Search Results

LIGAFIX® is indicated for use in anterior cruciate ligament reconstruction to provide interference fixation of grafts.
LIGAFIX® is a cannulated, sterile, single-use, resorbable interference bone screw made of a mixture of tri calcium phosphate (β-ΤCP) and Poly Lactic Acid (PLA) designed for the interference fixation of grafts in anterior cruciate ligament reconstruction.

LIGAFIX® is a resorbable cannulated screw designed for the interference fixation of grafts in anterior cruciate ligament reconstruction. LIGAFIX® interference bone screw is made of a 30% ceramic (ß-TCP) / 70% polymer (Poly Lactic Acid -PLA)(6v composite. LIGAFIX® interference bone screws are supplied sterile and individually packaged in double heat sealed pouches. LIGAFIX® screws present a socket which accepts a screwdriver of triangular cross-section that inserts deep into the core of the screw, to produce improved torque distribution.

The provided text is a 510(k) Premarket Notification for the LIGAFIX® Interference screw. This type of FDA submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical studies with complex acceptance criteria typically seen for new drug applications or high-risk devices.

Therefore, the study described here is primarily a comparative study to a predicate device rather than a standalone clinical trial with defined acceptance criteria for efficacy. The "acceptance criteria" for this submission are fundamentally the demonstration of substantial equivalence.

Here's an analysis based on the provided document:

Description of the Study and Acceptance Criteria

The submission for the LIGAFIX® Resorbable Interference Screw (K050407) is a 510(k) premarket notification. The primary "study" involved demonstrating that the device is substantially equivalent to legally marketed predicate devices, specifically the BioLok® Screw (K002070) and BIOSORB® Resorbable Void Filler (K021963).

The "acceptance criteria" for this type of submission are met when the FDA determines that the new device has the same intended use, technological characteristics, and performs similarly to the predicate device, or if it has different technological characteristics, that they do not raise new questions of safety and effectiveness.

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

For a 510(k), explicit, quantitative acceptance criteria for a new clinical outcome are generally not presented in the same way as a full clinical trial. Instead, the "acceptance criteria" are implied by demonstrating equivalence in key performance areas to the predicate device. The "reported device performance" is essentially the evidence provided to satisfy this equivalence.

• Indicated for "anterior cruciate ligament reconstruction to provide interference fixation of grafts" (same as predicate, implied). |
  | Material Equivalence | "LIGAFIX® is substantially equivalent to its predicate device BioLok® in terms of... material..."
• LIGAFIX®: 30% ceramic (ß-TCP) / 70% polymer (Poly Lactic Acid -PLA) (6v composite)
• Predicate Material: Not explicitly detailed for BioLok® in this summary, but equivalence asserted. |
  | Design Equivalence | "LIGAFIX® is substantially equivalent to its predicate device BioLok® in terms of... design..."
• LIGAFIX®: Resorbable cannulated screw, socket accepts triangular screwdriver. Design features are presented as comparable to predicate. |
  | Function/Performance Equivalence | "LIGAFIX® is substantially equivalent to its predicate device BioLok® in terms of... function."
• Biological, mechanical and biocompatibility tests have been performed.
• Results confirmed that LIGAFIX® screws are highly biocompatible and presents the requisite strength to provide sustained fixation of the graft.
• LIGAFIX® screws strength retention profiles are compatible with the healing process. (These findings directly support functional equivalence to the predicate). |
  | Safety (no new safety questions) | "highly biocompatible" and "requisite strength" (implied no new safety concerns compared to predicate due to materials and mechanical properties). |

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

The summary does not describe a clinical trial with a "test set" of patients in the typical sense. The "performance data" mentioned are "Biological, mechanical and biocompatibility tests have been performed." These are typically bench tests and potentially in vitro or in vivo (animal) studies, not patient studies with a defined sample size.

• Sample Size for Test Set: Not applicable in the context of a human clinical test set. The sample sizes would refer to the number of screws or biological samples tested in laboratory/animal studies, which are not specified.
• Data Provenance: Not applicable for a clinical test set. The tests were performed by the manufacturer or a contracted lab. The submitter is from France ("Sciences et Bio Matériaux, ZI du Monge, F 65100 LOURDES - FRANCE"). These would be internal R&D test results.

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)

Not applicable. This is a medical device 510(k) submission based on bench testing and material characterization, not a study requiring expert clinical assessment for ground truth.

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

Not applicable. There was no clinical test set requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-enabled diagnostic device, and no MRMC study was conducted.

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

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

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

The "ground truth" here is established through objective scientific and engineering metrics from materials science, biomechanics, and biocompatibility testing, compared to established standards and the characteristics of the predicate device.

• Biocompatibility: Likely evaluated against ISO 10993 standards using in vitro and in vivo (animal) tests.
• Mechanical Strength: Measured through biomechanical testing (e.g., torque, pull-out strength, degradation profiles) using engineering standards.
• Material Composition: Verified through analytical chemistry techniques.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set."

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

Not applicable. There is no training set for this device.

