Search Results

The T3® Pro Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.

The T3® Pro Implants may also utilize immediate loading for these indications. The T3® Pro Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.

The T3® Pro Implants with the new ZimVie Implant Packaging System. The material and design of the subject device is identical to the primary predicate device T3® Pro Implants cleared in K213672.

The ZimVie Implant Packaging System configuration, similarly to the primary predicate device, consists of a titanium sleeve that is inserted into a polypropylene inner tray, covered with a Tyvek lid and heat-sealed. This assembly is then placed in a heat-sealed outer tray, covered with a Tyvek® lid. The outer tray is placed inside a cardboard box, and gamma sterilized. The new ZimVie Packaging System has been standardized to align the packaging across all ZimVie implant families. The subject device in the new ZimVie Packaging System has a shelf-life of two (2) years.

The provided FDA 510(k) clearance letter and associated documentation for the "T3 Pro Implants- ZimVie Packaging System" (K251660) do not describe acceptance criteria or a study proving the device meets those criteria in the context of an AI/human reader performance study.

Instead, this submission is for a medical device (endosseous dental implant) and its new packaging system. The "performance data" section explicitly states that no clinical data was included in the submission for the substantial equivalence determination. The focus of the provided document is to demonstrate equivalence to a previously cleared predicate device for the dental implant itself, with the primary change being the packaging system.

Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported device performance related to an AI-assisted or standalone AI system, nor can I provide details on sample size, expert adjudication, MRMC studies, or ground truth establishment, as these concepts are not discussed or relevant to the provided documentation for this specific 510(k) clearance.

The information provided describes non-clinical performance data related to the physical device and its packaging:

• Sterilization validation: Gamma irradiation sterilization to a sterility assurance level of 10^-6 according to ISO 13004 and ISO 11137.
• Aging studies: Demonstrating a shelf life of two (2) years for the implants, with packaging sterile barrier testing per ASTM F1980.
• Packaging studies: Simulated distribution and environmental conditioning per ISTA 3A and ASTM D4169.
• Biological evaluation: Leveraged from the primary predicate device, demonstrating no increased risks regarding biocompatibility. The material is Commercially Pure Titanium conforming to ASTM F67.
• MR Safety testing: Conducted according to ASTM F2503-13 on the primary predicate device (identical to the subject device) for MR Conditional determination.
• Bacterial Endotoxin Testing: Routinely performed using LAL assay in accordance with ISO 11737-3.

The acceptance criteria for this submission would primarily revolve around demonstrating that the new packaging system maintains the sterility, integrity, and safety of the dental implant for its stated shelf life, and that the dental implant itself remains identical to the previously cleared predicate device in all other aspects (materials, design, intended use, operating principle).

In summary, your request pertains to an AI/Software as a Medical Device (SaMD) study, while the provided document describes the 510(k) clearance process for a physical dental implant device and its new packaging.

Ask a specific question about this device

The A.L.P.S. Small Fragment Plating System is intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.

The 100 Degree Tubular Plate is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius, ulna, distal tibia (including intra-articular), fibularly in osteopenic bone.

Washers are intended to be used in conjunction with bone screws.

The A.L.P.S.® Small Fragment System is a titanium alloy (Ti-6Al-4V) plate and screw system that fuses locking screw technology with conventional plating techniques.The subject device consists of plates, The devices are available in sterile and nonsterile options, and vary by sizes and number of holes, making the device suitable for a wide range of patient anatomy and needs.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

This document is a 510(k) premarket notification summary for a medical device called the "A.L.P.S. Small Fragment Plating System." As such, it primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and the results of a specific study designed to "prove" the device meets those criteria in the way a clinical trial for an AI diagnostic might.

Key takeaway: The document confirms that for this type of device (metallic bone fixation system), clinical data and conclusions were not needed. The substantial equivalence is based on technological comparison and non-clinical tests related to MRI compatibility. Therefore, many of the questions related to acceptance criteria for algorithmic performance, sample sizes for test/training sets, expert adjudication, or MRMC studies are not applicable in this context.

