Search Results

The Mitek Biocryl Interference Screw is indicated for the fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.

The device described in this 510(k) is sterile, disposable implant designed to secure soft tissue to bone. The Mitek Biocryl Interference Screws are indicated for the fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.

The provided text is a 510(k) summary for the Mitek Biocryl Interference Screws, which is a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a study proving performance against defined acceptance criteria in the typical sense for a new, novel device.

Therefore, the information requested regarding acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment, which are common for algorithms or diagnostic devices, is not applicable to this specific document as it describes a modification to an existing device type and relies on demonstrating equivalence through design control and performance testing, not clinical outcome studies.

Here's why and what information can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Applicable. The document explicitly states: "This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled 'The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.' In support of this 510(k), Mitek has provided certification of compliance to 21 CFR 820.30 Design Control requirements, descriptions of Mitek's Design Control and Risk Analysis procedures, and the results of validation testing (performance testing) for the device modification."
• This indicates that performance was assessed against internal design control requirements and validation tests, not external, publicly defined acceptance criteria with reported metrics like sensitivity/specificity. The focus is on demonstrating that the modified device performs as intended and is equivalent to the predicate devices.

2. Sample Size for Test Set and Data Provenance:

• Not Applicable. No explicit "test set" in the context of clinical data or algorithm evaluation is mentioned. The "performance testing" referenced would likely involve bench testing (e.g., mechanical strength, degradation properties) for the device modification. The sample size for such engineering tests is not provided in this summary.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable. This type of information is relevant for studies involving human interpretation or subjective assessment, typically with diagnostic algorithms or imaging. This document describes an orthopedic implant, not a diagnostic device requiring expert ground truth establishment in this manner.

4. Adjudication Method:

• Not Applicable. No adjudication method is described as there's no "ground truth" to adjudicate in the context of this device type and submission.

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

• Not Applicable. This is not a diagnostic device or an AI-assisted interpretation tool. Therefore, an MRMC study is irrelevant.

6. Standalone Algorithm Performance:

• Not Applicable. This is a physical medical implant, not an algorithm.

7. Type of Ground Truth Used:

• Not Applicable. For a physical implant, "ground truth" would relate to its structural integrity, biocompatibility, and mechanical properties demonstrated through various engineering tests and material analyses, not clinical outcomes in the same way an algorithm is evaluated. The document states validation testing and compliance with design controls were performed.

8. Sample Size for Training Set:

• Not Applicable. This is a physical implant, not an algorithm that requires a training set.

9. How Ground Truth for Training Set was Established:

• Not Applicable. As above, it's not an algorithm requiring a training set and associated ground truth.

Summary of what is provided:

• Device Name: Mitek Biocryl Interference Screws
• Indication for Use: Fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.
• Study/Basis for Equivalence: Special 510(k) submission based on device modification. Demonstrated substantial equivalence through:
  • Certification of compliance to 21 CFR 820.30 Design Control requirements.
  • Descriptions of Mitek's Design Control and Risk Analysis procedures.
  • Results of validation testing (performance testing) for the device modification.
• Conclusion: Based on indications for use, technological characteristics, and comparison to predicate devices, substantial equivalence was shown.

Ask a specific question about this device

The RigidFix™ 2.7mm BTB Cross Pin Kit is indicated for femoral and tibial fixation of autograft or allograft ACL bone-tendon-bone (BTB) grafts.

The device described in this 510(k) is a sterile, disposable, device designed for single patient use only. The cross pins are constructed of bioabsorbable Poly Lactic Acid (PLA).

The provided document is a 510(k) summary for the "RigidFix™ 2.7mm BTB Cross Pin Kit," a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies with acceptance criteria in the way a new drug or high-risk medical device might.

Therefore, many of the requested elements (like acceptance criteria for a study, sample sizes for test/training sets of data, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for training) are not applicable to this type of regulatory submission as they pertain to clinical or AI/algorithm performance studies, which were not conducted or required for this device.

Here's an analysis based on the information provided:

Description of Acceptance Criteria and Proving Device Meets Criteria

This submission is a 510(k) Pre-market Notification for a Class II medical device (Appliance for reconstruction of bone to soft tissue). The core purpose of a 510(k) is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics as the predicate, or, if it has different technological characteristics, that the new characteristics do not raise new questions of safety and effectiveness.

