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The Arthrex Double Loaded Knotless FiberTak® Suture Anchor is intended to be used for suture (soft tissue) fixation to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
· Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
· Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
· Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure (Except Canada)
· Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair (Except Canada)

The Arthrex Double Loaded Knotless FiberTak Suture Anchor is an all-suture knotless anchor intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow and hip. The Arthrex Double Loaded Knotless FiberTak Suture Anchor is a sterile, single use implant device constructed from a hollow braid of polyester (sheath) preloaded on an inserter with a double loaded suture component composed of UHMWPE and polyester.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device: the "Arthrex Double Loaded Knotless FiberTak® Suture Anchor." This document describes a surgical implant and its intended uses, asserting its substantial equivalence to a previously cleared device. It does not describe an AI/machine learning device, nor does it contain information about acceptance criteria or a study that proves an AI device meets acceptance criteria.

The information you are requesting, such as ground truth, sample sizes for training/test sets, expert adjudication methods, or MRMC studies, are concepts applicable to AI/ML device evaluations, particularly for diagnostic imaging or assistive technologies. Since this document describes a physical surgical implant (a suture anchor), these concepts are not relevant to its regulatory submission.

Therefore, I cannot extract the requested information from the provided text for an AI/ML device. The document explicitly states the "Performance Data" is "Cyclic pull-out testing was conducted on the proposed devices submitted in this Special 510(k). The test data demonstrates that the proposed devices perform statistically equivalent to the predicate device. Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications." This type of testing is standard for mechanical implants, not AI.

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The Arthrex BioSuture is intended for soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs, including those with allograft tissues, are used for repair.

The proposed Arthrex BioSuture is a braided construct made of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester and coated with collagen coating. The proposed suture is braided flat with round ends and may be available in precut lengths in straight and loop configurations. The Arthrex BioSuture is packaged sterile for single use. The Arthrex BioSuture is a line extension to the Arthrex Bio-Suture consisting of a new size.

The provided document is a 510(k) summary for the Arthrex BioSuture, a surgical suture. It details the device's indications for use, technological characteristics, and conformity to established standards through performance testing. However, the document does not describe a study involving an AI/ML device, human readers, or any of the specific criteria typically associated with such studies (e.g., sample size for test sets, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, or training set details).

This document focuses on demonstrating substantial equivalence to predicate devices for a physical medical device (suture) through mechanical testing and comparison of attributes.

Therefore, most of the requested information regarding AI/ML device acceptance criteria and studies cannot be extracted from this document.

Here's an attempt to answer the questions based only on the provided text, highlighting what is present and what is absent:

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 "representative samples" for the Bacterial Endotoxins Test and generally mentions "mechanical testing."
• Data Provenance: Not specified.

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. This is not an AI/ML study involving human expert ground truth. The "ground truth" here is based on physical material properties and established industry standards for sutures.

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

• Not applicable. This is not an AI/ML study involving human expert ground truth adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This document describes a submission for a surgical suture, not an AI/ML device that assists human readers.

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

• Not applicable. This document is for a physical medical device (suture), not an algorithm.

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

• The "ground truth" or reference for comparison described in this document is based on:
  • Established physical and mechanical properties of surgical sutures: Primarily tensile strength (straight pull, knot pull) as defined by internal acceptance criteria and implicitly compared to predicate devices.
  • Regulatory standards: Specifically pyrogen limits as outlined in ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14.
  • Characteristics of legally marketed predicate devices: For demonstrating substantial equivalence in design, materials, manufacturing, and performance.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. This is not an AI/ML device that requires a training set.

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DYNATAPE suture is indicated for orthopedic procedural use in soft-tissue approximation, and or ligation, including use with allograft tissue.

DYNATAPE™ Suture is a sterile non-absorbable orthopedic suture. DYNATAPE™ Suture has a double sheath and core design, composed of Ultra High Molecular Weight Polyethylene and Polyester, with or without colorants, as well as a Silicone/NaCl core. DYNATAPE™ Suture's outer sheath is braided flat, with rounded tips.

The provided text does not describe acceptance criteria for a medical device's performance in the context of clinical or diagnostic accuracy studies. Instead, it refers to the DYNATAPETM Suture, a non-absorbable orthopedic suture, and its substantial equivalence to a predicate device.

