Search Results

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

The Maxx Libertas Bipolar Head is intended for use in combination with a Maxx Libertas Hip System femoral stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:

• Femoral neck and trochanteric fractures of the proximal femur;
• Osteonecrosis of the femoral head;
• Revision procedures where other devices or treatments for these indications have failed.

The Maxx Libertas Bipolar Head consists of three factory-assembled parts: a cobalt chromium outer shell, a UHMWPE liner, and a UHMWPE retention ring. The outer shell has a highly polished spherical outer surface for articulating with the acetabular joint socket. The liner has an hemispherical inner surface for articulating with the spherical head component of the Libertas femoral stem (28 mm). The retention ring provides a locking function to resist dislocation of the femoral head from the bipolar head.

The provided FDA 510(k) clearance letter and summary for the Maxx Libertas Bipolar Hip Head (K243634) describe the device and its intended use, but it does not contain information regarding statistically significant acceptance criteria derived from a clinical or standalone study comparing the device's performance against specific metrics.

Instead, the clearance is based on demonstrating substantial equivalence to a predicate device (BioPro Bipolar Head, K100761) primarily through non-clinical mechanical testing and engineering analysis. This type of submission relies on showing that the new device is as safe and effective as a legally marketed device, often by demonstrating similar design, materials, and performance in simulated conditions.

Therefore, many of the specific details requested in your prompt (e.g., sample size for test set, expert qualifications, MRMC study, ground truth type) are typically not included in a 510(k) summary that relies solely on bench testing and
engineering analysis for substantial equivalence.

Here's an analysis of the information that is available and what is not based on the provided document:

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

• Range of Motion tests were performed.
• Static push-out tests were performed.
• Static Lever-out tests were performed.
  Engineering Analysis:
• Impingement scenarios analysis was performed.

Overall Conclusion: The device performed "identical to the predicate device," supporting substantial equivalence. |

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

• Sample Size for Test Set: Not applicable/Not provided. The "test set" in this context refers to physical test articles used for mechanical testing, not a patient cohort or imaging dataset. The number of physical samples tested is not specified in the summary.
• Data Provenance: Not applicable/Not provided in the summary. Mechanical testing data does not have country of origin in the same way clinical data would.

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. For mechanical and engineering testing, "ground truth" is established by standard engineering principles, test methods (e.g., ASTM or ISO standards, though not explicitly cited here), and simulation results, not by human experts interpreting clinical data.

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

• Not applicable. This concept applies to human interpretation of clinical data in studies, not to device mechanical testing.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/software devices where human-in-the-loop performance is evaluated. The Maxx Libertas Bipolar Hip Head is a physical orthopedic implant.

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

• No, a standalone performance evaluation in the context of an "algorithm only" or AI device was not done. The "standalone" performance here refers to the mechanical and engineering performance of the physical device.

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

• The "ground truth" for demonstrating substantial equivalence for this device was established based on mechanical test results and engineering analysis comparing the subject device's performance to that of the predicate device under simulated conditions. There is no expert consensus, pathology, or outcomes data mentioned in this submission summary.

8. The sample size for the training set

• Not applicable. This term refers to data used to train AI models. This device is a physical orthopedic implant, not an AI/software device that requires a training set.

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

• Not applicable, as there is no training set for this type of device.

Summary of what the study did demonstrate:

The provided document indicates that the Maxx Libertas Bipolar Hip Head gained 510(k) clearance primarily by demonstrating substantial equivalence to a predicate device (BioPro Bipolar Head, K100761). This was achieved through:

• Mechanical Testing: Including Range of Motion, Static push-out, and Static Lever-out tests.
• Engineering Analysis: Specifically for impingement scenarios.
• Technological Comparison: The subject device was deemed "identical to the Predicate Device in design, material, chemical composition, principle of operation."

The conclusion was that the device "performed identical to the predicate device" based on these non-clinical tests, thus supporting its substantial equivalence for the stated Indications for Use.

