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The Aevumed PHANTOM™ Suture Anchors are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clabicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all Digits, Digital Tendon Transfers

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Hip: Capsular repair, Acetabular Labral Repair

The Aevumed PHANTOM™ Sutures Anchor with HS Fiber™ suture is a suture anchor manufactured from polyetheretherketone (PEEK) material and are preloaded on a disposable inserter assembly intended for fixation of soft tissue to bone. The Aevumed PHANTOM™ Suture Anchors are available in diameter sizes: 3.5mm and 4.5mm. They are offered sterile and are for single use only.

The document provided is an FDA 510(k) clearance letter for the Aevumed PHANTOM Suture Anchors. This type of device (a bone fixation fastener) is a physical implant and not an AI/ML-driven diagnostic or assistive technology. Therefore, the questions related to AI/ML device performance (such as acceptance criteria for AI performance, sample size for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment for training and test sets, and training set size) are not applicable to this submission.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Aevumed RAPID Suture Anchors, K223878) based on non-clinical performance and material characteristics, rather than diagnostic accuracy or AI effectiveness.

Here's an analysis based on the information provided, tailored to a medical device clearance:

1. Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study conducted was a non-clinical mechanical testing study. This involved direct comparative testing of the Aevumed PHANTOM™ Suture Anchor against its primary predicate device, the Aevumed RAPID™ Suture Anchor (K223878).

• Tests performed: Insertion testing, cyclic tensile testing, and static tensile testing.
• Key finding: The Aevumed PHANTOM™ Suture Anchor demonstrated "significantly higher pullout strength" in comparison to the predicate RAPID™ Anchor.
• Conclusion drawn: The data supports the relative safety of the device and demonstrates that it performs as intended and comparably (or superiorly in key mechanical aspects) to the predicate device.

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

• Sample Size: The document does not specify the exact number of devices (suture anchors) used in the non-clinical mechanical tests. These tests typically involve a statistically significant number of samples to ensure repeatability and reliability of the results.
• Data Provenance: The data is generated from laboratory-based non-clinical mechanical testing. This means the "data provenance" isn't in terms of patient population (e.g., country of origin, retrospective/prospective) but rather controlled experimental conditions.

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

• Not Applicable. For a physical medical device like a suture anchor, "ground truth" for non-clinical mechanical testing is established by engineering standards and validated testing methodologies, not by expert interpretation of patient data or images. The "ground truth" would be the measured physical properties (e.g., pullout strength).

4. Adjudication Method for the Test Set:

• Not Applicable. As mentioned above, this device does not involve human interpretation of data for its primary evaluation for 510(k) clearance. Mechanical tests have quantitative outputs, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• No. An MRMC effectiveness study is relevant for diagnostic imaging or AI-assisted diagnostic devices where human readers interpret cases. This is not applicable to a physical implantable device like a suture anchor.

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

• Not Applicable. This is not an algorithm-based device.

7. The Type of Ground Truth Used:

• The "ground truth" for demonstrating substantial equivalence for this device is based on objective engineering and mechanical performance data (e.g., measured pullout strength, tensile strength, and material properties) obtained from non-clinical laboratory testing, alongside adherence to established standards for biocompatibility and sterilization.

8. The Sample Size for the Training Set:

• Not Applicable. This device is not an AI/ML model, so there is no "training set."

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

• Not Applicable. There is no training set for this type of device.

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Iconix Speed Anchors are intended to be used for soft-tissue to bone fixation in the shoulder. They are indicated for use in rotator cuff repair.

The Iconix Speed Anchors are soft-tissue to bone fixation devices, provided preloaded on a disposable self-punching inserter. The device is composed of a braided polyester anchor body that contains two or three working sutures. The anchor is inserted into the bone using a self-punching mechanism, and the polyester sheath bunches as the anchor is deployed to allow for fixation in bone.

