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The KFx APPIANFx™ PEEK Suture Anchors and APPIANFx™ PEEK Tissue Anchors are intended for the fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow. Specifically: Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromio- clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tenodesis, deltoid repairs Foot and Ankle: Hallux valgus repairs, medial or lateral instability repairs/reconstructions, mid-foot reconstructions, metatarsal ligament repair Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, iliotibial band tenodesis, patellar tendon repair Hand/Wrist/Elbow: Scapholunate ligament reconstructions, ulnar or radial collateral ligament reconstructions, tennis elbow repair, biceps tendon reattachment.

The KFx APPIANFx™ PEEK Suture Anchors consist of a fixation device comprised of a body with deployable legs, a wedge, and a disposable suture loop preloaded in a delivery (insertion) handle. The KFx APPIANFx™ PEEK Tissue Anchors consist of a fixation device comprised of a body with deployable legs and a cleated wedge preloaded in a delivery (insertion) handle. Each device is intended for single use and may be used in arthroscopic and open procedures.

The provided text describes a 510(k) Premarket Notification for medical devices, specifically suture and tissue anchors. It details the device, its intended use, and states that non-clinical testing was performed. However, it does not contain information about formal acceptance criteria, a specific study proving those criteria were met, or any of the detailed aspects typically associated with clinical or performance studies for AI/software devices.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on material biocompatibility and non-clinical engineering tests.

Therefore, many of the requested categories cannot be filled from the provided text.

Here's a breakdown based on the information available:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a direct study proving specified performance metrics against such criteria in a clinical context. Instead, it makes a general statement:

Study Details (Based on available information)

1. 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. The study mentioned is "non-clinical test data (deployment, static pull-out, and cyclic suture retention testing)." These tests are typically conducted on a sample of devices, but the exact number is not provided.
   • Data Provenance: Not specified, but given it's non-clinical testing, it would likely be laboratory-generated data rather than patient data.

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

   • Not applicable: The study described is non-clinical (mechanical testing), not involving ground truth derived from expert review of medical images or patient outcomes.

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

   • Not applicable: No adjudication method mentioned as it's non-clinical mechanical testing, not a clinical study involving human judgment.

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:

   • No: This is a physical medical device (suture/tissue anchors), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant, and no AI component is involved.

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

   • No: See point 4. This is a physical device.

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

   • Engineering specifications/measurements: For the non-clinical tests (deployment, static pull-out, cyclic suture retention), the "ground truth" would be the measured physical properties and performance characteristics against predefined engineering standards or comparison to the predicate device's performance.

7. The sample size for the training set:

   • Not applicable: There is no mention of a training set as this is not an AI/machine learning device.

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

   • Not applicable: See point 7.

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The KFx APPIANFx PEEK Femoral Implant with Inserter is intended for use in tenodesis procedures with soft tissue grafts. utilizing either arthroscopic or open techniques during Anterior Cruciate Ligament (ACL), Posterior Cruciate Ligament (PCL), Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), and Medial Patellofemoral Ligament (MPFL) reconstruction.

KFx APPIANFx PEEK Femoral Implant with Inserter consists of a two body anchor fixation device comprised of a body with deployable arms and a wedge and a disposable suture loop preloaded in a delivery (insertion) handle. Technologically it is similar in design, materials and mode of operation to the KFx PEEK Bone Anchor with Pre-Attached Sutures and Delivery Handle.

The provided 510(k) summary describes a medical device, the KFx APPIANFx PEEK Femoral Implant with Inserter, and its substantial equivalence to a predicate device. This type of submission generally relies on non-clinical performance testing rather than clinical studies involving patient data and ground truth established by experts.

Therefore, many of the requested categories related to clinical study design, expert evaluation, and ground truth are not applicable in this context.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • The document mentions "non-clinical test data, which includes cycle testing and pullout strength." It does not specify the sample size for these engineering tests.
   • Data provenance is not applicable as this refers to non-clinical laboratory testing, not human-derived data.

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

   • Not applicable. This submission relies on engineering testing and comparison to a predicate device, not clinical ground truth established by medical experts for patient data.

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

   • Not applicable. This applies to expert review of clinical data, which was not part of this submission.

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 is a medical device (implant) and not an AI/imaging diagnostic device.

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

   • Not applicable. This is a medical device (implant) and not an AI/imaging diagnostic device.

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

   • Not applicable. The "ground truth" for this device's performance is established through engineering specifications and non-clinical mechanical testing results (e.g., strength measurements meeting defined thresholds, sterility levels, material composition verification), and comparison to the predicate device's known performance.