Ask a specific question about this device

The Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid is a single use disposable device intended to be worn by operating room personnel to protect a surgical wound from contamination.

The tested drugs are:

Simulated Gastric Acid Fluid was also tested with a minimum breakthrough greater than 240 minutes.

Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid is a sterile and disposable device. This glove is made of synthetic polyisoprene rubber inside coated with synthetic material to ease donning the glove. The device is intended to be worn on hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. These gloves were tested for use with Chemotherapy Drugs and Gastric Acid as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The device conforms to the following FDA recognized consensus standards: ASTM D3577-19, ASTM D6124-06, ASTM D5151-19, ASTM D412-16, ISO 11137-1:2006 + AMD1:2013 + AMD2:2018, ISO 11137-2:2013 + AMD1:2022, and ASTM D6978-05.

Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid is available in the following sizes: 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, and 9.0.

The provided document is a 510(k) clearance letter from the FDA for a medical device: "Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid." This document outlines the general requirements for the device and details the non-clinical testing performed to establish substantial equivalence to a predicate device.

However, it does not contain any information regarding clinical studies, AI/ML device performance, or human-in-the-loop studies. The device is a physical medical glove and not an AI-powered diagnostic or assistive tool. Therefore, the requested information elements related to AI/ML and clinical study methodologies are not applicable to this submission.

The document focuses on demonstrating the physical, chemical, and biological safety and performance of the gloves according to recognized consensus standards.

Here's the relevant information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The device underwent non-clinical testing against several recognized standards. The "Results" column consistently states "PASS," indicating that the device met the specified acceptance criteria for each test.

Chemotherapy Drug Permeation Results:

Warning: Carmustine: 15.8 minutes and Thiotepa: 24.6 minutes. Do not use with Carmustine and Thiotepa.

Summary of Study Information (Not Applicable for this Device Type)

The provided document describes a Class I medical device (Sterile Powder Free Synthetic Rubber Surgeon's Gloves) which is a physical product, not a software device or an AI/ML-driven system. Therefore, the following requested information points related to AI/ML device performance and clinical study methodologies are not applicable. The submission primarily relied on non-clinical (bench) testing to demonstrate substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a physical device tested via non-clinical laboratory methods according to recognized standards (e.g., ASTM, ISO). The specific sample sizes for each non-clinical test (e.g., number of gloves for tensile strength, number of samples for permeation, number of animals for biocompatibility) are part of the detailed test reports but are not summarized in this FDA summary document. Data provenance details like country of origin for test materials or retrospective/prospective nature are not specified as they are not relevant for this type of non-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" in the context of expert consensus is typically relevant for diagnostic AI/ML devices interpreting medical images or other complex data. For gloves, "ground truth" is established by adherence to quantitative physical, chemical, and biological performance standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used in clinical trials or expert review panels, not for standard physical/chemical testing of a device like a glove.
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 not an AI system nor does it involve human readers.
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 (expert consensus, pathology, outcomes data, etc.): For this device, the "ground truth" is adherence to the specified performance criteria defined by the listed consensus standards (e.g., ASTM D3577 for physical properties, ASTM D6978 for chemotherapy permeation, ISO 10993 for biocompatibility). These standards define acceptable quantitative limits or qualitative responses (e.g., "not an irritant").
8. The sample size for the training set: Not applicable. This device does not involve a "training set" as it is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This device does not involve a "training set."

Conclusion:

The FDA document K250313 confirms the clearance of sterile surgeon's gloves based on their adherence to established non-clinical performance and safety standards, including physical properties, sterility, and resistance to chemotherapy drugs and gastric acid. The document explicitly states that "[a] clinical study was not conducted in support of this submission." The questions related to AI/ML, clinical study designs, expert ground truth, and training data are not relevant to this specific device submission.