Here's the information that can be extracted or inferred from the provided text, with clarifications where questions are not applicable:

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

For this device, the "acceptance criteria" are related to established standards for materials and non-clinical performance, primarily demonstrating MR compatibility and structural integrity through existing test methods. The document doesn't provide specific quantitative acceptance criteria or performance metrics in a table format for this specific device's novel performance. Instead, it states that the device's technological characteristics are similar to predicates and that non-clinical tests were conducted.

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. The submission states: "Clinical data and conclusions were not needed for this device." The tests performed are non-clinical (e.g., MRI compatibility on a device, not on patient 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. As no clinical data or test sets requiring expert ground truth were used for this 510(k) submission.

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

• Not Applicable. As no clinical data or test sets requiring expert adjudication were used for this 510(k) submission.

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

• Not Applicable. This device is a metallic bone fixation system, not an AI diagnostic tool. No MRMC study was conducted.

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

• Not Applicable. This device is a metallic bone fixation system, not an algorithm.

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

• Not Applicable. Clinical ground truth was not required for the non-clinical tests performed. The "ground truth" for the device's properties would be based on engineering specifications, material standards, and physical testing outcomes against those standards.

8. The sample size for the training set

• Not Applicable. This device is a physical medical device, not an AI/ML algorithm. There is no training set in this context.

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

• Not Applicable. This device is a physical medical device, not an AI/ML algorithm. There is no training set or ground truth for such a set in this context.

Ask a specific question about this device

Immediate Molar Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.

Immediate Molar Dental Implants may also utilize immediate loading for these indications. Immediate Molar Dental Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. The Immediate Molar Dental Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to provide good primary stability. The Immediate Molar Dental Implants are intended for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications.

The Immediate Molar Dental Implants are also indicated for compatibility with the following OEM abutment systems:

The Immediate Molar Implants are basic screw-type designs available in tapered body geometry. The devices are manufactured from Commercially Pure Titanium (ASTM F67) and feature a roughened apex and traditional OSSEOTITE® coronal surface. The device is packaged in a Titanium sleeve that is inserted into a polypropylene inner tray, covered with a Tyvek lid and heat-sealed. This assembly is then placed inside a larger polyethylene thermoformed outer tray, covered with a Tyvek lid and heat-sealed. The outer tray is packaged inside a box. The device is sold sterile. The shelf life of the Immediate Molar Implants is 5 years and they are intended for single use only. The device is sterilized using gamma irradiation method. The implants are available in various platform options and feature an internal hex connection for mating with associated Biomet 3i internal connection restorative components and also a TSV connection for mating with associated Zimmer Dental TSV connection restorative components. The implants are also compatible with titanium abutments manufactured by Terrats Medical SL and Zfx GmbH. The implants are offered in a variety of diameters and lengths to accommodate varying patient anatomy. The T3 PRO Immediate Molar Implants are offered in 8, 10 and 11.5mm implant lengths for each of the implant body diameter sizes of 7, 8 and 9mm. The TSX Immediate Molar Implants are offered in 6, 8, 10 and 11.5mm implant lengths for each of the implant body diameter sizes of 7 and 8mm. The TSX Immediate Molar Implants are offered in 8, 10 and 11.5mm lengths for implant body diameter size of 9mm.

The provided text is a 510(k) summary for a medical device (Immediate Molar Implants) and does not contain information about acceptance criteria or a study proving that an AI/software device meets acceptance criteria.

The document explicitly states: "No clinical data were included in this submission." and focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, non-clinical testing (fatigue, MR compatibility, pull-out tests, surface area analysis, sterilization, biocompatibility, shelf life), and contractual agreements for compatible components.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving a device meets acceptance criteria using clinical or performance data, as this information is not present in the provided text. The document describes a dental implant, not an AI or software-based device that would typically have acceptance criteria presented in the manner requested.

Ask a specific question about this device

The Pectus Blu system is indicated for the treatment of Pectus Excavatum and other sternal deformities. It is intended to be used in pediatric (children and adolescents) and adult populations.

