. All subject device materials are identical to those of the predicate Mini Stealth All-Suture Anchors (K230094).

The primary differences between the subject and predicate devices (K230094) are the additions of the knotless feature, integrated repair suture tail, and suture passing loop. However, these design characteristics are similar to those found in the predicate RA Wedge Push-In Suture Anchors previously cleared under K190446 and K181076. No other changes are being made to the inserters or other instrumentation that may be used during a procedure.

This document is a 510(k) Premarket Notification from the FDA regarding the "Shadow Knotless All-Suture Anchors." It details the device's description, indications for use, technological characteristics, and evidence of substantial equivalence to predicate devices.

The provided text describes a medical device (suture anchors) and its regulatory clearance process, not an AI/ML powered medical device. Therefore, the requested information regarding acceptance criteria and studies that prove an AI/ML device meets those criteria cannot be extracted from this document. The concepts of "test set," "training set," "ground truth," "MRMC studies," "human readers improve with AI," and "standalone algorithm performance" are specific to the development and validation of AI/ML models in a healthcare context, which are not discussed here.

The document primarily focuses on demonstrating substantial equivalence of a physical medical device (suture anchors) to existing cleared devices through bench testing of mechanical properties.

However, I can extract the information that is present concerning the device's performance through bench testing, which serves as its "acceptance criteria" for demonstrating substantial equivalence.

Based on the provided document, here's what can be extracted, interpreted within the context of a physical medical device clearance, not an AI/ML model:

There is no information in this document about an AI/ML-powered device. The device in question is the "Shadow Knotless All-Suture Anchors," which is a physical implantable medical device. Therefore, many of the requested points related to AI/ML validation (e.g., test/training sets, ground truth establishment, MRMC studies, human-in-the-loop performance) are not applicable.

However, I can interpret the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this physical device's non-clinical performance testing.

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

The document states: "Performance testing consisted of design verification testing). All testing met acceptance criteria and demonstrated that the devices met design specifications and performed as intended."

While specific numerical acceptance criteria (e.g., "pullout force must be > X N") are not explicitly listed, the types of tests performed indicate the performance characteristics that were evaluated and met.

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

• Sample Size: Not explicitly stated for each test. The document generally refers to "the subject devices" and "the predicate devices" being tested.
• Data Provenance: The testing was "Nonclinical performance testing" conducted to demonstrate that the device met established performance characteristics and design requirements. This implies laboratory bench testing, not clinical data from patients or a specific country. This is a prospective test specifically for this device's clearance.

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

• Not applicable. This is for a physical device, and "ground truth" as it pertains to expert annotation in AI/ML is not relevant here. The "ground truth" for these tests would be the measurement standards and engineering specifications.

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

• Not applicable. This concept pertains to resolving discrepancies in expert annotations for AI/ML validation. For bench testing, test results are compared against predefined engineering specifications.

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

• Not applicable. This device is a physical medical implant, not an AI-powered diagnostic or assistive tool. MRMC studies are used to evaluate diagnostic imaging systems, often in the context of AI.

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

• Not applicable. This applies to AI/ML algorithms. The performance testing described (mechanical tests) is inherent to the device itself.

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

• For physical device testing, the "ground truth" is typically against engineering specifications, material standards, and performance benchmarks derived from predicate devices or established biomechanical principles. It's based on measured physical properties (e.g., force, diameter, strength).

8. The sample size for the training set:

• Not applicable. There is no AI/ML training set for this physical device.

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

• Not applicable. There is no AI/ML training set for this physical device.

In summary, the provided document is a 510(k) clearance letter for a physical medical device (suture anchors), not an AI/ML product. Therefore, most of the specific questions geared towards AI/ML validation are not addressed or applicable within this document. The "acceptance criteria" and "proof" for this device relate to its mechanical performance in non-clinical bench testing, demonstrating that it functions equivalently to previously cleared predicate devices.

