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The SuturePatch Tissue Reinforcement is intended for the management and protection of soft tissue injuries. The SuturePatch Tissue Reinforcement is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of the rotator cuff, patellar, achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear and sutures, or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair. The SuturePatch Tissue Reinforcement device reinforces and protects healing soft tissues.

The SuturePatch Tissue Reinforcement device is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, achilles, biceps, quadriceps, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to bone, provide mechanical strength for the repair.

The Arthrex SuturePatch Tissue Reinforcement device is a non-absorbable, permanent, implantable orthopedic surgical mesh intended for the reinforcement of soft tissue/tendon repair. It is manufactured from embroidered polyester yarns with integral reinforcements across its width and around its perimeter to provide improved stability and high suture retention strength. The SuturePatch is available in rectangular and trapezoidal patterns and configurable sizes. Sutures passed through soft tissue can also be passed throughout the SuturePatch with needles or suture passer.

This document is a 510(k) clearance letter for a medical device called "SuturePatch Tissue Reinforcement." It does NOT describe an AI/ML device or its acceptance criteria and a study proving it meets them. The text provided is wholly unrelated to AI/ML.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document is for a physical surgical mesh and details its regulatory clearance, not the performance of an AI/ML algorithm.

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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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The Arthrex SutureTape is intended for use in soft tissue approximation and/or ligation. The suture may be provided individually or be incorporated as a component, into surgeries where constructs including those with allograft tissues are used for repair.

The Arthrex SutureTape is comprised of non-absorbable sutures made of a polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester yarns but may also include nylon yarns.

The Arthrex 0.9 mm SutureTape is a 0.9 mm-wide tape suture with a round braided suture tail that is smaller than the tape portion. The tape and tail portion of the suture are implantable while the suture tail is not intended to be knotted. The flat tape portion of the Arthrex 0.9 mm SutureTape suture meets or exceeds USP performance standards for knot pull tensile strength for size 2 non-absorbable surgical sutures. The suture tail portions of the Arthrex 0.9 mm SutureTape suture meet the performance standards for USP 2-0 non-absorbable surgical suture, except for an oversize in diameter.

The Arthrex 0.9 mm SutureTape is supplied sterile, in pre-cut lengths, in various loop configurations, and in some cases, with various swaged needles and with stiffened ends. The Arthrex 0.9 mm SutureTape is available non-dyed, dyed, and fully or partially striped. Dyes may include D&C Blue No. 6 and Logwood Black. Suture strands that are dyed with Logwood black are made of nylon. Additional material for the Arthrex 0.9 mm SutureTape includes cyanoacrylate.

This document describes the 510(k) premarket notification for the Arthrex SutureTape, specifically the K221354 submission for the 0.9 mm SutureTape as a line extension. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against acceptance criteria for a new type of AI/medical imaging device.

Therefore, many of the requested elements (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth for test and training sets) are not applicable to this type of regulatory submission because it's a materials science and mechanical performance comparison for a medical device (suture), not an AI/imaging diagnostic device.

However, I can extract the relevant "acceptance criteria" and "reported device performance" based on the provided text, focusing on the mechanical and performance standards for sutures.

Acceptance Criteria and Reported Device Performance for Arthrex SutureTape

This submission (K221354) is for a line extension of the Arthrex SutureTape device, specifically the 0.9 mm SutureTape. The "proof" of meeting acceptance criteria is demonstrated through mechanical performance testing against established USP (United States Pharmacopeia) standards for surgical sutures and comparison to a legally marketed predicate device (K171296: Arthrex SutureTape).

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes (N numbers) for the mechanical performance tests (tensile strength, BET). It states that "representative samples" were used for the Bacterial Endotoxins Test. The data provenance is implied to be from internal testing conducted by Arthrex Inc., a U.S.-based company. The studies are prospective in the sense that they are conducted specifically for this regulatory submission to demonstrate compliance.

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

This is not applicable. Ground truth for mechanical devices like sutures is established through standardized laboratory testing (e.g., USP methods) rather than expert consensus on diagnostic images.

4. Adjudication Method for the Test Set

This is not applicable. No human adjudication is involved in evaluating the mechanical properties of a suture.

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

This is not applicable. This submission is for a surgical suture, not an AI or imaging diagnostic device.

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

This is not applicable. This is not an algorithmic device.

7. The Type of Ground Truth Used

The ground truth used for performance evaluation is USP (United States Pharmacopeia) performance standards for surgical sutures and comparison to the mechanical and physical properties of a legally marketed predicate device. This is a form of objective, standardized laboratory measurement rather than clinical outcomes or expert consensus.