Ask a specific question about this device

Indications for the Resorbable Interference Screw includes use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications include the following:

Shoulder: Batkart repair, SLAP lesion repair, acromio-clavioular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnat/radial collateral ligament

reconstruction.

Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction.

Elbow: Tennis elbow repair, ultar or radial collateral ligament reconstruction, biceps tendon reconstruction.

Knee: Extra-capsular repair, medial collateral ligament (MCL) repair, lateral collateral ligament (LCL) repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis reconstruction, patellar ligament/tendon repair, and vastus medialis obliquus (VMO) muscle advancement.

In addition to the above indications, the 7.0, 8.0, 9.0, 10.0, 11.0, and 12.0mm screws are indicated for the following uses:

• 1. To provide interference fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction.
• 2. To provide interference fixation during femoral and/or tibial fixation in anterior cruciate ligament reconstruction using a soft tissue graft (semitendinosus, gracilis).
• 3. To provide interference fixation during posterior cruciate ligament (PCL) reconstruction.

The 3 mm, 4 mm, 6 mm, 10 mm, 11 mm, and 12 mm as well as the 9 mm x 35 mm Resorbable Interference Screws are an addition to the 7 mm, 8 mm, and 9 mm interference screws already cleared in 510(K) K982497. They are made of the same LactoSorb® material as the predicate devices.

The provided text describes a 510(k) premarket notification for a medical device, the "Resorbable Interference Screw." This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through extensive studies.

Therefore, the input document does not contain the information requested for acceptance criteria and a study proving the device meets those criteria, as typically understood for new device performance claims.

Here's a breakdown of why and what information is present related to equivalency:

Why the requested information is not available in the document:

• Acceptance Criteria and Device Performance: The document does not define specific performance metrics (e.g., tensile strength, degradation rate, biocompatibility standards with defined thresholds) that the "Resorbable Interference Screw" had to meet. Instead, it relies on demonstrating that the new screw is substantially equivalent to existing, legally marketed screws.
• Study Proving Acceptance Criteria: Because specific acceptance criteria with defined thresholds are not provided, there's no study described that "proves" the device meets them in the conventional sense. The "study" mentioned is "Non-Clinical Testing" for substantial equivalence.

Information available related to equivalency:

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

   • Acceptance Criteria (Implicit for Substantial Equivalence): The implicit acceptance criterion is that the "Resorbable Interference Screw" must be substantially equivalent to the predicate devices.
     • Predicate Devices:
       • Arthrotek Interference Screw - Arthrotek Inc. (K982497)
       • Soft Tissue Screw and Washer - Arthrotek Inc. (K012572)
       • Resorbable Screw Anchor - Arthrotek Inc. (K012872)
   • Reported Device Performance (as demonstrated for substantial equivalence):
     • Non-Clinical Testing: "Mechanical testing was done on the 3.0 mm Resorbable Interference Screw. This testing indicated that the Resorbable Interference Screw was substantially equivalent to the predicate devices."
     • Materials & Manufacturing: "The Resorbable Interference Screw is made of the same materials, using the same manufacturing processes, and conforming to the same standards as the predicated Arthrotek Interference Screw (K982497)."
     • Intended Use & Indications: The new device shares the same intended use (soft tissue fixation to bone) and expanded indications (specific shoulder, wrist/hand, ankle/foot, elbow, and knee procedures, including ACL/PCL reconstruction) as the predicate devices and prior cleared versions.

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

   • The document states "Mechanical testing was done on the 3.0 mm Resorbable Interference Screw." It does not specify the sample size for this mechanical testing.
   • Data provenance (country, retrospective/prospective) is not mentioned.

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

   • Not applicable. This was mechanical testing, not a study requiring expert readers or ground truth established by clinical experts.

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

   • Not applicable. No adjudication method is mentioned as it was mechanical testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This is not an AI or imaging device. No MRMC study was performed.

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

   • Not applicable. This is not an AI device.

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

   • For the mechanical testing, the "ground truth" would be the established engineering and materials standards (implied by "conforming to the same standards as the predicated Arthrotek Interference Screw") and the performance characteristics of the predicate devices.

8. The sample size for the training set:

   • Not applicable. There is no mention of a "training set" as this is not a machine learning device.

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

   • Not applicable. There is no mention of a "training set."

Conclusion:

The document focuses on demonstrating substantial equivalence to existing devices through similar materials, manufacturing, intended use, and general performance (indicated by mechanical testing outcome). It explicitly states, "Clinical testing: Clinical testing was not required for these components to support substantial equivalence." This means the device was not subjected to a study designed to meet specific new acceptance criteria in the way a novel, high-risk device or an AI device might be.

Ask a specific question about this device

The DePuy Interference Screw Systems are intended to be used to provide interference fixation of bone-patellar tendon-bone grafts in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction and of soft tissue grafts in ACL reconstruction.

The DePuy Interference Screw Systems are cannulated fully threaded cancellous bone screws available in three diameters (7, 8, and 9mm) in three lengths (20, 25,and 30mm), and manufactured from titanium alloy (DePuy Profile Round Head Interference Screw) and from Poly-L-lactic acid (DePuy Phantom Absorbable Interference Screw).

