Search Results

The OsteoCentric® Unifi MI® TCS Plating System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including but not limited to periarticular and intraarticular fractures.

The OsteoCentric® UnifiMI® TCS Plating System consists of implants and instruments designed for fixation to treat fractures, deformations, revisions and replantations of bone and bone fragments. The purpose of the submission is for a line extension of the OsteoCentric Bone Plate and Screw System, which includes 2.7mm angle iron plates, additional screw sizes, and the inclusion of titanium as a material. The principal benefit of the proposed 2.7mm angle iron new plate geometry is that it allows for a stronger and more stable plate in a smaller form factor. Having a stronger and more stable plate in a smaller form factor has the potential clinical benefits of aiding the user in minimizing the incision required for the procedure and providing an option to the surgeon user that allows for the same strength and stability as a much larger plate, without having to disrupt as much soft tissue. This line extension has the same Indications for Use as the original system. This Line Extension will be known as the OsteoCentric® UnifiMI® TCS Plating System. The system features angle plates and bone screws for fixation that are locking or non-locking, and a set of instruments to facilitate installation and removal of the implants. The plates have screw holes, which allow for attachment to the bones or bone fragments. The plates are fabricated from medical grade stainless steel per ASTM F138 or Titanium per ASTM F136. Plates and screws are provided non-sterile. Instruments are provided non-sterile with instructions for sterilization.

This 510(k) clearance letter for the OsteoCentric® UnifiMI® TCS Plating System describes an orthopedic plating system, not an AI/software device. Therefore, the information typically found in a study proving acceptance criteria for an AI-based medical device (such as those involving performance metrics like sensitivity, specificity, or AUC, and details about training/test sets, expert ground truth, and reader studies) are not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices for a physical medical device (bone plates and screws) by assessing its mechanical performance.

Here's a breakdown based on the provided document, addressing the closest applicable points:

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

The document broadly states: "Engineering analysis was performed to demonstrate that the new bone plates and screws did not present a new worst-case. The data demonstrates that the subject device is substantially equivalent to the predicates."

While specific quantitative acceptance criteria and their corresponding reported performance values are not explicitly laid out in a table in this summary, the implicit acceptance criterion is:

• Acceptance Criterion: The mechanical strength and stability of the new 2.7mm angle iron plates and additional screw sizes must be equivalent to or better than the predicate devices, and not present a "new worst-case" scenario.
• Reported Device Performance: The data demonstrates substantial equivalence to the predicates in terms of mechanical strength and stability.

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

• Sample Size: Not explicitly stated in the public summary document. For mechanical testing of physical devices, this typically refers to the number of individual plates/screws tested.
• Data Provenance: Not applicable in the context of data acquisition for AI/software. The "data" here refers to the results of mechanical engineering tests (e.g., fatigue testing, static testing) performed on the physical devices. This testing would be done in a lab setting.

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

• Not applicable as this is a physical device clearance based on engineering testing, not clinical data requiring expert review for ground truth. The "ground truth" here is established by standardized mechanical testing methodologies (e.g., ASTM standards) and engineering principles.

4. Adjudication method for the test set:

• Not applicable. Mechanical test results are objective measurements (e.g., force, displacement), not subjective interpretations requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• No. This is a physical device, and MRMC studies are relevant for software/AI devices where human readers' performance with and without AI assistance is evaluated.

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

• Not applicable. This is not an algorithm.

7. The type of ground truth used:

• The "ground truth" for demonstrating substantial equivalence for this physical device is based on engineering analysis and standardized mechanical testing results. The performance of the subject device (strength, stability) is compared against the known performance characteristics of the predicate devices, likely derived from similar benchtop testing or regulatory submissions.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. No training set is involved.