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The Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:

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

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

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

Hand/Wrist: Scapholunate Ligament Reconstruction of Collateral Ligaments, Carpal Ligament Reconstruction, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP Joints for all Digits, Digital Tendon Repairs.

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

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

The Stealth and Mini Stealth All-Suture Anchors intended for the fixation of soft tissue to bone. The All-Suture Anchors feature a push-in design and are comprised entirely of suture material configured to provide an anchor in bone. The anchors create a secure fixation point for the reattachment of soft tissue to bone when they are inserted through a pilot hole and deployed against the inserter tip below cortical bone in the desired anatomy. The All-Suture Anchors feature four longitudinally arranged round bundles that bunch together and expand radially when deployed to achieve fixation. The All-Suture Anchors may be delivered arthroscopically using inserters and surgical instruments such as drills, guide tubes, and probes.

The subject device systems include two anchor sizes, the Stealth All-Suture Anchor which is designed for a 3.0mm diameter pilot hole and the Mini Stealth All-Suture Anchor which is designed for a 2.1mm diameter pilot hole. Both anchor systems are comprised of braided nonabsorbable ultra-high molecular weight polyethylene (UHMWPE) material and are available in a variety of configurations containing one or more working USP #2 sutures or 1.5mm suture tapes to facilitate a repair.

The Stealth and Mini Stealth All-Suture Anchors are pre-loaded on disposable inserters and provided sterile via ethylene oxide (EO), while the reusable instruments are non-sterile and are intended to be sterilized by the end user.

This document describes the premarket notification (510(k)) for the Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors, which are intended for the fixation of soft tissue to bone.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each performance test (e.g., number of anchors tested for insertion force or cyclic pullout). It also does not mention the country of origin of the data or whether the studies were retrospective or prospective. The testing was non-clinical, meaning it was likely conducted in a lab setting rather than involving human or animal subjects in a clinical trial.

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

This information is not applicable. The studies described are non-clinical performance and design verification tests, not studies requiring expert interpretation of diagnostic data to establish ground truth.

4. Adjudication method for the test set

This information is not applicable, as the tests are non-clinical performance evaluations with predefined pass/fail criteria rather than requiring expert adjudication of results.

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 studies were non-clinical performance tests comparing the subject devices to predicate devices.

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

This concept is not applicable as the device is a medical implant (suture anchor), not an AI algorithm. The performance tests were conducted on the physical device itself.

7. The type of ground truth used

The "ground truth" for the non-clinical performance tests was established by predefined engineering specifications, design requirements, and established standards (e.g., ASTM, ISO guidelines), as well as comparative performance to legally marketed predicate devices. For instance, for pullout strength, the ground truth would be a defined force threshold or equivalency to predicate device performance.

8. The sample size for the training set

This information is not applicable. This is a medical device approval based on non-clinical performance testing and substantial equivalence to predicate devices, not an AI model requiring a training set.

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

This information is not applicable for the same reason as above.

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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 Responsive Arthroscopy Thunderbolt System is intended for soft tissue to bone fixation for the following indications:

Shoulder: Bankart lesion repair, SLAP lesion repairs, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps Tenodesis

Foot and Ankle: Medial/lateral repair and reconstruction, Mid-and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair, Ankle Syndesmosis disruptions), and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures

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

Knee: ACL/PCL repair/reconstruction, ACL/PCL patellar bone-tendon-bone grafts, Double-Tunnel ACL reconstruction, Extracapsular repair: MCL, LCL, and posterior oblique ligament, Illiotibial band tenodesis, Patellar tendon repair, VMO advancement. Joint capsule closure

Hand and Wrist. Collateral ligament repair. Scapholunate ligament reconstruction. Tendon transfers in phalanx. Volar plate reconstruction

Hip: Acetabular labral repair

The Responsive Arthroscopy Thunderbolt System is a knotless system for the fixation of soft tissue to bone. The system includes a suture-button implant assembly made of Ti-6Al-4V ELI per ASTM F136 and ultra high molecular weight polyethylene, an implantable two holed plate made of Ti-6Al-4V EU per ASTM F136, and instrumentation including drills and drivers. The implants and single-use instruments are provided sterile, and the reusable instruments are non-sterile and are to be sterilized by the end user.

