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The Suture Button Repair System is intended for fixation of bone and soft tissue in upper extremity orthopedic procedures requiring ligament or tendon reconstruction in the hand, wrist, forearm, elbow and shoulder.

The Suture Button Repair System is comprised of the following Suture Button configurations in conjunction with accessories: (1) Distal Bicep Suture Button Repair configuration, (2) IOL Suture Button-Repair configuration and (3) CMC Suture Button Repair configuration. The implants are provided sterile for single use. The instruments are provided non-sterile and shall be sterilized by the end user.

The provided FDA 510(k) summary for the "Suture Button Repair System" does not describe a study involving an AI/Machine Learning device or a diagnostic device that requires establishment of ground truth by experts or a multi-reader multi-case (MRMC) comparative effectiveness study.

Instead, this document is a 510(k) submission for a surgical implant (Suture Button Repair System) and focuses on demonstrating substantial equivalence to a predicate device. The performance testing described is primarily bench-top mechanical testing and standard regulatory tests for medical devices (sterilization, biocompatibility, stability).

Therefore, I cannot extract the information requested in your prompt (acceptance criteria, details of a study proving device meets criteria, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) because these concepts are not applicable to the type of device and submission described in the input document.

The document states:

• "Non-clinical performance testing for the Suture Button Repair System included sterilization validation... biocompatibility testing... stability testing... The Suture Button Repair System was also evaluated for strength and elongation during cyclic loading and ultimate load to failure conditions." (Page 4)
• "Bench top performance testing demonstrated substantially equivalent mechanical performance as the predicate device." (Page 5)

This indicates that the "study" proving the device meets acceptance criteria was a series of engineering/mechanical tests, not a clinical study involving interpretation of images or data by human readers or AI.

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The TissueStat PTFE (polytetrafluroethylene) Suture and Delivery Device is indicated for use in all types of soft tissue approximation and / or ligation, including cardiovascular, dental, general surgical procedures and repair of the dura mater. TissueStat PTFE Sutures are not indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissues. TissueStat PTFE Sutures are provided sterile as a single use device.

The TissueStat PTFE surgical sutures are monofilament surgical sutures composed from expanded polytetrafluoroethylene (ePTFE) material. They are available uncoated and undyed in USP size 2/0. The sutures are attached to standard stainless steel surgical needles. The TissueStat Suture Delivery Device is a Class I Manual Surgical Instrument that assists with suture placement. The PTFE suture is loaded into the Suture Delivery Device and is delivered to the desired location through the device tip by pressing the actuation button on the device handle.

The provided documentation is a 510(k) premarket notification for a medical device called "TissueStat PTFE Suture and Delivery Device." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a standalone clinical study with defined performance metrics.

Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes for test sets, expert ground truth establishment, adjudication methods, or MRMC studies are not applicable to this type of regulatory submission and are not present in the provided text.

The "Performance Data" section outlines verification and validation testing conducted to support substantial equivalence, not a comparative effectiveness study or a study to meet specific clinical acceptance criteria in the way typically expected for an AI/ML device.

Here's the information that can be extracted or inferred from the provided text, and where the requested information is not available:

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

The document does not present a table of acceptance criteria and reported device performance in terms of clinical outcomes or diagnostic accuracy. Instead, it lists the types of performance testing conducted to verify that the device meets engineering and material standards for substantial equivalence.

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

Not applicable or not mentioned. The document primarily focuses on mechanical and biocompatibility testing for substantial equivalence, not a clinical study with a "test set" in the context of AI/ML or diagnostic performance. Therefore, there is no information about data provenance or sample sizes for such a clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable or not mentioned. The concept of "ground truth" established by experts is typically relevant for diagnostic or AI/ML device evaluations. This document describes a surgical suture and delivery device, where "ground truth" would relate to material properties and mechanical performance, established through standardized testing, not expert consensus on interpretations.

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

Not applicable or not mentioned. Adjudication methods are relevant for expert consensus in clinical studies, which is not the type of study described here.

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. The "TissueStat PTFE Suture and Delivery Device" is a physical medical device (suture and delivery system), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device and was not performed.

