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The GRYPHON X Anchor is intended for:
Shoulder: Biceps Tenodesis;
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique
Ligament Repair, Iliotibial Band Tenodesis, Medial Patellofemoral Ligament Reconstruction;
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament
Reconstruction

The HEALIX TRANSTEND Anchor is intended for:
Shoulder: Rotator Cuff, Partial Thickness Rotator Cuff, Biceps Tenodesis, Acromio-Clavicular Separation, Deltoid Repair;
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Mid-Foot Reconstruction, Hallux Valgus Repair, Metatarsal Ligament/Tendon Repairs;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique
Ligament Repair, Iliotibial Band Tenodesis;
Elbow: Lateral Epicondylitis Repair;
Wrist: Scapholunate Ligament Reconstruction;
Hip: Capsular Repair, Acetabular Labral Repair

The subject devices of this Traditional 510(k) are the GRYPHON X Anchors and the HEALIX TRANSTEND Anchors.

The proposed GRYPHON X Anchor is suture anchor preloaded on a disposable inserter assembly and is intended for fixation of suture to bone for various orthopedic procedures. The proposed anchor will be available with various suture offerings: ORTHOCORD™ Suture, PERMACORD™ Suture, DYNACORD™ Suture, and PERMATAPE™ 1.3mm Suture, offered in either single strand or double strand configurations with needle attachments. The GRYPHON X Anchors are offered with either a push-in (“P”) or threaded (“T”) anchor design and are available in absorbable BIOCRYL RAPIDE (BR) (P and T anchors) or non-absorbable PEEK materials (P anchors only). The implant is supplied sterile, ready to use.

The proposed HEALIX TRANSTEND Anchor is a suture anchor preloaded on a disposable inserter assembly and is intended for fixation of suture bone for various orthopedic procedures. This proposed device will be loaded with either one or two strands of PERMATAPE 1.3mm Suture and will be offered in PEEK material only. The implant is supplied sterile ready to use.

The proposed GRYPHON X product portfolio also contains a reusable instrument sterilization tray with lid (sold separately) – it's intended to store and protect the reusable instruments during transport and sterilization

This document is an FDA 510(k) Premarket Notification for orthopedic bone fixation devices (suture anchors). It details the substantial equivalence of the GRYPHON™ X Anchor and HEALIX TRANSTEND™ Anchor to existing predicate devices.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Preamble: The document states that the FDA has reviewed the 510(k) and determined the device is "substantially equivalent" to legally marketed predicate devices. This means that, for the purpose of this FDA clearance, the new devices (GRYPHON X and HEALIX TRANSTEND anchors) are considered as safe and effective as the already-marketed predicate devices. The basis for this determination is laid out in the acceptance criteria and non-clinical testing section below.

Regarding the specific requirements for "device meets the acceptance criteria" as requested in your prompt, it's important to understand that for a 510(k) submission like this, the "acceptance criteria" are primarily defined by:

1. Substantial Equivalence: Demonstrating that the new device has the same intended use and similar technological characteristics as a predicate device, or that any differences do not raise new questions of safety or effectiveness.
2. Performance Testing: Providing data from non-clinical (and sometimes clinical, though not typically required for Class II 510(k)s unless new questions of safety/effectiveness are raised) tests to support the substantial equivalence claim.

Therefore, the "acceptance criteria" table below will reflect the comparative aspects and performance tests mentioned in the document.

1. Table of Acceptance Criteria and Reported Device Performance

• Anchor design
• Materials
• Principle of operation
• Intended use | The anchor design, materials, principle of operation, and intended use of the subject devices are identical to that of the predicate devices. The main differences are additional suture configurations and additional indications for use (GRYPHON X only), which are addressed by the non-clinical testing. |
  | Performance - Fixation Strength:
• At T=0 (initial fixation)
• Over healing period (for absorbable materials) | Verification activities included an assessment of fixation strength for proposed indications at T=0 and over the healing period (for absorbable configuration). The results demonstrated that the devices continue to meet established design inputs and corresponding criteria. |
  | Performance - Insertion Force | Verification activities included an assessment of insertion force. The results demonstrated that the devices continue to meet established design inputs and corresponding criteria. |
  | Performance - Fatigue Strength | Verification activities included an assessment of fatigue strength. The results demonstrated that the devices continue to meet established design inputs and corresponding criteria. |
  | Performance - Needle Attachment Strength (for pre-loaded sutures) | Verification activities included an assessment of needle attachment strength for the pre-loaded sutures in scope of the submission. The results demonstrated that the devices continue to meet established design inputs and corresponding criteria. |
  | Overall Safety and Effectiveness - No New Issues | Results of the analyses demonstrated that there were no new issues of safety or effectiveness related to device performance. |

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

The document does not explicitly state the numerical sample sizes used for the non-clinical testing (e.g., number of anchors tested for fixation strength, insertion force, etc.). It generally refers to "verification activities" and "analyses" demonstrating that the devices meet criteria.
The data provenance is non-clinical testing, performed to support product safety and performance, typically done in vitro (bench testing). The document does not provide details on the location/country of origin of this data or if it's retrospective or prospective, but for 510(k) non-clinical testing, it is always prospective, often conducted by the manufacturer or a contract research organization.