Summary specific to this device type (physical orthopedic implant):

The "acceptance criteria" for this type of device primarily revolve around mechanical performance and material biocompatibility to ensure it is as safe and effective as existing legally marketed predicate devices. The study proving this involves:

• Non-Clinical Testing: "Engineering analysis was performed to demonstrate that the new bone plates and screws did not present a new worst-case." This would typically include:
  • Mechanical Testing: Such as static compression/tension/torsion tests, fatigue testing, push-out/pull-out tests for screw fixation. These tests are often conducted according to relevant ASTM or ISO standards for bone plates and screws.
  • Material Characterization: Ensuring the Titanium and Stainless Steel meet medical-grade specifications (ASTM F136, ASTM F138).
• Comparison to Predicates: The test results are then compared to the performance envelopes of the predicate devices. The "acceptance" is achieved if the new device's performance falls within an acceptable range, demonstrating it is "substantially equivalent" and does not introduce new safety or effectiveness concerns due to its mechanical properties or new geometry.

The document implicitly states that the acceptance criterion was met as the data demonstrated substantial equivalence to the predicates, particularly in showing that the "new bone plates and screws did not present a new worst-case."

Ask a specific question about this device

The OsteoCentric Bone Plate and Screw is intended for fixation of fractures, osteotomies, and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including, but not limited to periarticular, and intraarticular fractures

The subject system is a line extension that includes clavices (superior lateral, anterior mideral, and anterior midshaft) and additional locking and non-locking screws (2.1mm, and 2.7mm diameter). The plates and screws are fabricated from either medical grade stainless steel per ASTM F138 or Titanium per ASTM F136. Plates and screws are provided non-sterile. Instruments are provided non-sterile with instructions for sterilization.

This FDA 510(k) clearance letter is for a physical medical device (The OsteoCentric Bone Plate and Screw System), not an AI/Software as a Medical Device (SaMD). Therefore, the specific information requested in your prompt regarding AI/SaMD performance criteria, such as acceptance criteria based on accuracy, sensitivity, specificity, MRMC studies, training/test sets, and ground truth establishment, is not applicable to this document.

For traditional medical devices like the OsteoCentric Bone Plate and Screw System, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically addressed through non-clinical performance testing (e.g., mechanical testing, biocompatibility, sterilization validation) and comparison to predicate devices, rather than clinical studies involving human readers or AI algorithms.

However, I can extract the relevant information regarding the non-clinical testing and conclusions provided in the document:

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

The document doesn't present a formal table of acceptance criteria with numerical targets and reported performance in the way an AI/SaMD submission would. Instead, it states:

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 applicable. For mechanical testing of physical devices, "sample size" refers to the number of test articles (plates, screws) subjected to the engineering analyses. This specific number is not disclosed in the clearance letter but is part of the detailed test reports provided to the FDA.
• Data Provenance: Not applicable. The data comes from "Engineering analysis," which means laboratory testing and simulations performed on the device components themselves, not clinical data from patients or a specific country. This is in vitro data.

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. Ground truth for mechanical performance is established through objective, quantifiable engineering measurements against predefined standards or predicate device performance, not expert consensus interpretation.

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

Not applicable. Adjudication methods are relevant for subjective interpretations by multiple human readers, not for objective mechanical test results.

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 bone plate and screw system, not an AI-powered diagnostic tool.

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

Not applicable. This is a physical medical device.

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

The "ground truth" for this type of device's performance is based on objective engineering and mechanical properties (e.g., material strength, fatigue life, torsional rigidity, bending stiffness, screw pull-out strength). These properties are measured and evaluated against established industry standards (e.g., ASTM F138 for stainless steel, ASTM F136 for titanium) and/or comparison to predicate devices, which have a known history of safe and effective use.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI algorithm.

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

Not applicable. This is a physical medical device, not an AI algorithm.

In summary, the FDA 510(k) clearance for The OsteoCentric Bone Plate and Screw System relies on non-clinical engineering analysis and comparison to predicate devices to demonstrate substantial equivalence, rather than the types of performance studies typically conducted for AI/SaMD products.