Ask a specific question about this device

Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:

• Arsenic Trioxide (1 mg/ml)
• Bendamustine, (5 mg/ml)
• Blenoxane (15 mg/ml)
• Bleomycin (15 mg/ml)
• Bortezomib (1 mg/ml)
• Busulfan (6 mg/ml)
• Carboplatln (10 mg/ml)
• Carfilzomib (2 mg/ml)
• Cetuximab (2 mg/ml)
• Cisplatin (1 mg/ml)
• Cyclophosphamide (Cytoxan) (20 mg/ml)
• Cytarabine (100 mg/ml)
• Dacarbazine (DTIC) {10 mg/ml)
• Daunorubicin {5 mg/ml)
• Decitabine (5 mg/ml)
• Docetaxel (10 mg/ml)
• Doxorubicin HCL (2 mg/ml)
• Ellence (2 mg/ml)
• Erbitux (2 mg/ml)
• Eribilin Mesylate (0.5 mg/ml)
• Etoposide (Toposar) (20 mg/ml)
• Fludarabine (25 mg/ml)
• Fulvestrant (50 mg/ml)
• Gemcitabine (Gemzar) (38 mg/ml)
• Idarubicin (1 mg/ml)
• Ifosfamide (IFEX) (50 mg/ml)
• Irinotecan (20 mg/ml)
• Mechlorethamine HCL (1 mg/ml)
• Melphalan (5 mg/ml)
• Methotrexate (25 mg/ml)
• Mitomycin C (0.5 mg/ml)
• Mitoxantrone (2 mg/ml)
• Oxaliplatin (2 mg/ml)
• Paclitaxel (Taxol) (6 mg/ml)
• Paraplatin (10 mg/ml)
• Pemetrexed Disodium (25 mg/ml)
• Pertuzumab (30 mg/ml)
• Raltitrexed (0.5 mg/ml)
• Rituximab (Rituxan) (10 mg/ml)
• Temsirolimus (25 mg/ml)
• Thiotepa (10 mg/ml)
• Topotecan HCL (1 mg/ml)
• Trastuzumab (21 mg/ml)
• Trisenox (1 mg/ml)
• Velcade (1 mg/ml)
• Vinblastine (1 mg/ml)
• Vinorelbine (10 mg/ml)

Carmustine (3.3 mg/ml) permeation occurred at 60.0 minutes.

The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:

• Fentanyl Citrate Injection (100 mcg/2 ml)
• Gastric Acid Fluid/Fentanyl Citrate Injection Mix (50/50 Solution)

Caution: Testing showed a minimum breakthrough time of 60.0 minutes with Carmustine.

The following hazardous drugs and concentration had NO breakthrough detected up to 240 minutes:

• Cytovene (10 mg/ml)
• Retrovir (10 mg/ml)
• Triclosan (2 mg/ml)
• Zoledronic Acid (0.8 mg/ml)

Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid are disposable, 12"purple-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, nonsterile patient examination gloves.

The provided text is an FDA 510(k) clearance letter and summary for a medical glove, not an AI-powered medical device. Therefore, many of the requested fields related to AI study design (like "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone performance," "number of experts," etc.) are not applicable and cannot be found in the document.

However, I can extract the acceptance criteria and performance data for the glove based on the provided information, focusing on the non-clinical and clinical tests described.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

The Apollo TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

The Apollo TMS Therapy System is an electromagnetic device that non-invasively delivers a rapidly pulsed magnetic field to the cerebral cortex in order to activate neurons within a limited volume without inducing a seizure. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation (TMS).

The Apollo TMS Therapy System is comprised of the following principal components:

• User Interface
• Main Unit (with or without housing)
• Stimulation Coil
• Coil Positioning System

The operator controls the Apollo TMS Therapy System via the user interface (application software "Stimware"). "Stimware" is a treatment and data management software that administrates treatment protocols and the patient´s individual stimulation dose determined by the patient´s individual motor threshold. Stimulation is applied via the stimulation coil. For the treatment of major depressive disorder, the stimulation coil is positioned to the left dorsolateral prefrontal cortex (DLPFC) by means of the coil positioning system. The observed and documented increase in cortical excitability after high frequency rTMS has been shown to persist beyond the duration of the train of stimulation. For treatment of OCD, the stimulation coil is positioned to the dorsomedial prefrontal cortex (DMPFC).