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

• For this type of 510(k) submission, there isn't a "ground truth" derived from expert clinical assessment in the same way as, for example, an AI/imaging device. The "ground truth" here is the established performance characteristics and safety profile of the predicate devices.
• Expert involvement for establishing ground truth (e.g., radiologists for imaging studies) is not applicable or described in this document for these mechanical orthopedic implants. The "experts" involved are likely engineers, material scientists, and regulatory affairs professionals who conducted and reviewed the bench testing against predefined engineering specifications and regulatory standards. Their specific number or qualifications are not specified in this summary.

4. Adjudication Method for the Test Set

• Since this is primarily non-clinical, bench testing, adjudication methods (like 2+1, 3+1 concensus for clinical interpretations) are not applicable. The device performance is measured against engineering specifications and industry standards for mechanical properties.
• Any "adjudication" would involve internal quality control and regulatory review processes, rather than interpretation of clinical data by multiple experts.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, especially those that involve human interpretation of images (e.g., AI in radiology).
• The devices in this submission are mechanical orthopedic implants (suture anchors). Their effectiveness is proven through biomechanical testing (fixation strength, fatigue, etc.) and by demonstrating substantial equivalence to currently marketed devices, not through human reader performance.

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

• Not applicable. This question pertains to AI/software devices. The devices submitted are physical medical implants (suture anchors), not algorithms.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is implicitly established by engineering specifications, industry standards relevant to orthopedic implants, and the performance characteristics of the identified predicate devices.
• The tests performed (fixation strength, fatigue strength, insertion force, needle attachment strength) are benchmarked against what is considered acceptable for such devices on the market. The statement "Results of the analyses demonstrated that the devices continue to meet established design inputs and corresponding criteria" confirms this.
• There's no mention of pathology, outcomes data, or expert consensus in a clinical diagnostic sense being used as ground truth for this mechanical device.

8. The Sample Size for the Training Set

• Not applicable. This question is typically relevant for machine learning or AI models, which require training data. The devices in this submission are mechanical orthopedic implants. They do not involve "training sets" in the computational sense.

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

• Not applicable. As explained in point 8, there is no "training set" for these mechanical devices.

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HEALIX ADVANCE Knotless anchors:
The DePuy Mitek HEALIX ADVANCE Knotless BR anchors is indicated as follows:

• · Shoulder: Rotator Cuff Repair
• · Shoulder: Bicep Tenodesis
• · Shoulder: Deltoid Repair
• · Elbow: Ulnar Collateral Ligament (UCL)
• · Elbow: Radial Collateral Ligament (RCL)
• · Knee: Posterior Oblique
• · Knee: Medial Collateral Ligament (MCL)
• · Knee: Lateral Collateral Ligament (LCL)
• · Knee: liotibial (IT) Band Tenodesis
• · Knee: Anterior Cruciate Ligament (ACL) Repair
• · Knee: Secondary Fixation in ACL/PCL Reconstruction/Repair
• · Knee: Meniscal Root Repair
• · Foot and Ankle: Achilles Tendon Repair

The DePuy Mitek HEALIX ADVANCE KNOTLESS PEEK Anchors is indicated as follows:

• · Shoulder: Rotator Cuff Repair
• · Shoulder: Bicep Tenodesis
• · Shoulder: Deltoid Repair
• · Elbow: Ulnar Collateral Ligament (UCL)
• · Elbow: Radial Collateral Ligament (RCL)
• · Knee: Posterior Oblique
• · Knee: Medial Collateral Ligament (MCL)
• · Knee: Lateral Collateral Ligament (LCL)
• · Knee: liotibial (IT) Band Tenodesis
• · Knee: Anterior Cruciate Ligament (ACL) Repair
• · Knee: Secondary Fixation in ACL/PCL Reconstruction/Repair
• · Knee: Meniscal Root Repair
• · Foot and Ankle: Achilles Tendon Repair
• · Foot and Ankle: Lateral Stabilization
• · Foot and Ankle: Medial Stabilization

HEALIX ADVANCE Self-Punching anchors:
The DePuy Mitek HEALIX ADVANCE SP Biocomposite Anchors is indicated as follows:

• · Shoulder: Rotator Cuff Repair
• · Shoulder: Bicep Tenodesis
• · Shoulder: Deltoid Repair
• · Elbow: Ulnar Collateral Ligament (UCL)
• · Elbow: Radial Collateral Ligament (RCL)
• · Knee: Posterior Oblique
• · Knee: Medial Collateral Ligament (MCL)
• · Knee: Lateral Collateral Ligament (LCL)
• · Knee: liotibial (IT) Band Tenodesis
• · Knee: Anterior Cruciate Ligament (ACL) Repair
• · Knee: Secondary Fixation in ACL/PCL Reconstruction/Repair
• · Knee: Meniscal Root Repair

The DePuy Mitek HEALIX ADVANCE SP PEEK Anchors is indicated as follows:

• · Shoulder: Rotator Cuff Repair
• · Shoulder: Bicep Tenodesis
• · Shoulder: Deltoid Repair
• · Elbow: Ulnar Collateral Ligament (UCL)
• · Elbow: Radial Collateral Ligament (RCL)
• · Knee: Posterior Oblique
• · Knee: Medial Collateral Ligament (MCL)
• · Knee: Lateral Collateral Ligament (LCL)
• · Knee: liotibial (IT) Band Tenodesis
• · Knee: Anterior Cruciate Ligament (ACL) Repair
• · Knee: Secondary Fixation in ACL/PCL Reconstruction/Repair
• · Knee: Meniscal Root Repair
• · Foot and Ankle: Achilles Tendon Repair
• · Foot and Ankle: Lateral Stabilization
• · Foot and Ankle: Medial Stabilization

The subject devices of this Special 510(k) are the HEALIX ADVANCE Knotless anchors and HEALIX ADVANCE Self-Punching (SP) anchors.