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

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

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

For the mechanical and biocompatibility testing mentioned, the "ground truth" or reference would be established by:

• USP standards: For Suture Diameter (USP ), Suture Tensile Testing (USP ), and Needle Attachment Testing (USP ). These are standardized testing protocols.
• ISO 10993 and FDA Guidance: For Biocompatibility Risk Assessment, adherence to these standards forms the basis for demonstrating safety.

8. The sample size for the training set

Not applicable. The device is not an AI/ML product developed using training data.

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

Not applicable. The device is not an AI/ML product.

Summary of Relevant Information from the Document:

While the document does not present acceptance criteria and performance in the format of an AI/ML device evaluation, it does outline the type of performance data collected to demonstrate substantial equivalence:

Verification and Validation Testing Conducted:

• Mechanical Testing:
  • Suture Diameter Testing per USP
  • Suture Tensile Testing per USP
  • Needle Attachment Testing per USP
• Biocompatibility Testing:
  • Conducted a Biocompatibility Risk Assessment in accordance with ISO 10993-1 (2018) and FDA Guidance (2020).
  • The PTFE suture is an implant with permanent (>30 days) contact with tissue.

Conclusion:

The submission concludes that, based on the indications for use, technological characteristics, and performance testing in comparison to the predicate device, the TissueStat PTFE Suture and Delivery Device has been shown to be substantially equivalent to the legally marketed predicate device for its intended use. This means the testing demonstrated that the device meets the established engineering and safety standards equivalent to the predicate, and therefore, does not raise new questions of safety or effectiveness.

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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 Suture Anchors - HTA Headless Titanium Anchor and ZIP Anchors are indicated to be used for suture or tissue fixation in the elbow, shoulder, hand, wrist, foot, ankle, knee, and hip. Specific indications are listed below:

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

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

Hand Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)

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 Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Hip: Capsular repair, acetabular labral repair.

The Suture Anchors, manufactured by GM dos Reis Indústria e Comércio Ltda, are anchor-type implants, and are composed of two groups of anchors, manufactured in Titanium Alloy (ASTM F136) and Ultra High Molecular Weight Polyethylene – UHMWPE (which are called ZIP Anchor), that is the same raw material of the suture. The anchors are made available preloaded in a disposable inserter device, composed of a metal rod and a polymeric cable. The implant and disposable inserter devices are unique products and cannot be sold separately.

Implants of the Suture Anchors - GM Reis are classified as surgically invasive, non-absorbable, and non-active implantable medical devices. In addition, the implants, as well as, the inserter device, are for single-use and sold in sterile form - supplied as a sterile kit for ethylene oxide (ETO) according to ISO 11135 - "Preview Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices".

The Suture Anchors - GM Reis is composed of two different groups of anchors:

• HTA – Headless Titanium Anchor.
  • Anchor Diameters: ø1,7 mm; ø2,2 mm; ø2,7 mm; ø3,5 mm and ø5,0 mm
• -ZIP Anchor.
  • Ø0.9mm; Ø1.2mm; Ø1.5mm; Ø1.8mm; Ø1.9mm; Ø2.6mm.

This document is a 510(k) Premarket Notification from the FDA regarding "Suture Anchors - HTA Headless Titanium Anchor and ZIP Anchors." It details the device, its intended use, and a comparison to predicate devices, but it does not contain any information about acceptance criteria or a study proving the device meets those criteria for an AI/algorithmic device.

The document discusses non-clinical performance data for the suture anchors themselves (insertion torque, pullout strength, MRI compatibility) to demonstrate substantial equivalence to predicate devices, but this is for a physical medical device, not a software or AI-driven diagnostic or therapeutic tool.

Therefore, I cannot provide the requested information based on the provided text. The prompt asks for details about a study proving an AI/algorithmic device meets acceptance criteria, which is not what this FDA document is about.

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HS Fiber Cerclage sutures are indicated for use in general soft tissue approximation and/or ligation. These sutures may be used in cardiovascular surgeries, and orthopedic surgeries using allograft tissue. When used as a bone fixation cerclage, the sutures are intended for:

• · Trauma surgery indications including olecranon, ankle, patella, and some shoulder rewiring.
• · Repair of long bone fracture due to trauma or reconstruction.

