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The Q-Fix Suture Anchor is intended to be used for soft tissue to bone fixation for:

Shoulder: Bankart lesion repair; SLAP lesion repair; acromio-clavicular repair; capsular shift/capsulolabral reconstruction; deltoid repair; rotator cuff tear repair; biceps tenodesis

Foot & Ankle: Medial/Lateral repair and reconstruction; midfoot and forefoot repair; Hallux valgus reconstruction; Metatarsal ligament/tendon repair or reconstruction; Achilles tendon repair

Elbow: Ulnar or radial collateral ligament reconstruction; lateral epicondylitis repair; biceps tendon reattachment

Knee: Extra-capsular repair: medial collateral ligament (MCL), lateral collateral ligament (LCL) and posterior oblique ligament; Iliotibial band tenodesis (IBT); patellar tendon repair; vastus medialis obliquus advancement (VMO); joint capsule closure

Hand & Wrist: Collateral ligament repair; Scapholunate ligament reconstruction; Tendon transfers in phalanx; Volar plate reconstruction

Hip: Acetabular labral repair

The Q-Fix Suture Anchor (Q-Fix) is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. This family of suture anchors previously was available in two sizes, 1.8mm and 2.8mm. This submission proposes an additional size of Q-Fix Suture Anchor, the 1.8mm Q-Fix MINI Suture Anchor.

The Q-Fix consists of two primary parts: a bone anchor inserter, which is preloaded with the anchor. The anchor inserter is a disposable tool.

The entire product is packaged in a tray with a Tyvek® lid, and the finished product is sterilized by ethylene oxide. Both the anchor and inserter are designed for single use only.

The Q-Fix Suture Anchor consists of the bone anchor and associated instruments for implanting the bone anchor.

The provided text describes a 510(k) premarket notification for a medical device (Q-Fix Suture Anchor) and does not contain information related to software or AI device performance studies. The document focuses on demonstrating substantial equivalence to a predicate device, primarily through mechanical bench testing.

Therefore, I cannot provide the requested information regarding acceptance criteria and study proving a device meets those criteria, as there is no mention of a software or AI-driven device, nor are there any clinical studies involving human readers or ground truth establishment in the context of AI performance.

The document states:

• "No clinical or animal data are included in this submission." (Page 4, under "Clinical Data")
• "Bench testing was performed on both the proposed and predicate devices in accordance with the FDA Guidance Document, Testing Bone Anchors, April 1996. This in vitro testing involved insertion of the anchors into a simulated human bone substrate followed by both static and cyclic fatigue testing." (Page 4, under "Non-Clinical Data")

This submission is for a physical medical device (a suture anchor), and the testing described is mechanical, not related to diagnostic accuracy or AI performance.

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The Q-Fix Suture Anchor is intended to be used for soft tissue to bone fixation for:

Shoulder: Bankart lesion repair; SLAP lesion repair; acromio-clavicular repair; capsular shift/capsulolabral reconstruction; deltoid repair; rotator cuff tear repair; biceps tenodesis
Foot & Ankle: Medial/Lateral repair and reconstruction; midfoot and forefoot repair; Hallux valgus reconstruction; Metatarsal ligament/tendon repair or reconstruction; Achilles tendon repair
Elbow: Ulnar or radial collateral ligament reconstruction; lateral epicondylitis repair; biceps tendon reattachment
Knee: Extra-capsular repair: medial collateral ligament (MCL), lateral collateral ligament (LCL) and posterior oblique ligament; Iliotibial band tenodesis (IBT); patellar tendon repair; vastus medialis obliquus advancement (VMO); joint capsule closure
Hand & Wrist: Collateral ligament repair; Scapholunate ligament reconstruction; Tendon transfers in phalanx; Volar plate reconstruction
Hip: Acetabular labral repair

The purpose of this subnission is to seek clearance for modifications and additions to the accessory instrumentation used with the previously cleared Q-Fix Suture Anchor System (K132513). There are no changes to the previously cleared indications for use, materials, design, technology, method of anchor insertion and or tissue attachment.

The Q-Fix Suture Anchor System (Q-Fix) is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures.

The Q-Fix consists of two primary parts: a bone anchor inserter, which is preloaded with the anchor. The anchor inserter is a disposable tool.

The entire product is packaged in a tray with a Tyvek® Iid, and the finished product is sterilized by ethylene oxide. Both the anchor and inserter are designed for single use only.

The O-Fix Suture Anchor System consists of the bone anchor and associated instruments for implanting the bone anchor.

The Q-Fix™ Suture Anchor System is a medical device designed for soft tissue to bone fixation. The device underwent mechanical testing to demonstrate its safety and effectiveness.