7. The sample size for the training set:

   • Not applicable. This refers to non-clinical engineering tests, not machine learning model training.

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

   • Not applicable. This refers to non-clinical engineering tests, not machine learning model training.

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The KFx Peek Bone Anchor with Pre-Attached Sutures and Delivery Handle is intended for the fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow.

Specifically:

Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tenodesis, deltoid repairs

Foot and Ankle: Hallux valgus repairs, medial or lateral instability repairs/reconstructions. Achilles repairs/reconstructions, mid-foot reconstructions, metatarsal ligament repair.

Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, Iliotibial band tenodesis, patellar tendon repair.

Hand/Wrist/Elbow: Scapholunate ligament reconstructions, ulnar or radial collateral ligament reconstructions, tennis elbow repair, biceps tendon reattachment.

The KFx PEEK Bone Anchor with Pre-Attached Sutures and Delivery Handle is intended for the fixation of soft tissue to bone using Teleflex ForceFiber™ #2 nonabsorbable braided suture. The KFx PEEK Bone Anchor with Pre-Attached Sutures consists of a fixation device pre-loaded with suture in a delivery (insertion) handle. The PEEK bone anchor can be used in open or arthroscopic procedures.

The provided text does not describe acceptance criteria for a device, nor does it detail a study proving the device meets said criteria.

Instead, the document is a 510(k) summary for the KFx PEEK Bone Anchor with Pre-Attached Sutures and Delivery Handle. This type of document is submitted to the FDA to demonstrate that a new device is "substantially equivalent" to an already legally marketed device (predicate device), meaning it is as safe and effective.

Here's why the requested information cannot be extracted from this text:

• Acceptance Criteria & Device Performance: The document states that "Non-clinical test data has established that the devices satisfies functional performance requirements and is safe and effective when used as indicated." However, it does not list specific acceptance criteria (e.g., tensile strength threshold, insertion force limits) or the reported performance values from those tests. It merely makes a general claim.
• Study Details (Sample Size, Ground Truth, Training Set, etc.): The document only mentions "Non-clinical test data." It does not provide any specifics about the studies conducted, such as sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for either test or training sets. This is typically because a 510(k) submission for a device like a bone anchor relies heavily on material equivalence, design similarity, and established performance of predicate devices, rather than clinical trials with human subjects or AI algorithm validation studies that would require such detailed information.

In summary, the provided text confirms the device's substantial equivalence to predicate devices based on materials, design, and operation, and mentions "non-clinical test data" confirming functional performance requirements. However, it does not offer the detailed breakdown of acceptance criteria and study particulars you've requested.

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The intended use of the KFx Suture Lock Tissue Fixation System is for the fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow. Specifically:
Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tenodesis, deltoid repairs.
Foot and Ankle: Hallux valgus repairs, medial or lateral instability repairs/reconstructions, Achilles repairs/reconstructions, mid-foot reconstructions, metatarsal ligament repair.
Knee: Medial collateral ligament repairs, lateral ligament repairs, posterior oblique ligament repairs, lliotibial band tenodesis, patellar tendon repairs.
Hand, Wrist and Elbow: Scapholunate ligament reconstructions, ulnar or radial collateral ligament reconstructions, tennis elbow repair, biceps tendon reattachment.

The KFx Tissue Fixation System consists of a Nail Bone Anchor with two suture leads pre-loaded in a single use insertion handle and a Bone Screw Anchor (also pre-loaded in a single use delivery handle) used to capture the sutures, eliminating the need to tie suture knots. The KFx Tissue Fixation System also includes re-usable surgical instruments for the implantation of the Nail Bone and Bone Screw Anchors.
Devices are provided "STERILE"; sterilization is by Ethylene Oxide (EO) gas and provides a sterility assurance level of 10-6.

The provided text describes the KFx Suture Lock Nail Bone Anchor, a medical device for tissue fixation. It refers to "Bench test results" that "indicate that the device is safe and satisfies functional performance requirements" and concludes that the device is "substantially equivalent" to a previously cleared predicate device.

However, the document does not provide specific acceptance criteria or detailed results of a study in a tabular format as requested. It states that the device is substantially equivalent to a previously cleared device (K072063). The "Biocompatibility and Performance Data" section provides a high-level summary of the study findings, but lacks the granular details needed to fill out all the requested information about a specific study proving it meets acceptance criteria.

Therefore, much of the requested information cannot be extracted directly from the provided text.

Here is what can be inferred or stated based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

1. 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.
   • Data provenance: Not specified (bench tests are typically conducted in a controlled lab environment, not on human data in the context of this device). The document refers to "bench test results."

