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Smith & Nephew TWINFIX Ti Preloaded Suture Anchor with Needles, SL are intended for use only for the fixation of non-absorbable, synthetic, surgical suture material for the following indications.

Shoulder
Bankart lesion repairs, SLAP lesion repairs, Acromiolavicular separation repairs, Rotator cuff tear repairs, Capsular shift or Capsulolabral reconstructions, Biceps tenodesis, and Deltoid Repairs

Foot and Ankle
Hallux valgus reconstruction, Medial or Lateral instability repairs/reconstructions, Achilles tendon repair/reconstructions, Mid-foot reconstruction, Metatarsal ligament/tendon repairs/reconstructions

Elbow. Wrist and Hand
Scapholunate ligament reconstruction, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Biceps tendon reattachment

Knee
Extra-capsular repairs: Medial collateral ligament repair, Lateral ligament repair, Posterior oblique ligament, lliotibial band tenodesis, Patellar tendon repair - Vastus medialis obliquous advancement

The Smith & Nephew TWINFIX* Ti 3.5 Suture Anchor with two ULTRABRAID Sutures #2 with Needles, SL are designed to provide secure reattachment of soft tissue to bone. Attachment of soft tissue is performed by the surgeon's preferred technique. TWINFIX Ti 3.5 Suture Anchor with two ULTRABRAID Sutures #2 with Needles, SL consists of a titanium alloy suture anchor and non-absorbable sutures with attached stainless steel needles. The non-absorbable sutures are offered either braided, silicone or PTFE impregnated, polyester (USP) or braided, uncoated, UHMW polyethylene and UHMW polyethylene with monofilament polypropylene or nylon co-braid. An insertion device is also offered which contains a stainless steel shaft with a ABS and polycarbonate handle. The TWINFIX Ti is designed to provide secure reattachment of soft tissue to bone. Attachment of soft tissue is performed by the surgeon's preferred technique.

Here's an analysis of the provided text regarding the Smith & Nephew TWINFIX Ti 3.5 Suture Anchor's acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance

Study Details

The provided text does not describe a study involving AI or software performance, but rather a traditional medical device 510(k) submission for a physical surgical anchor. Therefore, many of the requested categories (e.g., sample size for test/training sets, expert qualifications, MRMC studies, ground truth types related to AI) are not applicable.

Here's what can be extracted from the provided document:

1. Sample size used for the test set and the data provenance: Not applicable. The document refers to "Mechanical test data" but does not specify sample sizes or data provenance in terms of origin or retrospective/prospective nature. This generally refers to bench testing performed in a laboratory setting.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a mechanical device, ground truth is established through physical measurements against defined engineering specifications.

3. Adjudication method for the test set: Not applicable.

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 not an AI-enabled device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

6. The type of ground truth used: For a mechanical device, the ground truth is established by engineering specifications and validated testing methods (e.g., ASTM standards or internal protocols) for physical properties like insertion force, pull-out strength, fatigue, etc.

7. The sample size for the training set: Not applicable. There is no AI training set for this physical device.

8. How the ground truth for the training set was established: Not applicable.

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The Smith & Nephew TWINFIX Ultra Ti Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder:

• Bankart lesion repairs Slap lesion repairs Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs . Deltoid repairs Rotator cuff tear repairs Biceps tenodesis
• Foot & Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstruction Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions

Knee: Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Patellar realignment and tendon repairs: Vastus medialis obliquous advancement Iliotibial band tenodesis.

Elbow:

• Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment

The TWINFIX Ultra Ti is a suture anchor manufactured from Titanium alloy and is offered in diameters of 4.5, 5.5, and 6.5 mm sizes. The anchor is preloaded with suture preassembled onto a stainless steel inserter.

The provided text describes the Smith & Nephew TWINFIX Ultra Ti Suture Anchor and its regulatory clearance, but it does not contain the detailed information requested regarding acceptance criteria and a specific study proving the device meets those criteria, especially in the context of an AI/algorithm-based device.

The document is a 510(k) summary for a medical device (a suture anchor), which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a study format often seen for diagnostic or AI devices.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.