The "acceptance criteria" mentioned relate to non-clinical testing for material properties and regulatory compliance, not performance in a diagnostic or clinical accuracy sense. Specifically, the text states:

• USP Knot Tensile Strength: The DYNATAPE™ Suture "meets USP knot tensile strength for size 2 non-absorbable sutures."
• In-vitro approximation force over time: This testing was conducted to demonstrate the laxity resistance of the suture.
• Sterility testing: Testing was conducted.
• Biocompatibility, stability, in-vivo testing of the predicate device: These were included by reference (K181182).
• Bacterial endotoxin testing: Completed as part of another submission (K200949), meeting endotoxin limits.

The study presented is a 510(k) Premarket Notification, which aims to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device. This is a regulatory pathway, not a clinical trial to establish device performance in terms of diagnostic accuracy or comparative clinical effectiveness.

Therefore, most of your specific questions regarding sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information are not applicable to the information provided in this document, as it focuses on non-clinical testing and substantial equivalence.

Here's a breakdown of what can be extracted and why other parts are not applicable:

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)

• The document describes non-clinical laboratory testing (e.g., mechanical property tests, sterility tests). It does not provide details on specific sample sizes for these tests, nor does it refer to a "test set" in the context of patient data or clinical studies. Data provenance (country, retrospective/prospective) is not applicable or provided for these types of non-clinical tests.

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. "Ground truth" in this context refers to clinical outcomes or expert diagnoses, which are not part of this 510(k) summary for a surgical suture based on non-clinical testing.

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

• Not applicable. This pertains to clinical studies involving multiple readers or evaluators, not non-clinical laboratory testing of a device's material properties.

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 document is about a surgical suture, not a diagnostic imaging device or an AI-assisted system.

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

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

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

• For the non-clinical tests described, the "ground truth" would be established by standardized testing methods and specifications (e.g., USP standards for tensile strength) rather than expert clinical consensus or pathology.

8. The sample size for the training set

• Not applicable. There is no mention of a "training set" as this document is not about an algorithm or machine learning model.

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

• Not applicable. See point 8.

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The HEALIX ADVANCE Anchor is indicated for use in soft-tissue-to-bone fixation in association with postoperative immobilization as follows:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromioclavicular 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 Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

The proposed HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is a line extension to the currently marketed HEALIX ADVANCE™ Anchor family. HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is a threaded suture anchor preloaded on a disposable inserter assembly. HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is available in absorbable BR and non-absorbable PEEK materials. HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is provided sterile and is for single use only.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures. This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a detailed study of acceptance criteria and performance for a novel AI/software device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set information is not present in the provided text. The document describes a traditional medical device (suture anchor) and its non-clinical testing for safety and effectiveness, not a computational device with performance metrics typically found in AI/software submissions.

Specifically, the document states:

• Non-clinical Testing: "Device safety and effectiveness is supported by non-clinical testing performed on the proposed device and / or its predicate. Performance testing included straight and knot tensile strength, suture approximation force, anchor fixation post cyclic loading and sterility."
• Safety and Performance: "Results of performance testing have demonstrated that the proposed devices are suitable for their intended use. Based on similarities in the indications for use, technological characteristics, and performance in comparison to the predicate devices, the proposed HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures has shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act."

This indicates that the "acceptance criteria" were essentially demonstrating equivalence to existing predicate devices through mechanical performance testing relevant to a physical suture anchor, as opposed to accuracy, sensitivity, or specificity metrics for an AI system.

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The HEALIX TiTM Anchors with DYNACORD™ is intended for:

Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromioclavicular; 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. 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 TiTM Anchor with DYNACORDTM Suture is a threaded suture anchor preloaded on a disposable inserter assembly intended for fixation of soft tissue to bone. HEALIX TiTM Anchors with DYNACORDTM Suture is available in Titanium material, which is a common material used on existing Depuy Mitek devices. Devices with needles will be offered to facilitate suture passage through tissue. The HEALIX TiTM Anchor with DYNACORDTM Suture is provided sterile and is for single use only.

This document is a 510(k) premarket notification for a medical device called the HEALIX Ti™ ANCHOR with DYNACORD™. It establishes substantial equivalence to a predicate device, meaning it does not require a new study to prove its safety and effectiveness in the same way a novel device would. Therefore, the information typically found in an AI/Software as a Medical Device (SaMD) submission regarding acceptance criteria, training/test sets, expert adjudication, and MRMC studies is not applicable here.

The provided text focuses on the non-clinical testing performed to demonstrate the device's substantial equivalence to a predicate, rather than a clinical study evaluating the performance of an AI/SaMD.