The provided FDA 510(k) clearance letter and summary for the Apollo TMS Therapy System (K243539) indicate that the device is substantially equivalent to predicate devices. This clearance is based on non-clinical performance data and a comparison to existing cleared devices rather than a de novo clinical comparative effectiveness study.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission are primarily based on demonstrating substantial equivalence to existing legally marketed predicate devices, particularly for the extended indication of Obsessive-Compulsive Disorder (OCD) treatment. The criteria are therefore focused on matching or being demonstrably similar to the predicate device's performance, especially for the OCD treatment parameters, and adhering to recognized safety and performance standards.

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

The submission does not detail a specific "test set" sample size with patient data for efficacy, as it claims substantial equivalence primarily through non-clinical performance testing and direct comparison of specifications and treatment parameters to already cleared devices.

The "study" relies on:

• Non-clinical performance testing: This would involve engineering and laboratory testing for electrical safety, EMC, usability, temperature, and stimulation intensity, rather than a sample size of patients.
• Leveraged data from prior clearances (K180313 and K232639): This indicates that data from previously cleared versions of the Apollo TMS Therapy System was used as a basis.
• Primary predicate device (HORIZON® 3.0 TMS Therapy System K222171): The effectiveness of the OCD treatment protocol is derived from the established effectiveness of this predicate device, which was itself cleared based on its own clinical or non-clinical data.

Data Provenance: Not specified in terms of country of origin or retrospective/prospective for patient data, as direct clinical effectiveness data for the subject device was not required for this 510(k) clearance due to the substantial equivalence claim. The non-clinical testing would have been conducted by the manufacturer (MAG & More GmbH, Germany).

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

This information is not applicable as the submission does not describe a clinical study where experts established ground truth for a test set of patient data. The clearance is based on comparison to a predicate device and non-clinical engineering tests.

4. Adjudication method for the test set

This information is not applicable as there was no clinical test set requiring expert adjudication.

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. The Apollo TMS Therapy System is a therapeutic device that directly applies magnetic stimulation, not an imaging analysis or diagnostic AI device that involves "human readers" or AI assistance in interpretation. No MRMC study was conducted or mentioned.

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

This information is not applicable in the context of an "algorithm only" performance study. The Apollo TMS Therapy System is a hardware device with controlling software. Its performance is always "standalone" in the sense that the device itself (hardware+software) delivers the therapy; there isn't a separate "human-in-the-loop" performance associated with its direct therapeutic action, but rather clinical oversight and operation by a healthcare professional. The software verification and validation are noted, but this is for the control system's reliability, not an "algorithm-only performance" in the diagnostic AI sense.

7. The type of ground truth used

For the effectiveness of the OCD treatment, the "ground truth" is essentially the established clinical efficacy of the primary predicate device (HORIZON® 3.0 TMS Therapy System K222171), whose OCD treatment protocol the Apollo TMS Therapy System replicates. The substantial equivalence claim means that because the subject device's treatment parameters are identical and its output stimulation is adequately similar, it can be expected to achieve the same therapeutic effect.

For the safety and performance of the device itself (e.g., electrical safety, temperature limits, consistent stimulus delivery), the "ground truth" is established through adherence to recognized consensus standards (e.g., IEC 60601-1) and successful non-clinical engineering tests.

8. The sample size for the training set

This information is not applicable. The Apollo TMS Therapy System is not an AI/ML device in the sense of requiring a large "training set" of patient data for its primary function. Its software (Stimware) manages protocols and patient data, but it's not "trained" on patient outcomes to learn or adapt therapeutic delivery in an AI sense.

