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The Biomet Microfixation Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion. The Biomet Microfixation Sternal Closure System is intended for use in patients with normal and poor bone quality.

Biomet Microfixation Sternal Closure System contains a variety of plates and 2.4mm and 2.7mm diameter self-drilling screws with maximum length of 20mm. The tip of the screw is designed so that a predrilled hole is not required, but may be used. Material: Titanium. Sterility Information: The Biomet Microfixation Sternal Closure System will be marketed as non-sterile, single use devices. Validated steam sterilization recommendations are included in the package insert.

The provided document is a 510(k) summary for the Biomet Microfixation Sternal Closure System. It is focused on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than describing a clinical study with detailed acceptance criteria and performance metrics typically found in clinical trials for AI/software devices. Therefore, much of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and specific study types (MRMC, standalone) is not applicable or not available in this type of regulatory submission.

The document primarily describes mechanical non-clinical testing to support the substantial equivalence claim.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" in the sense of predefined thresholds for clinical performance metrics (e.g., sensitivity, specificity) that a new AI device might have. Instead, the "performance" is demonstrated through mechanical non-clinical testing comparing the device to a predicate.

Study Proving Device Meets Acceptance Criteria:

A mechanical non-clinical testing study was performed.

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

• Test Set Sample Size: Not specified in terms of number of samples, but the testing involved a "polyurethane foam substrate" to simulate bone.
• Data Provenance: The mechanical testing was conducted using a "polyurethane foam substrate which simulates Osteoporotic bone." The article "Compressive properties of commercially available polyurethane foams as mechanical models for osteoporotic human cancellous bone" by Patel et al. is referenced as the basis for this simulation. This is a retrospective selection of a material model for testing, not real-world patient data.

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

• Not Applicable. Ground truth, in the context of diagnostic accuracy, is not relevant for this type of mechanical device testing. The "ground truth" here is the physical properties of the materials and the defined testing methodologies.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication is not relevant for mechanical device testing.

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

• No. An MRMC study is relevant for comparing diagnostic performance with and without AI assistance using human readers. This document describes a mechanical device, not a diagnostic AI system.

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

• Not Applicable. This is a hardware device, not an algorithm. The testing described is intrinsic to the device's physical properties.

7. Type of Ground Truth Used

• Physical properties and standardized test methods. The "ground truth" for this testing is the quantifiable mechanical performance (fatigue, shear force, lateral pull apart) of the device and the predicate under controlled laboratory conditions using a simulated bone substrate.

8. Sample Size for the Training Set

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

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

• Not Applicable. No training set was used.

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Biomet Microfixation SternaLock Blu Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures

Biomet Microfixation Sternal Closure System contains plates and 2.4mm and 2.7mm diameter self-drilling screw with maximum length of 20mm. The screw is designed so that a predrilled hole is not required, but may be used.

The provided text describes a 510(k) premarket notification for the Biomet Microfixation Sternal Closure System. The acceptance criteria and the study proving it meets these criteria are outlined in the "Substantial Equivalence" section of the document.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size: Not explicitly stated. The document refers to "mechanical testing" and "the devices" which implies a sample of devices were tested, but the specific number is not provided.
• Data Provenance: Not explicitly stated. However, given that it's mechanical testing of a medical device, it would be considered prospective testing performed in a controlled laboratory setting. The origin isn't specified beyond being conducted by Biomet Microfixation.

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

• Number of Experts: Not applicable. The "ground truth" for this type of mechanical testing is based on established engineering parameters and predicate device performance, not expert human interpretation.
• Qualifications of Experts: N/A

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. The tests are objective mechanical measurements, not subjective evaluations requiring adjudication.

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

• MRMC Study: No. This is a medical device (sternal closure system) involving physical implantation and mechanical performance, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.
• Effect Size: N/A

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

• Standalone Performance: Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used:

• The ground truth for the mechanical testing (Torsional insertion and fracture test) was based on: Established engineering parameters and the performance characteristics of predicate devices. The new device was required to "Meet or exceed parameters of predicates."

8. The sample size for the training set:

• Sample Size: Not applicable. This document describes mechanical testing for a physical implant, not a machine learning model that requires a training set.

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

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

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This device is intended for use in surgical procedures to repair Pectus Excavatum and other chest wall deformities.

