Search Results

The Lorenz Orthodontic Anchorage System implants are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth.

The Walter Lorenz Surgical Orthodontic Anchorage System is comprised of a variety of plates and screws designed to provide anchorage for orthodontic procedures.

The provided text is a 510(k) summary for the Lorenz Orthodontic Anchorage System. It describes the device, its intended use, materials, and substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.

Therefore, I cannot provide the requested information in the table format or answer the specific questions about studies, sample sizes, ground truth, or expert involvement, as that data is not present in the provided submission.

The document essentially states that the device is substantially equivalent to previously cleared devices based on its application and function. This type of submission (510(k)) typically relies on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials with specific acceptance criteria and performance metrics like those for a PMA submission or some de novo classifications.

Ask a specific question about this device

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

The Lorenz Titanium Fracture / Rexastructive Devices are comprised of a variety of titanium fracture and reconstruction plates and screws with shapes and sizes designed for neassion of modition of marco on a varior of manum natures. The screws have both cross drive and canter dive head features, lag sames and as males will includes will includes straight, angle, double angle, and crescent, options with various lengths and thickness.

The Lorenz Titanium Fracture / Reconstructive Pre-Bent Plates are comprised of a specific range of existing plates. The plate is pre-shaped based on a CT Scan provided by the Surgeon specifically for a certain patient.

The Pro-batt plates may, in special cases, be attached to our Temporary Add-on Condyle (cleared under K002790). In these cases, the package inserts for both the Temporary Add-on Condyle will be included with the product. The poduct of the postkage insert for the Temporay Add-on Condyle is specific in identifying that on only indicated for temporary reconstruction and is not intended to a permanent implant

This document is a 510(k) summary for the Walter Lorenz Surgical Mandibular Fracture/Reconstruction Devices and Pre-bent Plates. It does not describe a study that uses acceptance criteria and reports on device performance in the way requested by the prompt for an AI/CADe device. Instead, it details the substantial equivalence of the new device to previously cleared predicate devices.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set details) because this document does not pertain to the validation of an AI/CADe system. It is a regulatory submission for a physical surgical device.

Ask a specific question about this device

Lorenz 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.

The Lorenz Sternal Closure System 2.4 self drilling screws are 2.4 mm in diameter and the lengths may range up to 16mm. The tip of the screw is designed so that a predrilled hole is not required, but may be used. Material: Titanium. The Lorenz Sternal Closure System will be marketed as non-sterile, single use devices.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance results from a study, sample sizes, expert qualifications, or details about ground truth establishment. The document is a 510(k) summary for the Lorenz Sternal Closure System, primarily focusing on its intended use, description, materials, sterility, and substantial equivalence to previously cleared devices. It also lists possible risks associated with the device.

Therefore, I cannot fulfill your request for the table and study details based on the given input.

Ask a specific question about this device

The Lorenz Twist Drills are intended to be used for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.

Lorenz Twist drills are drill bits which can either be attached to a manual instrument handle or attached to a powered handpiece/drill motor and used to drill holes in bone.

This document, K062842, is a 510(k) summary for the Lorenz Twist Drills. A 510(k) submission is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device and does not, therefore, require a Premarket Approval (PMA).

This document does not contain information regarding detailed acceptance criteria or a study that proves the device meets specific performance criteria beyond substantial equivalence. 510(k) submissions typically focus on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics, intended use, and performance data if relevant, rather than detailed clinical studies with specific performance benchmarks common for novel devices.

Therefore, many of the requested fields cannot be filled from the provided text because such information is not typically included in this type of FDA submission for devices like simple surgical drills.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Explanation: The document does not describe specific numerical acceptance criteria (e.g., drill bit sharpness, durability over a certain number of uses, or specific force required for drilling) or quantitative performance data to meet such criteria. The 510(k) process for a device like a twist drill primarily relies on demonstrating substantial equivalence to legally marketed predicate devices, implying that the performance is similar and acceptable based on the predicate's established safety and effectiveness. The materials (Stainless Steel) are mentioned, which is a key characteristic for comparison.

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.
• Data Provenance: Not specified.

Explanation: This 510(k) summary does not mention any specific test sets, clinical studies, or data provenance to evaluate the device's performance in a quantitative manner. The evaluation is centered on a comparison to predicate devices.