1. Acceptance Criteria and Reported Device Performance:

The acceptance criteria are not explicitly quantifiable performance metrics in the provided text, but rather a demonstration of substantial equivalence to the predicate device and adherence to design, performance, and safety specifications based on mechanical testing.

2. Sample Size and Data Provenance for Test Set:

• Sample Size: Not explicitly stated. The text mentions "Bench testing was performed on both the proposed and predicate devices," implying multiple units were tested, but the exact number is not provided.
• Data Provenance: The testing was "in vitro," involving insertion of anchors into a "simulated human bone substrate." This indicates the data is from laboratory bench testing, rather than from human or animal subjects. The origin (country) is not specified beyond "ArthroCare Corporation" which is located in Austin, Texas, USA. The testing is prospective as it was conducted specifically for this submission.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. This device is a mechanical implant, and its performance was assessed through bench testing, not through expert interpretation of data or images. Therefore, clinical experts were not required to establish ground truth for the device's mechanical performance.

4. Adjudication Method:

Not applicable, as no expert adjudication was involved for this type of mechanical bench testing.

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

No MRMC comparative effectiveness study was done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data. The Q-Fix™ Suture Anchor System is a surgical implant, and its performance is evaluated mechanically rather than through human interpretation.

6. Standalone (Algorithm Only) Performance:

Not applicable. The Q-Fix™ Suture Anchor System is a medical implant, not an AI algorithm. Its performance is inherent to its physical design and mechanical properties, not an algorithm.

7. Type of Ground Truth Used:

The ground truth for evaluating the device's performance was established through mechanical testing against predefined specifications and comparison to the predicate device. This involved "static and cyclic fatigue testing" in a "simulated human bone substrate."

8. Sample Size for Training Set:

Not applicable. As a medical implant, there is no "training set" in the context of machine learning or AI. The design and manufacturing process would involve internal testing and validation, but not a training set as understood in AI/ML.

9. How Ground Truth for Training Set was Established:

Not applicable, as there is no training set. The "ground truth" for the device's design and manufacturing would be based on engineering principles, material science, and regulatory standards.

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The Q-Fix Suture Anchor is intended to be used for soft tissue to bone fixation for:

Shoulder: Bankart lesion repair; SLAP lesion repair; acromio-clavicular repair; capsular shift/capsulolabral reconstruction; deltoid repair; rotator cuff tear repair; biceps tenodesis

Foot & Ankle: Medial/Lateral repair and reconstruction; midfoot and forefoot repair; Hallux valgus reconstruction; Metatarsal ligament/tendon repair or reconstruction; Achilles tendon repair

Elbow: Ulnar or radial collateral ligament reconstruction; lateral epicondylitis repair; biceps tendon reattachment

Knee: Extra-capsular repair: medial collateral ligament (MCL), lateral collateral ligament (LCL) and posterior oblique ligament; Iliotibial band tenodesis (IBT); patellar tendon repair; vastus medialis obliquus advancement (VMO); joint capsule closure

Hand & Wrist: Collateral ligament repair; Scapholunate ligament reconstruction; Tendon transfers in phalanx; Volar plate reconstruction

Hip: Acetabular labral repair

The Q-Fix Suture Anchor System (Q-Fix) is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures.

The Q-Fix consists of two primary parts: a bone anchor inserter, which is preloaded with the anchor. The anchor inserter is a disposable tool.

The entire product is packaged in a tray with a Tyvek® lid, and the finished product is sterilized by ethylene oxide. Both the anchor and inserter are designed for single use only.

The Q-Fix Suture Anchor System consists of the bone anchor and associated instruments for implanting the bone anchor.

Here's an analysis of the provided text regarding the ArthroCare Q-Fix Suture Anchor System, focusing on acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative-only acceptance criteria in a dedicated table format. Instead, it describes acceptance based on the device performing as intended and its mechanical properties being "substantially equivalent" to a predicate device. The "Comparison of Technological Characteristics" table serves as a form of acceptance criteria by showing that the proposed device is largely identical or very similar to the predicate device.

Table of Acceptance Criteria and Reported Device Performance:

Study Information

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

   • The document states: "Bench testing was performed on both the proposed and predicate devices in accordance with the FDA Guidance Document, Testing Bone Anchors, April 1996."
   • It mentions "insertion of the anchors into a simulated human bone substrate followed by both static and cyclic fatigue testing."
   • Sample Size: The exact sample size (number of anchors tested) for the bench testing is not specified in the provided text.
   • Data Provenance: The data is from in vitro bench testing using a "simulated human bone substrate." There is no mention of country of origin as it's not human data. The study is inherently prospective in its design as laboratory testing.