For this device, the "acceptance criteria" are predominantly related to demonstrating functional equivalence and safety through bench testing and biocompatibility testing, rather than clinical performance metrics in a study involving human subjects. The acceptance criteria for these tests would typically be defined as meeting certain material properties, mechanical strength thresholds, and biological compatibility standards that are comparable to or better than the predicate device and established industry standards.

The "study" that proves the device meets these criteria is the functional and integrity bench testing and biocompatibility testing performed.

1. Table of Acceptance Criteria and Reported Device Performance:

Since the document does not explicitly list numerical acceptance criteria or detailed results of specific tests (e.g., "tensile strength must be > X MPa, and device achieved Y MPa"), a precise table cannot be constructed. However, based on the text, the general acceptance criteria and performance can be inferred:

Regarding the other requested information:

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

• Not Applicable. This submission details design verification and validation through bench testing and biocompatibility, not clinical data sets involving human subjects. Therefore, there's no "test set" of patient data, data provenance, or retrospective/prospective nature to describe in that context. The "sample size" for bench tests would refer to the number of devices tested, which is not specified in this summary.

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. As no clinical "test set" data from patients was used, there was no need for experts to establish ground truth in this manner. Evaluation was based on engineering and biological testing standards.

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

• Not Applicable. No human-based adjudication of patient data was required for this type of submission.

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/algorithm-based device and no MRMC studies were conducted or relevant.

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

• Not Applicable. This is a hardware implantable device, not an algorithm.

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

• For the functional and integrity testing, the "ground truth" would be established engineering specifications, mechanical principles, and validated test methods.
• For biocompatibility, the "ground truth" is established biological safety standards as outlined in documents like ISO 10993 (referenced as "International Standard to die FDA garadies dooament, OB B Medical Devices Part 1: Evaluation and Testing" and FDA Memorandum #G95-1).

8. The sample size for the training set:

• Not Applicable. No machine learning model or "training set" was involved.

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

• Not Applicable. As above, no training set was used.

Ask a specific question about this device

The Mitek BioKnotless Suture Anchor is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: Shoulder; Bankhart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulolabral reconstruction, biceps tenodesis, deltoid repair. Ankle; Lateral instability, medial instability, Achilles tendon repair/reconstruction, midfoot reconstruction. Foot; Hallux Valgus reconstruction. Elbow; Tennis elbow repair, Biceps tendon reattachment. Knee; Extra capsular repairs, reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.

The device described in this 510(k) is a sterile, preloaded, disposable, absorbable suture anchor/inserter assembly designed to allow soft tissue repair to bone. The product is designed for single patient use only. The anchor is constructed of Polylactic Acid (PLA) and the Panacry)™ suture is a braided long term absorbable suture.

This document describes the BioKnotless Anchor, a sterile, preloaded, disposable, absorbable suture anchor/inserter assembly designed for soft tissue repair to bone. The information provided outlines the safety and effectiveness summary as required for a 510(k) premarket notification.

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

The document does not explicitly state quantitative acceptance criteria or a specific table detailing such criteria. However, it mentions the types of tests performed and the conclusion regarding substantial equivalence.

2. Sample sized used for the test set and the data provenance

The document does not specify the sample sizes for the functional and integrity bench testing or the biocompatibility testing. The data provenance is not explicitly stated beyond the mention of "bench testing" and "in vitro testing," which generally implies laboratory-controlled studies. There is no information regarding country of origin or whether the data was retrospective or prospective in a clinical sense, as these were bench and in vitro tests, not human studies.

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. The study involved bench testing and in vitro performance, not expert-derived ground truth as would be relevant for diagnostic AI/medical imaging devices. The "ground truth" here would be the physical properties and performance measured directly by scientific methods and instrumentation.

4. Adjudication method for the test set

This section is not applicable for the type of testing described (bench and in vitro performance). Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving expert interpretation, which is not the case here.

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

No, an MRMC comparative effectiveness study was not done. This device is a physical surgical anchor, not an AI or diagnostic imaging device that involves human readers or AI assistance.

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

This section is not applicable. The BioKnotless Anchor is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's evaluation was based on objective, measurable physical and chemical properties and performance characteristics. This includes:

• Mechanical Strength: Measured through tests like anchor pullout from bone.
• In Vitro Performance: Other measurable mechanical properties under laboratory conditions.
• Biocompatibility: Assessment against established international standards (ISO-10933), likely involving laboratory assays and material characterization.

These are not "expert consensus," "pathology," or "outcomes data" in the traditional sense, but rather direct measurements of the device's physical and biological interactions.