The Pectus Blu Support Bar and Stabilizers (including Pectus Blu TruLink™ Stabilizers) are surgical implants intended to aid treatment of Pectus Excavatum deformity in adults and pediatric patients (children and adolescents) for which the rib cage across the sternum measures 7 inches (17.78 centimeters) or larger. The Pectus Blu Support Bar provides the surgeon with a means to reposition bony structures (sternum, breastbone) by applying internal force outwardly eliminating the funnel shape deformity. Recommended implantation time is 2-3 years but may vary based on surgeon preference and patient. These devices are offered in a generic pre-bent shape that can be further shaped intraoperatively. These devices are intended to be used in professional healthcare facilities.

This FDA 510(k) summary (K241709) describes the Pectus Blu Support Bar System, which is indicated for the treatment of Pectus Excavatum and other sternal deformities in pediatric and adult populations. The submission is for a line extension to the previously cleared Pectus Blu Support Bar System (K212841), with the addition of Pectus Blu TruLink™ Stabilizers. As such, the FDA has determined substantial equivalence based on a comparison to the predicate device, rather than requiring a new clinical study with specific acceptance criteria related to disease detection or diagnosis.

Here's an analysis of your questions based on the provided document:

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

Based on the provided FDA 510(k) summary, specific acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) for the device are not applicable and not provided. The device is a surgical implant, not a diagnostic tool. The submission focuses on demonstrating substantial equivalence to a predicate device, meaning it performs as intended and is as safe and effective as the already cleared device.

The performance data mentioned (in section 8) refers to Verification and Validation attachments, which would typically include engineering tests, biocompatibility tests, mechanical strength tests, and other non-clinical performance characteristics to ensure the device meets its design specifications and performs as intended. These are not diagnostic accuracy metrics.

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

This information is not applicable and not provided in the FDA 510(k) summary. Since this is a submission for a surgical implant and not a diagnostic AI device, there isn't a "test set" in the context of diagnostic performance evaluation. The "performance data" refers to non-clinical testing of the device's physical properties.

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 applicable and not provided. "Ground truth" in the context of expert review for a diagnostic test set is irrelevant for a surgical implant.

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

This information is not applicable and not provided. Adjudication methods are used in diagnostic studies to resolve discrepancies among expert readers, which is not relevant here.

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

This information is not applicable and not provided. MRMC studies are conducted to evaluate the performance of diagnostic devices, particularly those involving AI assistance for human readers. This device is a surgical implant, not a diagnostic tool with AI assistance.

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

This information is not applicable and not provided. "Standalone" performance refers to the performance of a diagnostic algorithm without human intervention. This device is a physical surgical implant.

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

This information is not applicable and not provided. "Ground truth" typically refers to a definitive diagnosis or condition used to evaluate a diagnostic test. For a surgical implant, the "truth" is whether the device functions as intended, is biocompatible, and structurally sound, which is assessed through non-clinical testing and clinical experience (though a new clinical study wasn't required for this 510(k)).

8. The sample size for the training set

This information is not applicable and not provided. Training sets are used in the development of AI algorithms. This device is a physical surgical implant.

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

This information is not applicable and not provided. This question is pertinent to AI algorithm development, which is not the subject of this 510(k) submission.

Ask a specific question about this device

The BellaTek Bars are indicated for attachments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The BellaTek Bars are intended for attachment to a minimum of two (2) abutments.

All digitally designed BellaTek Bars are intended to be sent to Biomet 3i for manufacture.

The BellaTek Bars are indicated for compatibility with the following abutment systems:

· Universal Multi-Unit Abutments manufactured by Terrats Medical SL., 2.9-5.7mm, Angled, max 30 degrees

• · ZimVie Eztetic Implant System
• · ZimVie TSX Implant System
• · ZimVie Tapered Screw-Vent System
• · ZimVie Low Profile Abutments, 3.4-6.0mm, Angled, max 30 degrees
  • · ZimVie Osseotite Implant System
  • ZimVie T3 and T3 PRO Implant System
• · ZimVie Tapered Abutments, 3.5-5.7mm, Angled, max 30 degrees
  • · ZimVie TSX Implant System
  • · ZimVie Tapered Screw-Vent Implant System .

