Search Results

The VersaTap™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The VersaTap™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as:
• Shoulder: Rotator cuff repair, biceps tenodesis, SLAP repair, Bankart repair
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus
• Elbow: Tennis elbow repair
• Knee: Medial and lateral collateral ligament repair.
• Wrist: Scapholunate ligament reconstruction.

The VersaPEEK™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The VersaPEEK™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as:
• Shoulder: Rotator cuff repair, biceps tenodesis, SLAP repair, Bankart repair
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus
• Elbow: Tennis elbow repair
• Knee: Medial and lateral collateral ligament repair.
• Wrist: Scapholunate ligament reconstruction.

The MicroTi™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The MicroTi™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as:
• Elbow: Ulnar/Medial Collateral Ligament Repair
• Foot/Ankle: Achilles Tendon Repair, Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-foot Reconstruction, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
• Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/ Radial Collateral Ligament Reconstruction.

The VersaLat™ Ti Suture Anchor is intended to use for fixation of soft tissue and ligaments to bone/ healthy tissue during tendon and ligament repairs, during procedures such as:
• Shoulder: Rotator Cuff Repair, Biceps Tenodesis
• Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction.
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, and Iliotibial Band Tenodesis
• Foot/Ankle: Lateral stabilization, medial stabilization, Achilles tendon repair, mid-foot reconstruction, hallux valgus reconstruction, metatarsal ligament repair, metatarsal tendon repair, bunionectomy, and digital tendon transfers.

The VersaLat™ Suture Anchor is intended to use for fixation of soft tissue and ligaments to bone/ healthy tissue during tendon and ligament repairs, during procedures such as:
• Shoulder: Rotator Cuff Repair, Biceps Tenodesis
• Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction.
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, and Illiotibial Band Tenodesis.
• Foot/Ankle: Lateral stabilization, medial stabilization, Achilles tendon repair, mid-foot reconstruction, hallux valgus reconstruction, metatarsal ligament repair, metatarsal tendon repair, bunionectomy, and digital tendon transfers.

Device Description

The VersaTap™ Suture Anchor is a self-tapping suture anchor. This anchor is designed to combine the advantages of both PEEK and Titanium. The titanium tip makes the product self-tapping, whilst the majority of the anchor is manufactured from PEEK to minimize post-operative imaging effects.

The VersaPEEK™ Suture Anchor is manufactured completely from PEEK. This material composition minimizes post-operative imaging effects. The suture anchor is designed for ultimate mechanical properties (pullout strength, tensile strength, etc). The VersaPEEK™ Suture Anchor also has a variety of suture/suture tape configurations.

The MicroTiTM Suture Anchor is a small screw-in suture anchor used in a variety of small-joint applications. Despite its small diameter, the specially engineered thread combines with cortical bone to provide tremendous pull-out strength.

The VersaLat™ Ti Suture Anchor is a knotless-/suture anchor. This titanium screw-in anchor can be combined with the VersaTap™ Suture Anchor in double rotator cuff repair surgery. Flexibility is what differentiates this anchor from its competitors with surgeons being able to fixate any number of sutures/tapes (K150438) by adjusting the size of the characteristic front loop. The extra suture provided by this anchor can also be used for the fixation of the biceps tendon or any ligament fragments.

The VersaLat™ Suture Anchor is a knotless-/suture anchor. This titanium screw-in anchor can be combined with the VersaTap™ Suture Anchor in double rotator cuff repair surgery. Flexibility is what differentiates this anchor from its competitors with surgeons being able to fixate any number of sutures/tapes (K150438) by adjusting the size of the characteristic front loop. The extra suture provided by this anchor can also be used for the fixation of the biceps tendon or any ligament fragments.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for several suture anchor devices (VersaTap™, VersaPEEK™, MicroTi™, VersaLat™ Ti, and VersaLat™ Suture Anchors). This document focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical testing. It does not involve AI/ML technology, imaging, or human reader studies.

Therefore, many of the requested criteria, such as "acceptance criteria and reported device performance" in the context of an AI/ML study, "sample size for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," and "training set details," are not applicable to this type of submission.

The study described here is a mechanical and biocompatibility assessment of medical devices, not an AI/ML performance study.

Here's an adaptation of the requested information based on the provided document:

Acceptance Criteria and Study for Suture Anchors (Non-AI/ML Medical Device)

The provided submission, K242296, for the VersaTap™, VersaPEEK™, MicroTi™, VersaLat™ Ti, and VersaLat™ Suture Anchors, is a 510(k) Premarket Notification. The purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to prove performance of an AI/ML algorithm or derive clinical effectiveness from human reader studies.