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size for Test Set and Data Provenance:
   The document does not specify the exact sample size used for the mechanical testing. The data provenance is not explicitly stated in terms of country of origin, but the testing was conducted to support a submission to the FDA (United States). The testing appears to be prospective, as it was conducted to demonstrate substantial equivalence for a new indication.

3. Number of Experts and Qualifications:
   Not applicable. This is a medical device submission based on mechanical testing and substantial equivalence, not a study requiring expert readers for image or data interpretation.

4. Adjudication Method:
   Not applicable for this type of submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
   No, an MRMC comparative effectiveness study was not done. This submission focuses on the mechanical equivalence of a new indication for a medical device through lab testing, not human performance with AI assistance.

6. Standalone Performance:
   Yes, a standalone performance assessment was conducted in the form of mechanical testing of the device's pull-out loads. The performance was assessed independently of human interaction during the test.

7. Type of Ground Truth Used:
   The "ground truth" in this context is the established mechanical performance (pull-out loads) of a legally marketed predicate device (Linvatec BioScrew) for PCL reconstruction, as presented in published literature. The DePuy devices' performance was compared against this established benchmark.

8. Sample Size for Training Set:
   Not applicable. This is a medical device submission based on mechanical testing and substantial equivalence. There is no "training set" in the context of an algorithm or AI.

9. How Ground Truth for Training Set Was Established:
   Not applicable, as there is no training set. The comparison was made against published data for a predicate device.

Ask a specific question about this device

The DePuy Interference Screw Systems are intended to be used to provide interference fixation of bone-patellar tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction and of soft tissue grafts in ACL reconstruction.

The DePuy Interference Screw Systems are cannulated fully threaded cancellous bone screws available in three diameters (7, 8, and 9mm) in three lengths (20, 25,and 30mm), and manufactured from titanium alloy (DePuy Profile Round Head Interference Screw) and from Poly-L-lactic acid (DePuy Phantom Absorbable Interference Screw).

The provided text does not contain any acceptance criteria or a study that proves the device meets specific criteria in the way a typical medical device study would be presented with performance metrics.

Instead, the document is a 510(k) premarket notification summary for a medical device (DePuy Profile™ Round Head Interference Screw and DePuy Phantom™ Resorbable Interference Screw). This means the manufacturer is seeking to demonstrate that their new device is "substantially equivalent" to an already legally marketed predicate device, rather than proving its safety and effectiveness through a new clinical trial with specific acceptance criteria.

The "Basis of Substantial Equivalence" section describes the rationale for this claim:

• Materials and Design Similarity: The screws are similar in design and materials to previously cleared DePuy Advantage and Hyloc Interference screws.
• Minor Differences: There are only minor design changes and fewer screw length options compared to previously cleared devices.
• Additional Indication: The key difference is an additional indication for interference fixation of soft tissue grafts in ACL reconstruction.
• Mechanical Testing: To support this additional indication, mechanical testing in cadaver bone was performed.

Here's how to address your specific points based on the provided text, while noting the limitations:

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

The document does not explicitly state specific quantitative acceptance criteria or detailed performance metrics in a table format as you would expect from a performance study.

Instead, it states:
"Mechanical testing in cadaver bone has shown that the average insertion torque and pull-out strength of the Profile Round Head Interference Screws and the Phantom Absorbable Interference Screws are comparable to those of the previously cleared DePuy SofThread Soft Tissue Interference Screw and Linvatec BioScrew indicated for interference fixation of soft tissue grafts in ACL reconstruction."

• Acceptance Criteria (Implied): "Comparable" average insertion torque and pull-out strength to predicate devices.
• Reported Device Performance: "Comparable" average insertion torque and pull-out strength.

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

• Sample Size: Not specified. The text only mentions "cadaver bone" but does not give the number of samples or tests performed.
• Data Provenance: The study appears to be a bench/mechanical study using "cadaver bone." The country of origin of this data is not specified, but the firm is located in Warsaw, Indiana, USA, suggesting the testing likely occurred in the US or a related facility. This would be considered prospective testing for the purpose of demonstrating substantial equivalence, although not a clinical trial.

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 to the provided document. The study was a mechanical/bench test on cadaver bone, not a diagnostic or clinical study requiring expert review to establish ground truth.

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

This question is not applicable. There was no clinical or diagnostic test set requiring adjudication. The comparison was based on quantitative mechanical properties (insertion torque and pull-out strength).

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. The device is a bone screw, not an AI or imaging diagnostic device.

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

This question is not applicable. The device is a bone screw, not an algorithm.

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

For the mechanical testing, the "ground truth" (or reference) was the established mechanical performance (insertion torque and pull-out strength) of the predicate devices (DePuy SofThread Soft Tissue Interference Screw and Linvatec BioScrew). The goal was to show comparability, not to establish a new clinical ground truth.

8. The sample size for the training set

This question is not applicable. There was no "training set" in the context of an AI/algorithm. If interpreted loosely as the historical data from which the "comparable" predicate devices were developed, that information is not provided.

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

This question is not applicable as there was no training set in the context of an AI/algorithm.

Ask a specific question about this device