The Riverpoint Medical HS Fiber® Cerclage sutures are non-absorbable, sterile, surgical sutures composed of multiple single strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HS Fiber Cerclage sutures are available in common sizes and lengths with or without pre-attached needles. Suture supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. The device is sterilized by ethylene oxide gas, and is provided sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.

Here's a breakdown of the acceptance criteria and study information for the Riverpoint Medical HS Fiber® Cerclage, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not explicitly state the sample sizes used for each specific test set. It broadly mentions tests performed, but not the number of units or samples involved in, for example, the tensile strength or fatigue strength testing.

Regarding data provenance, the study appears to be non-clinical, laboratory-based testing conducted by the manufacturer, Riverpoint Medical, LLC. No information is given about the country of origin of the data beyond the manufacturer's location in Portland, Oregon, USA. The studies are retrospective in the sense that they are conducted on manufactured devices as part of the submission process, not on a prospective cohort of patients.

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

This information is not applicable as the studies described are non-clinical, mechanical, and material characteristic tests, not studies requiring expert interpretation of medical images or patient data to establish a ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

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

An MRMC comparative effectiveness study was not done. The device is a physical medical device (suture) and not an AI/software-based medical device that would involve human readers or AI assistance.

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

A standalone performance study was not done. Again, this is a physical medical device, not an algorithm.

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

The "ground truth" for the non-clinical performance studies were:

• Established standards and specifications: United States Pharmacopeia (USP) requirements for sutures (primarily for needle attachment and tensile strength), and various ISO and EN standards for sterilization, biocompatibility, packaging, and usability.
• Predicate device performance: Comparative testing was conducted against a predicate device (Arthrex FiberTape Cerclage - K170206) to demonstrate comparable performance in areas like tensile strength, fatigue strength, creep, and wear debris.

8. The Sample Size for the Training Set

This information is not applicable as there is no "training set" for this type of physical medical device. The device is manufactured based on design specifications and then tested against these specifications and regulatory standards.

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

This information is not applicable for the same reason as point 8.

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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 GRAPPLER™ Suture Anchor System is intended for the fixation of soft tissue to bone including:

Elbow: Biceps Tendon Reattachment, Lateral Epicondylitis Repair, Tennis Elbow Repair

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, Ulnar or Radial Collateral Ligament Reconstruction, TFCC

Foot/Ankle: Lateral Stabilization (Brostrom-Gould, Chrisman-Snook Repair), Ankle Ligament Repair, Medial Stabilization (Deltoid Repair, Spring Ligament Reconstruction), Achilles Tendon Repair, Metatarsal Ligament Repair, Syndesmosis Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, LisFranc Repair

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Extra Capsular Reconstruction, Patellar Ligament and Tendon Avulsion Repair

Hip: Capsular Repair, Acetabular Labral Repair

The GRAPPLER™ Suture Anchor System consists of suture anchors, suture, and the accompanying instrumentation for the intended use of soft tissue damage repair. The anchors are provided in PEEK, titanium, and suture materials in multiple sizes and lengths. Each anchor is accompanied by round suture or suture tape composed of UHMWPE and PGLA.

This document is for a medical device called the "GRAPPLER™ Suture Anchor System," which is a physical device used to fix soft tissue to bone. It is not an AI/ML powered device, and therefore, does not have the types of acceptance criteria and study designs that would typically apply to such devices (e.g., diagnostic performance metrics like sensitivity, specificity, AUC, or MRMC studies for human-in-the-loop performance).

The document details the substantial equivalence determination for this device, comparing it to legally marketed predicate devices. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and material testing to ensure the device performs as intended and is safe, rather than clinical performance studies measuring diagnostic accuracy or reader improvement.

Analysis of Acceptance Criteria and Device Performance (Based on Provided Text):

1. Table of Acceptance Criteria and Reported Device Performance:

The provided text does not present the acceptance criteria in a formal table with specific numerical values or targets. Instead, it describes the types of tests performed and states that "All performance testing conducted for the GRAPPLER™ Suture Anchor System met the predetermined acceptance criteria or were otherwise considered acceptable."

