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The PULLUP®, BT LOOP®, PULLUP® CLIP and PULLUP® TEX CLIP cortical fixation devices are indicated in adults for reconstruction of the anterior cruciate ligament.

• PULLUP®, PULLUP® CLIP, PULLUP® TEX CLIP must be used with a Soft Tissue Transplant.
• BT LOOP® must be used with a Bone Tendon Bone Transplant.

The RIGIDLOOP™ T, RIGIDLOOP™ BTB, RIGIDLOOP™ Clip and RIGIDLOOP™ Suture Loop cortical fixation devices are indicated in adults for reconstruction of the anterior cruciate ligament.

• RIGIDLOOP™ T, RIGIDLOOP™ Clip, RIGIDLOOP™ Suture Loop must be used with a Soft Tissue Transplant.
• RIGIDLOOP™ BTB must be used with a Bone Tendon Bone Transplant.

• PULLUP®: comprises a titanium button-plate, and an adjustable nonabsorbable braided loop. The system is preloaded with traction and flip threads, and is designed to be used with a soft tissue graft. Standard and XL sizes.

• BT LOOP®: comprises a titanium button-plate, and an adjustable nonabsorbable braided loop. The system is preloaded with traction and flip threads, as well as a temporary split suture, and is designed to be used with a bone-tendon-bone graft. It is assembled on a holder that can be mounted on the GraftTech® preparation station. Standard and XL sizes.

• PULLUP® CLIP: comprises a titanium button-plate only, is designed to be used with a soft tissue graft, and can either be connected to another PULLUP® CLIP button-plate by using the PULLUP® TEX CLIP nonabsorbable braided loop, or can be connected to another PULLUP® device. Standard and XL sizes.

• PULLUP® TEX CLIP: Comprises a nonabsorbable braided loop. One size only.

Standard models are used for cortical tunnels with a diameter of 4.5 mm; XL models are used for cortical tunnels with a diameter between 5 and 10 mm.

The implants are supplied sterile, individually packaged, ready to use.

The PULLUP®, PULLUP® CLIP, BT LOOP® and PULLUP® TEX CLIP devices are also sold under the trade names RIGIDLOOP™ T, RIGIDLOOP™ Clip, RIGIDLOOP™ BTB and RIGIDLOOP™ Suture Loop respectively.

I apologize, but based on the provided FDA 510(k) Clearance Letter (K250844), the device in question is a bone fixation fastener, specifically for anterior cruciate ligament (ACL) reconstruction.

The document describes non-clinical tests performed to demonstrate substantial equivalence, such as:

• Ultimate failure load (post-fatigue tensile strength) and fatigue displacement
• Biocompatibility testing (ISO 10993-1:2018)
• Bacterial endotoxin testing (ISO 11737-3:2023)
• Shelf-life, storage, and stability testing (ISO 11607-1:2019 for packaging)
• Sterile adoption (ISO 11137-1:2006)
• MRI safety evaluation (ASTM F2503 - 20, IEC 62570:2014, FDA guidance)

The provided text explicitly states "Not Applicable" for clinical tests and indicates that "Changes in design are minor, and do not raise new or different questions of safety and effectiveness compared with the predicate device." This means that no human clinical study was conducted or reported in this 510(k) submission to assess the device's performance in terms of diagnostic accuracy or human-AI interaction.

Therefore, I cannot provide the information requested regarding:

1. A table of acceptance criteria and reported device performance directly related to AI or diagnostic accuracy.
2. Sample size for a test set (as no clinical test set for AI performance was mentioned).
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study.
6. Standalone AI performance.
7. Type of ground truth used (in an AI context).
8. Sample size for a training set (AI model training).
9. How ground truth for a training set was established (AI model training).

The 510(k) summary focuses on the mechanical, material, and safety aspects of the physical implant device, demonstrating its equivalence to existing predicate devices through bench testing and material science principles, not through AI performance or diagnostic accuracy studies.

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The PULLUP® device is designed to be used as juxtacortical fixation for ACL reconstruction.

The PULLUP® Adjustable Juxtacortical Fixation Device consists of an adjustable nonabsorbable braided loop and titanium button. The system is preloaded with traction threads. The PULLUP® Adjustable Juxtacortical Fixation Device is available in 2 versions: -PULLUP® for cortical tunnels having a diameter of 4.5 mm - PULLUP®XL for cortical tunnels having a diameter between 5 and 10 mm - The implant is supplied sterile, ready to use.

The provided document is a 510(k) premarket notification for a medical device called the PULLUP® Adjustable Juxtacortical Fixation Device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical trial to establish safety and effectiveness from scratch.

Therefore, the document does not contain the detailed information on acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device, clinical trial, or diagnostic test. Instead, it demonstrates the device's performance through non-clinical performance testing to establish equivalence to predicate devices.

Here's an analysis based on the information available in the document, framed against your requested categories, with explanations for what is not present:

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

The document does not provide a formal table of acceptance criteria with corresponding performance metrics in the way one would expect for an AI/ML device or a clinical outcome study. Instead, it makes a general statement about non-clinical performance testing:

The "non-clinical performance testing" would typically involve bench testing for mechanical properties (e.g., strength, fatigue, pull-out force) designed to show equivalence to the predicate devices. The specific metrics, thresholds, and results of these tests are not provided in this summary.

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 applicable and therefore not provided. The document states, "No clinical data has been presented." The performance testing mentioned is non-clinical (i.e., bench testing, not human patient 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)

This information is not applicable. Since no clinical data or human-interpreted data is referenced, there's no ground truth established by experts in this context.

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

This information is not applicable, as there is no human interpretation of data requiring 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

This information is not applicable. The device is a mechanical fixation device, not an AI/ML diagnostic or assistive tool.

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

This information is not applicable. The device is a mechanical fixation device; there is no algorithm involved.

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

For the non-clinical performance testing, the "ground truth" would be established by validated engineering test methods and relevant ASTM/ISO standards for mechanical testing of orthopedic implants. This often involves measuring parameters like tensile strength, cyclic loading, and pull-out strength, comparing the results of the new device against the known performance of the predicate devices under identical test conditions. Specific details are not disclosed in this summary.

8. The sample size for the training set

This information is not applicable. There is no AI/ML algorithm requiring a training set.

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

This information is not applicable. There is no AI/ML algorithm requiring a training set.

In summary: The provided 510(k) summary is for a physical medical device. It relies on non-clinical performance testing to demonstrate substantial equivalence to predicate devices (Arthrex TightRope RT and Biomet ToggleLoc System) in terms of safety and effectiveness. It explicitly states that "No clinical data has been presented." Therefore, the detailed information requested regarding AI/ML device studies, human readers, ground truth establishment by experts, and clinical trial specifics (like sample size, data provenance, adjudication) is not relevant or available in this document.

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