The BellaTek Bars are intended to disperse the load of a prosthesis across dental implant-abutment assemblies. They also provide support for prosthetic devices such as artificial teeth, and to restore the patient's chewing function. The subject devices are identical to the reference predicate device CAM StructSURE Precision Milled Bars cleared in K080864 (SE 07/21/2008) with the only addition of the new connection geometry. The subject device has a new bar-to-abutment connection tailored to the multi-unit restorative abutment component(s) with which the device is intended to be used. Similar to the primary predicate device (K233083), the BellaTek Bars are manufactured out of commercially pure titanium per ASTM F67 or Titanium Alloy per ASTM F136. The BellaTek Bars are placed in a nylon bag and sealed in same manner as the reference predicate device (K080864). A label is applied to the bag.

Like the primary predicate device (K233083), the BellaTek Bars are offered in two types. A Type I Bar is a Titanium Alloy bar designed for use with removable overdentures. A Type II Bar is a Pure Titanium or Titanium Alloy bar designed for fixed prosthesis. All BellaTek Bars (Dolder, Primary, Hader, Hybrid, Freeform, Canada, Wraparound and Copy Milled) are designed to match an individual patient. The bars are designed from a three-dimensional optical and/or digital scanner system that scans the casting of a patient's impression and then is machined using a CAD/CAM software system in accordance with customer specifications, within the limits of design defined in tables below. The subject devices are provided non-sterile in same manner as the predicate devices.

The BellaTek Bars are dental implant abutments intended to restore chewing function in partially or fully edentulous jaws by attaching to a minimum of two abutments.

Here's an analysis of the acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the acceptance criteria are primarily aligned with demonstrating substantial equivalence to a predicate device through materials, design specifications, and performance bench testing. Specific quantitative performance targets are not explicitly listed in an "acceptance criteria" table format in the provided document, but rather implied through comparison to existing standards and predicate devices.

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

• Sample Size: Not explicitly stated as a number of devices or cases. The document refers to "worst case design" being validated. For sterilization, the validation process implies testing units to demonstrate SAL. For biocompatibility, "representative Biomet 3i patient-specific bar devices" were used. For MRI review, it was a "non-clinical worst-case MRI review... based on the entire system including all variations." This suggests a methodology of evaluating design limits and material properties rather than a large clinical test set.
• Data Provenance: The studies are non-clinical (bench testing, material analysis, literature review, MRI rationale). No specific country of origin for non-clinical data is mentioned, but the standards followed (e.g., ASTM, ISO, EN ISO) are international. The studies are by nature prospective as they are conducted to support the specific device submission, but they leverage established scientific literature and standards.

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

Given that the studies are non-clinical bench tests, material characterizations, and literature reviews, the concept of "experts establishing ground truth for a test set" in a clinical diagnostic sense does not directly apply. The "ground truth" for these types of studies is established by:

• Regulatory Standards: Adherence to recognized standards like ASTM F136, ASTM F67, ISO 10993-1, ISO 10993-5, EN ISO 17665-1, and FDA guidance documents.
• Engineering and Scientific Expertise: The performance of bench tests, material analysis, and MRI safety assessments would be conducted by engineers, material scientists, and physicists with expertise in these areas. While individual names or specific numbers aren't listed, this expertise is inherent in conducting such tests.
• Literature: The MRI safety assessment explicitly mentions using "published literature" as part of its scientific rationale, implying leveraging the consensus of experts in that field.

No specific number of experts or their detailed qualifications (e.g., "radiologist with 10 years of experience") are provided in the context of establishing ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to the process of resolving discrepancies among multiple human readers in clinical studies where subjective interpretation is involved (e.g., image reading). The studies described here are non-clinical, objective evaluations (bench testing, material analysis).