Here's an interpretation based on the text:

Notes:

• The document states: "The device performance was characterized via torsional strength, insertion/removal torque, pullout testing and tensile testing."
• "Device shelf life was validated through real time and accelerate aging events assessed with seal strength, visual inspection, dye penetration, pressurization evaluations."
• "Device sterility was validated through bioburden testing. Pyrogenicity was verified through bacterial endotoxin (LAL) testing."

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

• Sample Size: The document does not specify the sample sizes (e.g., number of anchors tested) for each of the performance tests (torsional strength, tensile, etc.). It only mentions that "All testing was performed on finished devices."
• Data Provenance: Not applicable in the context of clinical data for an AI/ML device. The data provenance refers to the results of in-house or contracted laboratory mechanical and material testing. The country of origin of this testing data is not specified. It is inherently "prospective" in the sense that the tests were conducted specifically for this submission.

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

• Not applicable. This is a physical device, and its acceptance criteria are based on engineering and material performance standards, not on expert consensus for clinical interpretations or diagnoses.

4. Adjudication Method for the Test Set:

• Not applicable. Ground truth for mechanical testing is established by direct measurement against engineering specifications, not through expert adjudication.

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

• No. An MRMC study is typically performed for AI-powered diagnostic devices to assess how the AI assists human readers. This device is a physical surgical implant, so an MRMC study is not relevant.

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

• Not applicable. This is not an algorithm. The "standalone performance" refers to the mechanical and material performance of the device itself (e.g., its tensile strength, resistance to torque), which was indeed assessed through the tests mentioned.

7. The Type of Ground Truth Used:

• The "ground truth" for this device's acceptance is based on engineering specifications and established material and mechanical testing standards. For example, a suture anchor must withstand a certain pullout force, or its material must have a certain tensile strength. These are objective, measurable criteria, not subjective interpretations.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device, so there is no "training set."

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

• Not applicable. As there is no training set for an AI/ML model, there is no corresponding ground truth establishment process.

Summary for this Specific Device:

The provided document is a 510(k) clearance letter for a physical medical device (suture anchor). The "acceptance criteria" and "study" described pertain to engineering and material performance testing, rather than clinical diagnostic performance or AI model validation. The FDA granted clearance based on the device demonstrating substantial equivalence to existing predicate devices, supported by data showing it meets relevant mechanical, material, sterility, and shelf-life requirements. The type of information requested in the prompt (e.g., MRMC studies, training/test sets for AI, expert adjudication) is typically relevant only for AI/ML-powered medical devices.

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The EXPERT - Joint Fixation System is intended as an adjunct in fracture repair involving metaphyseal and periarticular bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and nails, with fracture braces and casting.

The Mini EXPERT, EXPERT Knotless and EXPERT Knotless Dual are intended to provide fixation during the healing process following:

Mini EXPERT

When used for fixation of bone, the Mini EXPERT is intended as fixation posts, distribution bridges, or for distributing suture tension over areas of ligament or tendon repair, such as:

• Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions;

• Tarsometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and

• Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process of the ligament at the base of the thumb metacarpal by providing stabilization between the first and second metacarpal when the trapezium has been excised due to osteoarthritis.

EXPERT Knotless and EXPERT Knotless Dual

Syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.

The EXPERT – Joint Fixation System is available in three models. Each model is composed of different medical devices (i.e. plates, surgical suture) assembled together for the purpose of use as a set. Each set is composed of plates from different sizes and shapes made of Titanium Alloy (ASTM F136) associated with non-absorbable surgical sutures and/or surgical meshes made of an Ultra-High Molecular Weight Polyethylene (UHMWPE).

The metallic components are manufactured by GM dos Reis Indústria e Comércio Ltda and the nonabsorbable Surgical Sutures and Surgical Suture Meshes are purchased in bulk from River Point Medical (K100006).

Each EXPERT model comes with a transient use guidewire accessory in the same package. The guidewire is made of Stainless Steel (ASTM F138) to aid in the EXPERT - Joint Fixation System placement.

