Search Results

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.

Ask a specific question about this device

The Arthrex CMC Mini TightRope, when used for fixation of bone-to-bone or soft-tissue-tobone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, the Arthrex CMC Mini TightRope is indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the suspension of the thumb metacarpal during the healing 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 CMC Mini TightRope consists of two oblong stainless steel buttons and a single strand of #2 FiberWire.

The provided FDA 510(k) summary is for the Arthrex CMC Mini TightRope, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a comprehensive clinical study in the way a diagnostic AI device would.

Therefore, many of the requested categories related to AI device performance evaluation (such as test set sample size, expert ground truth, MRMC studies, training set details) are not applicable to this document or this type of medical device clearance.

However, I can extract the relevant information from the provided text as it pertains to the device's substantial equivalence.

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

The concept of "acceptance criteria" and "reported device performance" in the context of this 510(k) submission relates to demonstrating substantial equivalence to a predicate device, rather than meeting specific quantifiable performance metrics as one might see for a diagnostic tool. The acceptance is that the device is substantially equivalent to the predicate.

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

• Sample Size: Not applicable. This is a 510(k) for a medical implant, not a diagnostic device evaluated with a test set of data. The "test" for this device is based on demonstrating substantial equivalence through comparison of design, materials, and intended use with a predicate device, often supported by bench testing (though not detailed here) rather than human subject data sets.
• Data Provenance: Not applicable.

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

• Number of Experts/Qualifications: Not applicable. This submission does not involve clinical data requiring expert review for ground truth establishment.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. There is no test set or adjudication process described in this 510(k) summary.

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

• MRMC Study/Effect Size: Not applicable. This device is a surgical implant, not an AI-assisted diagnostic tool.

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

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

7. The type of ground truth used

• Type of Ground Truth: Not applicable. This submission relies on demonstrating substantial equivalence to a predicate device, not on diagnostic accuracy against a ground truth.

8. The sample size for the training set

• Sample Size: Not applicable. There is no training set for a medical implant in this context.

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

• Ground Truth Establishment: Not applicable.

Ask a specific question about this device

The Arthrex Mini TightRope and Mini TightRope FT are intended as adjuncts in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

Specifically, the Arthrex Mini TightRope and the Mini TightRope FT are intended to provide fixation during the healing process following:

1. Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions;
2. Tarsometatarsal (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 – 2nd metatarsal intermetatarsal angle.

The Arthrex Mini TightRope and the Mini TightRope FT, 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 Mini TightRope and the Mini TightRope FT are indicated for Carpal Metacarpal (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 metacarpals when the trapezium has been excised due to osteoarthritis. The Mini TightRope and Mini TightRope FT are also indicated for use as adjuncts in the suspension of the thumb metacarpal during the healing 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 Mini TightRope devices are designed in two basic configurations: two metal buttons and a pre-threaded FiberWire suture and; one metal button, one bioabsorbable suture anchor.

The provided text describes the Arthrex Mini TightRope devices and their intended use, but it does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner typically associated with AI/ML device evaluations.

Instead, this document is a 510(k) premarket notification for a medical device (Mini TightRope) seeking clearance for an expanded indication. The evaluation for this type of device relies on demonstrating substantial equivalence to a previously cleared predicate device, rather than meeting quantitative performance metrics against a defined acceptance criterion through a study as would be seen for an AI/ML diagnostic or prognostic tool.

Therefore, many of the specific points requested (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types, training set size, and ground truth establishment for training set) are not applicable to this type of traditional medical device submission based on the provided text.

Based on the provided text, here's what can be extracted and inferred:

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):

• Not Applicable. This submission is based on demonstrating substantial equivalence to a predicate device and mechanical testing, not a clinical study on a patient test set in the conventional sense for AI/ML. The "mechanical testing data" would refer to laboratory tests on the device itself.
• Data Provenance: The document does not specify the origin of the mechanical testing 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. No ground truth establishment for a patient "test set" is described for this device as it's a mechanical device, not an AI/ML diagnostic.

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

• Not Applicable. No human adjudication for a test set is described.

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 mechanical surgical implant, not an AI/ML imaging or diagnostic device that assists human readers.

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

• Not Applicable. This is a mechanical surgical implant, not an AI/ML algorithm.