Here's an analysis based on the provided document:

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

The document describes non-clinical testing, not performance against specific clinical acceptance criteria of an AI/SaMD. The "acceptance criteria" here relate to engineering and material performance for a physical implant.

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

• Sample Size: Not specified in terms of number of anchors tested, but general non-clinical testing was conducted.
• Data Provenance: Not applicable in the context of clinical data for AI/SaMD. This refers to lab-based testing of physical properties.

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

• Not applicable as this is not an AI/SaMD and does not involve human expert labeling of data. The "ground truth" for these tests would be the established engineering and materials science standards.

4. Adjudication method for the test set:

• Not applicable for non-clinical engineering tests.

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, not an AI/SaMD.

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

• Not applicable. This is a physical medical device, not an AI/SaMD.

7. The type of ground truth used:

• For the non-clinical testing, the "ground truth" is defined by established engineering standards, USP specifications for suture materials, and biological safety standards (e.g., ISO standards for biocompatibility, endotoxin limits).

8. The sample size for the training set:

• Not applicable. This is not an AI/SaMD.

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

• Not applicable. This is not an AI/SaMD.

In summary, the provided document is a regulatory submission for a physical medical device (suture anchor) based on demonstrating substantial equivalence to an existing predicate device through non-clinical performance and safety testing, not through clinical trials or evaluations of an AI/SaMD.

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The HEALIX ADVANCE Anchor is indicated for use in soft tissue to bone fixation 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 Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Hip: Capsular Repair, Acetabular Labral Repair

The HEALIX ADVANCETM Anchor with DYNACORDTM Suture is a threaded suture anchor preloaded on a disposable inserter assembly. HEALIX ADVANCETM Anchors with DYNACORDTM Suture are available in absorbable BR and non-absorbable PEEK materials. Devices with needles will be offered to facilitate suture passage through tissue. The HEALIX ADVANCETM Anchor with DYNACORDTM Suture is provided sterile and is for single use only.

The provided text is a 510(k) summary for the HEALIX ADVANCE™ Anchor with DYNACORD™ Suture. It describes the device, its intended use, and substantial equivalence to predicate devices, supported by non-clinical testing. However, it does not contain information related to a study proving a device meets acceptance criteria for an AI/algorithm-based medical device performance.

Specifically, the document discusses a suture anchor (a physical medical device used in orthopedic surgery), not an image-based AI or algorithm. Therefore, the requested information (acceptance criteria for an AI, sample sizes for AI test/training sets, expert ground truth establishment, MRMC studies, standalone AI performance) is not applicable to this document.

The "studies" mentioned in the document are non-clinical physical tests of the suture anchor and suture, such as:

• suture diameter
• knot tensile strength
• suture approximation force
• chemical characterization
• anchor fixation (in-vitro and in-vivo)
• torque testing
• biocompatibility
• sterility
• packaging
• shelf-life
• bacterial endotoxin testing

These tests are to demonstrate the physical properties and safety of the orthopedic implant and suture, not the performance of an AI algorithm.

Therefore, I cannot provide the requested table or details about an AI study based on the provided text.

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The HEALIX ADVANCE Anchor is indicated for use in soft tissue to bone fixation 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 Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Hip: Capsular Repair, Acetabular Labral Repair

The HEALIX ADVANCETM Anchor with DYNACORDTM Suture is a threaded suture anchor preloaded on a disposable inserter assembly intended for fixation of soft tissue to bone. HEALIX ADVANCETM Anchors with DYNACORDTM Suture are available in absorbable BR and non-absorbable PEEK materials. Devices with needles will be offered to facilitate suture passage through tissue. The HEALIX ADVANCETM Anchor with DYNACORDTM Suture is provided sterile and is for single use only.

The provided text describes the HEALIX ADVANCE™ Anchor with DYNACORD™ Suture, which is a medical device for soft tissue to bone fixation. However, the document does not contain information about specific acceptance criteria or a dedicated study providing quantitative performance metrics by which the device's performance can be explicitly measured against pre-defined criteria.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (K133794 HEALIX ADVANCE™ Anchor with PERMACORD™ Suture) through non-clinical testing. This type of submission relies on showing that the new device has similar technological characteristics and performs comparably to a device already cleared by the FDA, rather than conducting a de novo study against specific acceptance criteria.