In order to promote a correct placement of EXPERT – Joint Fixation System, GMReis has also available a range of instruments (class I exempt) to serve the surgeon such as drill bits, drill guides, plier, among others. GMReis recommends the use of these instruments in order to ensure the compatibility with the subject devices and promote the success of the procedure.

This document describes the EXPERT - Joint Fixation System and its substantial equivalence to predicate devices, focusing on the mechanical performance of the device rather than AI/software performance. Therefore, many of the typical acceptance criteria and study design elements found in AI/ML medical device submissions (such as ground truth establishment involving expert consensus, MRMC studies, or standalone algorithm performance) are not applicable here.

The "study" in this context refers to mechanical testing that demonstrates the device's physical performance characteristics are comparable to legally marketed predicate devices.

Here's a breakdown based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to existing predicate devices through mechanical testing. The document states:

• "The performance of the subject devices compared with the predicate devices are demonstrated through mechanical testing."
• "The documentation submitted in this premarket notification demonstrates that the subject devices have comparable features and performance and, therefore, are substantially equivalent to the identified predicate devices."

Since this is a 510(k) submission for a physical medical device (joint fixation system) and not an AI/ML diagnostic or prognostic tool, the "performance" is related to its physical and functional characteristics (e.g., strength, durability, fixation capability) as compared to the predicates. The document does not explicitly list quantitative acceptance criteria values or detailed reported device performance data in a table format. Instead, it relies on the conclusion that mechanical tests confirm comparability.

Table of Acceptance Criteria and Reported Device Performance (Inferred from 510(k) Context):

Study Information (Mechanical Testing for Substantial Equivalence)

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not specified in the provided summary. For mechanical testing of medical devices, sample sizes are typically determined by statistical rationale to ensure robustness and representativeness of the device's performance.
   • Data Provenance: The testing was conducted as part of the submission by GM dos Reis Indústria e Comércio Ltda, a Brazilian company. The data would be prospective, as it was generated specifically for this 510(k) submission.

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

   • Not Applicable. This is a submission for a physical joint fixation system, not an AI/ML device requiring human expert annotation of medical images or clinical outcomes for ground truth. Ground truth for mechanical performance is established through standardized engineering tests and material science evaluations.

3. Adjudication Method for the Test Set:

   • Not Applicable. See point 2.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • Not Applicable. This type of study is relevant for AI/ML devices that assist human readers (e.g., radiologists) in diagnostic tasks. The EXPERT - Joint Fixation System is a physical implant.

5. Standalone (Algorithm Only) Performance:

   • Not Applicable. No algorithms or software are involved in the primary function or assessment of this physical device.

6. Type of Ground Truth Used:

   • Engineering Specifications and Standardized Test Methods: For mechanical performance, ground truth is established by universally accepted engineering principles, material standards (e.g., ASTM, ISO), and validated test methods (e.g., fatigue testing, tensile strength). For biocompatibility, it's established by adherence to ISO 10993 series standards and AAMI/ANSI ST72.

7. Sample Size for the Training Set:

   • Not Applicable. There is no "training set" in the context of mechanical testing for a physical medical device. Device design and manufacturing processes are refined through engineering iterations.

8. How the Ground Truth for the Training Set Was Established:

   • Not Applicable. See point 7.

Summary of Information NOT Applicable to this Submission:
Due to the nature of the device (a physical joint fixation system) and the regulatory submission (510(k) based on substantial equivalence through mechanical testing), the following elements, commonly associated with AI/ML device evaluations, are not found in the provided document:

• Detailed quantitative performance metrics in a readily available table.
• Specific sample sizes for a "test set" in the context of clinical/image data.
• Data provenance involving patient demographics or retrospective/prospective medical data collection.
• Number/qualifications of experts for ground truth establishment.
• Adjudication methods.
• MRMC studies.
• Standalone algorithm performance.
• Training set information.

The document unequivocally states: "No clinical data were included in this submission." This further confirms that the evaluation focused on physical and mechanical properties, not clinical outcomes or human performance with AI assistance.