The HEALIX ADVANCE Knotless Anchor is a one-piece implantable cannulated, threaded anchor designed to secure soft tissue to bone utilizing suture (provided separately). The anchor is preloaded on a disposable inserter shaft with handle, held in place by a #2 ORTHOCORD stay suture comprised of Ultra-High Molecular Weight Polyethylene (UHMWPE) and violet Polydioxanone (PDS). During implantation, the stay suture may be discarded or incorporated into the repair at the surgeon's discretion. The anchor is provided preloaded on a single-use driver. The anchor is offered in three sizes: 4.75mm, 5.5mm and 6.5mm. The anchors are available in two materials: Biocryl Rapide® (BR) and Polyetheretherketone (PEEK) materials. The Biocryl Rapide material is a biocomposite material of 70% PLGA copolymer (85% PLLA/15% PGA) and 30% β-TCP. The HEALIX ADVANCE KNOTLESS Anchor is provided sterile and is for single use only.

The HEALIX ADVANCE SP Anchor is a two-piece "self-punching" design consisting of a cannulated, threaded anchor and dilator designed to secure soft tissue to bone utilizing suture (provided separately). The anchor-dilator are preloaded on a disposable inserter shaft with handle, held in place by a non-absorbable stay suture comprised of Ultra-High Molecular Weight Polyethylene (UHMWPE) and Green poly (ethylene terephthalate) (PET). During implantation, the stay suture may be discarded or incorporated into the repair at the surgeon's discretion. The HEALIX ADVANCE SP Anchor is offered in three sizes: 4.9mm, 5.5mm and 6.5mm. The anchors are available in two materials: Biocomposite (Biocryl) and Polyetheretherketone (PEEK) material. Biocryl is an absorbable biocomposite of Polylactic Acid (PLA) and Tricalcium Phosphate (TCP). The HEALIX ADVANCE SP Anchor is provided sterile and is for single use only.

The provided text is a 510(k) summary for medical devices, specifically suture anchors. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than reporting on a study designed to establish acceptance criteria for a new device's performance. Therefore, most of the requested information regarding acceptance criteria and performance study details for a new device is not present in this document.

However, I can extract what is available and clarify what is missing.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria or specific reported device performance in the format usually associated with a clinical or detailed performance study. The "Non-clinical Testing" section broadly states that "Verification activities were performed on the proposed device. Verification included an assessment of fixation strength for proposed indications at T=0 and over the healing period, as well as assessment of insertion force." The "Safety and Performance" section concludes that "Results of the analyses demonstrated that the devices continue to meet established design inputs and corresponding criteria, and that there were no new issues of safety or effectiveness related to device performance."

This suggests that the "acceptance criteria" were the "established design inputs and corresponding criteria" that the devices were verified against, and the "reported device performance" was that they met these criteria. However, no specific metrics, thresholds, or quantitative results are provided in this summary.

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

The document states that "Verification activities were performed on the proposed device," which would constitute the "test set" for these non-clinical tests. However, it does not specify the sample size used for these tests (e.g., how many anchors, how many iterations).

The data provenance is non-clinical/bench testing, likely performed in-house by the manufacturer (DePuy Synthes Mitek Sports Medicine) or a contracted lab. There is no mention of country of origin of data or whether it's retrospective or prospective, as these terms typically apply to human subject studies.

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

This information is not applicable or not provided in this type of submission. The "ground truth" for non-clinical performance tests usually refers to objective measurements and established engineering or biomechanical principles, not expert consensus as would be used in diagnostic imaging or clinical outcome studies.

4. Adjudication Method for the Test Set

This is not applicable or not provided. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human reviewers (experts) establishing ground truth in subjective assessments, such as interpreting medical images. For non-clinical device performance testing, objective measurements are typically taken, and any discrepancies would be resolved through standard engineering verification and validation protocols, not through expert adjudication in this sense.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

No MRMC comparative effectiveness study was mentioned or conducted as this is a submission for a physical medical device (suture anchors), not a diagnostic algorithm or a device requiring human interpretation for its primary function.

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

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

7. The Type of Ground Truth Used

For the non-clinical (bench) testing, the "ground truth" would be the objective measurements obtained from testing the fixation strength and insertion force of the anchors, compared against the pre-defined engineering specifications and design inputs. This is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this type of non-clinical device performance testing. Training sets are relevant for machine learning algorithms.

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

This is not applicable, as there is no training set for this type of submission.

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MILAGRO ADVANCE PEEK Interference Screws (7x23mm, 8x23mm, 9x23mm):

The DePuy Mitek MILAGRO ADVANCE PEEK Interference Screw is indicated as follows:

· Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures.

• · Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction
• · Knee: Medial and lateral collateral ligament repair
• · Knee: Medial patellofemoral ligament reconstruction (femur fixation)
• · Shoulder: Proximal Biceps Tenodesis
• · Elbow: Distal Biceps Tenodesis

· Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Reconstruction, Flexor Hallucis Longus for Achilles Tendon Reconstruction. Tendon Transfer in the Foot and Ankle

MILAGRO ADVANCE PEEK Interference Screws (7x30mm, 8x30mm):

The DePuy Mitek MILAGRO ADVANCE PEEK Interference Screw is indicated as follows:

· Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures.

· Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction

· Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Recorstruction, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle

MILAGRO ADVANCE BR Interference Screws (7x23mm, 8x23mm, 9x23mm):

The DePuy Mitek MILAGRO ADVANCE BR Interference Screw is indicated as follows:

· Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures.

• · Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction
• · Knee: Medial and lateral ligament repair, medial patellofemoral ligament reconstruction (femur fixation)
• Shoulder: Proximal Biceps Tenodesis
• · Elbow: Distal Biceps Tenodesis

· Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Reconstruction, Flexor Hallucis Longus for Achilles Tendon Reconstruction. Tendon Transfer in the Foot and Ankle

MILAGRO ADVANCE BR Interference Screws (8x30mm, 7x30mm):

The DePuy Mitek MILAGRO ADVANCE BR Interference Screw is indicated as follows:

· Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures.

· Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction

· Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Recor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle

MILAGRO BR Interference Screws (7x15mm, 6x12mm, 5x12mm):

The DePuy Mitek MILAGRO BR Interference Screws designed to attach soft tissues to bone in orthopedic surgical procedures for the following indications:

· Shoulder: Proximal Biceps Tenodesis, Acromio-Clavicular Repair

· Elbow: Distal Biceps Tenodesis, Ulnar Collateral Ligament Repair

· Knee: Collateral Ligament Repair, Medial Patellofemoral Ligament Reconstruction (patella fixation)

· Foot and Ankle: Lateral Stabilization. Medial Stabilization. Mid-Foot Reconstruction. Tendon Transfer in the Foot and Ankle

MILAGRO BR Interference Screws (5x23mm, 6x23mm, 6x30mm, 6x30mm):

The DePuy Mitek MILAGRO Interference Screw is indicated as follows:

• · Knee: (ST) graft to the tibia and/or femur during cruciate ligament reconstruction procedures
• · Knee: Medial and lateral collateral ligament repair*
• · Shoulder: Proximal bicep tenodesis *
• Elbow: Distal bicep tenodesis*

· Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Recor Hallucis Longus for Achilles Tendon Reconstruction. Tendon Transfer in the Foot and Ankle

• These indications do not apply to 5x30mm Screws and 6x30mm Screws

The subject devices of this Special 510(k) are the MILAGRO Interference Screws and the Milagro ADVANCE Interference Screws. These interference screws are cannulated, threaded, tapered fasteners for use in interference fixation of soft tissue grafts and/or bone-tendon-bone grafts.

The MILAGRO Interference Screws and MILAGRO ADVANCE Interference Screws are offered in varying sizing configurations. The devices are offered in absorbable Biocryl Rapide material which is a biocomposite material of 70% PLGA copolymer (85% PLLA/15% PGA) and 30% β-TCP or PEEK (Polyether ether ketone) material.

The devices are provided sterile via Ethylene Oxide (EO) sterilization and are for single use only.

The provided document is a 510(k) Premarket Notification from the FDA for DePuy Mitek MILAGRO Interference Screws. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through clinical trials and detailed acceptance criteria for an AI/software as a medical device (SaMD).

Therefore, the document does not contain the information requested regarding acceptance criteria and studies for an AI/SaMD. Specifically:

• No acceptance criteria table or device performance is reported in the context of an AI/SaMD. The document mentions "performance testing for insertion force" and "assessment of fixation strength" for the physical interference screws, which are not relevant to AI/SaMD performance.
• No sample size information for a test set for AI/SaMD is present.
• No data provenance for AI/SaMD is mentioned.
• No information regarding experts for ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or types of ground truth is available.
• No information about training set size or ground truth establishment for a training set for AI/SaMD is provided.

The document primarily focuses on:

• Device Identification: MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw.
• Regulatory Information: Class II medical device, product codes MAI, MBI, regulated under 21 CFR 888.3030.
• Substantial Equivalence: Listing predicate devices (K103831, K143660, K123362, K161001). The primary reason for this 510(k) is a modification to the labeling to add additional foot and ankle indications, asserting that the "anchor design, materials, principal of operation, and intended use of the subject devices are identical to that of the predicate devices."
• Indications for Use: Detailed list of applications in knee, shoulder, elbow, foot, and ankle for various screw types and sizes.
• Non-clinical Testing: Briefly states "Verification activities were performed... included an assessment of fixation strength... as well as performance testing for insertion force," concluding that these tests demonstrated suitability for the additional indications.

In summary, the provided text does not describe an AI/software medical device or the specific types of studies (like MRMC or standalone performance evaluations) that would involve acceptance criteria for AI algorithms. It pertains to a physical orthopedic implant and its substantial equivalence to previously cleared devices.

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The FMS VUE™ Fluid Management and Tissue Debridement System is intended to provide controlled fluid distention and suction, controlled cutting, shaving and abrading of bone and tissue for use in arthroscopic surgery of the shoulder, knee, ankle, elbow, wrist and hip joints.