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

This information is not applicable for the same reasons as point 8.

Ask a specific question about this device

Zirconia Implants:
The Neodent Implant System is intended to be surgically placed in the bone of upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusion loading. Multiple teeth applications can be rigidly splinted. The implants with length of 5 mm (short implants) may be used only with two-stage surgical procedures. The recommended healing time before loading is between 10 to 12 weeks.

Zi Transmucosal Cover Screw and Healing:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted.

Zi Transmucosal Provisional Coping:
The Neodent Implant System is intended for surgical procedures in maxilla or mandible, providing support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single- or multi-unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Zi Transmucosal Abutment Replacement Screw:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Zi Transmucosal Universal Base:
The Universal Ceramic Base Zi Transmucosal 5.0 is an abutment placed over Neodent Zi Transmucosal 5.0 Ceramic Implant System in order to provide support for custom-made prosthetic restorations, such as copings or crowns. It may be used for cement or screw-retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

Zirconia Base for Bridge:
The Zirconia Base for Bridge is an abutment placed over Neodent Zirconia Implants in order to provide support for custom-made prosthetic restorations. It may be used for cement or screw-retained multi-unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

Zirconia Base C:
The Zirconia Base C is an abutment placed over Neodent Zirconia Implants in order to provide support for customized prosthetic restorations, such as copings or crowns. It may be used for single-unit restorations that are screw- or cement-retained in esthetic areas over implants installed in the maxilla or mandible. All copings and/or crowns digitally designed for use with the Titanium Base C are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.

This premarket notification includes new ceramic devices into Neodent Implant System, which are compatible with Zirconia Implant System. The Zirconia Implants and Abutments proposed on this submission are similar to devices already cleared in previous submissions of Neodent Implant System – Zirconia Implant System, according to predicate devices described above. This submission intends to expand the portfolio with new solutions and diameter, in order to provide more treatment options to the customers.

The Zirconia Implants are manufactured in Zirconia Y-TZP and are available in Bone Level (BL) or Tissue Level (TL or Transmucosal) configurations. The Zirconia Implants (BL) are available in a diameter of 5.0 mm and lengths in a range of 8 to 13 mm. The Zi Transmucosal Implants (TL) are available in a diameter of 5.0 mm and lengths in a range of 5 to 11.5 mm.

The Zi Transmucosal Healing and Cover Screw are temporary abutments manufactured in PEEK and used during the healing phase. They are compatible with the Zi Transmucosal Implants Ø5.0. The Zi Transmucosal Healing Abutment is available in the heights of 2 and 3.5mm.

The Zi Transmucosal Provisional Coping is a temporary abutment made of polycarbonate (PC) and has a double function: used for molding procedures or production of provisional restoration.

The Zi Transmucosal Abutment Replacement Screw is a prosthetic component manufactured in titanium alloy and used to fix the fix the Zi Transmucosal Base to the Zi Transmucosal Implant.

The Zi Transmucosal Universal Base is a two-piece abutment of base and top-half prosthetic structure to provide support for customized single-unit restorations over Zi Transmucosal Implant (TL). The base is manufactured in Zirconia Y-ZTP and used with a patient-specific top-half prosthetic structure. The two-piece abutment has a cementable portion of 4mm and is available with gingival heights of 0.3, 1.0 and 1.5 mm. The top-half prosthetic structure to be used with Zi Transmucosal Universal Base must be designed and milled in a Straumann Validated Milling center, using the following restoration materials and dimensions:
Material: IPS e.max CAD HT, Associated Material 510(k): K132209, Minimum wall thickness: 0.9 mm, Maximum angulation: 30°
Material: IPS e.max CAD LT, Associated Material 510(k): K132209, Minimum wall thickness: 0.9 mm
Material: N!ce, Associated Material 510(k): K171773, Minimum wall thickness: 1.0 mm
Material: IVOCLAR Multilink cement, Associated Material 510(k): K130436, Minimum wall thickness: N/A
Material: Zirconia N!ce® LT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: Zirconia N!ce® HT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: Zirconia N!ce® XT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: PMMA N!ce, Associated Material 510(k): K071548, Minimum wall thickness: 0.7 mm
Material: Panavia—Kuraray Cement, Associated Material 510(k): K150704, Minimum wall thickness: N/A, Maximum angulation: N/A