Ask a specific question about this device

The OsteoCentric Cannulated Fasteners and Nuts is indicated for use in bone reconstruction, osteotomy, arthrodesis (joint fusion), and fixation of fractures and ligaments:

The OsteoCentric 2.4mm and 3.0mm Cannulated Screw are intended for fixation of fractures and non-unions of small bones and small bone arthrodesis. Examples include scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies.

The OsteoCentric 3.5mm Cannulated Screws are intended for the arthrodesis or fixation of fractures and fragments of hand, midfoot, and forefoot bones, extremity osteochondritis dissecans lesions, and for extremity ligament fixation.

The OsteoCentric 4.5mm to 8.0mm Cannulated Screws are intended for fixation of long bone fractures and fragments. Iong bone osteotomies, femoral neck fractures, slipped capital femoral epiphyses, as an adjunct to treatment with a dynamic hip screw (DHS) in basilar neck fractures, tibial plateau fractures, pediatric femoral neck fractures, intercondylar femur fractures, fixation of the pelvis and pelvic joints, and arthrodesis (e.g., ankle, subtalar).

The OsteoCentric 7.0mm and 8.0mm Cannulated Nut is indicated for reduction and stabilization of fractures or inter-osseous distances (e.g. syndesmosis injuries).

The OsteoCentric Technologies Cannulated Fasteners and Nuts come in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The fasteners are provided non- sterile and are manufactured from Stainless Steel per ASTM F138 or from Titanium per ASTM F136 or F1295. Instrumentation is also provided non-sterile to properly insert the OsteoCentric Technologies Cannulated Fasteners and Nuts. All instrumentation is intended to be reusable, with the exception of the guidewires are provided non-sterile and are intended for single-use only.

The provided text is a 510(k) summary from the FDA for a medical device (cannulated fasteners and nuts). It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria related to a software or AI based medical device.

The document primarily focuses on the physical characteristics, materials, and mechanical applications of bone fixation fasteners and nuts, asserting that the new device is "physically and technologically identical" to a previously cleared predicate device. There is no mention of an algorithm, AI, or any data-driven performance study typically associated with the type of questions asked (e.g., sample size, expert ground truth, MRMC studies, standalone performance).

Therefore, I cannot fulfill your request to describe acceptance criteria and associated study details for an AI/software device based on the provided text. The document is for a hardware medical device, not a software one.

Ask a specific question about this device

The OsteoCentric Dental Implants are indicated for surgical placement in partially or completely edentulous upper or lower jaws to provide a means for prosthetic attachment to restore a patient's chewing function. The OstecCentric Implants are indicated for immediate loading only when primary stability is achieved and with the appropriate occlusal loading.

The OsteoCentric Dental Implants are intended to be used with the Implant Logistics 300, 400, and 500 Series abutments and healing caps.

The OsteoCentric Dental Implants consist of self-tapping and threaded endosseous implants with root-form or wide thread forms, and cover screws. The root-form implant diameters range from 3.5 mm to 5.5 mm (8 mm to 14 mm lengths) and the wide thread implant diameters are available in 4.1 mm and 4.5 mm (8 mm lengths), 5.5 mm (8 mm to 12 mm lengths), and 6.5 mm (8 mm to 10 mm lengths). The specific diameters and length combinations are specified below:

• Root Form Implants:
  • Ø 3.5/ 8, 10, 12, and 14 mm
  • Ø 4.0/ 8, 10, 12, and 14 mm
  • Ø 4.5/ 8, 10, 12, and 14 mm
  • Ø 5.0/ 8, 10, 12, and 14 mm
  • Ø 5.5/ 8, 10, 12, and 14 mm
• Wide Form Implants:
  • Ø 4.1/ 8, 10, 12, and 14 mm
  • Ø 4.5/ 8, 10, 12, and 14 mm
  • Ø 5.5/ 8, 10, and 12 mm
  • Ø 6.5/ 8 and 10 mm

Cover screws provide protection to the threads of the connection during endosseous and gingival healing. Cover screws are pre-packaged with each implant. The OsteoCentric dental implants and cover screws are provided sterile. The implants, and cover screws are manufactured from titanium alloy (Ti-6A1-4V ELI; ASTM F136) or wrought titanium alloy (Ti-6Al-4V; ASTM F1472).