The FMS VUE Fluid Management and Tissue Debridement System is an arthroscopic pump system designed to provide optimal visibility of the surgical field by computer-controlled fluid regulation of intra-articular pressure, and flow during arthroscopic procedures. The system integrates a tissue debridement for controlled cutting, burring, shaving and abrading of bone and soft tissue.
The FMS VUE Fluid Management and Tissue Debridement System consists of irrigation pump, which controls joint pressure, and the suction pump, which controls the flow of saline and waste from the joint.
The FMS VUE Fluid Management and Tissue Debridement System includes an integrated shaver console, intended to provide controlled cutting, burring, shaving and abrading of bone and soft tissue.
The FMS VUE Fluid Management and Tissue Debridement System is designed to work with the existing FMS VUE platform accessories including: foot pedal, remote hand control, shaver handpieces, FMS connect cable, tubing sets, blades, and burrs.
The FMS VUE Fluid Management and Tissue Debridement System contains updates in the hardware, which include replaced near obsolescence components and new real panel connectors.
The FMS VUE Fluid Management and Tissue Debridement System software modification includes an additional shaver oscillation profile algorithm.

The provided document is a 510(k) summary for the DePuy Mitek, Inc. FMS VUE™ Fluid Management and Tissue Debridement System, seeking substantial equivalence to a previously cleared predicate device (K130169). The submission highlights hardware updates and a software modification (an additional shaver oscillation profile algorithm).

Crucially, this document is for a medical device (arthroscopic pump and debridement system) and not an AI/ML powered device that would typically have the acceptance criteria and study information you're asking for related to AI model performance (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by experts).

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are related to the hardware and software changes for a physical medical device, demonstrating that the modified device remains as safe and effective as its predicate.

Therefore, many of the requested points in your prompt are not applicable to the information contained in this 510(k) summary. I will address the applicable points based on the document's content.

Acceptance Criteria and Device Performance (Non-AI/ML Context)

The acceptance criteria here are focused on demonstrating that the updated FMS VUE system maintains its functional performance, electrical safety, electromagnetic compatibility, and software integrity, proving it is substantially equivalent to the predicate device despite hardware and minor software changes.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

• Pressure Security Test (Low & High Pressure Fault Checks): Performed. Results not detailed but implied to be acceptable.
• DUO (Inflow/Outflow) Performance: Performed. Results not detailed but implied to be acceptable.
• SOLO (Inflow) Performance: Performed. Results not detailed but implied to be acceptable.
• RFID Capability Functional Testing with existing electrical accessories (Foot Pedal, Remote Hand Control, Shaver Handpieces, FMS Connect Cable): Performed. Results not detailed but implied to be acceptable.
• Backflow-Prevention Valve Testing (Dye Leak Testing): Performed. Results not detailed but implied to be acceptable.
• Microbial and Viral Ingress Testing: Performed. Results not detailed but implied to be acceptable.
  Overall: "Results of functional performance testing were compared to the predicate device and have demonstrated that the proposed device is suitable for its intended use." |
  | Software Verification & Validation | - Software verification and validation (V&V) testing was conducted. Documentation provided as per FDA guidance "Content of Premarket Submission for Device Software Functions" (Basic Documentation level).
• "The software development process for the subject FMS VUE Fluid Management and Tissue Debridement System software conforms to all clauses of IEC 62304 standard." (IEC 62304 is a standard for medical device software life cycle processes). |
  | Electrical Safety & EMC | - "The subject FMS VUE Fluid Management and Tissue Debridement System complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC." (These are international standards for medical electrical equipment safety and electromagnetic compatibility). |

Study Information (as applicable to this non-AI/ML medical device submission)

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

   • The document describes "functional performance testing" of the physical device. This doesn't involve "test sets" of patient data in the way an AI/ML model would. Instead, it refers to testing the physical device and its components (e.g., pressure transducers, pumps, software algorithms for fluid control, electrical safety tests).
   • The provenance of data is from laboratory testing and verification conducted by the manufacturer, DePuy Mitek, Inc. (a Johnson & Johnson company). It is implicitly prospective testing for the design verification and validation of the modified device. No specific patient data or geographic origin is relevant here.

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

   • This question is not applicable. "Ground truth" in the context of an AI/ML model's diagnostic or predictive performance is not relevant for the functional performance testing of a fluid management and tissue debridement system. The "ground truth" here is the engineering specifications and performance requirements established by the manufacturer, verified through standard test methods and adherence to regulatory standards (e.g., IEC 60601-1, IEC 62304).

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

   • This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for establishing ground truth from multiple expert readers in imaging studies. This is a functional and safety verification of a physical device.

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:

   • This question is not applicable. The device is a physical arthroscopic fluid management and tissue debridement system, not an AI/ML-powered diagnostic or assistive tool for human readers. No MRMC study was performed or required. The document explicitly states: "No human clinical testing was conducted to determine the safety and effectiveness of the FMS VUE Fluid Management and Tissue Debridement System."

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

   • The device has an integrated shaver console with an "additional shaver oscillation profile algorithm." The software verification and validation would have tested this algorithm's performance within the system, which can be seen as a form of standalone testing for the algorithm's functional correctness. The document states: "Software verification and validation testing was conducted..." and "The software development process... conforms to all clauses of IEC 62304 standard." This implicitly covers testing of the algorithm without a human-in-the-loop, to ensure it performs as programmed.