The Zi Base for Bridge is a two-piece abutment of base and top-half prosthetic structure to provide support for customized multi-unit restorations over Zirconia Implants (BL). The base is manufactured in Zirconia Y-ZTP and used with a patient-specific top-half prosthetic structure. The two-piece abutment has a cementable portion of 4mm and is available with gingival heights of 1.5, 2.5 and 3.5 mm. The top-half prosthetic structure to be used with Zi Base for Bridge must be designed and milled in a Straumann Validated Milling center, using the following restoration materials and dimensions:
Material: Zirconia N!ce® LT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm, Maximum angulation: 30°
Material: Zirconia N!ce® HT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: Zirconia N!ce® XT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: PMMA N!ce, Associated Material 510(k): K071548, Minimum wall thickness: 0.7 mm
Material: Panavia—Kuraray Cement, Associated Material 510(k): K150704, Minimum wall thickness: N/A, Maximum angulation: N/A

The Zi Base C is a two-piece abutment of base and top-half prosthetic structure to provide support for customized single-unit restorations over Zirconia Implants (BL). The base is manufactured in Zirconia Y-ZTP and used with a patient-specific top-half prosthetic structure. The two-piece abutment has a cementable portion of 4mm and is available with gingival heights of 1.5, 2.5, 3.5 and 4.5 mm. The top-half prosthetic structure to be used with Zi Base C must be designed and milled in a Sirona InLab Validated Workflow, using the following restoration materials and dimensions:
Material: IPS e.max CAD, Associated Material 510(k): K132209, Minimum wall thickness: 0.9 mm, Maximum angulation: 20°
Material: IVOCLAR Multilink cement, Associated Material 510(k): K130436, Minimum wall thickness: N/A, Maximum angulation: N/A

All these abutments have an internal connection with the implants (ZiLock) and the prosthetic platform is identical for all subject devices described in this submission. They are intended for single use and provided sterile via Ethylene Oxide method, along with undergoing moist heat sterilization after end-user customization.

The provided FDA 510(k) clearance letter and its associated summary for the Neodent Implant System - Zirconia Implant System contain extensive information about the device, its intended use, and comparisons to predicate devices. However, it does not include specific acceptance criteria with numerical thresholds directly stated within the tables, nor does it detail a study that directly proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or image quality assessments.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through various tests, implying that if the new device performs similarly to or better than previously cleared devices, it meets the necessary standards. The performance testing section describes the types of tests conducted (e.g., dynamic fatigue, torsion, insertion, pull-out, and software validation), but it does not present clear quantitative acceptance criteria or the specific performance results in a comparative table format.

Therefore, many of the requested fields cannot be directly extracted from the provided text as they pertain more to the performance evaluation of AI/software in interpreting medical images, which is not the primary focus of this dental implant submission.

Here's an attempt to answer the questions based on the available information, noting where information is not explicitly provided in the document:

Acceptance Criteria and Device Performance Study for Neodent Implant System - Zirconia Implant System

The FDA 510(k) summary for the Neodent Implant System - Zirconia Implant System focuses on demonstrating substantial equivalence to predicate devices through a combination of bench testing, software validation, MRI compatibility, biocompatibility, and sterilization validation. It does not present specific quantitative acceptance criteria or performance metrics directly from a comparative study in the way one might expect for an AI/software-based medical device (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implicitly met by demonstrating that the proposed devices perform at a level substantially equivalent to legally marketed predicate devices under standardized testing conditions.