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. No ground truth establishment for a test set is described in this 510(k) summary. Surgical drills, particularly those intended for general bone drilling, typically do not require expert-established ground truth in the same way an AI diagnostic device would.

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

Not applicable. No adjudication method is mentioned as there is no described test set requiring one.

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 device is a manual/powered surgical drill, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.

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

Not applicable. This device is a physical surgical instrument, not an algorithm.

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

Not applicable. As noted earlier, ground truth in the context of expert consensus or pathology is typically for diagnostic devices. For a surgical drill, the "ground truth" of its function would be its ability to drill holes in bone effectively and safely, traditionally assessed through engineering tests and comparison to established predicate devices, rather than a clinical ground truth established by experts in a diagnostic sense.

8. 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.

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

Not applicable. There is no mention of a training set or ground truth establishment for such a set.

Ask a specific question about this device

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

Pectus Pre-bent Support Bar: A stainless steel or titanium bar, variable length from 7 to 17 inches, and 0.50 inches wide, with two holes and notches on both ends for sutures to secure the bar to the lateral chest wall. The bar is pre-shaped based on a CT Scan provided by the Surgeon specifically for a certain patient. The titanium bar is only used when the patient has a nickel allergy.

Pectus Titanium Support Bar Stabilizer: A titanium elongated plate with a dovetail slot in the center of the plate for the Pectus Bar to slide into. Two lips come up over the bar to secure the Pectus Bar within the slot of the stabilizer. The stabilizers have two holes on either side of the slot to suture the stabilizer to the lateral chest wall together with the support bar preventing lateral movement and flipping of the bar.

The provided text is a 510(k) Summary for a medical device (Lorenz Pectus Support Bar System) and associated FDA correspondence. This type of document is a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device, not necessarily to prove that the device meets specific acceptance criteria through a clinical study with performance metrics in the way a clinical trial for a new drug or diagnostic algorithm would.

Therefore, the requested information about acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not present in this document. This 510(k) relies on comparison to previously cleared devices.

Here's why the information you're asking for isn't in this document:

• Acceptance Criteria & Reported Performance: The 510(k) process for this type of device (metallic bone fixation appliances) typically focuses on material safety, mechanical properties, and design similarity to a predicate device. Performance is largely inferred from the predicate device's established safety and effectiveness. There isn't a table of specific clinical "acceptance criteria" (e.g., sensitivity, specificity for a diagnostic device) and reported device performance in this context.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone: These are all elements typically found in clinical studies, especially for diagnostic or AI-driven devices. This 510(k) submission is for a surgical implant, where clinical outcomes are often assessed through post-market surveillance or through specific clinical trials if the device is novel enough to warrant a PMA (Premarket Approval) rather than a 510(k). The focus here is on engineering and material equivalence to existing devices.
• Ground Truth: For a surgical implant, "ground truth" wouldn't be established in the same way as for a diagnostic device (e.g., pathology slide for cancer detection). Clinical success (e.g., correction of deformity, absence of complications) would be the outcome measure, but this document specifies the device's intended use and substantial equivalence, not a trial demonstrating these outcomes.
• Training Set: This device is a physical implant, not an AI algorithm. Therefore, there is no "training set" in the computational sense.

Summary based on the provided document:

• No acceptance criteria for device performance (e.g., sensitivity/specificity) is defined or studied in this document. The acceptance is based on demonstrating substantial equivalence to predicate devices (K981789 and K972420).
• No clinical study demonstrating device performance against specific acceptance criteria is described.
• The document does not contain information about:
  • Sample sizes for test or training sets.
  • Data provenance.
  • Number or qualifications of experts.
  • Adjudication methods.
  • Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
  • Standalone algorithm performance.
  • Type or method of establishing ground truth in a clinical study context.

The "study" that proves the device meets "acceptance criteria" in the context of this 510(k) submission is the comparison of its technological features and materials to predicate devices, and the conclusion that it is substantially similar in application and function. The acceptance criteria here are regulatory: demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Ask a specific question about this device

OtoMimix™ is indicated for the following:

1. Augmentation or coupling of the middle ear ossicles.
2. Attachment of the middle ear ossicles to middle ear implants.
3. Mechanical stabilization of middle ear prostheses
4. Reconstruction of the posterior canal wall

OtoMimix™ is a sterile calcium phosphate Bone Replacement product. When mixed with a stering solution, it becomes moldable material for use in otology procedures. With time, this moldable filler material hardens.