Sutures supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. Suture dyes are FDA approved. The inserters are comprised of metallic shaft with over molded handle. The device is sterilized by ethylene oxide gas and is provided sterile for single use. Iconix Speed Anchors are available in common sizes and lengths and will be sold sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.

The classification for the Iconix Anchor is FDA Class II device with product classification 21 CFR §888.3040: Smooth or threaded metallic bone fixation fastener, Product Code MBI.

The provided FDA 510(k) clearance letter and summary for the Iconix Speed Anchor does not describe a study that involves software performance, AI algorithms, or human-in-the-loop assessments. Instead, it describes mechanical and biological performance testing for a physical medical device (bone anchor).

Therefore, I cannot provide details for most of your requested points, as they are specific to AI/software device studies.

However, I can extract the information related to the device's performance testing and acceptance criteria as described in the document.

1. Table of Acceptance Criteria and the Reported Device Performance

The 510(k) summary states that "Results of performance testing for the Iconix Speed Anchor device concluded that the device performed comparably to the predicate device in insertion, cyclic and pullout testing and the validations performed demonstrated that the Iconix Speed Anchor met all requirements for its intended use."

However, the document does not explicitly state specific quantitative acceptance criteria (e.g., "pullout strength > X N") or the exact reported performance values for the Iconix Speed Anchor in these tests. It only states that the device performed "comparably" to the predicate.

The following information cannot be provided as the provided document describes a physical medical device (bone anchor), not an AI/software device study.

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" in this context refers to physical units of the device subjected to mechanical and biological testing, not a dataset for an AI model. The document does not specify the number of samples for each mechanical test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's mechanical performance is typically established through direct physical measurement under controlled conditions, not expert consensus.
4. Adjudication method: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For mechanical tests (insertion, cyclic, pullout), the "ground truth" is the measured physical performance of the device. For biological tests, it's compliance with ISO standards. For usability, it's observation in cadaveric models.
8. The sample size for the training set: Not applicable. The device is a physical product, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

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The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures.

The OTS 25-L All-Suture Anchors may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, both may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In conjunction with appropriate postoperative immobilization throughout the healing period, the suture anchor system stabilizes the damaged soft tissue.

OTS 25-L is an all-suture anchor. It is a soft-tissue fixation device with an expandable push-in design, provided preloaded on a disposable inserter. The device is constructed of a flat suture sleeve that is interlaced longitudinally along its central width by two #2 suture strands. The flat suture sleeve and the double loaded suture strands are folded back on themselves at the distal end of the disposable inserter. The device consists of the following components and accessories: non-absorbable, single use, suture anchor is made of a braided polyester sleeve; inserter; drill bit; and drill guide are made of stainless steel; and drill guide obturator is made of polypropylene.

The disposable inserter has a stainless-steel shaft supporting a forked shaped tip, with a handle, and is provided sterile, for single use.

The provided document is an FDA 510(k) clearance letter for a medical device called "OTS 25-L (100-5)". This letter does not contain any information about the acceptance criteria or reported performance for a software or AI/ML device.

Instead, the document describes a physical medical device (a smooth or threaded metallic bone fixation fastener, specifically an all-suture anchor) and its non-clinical testing for substantial equivalence to a predicate device. The change in this submission (K251310) is a labeling change to allow the device to be packed with autologous bone marrow.

Therefore, I cannot provide the requested information for an AI/ML device based on this input. The output would be:

Based on the provided FDA 510(k) clearance letter for the OTS 25-L (100-5) medical device, there is no information regarding acceptance criteria or a study that proves a software or AI/ML device meets acceptance criteria. The document describes a physical medical device (an all-suture anchor) and its non-clinical testing to support a labeling change.