The acceptance criteria and supporting studies are based on non-clinical testing to ensure the new devices are as safe and effective as their predicates.

1. Table of Acceptance Criteria (for Non-Clinical Testing) and Reported Device Performance

Acceptance Criteria Category	Specific Test/Requirement	Acceptance Criteria (Implicit)	Reported Device Performance and Conclusion
Mechanical Performance	Insertion Torque Testing	Performance comparable to or better than the predicate device to ensure proper implantation and stability.	Substantial equivalence supported by the results of mechanical testing, including insertion torque. The devices support safety and effectiveness. (Details not explicitly quantified in this summary, but determined to be acceptable).
	Static Pullout Testing	Performance comparable to or better than the predicate device to ensure adequate fixation strength.	Substantial equivalence supported by the results of mechanical testing, including static pullout. The devices support safety and effectiveness. (Details not explicitly quantified in this summary, but determined to be acceptable).
	Dynamic Pullout (Fatigue)	Justification for not performing dynamic pullout testing explicitly, demonstrating it's unnecessary to prove equivalence or safety.	Justification for dynamic pullout (fatigue) testing provided according to FDA guidance.
	Component Interconnection	Assurance of proper and secure connection of device components.	Justification for component interconnection provided.
	Corrosion Testing	Materials and design ensure resistance to corrosion in the body environment.	Justification for corrosion testing provided.
Biocompatibility	Material Composition	Materials must be biocompatible and safe for implantation, consistent with previously cleared devices. Performance must be non-pyrogenic.	Subject devices manufactured using the same approved suppliers, manufacturing facilities, processes, chemicals, materials, and cleaning processes as predicate devices. All materials and processes have been used in previously cleared devices. Tested to be non-pyrogenic. Biocompatibility is substantially equivalent.
Sterility	Sterility	Devices must achieve and maintain sterility for their shelf-life.	Methods, thresholds, and criteria for sterility are identical to the predicate device.
Shelf-Life	Shelf-Life	Devices must maintain their properties and safety over their intended shelf-life.	Methods, thresholds, and criteria for shelf-life are identical to the predicate device.
Packaging	Packaging Integrity	Packaging must protect the device and maintain sterility until use.	Methods, thresholds, and criteria for packaging are identical to the predicate device.
Quality Control	Manufacturing QA	Manufacturing processes adhere to established quality systems (ISO 13485, ISO 9001).	All manufacturing is conducted according to processes defined by ISO 13485 and ISO 9001. Methods, thresholds, and criteria for quality control measures are identical to the predicate device.

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

This is not an AI/ML study with a "test set" of data in the traditional sense. It's a medical device submission based on non-clinical bench testing and comparison to predicates.

Sample Size:
- For mechanical testing (insertion torque, static pullout), specific sample sizes would have been used per test standards (e.g., ASTM, ISO). These exact numbers are not detailed in the summary document but are implied to be sufficient for demonstrating equivalence.
- For biocompatibility, the assessment relies on the prior clearance of the same materials and processes in predicate devices. New testing (e.g., non-pyrogenic) would involve a sample size relevant to that specific test.
Data Provenance: The data provenance is from bench laboratory testing conducted by Ortho-Design (Pty) Ltd in South Africa. It is prospective testing of the new devices and comparison to the known performance and characteristics of the already cleared predicate devices.

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

This is not applicable as this is not an AI/ML study involving human interpretation of data where "ground truth" is established by experts in an annotation or diagnostic capacity.
The "ground truth" in this context is established by engineering and biocompatibility standards and the documented performance of legally marketed predicate devices, as determined by mechanical and chemical testing.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or diagnostic "test set" requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant to AI/ML software where the aim is to evaluate how AI assistance impacts human reader performance (e.g., in medical imaging diagnosis). This submission pertains to physical medical devices (suture anchors) and their mechanical/biocompatibility characteristics.

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

Not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence for these suture anchors is established through:

Engineering Standards: Adherence to recognized national and international standards for mechanical testing of bone anchors (e.g., those referenced in the FDA Guidance: 'Bone Anchors - Premarket Notification (510(k)) Submissions').
Predicate Device Performance: The established safety and effectiveness profile of the legally marketed predicate devices (cleared in K212381), which serve as the benchmark for equivalence.
Material Biocompatibility Data: Established safety profiles of the materials (PEEK, Titanium) as used in previously cleared medical devices, and specific biocompatibility testing (e.g., pyrogenicity) performed on the subject devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML study involving a "training set" of data.

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

Not applicable. As there is no "training set," there is no ground truth established for it.