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

   • This question is not applicable in the typical sense for AI/ML. The "ground truth" for the device's functional performance are the engineering specifications, validated test methods, and compliance with recognized industry standards (e.g., pressure output accuracy, flow rates, software logic, electrical safety limits).

7. The sample size for the training set:

   • This question is not applicable. This is not an AI/ML system that requires a "training set" of data in the manner of deep learning models. The software algorithms are likely rule-based or control-loop algorithms, not learned from large datasets.

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

   • This question is not applicable for the same reason as point 7.

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Milagro Interference Screw (5x12, 6x12, 7x15, 8x15)

The MILAGRO BR Interference Screws are designed to attach soft tissues to bone in Orthopedic surgical procedures for the following indications:

Shoulder: Proximal Biceps Tenodesis, Acromio-Clavicular Repair

Elbow: Distal Biceps Tenodesis, Ulnar Collateral Ligament Repair

Knee: Collateral Ligament Repair, Medial Patellofemoral Ligament Reconstruction (patella fixation)

Milagro Advance Interference Screw (7x23, 8x23, 9x23)

The MILAGRO ADVANCE Interference Screw is intended for attachment of soft tissue grafts or bone-tendon-bone grafts to the tibia and/or femur during cruciate ligament reconstruction procedures.

Additionally, the 7, 8 and 9mm x 23mm screws are indicated for: medial and lateral ligament repart, medial patellofemoral ligament reconstruction (femur fixation) of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.

The proposed devices are interference screws used for attachment of soft tissue to bone in Orthopedic surgeries. The proposed devices are cannulated, threaded interference screws, made of absorbable Biocryl® Rapide™ (composite of β-TCP and PLGA copolymer). The devices are provided as sterile (EtO), and are for single patient use only.

There is no accessory accompanied with the devices. Manual Orthopedic instruments such as tap and driver are used for screw insertion. Instruments are classified as LXH: Orthopedic Manual Surgical Instruments, Class I Exempt device, regulated per 21 CFR 888.4540. No new instrumentation is developed for the purpose of this submission.

This document is a 510(k) Premarket Notification from the FDA regarding the Milagro / Milagro Advance Interference Screw. It focuses on establishing substantial equivalence to a predicate device rather than presenting a novel device requiring extensive clinical trials with specific acceptance criteria related to accuracy or performance metrics.

Therefore, the requested information components related to acceptance criteria, ground truth, expert adjudication, and comparative effectiveness studies typical for AI/CAD devices are not applicable in this context. The device is a bone fixation appliance, not an AI or diagnostic device.

Here's a breakdown of the available information based on your request, highlighting why certain sections are not applicable:

1. Table of acceptance criteria and reported device performance:

   • Acceptance Criteria: Not explicitly defined in terms of numerical performance thresholds as this is a medical implant seeking substantial equivalence, not a diagnostic or AI device with performance metrics like sensitivity/specificity. The implicit "acceptance criterion" is demonstrating substantial equivalence to the predicate device in terms of safety and effectiveness for the stated indications for use.
   • Reported Device Performance:
     | Performance Metric | Reported Performance |
     | :----------------- | :------------------- |
     | Fixation Strength | Demonstrated substantial equivalence to the predicate device. |

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

   • Sample Size: Not specified in the provided document. The study was "bench-top mechanical testing," implying lab-based material or device samples, not patient data.
   • Data Provenance: Not applicable. This was a physical bench-top test, not a study involving human data.

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

   • Not applicable. The ground truth for mechanical testing is typically established by engineering standards and measurement accuracy, not expert consensus as in diagnostic imaging.

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

   • Not applicable. This is not a human-readable diagnostic test; it's mechanical performance assessment.

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 a medical implant, not an AI or diagnostic tool that would involve human readers.

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

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

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

   • The "ground truth" for the mechanical testing would be defined by engineering standards and measured physical properties (e.g., force required for failure, displacement under load) obtained through controlled laboratory experiments. It's not clinical data like pathology or outcomes.

8. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

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

   • Not applicable. As above, this is not an AI device.

Summary of the Study:

The study conducted was bench-top mechanical testing to assess the fixation strength of the Milagro / Milagro Advance Interference Screw. The primary goal was to demonstrate that its fixation performance was substantially equivalent to that of the predicate device (Bioraptor Knotless Anchor and BioTenodesis Interference Screw). The document explicitly states: "The data demonstrated substantial equivalence of fixation performance." There were no changes to the material, packaging system, or sterilization, further supporting the substantial equivalence claim.

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The VAPR Electrodes, for use with the VAPR VUE Radiofrequency System, are intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery.

The VAPR TRIPOLAR 90 Suction Electrode is a single use, one-piece bipolar RF suction electrode for use in a surgical setting by a surgeon trained in arthroscopic surgery. The VAPR TRIPOLAR 90 Suction Electrode is an RF device which incorporates 3 electrodes in the probe tip: one active electrode and two return electrodes. This configuration optimizes ablation and coagulation in a single device. It has been designed to facilitate access and control the delivery of RF energy to the joint space. The connector plug of the VAPR TRIPOLAR 90 Suction Electrode is designed to interface only with the VAPR VUE Radiofrequency Generator. It has an internal identification code which automatically adjusts the VAPR VUE Generator to the optimal default and accessible powers and waveforms. If required, the settings for the VAPR TRIPOLAR 90 Suction Electrode can be modified within safe pre-determined limits by accessing the generator or footswitch control. It is intended to be only operated with the VAPR VUE generator at pre-determined default settings specific for this device. The VAPR TRIPOLAR 90 Suction Electrode has three sets of buttons to address surgeon preference when holding the electrode. Each pair of buttons offers the same functionality and are ergonomically positioned for surgeon comfort. In addition the VAPR TRIPOLAR 90 Suction Electrode features vacuum fluid extraction which enhances the efficiency of the electrode and assists in the removal of bubbles and debris created during activation within the operating site. The design includes the ability to vary flow rate to allow the surgeon to make adjustments depending on particular procedural requirements.