Therefore, many of the requested details cannot be extracted from this document. Below is a summary of what is available and what is not:

HEALIX ADVANCE™ Anchor with DYNACORD™ Suture Device Performance Summary

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 in the document. The non-clinical testing refers to "anchor fixation testing," "in-vitro testing," "torque testing," "suture testing per USP," "suture approximation force testing," and "in-vivo testing," but the number of samples or specimens for each test is not provided.
• Data Provenance: The testing was "performed on the proposed device and/or its predicates." No information on country of origin or whether it was retrospective or prospective is given. Given the nature of mechanical/biocompatibility testing, it would generally be prospective laboratory testing.

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

• Not applicable for this type of submission. This device is a physical implant, and its performance is evaluated through mechanical, chemical, and biological testing, not by expert review of data like in an AI/imaging study. Ground truth is established by standardized testing methods and measurements.

4. Adjudication Method for the Test Set:

• Not applicable. As noted above, this device's performance is determined by objective physical and biological tests, not by human expert adjudication of interpretations.

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

• No. This is a physical medical device, not an AI or imaging diagnostic tool. MRMC studies are not relevant for this product.

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

• Not applicable. This phrase typically refers to the performance of an AI algorithm in isolation. This is a physical device, and its performance is assessed directly through non-clinical testing.

7. The Type of Ground Truth Used:

• Objective Test Results / Standardized Measurements: Ground truth for this device's performance is established by the results of various non-clinical tests (e.g., tensile strength in Newtons, torque in Nm, presence/absence of bacterial endotoxins within specified limits, biocompatibility as determined by in-vivo models). These are direct measurements or observations against established material and biological standards (e.g., USP standards).

8. The Sample Size for the Training Set:

• Not applicable. This submission does not involve machine learning or AI, so there is no "training set."

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

• Not applicable. As there is no training set for this device.

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CP-Fiber is indicated for use in soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, neurological, and orthopedic surgeries.

CP-Fiber is a synthetic non-absorbable suture composed of a braided polyblend. As with all surgical sutures, CP-Fiber is a single-use device. This submission expands the indications for use to include orthopedic surgeries.

The provided document is a 510(k) summary for a medical device (CP-Fiber suture). While it describes the device's intended use and substantial equivalence to predicate devices, it does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria.

This document focuses on regulatory approval based on demonstrating equivalence to existing products rather than presenting a performance study with detailed acceptance criteria and results.

Therefore, I cannot extract the requested information from the provided text.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for a test set, nor its data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Results of a standalone algorithm performance study.
7. The type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

The document states: "Testing activities demonstrate that the product complies with USP requirements for nonabsorbable sutures." This is a general statement about compliance with a standard, but it doesn't provide the detailed acceptance criteria or study results that you're asking for.

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The MedShape Solutions, Inc., WedgeLoc™ 180X Suture Anchor with Opti-Fiber™ Sutures are intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist and elbow in the following procedures:

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

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

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

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

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

WedgeLoc™ 180X Suture Anchor with Opti-Fiber™ Sutures

This document, K091202, is a Special 510(k) summary for the MedShape Solutions WedgeLoc™ 180X Suture Anchor with Opti-Fiber™ Sutures. It asserts substantial equivalence to a previously cleared device (K083792) and other predicate devices, rather than detailing a new study with specific acceptance criteria and performance data for the 180X model itself.

Therefore, many of the requested categories for a new clinical study are not directly applicable or available in this submission. This 510(k) is primarily focused on demonstrating that the minor changes to the WedgeLoc™ suture anchor (the "180X" designation) do not raise new questions of safety and effectiveness, and thus do not require new acceptance criteria or a dedicated study for the device's performance against such criteria.

Here's the breakdown of what can be extracted from the provided text, and what cannot:

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

No explicit acceptance criteria or reported device performance against such criteria are provided for the WedgeLoc™ 180X Suture Anchor in this document. The submission argues for substantial equivalence based on the predicate device's established performance and the minor nature of the changes.

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

Not applicable. This 510(k) does not describe a new clinical study with a test set.

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

Not applicable. This 510(k) does not describe a new clinical study with a test set and ground truth establishment.

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

Not applicable. This 510(k) does not describe a new clinical study with a test set and adjudication.

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

Not applicable. This device is a medical implant (suture anchor), not an AI-assisted diagnostic tool.

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

Not applicable. This device is a medical implant (suture anchor), not an algorithm.

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

Not applicable. This 510(k) does not describe a new study that required ground truth establishment. The basis for substantial equivalence relies on the established safety and effectiveness of the predicate device.

