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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.

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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.

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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.

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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)

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.

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