8. The sample size for the training set

This section is not applicable. There is no "training set" in the context of evaluating a physical medical device like a surgical anchor. Training sets are relevant for machine learning algorithms.

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

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

Ask a specific question about this device

The RigidFix™ Tibial ACL CrossPin System is indicated for tibial fixation of autograft or allograft ACL soft tissue grafts (semitendinosus and gracilis).

The device described in this 510(k) is a sterile, disposable device designed for single patient use only. The crosspins are constructed of bioabsorbable Poly L-lactic Acid (PLA).

The provided text describes a medical device, the RigidFix™ Tibial Soft Tissue ACL Crosspin System, and its submission for FDA 510(k) clearance. However, it does not include detailed acceptance criteria or the specifics of a study proving the device meets those criteria in the way you've outlined for performance metrics (e.g., sensitivity, specificity, or improvement over human readers).

Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on functional and integrity bench testing and biocompatibility testing. This is a common pathway for Class II medical devices in the US, where the aim is not to prove superiority, but rather that the new device is as safe and effective as a legally marketed predicate.

Here's an analysis based on the information provided, addressing your requested points as much as possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria (e.g., specific tensile strength values, percentage reduction in failure rate) and corresponding reported device performance in the manner you'd expect for an AI/diagnostic device.

Instead, the "acceptance criteria" are implicitly met by:

Important Note: The document states, "Specifically, testing was performed to determine the initial fixation strength of the Tibial RigidFix CrossPin System when used for Hamstring Grafted ACL Reconstructions." However, it does not provide the specific numerical results of this testing or the pre-defined target values that would constitute "acceptance." The conclusion is that the data supported substantial equivalence.

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

• Test Set Sample Size: Not specified. This would typically refer to the number of biological samples or specimens used in the bench testing.
• Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory environment, not on human subjects. Therefore, there is no country of origin for human data, and it is not retrospective or prospective in the clinical trial sense.

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

• Number of Experts: Not applicable. For bench testing of initial fixation strength and biocompatibility, "experts" in the sense of clinical specialists establishing a "ground truth" for diagnostic purposes aren't typically involved. The "ground truth" is derived from engineering measurements and established biological safety standards.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Adjudication methods (like 2+1) are typically used in clinical studies or diagnostic performance evaluations involving human interpretation. For bench testing, results are usually objectively measured and compared against engineering specifications or established standards.

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

• Was it done?: No, an MRMC study was not done.
• Effect Size: Not applicable, as no MRMC study was performed. MRMC studies are relevant for evaluating the impact of AI on human reader performance, which is not the type of evaluation described for this device.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

• Was it done?: Essentially, yes. The "functional and integrity bench testing" and "biocompatibility testing" represent a standalone evaluation of the device's physical and biological properties. There is no "human-in-the-loop" component to how the device functions in these tests. The device's performance is measured directly (e.g., how much force it can withstand, its biological interaction with tissues).

7. Type of Ground Truth Used

• Ground Truth Type:
  • Bench Testing (Functional/Integrity): The ground truth is based on engineering measurements and biomechanical properties, compared against established performance characteristics of predicate devices or industry standards for fixation strength.
  • Biocompatibility Testing: The ground truth is based on biological safety standards as outlined in ODE Blue Book Memorandum #G95-1 (ISO-10933), which involves in-vitro and/or in-vivo tests to assess toxicity, irritation, sensitization, etc.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is a physical implant, not an AI algorithm that requires a "training set" of data. The manufacturing process is validated, and the device itself is tested.

9. How Ground Truth for the Training Set Was Established

• Ground Truth Establishment: Not applicable, as there is no training set for this type of device.

In summary: The provided document is a 510(k) summary for a medical device (a crosspin system) seeking clearance based on substantial equivalence. The "acceptance criteria" and "study" described are focused on bench testing for physical performance and biocompatibility testing against established regulatory standards, rather than clinical efficacy trials or AI algorithm performance evaluations. The key outcome is that the testing data supported the claim of substantial equivalence to predicate devices.

Ask a specific question about this device

The Mitek RapidLoc™ Meniscal Repair System is intended for use in the arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) located in the vascularized area of the meniscus (red-red and red-white zones).

The Mitek RapidLoc™ Meniscal Repair System described in this 510(k) is a sterile, two I router Description: "Ho witting of a molded PLA Backstop and Tophat.

This 510(k) premarket notification describes a medical device, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and training data, which are typically associated with performance validation of AI/ML models, is not applicable in this context.

