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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 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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The RIGIDLOOP Adjustable Cortical Fixation System is indicated for fixation of soft tissue to bone in Femoral Cruciate Ligament Reconstruction.

The proposed device is a cortical fixation system composed of titanium button, adjustable suture (Ultra-high molecular polyethylene (UHMWPE)), leading suture (UHMWPE and green Polyester (PET) co-braid) and training suture (green PET). Length of the suture loops is adjustable to the desired length. The proposed device provides a fixation in cruciate ligament reconstructive surgery. The device is provided as sterile for single patient use only.

The provided text describes a medical device, the RIGIDLOOP™ Adjustable Cortical Fixation System, and its 510(k) summary for FDA clearance. This document type (510k summary) typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with acceptance criteria.

Based on the provided text, the following information can be extracted regarding acceptance criteria and the "study" that proves the device meets them:

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

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. The document only states "Fixation strength testing (bench-top) was conducted." This implies an engineering test, not a clinical study with human subjects.
• Data Provenance: Not specified, but likely laboratory/bench testing data rather than human subject data.

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 to the type of testing described. The "ground truth" for bench testing would be measured physical properties, not expert consensus on medical images or clinical outcomes.

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

• This information is not applicable as the described testing is bench-top, not a clinical study requiring adjudication of expert interpretations.

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

• This information is not applicable. The RIGIDLOOP™ system is a medical device for orthopedic surgery, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted or is relevant to this device's clearance.

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

• This information is not applicable. The RIGIDLOOP™ system is a physical surgical device, not an algorithm.

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

• For the fixation strength testing, the "ground truth" would be direct physical measurements of load, displacement, and failure points, consistent with engineering and biomechanical bench-top testing standards. For biocompatibility, it would be results from standardized biocompatibility assays.

8. The sample size for the training set:

• This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The "training suture" mentioned in the description is for surgical training, not algorithm training.

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

• This information is not applicable for the same reason as above (not an AI/machine learning device).

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The GRYPHON BR 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 Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Hip: Capsular Repair, Acetabular Labral Repair

The GRYPHON PEEK Anchor is intended for:
Shoulder: Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Elbow: Ulnar or Radial Collateral Ligament Reconstruction
Hip: Capsular Repair, Acetabular Labral Repair

The Gryphon™ Anchor with Permacord™ is a suture anchor preloaded on a disposable inserter assembly intended for fixation of suture to bone. Gryphon Anchors are available in absorbable BR and non-absorbable PEEK materials. Permacord suture is non-absorbable. The Gryphon Anchor with Permacord suture is supplied sterile and is for single use only.

This looks like a 510(k) submission for a medical device, specifically a suture anchor, and not an AI/ML device. Therefore, the typical acceptance criteria and study design for AI/ML performance evaluation do not apply here.

The document describes the Gryphon™ Anchor with Permacord™ as a suture anchor preloaded on a disposable inserter assembly, available in absorbable BR and non-absorbable PEEK materials with non-absorbable Permacord suture.

Here's an analysis based on the provided text, focusing on the information available and noting where AI/ML specific criteria are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is not an AI/ML device, the "acceptance criteria" are not related to diagnostic accuracy metrics (e.g., sensitivity, specificity). Instead, they relate to safety and performance specifications for a medical implant like a suture anchor. The document states:

The study that "proves" the device meets the acceptance criteria is described as "Verification activities were performed on the implant and / or its predicates. Testing assessments include pull out testing and in-vitro testing." This non-clinical testing demonstrated that the device is "substantially equivalent" to predicate devices.

2. Sample Size for Test Set and Data Provenance:

This information is not applicable as the described testing is non-clinical performance and material testing for a physical medical device, not an AI/ML diagnostic or predictive model. There isn't a "test set" in the context of patient data.

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

This information is not applicable. Ground truth, in the context of AI/ML, refers to clinically verified labels or outcomes. For a physical device, testing involves engineering and materials science experts conducting physical tests, not clinical evaluations of patient data for ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as points 2 and 3.

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

This information is not applicable. MRMC studies are used to evaluate the impact of AI on human reader performance, which isn't relevant for a physical implant device.

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

This information is not applicable. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used:

For the performance testing, the "ground truth" would be the objective measurement of mechanical properties (e.g., maximum load at failure for pull-out strength) under controlled laboratory conditions, compared against pre-defined engineering specifications or predicate device performance. It is not expert consensus, pathology, or outcomes data in the AI/ML sense.

