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The Persona Partial Knee system is limited to the medial tibiofemoral compartment of the knee intended for patients with painful and/or disabling knee joints due to the following indications:

• Noninflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis, avascular necrosis;
• traumatic arthritis;
• previous tibial condyle or plateau fractures with loss of anatomy or function;
• varus deformities; and
• revision of the articular surface of a previously implanted Persona Partial Knee System providing that the tibial plate locking mechanism is not compromised and the femoral and tibial plate components remain well fixed and undamaged.

The Persona Partial Knee System is a single use implant intended for implantation with bone cement.

The purpose of this submission is to add a line extension of Size B to the Persona Partial Knee system (PPK). The Persona Partial Knee System is a partial knee replacement for the medial compartment of the knee and is modular in design consisting of three components: a unicondylar cobalt-chromium-molybdenum (Co-Cr-Mo) alloy femoral component, a unicondylar titanium (Ti-6Al-4V) alloy tibial tray, and a unicondylar articular surface manufactured using the previously cleared Vivacit-E ® Vitamin-E Highly Crosslinked Polyethylene (VEHXPE).

This FDA 510(k) clearance letter for the Persona Partial Knee is for a medical implant (a knee replacement prosthesis), not an AI/software device. Therefore, the information requested in the prompt, such as "number of experts used to establish ground truth" or "multi reader multi case (MRMC) comparative effectiveness study," is not relevant to this type of device.

The clearance is based on the substantial equivalence principle, meaning the device is shown to be as safe and effective as a previously cleared predicate device. The performance data mentioned in the document refers to non-clinical testing (e.g., mechanical tests, material characterization) to ensure the implant meets established engineering and biocompatibility standards, not an AI algorithm's diagnostic performance.

Here's why the prompt's specific questions cannot be fully answered from this document:

• No AI/Software Component: The Persona Partial Knee is a physical medical device (implant), not a digital health product driven by AI or software.
• Substantial Equivalence: The clearance relies on demonstrating the new "Size B" line extension of the Persona Partial Knee is substantially equivalent to its own previously cleared version (K161592). This typically involves showing that the new size has similar design features, materials, and performance characteristics (e.g., strength, durability, biocompatibility) to the predicate.
• Performance Data Type: The "Performance Data" referenced is non-clinical. For an implant, this would involve mechanical testing (e.g., fatigue testing, wear testing), material characterization, biocompatibility testing, etc., to ensure the device performs as intended and is safe when implanted. It does not involve human readers, expert consensus for ground truth, or analysis of diagnostic accuracy.

Therefore, I cannot provide a table of acceptance criteria or details about a study evaluating AI performance from this document because it is not an AI/software device.

The document does state in the "Summary of Performance Data" section:
"The performance data provided in the performance testing section indicate the proposed devices meet the established acceptance criterion; therefore, are as safe and effective and substantially equivalent to the legally marketed predicate devices from a performance standpoint."

However, it does not detail what those acceptance criteria are or how the performance data was generated beyond stating it was "performance testing." For an implant, these acceptance criteria are typically engineering specifications (e.g., minimum load bearing capacity, maximum wear rate, specific material properties) derived from recognized standards (e.g., ISO, ASTM).

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Acetabular Liners:
The Trabecular Metal™ Revision Shell Liner is indicated for cemented use in the Trabecular Metal Revision Shell for initial placement or as an in situ replacement polyethylene bearing surface for joint instability, wear and/or damage.

Constrained Liners:
The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is intended to be cemented into a Trabecular Metal Acetabular Revision System shell; the shell is intended for cementless fixation into the acetabulum. The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is indicated for use as a component of a total hip prosthesis in complex primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability and for whom all other options to constrained acetabular components have been considered.

The Trabecular Metal Acetabular Revision System (TMARS) Acetabular Liner and Cemented Constrained Liner are polyethylene/metal acetabular liners, which, when used with a Trabecular Metal Acetabular Revision System Shell, forms the acetabular component of a total hip prosthesis. The acetabular liner constructs are manufactured from Longevity highly cross-linked ultra-high molecular weight polyethylene (UHMWPE). The cemented constrained liners are manufactured from Longevity highly cross-linked UHMWPE and contain a titanium alloy constraining ring. All devices in the scope of this 510(k) are sterile, single-use items.

The provided FDA 510(k) clearance letter (K243571) for the Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through the kind of study layout often associated with novel AI/software devices.

This submission is for a medical device (hip joint prosthesis components) and the "studies" conducted are non-clinical bench tests to ensure the new device performs similarly and safely to already approved devices. Therefore, the response will reflect the information provided, which is typical for a traditional medical device 510(k) clearance.