This FDA 510(k) summary for the Responsive Arthroscopy Thunderbolt System does not contain information about acceptance criteria and a study proving a device meets them in the context of an AI/ML powered medical device.

The document describes a traditional medical device (a suture-button implant system) for soft tissue to bone fixation. The performance testing mentioned is for the physical characteristics of this implant, not for an AI algorithm's diagnostic or predictive capabilities.

Therefore, I cannot extract the requested information regarding AI/ML device performance, sample sizes, ground truth, expert qualifications, adjudication, or MRMC studies from this text. The "Performance Testing" section lists typical tests for an implantable medical device, such as static and cyclic pullout force, suture characterization, biocompatibility, sterility, packaging, shelf-life, and pyrogenicity. These are not relevant to the acceptance criteria for an AI/ML system's diagnostic or prognostic performance.

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The Responsive Arthroscopy Interference Screws are intended to be used for fixation of tissue including ligament, tendon, soft tissue, or bone to bone. Interference fixation with PEEK or Titanium Interference Screws is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate. Specifically, screws are intended for use 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, Anterior Shoulder Instability

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfers in the Foot and Ankle, Bunionectomy

Knee: Anterior Cruciate Ligament Repair, Posterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collament Reconstruction, Lateral Epicondylitis Repair

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

The Responsive Arthroscopy Interference Screw System is a family of interference screws for the reattachment and fixation of tissue including ligament, tendon, soft tissue, or bone to bone. The system includes cannulated interference screws in both polyether ether ketone (PEEK) per ASTM F2026 and Ti-6Al-4V ELI titanium alloy per ASTM F136, along with drivers, sizers, reamers, taps, and guide wires for screw insertion.

The only design differences in the subject device are regarding interference screw length, cannulation, and driving feature. The screws are available in a variety of sizes to accommodate various procedures and patient anatomies. RA PEEK Interference Screws are offered with diameters from 7-12mm and lengths from 15-35mm. RA Titanium Interference Screws are offered with diameters from 7-10mm and lengths from 20-35mm.

The RA Interference Screw System implants are provided sterile. The RA Interference Screw System single-use instruments are provided sterile, and the RA Interference Screw System reusable instruments are non-sterile and are to be sterilized by the end user. All RA Interference Screw implants and single-use instruments are sterilized with ethylene oxide (EO).

This document pertains to the 510(k) clearance of the Responsive Arthroscopy Interference Screw System and does not contain information about the performance or acceptance criteria of an AI/ML powered medical device or a study proving its performance. The provided text is a 510(k) clearance letter and associated summary documents for a physical medical device (interference screws) and explicitly discusses mechanical and material properties, not an AI/ML algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth for the training set, as these concepts are not applicable to the content of the provided document.

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The Responsive Arthroscopy Knotless Push-In Suture Anchors are intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, 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, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Bunionectomy, Digital Tendon Transfers.

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Vastus Medialis Obliquus Advancement, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure.

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

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

Hip: Capsular Repair, Acetabular Labral Repair.

The Responsive Arthroscopy (RA) Knotless Push-In Suture Anchor System is an updated version of the RA Knotless Push-In Suture Anchor System previously cleared under K180951. The RA Knotless Push-In Suture Anchor is intended for fixation of suture (soft tissue) to bone. The system includes a variety of anchors made of polyetheretherketone per ASTM F2026 (PEEK) along with repair suture tape, inserters, drills, broaches, and guides.