The OtoMimix™ device is a calcium phosphate bone replacement product intended for use in otology procedures for augmentation or coupling of middle ear ossicles, attachment of ossicles to middle ear implants, mechanical stabilization of middle ear prostheses, and reconstruction of the posterior canal wall. The provided document does not contain an explicit list of acceptance criteria or a detailed study proving the device meets specific performance metrics. Instead, the submission relies on demonstrating substantial equivalence to previously approved predicate devices to establish its safety and effectiveness.

Here's an analysis based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

As there are no explicit quantitative acceptance criteria or detailed performance study results (e.g., success rates, functional outcomes, specific measurements) provided in the summaries for OtoMimix™, a direct table comparing "acceptance criteria" against "reported device performance" cannot be fully constructed in the conventional sense for a performance study.

However, we can infer the "acceptance criteria" from the substantial equivalence comparison to predicate devices, focusing on material composition, indications for use, and critical characteristics. The "reported device performance" in this context is the assertion that OtoMimix™ shares these characteristics with the approved predicates.

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

The document does not describe a clinical "test set" in the context of a performance study for OtoMimix™. The device's safety and effectiveness are established through substantial equivalence to predicate devices. This means that instead of conducting a new large-scale clinical trial for OtoMimix™, its characteristics (materials, indications, technological features) were compared to predicates already legally marketed.

The key 'data' supporting equivalence are:

• Material composition: OtoMimix™ uses Calcium Phosphate cement, which is stated to be the "Same as Mimix Predicate."
• Ototoxicity: "Demonstrated to be non-ototoxic (Dornhoffer et al.)" for OtoMimix™, similar to the Mimix predicate. This likely refers to preclinical or clinical data associated with the material class or directly with the Mimix predicate, rather than a specific new study on OtoMimix™ itself in this submission. The origin of this Dornhoffer et al. data (country, retrospective/prospective) is not specified.

Therefore, there is no direct "test set" with a specified sample size or explicit data provenance for OtoMimix™'s performance study within this submission.

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

Not applicable. As noted above, there was no independent "test set" requiring expert ground truth establishment for OtoMimix™'s performance study. The evaluation was primarily a comparison of device characteristics against approved predicate devices by the FDA review team.

4. Adjudication method for the test set

Not applicable. There was no "test set" for which adjudication of results would be required. The FDA's review process determines substantial equivalence based on the submitted information and comparison to predicates.

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 device is a surgical implant/cement, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is irrelevant to this submission.

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

Not applicable. This device is a physical product (bone replacement material), not a software algorithm.

7. The type of ground truth used

The "ground truth" for the substantial equivalence determination relies on:

• Predicate Device Approvals: The regulatory history and approved characteristics of Mimix (K990290, K003494), Oto-Cem (K011338), and Incus Stapes Prosthesis (K861369). These devices already have established safety and effectiveness.
• Material Science/Bench Testing: The assertion that OtoMimix™'s material, technological features, and ototoxicity are "Same as Mimix Predicate," implying that the data (e.g., biocompatiability, mechanical properties, ototoxicity studies like Dornhoffer et al.) associated with the Mimix predicate serve as the basis for OtoMimix™.
• Literature/Expert Consensus: The affirmation that hydroxyapatite is a commonly used material for middle ear prostheses and has an "Extensive history of middle ear use."

8. The sample size for the training set

Not applicable. This device is a physical product, not a machine learning model, so there is no training set.

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

Not applicable.

Ask a specific question about this device

The Lorenz Resorbable Distraction System includes devices intended for use in bone stabilization and elongation (lengthening) when correction of oral (alveolar ridge), cranial, and maxillofacial deficiencies or post-traumatic defects require gradual bone distraction. The Lorenz Resorbable System also includes devices intended for use in bone stabilization and elongation (lengthening) when correction of mandibular deficiencies or post-traumatic defects require gradual bone distraction in patients two (2) years old or younger. The mid-face distractor is indicated primarily for LeFort III osteotomies.