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. The provided document states: "No clinical data were included in this submission." Therefore, no MRMC study or AI assistance evaluation was conducted or reported.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical dental implant bar, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used for these studies is based on:

• Regulatory Standards and Specifications: Adherence to performance parameters detailed in FDA guidance documents (e.g., "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments"), and international standards (ASTM, ISO, EN ISO).
• Material Properties: Data derived from chemical and mechanical testing of the materials (ASTM F136, ASTM F67).
• Biocompatibility Endpoints: Established biological safety endpoints defined by ISO 10993 standards.
• MRI Safety Rationale: Scientific principles and published literature related to magnetic fields and medical devices.
• Demonstration of Substantial Equivalence: Direct comparison of technological characteristics and performance to legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The design and manufacturing processes are developed through traditional engineering methods and validated through the testing described.

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

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

Ask a specific question about this device

Kirschner Wires are used for;
· As guide pins for insertion of other implants
· Bone reconstructions
· Fixation of bone fractures and osteotomies
· Implanted through the skin for traction applied to the skeletal system

Biomet Inc manufactures a variety of internal fixation devices intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Biomet Kirschner Wires (K-wires) are rigid yet malleable wires with penetrating tips such that they may be inserted through tissue and into bone to alow for traction of bone fragments as desired or for alignment quides for other bone fixation implants. These wires are available in multiple diameters, same length and unthreaded (smooth) versions.
Biomet Kirschner Wires are single use and provided in both sterile configurations. Unless supplied sterile, metallic internal fixation devices must be sterilized prior to surgical use.

The provided text describes a 510(k) premarket notification for Biomet Kirschner Wires (K-Wires). It states that the device is substantially equivalent to a predicate device based on its indications for use, technological characteristics, and conformance to specific standards.

However, the document does not contain the detailed information requested regarding the acceptance criteria and the study that proves the device meets those criteria, specifically concerning data provenance, sample sizes for test and training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies, as these aspects are typically relevant for AI/ML-driven medical devices or diagnostic tools. The Biomet Kirschner Wires are described as "rigid yet malleable wires with penetrating tips," implying they are a physical medical device, not a software-based or AI-enabled device.

Therefore, many of the requested categories are not applicable to the information provided in the given text.

Here's a breakdown of the available information based on your request:

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

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

• Sample Size for Test Set: Not specified. Testing for conformance to ASTM standards typically involves a defined sample size as per the specific standard, but this detail is not present in the document.
• Data Provenance: Not applicable in the context of device conformance to ASTM physical/mechanical standards.

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

• Not applicable. This is not a diagnostic device requiring expert interpretation for ground truth. Conformance to ASTM standards is typically evaluated by technical testing against predefined specifications.

4. Adjudication method for the test set

• Not applicable. Conformance to ASTM standards involves objective measurement and comparison against specified limits, not expert adjudication.

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

• Not applicable. This is a physical bone fixation device, not a diagnostic imaging or AI-assisted diagnostic tool.

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

• Not applicable. This device is not an algorithm.

7. The type of ground truth used

• Ground Truth Type: Conformance to established industry standards (ASTM F138-19 for mechanical properties and ASTM F366-17 for dimensional properties). These standards themselves define the "ground truth" or acceptable parameters for such devices.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms. Its design and manufacturing are based on established engineering principles and materials science.

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

• Not applicable. Since there is no training set for an algorithm, the method for establishing its ground truth is irrelevant. The "ground truth" for the device's characteristics is inherently defined by the ASTM standards it aims to meet.

Ask a specific question about this device

The PSPS bone model is indicated, based on patient-specific radiological images (CT scans), to assist in pre-operative orthopedic planning for patients able to undergo orthopedic procedures and able to be radiologically scanned.

The PSPS bone model is a diagnostic tool to visually aid in orthopedic pre-operative surgical planning for skeletally mature individuals.

Be advised, the quality of medical images determines the accuracy of the 3D bone models. Zimmer Biomet recommends using CT Protocol PMI® Patient-Matched Implants CT Protocol. Only images obtained less than six (6) months prior should be used for simulating and/or evaluating orthopedic treatment options.