The only differences in the subject device are regarding suture geometry, anchor body geometry, and internal screw geometry. The RA Knotless Push-In Suture Anchor System anchors are available in a variety of geometries and configurations to accommodate various procedures and patient anatomies. RA Knotless Push-In Suture Anchor System anchors range in diameter from 3.5mm to 4.75mm and are either pre-loaded with or accept #2 suture or 2.5mm suture tape.

The RA Knotless Push-In Suture Anchor System anchors are pre-loaded on inserters and provided sterilized with ethylene oxide. The RA Knotless Push-In Suture Anchor System reusable instruments are non-sterile and are to be sterilized by the end user.

The provided text describes a 510(k) premarket notification for a medical device, the "Responsive Arthroscopy Knotless Push-In Suture Anchor System." This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets acceptance criteria in a clinical study. Therefore, several of your requested points related to clinical study design, ground truth establishment, expert involvement, and reader studies are not applicable to this type of regulatory submission.

The FDA 510(k) process for Class II medical devices like this one typically relies on bench testing and comparison to predicate devices, not extensive clinical trials with human subjects to prove performance metrics in the way you've outlined for diagnostic AI.

Here's a breakdown of the information that is available and a note on what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The submission demonstrates substantial equivalence through various performance tests, but it does not specify explicit "acceptance criteria" in a numerical sense as one would expect for a diagnostic AI study (e.g., AUC > 0.9, sensitivity > 90%). Instead, the "acceptance criteria" for a 510(k) are generally that the new device performs as well as or better than the predicate device, or at least does not introduce new safety or effectiveness concerns, for its intended use. The performance reported aims to support this substantial equivalence.

Study Proving Substantial Equivalence:

The provided document describes a 510(k) Pre-Market Notification submission, which is a regulatory pathway to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. The "study" in this context refers to the collection of bench testing and risk assessments performed to support this claim.

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

• Sample Size for Test Set: Not explicitly stated numerically for each test. Bench testing involves a certain number of samples, but these are material/device samples, not patient data.
• Data Provenance: The "data" comes from bench testing (laboratory mechanical tests) of the device components and system. It is not clinical data from patients, so concepts like "country of origin" or "retrospective/prospective" patient data do not apply.

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

Not applicable. This is not a diagnostic AI study involving expert radiologists/pathologists. The "ground truth" for bench testing is derived from established engineering and materials science principles, industry standards (e.g., ASTM F2026 for PEEK), and comparison to the predicate device's known performance.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation of data in the sense of a diagnostic study that would require adjudication. Bench test results are quantitative measurements.

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

Not applicable. This is not a study of AI assistance or human reader performance.

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

Not applicable. This device is a mechanical surgical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this regulatory submission is based on:

• Performance standards and literature: Established engineering principles, material properties (e.g., ASTM F2026 for PEEK), and industry standards for surgical implants.
• Predicate device performance: The performance of the Responsive Arthroscopy Suture Anchor System (K180951) serves as the primary benchmark.
• Risk assessment: Evaluation against known biological and mechanical risks associated with similar devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI or machine learning device requiring a training set.

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

Not applicable.

Summary of Device and Regulatory Context:

The "Responsive Arthroscopy Knotless Push-In Suture Anchors" are intended for surgical fixation of soft tissue to bone in various joints (shoulder, foot/ankle, hip, knee, hand/wrist, elbow). Key features mentioned are:

• Made of PEEK (polyetheretherketone) per ASTM F2026.
• Available in 3.5mm to 4.75mm diameters.
• Pre-loaded with or accept #2 suture or 2.5mm suture tape (ultra-high molecular weight polyethylene).
• Introduces changes in "suture geometry, anchor body geometry, and internal screw geometry" compared to its predicate.
• Sterilized with ethylene oxide (anchors). Reusable instruments are non-sterile and sterilized by the end-user.

The FDA's determination of substantial equivalence for this Class II device means that, based on the submitted information (primarily bench testing and comparison to the predicate), the new device is as safe and effective as a legally marketed predicate device. This pathway does not typically require clinical trials in the sense of demonstrating new clinical efficacy or diagnostic accuracy with human subjects.

