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The Knotilus+ PEEK Knotless Anchor is intended to be used for soft-tissue to bone fixation in the shoulder, foot and ankle, knee, hand and wrist, elbow, and hip in skeletally mature pediatric and adult patients. It is indicated for use in the following procedures:

2.4x11.3mm, 2.9x12.5mm, and 2.9x15.5mm:

Shoulder: Rotator Cuff Repair. Bankart Repair. SLAP Lesion Repair. Biceps Tenodesis. Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift, or Capsulolabral Reconstruction Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament and Tendon Repair Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand and /Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair Hip: Acetabular Labral Repair

2.4x8.9mm:

Hip: Acetabular Labral Repair

The Knotilus+ PEEK Knotless Anchors (herein referred to as the subject device(s)) are bone anchors with a push-in mechanism. The subject device system is comprised of a poly-ether-etherketone (PEEK) eyelet and anchor, pre-assembled onto a disposable stainless-steel inserter, which enables insertion of the anchor into bone after creation of a pilot hole. The devices are single use, provided sterile, and are packaged in sterile barrier systems (SBS).

The provided text is a 510(k) premarket notification clearance letter for the Stryker Endoscopy Knotilus+ PEEK Knotless Anchor. It details the device's intended use, regulatory classification, and a summary of performance testing and conclusions regarding its substantial equivalence to predicate devices. However, the document does not contain the kind of detailed information typically found in a study report for an AI/software device, such as specific acceptance criteria for performance metrics, detailed sample sizes for training or test sets, data provenance, expert qualifications, adjudication methods, or MRMC study results.

The device in question, the Knotilus+ PEEK Knotless Anchor, is a physical medical device (a bone anchor) and not an AI or software-driven device. Therefore, the questions related to AI/software performance criteria, ground truth, expert adjudication, and MRMC studies are not applicable to this submission.

Here's a breakdown of the information that can be extracted relevant to the device and its testing, and why other requested information is not present:

1. Table of acceptance criteria and the reported device performance

Study that proves the device meets the acceptance criteria:

The document states: "Non-clinical benchtop testing was performed to evaluate the performance characteristics of the Knotilus+ PEEK Knotless Anchor, including ultimate tensile strength (UTS) and insertion testing." It also mentions "Bacterial endotoxin testing was performed on the Knotilus+ PEEK Knotless Anchor".

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) summary. These details are typically found in a full test report, which is not part of this clearance letter. Given this is a physical device, "data provenance" like country of origin for clinical data or retrospective/prospective studies is generally not applicable to bench testing, which uses manufactured device samples.

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 is not applicable as this is a physical medical device, not an AI/software device requiring "ground truth" established by human experts in the context usually meant for AI. The performance testing (tensile strength, insertion, endotoxin) are objective measurements performed in a laboratory setting according to engineering and bioload testing standards.

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

Not applicable for a physical medical device. Adjudication methods are relevant for subjective assessments, often in clinical trials or AI performance evaluations, not for objective benchtop engineering tests.

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. MRMC studies are used to evaluate diagnostic imaging systems or AI software performance in clinical settings. This device is a surgical implant, and no such study type would be relevant to its clearance.

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

Not applicable. This is not an algorithm or software device.

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

Not applicable. For physical benchtop testing, the "ground truth" is typically the quantitative measurement obtained through calibrated testing equipment using established engineering and material science methodologies. For example, the "ground truth" for ultimate tensile strength is the physical force recorded by the testing machine at the point of failure.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable. This is a physical device, not an AI model requiring a training set and associated ground truth establishment.