The OsteoCentric Dental Implants are intended for use with compatible abutments and healing caps manufactured by Implant Logistics.

This document is a 510(k) summary for OsteoCentric Dental Implants, a Class II medical device. The primary purpose of this type of submission is to demonstrate substantial equivalence to an already legally marketed predicate device, not necessarily to prove specific performance metrics against pre-defined acceptance criteria in the same way one might for a novel device or a software-as-a-medical-device (SaMD).

Therefore, the information typically requested regarding acceptance criteria, specific study designs (like MRMC), expert ground truthing, and training/test set details for AI/ML-based devices is not present in this document. This submission focuses on comparing the new device's design, materials, and mechanical performance (fatigue testing) to a predicate device, along with leveraging existing data for biocompatibility, sterility, shelf-life, etc.

Here's an attempt to answer your questions based on what is available in the document, and where applicable, explaining why the information is not present:

Analysis of the Provided Document for Acceptance Criteria and Device Performance Study Information:

The provided document is a 510(k) summary for OsteoCentric Dental Implants. This is a traditional medical device (dental implants), not a software or AI/ML-based device that would typically involve a test set, expert ground truth, multi-reader studies, or large training sets. The "acceptance criteria" here refer to demonstrating substantial equivalence to a predicate device, focusing on material, design, and mechanical performance, rather than clinical performance metrics in the way your questions are framed for AI/ML.

Here's a breakdown based on your questions:

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

• Acceptance Criteria: For this type of device, the acceptance criteria are not clinical performance metrics in the sense of sensitivity/specificity, but rather engineering and safety benchmarks to demonstrate substantial equivalence to the predicate. The key "acceptance criterion" mentioned is fatigue testing per ISO 14801.
• Reported Device Performance: The document states: "As noted in the table above, the subject and predicate devices are identical with respect to design, materials of construction, method of stabilization, implant size offerings, surface treatment, and sterility status. A gripping feature was introduced to the implant to eliminate the need for a carrier; however, as demonstrated by fatigue testing, the introduction of this feature does not impact substantial equivalence."
  • This implies that the device met the fatigue testing requirements of ISO 14801, demonstrating that the design change (the gripping feature) did not negatively impact its mechanical performance compared to the predicate. Specific numerical results of the fatigue testing are not provided in this summary document, only the statement that it was performed and met the criteria for substantial equivalence.

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 in the context of this 510(k) summary. This is a mechanical device, not an AI/ML system. The "test set" would refer to the mechanical samples used for fatigue testing. The document does not specify the number of samples tested for fatigue, only that "Fatigue testing per ISO 14801" was performed.
• Data provenance for mechanical testing is typically in-house or third-party lab testing, not patient data in the sense of retrospective/prospective clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable. This relates to AI/ML ground truthing, which is not part of this device's submission. Ground truth for mechanical testing is established by engineering standards (e.g., ISO 14801 thresholds for failure) and laboratory measurements.

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

• Not applicable. This relates to human expert review for AI/ML validation.

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 a hardware device, not an AI assistance tool.

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

• Not applicable. There is no algorithm.

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

• For the mechanical aspects, the "ground truth" implicitly refers to the failure criteria defined by ISO 14801 and the material properties and design specifications. For biocompatibility, sterilization, etc., the "ground truth" is adherence to relevant ISO standards and regulatory guidelines, which was demonstrated by leveraging data from the predicate device.

8. The sample size for the training set

• Not applicable. This is a hardware dental implant, not an AI/ML system that requires a "training set."