8. The Sample Size for the Training Set

This is not applicable. This is not an AI/machine learning device that requires a training set.

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

This is not applicable. This is not an AI/machine learning device that requires a training set.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the Arthrex 0.9 mm SutureTape meets acceptance criteria is primarily a series of bench tests and laboratory evaluations designed to demonstrate that the device's mechanical properties and safety aspects (like pyrogenicity) conform to well-established industry standards (USP) and are substantially equivalent to a pre-existing, legally marketed predicate device. The key performance indicators evaluated were:

• Knot pull tensile strength of the flat tape portion.
• Tensile strength of the braided suture tail portion.
• Needle pull tensile strength of any attached needles.
• Bacterial Endotoxins Test (BET) for pyrogenicity.

The conclusion is that "Any differences between the proposed and predicate devices are considered minor and do not raise questions concerning safety or effectiveness," and based on "technological characteristics, and the tensile test data submitted, Arthrex Inc. has determined that the proposed device is substantially equivalent to the currently marketed predicate device." This demonstrates that the new line extension performs as expected for its intended use as a surgical suture.

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Arthrex FiberTape and TigerTape cerclage sutures are intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair.

When used as bone fixation cerclage the sutures are intended for:

• · Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty
• · Sternotomy indications including the "rewiring" of osteomized sternums
• · Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring
• Treatment of anterior glenoid bone loss using the Latarjet or bone block procedure (allograft or autograft)
  ·Repair of long bone fractures due to trauma or reconstruction

The proposed Arthrex FiberTape and TigerTape Cerclage devices are available as a flat braided suture assembled in a loop configuration. Cerclage is assembled on an HDPE card or on an ABS loader. The devices are manufactured from a polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester materials. These materials are identical to those cleared in K170206. For the loop assembly, the looped end of the suture is tied as a hitch over a sheath that secures a double loop.

This document is a 510(k) summary for the Arthrex FiberTape and TigerTape Cerclage Sutures. It describes the device, its intended use, and the data submitted to demonstrate substantial equivalence to a predicate device. This is a medical device submission, not a study of an AI/ML powered device. Therefore, it does not contain the information required to answer the questions about acceptance criteria for an AI/ML powered device.

The document discusses mechanical testing and bacterial endotoxin testing to demonstrate that modifications do not negatively impact mechanical strength or pyrogen limits, which are typical for physical medical devices. It also mentions "clinical literature was provided to justify the testing conditions and acceptance criteria of the subject Arthrex Cerclage Sutures," but it does not detail these criteria or the results of a clinical study, particularly not one involving AI/ML.

Therefore, I cannot provide the requested information. The prompt asks for details about an AI/ML powered device study, but the provided text describes a submission for a physical medical device (sutures).

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The PERMALOOP Suture is indicated for orthopedic procedural use in soft-tissue approximation including use with allograft tissue.
The PERMATAPE Suture is indicated for orthopedic procedural use in soft-tissue approximation including use with allograft tissue.

The PERMATAPE™ Suture is a 1.3mm wide, synthetic, sterile, flat braided suture composed of dyed and un-dyed (chromium cobalt aluminum oxide

This document describes the FDA's 510(k) clearance for the PERMALOOP Suture and PERMATAPE Suture, which are non-absorbable polyethylene surgical sutures. The information provided focuses on the substantial equivalence to predicate devices rather than a standalone clinical study with detailed acceptance criteria and performance metrics for a specific algorithm or AI.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, how ground truth for training set was established) are not applicable as this isn't a submission for an AI-powered diagnostic device but a traditional medical device (surgical suture).

However, I can extract the available information regarding testing and performance for the sutures.

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices like sutures, the "acceptance criteria" are typically defined by recognized standards and guidelines, and "device performance" is demonstrated through compliance with these standards.

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

The document does not specify the exact sample sizes for each physical and chemical test mentioned (e.g., how many sutures were tested for tensile strength or how many batches for sterilization validation).

• Data Provenance: The studies were non-clinical (laboratory testing) performed by the manufacturer, Medos International SARL / DePuy Synthes Mitek Sports Medicine.

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

Not applicable. For physical device testing, "ground truth" is established by adherence to recognized engineering and material science standards, not by expert consensus in the same way as, for example, image interpretation.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically relevant for human-in-the-loop studies or ground truth establishment based on expert disagreement, which is not the case here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is not an AI-powered device.