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

As mentioned, explicit numerical acceptance criteria and reported device performance in a comparative table (e.g., for diagnostic accuracy) are not provided in this 510(k) summary. The summary indicates that tests were conducted according to relevant ISO standards and FDA guidance, and the results demonstrated that the subject devices exhibit a level of performance substantial equivalent to the predicate and reference devices.

Below is a conceptual table based on the types of tests mentioned, noting that specific numerical acceptance criteria and performance data are not detailed in the provided text.

Ask a specific question about this device

The KLS Martin Ixos system is indicated for use in forearm fractures, osteotomies, and arthrodeses. This system is intended for adults, as well as adolescents (12-21 years) and children (2-12 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.

The KLS Martin Ixos System consists of metallic plates used in conjunction with bone screws and locking pins intended for the internal fixation, alignment, stabilization, and reconstruction of the distal radius and/or ulna. Plates are manufactured from Ti-6Al-4V and are available in various shapes and dimensions. The system also includes the necessary instruments to facilitate placement of the implants. The manufacturing process, sterilization methods, materials and packaging are identical to those of the cleared predicate device, KLS Martin LINOS Wrist System (K222624).

The provided FDA 510(k) clearance letter for the KLS Martin Ixos System does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria for an AI/software device.

This document describes a metallic bone fixation appliance, not a software or AI medical device. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states "Clinical Performance Data: Not Applicable" and details mechanical performance testing (in accordance with ASTM F382) and MR compatibility testing (per various ASTM standards). These are standard tests for orthopedic implants to demonstrate their static and dynamic strength, and safety in an MRI environment.

Therefore, I cannot extract the following information as it is not present in the provided text:

• A table of acceptance criteria and the reported device performance (for AI/software).
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth
• Adjudication method
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc)
• The sample size for the training set
• How the ground truth for the training set was established

The document focuses on demonstrating substantial equivalence to predicate orthopedic implants based on:

• Same intended use/indications for use.
• Similar technological characteristics: manufactured from the same materials (Ti-6Al-4V), using the same manufacturing methods, and having similar principles of operation.
• Performance data: Non-clinical comparative static and dynamic mechanical performance testing against a secondary predicate (Stryker VariAx 2 distal radius plates) and MR compatibility testing.

In summary, the provided document is a 510(k) clearance for a physical medical device (bone plate system), not an AI/software device, and thus does not include the type of performance evaluation details (e.g., ground truth, reader studies, training data) relevant to AI/software.

Ask a specific question about this device

The FilmArray GI Control Panel M238 is intended for use as an external positive and negative assayed quality control to monitor performance of the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel and the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid assays on the BIOFIRE FILMARRAY systems. BIOFIRE FILMARRAY Gastrointestinal (GI) Panel and the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid assays qualitatively detect the following targets: Campylobacter (C. jejuni/C. coli/C. upsaliensis), Clostridium (Clostridioides) difficile toxin A/B, Plesiomonas shigelloides, Salmonella, Vibrio (V. parahaemolyticus/V. vulnificus/V. cholerae), Yersinia enterocolitica, Enteroaggregative E. coli (EAEC), Enteropathogenic E. coli (EPEC), Enterotoxigenic E. coli (ETEC) lt/st, Shiga-like toxin-producing E. coli (STEC) stx1/stx2, E. coli O157, Shigella/Enteroinvasive E. coli (EIEC), Cryptosporidium, Cyclospora cayetanensis, Entamoeba histolytica, Giardia lamblia, Adenovirus F 40/41, Astrovirus, Norovirus GI/GII, Rotavirus A, and Sapovirus. The FilmArray GI Control Panel M238 contains synthetic RNA transcripts in stabilizing solution, buffers, and preservatives. The FilmArray GI Control Panel M238 is designed for and intended to be used solely with the BIOFIRE FILMARRAY GI Panel and the BIOFIRE FILMARRAY GI Panel Mid assays. This product is not intended to replace manufacturer internal controls provided with these devices.