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The Responsive Arthroscopy Wedge Push-In Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, hip, 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, Achilles Tendon Repair, Hallux Valqus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy, Digital Tendon Transfers.

Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Vastus Medialis Obliguus Advancement. Patellar Tendon Repair. Posterior Oblique Ligament Repair. Iliotibial Band Tenodesis, Joint Capsule Closure.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collament Reconstruction, Carpal Ligament Reconstruction, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP Joints for all Digits, Digital Tendon Transfers.

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

Hip: Capsular Repair, Acetabular Labral Repair, Gluteus Medius Repair.

The Responsive Arthroscopy (RA) Wedge Push-In Suture Anchor is a knotless suture anchor for the fixation of soft tissue to bone. The system includes suture anchors made of polyether ether ketone per ASTM F2026 (PEEK) along with repair sutures, passing sutures, inserters, drills, and guide tubes. The suture anchor inserters and instrumentation are available in a variety of geometries and configurations to accommodate various procedures and patient anatomies.

This document is a 510(k) summary for a medical device (Responsive Arthroscopy Wedge Push-In Suture Anchors) and does not describe artificial intelligence/machine learning (AI/ML) software. Therefore, the requested information about acceptance criteria and study details related to an AI/ML device is not present in the provided text.

Specifically, the document focuses on demonstrating substantial equivalence of a physical medical device (suture anchors) to a predicate device through material, design, function, performance, and intended use comparisons, along with bench testing. It does not mention any AI/ML components or studies.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for an AI/ML device based on this input.

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The Responsive Arthroscopy Wedge Push-In Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, hip, 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, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy, Digital Tendon Transfers.

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Vastus Medialis Obliquus Advancement, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis, Joint Capsule Closure.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Carpal Ligament Reconstruction, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP Joints for all Digits, Digital Tendon Transfers.

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

Hip: Capsular Repair, Acetabular Labral Repair, Gluteus Medius Repair.

The Responsive Arthroscopy (RA) Wedge Push-In Suture Anchor is a knotless suture anchor for the fixation of soft tissue to bone. The system includes suture anchors made of polyether ether ketone per ASTM F2026 (PEEK) along with repair sutures, passing sutures, inserters, drills, and guide tubes. The suture anchor inserters and instrumentation are available in a variety of geometries and configurations to accommodate various procedures and patient anatomies.

This document is a 510(k) Premarket Notification from the FDA regarding the "Responsive Arthroscopy Wedge Push-In Suture Anchors." It primarily focuses on demonstrating substantial equivalence to predicate devices for a medical implant and does not contain information about an AI/ML powered medical device or associated acceptance criteria and study data as requested in your prompt.

Therefore, I cannot provide the requested information based on the provided text. The document describes a physical medical device (suture anchors), not a software or AI-based diagnostic tool.

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The Responsive Arthroscopy Large Screw-In Suture Anchors are intended to 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, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.

The Responsive Arthroscopy Large Push-In 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, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial 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 Epicondylitis Repair.

The Responsive Arthroscopy Small Push-In Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures.
Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Bunionectomy, Digital Tendon Transfers.
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Vastus Medialis Obliquus Advancement, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Carpal Ligament Reconstruction, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP Joints for all Digits, Digital Tendon Transfers.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Hip: Capsular Repair, Acetabular Labral Repair.