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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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Shoulder

• Rotator Cuff Repair
• · Bankart Repair
• · SLAP Lesion Repair
• · Biceps Tenodesis
• · Acormio-Clavicular Separation Repair
• · Deltoid Repair
• Capsular Shift or Capsulolabral Reconstruction

Hand and Wrist

• Scapholunate Ligament Reconstruction
• Carpal Ligament Reconstruction
• · Repair/Reconstruction of collateral ligaments
• · Repair of flexor and extensor tendons at the PIP, DIP, and MCP joints for all digits
• · Digital tendon transfers

Elbow

• Biceps Tendon Reattachment
• · Ulnar or Radial Collateral Ligament Reconstruction

Hip

• · Capsular Repair
• Acetabular Labral Repair

Foot and 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
• Posterior oblique ligament repair
• Illiotibial band tenodesis reconstruction
• Patellar ligament/tendon repair

The BoneCam Suture Anchor Delivery Systems are for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. The BoneCam Suture Anchor Delivery System consists of a single anchor with integrated multiple suture attachment. The anchors are provided loaded on individual inserters with integrated sutures with or without needles, sterile (EtO), for single use only. The BoneCam Suture Anchor Delivery Systems have a shelf life of 2 years. Implants are fabricated from Solvay Zeniva ZA-500, ZA-600, or ZA-600 CF30 PEEK (ASTM F2026).

Here's a breakdown of the acceptance criteria and study information for the Valeris Medical Inc. Bonecam Suture Anchor, based on the provided document:

This document is a 510(k) summary for a medical device (Bonecam Suture Anchor), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel AI performance. Therefore, many of the requested fields related to AI performance, ground truth, and expert evaluation are not applicable (N/A) for this type of submission.

Acceptance Criteria and Device Performance (Not applicable for AI performance in this document)

This document does not provide specific acceptance criteria or reported performance for an AI-powered device. Instead, it focuses on demonstrating the substantial equivalence of the Bonecam Suture Anchor to a predicate device, K152255, by comparing their technological characteristics and performing bench testing.

Study Information

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

   • Sample Size: Not specified for human subject data. For bench testing: "Axial Pull-Out per ASTM F543-17 testing was conducted..." The exact number of samples tested is not provided in this summary but would be detailed in the full test report.
   • Data Provenance: N/A for human subject data. For bench testing, it's laboratory testing for mechanical performance characteristics of the device materials.

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

   • Number of Experts: N/A (No clinical study involving expert ground truth determination is described).
   • Qualifications of Experts: N/A

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

   • N/A (No clinical study requiring adjudication is described).

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

   • No. This is a medical device (suture anchor) submission, not an AI device. Therefore, no MRMC study or AI assistance improvement effect size is mentioned or applicable.

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

   • No. This is a medical device, not an AI algorithm.

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

   • N/A (No AI algorithm or clinical endpoint requiring ground truth is described). For the mechanical testing, the "ground truth" would be the measured physical properties according to the ASTM standard.

7. The sample size for the training set:

   • N/A (No AI algorithm training set is mentioned).

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

   • N/A (No AI algorithm training set is mentioned).

Summary of Relevant Information from the Document:

• Device Name: Bonecam Suture Anchor
• Purpose of Submission: Demonstrate substantial equivalence to a predicate device (K152255) for approval to market.
• Key Comparisons for Substantial Equivalence:
  • Intended Use/Indications for Use: Identical to predicate device.
  • Materials: Similar (both Solvay ZENIVA PEEK), with the subject device offering additional configurations (ZA-600, ZA-600 CF30 PEEK) and an additional UHMWPE suture manufacturer.
  • Design Features: Same general design as the predicate, with an additional suture port for more options.
  • Sterilization and Shelf-Life: Identical (sterile (EtO), 2-year shelf life).
  • Biocompatibility: Established according to ISO 10993-1.
• Performance Data: "Axial Pull-Out per ASTM F543-17 testing was conducted to confirm the material additive did not introduce any new risk." This bench test demonstrates mechanical performance, but specific results or acceptance criteria are not detailed in this summary.
• Conclusion: The subject device is considered substantially equivalent to the predicate device, and safe and effective for its intended use, based on the documented comparisons and performance testing.

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