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

• Not applicable. As above, no training set for this type of device.

In summary, the provided document is a 510(k) submission for a non-AI/ML dental implant. The "acceptance criteria" and "study" are primarily focused on demonstrating engineering and safety equivalence to a predicate device via standardized mechanical testing (like fatigue) and compliance with general device regulations (biocompatibility, sterilization, etc.), often by leveraging existing data from the predicate. The detailed breakdown of AI/ML validation (test sets, ground truth experts, MRMC studies) is not relevant to this type of traditional medical device submission.

Ask a specific question about this device

The Integrity-SI® Fusion System is intended for sacroiliac joint fusion for the following conditions:

• Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months.
• To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
• Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

The Integrity-SI® Fusion System consists of partially and fully threaded, self-tapping cannulated titanium implants designed to be inserted across sacroiliac joint providing stability for joint arthrodesis when used in conjunction with allograft or autograft. The surgical implants are available in various sizes to accommodate patient anatomy. The 8 mm, 10 mm, and 12 mm diameter screws are offered in partially and fully threaded version in lengths from 40 - 1 10 mm, in 2.5 mm increments and are available in non-coated or hydroxyapatite-coated (HA) versions. The screws also include a pre-assembled washer for improved joint compression. The fully threaded 6.5 mm diameter, optional, secondary fasteners are offered for additional rotational stability in lengths of 30 - 70 mm, in 5 mm increments and are only intended for use in conjunction with a primary 8 mm, 10 mm, or 12 mm screw.
The screws are provided in sterile and non-sterile options.

The provided FDA 510(k) clearance letter and summary for the Integrity-SI® Fusion System does not contain information related to an AI-powered medical device or software.

The device described is a mechanical implant system for sacroiliac joint fusion, consisting of screws and instruments. The performance data presented refers to mechanical testing of the implant's physical properties (torsional properties, driving/removal torque, axial pullout) against an ASTM standard (ASTM F543-17).

Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and study proving an AI device's performance, as the provided text doesn't describe an AI device.

To answer your request, you would need to provide an FDA clearance document or similar report for an AI-powered medical device.

Ask a specific question about this device

The OsteoCentric ACL Fixation Fasteners are used to provide bone fixation in orthopedic procedures, including bonetendon-bone graft fixation in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction of the knee.

The OsteoCentric ACL Fastener System consists of ACL Fixation Fasteners and select singleuse and reusable instrumentation to facilitate implantation.

The ACL Fixation Fasteners are threaded titanium interference screws with a tapered tip for easy insertion into bone. The fasteners are cannulated to allow the use of a guidewire to assist with placement of the fastener into the bone tunnel. The fastener is used to maintain the fixation of bone-tendon-bone grafts in orthopedic procedures. The ACL Fixation Fasteners are provided sterile.

ACL Fixation single-use instruments are: a 2.4mm OD stainless steel drill-tipped passing pin, a 1.6mm OD nitinol guidewire, and a stainless-steel graft retractor. The ACL single-use instruments are provided sterile.

ACL Fixation reusable instruments are: a 2.5mm hex driver, and a 3.5mm Hex Driver. The ACL Fixation reusable instruments are provided non-sterile and must be sterilized prior to use.

The provided text is a 510(k) summary for the OsteoCentric ACL Fixation System. It describes the device, its intended use, and its equivalence to predicate devices, supported by performance testing. However, the document does not contain any information about a study involving AI, human readers, or the establishment of ground truth for an AI system.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/human reader study, as the provided input does not discuss such a study. The performance data mentioned (Torsional Properties, Driving Torque, Removal Torque, Engineering analysis comparison of theoretical axial pullout, Axial Pushout) are all mechanical tests for the physical medical device itself, not for an AI algorithm's performance in image analysis or similar tasks.