Ask a Question

Ask a specific question about this device

K Number

K212381

Device Name

VersaTap, VersaLat, DueLock, VersaTi, MiniTi

Manufacturer

Ortho-Design (Pty) Ltd

Date Cleared

2021-12-06

(126 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K063453,K130274,K070758,K063456,K200523,K120942,K061665,K173788,K130917,K190728,K203495,K201786,K101679,K193295,K121018,K050358,K201083,K071257,K111000

Why did this record match?

Reference Devices :

K063453, K130274, K070758, K130274, K070758, K130274, K070758, K063456, K130274, K063453, K200523, K070758

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Shoulder: Rotator cuff repair, biceps tenodesis, SLAP repair, Bankart repair
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus
Elbow: Tennis elbow repair
Knee: Medial and lateral collateral ligament repair.
Wrist: Scapholunate ligament reconstruction

The VersaLat™ Suture Anchor is intended to use for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as:

Shoulder: Rotator Cuff Repair, Biceps Tenodesis

Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, and Iliotibial Band Tenodesis

The DueLock™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The DueLock™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as:

Shoulder: Rotator Cuff Repair, Bankart Repair, Capsular Shift and Capsulolabral Reconstruction, Subscapularis Tendon Tears

Elbow: Ulnar/Radial Collateral Ligament Reconstruction, and Lateral Epicondylitis repair
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Mid-foot Reconstruction, Hallux Valgus Reconstruction, Metatarsal Ligament Repair, Metatarsal Tendon Repair.

Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/ Radial Collateral Ligament Reconstruction.
Hip: Acetabular labral repair.

The VersaTi™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as:

The MiniTi™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The MiniTTM Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixsue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as:

Elbow: Ulnar/Medial Collateral Ligament Repair

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

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

Device Description

The VersaTap™ Suture Anchor is a self-tapping suture anchor mostly used as a medial row anchor in rotator cuff repair surgery. This anchor is ingeniously designed to combine the advantage of both PEEK and Titanium. The titanium tip allows for self-tapping ability whilst the majority of the anchor is manufactured from PEEK which minimizes post-operative imaging effects.

The VersaLat™ Suture Anchor is an innovative knotless-/suture anchor inspired by a top orthopedic shoulder surgeon. This PEEK screw-in anchor can be combined with the VersaTap™ Suture Anchor in double rotator cuff repair surgery. Flexibility is what differs this anchor from its competitors with surgeons being able to fixate any number of sutures/tapes (K150438) by adjusting the size of the characteristic front loop. The extra suture provided by this anchor can also be used for the fixation of the biceps tendon or any ligament fragments

The DueLock™ Suture Anchor is a flexible anchor that combines the functional push-in anchors into one multi-purpose suture anchor can be used as a knotless suture anchor as well as a push-in, preloaded suture anchor used in both small and large-joint repairs.

The VersaTi™ Suture Anchor is a self-tapping suture anchor mostly used as a medial row anchor in rotator cuff repair surgery. The anchor is designed for ultimate mechanical properties (pull-out strength, etc.) and ease of use. VersaTi™ Suture Anchor is recommended for use in small and large-joint repairs without the need for tapping or drilling.

The MiniT™ Suture Anchor is a small screw-in suture anchor used in a variety of small-joint applications. Despite its small diameter, the specially engineered thread combines with cortical bone to provide tremendous pull-out strength.

AI/ML Overview

This document describes the acceptance criteria and study data for several Suture Anchors (VersaTap™, VersaLat™, DueLock™, VersaTi™, and MiniTi™). The device's performance is demonstrated through non-clinical testing to show substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by demonstrating "similar or improved" performance compared to predicate devices or established literature, and by meeting regulatory requirements.