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

The performance testing described is "standalone" for the device, meaning it evaluates the physical and chemical properties of the suture itself. However, this is not an algorithm, so the term doesn't apply in the common AI/algorithm context.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing of the PERMALOOP and PERMATAPE Suture is established by:

• Performance Standards: Adherence to established standards such as USP (United States Pharmacopeia) for tensile strength and needle attachment strength.
• Sterilization Standards: Compliance with international standards like ANSI/AAMI/ISO 11135 for Ethylene Oxide Sterilization.
• Biocompatibility/Safety Standards: Compliance with standards for EO residuals (AAMI/ANSI/ISO 10993-7) and non-pyrogenicity (ANSI/AAMI ST-72, USP, EP).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. The design, materials, and manufacturing processes are based on established engineering principles and prior validated devices.

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

Not applicable. As noted above, this is not an AI/machine learning device.

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The Arthrex Knotless Mini TightRopes are intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct to external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

Specifically, the Arthrex Knotless Mini TightRopes are intended to provide fixation during the healing process following:

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

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

3. Hallux Valgus reconstruction (correction) by providing for the reduction of 1st metatarsal intermetatarsal angle.

The Arthrex Knotless Mini TightRopes, when used for fixation of bone-to-bone or soft-tissue-to-bone, are intended as fixation posts, distribution bridges, or for distributing suture tension over areas of ligament or tendon repair.

Specifically, the Arthrex Knotless Mini TightRopes are indicated for Carpal (CMC) joint arthroplasty as an adjunct in the healing process of the thumb metacarpal by providing stabilization between the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis. The Arthrex Knotless Mini TightRopes are also indicated for use as adjuncts in the suspension of the thumb metacarpal during process of hematoma distraction arthroplasty by providing stabilization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.

The Arthrex Knotless Mini TightRopes are suture and button constructs that consist of two buttons, one or more suture strands and various ancillary instruments to aid in insertion. The buttons are manufactured from titanium alloy conforming to ASTM F136 (Ti-6AL-4V ELI). The sutures are manufactured from UHMWPE, polyester and/or nylon. The devices are sold sterile and are single-use.

This document describes the Arthrex Knotless Mini TightRopes device. It appears to be a 510(k) Summary for a medical device cleared by the FDA, primarily focusing on proving substantial equivalence to predicate devices rather than providing a detailed study of its performance against specific acceptance criteria in a clinical context.

Therefore, many of the requested categories for describing an AI/device performance study and its acceptance criteria are not applicable to this document as it's a submission for a mechanical implant, not an AI or digital health device, and the "performance data" refers to mechanical testing.

However, I can extract the information that is present and indicate where information is not available or not relevant for this type of device submission.

Here's an attempt to answer your request based on the provided text, while noting the limitations:

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

For a mechanical implant, acceptance criteria are typically defined by demonstrating substantial equivalence to a predicate device through mechanical testing. The document states that the new device must perform "statistically equivalent" to the predicate.

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: The document does not specify the exact sample sizes (e.g., number of devices tested) for the mechanical, MRI, endotoxin, or biocompatibility tests.
• Data Provenance: Not explicitly stated, but these are typically laboratory tests performed by the manufacturer or contracted labs, not clinical data from a specific country or retrospective/prospective clinical studies.

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 is not applicable. The ground truth for this device is based on established engineering standards (ASTM, ISO) and comparison to predicate device performance through objective material and mechanical testing, not expert interpretation of clinical data or images.

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

This is not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints. The described tests are objective laboratory measurements.

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

This is not applicable. This is a physical implant, not an AI or imaging device, and no MRMC study was conducted or is relevant to its clearance.

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

This is not applicable. This is a physical implant.

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

The "ground truth" for this device, in the context of its 510(k) clearance, is primarily defined by:

• Established engineering standards (e.g., ASTM for mechanical properties and MRI safety, ISO for biocompatibility).
• The performance characteristics of the legally marketed predicate devices (K133275 and K061925), which serve as the benchmark for "substantial equivalence."

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of this type of mechanical device submission.

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

This is not applicable. See point 8.

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The Knotless TensionTight Button Implant System is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip 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 Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
• Hip: Acetabular Labral Repair

The Knotless TensionTight Button Implant System consists of an oblong Titanium alloy button with locking trap door preloaded on an inserter with a suture threader and nitinol loop and two Arthrex #5 FiberLink sutures (K122374). The button and sutures are packaged with class I exempt instrumentation.