8. Sample Size for the Training Set:

This information is not applicable as there is no AI/ML algorithm being trained.

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

This information is not applicable as there is no AI/ML algorithm being trained.

In summary, the provided document describes a 510(k) submission for a physical medical device (suture anchor) and focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing and material characterization. The concepts of acceptance criteria, test sets, ground truth, and studies as typically applied to AI/ML devices are not relevant to this submission.

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The HEALIX ADVANCE Anchor is indicated for use in soft tissue to bone fixation in association with post-operative immobilization as follows:

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 Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction;
Hip: Capsular Repair, Acetabular Labral Repair.

The Healix Advance" Anchor with Permacord™ suture is a threaded suture anchor preloaded on a disposable inserter assembly intended for fixation soft tissue to bone. Healix Advance Anchors are available in absorbable BR and non-absorbable PEEK materials. Permacord suture is a non-absorbable suture that conforms to USP, except for oversized diameter. Healix Advance Anchors with Permacord are provided sterile and is for single use only.

The provided text describes the Healix Advance™ Anchor with Permacord™ suture and its substantial equivalence to predicate devices, but it does not detail specific acceptance criteria or a study proving the device meets those criteria in the typical format you've requested for AI/software-based medical devices.

Instead, the submission focuses on demonstrating safety and effectiveness through substantial equivalence to already legally marketed devices, which is a common pathway for predicate-based medical devices. The "study" here refers to non-clinical testing performed to show that the new device performs comparably to its predicates.

Here's an interpretation based on the provided text, formatted to align with your request where possible, but with clear indications where the information is not present in the document.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document states "Verification activities were performed on the implant and / or its predicates" and "Testing assessments include pull out testing, insertion and failure torque, in-vitro testing and suture testing per USP." This implies engineering bench testing, which would involve a certain number of samples, but the exact count is not provided.
• Data Provenance: The testing appears to be internal lab testing ("Verification activities were performed"), not necessarily in a country of origin context. It is non-clinical/bench testing. It is retrospective in the sense that it's evaluating a final design against pre-defined performance metrics, but the data itself is generated prospectively for the submission.

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

• Not applicable. This is a medical device for physical implantation, not an AI/software device that requires human expert review for "ground truth" labels. The "ground truth" for this device's performance is established by engineering specifications and material standards (like USP) as well as the performance of predicate devices.

4. Adjudication Method for the Test Set

• Not applicable. As this is not an AI/software device requiring human judgment for data labeling, there is no adjudication method in the context described. Performance is measured against engineering and material specifications.

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

• Not applicable. This is a physical medical device (suture anchor), not an AI system.

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

• Not applicable. This is a physical medical device.

7. The type of ground truth used

• For this type of device, the "ground truth" is defined by:
  • Engineering Specifications: Specific quantifiable values for pull-out strength, torque, etc.
  • Material Specifications: Adherence to established standards such as USP (United States Pharmacopeia) for sutures.
  • Predicate Device Performance: The demonstrated safe and effective performance of the predicate devices. The new device is shown to be substantially equivalent to these devices.

8. The Sample Size for the Training Set

• Not applicable. This product is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. This product is a physical medical device, not an AI/ML algorithm that requires a training set and associated ground truth establishment.

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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 Biocry18 Rapide " (composite of ß-TCP and PLGA copolymer). Orthocord suture (absorbable polydioxanone (PDS®) and non-absorbable polyethylene braided composite suture) is preloaded on the anchor. The suture incorporates a pre-tied sliding knot (ProKnot knot). The device is provided as sterile; the device is for single patient use only.

The provided text describes a 510(k) summary for the GRYPHON™ ANCHOR w/PROKNOT™ TECHNOLOGY. This is a medical device, specifically a suture-anchor for soft tissue fixation to bone. The summary details its classification, predicate devices, and indications for use.

However, the document focuses on demonstrating substantial equivalence to predicate devices rather than providing specific acceptance criteria and detailed study results as would be typical for a new, non-equivalent device. The information available about performance testing is limited.

Here's an analysis 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

• Test Set Sample Size: Not specified. The document only mentions "fixation force testing was conducted." The number of samples tested is not quantified.
• Data Provenance: The testing was "in vitro." The country of origin for the data is not specified, but the applicant is DePuy Mitek, a Johnson & Johnson company, located in Raynham, MA, USA, suggesting the testing was likely conducted in the US or by a contracted lab. The testing is non-clinical.