This document describes the VAPR® Tripolar 90™ Suction Electrode developed by DePuy Mitek Incorporated. The device is a single-use, one-piece bipolar RF suction electrode intended for resection, ablation, and excision of soft tissue, hemostasis of blood vessels, and coagulation of soft tissues in patients requiring arthroscopic surgery.

The acceptance criteria for the VAPR® Tripolar 90™ Suction Electrode and the study that proves the device meets these criteria are summarized below.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the battery of tests conducted. For all tests, the reported device performance was "Acceptable."

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

The document does not specify the sample sizes used for each individual test. The tests were performed to demonstrate substantial equivalence to predicate devices for regulatory clearance. The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data provided, though it can be inferred that the testing was conducted by or on behalf of DePuy Mitek, Inc. (a U.S. company) to meet FDA requirements.

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

This information is not provided in the document. The tests seem to be primarily engineering and bench-top evaluations, rather than clinical studies requiring expert interpretation of results for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the tests (biocompatibility, electrical safety, performance testing), an adjudication method in the context of expert consensus on medical image interpretation or clinical outcomes is not applicable here.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states that "No clinical studies are required to demonstrate safety and efficacy of the device in support of an application for premarket clearance." Therefore, there is no effect size of human readers improving with or without AI assistance.

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

This device does not involve an algorithm or AI. It is a physical medical device. Therefore, a standalone performance study in this context is not applicable. The performance tests evaluate the device's physical and electrical characteristics and its interaction with biological tissues in a controlled environment.

7. The Type of Ground Truth Used

The "ground truth" for the various tests appears to be established by:

• Biocompatibility: Conformance to recognized international standards (ISO-10993).
• Electrical Safety: Conformance to recognized international electrical safety standards (IEC 60601-1, IEC 60601-2-2).
• Performance Data: Acceptable outcomes based on internal engineering specifications and testing protocols, designed to demonstrate the device performs as intended and is substantially equivalent to predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. The VAPR® Tripolar 90™ Suction Electrode is a physical medical device, not an AI or machine learning algorithm that requires a training set.

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

This information is not applicable, as there is no training set for this device.

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The Healix Ti Anchor is intended for:

• 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
• Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Patellar Tendon repair and secondary fixation in ACL/PCL reconstruction repair
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
• Hip: Capsular Repair, Acetabular Labral Repair

The Healix Ti™ Anchor with Permacord™ is a non-absorbable suture anchor preloaded on a disposable inserter assembly intended for fixation of suture to bone. The Healix Ti Anchors are manufactured of Titanium material. Permacord suture is non-absorbable. The anchor is provided in three sizes: 4.5mm, 5.5mm and 6.5mm. The Healix Ti Anchor with Permacord suture is supplied sterile and is for single use only.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for the device, nor does it provide specific numerical performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device through various non-clinical tests.

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

The document mentions "Verification activities were performed on the implant and / or its predicates. Testing assessment includes pull out testing." However, it does not provide any details regarding the sample size used for these tests, nor the data provenance (country of origin, retrospective or prospective). Given the nature of a 510(k) summary, these granular details are often found in the full submission, not the publicly available summary.

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

This type of information is not applicable to this document. The device in question is a medical implant (suture anchor), not an AI or diagnostic device that requires expert review for ground truth establishment. The "ground truth" for this device would be its physical and mechanical performance characteristics.

4. Adjudication Method for the Test Set

This is not applicable for the reasons stated above.

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 is not applicable as the device is a medical implant, not an AI or diagnostic tool that would involve human readers.

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

This is not applicable as the device is a medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering and mechanical testing data, primarily "pull out testing" to demonstrate its fixation strength in bone. It also relies on the established performance and safety record of its predicate devices.

8. The Sample Size for the Training Set

This is not applicable as the device is hardware (medical implant) and not an AI algorithm that would require a training set.

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

This is not applicable as the device is hardware and does not have a training set or associated ground truth in the context of machine learning.

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The VAPR® ARCTIC™ Suction Electrode for use with the VAPR VUE® RF System is intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery of the hip.

The VAPR® ARCTIC™ Electrode is a single use, one-piece bipolar suction articulating electrode for use in arthroscopic surgery of the hip. The electrode has a hand-controlled articulating tip to improve access and suction capabilities. This will enhance the efficiency of the electrode and extend the utility of the system by assisting in the removal of bubbles and debris created during activation within the operating site.

The ARCTIC Electrode has been designed to facilitate access and control the delivery of RF energy to the joint space. The plug of the ARCTIC Electrode is designed to fit the VAPR VUE® generator socket only. It has an internal identification capacitor code which automatically adjusts the VAPR VUE Generator to the optimal default and accessible powers and waveforms. If required, the settings for the device can be modified within safe pre-determined limits by accessing the generator or footswitch control. It is intended to be run only off the VAPR VUE electrosurgical generator at pre-determined default settings specific for the device.