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

• The "ground truth" for this device's performance is established through mechanical testing data (shear and tensile strength) and clinical literature review to support its adequacy for providing stabilization as an "adjunct in the suspension of the thumb metacarpal during the healing process of hematoma distraction arthroplasty."

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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

• Not Applicable. There is no "training set" and associated ground truth establishment for this type of device.

Ask a specific question about this device

The Arthrex Mini TightRope and Mini TightRope FT are intended as adjuncts in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

Specifically, the Arthrex Mini TightRope and the Mini TightRope FT are intended to provide fixation during the healing process following:

1. Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions;
2. Tarsometatarsal (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 -2nd metatarsal intermetatarsal angle.

The Arthrex Mini TightRope and the Mini TightRope FT, 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 Mini TightRope and the Mini TightRope FT are indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process of the reconstruction of the ligament at the base 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 Mini TightRope is designed as either two metal buttons with a pre-threaded FiberWire suture or as one metal button, one bioabsorbable suture anchor with one pre-threaded FiberWire suture.

The provided text is a 510(k) summary for the Arthrex Mini TightRope device. It focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance and does not contain information about acceptance criteria or specific study results to prove device performance in the context of AI/machine learning.

Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and study results, as this type of data is not present in the provided document. The document describes a medical device, its intended use, and its substantial equivalence to other devices, which is a regulatory and functional description rather than a performance evaluation with quantifiable metrics against acceptance criteria.

The information you are asking for, such as sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, are characteristic of studies evaluating AI/machine learning medical devices, which this document does not describe.

Ask a specific question about this device

The Mini TightRope FT Repair Kit is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

Specifically, the Mini TightRope FT Repair Kit is 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 - 2nd metatarsal intermetatarsal angle.

The Mini TightRopeTM FT Repair Kit is designed as one metal button, one bioabsorbable suture anchor, and one FiberWireTM suture. The button and anchor are pre-threaded with FiberWire looped twice.

The provided text is a 510(k) summary for the Arthrex Mini TightRope FT Repair Kit. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and a detailed performance evaluation. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not available in the provided document.

Here's a breakdown of what can be extracted and what is not present:

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

• This information is not present in the provided document. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, not on specific performance metrics against defined acceptance criteria.

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

• This information is not present. The document does not describe any clinical or pre-clinical performance testing with a specific 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)

• This information is not present. No ground truth establishment for a test set is discussed.

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

• This information is not present. There is no mention of a test set or an adjudication method.

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 present. The device is described as a medical implant, not an AI-assisted diagnostic tool. Therefore, an MRMC study with AI assistance is not applicable.

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

• This information is not present. The device is a surgical repair kit, not an algorithm.

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

• This information is not present. No ground truth for performance evaluation is discussed.

8. The sample size for the training set

• This information is not present. The device is not an algorithm that requires a training set.

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

• This information is not present. Not applicable as the device is not an algorithm.

Summary of available information:

The document describes the Arthrex Mini TightRope FT Repair Kit (K071978) and its intended use, which includes:

• Adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated.
• Adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
• Specifically, fixation during the healing process following:
  • Syndesmotic trauma (e.g., fixation of dorsal distal radioulnar ligament disruptions).
  • Tarasometatarsal (TMT) injury (e.g., fixation of foot soft tissue separations due to a Lisfranc injury).
  • Hallux Valgus reconstruction (correction) by providing for the reduction of the 1st metatarsal - 2nd metatarsal intermetatarsal angle.

The entire 510(k) submission is based on demonstrating substantial equivalence to a predicate device, the Arthrex Mini TightRope Repair Kit (K061925). The key argument for equivalence is that "the basic features and intended uses are the same. Any differences... are considered minor and do not raise questions concerning safety and effectiveness."

The FDA's letter confirms that the device is deemed "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed subject to general controls. It does not provide details of specific performance criteria or outcomes from a new study beyond the comparison to the predicate device.

Ask a specific question about this device

The Mini TightRope™ Repair Kit is interided as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

Specifically, the Arthrex Mini TightRope™ Repair Kit is 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 -2nd metatarsal intermetatarsal angle.

The Mini TightRope™ Repair Kit is designed as two differently sized metal buttons and FiberWire™ suture. The buttons are pre-threaded with FiberWire suture, looped twice through the buttoriholes. A pull-through FiberWire suture is looped through one button.