This distractor system is identical to the one cleared in 510(k) Premarket Notification (K002083). This device is composed of the same Lactosorb® end plates and fixation screws, and stainless steel drive screws with the added indication of mandibular distraction. The Mandibular Distractor is the same as our previously cleared Alveolar Ridge Resorbable Distractor (K002083) with the added indication of mandibular distraction. The Alveolar Ridge Resorbable Distractor is an implantable device used to increase the height of the maxilla or mandible or to replace bone in the Alveolar Ridge, used for multiple tooth deficiencies. This device is composed of two resorbable plates and a stainless steel drive screw. Several lengths of drive screw can be selected to achieve up to 25 mm of distraction. The Mandibular Distractor can incorporate either of the two Alveolar Ridge resorbable devices with no design changes. In addition, a third device is included that is identical to the two Mandibular or Ramus lengthening devices with no design changes. Each device is composed of two resorbable Alveolar Ridge resorbable plates and a stainless steel drive screw with permanently attached shaft extension. The devices would be positioned internally with drive screws externalized on the external activated side of the advancement. Complete osteotomy would be completed prior to device placement. Lactosorb plates would be affixed to bone using Lactosorb screws. Distraction would be completed by turning the drive screw using the attached shaft extension, causing the plates to separate. After distraction and consolidation, the drive shaft is detached from the plates and removed while the plates and screws remain internal and are resorbed.

Walter Lorenz Surgical, Inc. manufactures and distributes distraction devices for use in bone stabilization and elongation (lengthening) when correction of oral, cranial, mandibular and maxillofacial deficiencies or post traumatic defects require gradual bone distraction. Each implantable distraction device has a titanium alloy drive screw mechanism and LactoSorb® resorbable connection plates, which are implanted by fixation with LactoSorb® bone screws. Each device is made from one of the following material(s): LactoSorb®, Titanium 6Al 4V Alloy, ASTM F-136, Stainless Steel, ASTM F-138. LactoSorb® is a resorbable copolymer, a polyester derivative of lactic and glycolic acids. Polylactic/polyglycolic acid copolymer degrades and resorbs IN VIVO by hydrolysis into lactic and glycolic acids that are then metabolized by the body.

This document is a 510(k) Premarket Notification for the Lorenz Resorbable Distraction System, which means it's a submission to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. It is not a clinical study report that establishes performance criteria through testing and provides acceptance criteria.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as this information is not present in the provided text. The document focuses on demonstrating substantial equivalence to a previously cleared device (K002083 and others) rather than presenting new performance data from a specific study.

The document states:

• "This distractor system is identical to the one cleared in 510(k) Premarket Notification (K002083)." (Page 0)
• "The Mandibular Distractor is the same as our previously cleared Alveolar Ridge Resorbable Distractor (K002083) with its added indication of mandibular distraction." (Page 0)
• "Lactosorb® Biocompatibility has been provided by 510(k) notifications for use in bone plates (K992355, K992158, K971870, K960988, K955729) and bone screws (K981666, K960988) for cranial and maxillofacial use." (Page 0)
• The "Substantial Equivalence" section lists other Lorenz Distraction Systems and Resorbable Fixation Screws and Plates as comparators. (Page 1)

These statements indicate that the submission relies on the established safety and effectiveness of the predicate devices. The listed "RELATED ARTICLES" are general academic papers on distraction osteogenesis and resorbable fixation, not specific studies conducted by the manufacturer for this particular 510(k) submission to establish new performance metrics.

In summary, the provided text does not contain:

1. A table of acceptance criteria and reported device performance.
2. Information on sample sizes, data provenance, or ground truth for a test set.
3. Details about expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance.
4. Information on training set size or how its ground truth was established, as this is not a machine learning device.

The document is a regulatory submission demonstrating equivalence, not a detailed technical report of a performance study.

Ask a specific question about this device

Self-Drilling Radiographic Markers are used as radiopaque markers and may be implanted into bone during orthopedic or other surgical procedures. These devices are used to measure movement of implants or serve as a reference point to locate anatomical structures with the aid of an X-ray.