The provided text describes a 510(k) premarket notification for the VAPR® ARCTIC™ Suction Electrode. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information about acceptance criteria, detailed study design, and AI performance is not explicitly available in the provided text.

However, I can extract information about the types of tests performed to ensure safety and performance, which can be seen as meeting product specifications and user needs.

Here's a breakdown of the available information:

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

The document does not provide a specific table of quantitative acceptance criteria and their corresponding reported performance values. Instead, it lists various verification and validation tests performed to ensure the device meets its specifications and user needs. The conclusion states that the "Results of performance and safety testing have demonstrated that the modified device is suitable for its intended use."

Here's a summary of the types of tests conducted:

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

The document does not specify the sample size for individual tests, nor does it provide details about data provenance (e.g., country of origin, retrospective/prospective nature). The tests appear to be laboratory or bench-top tests of the device components and functionality.

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

This information is not applicable. The device is an electrosurgical tool, and its performance is evaluated against engineering specifications and functional requirements, not through expert-labeled diagnostic data. Therefore, there's no "ground truth" in the clinical imaging or diagnostic sense being established by experts for a test set in this context.

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

This is not applicable. Adjudication methods are typically used in clinical studies or studies involving expert interpretation of data (e.g., medical images). This document describes device performance and safety testing, not diagnostic performance.

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 is not applicable. The VAPR® ARCTIC™ Suction Electrode is an electrosurgical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related effectiveness metrics are not relevant to this submission.

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

This is not applicable. As stated above, this device is a surgical instrument, not an algorithm, and the concept of "standalone" performance for an algorithm is not relevant here.

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

The "ground truth" for this device's performance is established by engineering specifications, industry standards (listed in Table 2), and functional requirements for surgical tools. This includes measurements of physical properties (e.g., articulation angle, tensile strength), electrical properties, biological compatibility, and demonstration of proper function (e.g., activation, suction flow, non-clogging). It does not involve clinical "ground truth" in the diagnostic sense.

8. The sample size for the training set

This is not applicable. This device is not an AI algorithm that requires a training set.

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

This is not applicable. This device is not an AI algorithm that requires a training set or ground truth establishment for a training set.

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Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction
Hip: Capsular Repair, Acetabular Labral Repair

The proposed device is a suture-anchor to be used for soft tissue fixation to bone. The Gryphon Anchor is a cannulated, ribbed anchor, made of either non-absorbable PEEK (Polyetheretherketone) or absorbable Biocryl® RapideTM (composite of β-TCP and PLGA copolymer). Size #1 blue Permacord™ suture (UHMWPE braided suture) is preloaded on the anchor. The suture incorporates a pre-tied sliding knot (ProKnot knot). The Permacord suture is a non-absorbable suture that conforms to USP except for oversized diameter. The device is provided as sterile; the device is for single patient use only.

The provided document describes a 510(k) submission for a medical device, the GRYPHON™ ANCHOR w/PROKNOT™ Technology. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets new acceptance criteria through a clinical or performance study with a test set, ground truth experts, and MRMC studies as typically seen in AI/Software as a Medical Device (SaMD) submissions.

The "study" in this context is the non-clinical testing performed to show the new device performs similarly to the predicate device.

Here's how to interpret the information based on the provided text, addressing your points where possible, and noting when the information is not applicable to this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (an orthopedic anchor), the "acceptance criteria" are typically related to mechanical performance characteristics that demonstrate equivalence to the predicate.

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

• Sample Size for Test Set: Not explicitly stated. For mechanical testing of medical devices like this, the "sample size" refers to the number of physical anchors and sutures tested. This is typically determined by engineering standards and statistical power calculations to demonstrate a certain level of confidence in the performance. The document only states "Fixation strength testing, suture knot strength testing and suture fray testing were conducted."
• Data Provenance: The testing was "conducted" by DePuy Mitek. The provenance of the "data" itself (e.g., patient data, country of origin, retrospective/prospective) is not applicable here as this is mechanical testing of the device itself, not clinical data from patients.

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

• This is not applicable for this type of device submission. Ground truth, in the context of expert review, is relevant for diagnostic devices or AI/SaMD where human interpretation or clinical outcomes are the gold standard. For an orthopedic anchor, the "truth" is established by physical measurements and engineering specifications, not expert consensus.

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

• Not applicable. Adjudication methods are used in studies involving human interpretation or clinical outcomes to resolve discrepancies in ground truth labeling. For mechanical testing, the "adjudication" is based on objective measurements and established thresholds.

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. MRMC studies are specific to diagnostic imaging devices, particularly those involving AI. This device is a surgical implant (an anchor), not an imaging or diagnostic tool.

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

• Not applicable. This device does not have an algorithm component.

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

• The "ground truth" for this device's performance relies on engineering specifications, standardized test methods (e.g., ASTM standards, USP for sutures), and direct physical measurements (e.g., force required for fixation failure, suture break strength, degree of fraying). The "truth" is objective, measurable, and compared against established performance criteria from the predicate devices.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of machine learning. The design and manufacturing processes are established through engineering principles, not data-driven training.

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

• Not applicable. As there is no training set, there is no ground truth to establish for it.

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