2. 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):

   • Not applicable as this is a mechanical device evaluated through bench testing, not image analysis or clinical expert review.

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

   • Not applicable; this would typically be relevant for studies involving human interpretation or clinical endpoints.

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:

   • No MRMC study was done, as this is a mechanical bone anchor device, not an AI or imaging diagnostic tool.

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

   • Not applicable; this is a physical medical device, not a software algorithm.

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

   • The "ground truth" (or basis for evaluation) appears to be derived from established engineering and biocompatibility standards for medical devices and comparison to a predicate device. For mechanical performance, this would involve quantitative measurements against specified thresholds, but these thresholds are not provided.

7. The sample size for the training set:

   • Not applicable, as this is not a machine learning model.

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

   • Not applicable, as this is not a machine learning model.

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The KFx Tissue Fixation System (comprised of the KFx Suture Lock Bone Screw Anchor and KFx Suture Lock Nail Bone Anchor) and Accessories are intended for the fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow. Specifically:

Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromioclavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tenodesis, deltoid repairs

Foot and Ankle: Hallux valgus repairs, medial or lateral instability repairs/reconstructions, Achilles repairs/reconstructions, mid-foot reconstructions, metatarsal ligament repair.

Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, Iliotibial band tenodesis, patellar tendon repair.

Hand/Wrist/Elbow: Scapholunate ligament reconstructions, ulnar or radial collateral ligament reconstructions, tennis elbow repair, biceps tendon reattachment.

The KFx Tissue Fixation System is intended for the fixation of soft tissue to bone using Teleflex ForceFiber® #2 braided suture. The KFx 5.5mm Suture Lock Bone Screw Anchor component of the Tissue Fixation System is used to capture the Nail Bone Anchor sutures, eliminating the need to tie suture knots.

The KFx Nail Bone Anchor and the KFx Suture Lock Bone Screw Anchors are provided "STERILE"; sterilization is by Ethylene Oxide (EO) gas.

The provided text describes a medical device submission (K080229) for the KFx 5.5mm Suture Lock Bone Screw Anchor. This is a 510(k) Premarket Notification for a modified device, establishing substantial equivalence to a previously cleared predicate device (K072063).

It does not contain any information about a study involving AI or software, or acceptance criteria related to such a study. The document focuses on the mechanical performance and biocompatibility of a physical bone anchor in comparison to a predicate device.

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these items are not discussed in the provided text.

The closest relevant information is:

Acceptance Criteria and Device Performance (Bench Testing):

Remaining Requested Information (Not Available in the Text):

• Sample sized used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. The "ground truth" here is likely mechanical testing standards and biocompatibility standards, not expert clinical interpretation.
• Adjudication method: Not applicable/mentioned for physical device bench testing.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is for a physical medical device, not an AI/software.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, not applicable.
• The type of ground truth used: For biocompatibility, it's established standards and data on similar materials. For functional performance, it's likely engineering specifications and comparison to the predicate device's performance.
• The sample size for the training set: Not applicable; there is no "training set" in the context of this physical device submission.
• How the ground truth for the training set was established: Not applicable.

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The KFx Tissue Fixation System and optional accessories are intended for the fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow.

Specifically:

Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tenodesis, deltoid repairs.

Foot and Ankle: Hallux valgus repairs, medial or lateral instability repairs/reconstructions, Achilles repairs/reconstructions, mid-foot reconstructions, metatarsal ligament repair.

Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, Iliotibial band tenodesis, patellar tendon repair.

Hand/Wrist/Elbow: Scapholunate ligament reconstructions, ulnar or radial collateral ligament reconstructions, tennis elbow repair, biceps tendon reattachment.

The KFx Tissue Fixation System consists of

• KFx Nail Bone Anchor with two suture leads, mounted to a single use handle .
• . KFx Suture Lock Bone Anchor mounted to a single use handle
• . Optional KFx Targeting Grasper
• Optional Suture Management Device(s) .
• . Optional Screw Removal device
• Optional Starter Awl .

The provided 510(k) summary for the KFx Tissue Fixation System and Accessories does not contain information about the acceptance criteria and a study proving the device meets those criteria, as typically described in terms of performance metrics like sensitivity, specificity, accuracy, or other quantitative measures. Instead, it focuses on demonstrating substantial equivalence to predicate devices through physical bench testing and biocompatibility assessment.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implies acceptance criteria by stating the device "meets its specifications" and "does not raise new issues of safety or effectiveness," rather than specifying quantitative, pre-defined thresholds for performance metrics.