Acceptance Criteria and Study for Mini TightRope™ Repair Kit

The provided document (K061925) is a 510(k) summary for a medical device called the Mini TightRope™ Repair Kit. It outlines the intended use and establishes substantial equivalence to predicate devices, rather than performing a de novo study with specific performance acceptance criteria and a detailed study validating those criteria.

Therefore, the typical structure for a study demonstrating acceptance criteria for device performance, especially in the context of AI/software or diagnostic devices, is not present in this document. This K-number filing is for a physical orthopedic implant/fixation device, and substantial equivalence is shown by demonstrating similar features, intended use, and safety/effectiveness profile to already approved devices.

However, I can extract the implied 'acceptance criteria' in the context of a 510(k) submission, which is primarily demonstrating substantial equivalence to predicate devices. The "study" in this case refers to the arguments and justifications made within the 510(k) submission itself to support this claim.

Implied Acceptance Criteria and Reported Device Performance (Based on Substantial Equivalence)

Specific Indications:

1. Syndesmotic trauma (e.g., DRUL disruptions)
2. Tarsometatarsal (TMT) injury (e.g., Lisfranc injury)
3. Hallux Valgus reconstruction (reduction of 1st-2nd metatarsal intermetatarsal angle). |
   | Similar Technological Characteristics/Design | The device consists of two differently sized metal buttons and FiberWire™ suture. The buttons are pre-threaded with FiberWire suture, looped twice through the buttonholes. A pull-through FiberWire suture is looped through one button. |
   | Similar Materials | Metal buttons and FiberWire™ suture (implied to be similar or equivalent to predicate device materials in terms of biocompatibility and mechanical properties, though not explicitly detailed in this summary). |
   | Similar Principles of Operation | Provides fixation during the healing process. Operates on the principle of a "button/suture" system for bone fixation. |
   | No New Questions of Safety & Effectiveness | Arthrex states: "Any design differences between the Arthrex Mini TightRope™ Repair Kit when compared to predicate devices... are considered minor and do not raise any questions concerning safety and effectiveness. Any differences have been found to have no apparent effect on the performance, function, or intended use of the device." |

Study Details (as inferred from a 510(k) submission focused on substantial equivalence):

Given the nature of a 510(k) for a physical implant, the concept of a "test set," "ground truth," "MRMC," or "standalone algorithm performance" as typically applied to AI/software or diagnostic devices is not applicable here. The "study" is the comparison made to predicate devices.

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

   • Test Set Sample Size: Not applicable in the traditional sense for this type of device submission. There isn't an "image dataset" or "patient cohort" test set for algorithm validation. The "test" is a comparison to established predicate devices.
   • Data Provenance: The "data" here refers to the known performance, safety, and regulatory history of the predicate devices:
     • K041189: TRIM-IT Family (Arthrex, Inc.)
     • K052776: TightRope AC Device (Arthrex, Inc.)
     • K043248: TightRope Syndesmosis Device (Arthrex, Inc.)
       These are existing, legally marketed devices.

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

   • Not applicable. Ground truth, in the context of AI/diagnostic devices, refers to a definitive diagnosis or outcome. For this mechanical device, "ground truth" is established through engineering principles, mechanical testing (often referenced in full 510(k) submissions, but not detailed here), and the clinical history of the predicate devices. Experts involved would be product engineers, regulatory specialists, and potentially clinical consultants, but not in the context of creating a labeled test set.

3. Adjudication method for the test set:

   • Not applicable. There is no ambiguous "test set result" requiring adjudication. The comparison is based on objective device characteristics and intended uses.

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

   • Not applicable. This is a physical orthopedic fixation device, not an AI or diagnostic tool.

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

   • Not applicable. This is a physical orthopedic fixation device, not an algorithm.

6. The type of ground truth used:

   • The "ground truth" is implicitly the established safety and effectiveness of the predicate devices based on their prior regulatory clearance, clinical use, and documented performance (e.g., mechanical strength, biocompatibility, historical clinical outcomes).

7. The sample size for the training set:

   • Not applicable. There is no computational "training set" for an algorithm.

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

   • Not applicable.

Ask a specific question about this device