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The RoG™ 5.5 mm Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:

• . Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
• . Wrist/hand indications:- Ulnar/Radial collateral ligament reconstruction, scapholunate ligament reconstruction.
• . Foot/ankle indications:- Achilles tendon repair/reconstruction, hallax valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
• Elbow indications: Biceps tendon reconstruction, ulnar or radial collateral . ligament reconstruction, lateral epicondylitis repair.
• . Knee indications: - Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure.

The RoG™ 2.9mm Suture Anchor is indicated for use in soft tissue reattachment procedures. Specific indications are as follows:

• Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair, . capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
• Wrist/hand indications: Scapholunate ligament reconstruction. .
• . Elbow indications: - Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction.
• . Knee indications: - Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure, extracapsular repair, vastus medialis obliquus (VMO) muscle advancement.

The RoGTM 5.5 mm Knotless Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:

• . Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
• Wrist/hand indications: Ulnar/Radial collateral ligament reconstruction, . scapholunate ligament reconstruction.
• . Foot/ankle indications: - Achilles tendon repair/reconstruction, hallax valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
• . Elbow indications: - Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair.
• Knee indications: Lateral collateral ligament repair, medial collateral ligament . repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure.

The subject device is screw-like in shape and composed exclusively of PEEK plastic. It is available in both standard ("knotted") and "knotless" configurations. It is also available in diameters of 5.5mm and 2.9mm and lengths of 10mm and 17mm. It is provided sterile and supplied with non-absorbable polyethylene suture. The anchor is supplied with reusable taps and guides of corresponding size.

Here's an analysis of the provided text regarding the RoGTM Suture Anchor, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for a medical device (suture anchor), not a scientific study report for an AI/ML medical device. Therefore, much of the requested information (like ground truth, expert adjudication, AI performance metrics, sample sizes for training/test sets) is not applicable to this type of device and submission. This document describes a physical surgical implant, not a diagnostic or prognostic algorithm.

The "performance characteristics" and "safety characteristics" sections in this 510(k) relate to the physical and material properties of the suture anchor and its components. The "study" mentioned is in the context of demonstrating that these characteristics have not changed from a previously cleared predicate device, and that sterility and material biocompatibility standards are met.

Description of Acceptance Criteria and Study Findings

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable/not specified. For this physical device, "test set" would typically refer to the number of units tested for mechanical properties, material integrity, and sterility. The document only states "Testing has shown the anchor, suture and packaging to be stable for the proposed period" for the extended expiration date, without providing specific numbers.
• Data Provenance: Not applicable/not specified in terms of country of origin or retrospective/prospective. The data pertains to material and product testing, likely conducted by the manufacturer or their suppliers.

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

• Not Applicable. This is a physical medical device (suture anchor), not a diagnostic algorithm requiring expert "ground truth" for a test set. Ground truth, in this context, would involve laboratory analysis and adherence to established material and performance standards (e.g., ISO standards, USP).

4. Adjudication Method for the Test Set

• Not Applicable. No human adjudication method (like 2+1, 3+1) is relevant for a physical device like a suture anchor. Evaluation involves objective measurements and adherence to engineering and material science standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC study is relevant for evaluating the impact of an AI algorithm on human reader performance, typically in imaging diagnostics. This is a surgical implant and does not involve human "readers" interacting with an AI system.

6. Standalone (Algorithm Only) Performance Study

• No. This is a physical medical device, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used

• Expert Consensus, Pathology, Outcomes Data, etc.: Not applicable in the traditional sense for an AI/ML device. For this suture anchor, the "ground truth" consists of:
  • Material specifications and biocompatibility standards (e.g., ISO 10993).
  • Sterilization efficacy standards (e.g., ISO 11135).
  • Suture quality standards (e.g., U.S. Pharmacopeia, FDA Guidance).
  • Mechanical performance test results (implied for "performance characteristics" and stability testing, though specific data is not provided in this summary).

8. Sample Size for the Training Set

• Not Applicable. As this is not an AI/ML device, there are no "training sets" in the context of machine learning. The design and manufacturing processes are established using engineering principles and regulatory standards.

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

• Not Applicable. Since there is no training set for an AI/ML algorithm, this question is not relevant.

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The RoG™ 5.5 mm Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:

• . Shoulder indications: - Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
• Wrist/hand indications: Ulnar/Radial collateral ligament reconstruction, . scapholunate ligament reconstruction.
• Eoot/Ankle indications: Achilles tendon repair/reconstruction, hallax valgus . reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
• . Elbow indications: - Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair.
• Knee indications: Lateral collateral ligament repair, medial collateral ligament . repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure.