In summary, none of the requested information regarding AI acceptance criteria, study design (sample size, data provenance, expert consensus, adjudication, MRMC, standalone performance), or training set details is present in the provided document.

The document is a standard medical device 510(k) submission focusing on demonstrating substantial equivalence of a physical implantable device (an ACL fixation fastener) to existing devices based on material properties and mechanical performance.

Ask a specific question about this device

The OsteoCentric Integrated Hip Fastener System is indicated for stable and unstable intertrochanteric, subtrochanteric, and basilar neck fractures in which a stable medial buttress can be reconstructed.

The OsteoCentric Integrated Hip Fastener System is indicated for femoral neck fractures including intracapsular, transcervical, and subcapital fractures.

The OsteoCentric Integrated Hip Fastener System is internal fixation of intertrochanteric and femoral neck fractures of the proximal femur. The OsteoCentric Integrated Hip Fastener System consists of plates and screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. Integrated Hip Fasteners which are lag screws implanted through the femoral neck and head are offered in Ø11, Ø13, & Ø15mm sizes with lengths ranging from 50 – 140mm in 5mm increments. Hip side plates are offered in 1-hole to 19-hole configurations (48 – 330mm length). 6.0mm support fasteners are offered in 55 – 125mm lengths. 5.2mm shaft fasteners are offered in 28 – 46mm locking fasteners for the trochanter plate are offered in 16 – 40mm lengths. Compression and attachment screws are also available. Devices are provided non-sterile. All implantable devices are manufactured from stainless steel per ASTM F138.

This document is a 510(k) Premarket Notification from the FDA regarding the OsteoCentric Integrated Hip Fastener System. It does not describe an AI/ML medical device or a study involving human readers and AI assistance for diagnostic purposes. Instead, it concerns a traditional medical device (metallic bone fixation appliances) and its substantial equivalence to previously cleared predicate devices.

Therefore, the specific information requested about acceptance criteria, study design, expert involvement, and reader performance for an AI/ML device is not present in the provided text. The document focuses on the physical characteristics of the hip fastener system (e.g., sizes, materials) and its intended use for treating hip fractures.

To answer your request, if this were an AI/ML device submission, the FDA would require detailed information on its performance, typically including:

1. Acceptance Criteria and Performance Table: This would outline the metrics (e.g., sensitivity, specificity, AUC) the device needed to achieve and the reported performance.
2. Sample Size and Data Provenance: Details on the number of cases in the test set, their origin (e.g., multi-site, geographical distribution), and whether the data was collected retrospectively or prospectively.
3. Ground Truth Experts: The number and qualifications of clinicians who established the definitive diagnosis for the test cases.
4. Adjudication Method: How disagreements among experts were resolved to form the ground truth (e.g., majority vote, senior expert arbitration).
5. MRMC Study: If applicable, a human-in-the-loop study comparing diagnostic accuracy with and without AI assistance, quantifying the improvement.
6. Standalone Performance: The algorithm's performance without human interaction.
7. Type of Ground Truth: Whether the ground truth was based on expert consensus, pathology, long-term outcomes, or other definitive sources.
8. Training Set Sample Size: The number of cases used to train the AI model.
9. Training Set Ground Truth: How the ground truth for the training data was established.

Since this document pertains to a mechanical medical device, none of this information is relevant or provided within the text.

Ask a specific question about this device

The Integrity-SI Fusion System is intended for sacroiliac joint fusion for the following conditions:

1. Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months.

2. To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

3. Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint

The Integrity-SI Fusion System consists of partially and fully threaded, self-tapping cannulated titanium implants designed to be inserted across sacroiliac joint providing stability for joint arthrodesis when used in conjunction with allograft or autograft. The surgical implants are available in various sizes to accommodate patient anatomy. The 10mm and 12mm diameter screws are offered in partially and fully threaded version in lengths from 40-110mm, in 5mm increments. All fastener sizes are available in non-coated or hydroxyapatite-coated (HA) versions. The 10mm and 12mm screws also include a pre-assembled washer for improved joint compression. The fully threaded 6.5mm diameter, optional secondary fasteners are offered for additional rotational stability in lengths of 30 - 70 mm, in 5mm increments and are only intended for use in conjunction with a primary 10mm or 12mm screw.