The Biomet Microfixation Adkins Strut is a surgical implant intended to aid treatment of Pectus Excavatum and other sternal deformities. The strut provides the surgeon with a means to reposition bony structures (sternum, breastbone) by providing internal stabilization and fixation of the chest wall following surgical procedures such as the Ravitch procedure. The struts are available in various lengths with two holes on each end for sutures to secure the bar to the lateral chest wall. The titanium struts are used when the patient has a nickel allergy.

The provided text is a 510(k) summary for the Biomet Microfixation Adkins Strut. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance data for the new device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment for a new device performance study is not available in the provided text.

The 510(k) summary explicitly states:

"Substantial Equivalence Biomet Microfixation considers the Adkins Struts equivalent to the American V. Mueller Adkins Strut (Pre-amendment device)."

This indicates that the submission relies on the pre-amendment status of the predicate device, implying that extensive new device performance studies to establish specific acceptance criteria were not required in the same way they would be for a novel device. The FDA's letter (Page 1 of the filing) reiterates this by stating they have determined the device is "substantially equivalent...to legally marketed predicate devices."

As a result, I cannot populate the table or answer the specific questions about device performance against acceptance criteria based on this document.

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Intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.

The Mandibular Fracture / Reconstructive Devices (TraumaOne) are comprised of a variety of titanium fracture and reconstruction plates and screws with shapes and sizes designed for internal fixation of mandibular fractures and reconstruction procedures. The screws have locking head features. The plates have threaded through holes (which allows them to work with either the locking screws) and will include straight, angle, double angle, and crescent options with various lengths and thickness.

The provided text is a 510(k) summary for the Biomet Microfixation Mandibular Fracture / Reconstruction Devices (TraumaOne). This document is for a medical device (bone plates and screws for mandibular fractures) and focuses on demonstrating substantial equivalence to previously cleared devices, rather than detailing a clinical study with acceptance criteria and performance metrics for an AI/algorithm-based device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not present in the provided document.

This 510(k) summary describes:

• Device Name: Mandibular Fracture / Reconstructive Devices (TraumaOne)
• Intended Use: Stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.
• Contraindications: Active infection, foreign body sensitivity, limited blood supply/insufficient bone/latent infection, uncooperative patients, and unsupported use in mandibular resection cases without a graft.
• Description: Variety of titanium fracture and reconstruction plates and screws with locking head features.
• Sterility Information: Non-sterile, single-use devices.
• Possible Risks: Poor bone formation, nonunion, migration/bending/fracture of implant, metal sensitivity, decrease in bone density (stress shielding), pain/discomfort, increased fibrous tissue response, necrosis of bone, inadequate healing, and device failure if used to bridge resections without a graft.
• Substantial Equivalence to: Lorenz Titanium Fracture / Reconstructive Devices (K001238) and Lorenz Reconstruction System (K980512).

Conclusion: The provided document is a regulatory submission for a physical medical device (implants) seeking 510(k) clearance based on substantial equivalence. It does not involve an AI or algorithm-based device, and thus, the specific questions related to AI device evaluation (acceptance criteria, study design for performance, ground truth establishment, reader studies, etc.) are not applicable or answerable from this text.

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The Biomet Microfixation LactoSorb® Pectus Stabilizer is intended to be used with Lorenz Pectus Support Bars cleared via K972420 and K061384 for repairing Pectus Excavatum and other sternal deformities when additional stabilization is necessary.

The LactoSorb® Pectus Stabilizer provides the surgeon with a means to secure the Pectus Support Bar to the chest wall. The Biomet Microfixation Pectus Bar is used to reposition bony structures (sternum, breastbone) by applying internal force outwardly eliminating the funnel shaped deformity. The LactoSorb® Pectus Stabilizer is a resorbable implant and does not require removal.

The provided text is a 510(k) summary for the Biomet Microfixation LactoSorb® Pectus Stabilizer. It describes the device, its intended use, possible adverse effects, and claims substantial equivalence to predicate devices.

However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or any other data related to a clinical or performance study demonstrating the device meets specific acceptance criteria.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo clinical performance studies with acceptance criteria, as might be seen for novel devices or PMAs.

Therefore, I cannot provide the requested table and study details from the given text.

Summary of what is missing in the provided text to fulfill your request:

• Acceptance Criteria and Reported Device Performance: No specific performance metrics or thresholds are mentioned. The document focuses on device description and intended use.
• Study Details: There is no description of any study (clinical or non-clinical) conducted to evaluate the device's performance against defined acceptance criteria.
• Sample Sizes, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth Type, Training Set Details: All these elements relate to a performance study, which is not present in the provided 510(k) summary.

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