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

   • There is no mention of human experts being used to establish ground truth for this mechanical/bench test. The "ground truth" here is objective mechanical performance measured against predefined standards or comparison to a predicate device.

3. Adjudication method for the test set:

   • No adjudication method (like 2+1, 3+1, none) is applicable or mentioned, as this involves mechanical testing, not expert review of subjective data.

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, an MRMC comparative effectiveness study was not done. This device is a mechanical medical implant (suture anchor), not an AI diagnostic or assistance system. Therefore, the concept of "human readers improve with AI" is not applicable.

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

   • No, a standalone algorithm-only performance study was not done. As mentioned, this is a mechanical device, not an algorithm.

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

   • The "ground truth" used for this submission is based on objective mechanical test results (static and cyclic fatigue testing) against established FDA guidance for bone anchors, and direct comparison of technological characteristics to a legally marketed predicate device to establish substantial equivalence.

7. The sample size for the training set:

   • This is not an AI/machine learning device, so there is no training set in the traditional sense.

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

   • Not applicable as there is no training set.

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The Eleven Blade Solutions, Inc. Q-Fix™ Suture Anchor System is intended for soft tissue to bone fixation for:
Shoulder
Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff repair, Biceps tenodesis
Foot and Ankle
Medial/lateral repair and reconstruction, Mid and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair
Elbow
Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment
Knee
Extra-capsular repair: MCL, LCL, and posterior oblique ligament, Illiotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure
Hand and Wrist
Collateral ligament repair, Sacpholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction
Hip
Acetabular labral repair

The Q-Fix™ Suture Anchor is an all-suture anchor device designed for soft tissue to bone fixation by expanding against bone when deployed. Made of a polyester sleeve-type structure with one or more strands of UHMWPE suture threaded through it, the anchor is provided preloaded on a disposable inserter. The inserter is used to deploy the anchor into the bone, with the suture remaining slideable within the anchor to facilitate attachment of the soft tissue. The one-time use anchor is provided sterile, preloaded on the inserter. Additional accessory instruments, including a drill bit and drill guide with obturator are single use devices provided sterile for use during the orthopedic procedure.

The Q-Fix™ Suture Anchor System is a medical device designed for soft tissue to bone fixation. The provided document is a 510(k) summary, which indicates that the device is seeking substantial equivalence to already marketed predicate devices. This type of submission focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving absolute safety and efficacy through extensive clinical trials. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the demonstration of substantial equivalence through bench testing compared to predicate devices.

Here's an analysis based on the provided text:

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

The document does not explicitly state quantitative "acceptance criteria" in a table format with corresponding "reported device performance" values for the Q-Fix™ Suture Anchor System. Instead, it states that bench studies were conducted to evaluate performance characteristics and demonstrate equivalence to predicate devices. The implicit acceptance criterion is that the Q-Fix™ Suture Anchor System's performance characteristics are "equivalent to the predicate devices and thus provide equivalent fixation strength within their intended use."

The performance characteristics evaluated were:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "bench studies" for Anchor Pull-out Strength, Cyclic Displacement, and Device Insertion Testing. However, it does not specify the sample sizes used for these tests. It also does not provide information on the country of origin of the data or whether the studies were retrospective or prospective, as these are bench tests and not human or animal studies.

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 question is not applicable in the context of this 510(k) summary. The "ground truth" for bench testing of a suture anchor system is typically based on established engineering and biomechanical standards, not on expert clinical consensus. The assessments are objective measurements of physical properties.

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

This question is not applicable. Adjudication methods are typically used in clinical studies or image interpretation studies where expert consensus is needed. For bench testing of physical properties, measurements are objective and do not require expert adjudication in the same way.

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 question is not applicable. An MRMC comparative effectiveness study is used for evaluating diagnostic aids or imaging devices where human interpretation is involved. The Q-Fix™ Suture Anchor System is a surgical implant, and its performance is evaluated through biomechanical bench testing.

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

This question is not applicable. The Q-Fix™ Suture Anchor System is a physical medical device, not an algorithm or AI system. Its performance is inherent to its physical properties and design.

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

For the bench studies, the "ground truth" for assessing device performance is based on objective biomechanical measurements against established engineering and material science principles, and comparison to the performance characteristics of the predicate devices. It is not based on expert consensus, pathology, or outcomes data, as these are typically relevant for clinical studies.

8. The sample size for the training set

This question is not applicable. This device is a physical medical implant, not an AI or machine learning algorithm. Therefore, there is no "training set."

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

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

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