The provided FDA 510(k) clearance document for the "Integrity-SI Fusion System" does not contain information about acceptance criteria, device performance results from a study, or details about a clinical study involving AI or human reader performance.

This document is a standard 510(k) clearance letter and a summary, which primarily establishes substantial equivalence to a predicate device based on technological characteristics and intended use, rather than requiring new clinical performance data for devices like this one (a metallic bone fixation fastener).

Specifically, the document states two key points that explain why the requested information is not present:

• "There are no changes to the technological characteristics of the OsteoCentric Integrity-SI Fusion System. The device is identical to the predicate device with respect to the design, materials, sterilization, and manufacturing methods." (Section VI. Comparison of Technological Characteristics to the Predicate)
• "There were no changes in the design, materials, sterilization, or manufacturing methods of the device. Therefore, no new performance data was required to demonstrate the substantial equivalence of the subject device to the predicate device." (Section VII. Performance Data)

Because no new performance data was required, there is no mention of a test set, training set, ground truth establishment, expert consensus, MRMC studies, or standalone algorithm performance.

Therefore, I cannot provide the requested table and study details based on the information given in the input. The device is a physical implant (a bone fastener), not an AI/software device that would typically undergo the type of performance validation described in your prompt.

Ask a specific question about this device

The OsteoCentric Spine MIS Pedicle Fastener System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

The OsteoCentric Spine MIS Pedicle Fastem is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origins with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the OsteoCentric Spine MIS Pedicle Fastener System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origins with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); turnor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The OsteoCentric Spine MIS Pedicle Fastemer System is a posterior fusion spinal fixation system which consists of non-sterile pedicle fasteners (Ø4.5 - 08.5, 25 - 180 mm), cannulated pedicle fasteners (05.5 - 08.5, 25 - 100 mm), reduction fasteners, extended tab implants, locking caps, and rods (05.5, 30 - 180 mm). The fasteners are used to attach the system components to the non-cervical spine and allows a surgeon to build an implant construct with the intent to stabilize the operative site during the fusion process.

The implant components are manufactured from titanium alloy (ASTM F136).

The provided text is a 510(k) Summary for the OsteoCentric Spine MIS Pedicle Fastener System. This document is a regulatory submission to the FDA, demonstrating "substantial equivalence" to a legally marketed predicate device, rather than a study proving the device meets specific performance acceptance criteria for a new AI/software medical device.

Therefore, the information required to answer your prompt, which focuses on acceptance criteria and a study proving an AI/software device's performance (including sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, etc.), is not present in the provided text.

The document states:

• "The OsteoCentric Spine MIS Pedicle Fastener System's components were previously cleared under predicate K151648. No additional performance data was submitted to demonstrate the substantial equivalence of the subject device to the predicate." (Page 5, Section VII. Performance Data)

This explicitly indicates that no new performance study was conducted or submitted for this specific 510(k) application (K221332) to demonstrate the device meets new acceptance criteria. Instead, it relies on the prior clearance of its components and its substantial equivalence to an existing predicate device (K151648) based on identical indications for use, materials, sterilization, and manufacturing methods.

In summary, based on the provided text, I cannot answer the questions about acceptance criteria, study details, sample sizes, expert involvement, or ground truth establishment because no such performance study was conducted or submitted for this device's 510(k) clearance.

Ask a specific question about this device

The OsteoCentric 2.4mm and 3.0mm Cannulated Screw are intended for fixation of fractures and non-unions of small bones and small bone arthrodesis. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies.