The Patient Specific Planning Solution™ 3D Bone Model is a 3-dimensional representation of the requested anatomical bone site. The Bone Models are diagnostic tools to allow the Surgeon to physically and visually aid in pre-operative orthopedic planning to facilitate the implantation of medical devices.

The Patient Specific Planning Solutions™ are designed of polyamide (nylon) using additive manufacturing (selective laser sintering), based on the approved/finalized orthopedic pre-surgical plan and shipped prior to surgery. The Bone Models are provided non-sterile and are used pre-operatively for education, planning to aid in component selection, sizing, and placement based on patient specific radiological images (CT scan). Physical bone models' critical bony areas are printed at <1mm mean deviation.

The full-scale 3D printed Patient Specific Bone Model is shipped to the patient's surgery to facilitate pre-operative planning.

This document does not contain the detailed information necessary to fully answer all aspects of your request, specifically regarding a multi-reader multi-case (MRMC) comparative effectiveness study, the number of experts for human-in-the-loop studies, the adjudication method, or specific effect sizes. The submission focuses on substantial equivalence to a predicate device, Mimics Medical (K183105), rather than a detailed performance study against specific acceptance criteria for a new AI algorithm.

However, based on the provided text, here's what can be extracted and inferred regarding the device's acceptance criteria and proven performance:

Device: Patient Specific Planning Solution™ Bone Models

Device Function Summary: These are 3D printed physical bone models derived from patient-specific CT scans. They are intended as diagnostic tools to visually aid in orthopedic pre-operative surgical planning and to facilitate the implantation of medical devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided are primarily related to the geometric accuracy of the 3D-printed bone models compared to the digital input. The performance summary refers to the device utilizing the same geometric accuracy testing as its predicate.

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

• Sample Size: Not explicitly stated. The document mentions "Summary of Performance Data" and speaks generally about "geometric accuracy of models testing" and "Additional design and test method validation" but does not provide specific numbers of models or datasets used for these tests.
• Data Provenance: Not explicitly stated. The bone models are based on "patient-specific radiological images (CT scans)." No information on the country of origin or whether the data was retrospective or prospective is provided. Given the nature of a 510(k) submission for manufacturing medical devices, the data would typically be derived from existing clinical CT scans.

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

Not applicable/Not stated. The "ground truth" for geometric accuracy testing would typically be the digital 3D model from which the physical model is printed (the "input digital replica"), not expert consensus on medical images for diagnostic purposes. The document doesn't describe any studies involving expert readers for image interpretation or diagnosis. The device's role is to provide a physical model for pre-surgical planning.

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

Not applicable/Not stated. No adjudication method is mentioned as this is not a study assessing diagnostic accuracy of an AI algorithm on images, but rather the manufacturing accuracy of a physical model.

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

No. An MRMC comparative effectiveness study was not performed or mentioned. The submission is for a physical bone model, not an AI software intended to assist human readers in image interpretation or diagnosis. The predicate device, Mimics Medical, is software for creating 3D models from medical images.

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

Yes, in a sense, the geometric accuracy testing of the physical models against the digital models can be considered a standalone performance evaluation of the manufacturing process and the resulting physical product. It asserts that the physical models meet the specified dimensional tolerances (<1mm mean deviation in critical bony areas).

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

The ground truth used for assessing the geometric accuracy of the physical bone models is the digital 3D model (the "input digital replica") generated from the patient's CT scans. The deviation of the physical model from this digital blueprint is measured.

8. The sample size for the training set

Not applicable/Not stated. This is a 510(k) submission for a physical device manufactured based on given digital data, not an AI algorithm that undergoes training. The "Mimics Medical" software mentioned is the predicate, which is used for segmentation and 3D model creation, but details about its training are not part of this submission.

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

Not applicable, as no training set for an AI algorithm is described in this document for the device itself.

Ask a specific question about this device

The Comprehensive® Segmental Revision System is intended for use in cases of:

• 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• 2. Revision where other devices or treatments have failed.
• 3. Correction of functional deformity.
• 4. Oncology applications including bone loss due to tumor resection.