The Responsive Arthroscopy Knotless Push-In Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures.
Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Bunionectomy, Digital Tendon Transfers.
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Vastus Medialis Obliquus Advancement, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
Elbow: Bicens Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Hip: Capsular Repair, Acetabular Labral Repair,

The Responsive Arthroscopy (RA) Suture Anchor System is a family of suture anchors for the fixation of soft tissue to bone. The system includes a variety of suture anchors made of polyether ether ketone per ASTM F2026 (PEEK) along with repair sutures, inserters, taps, punches, drills, and quide tubes.
The suture anchors are available in a variety of geometries and configurations to accommodate various procedures and patient anatomies. RA Suture Anchors range in diameter from 2.5mm to 5.5mm and are either pre-loaded with or accept #2 suture.
The RA Suture Anchor System implants are pre-loaded on inserters and provided sterile, RA Suture Anchor System single-use instruments are provided sterile, and the RA Suture Anchor System reusable instruments are non-sterile and are to be sterilized by the end user. All RA Suture Anchor System implants and single-use instruments are sterilized with ethylene oxide (EO).

The provided text describes a 510(k) premarket notification for the Responsive Arthroscopy Suture Anchor System. This document outlines the device's indications for use, technological characteristics, and performance testing to demonstrate substantial equivalence to legally marketed predicate devices.

However, the provided text DOES NOT contain information about a study proving the device meets acceptance criteria related to an AI/ML-driven medical device. Specifically, it lacks:

• A table of acceptance criteria and reported device performance (for an AI model).
• Sample sizes, data provenance, expert numbers, adjudication methods, MRMC studies, or standalone algorithm performance, as these are related to the evaluation of AI/ML models.
• Details on ground truth establishment for AI training or test sets.

The document focuses on the substantial equivalence of a physical medical device (suture anchors) based on its mechanical performance and material properties. The performance testing mentioned ("Suture Characterization," "Insertion Torque Testing," "Static & Fatigue Pullout Force Testing," "Suture Locking Force Testing," "Bacterial endotoxin testing") are engineering and biocompatibility tests typical for a physical orthopedic implant, not studies for an AI/ML algorithm.

Therefore, I cannot fulfill the request as it is predicated on the assumption that the provided text describes an AI/ML device and its validation. The content of the document is solely for a physical medical device.

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The Responsive Arthroscopy Interference Screws are intended to be used for fixation of tissue including ligament, tendon, soft tissue, or bone to bone. Interference fixation with PEEK or Titanium Interference Screws is appropriate for surgeries of the knee, shoulder, elbow, and hand/wrist where the sizes offered are patient appropriate. Specifically, screws are intended for use 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, Anterior Shoulder Instability

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfers in the Foot and Ankle, Bunionectomy

Knee: Anterior Cruciate Ligament Repair, Posterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

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

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

The Responsive Arthroscopy (RA) Interference Screw System is a family of interference screws for the reattachment and fixation of tissue including ligament, tendon, soft tissue, or bone to bone. The system includes cannulated interference screws in both polvether ether ketone (PEEK) per ASTM F2026 and Ti-6AI-4V ELI titanium alloy per ASTM F136, along with drivers, taps, and guide wires for screw insertion.

The screws are available in a variety of sizes to accommodate various procedures and patient anatomies. RA PEEK Interference Screws are offered with diameters from 7-12mm and lengths from 20-35mm. RA Titanium Interference Screws are offered with diameters from 7-10mm and lengths from 20-35mm.

The RA Interference Screw System implants are provided sterile, and the RA Interference Screw System instruments are non-sterile and are to be sterilized by the end user. The RA PEEK Screws are sterilized with ethylene oxide (EO). The RA Titanium Interference Screws are sterilized with gamma radiation.

The provided text describes the 510(k) premarket notification for the "Responsive Arthroscopy Interference Screw System." This document is a regulatory submission to demonstrate that the new device is substantially equivalent to legally marketed predicate devices. It focuses on the device's design, materials, indications for use, and performance testing to support this claim.

However, the text does not contain the specific information requested about acceptance criteria and study details related to an AI/ML device. The document is about a mechanical surgical screw system, not an AI/ML-driven diagnostic or treatment device. Therefore, I cannot provide the requested details using the provided input.

The sections for acceptance criteria, study design, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information are not applicable to the submitted document.

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