Here's an analysis of the provided document against your requested criteria:

Acceptance Criteria and Device Performance for Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners (K243571)

Based on the provided 510(k) summary, the device's acceptance criteria are primarily demonstrated through non-clinical bench testing, ensuring the new device's performance is comparable to its predicate devices and meets relevant material standards. The goal is to establish substantial equivalence, not to demonstrate a specific improvement in performance over a human baseline or a novel AI-driven diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not detail specific sample sizes for each non-clinical test (e.g., how many liners were tested for push-out). These are typically bench tests conducted on a sufficient number of samples to statistically validate the mechanical properties. The "data provenance" in this context is from laboratory bench testing, not patient data. Therefore, concepts like country of origin or retrospective/prospective don't apply as they would for clinical studies.

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

This information is not applicable (N/A) for this type of device submission. Ground truth, typically established by expert consensus or pathology in diagnostic studies, is not a concept used for evaluating mechanical components of a hip prosthesis in a 510(k) de novo submission. The "ground truth" here is adherence to engineering standards and comparison to predicate device performance through physical testing.

4. Adjudication Method for the Test Set

This information is not applicable (N/A). Adjudication methods (like 2+1, 3+1, none) are relevant for studies involving human interpretation (e.g., radiologists reviewing images) where disagreements need resolution to establish a ground truth. For mechanical bench testing, the results are objectively measured against defined criteria or compared to predicate performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic algorithms, often comparing human readers with and without AI assistance on a set of cases. This 510(k) is for an orthopedic implant, not a diagnostic AI device.

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

This information is not applicable (N/A). This product is a physical medical device (an acetabular liner), not an AI algorithm. Therefore, "standalone algorithm" performance is not relevant.

7. The Type of Ground Truth Used

As mentioned in point 3, the concept of "ground truth" in the diagnostic AI sense (expert consensus, pathology, outcomes data) is not applicable here. The "truth" or reference for this device's performance is established by:

• Engineering specifications and material standards (e.g., ASTM F648).
• Performance of legally marketed predicate devices (demonstrating substantial equivalence through comparative bench testing).
• Biocompatibility standards (ISO 10993-1).

8. The Sample Size for the Training Set

This information is not applicable (N/A). This device is not an AI/ML algorithm that requires a "training set."

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

This information is not applicable (N/A). As there is no training set for an AI algorithm, there is no ground truth to establish for it.

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The A.L.P.S Proximal Humerus Plating System is indicated for fixation of fractures and fracture dislocations, fusions, osteotomies and non-unions of the humerus, particularly in osteopenic bone.

The A.L.P.S. Proximal Humeral Plating System is made from a titanium alloy and is available in configurations for both the left and right sides, as well as in various lengths. This system includes both locking and non-locking screws/pegs, along with multidirectional screws crafted from titanium alloy and cobalt chromium. It comes complete with general orthopedic instrumentation and system-specific instruments designed for use during implant installation.

Implants are available in both gamma-sterilized and non-sterile options. The disposable instruments are provided only in a sterile condition, while the reusable instruments are offered non-sterile, allowing users to perform steam sterilization before use.

This FDA 510(k) clearance letter is for a medical device called the "A.L.P.S. Proximal Humerus Plating System," which is a metallic bone fixation appliance. As such, it is not an AI/ML (Artificial Intelligence/Machine Learning) device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for an AI device is not applicable to this submission.

The FDA clearance for this device is based on comparing its technological characteristics and intended use to a legally marketed predicate device (K143697 - Biomet Proximal Humerus Plating System) and demonstrating substantial equivalence through non-clinical mechanical testing, rather than an AI performance study.

Summary of available information relevant to device performance and clearance (not AI-related):

• Acceptance Criteria & Reported Performance: The document states that the subject device's performance was evaluated through non-clinical testing. These tests include:

  • Implant Construct Axial Load Static Testing (for plates)
  • Implant Construct Axial Load Fatigue Testing (for plates)
  • Screw and Peg Performance Testing
  • The conclusion is that "any differences do not raise any different questions of safety and effectiveness; and the proposed device is at least as safe and effective as the legally marketed predicate devices." Specific numerical acceptance criteria and reported performance values from these mechanical tests are not provided in this clearance letter.

• Study Type: Non-clinical (mechanical) testing, not a clinical or AI performance study.

• Sample Size (Test Set): Not applicable in the context of an AI device's test set. For mechanical testing, the number of implants/constructs tested would be used, but this is not specified.

• Data Provenance (Test Set): Not applicable for an AI device. The "data" here refers to the results from mechanical testing of the device components.

• Number of Experts & Qualifications (Ground Truth for Test Set): Not applicable, as no expert-derived ground truth for an AI model's output is relevant here.

• Adjudication Method (Test Set): Not applicable.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not conducted, as this is not an AI-assisted device.

• Standalone Performance (Algorithm Only): Not applicable, as there is no algorithm.

• Type of Ground Truth Used: Not applicable in the AI sense. The "ground truth" for this device would be established engineering standards and physical measurements from the mechanical tests.

• Sample Size for Training Set: Not applicable, as there is no AI model.

• How Ground Truth for Training Set was Established: Not applicable.

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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.