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

The document does not specify the sample size used for the physical bench testing. It only states "Results of physical bench testing." The data provenance (e.g., country of origin, retrospective or prospective) is not mentioned.

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

This information is not applicable to the type of testing described (physical bench testing and biocompatibility). Ground truth is typically established for diagnostic or screening devices, often involving expert clinical review, pathology, or imaging interpretations.

4. Adjudication Method for the Test Set

This information is not applicable, as there is no mention of expert review or clinical adjudication methods being used for the physical bench testing.

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

No MRMC study was performed or mentioned. The device is a physical fixation system, not a diagnostic or imaging device that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study for an algorithm was performed or mentioned. The device is a physical medical device, not an AI/algorithm-based system.

7. Type of Ground Truth Used

For the physical bench testing, the "ground truth" implicitly would be the engineering specifications and performance expectations for mechanical strength, durability, and functional integrity of the fixation system. For biocompatibility, the ground truth is established by standard material biocompatibility testing protocols (e.g., ISO 10993 series) against known compatible materials.

8. Sample Size for the Training Set

This is not applicable as the device is a physical medical device, not an AI/machine learning system that requires a training set.

9. How Ground Truth for the Training Set Was Established

This is not applicable, as there is no training set for this type of device.

Summary of Study Type:

The study described is primarily a bench testing and biocompatibility assessment intended to demonstrate that the KFx Tissue Fixation System meets its engineering specifications and does not introduce new safety or effectiveness concerns compared to legally marketed predicate devices. This type of study supports a claim of substantial equivalence for a Class II medical device. It is not a clinical study involving patient outcomes, expert image interpretation, or AI performance evaluation.

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The KFx Knotless Fixation System and Accessory Targeting Grasper are intended for the fixation of soft tissue to bone during rotator cuff repair.

The KFx Knotless Fixation System consists of:

• . KFx Nail Bone Anchor with two suture leads, mounted to a single use handle
• KFx Suture Lock Bone Screw Anchor mounted to a single use handle .
• Optional KFx Targeting Grasper. .

Here's an analysis of the provided text regarding the KFx Knotless Fixation System's acceptance criteria and studies:

The provided documents do not detail specific quantitative acceptance criteria or a dedicated study proving the device meets those criteria in a typical AI/software-as-a-medical-device (SaMD) context. Instead, this 510(k) submission focuses on demonstrating substantial equivalence to predicate devices, which is a common regulatory pathway for many medical devices that are not SaMDs.

Therefore, many of the requested points related to AI performance, ground truth, expert adjudication, and sample sizes for training/test sets are not applicable to this submission.

Here's a breakdown based on the information available:

Acceptance Criteria and Device Performance

Study Proving Acceptance Criteria:
The study that proves the device meets the acceptance criteria is described as "physical bench testing." The results of this testing were used to demonstrate that the KFx Knotless Fixation System meets its specifications and does not raise new issues of safety or effectiveness.

Detailed Information (as applicable)

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

   • Sample Size: Not specified. "Physical bench testing" does not typically refer to patient data or a test set in the same way an AI model would have one. It refers to a series of mechanical or functional tests on the device itself.
   • Data Provenance: Not applicable in the context of patient data. The tests were performed on the device.

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

   • Not applicable as this is a physical device, not an AI/SaMD. "Ground truth" in this context would likely refer to engineering specifications or industry standards against which the bench tests were measured, not expert-labeled data.

3. Adjudication method for the test set:

   • Not applicable.

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:

   • No. This is a physical medical device, not an AI system.

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

   • No. This is a physical medical device, not an AI algorithm.

6. The type of ground truth used:

   • For the physical tests, the "ground truth" would be the pre-defined engineering specifications and performance standards for bone anchors and fixation systems (e.g., tensile strength, fixation strength, design tolerances). The document only broadly states the device "meets its specifications."

7. The sample size for the training set:

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

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

   • Not applicable. This is a physical device.

Summary from the provided documents:

The KFx Knotless Fixation System gained clearance based on a 510(k) pathway, which relies on demonstrating substantial equivalence to already legally marketed predicate devices. The primary evidence presented for safety and effectiveness is:

1. Physical bench testing to show the device "meets its specifications" and prevents new safety/effectiveness concerns.
2. Biocompatibility assessment by confirming the use of materials identical to those in predicate devices and commonly used in similar medical devices.
3. Comparison of intended use, design, and technology to predicate devices.

The document does not contain the type of detailed statistical study, expert consensus, or performance metrics that would be relevant for an AI/SaMD device's acceptance criteria and validation.

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