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The HEALIX ADVANCE SP PEEK Anchor is indicated for use in the following procedures for reattachment of soft tissue to bone:
• Shoulder: Rotator cuff repair, biceps tenodesis, deltoid repair
• Knee: Posterior oblique repair, medial collateral ligament (MCL) reconstruction, lateral collateral ligament reconstruction, iliotibial (IT) band tenodesis
• Foot/Ankle: Achilles tendon repair

The HEALIX ADVANCE SP PEEK Anchor is a two-piece “self-punching” design consisting of a cannulated, threaded anchor and dilator which are permanently implanted into the body. The anchor-dilator are preloaded on a disposable inserter shaft with handle, held in place by a non-absorbable stay suture comprised of Ultra-High Molecular Weight Polyethylene (UHMWPE) and Green poly (ethylene terephthalate) (PET). During implantation the stay suture may be discarded or incorporated into the repair at the surgeon's discretion. The proposed HEALIX ADVANCE SP PEEK Anchor is offered in two sizes, 4.9 mm and 5.5 mm and is molded from Polyetheretherketone (PEEK) material. The HEALIX ADVANCE SP PEEK Anchor is provided sterile via Ethylene Oxide (EO) sterilization and is for single use only.

Here's an analysis of the provided text regarding the HEALIX ADVANCE™ SP PEEK Anchor, focusing on acceptance criteria and supporting studies.

Based on the provided FDA 510(k) summary for the HEALIX ADVANCE™ SP PEEK Anchor, the device is a medical implant, and the approval process primarily focuses on engineering and biocompatibility performance testing rather than AI/machine learning performance. Therefore, many of the requested categories related to AI/ML studies (such as MRMC, standalone algorithm performance, number of experts for ground truth, sample size for training set, etc.) are not applicable to this specific device and submission.

The acceptance criteria here concern the mechanical integrity, sterility, and biocompatibility of the anchor.

Acceptance Criteria and Reported Device Performance

Details Regarding the Study/Testing:

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

   • The 510(k) summary does not specify the exact number of samples (e.g., how many anchors were tested for fixation strength, how many were subjected to cyclic migration). This information would typically be detailed in the full test reports submitted to the FDA, but is summarized here.
   • Data Provenance: The device is manufactured by Medos International SARL in Switzerland (CH 2400, Switzerland), though the submitter is DePuy Synthes Mitek in Massachusetts, USA. The testing would have been conducted by the manufacturer or a contracted lab. The studies are non-clinical (benchtop and lab-based), not human subject data. Therefore, concepts like country of origin for data (in a clinical sense) or retrospective/prospective are not directly applicable.

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

   • Not Applicable. For this type of medical device (suture anchor), "ground truth" is established by engineering standards, material specifications, and validated test methods, not by expert interpretation of clinical data in the way one would for an AI diagnostic algorithm. The "experts" involved would be engineers, materials scientists, and quality assurance specialists.

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

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where subjective interpretation is involved. For engineering performance testing, the results are quantitative and objective, based on validated test protocols and measuring equipment.

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 device is a mechanical implant, not an AI diagnostic tool. MRMC studies are used to evaluate diagnostic imaging devices or AI algorithms that assist human interpretation.

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

   • Not Applicable. This device is a mechanical implant with no AI component, so there is no algorithm to test in a standalone manner.

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

   • For mechanical performance tests (fixation strength, torque, migration): The "ground truth" is determined by engineering specifications and validated biomechanical test methods that simulate physiological loads. The objective is to demonstrate that the device meets predefined mechanical thresholds and performance characteristics.
   • For sterilization and biocompatibility: The "ground truth" is established by international standards (ISO, AAMI) and regulatory guidelines (USP, EP), which define acceptable levels for sterility, endotoxin, and material safety.

7. The sample size for the training set:

   • Not Applicable. This device does not use machine learning or AI, so there is no "training set."

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

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

In summary, the HEALIX ADVANCE™ SP PEEK Anchor is a conventional medical device whose substantial equivalence and safety/effectiveness are demonstrated through non-clinical engineering, material, and sterilization testing, not through AI/ML performance studies or clinical reader studies.

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SECULOK™ Suture Anchor is for fixation or reattachment of soft tissue including ligament and tendon to bone especially with below indications.

• Shoulder:
  Bankart repair, SLAP lesion repair, Acromio-Clavicular separation repair, Rotator Cuff repair, Capsular shift or Capsulolabral reconstruction, Biceps tenodesis, Deltoid repair.