The OsteoCentric 3.5mm Cannulated Screws are intended for fixation of small bones and small bone fragments, such as fractures of the metatarsals, arthrodesis of the carpals and phalanges, steochnondritis dissecans, and ligament fixation.

The OsteoCentric 4.5mm Cannulated Screws are intended for fracture fixation of long bones and long bone fragments.

The OsteoCentric 6.5mm to 8.0mm Cannulated Screws are intended for fracture fixation of long bones and long bone fragments, long bone osteotomies, femoral neck fractures, slipped capital femoral epiphyses as an adjunct to treatment with a dynamic hip screw (DHS) in basilar neck fractures, tibial plateau fractures, ankle arthrodesis, pediatric femoral neck fractures, intercondylar femur fractures, SI joint disruptions, fixation of pelvis and iliosacral joints, and subtalar arthrodesis.

The OsteoCentric 7.0mm and 8.0mm Cannulated Nut is indicated for fracture fixation where fracture compression is desired, and where insertion of the nut-and-bolt system does not increase the risk of morbidity due to the need for surgical access to both sides of the compressed area. The device may also be used when compression between separate bones is desired (e.g. syndesmosis) as long as there is not increased morbidity associated with the insertion of a nutand-bolt system, as discussed above.

The OsteoCentric Technologies Cannulated Fasteners and Nuts consists of cannulated screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The screws and nuts are provided non-sterile. The screws and nuts are manufactured from Stainless Steel per ASTM F138 or from Titanium per ASTM F136 or F1295. The purpose of this submission is to modify the indications for use.

Here's an analysis of the provided text regarding the acceptance criteria and study for the device:

Regarding Acceptance Criteria and Supporting Study:

The document does not contain any explicit acceptance criteria or a study that proves the device meets those criteria.

Instead, the document is a 510(k) Premarket Notification for OsteoCentric Technologies' Cannulated Fasteners and Nuts. The core of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, rather than proving performance against specific acceptance criteria through new testing.

The key statement that clarifies this is:

"No performance testing was required, as no physical changes were made to the devices, the ranges of sizes are comparable to predicate devices with the same indications, and no additional testing is required for the indications modifications proposed."

Therefore, most of the requested information regarding acceptance criteria, performance data, sample sizes, and expert reviews is not applicable or not present in this specific regulatory submission. The substantial equivalence argument relies on the existing clearance of predicate devices and the lack of significant changes to the subject device that would warrant new performance testing.

However, based on the information provided, we can infer some details related to the regulatory pathway and the basis for clearance:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The "acceptance criteria" here are inferred from the substantial equivalence argument. The document explicitly states "No performance testing was required," meaning there are no new, specific quantitative performance metrics or studies reported in this submission to meet new acceptance criteria. The criteria for clearance are met by demonstrating equivalence to devices that already met prior acceptance criteria.

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

• Not Applicable. The document explicitly states: "No performance testing was required." Therefore, there was no 'test set' in the context of new performance data for this submission. The substantial equivalence is based on the characteristics of the device being analogous to already cleared predicate devices.

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

• Not Applicable. As no new performance testing was conducted, there was no test set requiring ground truth established by experts within the scope of this submission. The ground truth for the predicate devices' original clearances would have been established, but that information is not part of this document.

4. Adjudication method for the test set

• Not Applicable. No new test set or performance study was conducted.

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 medical implant (cannulated fasteners and nuts), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

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

• Not Applicable. This device is a medical implant, not an algorithm or software. Standalone algorithm performance is not relevant.

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

• Not Applicable. No new ground truth was established for this submission, as no new performance testing was conducted. The clearance is based on substantial equivalence to predicate devices, which would have had their performance and safety established through various means (including historical usage, engineering principles, and potentially prior testing) during their initial clearance processes.

8. The sample size for the training set

• Not Applicable. This device is a physical medical implant, not an AI or machine learning model that requires a "training set."

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

• Not Applicable. As explained above, there is no training set for this device.

Ask a specific question about this device