The provided document focuses on demonstrating substantial equivalence of the Mitek RapidLoc™ Meniscal Repair System to predicate devices through performance testing and similarities in design, operating principle, and biocompatibility.

Here's a breakdown of the relevant information from the document, tailored to a non-AI/ML medical device submission:

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

The document does not explicitly state numerical "acceptance criteria" against which the device performance is measured in a quantitative table format. Instead, it indicates that "Safety and Performance data has been provided to support substantial equivalence." The reported performance is in comparison to predicate devices.

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 does not specify the sample sizes used for the performance testing (strength and suture comparisons) nor does it provide details on data provenance (country of origin, retrospective/prospective). This type of detail is typically found in the full testing reports or study protocols, not usually in the 510(k) summary itself.

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. For a physical medical device like a meniscal repair system, "ground truth" as it relates to expert consensus for diagnostic interpretation is not relevant. Performance testing involves objective measurements of physical properties (e.g., strength).

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

This question is not applicable. Adjudication methods are typically employed for subjective evaluations or consensus-building in clinical assessments, not for objective mechanical performance testing of a physical device.

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 surgical implant, not an imaging or diagnostic aid that would involve human "readers" or AI assistance.

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

This question is not applicable, as the device is not an algorithm or AI system.

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

This question is not applicable in the typical sense for an AI/ML device. For this physical device, the "ground truth" against which performance is measured would be established engineering standards, biomechanical principles, and the performance characteristics of legally marketed predicate devices.

8. The sample size for the training set:

This question is not applicable. The device is not an AI/ML model, so there is no "training set."

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

This question is not applicable, as the device is not an AI/ML model.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

The ReSolve ™ QuickAnchor is used for the fixation of absorbable monofilament polydioxanone surgical suture to bone. This product is intended for the following indications:

Cranio/Maxillofacial:

Repair, reconstruction or reattachment of tendons, ligaments, muscles and soft tissue flaps to the parietal, temporal ridge, frontal, mandible, maxilla, zygoma and periorbital bones of the skull.

The device described in this 510(k) is a sterile implant used to anchor or lock suture within pre-drilled bone sites and firmly secure soft tissue to bone.

The provided document describes a medical device, the ReSolve™ QuickAnchor, and its 510(k) premarket notification. It outlines performance data related to its safety and mechanical characteristics, rather than diagnostic or AI-driven performance. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable as they relate to studies of diagnostic accuracy or AI system performance.

Here's an analysis of the available information:

Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The study conducted to prove the device meets acceptance criteria involved several mechanical and material tests.

1. Table of Acceptance Criteria and Reported Device Performance (as above)

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

• Test Set Sample Size: Not explicitly stated. The document mentions "preserved human cadaver skull" for pullout force testing but does not provide the number of specimens or tests conducted.
• Data Provenance: The pullout force testing was conducted on "preserved human cadaver skull," indicating the use of human anatomical specimens, likely from the country where the testing was performed (not specified). This is a prospective study in terms of testing the device, but the cadaver material itself is "retrospective" in the sense that it's from deceased individuals.

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

• Not Applicable. This device is a mechanical implant, not a diagnostic tool or AI algorithm. Ground truth, in this context, would be established by physical measurements and engineering standards, not expert interpretation of outputs.

4. Adjudication method for the test set:

• Not Applicable. As this is a mechanical device being tested for physical properties, there is no "adjudication method" in the sense of reconciling subjective expert interpretations. Results would be based on quantitative measurements.

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

• Not Applicable. This is not a diagnostic device or AI system that involves human readers or AI assistance.

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

• Not Applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for the performance testing of this device is derived from direct physical measurements and mechanical properties. For example:
  • Pullout force: Measured by applying a force until the anchor disengages, compared against established biomechanical requirements for similar devices or anatomical structures.
  • Strength comparison: Directly comparing measured forces/strengths of the ReSolve™ QuickAnchor against those of predicate devices.
  • Skull thickness measurements: Direct physical measurements of skull bone thickness to ensure the device is compatible with the intended anatomical sites.
• It is based on objective, quantifiable engineering and biomechanical principles, not expert consensus, pathology, or outcomes data in the traditional sense of diagnostic validation.

8. The sample size for the training set:

• Not Applicable. This is a physical device, not an AI algorithm that requires a "training set."

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

• Not Applicable. This is a physical device, not an AI algorithm.

Ask a specific question about this device