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The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) to bone in the elbow, shoulder, hand/wrist, foot/ankle, knee, and hip the following procedures:

• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty)
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-Foot Reconstruction
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
• Hip: Acetabular Labral Repair and Reconstruction

The fundamental technology of the Arthrex FiberTak Suture Anchors is that the Arthrex FiberTak Anchors are "all-suture" soft-tissue fixation devices with a push-in design. The subject device is FiberTak Anchor with 1.3 mm SutureTape (White/Blue) and is a knotted FiberTak with a Polyester Sheath and a Polyester/UHMWPE repair suture.

The subject device is preloaded on a disposable inserter, which facilities deployment. The subject anchor and connected sutures are impacted into a pilot hole. The suture is then manually tensioned to set the anchor by "bulging/bunching" the suture sleeve within the pilot hole. Once the anchor is set, the suture is passed around the soft tissue and is fixated via its surgical technique. The device is provided sterile and is intended for single-use.

The provided FDA 510(k) Clearance Letter concerns a physical medical device (suture anchor) and not an AI/Software as a Medical Device (SaMD). Therefore, the questions related to AI acceptance criteria, training sets, ground truth establishment by experts, MRMC studies, and stand-alone algorithm performance are not applicable to this document.

The clearance for the Arthrex FiberTak Suture Anchor is based on substantial equivalence to existing predicate devices, primarily demonstrated through performance testing rather than clinical study data from image analysis or diagnostic tasks.

Here's an analysis of the provided text based on the nature of the device:

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):

• Sample Size: Not specified in the provided text. The document states "Straight Pull testing... was conducted." For mechanical testing, the "sample size" would refer to the number of anchors tested, which is typically outlined in the test report referenced (ASTM F3690).
• Data Provenance: Not specified. It's likely that the testing was performed in a lab setting (in vitro) to regulatory standards (ASTM F3690). This is not retrospective or prospective clinical data.

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

• Not Applicable. This is a physical device clearance based on mechanical testing and substantial equivalence, not on diagnostic accuracy established by expert consensus. There is no "ground truth" established by experts in the context of image interpretation or diagnosis.

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

• Not Applicable. As per point 3, there is no expert panel or image interpretation data that would require 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:

• Not Applicable. This is not an AI-assisted diagnostic device.

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

• Not Applicable. This is not an algorithm.

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

• The "ground truth" in this context refers to the objective mechanical performance characteristics of the device (e.g., force at failure, displacement) as measured by standardized engineering tests (e.g., ASTM F3690). The "truth" is derived from these empirical measurements, not expert interpretation of clinical data.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not a machine learning model.

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

• Not Applicable. There is no "training set" or "ground truth" in the context of machine learning for this device.

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The Arthrex PushLock Suture Anchors (2.9 - 4.5 mm) are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Hand/Wrist: Scapholunate Ligament Reconstruction, UInar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis repair.

Hip: Capsular repair (2.9 x 15.5 - 24 mm only), acetabular labral repair.

The Arthrex PushLock Suture Anchors (2.5 mm) are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder. Specific indications are listed below:

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

The Arthrex Short Suture Anchors (2.0 - 2.4 mm) are intended to be used for suture (soft tissue) fixation to bone in the hip. Specifically, acetabular labral repair.

The Arthrex Self-Punching PushLock Suture Anchors (3.5 mm) are intended to be used for suture (soft tissue) fixation to bone in the shoulder:

Shoulder: Rotator Cuff Repair

The Arthrex PushLock Suture Anchor is a two piece "push-in" suture anchor device comprised of a polyetheretherketone (PEEK) anchor body with a polyetheretherketone (PEEK) eyelet pre-loaded on a disposable inserter. The anchors are threaded and range from 2.0 mm to 4.5 mm in diameter and 8.6 mm to approximately 24 mm in length. The device is sold sterile and is single-use.

The Arthrex Self-Punching PushLock Suture Anchor is a "push-in" suture anchor comprised of a polyetheretherketone (PEEK) anchor body with a polyetheretherketone (PEEK) eyelet pre-loaded on a disposable inserter. The anchor body is fully threaded and barbed. The anchor is 3.5 mm in diameter and 19.8 mm in length. The device is sold sterile and is single-use.