The Self-drilling Radiographic Markers are zirconium bone screws used as radiographic markers, and may be implanted into bone during orthopedic or other surgical procedures. These devices are used to measure movement of implants after surgery with the aid of an Xray. Self-drilling Radiographic Markers are applied with manual surgical instruments.

This document describes a 510(k) premarket notification for a Self-Drilling Radiographic Marker. A 510(k) submission primarily demonstrates substantial equivalence to a predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, many of the requested details about acceptance criteria, specific study design elements, and performance metrics are not typically found or required in a 510(k) submission of this nature. The provided text focuses on comparing the new device to a predicate device based on technological features and intended use.

Here's an analysis based on the provided text, addressing the points where information is available or noting its absence:

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

This information is not provided in the 510(k) submission. For devices cleared through 510(k) that are substantially equivalent to a predicate, explicit performance acceptance criteria and reported numerical performance metrics from a study are generally not required if the technological characteristics and intended use are similar, and safety/effectiveness are deemed comparable. The 510(k) focuses on demonstrating equivalence.

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

This information is not provided. As this is a medical device (radiographic marker) cleared via 510(k) based on substantial equivalence to a predicate, a clinical study with a "test set" in the context of an AI/imaging algorithm is not applicable. The documentation discusses the device's material and intended use, not its performance in an imaging study against a ground truth.

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 information is not provided and is not applicable to this type of 510(k) submission. Ground truth establishment with experts is relevant for diagnostic devices that analyze images or data, not for passive implantable markers.

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

This information is not provided and is not applicable.

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 information is not provided and is not applicable. This device is a radiographic marker, not an AI or imaging diagnostic tool that would assist human readers.

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

This information is not provided and is not applicable. This device is an implantable marker, not an algorithm.

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

This information is not provided and is not applicable.

8. The sample size for the training set

This information is not provided and is not applicable. There is no "training set" in the context of an implantable radiographic marker whose clearance is based on substantial equivalence to a predicate device.

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

This information is not provided and is not applicable.

Summary of the 510(k) Submission for Self-Drilling Radiographic Markers:

The 510(k) submission (K04099D) for the Self-Drilling Radiographic Markers demonstrates substantial equivalence to a predicate device (Stainless Steel Self-Drilling Radiographic Marker, K014148). The core argument for acceptance is based on the similarity of:

• Intended Use: Both the new and predicate devices are zirconium/stainless steel screws used as radiographic markers, implanted into bone during orthopedic or other surgical procedures to measure implant movement or serve as reference points with X-ray aid.
• Technological Characteristics:
  • Both are non-absorbable materials (zirconium for the new device, stainless steel for the predicate).
  • Both are listed in the FDA's Biomaterials Compendium and recognized standards.
  • Both are implanted into bone during surgical procedures at a surgical location.
  • The metallic materials and their intended use as radiographic markers are considered "technically equivalent."

Conclusion: The FDA concluded that the device is substantially equivalent to the legally marketed predicate device (K014148), allowing it to proceed to market under the general controls provisions of the Medical Device Amendments. This clearance is not based on a study with specific, pre-defined quantitative acceptance criteria and performance metrics typically associated with AI or diagnostic imaging algorithms, but rather on a comparison of safety and effectiveness to a currently marketed device.

Ask a specific question about this device

The Lorenz Self-Drilling IMF Screw is intended for use as a bone screw in temporary fixation of the maxilla and mandible, providing indirect stabilization of fractures of the maxilla and/or the mandible.

The Self-drilling IMF bone screw for maxillomandibular fixation is 2.0mm in diameter and the thread lengths may range from 5mm - 11mm. The head has a relief groove which may or may not have a hole in which wire or elastic bands can be wrapped around the screws which are temporarily implanted in the maxilla and mandible.

This document is a 510(k) premarket notification for a medical device (Lorenz Self-Drilling IMF Screws). It primarily serves to demonstrate substantial equivalence to a predicate device, rather than providing a detailed study that proves the device meets specific acceptance criteria based on performance studies.

Therefore, many of the requested categories (acceptance criteria table, sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth was established) are not applicable or not provided in this type of regulatory submission.

The document focuses on comparing the new device's technological features and intended use to a previously cleared predicate device. It demonstrates similarity in materials and application, rather than presenting a performance study with detailed acceptance criteria and results from clinical or experimental trials.