• Foot/Ankle:
  Medial or lateral stabilization, Achilles tendon repair.

• Elbow/Wrist/Hand:
  Ulnar or Radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment.

• Knee:
  Extra-capsular repairs: Medial/lateral ligament repair, posterior oblique ligament repair, Iliotibial band tenodesis Patellar realignment and tendon repairs : Vastus medialis obliquous advancement

The SECULOK™ Suture Anchor consists of two types, Suture Anchor and Knotless Anchor.

The Suture Anchor is an implant used for fixation of sutures into bone. The implant is made of PEEK (ASTM F2026) and works with preloaded 1 ~ 3 USP#2 size sutures (Ultra High Molecular Weight Polyethylene(UHMWPE, ASTM F2848)). The Suture Anchor is provided sterile as single package including the implant and inserter for users to use without additional process of sterilization in hospitals.

The Knotless Anchor is an implant used for fixation of sutures into bone. The implant is made of PEEK (implant body) and Titanium alloy (tip, ASTM F136) and fixate the USP #2 sutures without knotting. The Knotless Anchor is provided sterile as single package including the implant and inserter for users to use without additional process of sterilization in hospitals.

The SECULOK™ Suture Anchor comes preloaded on a disposable inserter made from surgical grade stainless steel and ABS plastic. The entire product is packaged in a box with a Tyvek® lid, and blister the finished product is sterilized by ethylene oxide. Both the implant, suture and inserter are designed for single use only and supplied non-pyrogenic.

Based on the provided text, the document describes a 510(k) premarket notification for the SECULOK™ Suture Anchor, demonstrating its substantial equivalence to predicate devices through performance testing.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that the acceptance criteria for performance testing were developed using data from the primary predicate devices: CrossFT BC Suture Anchor (K101100) and PushLock™ (K101679). The reported device performance is that "The all tests met all acceptance criteria and that verifies performance of the SECULOK™ Suture Anchor is substantially equivalent to predicate devices."

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

The document refers to "non clinical setting (bench testing)" for performance testing. It does not explicitly state the sample size used for each specific test or the "test set" in terms of data provenance (e.g., country of origin, retrospective/prospective). This information is typically detailed in the full test reports that support the 510(k) submission, but it's not present in this summary.

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

This section is not applicable to this type of submission. The performance testing described is bench testing of the physical device's mechanical properties, not a clinical study involving human or animal subjects where expert ground truth would be established for diagnoses or assessments. The "ground truth" for these tests is based on established engineering standards (ASTM, USP) and mechanical properties of predicate devices.

4. Adjudication Method for the Test Set:

This section is not applicable. Since the testing is bench testing of mechanical properties, no adjudication by human experts is involved. The results are quantitative measurements against defined criteria.

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 section is not applicable. The SECULOK™ Suture Anchor is a physical medical device (suture anchor), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance for human readers would not be relevant.

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

This section is not applicable. As explained above, the SECULOK™ Suture Anchor is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used:

For the performance testing, the "ground truth" is established by:

• Established engineering standards: ASTM F543-17 for torsional properties and driving torque, USP 29 for suture tensile strength.
• FDA guidance documents: Premarket Notification (510(k)) Submissions for Bone Anchors Draft Guidance (January 3, 2017) for axial pullout strength and fatigue tests.
• Mechanical performance data of legally marketed predicate devices: CrossFT BC Suture Anchor (K101100) and PushLock™ (K101679). The acceptance criteria were specifically "developed using the data of the primary predicate."

8. The Sample Size for the Training Set:

This section is not applicable. There is no "training set" in the context of this device and the described performance testing. Training sets are typically associated with machine learning or AI algorithm development, which is not relevant here.

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

This section is not applicable for the same reasons as point 8.

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The Stryker All-PEEK Knotless Anchor System is intended to be used for soft-tissue to bone fixation in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip.