The provided FDA 510(k) clearance letter describes a medical device, the Arthrex PushLock Suture Anchors, and its substantial equivalence to predicate devices, rather than a study proving the device meets performance criteria for an AI/CADe device. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth for an AI/CADe system cannot be extracted directly from this document.

However, I can extract information related to the device itself and the types of performance testing conducted to demonstrate its safety and effectiveness relative to its predicates.

Here's a breakdown of the available information based on your request, with an emphasis on what can be extracted and what cannot from this specific document:

Device Name: Arthrex PushLock Suture Anchors
K Number: K251145

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

This document does not specify quantitative acceptance criteria or detailed reported performance values for an AI/CADe system. Instead, it focuses on demonstrating substantial equivalence to predicate devices for a physical orthopedic implant. The performance data mentioned are general categories of testing for such devices.

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 provided in the 510(k) clearance letter. The document mentions "product functionality... sterilization validation, biological safety evaluation and temperature study testing," but does not detail the sample sizes for these tests, nor their provenance in terms of patient data. These tests are typically conducted on the physical device itself or its materials, not on clinical datasets in the way an AI/CADe study would use.

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 and not provided. This clearance is for a physical medical device (suture anchor), not an AI/CADe system that requires expert interpretation for ground truth establishment.

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

This information is not applicable and not provided for the reasons stated above.

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 and not provided. An MRMC study is relevant to AI/CADe systems, not a physical implant like a suture anchor.

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

This information is not applicable and not provided.

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

This information is not applicable in the context of an AI/CADe device's ground truth. For the Arthrex PushLock Suture Anchors, "ground truth" would relate to its physical properties, biocompatibility, and mechanical performance, which are evaluated through standardized test methods (e.g., ASTM standards) rather than expert consensus on clinical data or pathology reports. The document mentions "product functionality," "biological safety evaluation," and "sterilization validation," implying the use of established scientific and engineering principles for evaluation.

8. The sample size for the training set

This information is not applicable and not provided. There is no AI/CADe system being trained with clinical data.

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

This information is not applicable and not provided.

Summary of what the document does convey about the study (testing) conducted:

The submission aimed to obtain FDA clearance for the Arthrex PushLock Suture Anchors, sterilized using the Arthrex X-ray radiation sterilization process. The core of the "study" for this type of device is demonstrating substantial equivalence to existing legally marketed predicate devices.

The performance data supplied consisted of:

• Product functionality (including accelerated aging)
• Product induced radiation
• Sterilization validation
• Biological safety evaluation
• Temperature study testing

These tests compared the subject device to several predicate and reference devices, confirming that the new device, particularly with its new sterilization process, performs equivalently in terms of safety and effectiveness. The conclusion states that "Any differences between the Arthrex PushLock Suture Anchors and the predicate devices are considered minor and do not raise different questions of safety or effectiveness."

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The Smith & Nephew BIORAPTOR◊ Suture Anchor is indicated for the reattachment of soft tissue to bone for the following indications:

Hip:

• Hip Capsule Repair
• Acetabular labrum reattachment/reconstruction

Shoulder:

• Capsular stabilization
• Bankart repair
• Anterior shoulder instability
• SLAP lesion repairs
• Capsular shift or capsulolabral reconstructions
• Acromioclavicular separation repairs
• Deltoid repairs
• Rotator cuff tear repairs
• Biceps tenodesis

Foot and Ankle:

• Hallux valgus repairs
• Medial or lateral instability repairs/reconstructions
• Achilles tendon repairs/reconstructions
• Midfoot reconstructions
• Metatarsal ligament/tendon repairs/reconstructions
• Bunionectomy

Elbow, Wrist, and Hand:

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

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

Smith & Nephew BIORAPTOR◊ Curved 2.3 PK Suture Anchors are indicated for the reattachment of soft tissue to bone for the following indications:

Shoulder:

• Capsular stabilization
• Bankart repair
• Anterior shoulder instability
• SLAP lesion repairs
• Capsular shift or capsulolabral reconstructions
• Acromioclavicular separation repairs
• Deltoid repairs
• Rotator cuff tear repairs
• Biceps tenodesis

Foot and Ankle:

• Hallux valgus repairs
• Medial or lateral instability repairs/reconstructions
• Achilles tendon repairs/reconstructions
• Midfoot reconstructions
• Metatarsal ligament/tendon repairs/reconstructions
• Bunionectomy

Elbow, Wrist, and Hand:

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

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

The Smith & Nephew BIORAPTOR◊ Suture Anchor is intended for the reattachment of soft tissue to bone.

The Smith & Nephew BIORAPTOR◊ Curved 2.3 PK Suture Anchor is intended for the reattachment of soft tissue to bone.

The Smith & Nephew BIORAPTOR 2.3 PK and BIORAPTOR Curved 2.3 PK Suture Anchors are fixation devices intended to provide secure attachment of soft tissue to bone. The devices consist of a suture anchor with attached non-absorbable suture(s) preassembled to an insertion device. The BIORAPTOR Curved 2.3 PK Suture Anchors are preassembled to a flexible insertion device.

The provided FDA 510(k) clearance letter and summary for the BIORAPTOR Suture Anchors primarily focus on demonstrating substantial equivalence to a predicate device, particularly concerning a packaging modification. As such, the document does not contain the typical acceptance criteria and detailed study data (like sample size, expert consensus, MRMC studies, etc.) that would be found in a submission for a novel or significantly modified AI/medical imaging device.

The "Performance Data" section specifically mentions non-clinical testing related to the packaging modification. Therefore, I will extract information related to these non-clinical tests and frame them as 'acceptance criteria' and 'reported performance' for the device's packaging.

Here's the breakdown based on the provided document:

Acceptance Criteria and Device Performance for BIORAPTOR Suture Anchors (Packaging Modification)

The described study proves that the modified packaging for the BIORAPTOR Suture Anchors meets the acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document states "Non-clinical testing was completed on the subject device for the proposed packaging modification," but does not specify the exact sample size used for these tests.
• Data Provenance: The tests are non-clinical, conducted by the manufacturer (Smith & Nephew, Inc.). The document does not specify the country of origin for the data beyond the company's US headquarters (Andover, MA). These were likely prospective tests performed on the new packaging design.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• This information is not applicable to the type of non-clinical, packaging-related testing described. There is no 'ground truth' in the clinical sense (e.g., diagnosis, pathology) that requires expert consensus. The "ground truth" here is the adherence to engineering specifications and performance standards for packaging.

4. Adjudication Method for the Test Set

• This information is not applicable as the testing is engineering/laboratory-based for packaging performance, not clinical interpretation of data that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC study was not done. This type of study is relevant for AI/imaging devices where human readers interpret diagnostic images, often with and without AI assistance. The device in question is a physical suture anchor, and the described studies are non-clinical evaluations of its packaging.

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

• Not applicable. This concept applies to AI algorithms. The described studies are physical tests of a medical device's packaging.

7. The Type of Ground Truth Used

• The "ground truth" for these non-clinical tests is based on pre-defined engineering specifications and performance standards for medical device packaging (e.g., ISO or ASTM standards for sterile barrier systems, shelf life, and shipping integrity). It is not clinical ground truth like pathology or outcomes data.

8. The Sample Size for the Training Set

• Not applicable. This concept applies to machine learning models. The tests performed are physical, non-clinical evaluations related to manufacturing and packaging.

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

• Not applicable. This concept applies to machine learning models.