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

There is no mention of experts or ground truth establishment in the context of clinical studies for this device. The documentation focuses on non-clinical performance testing and comparison to predicate devices, which does not typically involve expert review of clinical cases.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this was non-clinical testing, not a clinical study involving adjudication of clinical cases.

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

Not applicable. This device is a surgical implant (suture anchor), not an AI-powered diagnostic device. Therefore, MRMC studies and AI assistance are not relevant to this submission.

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

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

7. The Type of Ground Truth Used

• For fixation force testing: The "ground truth" would be the measured physical properties of the device (e.g., pull-out strength, stiffness) compared against pre-defined engineering specifications or the performance of the predicate device. This is based on objective measurement rather than expert consensus or pathology in a clinical sense.
• For material biocompatibility: This typically involves established biocompatibility testing standards (e.g., ISO 10993 series) which determine if the material elicits an adverse biological response.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for this type of physical medical device submission, as it does not involve machine learning or AI models.

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

Not applicable.

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The RIGIDLOOP™ Cortical Fixation System is used for the fixation of soft tissue to bone in orthopedic procedures such as ACL repair.

The RIGIDLOOP Cortical Fixation System is a machined titanium implant designed to provide fixation in the repair of tendons and ligaments. It consists of a titanium implantable button with a pre-attached non-absorbable fiber loop. This implantable fiber loop has non-absorbable suture attached to the button for assisting in the button placement and is discarded after the device placement. The device is offered in size ranges of 15-60mm in 5mm increments. Reamers and depth gauges are provided separately as reusable accessories to assist in the placement of the RIGIDLOOP Cortical Fixation System.

The provided text describes the RIGIDLOOP Cortical Fixation System, a medical device for soft tissue to bone fixation, particularly for ACL repair. The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving novel efficacy through detailed clinical studies with acceptance criteria, sample sizes, and ground truth establishment in the way an AI/ML device would be evaluated.

Therefore, many of the requested elements for an AI/ML device study are not directly applicable or available in the provided document. However, I can extract information related to the device's performance assessment and substantial equivalence claims.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance
   • The document does not provide explicit, quantitative acceptance criteria in the format typically seen for AI/ML device performance (e.g., minimum sensitivity, specificity, or AUC).
   • Instead, the assessment is based on demonstrating "substantial equivalence" to predicate devices through comparisons of materials, design, and principal operation, supported by non-clinical testing.
   • Reported Device Performance: The document states, "Results of performance testing have demonstrated that the proposed devices are suitable for their intended use." This is a qualitative statement of suitability rather than specific performance metrics against acceptance criteria.

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

   • This information is not provided in the document. The document describes "verification activities" and "testing assessments" but does not detail the sample sizes for these tests, nor their provenance, as these are non-clinical (mechanical, sterilization, biocompatibility) rather than clinical studies with patient 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)

   • This information is not applicable/not provided for this type of device submission. The device is a mechanical implant, not an AI/ML diagnostic tool requiring expert-established ground truth from medical images or clinical data. "Ground truth" in this context would likely refer to engineering specifications and test results, not expert medical consensus on diagnostic interpretations.

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

   • This information is not applicable/not provided. Adjudication methods are typically used in clinical studies involving human interpretation (e.g., radiology reads) to resolve discrepancies in ground truth, which is not relevant for this device.

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

   • This information is not applicable/not provided. The RIGIDLOOP Cortical Fixation System is a physical implant; it is not an AI algorithm that assists human readers/clinicians, so no MRMC study or AI assistance effect size is relevant to this submission.

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

   • This information is not applicable/not provided. This device is a mechanical implant, not an algorithm.

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

   • For this device, "ground truth" would relate to the performance of the implant itself, evaluated through non-clinical testing. The document states "Verification activities were performed on the implant and / or its predicates. Testing assessments include pull out testing, shelf-life, sterilization and biocompatibility."
   • Therefore, the "ground truth" would be established by engineering tests and standards (e.g., measuring pull-out strength against a specification, verifying sterility, confirming biocompatibility per standards).

8. The sample size for the training set

   • This information is not applicable/not provided. There is no "training set" in the context of this device because it is not an AI/ML algorithm.

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

   • This information is not applicable/not provided. As above, there is no training set for this device.

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