When used in a proximal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for:
Treatment of acute or chronic fractures with humeral head (shoulder) involvement, which are unmanageable using other treatment methods.

When used as a distal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for:
Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement, which are unmanageable using other treatment methods.

Biomet Comprehensive Segmental Revision System is indicated for use in a reverse application in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically suited to receive the implants and a functional deltoid muscle is necessary. For the US and Canada only: reverse application is limited to proximal humeral replacement.

The Comprehensive Segmental Revision System is intended for use with or without bone cement in the proximal shoulder.

The Comprehensive Segmental Revision System is intended for use with bone cement in distal humeral applications.

Tissue Attachment Augments provide the option for tissue stabilization and attachment Augments are not available in all markets.

The Comprehensive Segmental Revision System (SRS) is a multi-piece orthopedic implant designed to replace the humerus up to and including the humeral side of the shoulder and elbow joints. The device is designed specifically for use in cases where there is extensive bone loss requiring extramedullary replacement of bone. The Tissue Attachment Augments provide the option for tissue stabilization and attachment.

The provided text describes a medical device, the "Comprehensive Segmental Revision System (SRS)," and its 510(k) premarket notification to the FDA. This document is a regulatory submission for a medical device and thus does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of an AI-powered diagnostic or predictive system.

The text does mention:

• Non-Clinical Tests/Justification: Coating Characterization, Fatigue Strength Report Flanges, Fatigue Strength Analysis Humeral Stems, Shot Peen Testing Summary, and MRI. These are engineering and material science tests relevant to the physical implant's safety and performance, not a study of an AI system's diagnostic accuracy.
• Clinical Tests: "None provided." This explicitly states that no clinical studies were performed for this specific submission to expand the indications of the device, as substantial equivalence was demonstrated through other means (comparison to predicates, engineering tests).

Therefore, based on the provided text, I cannot answer questions 1 through 9 as they relate to the performance evaluation of an AI device. The document is about a mechanical orthopedic implant, not an AI system.

Ask a specific question about this device

Biomet Comprehensive Reverse Shoulder products are in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically suited to receive the implants and a functional deltoid muscle is necessary.

The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coating are indicated for either cemented or uncemented biological fixation applications.

Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically suited to receive the implants and a functional deltoid muscle is necessary.

The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Titanium glenospheres are intents with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coating are indicated for either cemented or uncemented biological fixation applications.

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
5. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
   Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.

Humeral components with a porous coated surface coating are indicated for either cemented biological fixation applications.

The Comprehensive® Modular Hybrid® Glenoid is intended to be implanted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.

The Comprehensive Humeral Positioning Sleeves are for cemented use only and are intended for use with the Comprehensive Fracture Stem.

The Versa-Dial Humeral Head Prosthesis is intended for use only with the Comprehensive Shoulder Stems (Fracture, Primary and Revision), and the glenoid components of the Comprehensive Shoulder System.

The Titanium Versa-Dial Humeral Head Prosthesis is indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack suspected material sensitivity to cobalt alloy*

*The Titanium Versa-Dial Humeral Head Prosthesis is not for sale in Canada

Anatomic Applications

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Revision where other devices or treatments have failed.
4. Correction of functional deformity.
5. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
6. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may be suitable or may be inadequate.

Reverse Applications
The Comprehensive Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

Comprehensive Convertible Glenoid Baseplate components are intended for cementless applications with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented application. Huments with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

Biomet Comprehensive Reverse Shoulder products are in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixations. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

Comprehensive Shoulder System consists of partial and total shoulder replacement components use in cemented and uncemented applications. The devices are modular components consisting of humeral stems, modular heads and glenoid components for anatomic and humeral tray and glenosphere components for reverse configuration. The purpose of the current submission is to add MR Conditional labeling.

Here's an analysis of the provided information, addressing your questions about acceptance criteria and study details.

Important Note: The provided document is a 510(k) FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance criteria through extensive clinical trials. Therefore, much of the information you've requested regarding specific acceptance criteria, performance metrics, ground truth, and human reader studies is not present in this type of document because it is not required for a 510(k) submission for this type of device (implants). The "acceptance criteria" here implicitly refer to the device not posing new questions of safety or effectiveness compared to its predicates and meeting established standards for its material properties and MR compatibility.