Here's what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance:

Missing information: Explicit, quantifiable acceptance criteria. The performance is reported as "substantially equivalent" rather than a specific measure against a target.

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

• Sample size: Not specified. The document only states "Non-clinical testing that included insertion and pull-out strength was performed."
• Data provenance: Not specified. Given it's non-clinical testing of a physical device, it would likely be laboratory or bench testing, not patient data from a specific country.
• Retrospective/Prospective: Not applicable in the context of this device's non-clinical testing.

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

• This question is not applicable to the type of device and testing described. The "ground truth" for a suture anchor's mechanical performance (insertion and pull-out strength) would be established by direct physical measurement, not by expert interpretation.

4. Adjudication method for the test set:

• Not applicable. See point 3.

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. This is not an AI/diagnostic device. An MRMC study is not relevant here.

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

• No. This is a physical medical device (suture anchor), not an algorithm.

7. The type of ground truth used:

• For "insertion and pull-out strength," the ground truth would be direct physical measurements using force gauges or similar mechanical testing equipment.

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms. Its performance is based on material properties and design, tested mechanically.

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

• Not applicable. See point 8.

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The Extremity Medical Suture Anchor is intended for the fixation of suture and/or soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in the following procedures

Shoulder Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift of Capsulolabral Reconstruction Foot/Ankle Lateral Stabılızatıon, Medial Stabılızatıon, Achılles Tendon Repar, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Knee Medial Collateral Ligament Repair, Lateral Collateral Ligament Reparr, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction Filbow Biceps Tendon Reattachment, Tennis Elbow Repar, Ulnar or Radial Collateral Ligament Reconstruction

The EXTREMITY MEDICAL Suture Anchor

The provided text is a 510(k) summary for the EXTREMITY MEDICAL Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study for meeting specific acceptance criteria derived from device performance.

Therefore, the requested information regarding acceptance criteria, device performance testing, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details for a study proving the device meets acceptance criteria cannot be found in the provided document.

This type of 510(k) submission generally relies on a comparison of design, materials, and intended use to existing legally marketed devices, rather than extensive clinical performance studies with specific statistical acceptance criteria. The "study" here is essentially the comparison to predicate devices, and the "acceptance criterion" is substantial equivalence.

Here's what can be extracted based on the nature of the document:

While the document doesn't present traditional "acceptance criteria" and a "study" to meet them in the context of device performance metrics (like sensitivity, specificity, accuracy for an AI device, or specific mechanical thresholds for a medical device), it does present the implicit acceptance criteria for its regulatory pathway: Substantial Equivalence to legally marketed predicate devices.

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

• Same indications for use
• Similar design
• Similar materials
• Similar principles of operation | The EXTREMITY MEDICAL Suture Anchor is substantially equivalent to its predicate devices (TwinFix Ti 2.8 Suture Anchor K972326, TwinFix PK FP Suture Anchor K073509) based on:
• Same indications for use
• Similar design
• Similar materials
• Similar principles of operation |

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

• Sample Size: Not applicable. This 510(k) summary does not describe a performance study with a "test set" in the traditional sense of clinical or technical data. The "test set" here is conceptually the comparison of the new device's characteristics against the predicate devices.
• Data Provenance: Not applicable. The data is descriptive of the device itself and its comparison to existing devices, not empirical performance data from patients or laboratory tests for this specific device in this document.

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

• Not applicable. Ground truth establishment by experts for a test set is not described in this 510(k) summary, as it's not a performance study.

4. Adjudication method for the test set:

• Not applicable. No test set or adjudication method 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 device is a physical suture anchor, not an AI or imaging device, and therefore an MRMC study with human readers assisting AI is irrelevant.

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 algorithm.

7. The type of ground truth used:

• Not applicable in the context of a performance study. The "ground truth" for the 510(k) substantial equivalence claim is the established legal marketing status and characteristics of the predicate devices.

8. The sample size for the training set:

• Not applicable. There is no mention of a "training set" as this is not a study involving machine learning or statistical modeling.

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

• Not applicable.

In summary, the provided document is a regulatory submission for substantial equivalence of a physical medical device, not a report on a performance study with quantitative acceptance criteria and a test set.

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