This document is a 510(k) premarket notification from the FDA for a medical device called the "Knotless TensionTight Button Implant System." It does not describe an AI/ML powered device, and therefore does not contain the information requested in your prompt regarding acceptance criteria for AI algorithm performance or related studies (such as MRMC studies, ground truth establishment, or training/test set details).

The information provided pertains to the regulatory clearance of a mechanical implant system, with performance data focused on mechanical properties (static and dynamic pull-out testing) and biocompatibility, not AI algorithm performance.

Therefore, I cannot extract the requested information about AI acceptance criteria and study details from this document.

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The Arthrex SutureTape is intended for use in 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.

Arthrex SutureTape is a suture made of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester, and may include nylon. The proposed suture is braided flat with round ends, and is available in precut lengths in straight and loop configurations, and with or without needles. Arthrex SutureTape is packaged sterile for single use. New colorant additives meet the requirements of 21 CFR 73.1015 and 21 CFR 74.3054.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called "Arthrex SutureTape." This document details the regulatory clearance for a surgical suture and focuses on demonstrating substantial equivalence to previously cleared devices.

Crucially, this document does not describe acceptance criteria for an AI/ML-based device or a study proving that an AI/ML device meets such criteria. It pertains to a physical medical device (suture) and its mechanical and biocompatibility testing. Therefore, I cannot extract the information required to answer your prompt regarding acceptance criteria and study details for an AI/ML device.

The information you are asking for, such as sample size for a test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, types of ground truth, and training set details, are specific to the validation of AI/ML systems, particularly in medical imaging or diagnostic contexts. This document is about a surgical suture.

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The Arthrex FiberTape Cerclage suture is intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair. When used as a bone fixation cerclage the suture is intended for:

• · Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty.
• · Sternotomy indications including the "rewiring" of osteotomized sternums.
• · Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring.
• · Repair of long bone fractures due to trauma or reconstruction.

The Arthrex FiberTape Cerclage suture is available as a flat braided suture or assembled in a loop configuration. The Arthrex FiberTape Cerclage suture is braided from a polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester materials identical to those used in other cleared Arthrex sutures (K032245, K041553 and K122374). For the loop assembly, the looped end of the suture is tied as a hitch over a sheath that secures a double looped suture.

The provided document is a 510(k) premarket notification for the Arthrex FiberTape Cerclage suture, seeking clearance for its use as a bone fixation cerclage. This document focuses on demonstrating substantial equivalence to predicate devices based on design features, intended use, and performance data from various studies.

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative format with corresponding reported performance values for each criterion. Instead, it describes various tests performed to demonstrate substantial equivalence to predicate devices. The implicit acceptance criterion for each test is that the Arthrex FiberTape Cerclage performs equivalently or acceptably compared to the cleared predicate devices.

However, based on the Substantial Equivalence Summary, we can infer the types of performance aspects evaluated:

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

The document does not specify the exact sample sizes (e.g., number of units, number of tests) used for each of the performance tests (fatigue strength, tensile force, creep, knot strength, wear testing, bacterial endotoxins).

• Data Provenance: The studies appear to be pre-clinical, benchtop (in-vitro) studies conducted by the manufacturer (Arthrex Inc.) for the purpose of demonstrating substantial equivalence. There is no indication of country of origin for the data provided, nor whether it is retrospective or prospective, as these terms usually apply to clinical studies involving human or animal subjects. These are laboratory-based tests.

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

This type of information (number of experts, qualifications) is not applicable to the studies described. The tests performed are mechanical and chemical characterizations of the device, not diagnostic or clinical assessment studies that would require expert interpretation to establish a ground truth. The "ground truth" here is objective measurement against defined physical or chemical properties and standards (e.g., tensile strength, presence of endotoxins).

4. Adjudication Method for the Test Set

This is not applicable as there are no "readers" or subjective interpretations requiring adjudication for the benchtop tests described. The results are quantitative measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance

This is not applicable. The device is the "Arthrex FiberTape Cerclage suture," which is a physical surgical suture, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI-related effectiveness metrics are irrelevant 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 in point 5, this is not an AI algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the tests performed is based on objective, quantifiable physical and chemical properties and established standards.

• For mechanical tests (fatigue, tensile, creep, knot strength, wear), the "ground truth" is the measured performance data compared against the performance of predicate devices and engineering specifications.
• For the Bacterial Endotoxins Test, the "ground truth" is compliance with the pyrogen limit specifications outlined in USP .

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not an AI/machine learning device. The device itself is a physical product.

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

This is not applicable as there is no training set.

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