The RoG 2.9mm Suture Anchor is indicated for use in soft tissue reattachment procedures. Specific indications are as follows:

• Shoulder indications: Bankart repair, rotator cuff repair, SLAP lesion repair, . capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
• Wrist/hand indications: Scapholunate ligament reconstruction. .
• Elbow indications: Biceps tendon reconstruction, ulnar or radial collateral . ligament reconstruction.
• Knee indications: Lateral collateral ligament repair, medial collateral ligament . repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure, extracapsular repair, vastus medialis obliquus (VMO) muscle advancement.

The RoG 5.5 mm Knotless Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:

• Shoulder indications: Bankart repair, rotator cuff repair, SLAP lesion repair, . capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
• Wrist/Hand indications: Ulnar/Radial collateral ligament reconstruction, . scapholunate ligament reconstruction.
• Foot/Ankle indications: Achilles tendon repair/reconstruction, hallax valgus . reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
• Elbow indications: Biceps tendon reconstruction, ulnar or radial collateral . ligament reconstruction, lateral epicondylitis repair.
• Knee indications: Lateral collateral ligament repair, medial collateral ligament . repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure.

The subject device is screw-like in shape and composed exclusively of PEEK plastic. It is available in both standard ("knotted") and "knotless" configurations. It is also available in diameters of 5.5mm and 2.9mm and lengths of 10mm and 17mm. It is provided sterile and supplied with non-absorbable polyethylene suture. The anchor is supplied with reusable taps and guides of corresponding size.

Here's an analysis of the provided text regarding the RoGTM Sports Medicine Suture Anchor, focusing on acceptance criteria and supporting studies:

It's important to note that the provided text is a 510(k) Summary for a medical device seeking substantial equivalence to a predicate device. This type of submission relies heavily on demonstrating that the new device is as safe and effective as a previously cleared device, rather than requiring extensive de novo clinical trials with rigorous acceptance criteria for novel performance.

Therefore, the information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" will be focused on comparative performance to the predicate device and compliance with relevant standards, rather than clinical efficacy metrics typical of AI/software devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify a sample size for a "test set" or provide details on data provenance (e.g., country of origin, retrospective/prospective clinical data).

This is because the submission is for a material/design modification and an expiration date extension of an already cleared device (K111590). The focus is on demonstrating equivalence and stability, not on collecting new clinical performance data from a "test set" in the context of an AI/software device. The "testing" mentioned is likely focused on bench testing (e.g., tensile strength, degradation studies) for the expiration date extension.

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

This information is not applicable and not provided in the document. This type of detail (expert consensus, qualifications) is common for AI/software devices where human experts establish ground truth for image interpretation or diagnosis. For a physical device like a suture anchor, "ground truth" is established by engineering specifications, material properties, and standardized testing.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or performance evaluation of diagnostic/AI devices where inter-observer variability needs to be resolved to establish a robust ground truth.

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

There was no MRMC comparative effectiveness study done. This is a physical, implantable medical device, not an AI/software device intended to assist human readers or clinicians in diagnosis or interpretation. The concept of "human readers improving with AI assistance" is not relevant here.

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

There was no standalone performance study in the context of an algorithm or AI. This is a physical medical device.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" is established by:

• Engineering Specifications: The design, dimensions, and materials of the suture anchor.
• Material Standards: Compliance with ISO 10993 for biocompatibility of PEEK.
• Sterilization Standards: Compliance with ISO 11135 and ISO 10993-7.
• Suture Standards: Compliance with U.S. Pharmacopeia and FDA Class II Special Controls Guidance for Surgical Sutures.
• Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate device (K111590) serves as the "ground truth" for the overall device functionality and intended use.
• Stability Testing: (Likely bench testing) to confirm the stability of the anchor, suture, and packaging over the extended shelf life.

8. The Sample Size for the Training Set

This information is not applicable and not provided. "Training set" refers to data used to train machine learning models, which is not relevant for this physical medical device submission.

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

This information is not applicable and not provided. As there is no training set for an AI model, there is no ground truth established for one.

Ask a specific question about this device

The RoG™ 5.5 mm Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:

• . Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
• Wrist/hand indications:- Ulnar/Radial collateral ligament reconstruction. . scapholunate ligament reconstruction.
• . Foot/Ankle indications: - Achilles tendon repair/reconstruction, hallax valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
• Elbow indications:- Biceps tendon reconstruction, ulnar or radial collateral . ligament reconstruction, lateral epicondylitis repair.
• Knee indications:- Lateral collateral ligament repair, medial collateral ligament . repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure.