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The Zimmer Biomet Ceramic Heads are indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia, (2) avascular necrosis of the femoral head, (3) acute traumatic fracture of the femoral head or neck, (4) failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

When used with constrained acetabular liners, the Zimmer Biomet Ceramic Heads are intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.

The Zimmer Biomet Ceramic Heads are made from a composite ceramic containing approximately 75% alumina (Al2O3) and 25% zirconia (ZrO2) (percentage by weight). They are supplied with a 12/14 bore or a Type 1 bore. The scope of the subject submission is limited to the 22.2mm head diameter with multiple neck configurations.
The subject ceramic heads are intended for mating with Ti-6Al-4V alloy, Ti-6Al-7Nb alloy stems with tapered necks. They may only be used in combination with highly crosslinked or conventional polyethylene (PE) or metal-back polyethylene liners.

This document is a 510(k) clearance letter for a medical device: "Zimmer Biomet Ceramic Heads (22.2mm diameter)". It describes the device, its intended use, and states that no non-clinical or clinical tests were submitted to determine substantial equivalence.

Therefore,Based on the provided FDA 510(k) clearance letter for the "Zimmer Biomet Ceramic Heads (22.2mm diameter)", it is explicitly stated that no non-clinical and/or clinical tests were submitted to determine the substantial equivalence of the subject device with the predicate.

This means that the information requested regarding acceptance criteria and the study proving the device meets these criteria cannot be provided from this document. The clearance was based on:

• Technological Comparison: The only difference between the subject device and the predicate device (K181171, K200823) is the addition of a contraindication for the use of 22.2mm ceramic heads with stainless steel femoral stems. All other technological characteristics are identical.
• Indications for Use Comparison: The indications for use and intended use are identical to the predicate device.

Since no testing was performed or reported in this submission for device performance, the following information cannot be extracted:

1. A table of acceptance criteria and the reported device performance: No performance data was submitted.
2. Sample sizes used for the test set and the data provenance: No test set was used.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable as no test set was evaluated.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, as per the text "No Non-Clinical and/or Clinical Tests were submitted".
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device (hip prosthesis component), not an AI/software algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable as no training set (for an algorithm) was used.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) clearance relied on substantial equivalence to a predicate device based on identical technology and indications for use, with the only change being an additional contraindication. It did not involve new performance studies.

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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.

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When a mechanical alignment approach is utilized, this device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• Moderate valgus, varus, or flexion deformities.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
  When a personalized alignment approach is utilized, this device is indicated for patients with severe knee pain and disability due to:
• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Moderate valgus, varus, or flexion deformities.

The Persona Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial, and patellar bones.
The purpose of this submission is to add compatibility for cemented nonporous Persona tibial components with a stem extension to the current Personalized Alignment (PA) surgical technique option. In addition to the modifications regarding personalized alignment, this submission also discusses the updated geometric evaluations for the Persona Personalized Knee System as well as the shelf-life extension (5 years to 10 years) of its Vivacit-E VEXLPE implant components.

I'm sorry, but based on the provided text, I cannot describe the acceptance criteria and a study that proves the device meets those criteria, as the document does not contain this information. The text is a 510(k) premarket notification letter from the FDA to Zimmer Biomet regarding the Zimmer® Persona® Personalized Knee System, confirming its substantial equivalence to previously marketed devices.

The document focuses on:

• The FDA's determination of substantial equivalence (K243293).
• Regulatory information and requirements for medical devices.
• Indications for use of the Zimmer® Persona® Personalized Knee System.
• Identification of predicate devices (K240299, K222566).
• A brief description of the device and the purpose of the submission (adding compatibility for cemented nonporous Persona tibial components with a stem extension to the Personalized Alignment surgical technique; updated geometric evaluations; shelf-life extension for specific components).
• A summary of technological characteristics comparing the subject device to the predicate device, emphasizing their similarities regarding intended use, indications for use, variants/sizes, design features, material, and sterility, and noting a similar shelf life with an extension for Vivacit-E VEXLPE components.
• A general statement about performance data indicating the proposed devices meet established acceptance criteria and are as safe and effective as predicate devices.

However, the document does NOT include:

• A table of specific acceptance criteria and detailed reported device performance against those criteria.
• Information about sample sizes for test sets, data provenance, or the nature of prospective/retrospective studies.
• Details on the number or qualifications of experts used for ground truth establishment.
• Adjudication methods.
• Statements about multi-reader, multi-case (MRMC) comparative effectiveness studies or human reader improvement with AI assistance.
• Information on standalone algorithm performance.
• The specific type of ground truth used (e.g., pathology, outcomes data).
• Sample sizes for training sets or how ground truth for training sets was established.

The text primarily attests to substantial equivalence based on the similarity of the device to existing predicates and a general statement about meeting performance criteria, but it does not elaborate on the specific studies or data that would fulfill your request for detailed acceptance criteria and proof of adherence.

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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.

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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.

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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.

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