8. The sample size for the training set

Not applicable. This 510(k) does not describe a machine learning model or a training set.

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

Not applicable. This 510(k) does not describe a machine learning model or a training set.

Summary of the document's content relevant to acceptance criteria and study:

The core of this Special 510(k) is the assertion that the WedgeLoc™ 180X Suture Anchor is substantially equivalent to the predicate WedgeLoc™ Suture Anchor with Opti-Fiber™ Suture (K083792) and the Arthrex PushLock™ Suture Anchor (K051219).

• Acceptance Criteria: The implied "acceptance criteria" for this Special 510(k) are that the minor differences between the new device and its predicates do not raise new questions concerning safety and effectiveness. This is a regulatory acceptance criterion for the submission itself, not a performance criterion for the device in a clinical study.
• Study That Proves the Device Meets Acceptance Criteria: The "study" isn't a new clinical trial but rather a comparative analysis of the technological characteristics of the WedgeLoc™ 180X Suture Anchor against its predicate devices. The document states:
  • "The proposed WedgeLoc™ 180X Suture Anchor is is substantially equivalent to the predicate WedgeLoc™ Suture Anchor with Opti-Fiber™ Suture (K08379) and the Arthrex PushLock™ Suture Anchor (K051219) in which the basic features and intended uses are the same."
  • "In addition, the technological characteristics of the WedgeLoc™ 180X and the WedgeLoc™ Suture Anchors are equivalent."
  • "Any differences between the WedgeLoc™ 180X Suture Anchor and the predicate WedgeLoc™ or Arthrex PushLock™ Suture Anchors are considered minor and do not raise questions concerning safety and effectiveness."

In essence, the "proof" is the argument of substantial equivalence based on a comparison of features, intended use, and technological characteristics, rather than new device-specific performance data. The device's performance is accepted as equivalent to the already cleared predicate devices.

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Force Fiber® Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries.

The Force Fiber® Polyethylene is non-absorbable, sterile, surgical suture composed of ultra high molecular weight polyethylene (UHMWPE). It is available in white or white/blue cobraid, sizes 5-0 through 5 meeting USP requirements except for oversized diameter.

The provided text describes a 510(k) PreMarket Notification for the Force Fiber® Polyethylene Non-Absorbable Surgical Suture. It details the device, its intended use, and substantial equivalence to predicate devices, along with a summary of testing performed.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The text states "All sizes of Force Fiber® Polyethylene Non-Absorbable Surgical Suture have been tested." This implies that every available size (from 5-0 through 5) was included in the testing, but a specific numerical sample size for each test (e.g., number of sutures per size tested for tensile strength) is not provided.
• Data Provenance: The standard tests (USP 30, Class II Special Controls Guidance, ISO 10993 Part 1) are internationally recognized standards. The country of origin for the data generated from these tests is not explicitly stated, but it is implied to be from testing conducted by Teleflex Medical or accredited labs as part of their submission to the FDA in the USA. The testing is implicitly prospective, as it was conducted to demonstrate the safety and effectiveness of the new device for regulatory submission.

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

This information is not provided in the text. The ground truth for this type of device is established by adherence to recognized testing standards rather than expert consensus on interpretive data.

4. Adjudication method for the test set:

This information is not applicable and therefore not provided. Adjudication methods like "2+1, 3+1" are typically used for studies involving human interpretation (e.g., image reading), not for physical performance tests of surgical sutures against objective standards. The "adjudication" is essentially handled by the objective pass/fail criteria defined within the USP and ISO standards.

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 and therefore not provided. The device is a surgical suture, not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable and therefore not provided. The device is a physical medical device (suture), not an algorithm.

7. The type of ground truth used:

The ground truth used for this device is based on objective, quantitative measurements defined by established performance standards and guidance documents. Specifically:

• Knot Pull Tensile Strength: Based on USP 30 requirements.
• Needle Attachment: Based on USP 30 requirements.
• Diameter: Based on USP 30 requirements (with the noted exception for oversized diameter).
• Biocompatibility: Based on ISO 10993 Part 1 "Biological Evaluation of Medical Devices" for safety.

8. The sample size for the training set:

This information is not applicable and therefore not provided. This is not an AI/ML device that requires a "training set." The product is a manufactured physical device, and its performance is evaluated against established physical and biological standards.

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

This information is not applicable and therefore not provided, as there is no "training set" for a surgical suture.

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