It is indicated for use 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, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair and Bunionectomy

Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Secondary Fixation for ACL/PCL Reconstruction or Repair

Hand/Wrist: Scapholunate Ligament Reconstruction. Ulnar or Radial Collateral Ligament Reconstruction

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Reconstruction, Lateral Epicondylitis Repair

Hip: Capsular Repair, Acetabular Labral Repair

The Stryker All-PEEK Knotless Anchor System (herein referred to as the proposed device(s)) consists of poly-ether-ether-ketone (PEEK) cannulated screws with a separate eyelet. The anchor system is designed for insertion of the eyelet and screw into bone either directly or by using instrumentation for creation of a pilot hole. Alternatively, screws may be used without the eyelet for suture fixation in a pre-drilled pilot hole by means of a cannulated screwdriver. Screws and eyelets may be provided either preloaded on respective disposable screwdrivers and inserters, or separately for manual loading. A suture threader is included with the eyelet inserter to facilitate loading of suture through the eyelet. Anchor systems are provided sterile and are packaged in single-use sterile barrier systems (SBS) that include one or more screws with or without evelets.

This document describes the premarket notification (510(k)) for the Stryker All-PEEK Knotless Anchor System. Unlike AI/ML medical devices, this is a traditional medical device (an implantable anchor system), and as such, the information requested regarding AI/ML device testing (e.g., sample sizes for training/test sets, expert adjudication methods, MRMC studies, standalone performance, ground truth establishment) is not applicable.

The acceptance criteria and the study proving the device meets these criteria are focused on the mechanical and biocompatibility performance of the physical device.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state numerical acceptance criteria in a table format, but it describes the types of tests conducted and their qualitative outcomes. The primary performance characteristic evaluated for this type of device is its mechanical strength, specifically pull-out strength, and its biocompatibility.

Study Details (Applicable to Traditional Medical Devices)

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

   • Sample Size: Not explicitly stated. The document mentions "The proposed devices" and "predicate devices," implying multiple units were tested. The specific number of units tested for ultimate tensile strength, insertion, pyrogenicity, and endotoxins is not provided.
   • Data Provenance: The studies were benchtop non-clinical tests conducted by Stryker. There is no patient data involved, so concepts like "country of origin" or "retrospective/prospective" are not applicable.

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

   • This is not applicable for a traditional mechanical device. "Ground truth" in this context would be the objective measurement of physical properties (e.g., force in Newtons for pull-out strength) using validated test methods and equipment, not subjective expert assessment. The engineers and technicians performing the tests would be qualified in mechanical testing and material science.

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used for human-reviewed data (e.g., medical images). Here, the evaluation is based on objective, quantifiable physical measurements, not interpretation.

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

   • No, not applicable. MRMC studies are used for evaluating diagnostic or prognostic devices where human interpretation of data (e.g., images) is involved. This device is a surgical implant.

5. If a Standalone Performance Study (i.e. algorithm only without human-in-the-loop performance) was done:

   • No, not applicable. This refers to AI/ML algorithm performance. The "device" here is a physical implant. Its "standalone performance" is its mechanical integrity and biocompatibility, which was indeed evaluated in the benchtop studies.

6. The Type of Ground Truth Used:

   • The "ground truth" for this device's performance is objective physical and chemical measurements obtained through standardized engineering and biocompatibility testing. For instance, the "ground truth" for pull-out strength would be the measured force required to pull out the anchor from a bone substitute, compared against a validated standard or predicate device performance. For biocompatibility, it's the measured levels of pyrogens and endotoxins against established thresholds.

7. The Sample Size for the Training Set:

   • Not applicable. There is no "training set" as this is not an AI/ML device.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable.

Conclusion

The acceptance criteria for the Stryker All-PEEK Knotless Anchor System, as presented in the 510(k) summary, revolve around demonstrating substantial equivalence to an existing predicate device based on its intended use, indications for use, material composition, general design, operational principle, and crucially, equivalent or superior mechanical and biocompatibility performance through non-clinical benchtop testing. The document states that the proposed device demonstrated "equivalent or higher pull-out strength to the predicate devices" and passed biocompatibility tests, indicating it met the necessary performance criteria for 510(k) clearance.

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