Here's a breakdown based on the provided document:

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

• Not Applicable / Not Provided. This document is a 510(k) summary for substantial equivalence. It does not present specific performance criteria or results from a study designed to meet those criteria. The main "acceptance criteria" for a 510(k) is demonstrating substantial equivalence to a predicate device.

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 / Not Provided. No performance study with a test set is described in this 510(k) 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 / Not Provided. No ground truth establishment for a test set is described.

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

• Not Applicable / Not Provided. No test set or adjudication process is described.

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. This device is a bone screw (mechanical device), not an AI-powered diagnostic tool. MRMC studies are not relevant here.

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

• No. This device is a mechanical bone screw. "Standalone" performance in the context of algorithms is not relevant.

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

• Not Applicable / Not Provided. No ground truth, in the context of evaluating diagnostic or AI performance, is established or used here. The "ground truth" for a 510(k) typically relates to the safety and effectiveness of the predicate device based on its prior clearance.

8. The sample size for the training set:

• Not Applicable / Not Provided. There is no "training set" as this is a mechanical medical device, not an AI or diagnostic algorithm requiring data for training.

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

• Not Applicable / Not Provided. (See point 8).

Summary of the document's content:

The document (K040983) is a 510(k) premarket notification for the "Lorenz Self-Drilling IMF Screw." It demonstrates substantial equivalence to a predicate device (Lorenz IMF Screw, K983728).

• Device Description: The self-drilling IMF bone screw is 2.0mm in diameter with thread lengths from 5mm-11mm. It has a head with a relief groove for wire or elastic band wrapping.
• Intended Use: Temporary fixation of the maxilla and mandible, providing indirect stabilization of fractures of the maxilla and/or the mandible.
• Technological Features Comparison: Both the new and old devices are made of non-absorbable titanium. Both are implanted in bone during surgery for temporary fixation of the maxilla and mandible for fracture stabilization.
• Conclusion: The use of the modified IMF screws and the predicate IMF screws is substantially similar.

The "study" in this context is the comparison of technological features and intended use to the predicate device to establish substantial equivalence as required by the 510(k) process. This is a regulatory pathway, not a performance study in the traditional sense of evaluating specific metrics against predefined acceptance criteria for AI or diagnostic devices.

Ask a specific question about this device

Lorenz 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.

The Lorenz Sternal Closure System 2.4 self drilling screws are 2.4 mm in diameter and the lengths may range up to I the Lorental Storal Clobal v Systems so that a preditled hole is not required, but may be used.

This document is a 510(k) premarket notification for the "Lorenz Sternal Closure System," which is a metallic bone fixation appliance. The FDA determination is that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding specific acceptance criteria, device performance data, study details (like sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods), or any multi-reader multi-case (MRMC) or standalone studies.

The document primarily focuses on:

• Device Name: Lorenz Sternal Closure System
• Classification: Single/multiple component metallic bone fixation appliances and accessories (21 CFR 888.3030), Class II.
• Intended Use: Stabilization and fixation of fractures of the anterior chest wall, including sternal fixation following sternotomy and sternal reconstructive surgical procedures.
• Description: 2.4 mm self-drilling screws with variable lengths.
• Sterility: Marketed as non-sterile, single-use, with steam sterilization recommendations for hospitals.
• Substantial Equivalence: Claimed to be equivalent to Lorenz 2.4 Self Drilling Screw (K03228) and Lorenz Sternal Closure System (K011076).
• Possible Risks: Lists several potential complications associated with implants and surgical procedures.
• FDA Clearance: A letter from the FDA confirming substantial equivalence to predicate devices, allowing the device to be marketed.

Therefore, I cannot provide the requested table or details about acceptance criteria and study results because this information is not present in the provided text.

If this were a document about a software device or an AI/ML product, it would typically include a dedicated section for performance data, acceptance criteria, and study methodologies to demonstrate clinical efficacy and safety. For a physical implantable device like this, substantial equivalence is often established through material testing, mechanical performance testing (not detailed here), and comparison to predicate devices, rather than clinical studies with human readers or AI performance metrics.

Ask a specific question about this device