Summary of Limitations Based on Document Content:

The provided document details a 510(k) submission for a suture anchor with a packaging modification. The testing described is therefore focused on demonstrating that this packaging change does not compromise the device's safety, effectiveness, or equivalence to its predicate. The detailed information typically requested for AI/software devices (like expert consensus, MRMC studies, training data details) is not relevant or present in this type of submission for a physical, mechanical device's packaging.

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The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures.

The CONMED Argo Knotless® Anchor may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged tissue, in conjunction with appropriate postoperative immobilization throughout the healing period.

The CONMED Argo Knotless® Anchor is an implantable bone anchor, that is supplied single use, sterilized via ethylene oxide (ETO) to a SAL of 10⁻⁶. The threaded anchor and the suture eyelet are manufactured of PolyEtherEtherKetone (PEEK) material. Each size features a single use driver, a threaded anchor, suture eyelet, a 1.0mm UHMWPE Hi-Fi™, non-absorbable retention suture, and loader tab. The retention suture holds the PEEK eyelet in place on the driver and can be incorporated into the repair if desired. A maximum of six (6) Hi-Fi #2 suture, or 1.3mm Hi-Fi ribbon suture, or (2) two limbs of Hi-Fi tape, or one (1) bioresorbable reinforced implant can be threaded through the eyelet. The repair sutures are then tensioned and cleated on the driver cleat, if deemed necessary by the surgeon. These anchor configurations require a pre-prepared bone hole which can be created with Class I, Exempt instrumentation.

The provided FDA 510(k) clearance letter pertains to the CONMED Argo Knotless® Anchor, a medical device for reattaching soft tissue to bone. This document is a clearance letter, not a detailed study report. Therefore, it does not contain the level of detail typically found in a clinical study for AI/software devices. In particular, it does not include any information about AI or software, MRMC studies, or standalone algorithm performance. The acceptance criteria and performance data described relate to the mechanical and material properties of the physical medical device.

Here's an analysis of the provided information based on your questions:

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

The document does not explicitly state quantitative acceptance criteria for each test. Instead, it indicates that "Testing has been completed to demonstrate that CONMED Argo Knotless® Anchor performs as intended and is substantially equivalent to the predicate device." The performance data is summarized by the types of tests conducted.

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

The document does not specify specific sample sizes for any of the performance tests (e.g., insertion, pull displacement, cyclic loading).
The data provenance is from CONMED Corporation, the manufacturer, as part of their 510(k) submission. These are typically retrospective in the sense that the device has been manufactured and tested, and the results are then compiled for the submission. The tests are likely performed in a controlled laboratory or testing facility setting and do not involve human patient data in the context of device performance testing.

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

This question is generally applicable to AI/software performance where ground truth is established by human experts. For this physical device, the "ground truth" for mechanical properties is established through engineering standards and validated test methods. Therefore, experts would be engineers and technicians familiar with these standards and methods, but the document does not specify their number or qualifications beyond their implied role in executing the listed tests.

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

Not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies to resolve discrepancies in expert interpretations (e.g., radiology reads). For physical device performance testing, the results are typically quantitative and objective, measured against established engineering specifications, rather than subject to expert interpretation 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

Not applicable. This device is a physical medical implant, not an AI or software device. Therefore, MRMC studies and "human readers improving with AI assistance" are not relevant to this 510(k) submission.

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

Not applicable. As noted above, this clearance is for a physical medical device, not an AI algorithm.

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

The ground truth for the performance of this physical device is based on engineering specifications, industry standards (e.g., ISO 10993-1 for biocompatibility), and validated test methods. These tests establish whether the mechanical properties (insertion, pull displacement, cyclic loading) and material properties (biocompatibility, pyrogenicity) meet predetermined safety and performance benchmarks for orthopedic implants.

8. The sample size for the training set

Not applicable. This device is a physical medical device, not a machine learning model. Therefore, there is no "training set."

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

Not applicable. As there is no "training set" for a physical medical device, this question is not relevant.

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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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