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Testing	Meet or exceed performance of predicate devices in static pull-out, insertion torque, fatigue, and corrosion testing, as per FDA Guidance Document: Bone Anchors—Premarket Notification (510(k)) Submissions.	All devices (VersaTap, VersaLat, DueLock, VersaTi, MiniTi) demonstrated "similar or improved pull out force compared to the primary predicate" and met requirements for insertion torque, fatigue, and corrosion. (Direct comparison data is not provided in this summary, but the conclusion states equivalence). The VersaTap™ is designed to combine the advantage of both PEEK and Titanium. The titanium tip allows for self-tapping ability whilst the majority of the anchor is manufactured from PEEK which minimizes post-operative imaging effects. The VersaTi™ had its thread designed for optimal pull-out strength and mechanical stability, and thread design for cancellous and cortical fixation while the MiniTi™'s specially engineered thread combines with cortical bone to provide tremendous pull-out strength.
Biocompatibility	Compatibility with human tissues, as demonstrated by materials previously cleared by FDA for reference devices and manufacturing processes conforming to ISO 9001/ISO 13485.	For all devices, the materials, processes, and cleaning agents used have been previously cleared by the FDA for reference devices manufactured by the same facility (Elite Surgical Supplies) under an OEM agreement with Ortho-Design, conforming to ISO 9001 (and ISO 13485 for DueLock™).
Sterility	Achieve a Sterility Assurance Level (SAL) of 10^-6.	The Overkill Method was successfully conducted to achieve a SAL of 10^-6, based on IQ, OQ, and PQ results and identified parameters and tolerances.
Shelf-Life	Maintain mechanical and functional integrity for a specified shelf-life (3 years).	All devices have a validated shelf-life of 3 years using accelerated aging techniques. Real-time aging is ongoing. Implant components are made from PEEK OPTIMA (ASTM F2026) and Titanium Alloy (ASTM F136), which are historically used in implants and not mechanically affected by aging within 3 years.
Packaging	Ensure sterility and safe transfer to operative field, including appropriate labeling.	All devices are boxed individually in EtO sterilized double peel pouches (60g/m² medical plastic film and paper) for sterile transfer. Each package includes external labeling, an instruction leaflet, and individual patient labels. Instruments are provided separately in non-sterile trays.
Endotoxin/Pyrogenicity	Non-pyrogenic.	All devices were tested and found to be non-pyrogenic.

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

The document does not specify exact sample sizes for each mechanical test (static pull-out, insertion torque, fatigue, corrosion). It states that "This testing was done on the subject device and the primary predicate device" or "compared to the data found in literature". The data provenance is from non-clinical bench testing conducted by the manufacturer (Ortho-Design (Pty) Ltd in South Africa or their OEM, Elite Surgical Supplies). The comparison data for predicates sometimes comes from literature, implying retrospective use of published data.

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

Not applicable. This is a submission for medical devices that are primarily evaluated based on non-clinical (mechanical, material, sterilization) testing, not on diagnostic accuracy requiring expert interpretation of results or images. The "ground truth" for mechanical properties is established by standardized testing methods.

4. Adjudication Method for the Test Set

Not applicable, as this is related to human interpretation or diagnostic accuracy studies, which are not detailed in this submission. The "adjudication" for mechanical testing is based on objective measurements and comparison against established standards or predicate device performance.

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

No. This type of study (MRMC) is typically performed for diagnostic or AI-assisted devices that involve human interpretation of medical images or data. The submitted device is a physical medical implant (suture anchor).

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

Not applicable. The devices are physical implants, not algorithms or software.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims (e.g., pull-out strength, biocompatibility, sterility) is based on objective measurement results from standardized non-clinical tests (mechanical testing, chemical analysis for biocompatibility, sterility validation methods) and comparison to established regulatory standards and predicate device data.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The term "training set" is typically used in the context of machine learning model development.

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

Not applicable. As this is not an AI/ML device, there is no training set for which to establish ground truth.

Ask a Question

Ask a specific question about this device

K Number

K180759

Device Name

SECULOK Suture Anchor

Manufacturer

U & I Corporation

Date Cleared

2018-08-09

(140 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K070758,K101100,K120824,K101679

Intended Use

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

Device Description

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.

AI/ML Overview

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."

Test Performed	Acceptance Criteria (Source)	Reported Device Performance
Suture Anchor
Torsional Properties	Data from primary predicate: CrossFT BC Suture Anchor (K101100)	Met acceptance criteria
Driving Torque	Data from primary predicate: CrossFT BC Suture Anchor (K101100)	Met acceptance criteria
Axial Pullout Strength	Data from primary predicate: CrossFT BC Suture Anchor (K101100), and Premarket Notification (510(k)) Submissions for Bone Anchors Draft Guidance (January 3, 2017)	Met acceptance criteria
Axial Pullout Fatigue Test	Data from primary predicate: CrossFT BC Suture Anchor (K101100), and Premarket Notification (510(k)) Submissions for Bone Anchors Draft Guidance (January 3, 2017)	Met acceptance criteria
Knotless Anchor
Axial Pullout Strength	Data from primary predicate: PushLock™ (K101679), and Premarket Notification (510(k)) Submissions for Bone Anchors Draft Guidance (January 3, 2017)	Met acceptance criteria
Axial Pullout Fatigue Test	Data from primary predicate: PushLock™ (K101679), and Premarket Notification (510(k)) Submissions for Bone Anchors Draft Guidance (January 3, 2017)	Met acceptance criteria
Suture (part of the device)
Tensile Strength Test	USP 29	Met acceptance criteria

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.

Ask a Question

Ask a specific question about this device

Page 1 of 1