The RoG 2.9mm Suture Anchor is indicated for use in soft tissue reattachment procedures. Specific indications are as follows:

• Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair. . capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
• Wrist/hand indications:- Scapholunate ligament reconstruction. .
• Elbow indications: Biceps tendon reconstruction, ulnar or radial collateral . ligament reconstruction.
• . Knee indications:- Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair. Iliotibial band tenodesis, joint capsule closure. extracapsular repair, vastus medialis obliquus (VMO) muscle advancement.

The RoG 5.5 mm Knotless Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:

• Shoulder indications:- Bankart repair. rotator cuff repair. SLAP lesion repair. . capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
• . Wrist/Hand indications:- Ulnar/Radial collateral ligament reconstruction. scapholunate ligament reconstruction.
• Foot/Ankle indications:- Achilles tendon repair/reconstruction, hallax valgus . reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
• Elbow indications :- Biceps tendon reconstruction, ulnar or radial collateral ● ligament reconstruction, lateral epicondylitis repair.
• Knee indications:- Lateral collateral ligament repair, medial collateral ligament . repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure.

The subject device is screw-like in shape and composed exclusively of PEEK plastic. It is available in both standard ("knotted") and "knotless" configurations. It is also available in diameters of 5.5mm and 2.9mm and lengths of 10mm and 17mm. It is provided sterile and supplied with non-absorbable polyethylene suture. The anchor is supplied with reusable taps and guides of corresponding size.

This document is a 510(k) Summary for the RoG Sports Medicine Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed performance studies or specific acceptance criteria for a new AI/software device. Therefore, I cannot extract the requested information about acceptance criteria and a study proving the device meets them from the provided text.

The document states: "Performance characteristics of the anchors have not changes from those described in K110229 and L110230. The only changes to the device are supplying the device with non-absorbable suture and pre-sterilized."

This indicates that the current submission (K111590) is for a modified version of an already cleared device, and thus, extensive new performance studies (especially those involving AI or software as typically implied by your request) are not part of this particular submission. The focus is on demonstrating that the modifications (suture type and sterilization method) do not alter the substantial equivalence to the predicate devices.

Therefore, I cannot provide:

1. A table of acceptance criteria and the reported device performance: This is not present as the device itself hasn't undergone new performance testing for this submission. The "performance characteristics" are stated to be unchanged from predicate devices.
2. Sample size used for the test set and the data provenance: Not applicable for a non-AI/software device submission of this nature.
3. Number of experts used to establish the ground truth...: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as there is no algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The "Safety Characteristics" section mentions compliance with ISO 10993 (biocompatibility) and ISO 11135-1 (sterilization), but these are standards for material safety and manufacturing processes, not specific performance criteria for the device's functional use in the way described in your request for AI/software.

Ask a specific question about this device

The RoG 5.5 mm Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:

• . Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
• Wrist/hand indications:- Ulnar/Radial collateral ligament reconstruction, scapholunate ligament reconstruction.
• Foot/Ankle indications: Achilles tendon repair/reconstruction, hallax valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
• t Elbow indications:- Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair.
• Knee indications:- Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure.

The RoG 2.9mm Suture Anchor is indicated for use in soft tissue reattachment procedures. Specific indications are as follows:

• Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
• Wrist/hand indications:- Scapholunate ligament reconstruction. .
• . Elbow indications:- Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction.
• Knee indications:- Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure. extracapsular repair, vastus medialis obliquus (VMO) muscle advancement.

The subject device is screw-like in shape and composed exclusively of PEEK plastic. It is available in diameters of 5.5mm and 2.9mm and lengths of 10mm and 17mm. It is supplied non-sterile and is intended for sterilization by the user facility. It allows the user to secure a suture of his/her selection to the top of the anchor. The anchor is supplied with reusable taps and guides of corresponding sizes.

The provided document is a 510(k) summary for the RoG Suture Anchor, a medical device. It describes the device's technical specifications, intended use, and its equivalence to predicate devices, but it does not contain information about a study involving AI, human readers, or image analysis.

The 510(k) process is for demonstrating substantial equivalence to a legally marketed predicate device, primarily focusing on design considerations, materials, performance characteristics (mechanical testing), and indications for use. It typically does not involve the kind of clinical or comparative effectiveness studies with human readers or AI that your request outlines.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving a device meets these criteria in the context of AI performance, human readers, or ground truth establishment in the way you described, because the provided document does not pertain to such a device or study.

The "Performance Characteristics" section explicitly states: "Both sizes of subject were evaluated in accordance with FDA's Guidance Document for Testing Bone Anchor Devices (4/20/96). Testing consisted of tapping and pull testing with comparison to the corresponding size of predicate devices. The subject device was found to be equivalent to the corresponding sizes of the predicate devices in such testing." This indicates the evaluation was purely mechanical and comparative to existing similar devices.

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