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a shoulder replacement system seeking to add "MR Conditional" labeling, the "acceptance criteria" are related to established safety and performance standards for implants, particularly concerning their interaction with Magnetic Resonance (MR) environments. The performance data provided is entirely non-clinical and related to MR compatibility.

Table of Acceptance Criteria and Reported Device Performance

Study Details

As this is a 510(k) for a medical implant and not an AI/software device, many of the requested categories related to diagnostic performance or human reading studies are not applicable.

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: Not applicable in the context of diagnostic data. For the non-clinical MR compatibility tests, the "sample size" would refer to the number of device components tested according to the referenced ASTM standards. This specific number is not provided in the summary but would be detailed in the full test reports.
   • Data Provenance: Not applicable for diagnostic data. The MR compatibility tests are conducted in a controlled laboratory setting (likely in the US, where the company is based), not on patient data.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

   • Not applicable. Ground truth, in the AI/diagnostic context, refers to definitively established diagnoses or classifications. For an implant, "ground truth" relates to material science and engineering principles verified by standard testing methods and accredited labs.

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods are used to resolve discrepancies among expert opinions in diagnostic studies.

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

   • No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI systems, not for physical implants.

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

   • No, a standalone performance study in the AI sense was not done. The "performance" here is for the physical device's interaction with an MR field, which isn't an "algorithm-only" performance.

6. Type of Ground Truth Used:

   • For the core claims of equivalence (materials, design, etc.), the "ground truth" is established engineering and scientific principles, validated by testing against relevant ASTM standards and by comparison to the predicate devices. For MR compatibility specifically, the ground truth is defined by the objective measurements obtained through the standard ASTM test procedures (e.g., measured temperature rise, displacement force, artifact size) and compared against the limits established by those standards to determine "MR Conditional" status.

7. Sample Size for the Training Set:

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

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no training set.

Ask a specific question about this device

StageOne™ Select Hip Cement Spacer Molds with stainless steel reinforcement stems, adapters and inserts are indicated for use to mold a temporary hemi-hip replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using Refobacin Bone Cement R, assembled and inserted into the femoral medullary cavity following removal of the existing femoral and acetabular replacement implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

The hemi-hip prosthesis made from the StageOne™ Select Cement Spacer Molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.).

Due to the inherent mechanical limitations of the hemi-hip prosthesis material (Refobacin Bone Cement R), the temporary hemi-hip prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.

The StageOne™ Select Hip Cement Spacer Molds are sterile, single use medical devices made of silicone with a stainless steel reinforcement stem, head insert and neck length adapter. The device is used to create a temporary hip implant component made from antibiotic bone cement, Refobacin® Bone Cement R by injecting with a dispenser/gun into the mold. After removal of the initial femoral and acetabular implants, the prepared cement spacers are assembled using the neck length adapter and placed into the femoral joint space using Refobacin® Bone Cement R as the first stage of a two-stage revision surgical procedure. The temporary hemi-hip prosthesis remains in place (180 days or less) until the second stage of the two-stage revision procedure is performed to implant a conventional hip joint prosthesis.

The provided text is related to an FDA 510(k) premarket notification for a medical device called "StageOne™ Select Hip Cement Spacer Molds." It details the device's purpose, indications for use, and a comparison to predicate and reference devices to establish substantial equivalence.

However, the document DOES NOT contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the context of an AI/ML medical device submission. This document pertains to a physical medical device (cement molds) and the testing described is non-clinical (biocompatibility, packaging, shelf-life, sterilization, MRI analysis, fatigue performance, antibiotic elution, BET, and pyrogenicity testing) and does not involve AI/ML performance evaluation.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving device performance in the context of AI/ML, as the provided text does not contain such information.

If you have a different document related to an AI/ML medical device, please provide it, and I will be happy to assist.

Ask a specific question about this device