FilmArray GI Control Panel M238, P/N M238, is a quality control panel consisting of 2 single use, ready-to-use, liquid controls, FilmArray GI Control M239, P/N M239, and FilmArray GI Control M240, P/N M240. Each kit of FilmArray GI Control Panel M238 is comprised of 6 tubes of M239 and 6 tubes of M240. Together the 2 controls contain synthetic RNA corresponding to genome segments of all the pathogens detected by the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel and BIOFIRE FILMARRAY GI Panel Mid assays, suspended in a non-infectious solution of buffers, preservatives and stabilizers.

Each liquid control of FilmArray GI Control Panel M238 is processed separately according to the BIOFIRE GI Panel and BIOFIRE GI Panel Mid manufacturer's Instructions for Use for patient samples, stool samples in Cary Blair transport media obtained from individuals with signs and/or symptoms of gastrointestinal infection.

The provided FDA 510(k) clearance letter and summary discuss the validation of the FilmArray GI Control Panel M238. This device is an assayed quality control material, not an AI/ML-driven diagnostic device. Therefore, many of the requested elements the prompt is asking for (e.g., number of experts, adjudication methods, MRMC study, training sets, human-in-the-loop performance) are not applicable to this type of device.

However, I can extract and present the relevant information regarding its acceptance criteria and the study that proves it meets those criteria, focusing on the concepts applicable to quality control materials:

Device: FilmArray® GI Control Panel M238 (M238)

This device is an external positive and negative assayed quality control used to monitor the performance of the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel and the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid assays. It contains synthetic RNA transcripts as targets.

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for a quality control material like this is its ability to consistently produce the correct expected results (either positive or negative depending on the specific control) when tested with the target assay. The study demonstrated 100% correctness across all valid tests.

Table 1: Acceptance Criteria and Reported Device Performance

Study Details Proving Acceptance Criteria are Met

1. Sample Size Used for the Test Set and Data Provenance:
* Sample Size: A total of 165 samples were tested.
* 79 samples of FilmArray GI Control M239 (positive control)
* 86 samples of FilmArray GI Control M240 (negative control)
* Data Provenance: The device was manufactured at MMQCI's facility in Saco, Maine, and tested at 2 unspecified sites. The study was prospective in nature, as it involved the creation and testing of new control lots specifically for this submission. The country of origin of the data is implicitly the USA, given the FDA filing and US company address.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
* Not applicable in the conventional sense for a quality control material. The "ground truth" for a quality control material is its pre-defined composition, meaning it is designed to contain specific targets (for the positive control) or no targets (for the negative control). The BIOFIRE FILMARRAY GI Panel itself serves as the reference against which the control material's behavior is assessed.
* The study involved 9 operators, who presumably were trained laboratory personnel using the BIOFIRE FILMARRAY system according to its Instructions for Use. Their role was in executing the tests, not in establishing a medical "ground truth" through expert review as would be the case for image-based diagnostic AI.

3. Adjudication Method for the Test Set:
* Not applicable. The results are qualitative (Positive/Negative for specific targets, or Valid/Invalid run) and are determined by the automated output of the BIOFIRE FILMARRAY system. There is no subjective interpretation requiring adjudication among experts. The "adjudication" is purely objective: did the control material yield the expected automated result on the instrument?

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
* No. MRMC studies are typically performed for diagnostic imaging devices where human readers interpret patient cases. This device is a quality control material for an in vitro diagnostic (IVD) assay, not a diagnostic imaging device, nor does it involve human interpretation of complex medical cases. The study demonstrated the device's ability to monitor the performance of the BIOFIRE FILMARRAY system itself.

5. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* This question is more relevant to AI/ML software. In the context of this quality control material, its "standalone" performance refers to its ability to elicit the expected results from the BIOFIRE FILMARRAY system independently. The study demonstrates this functional performance, showing 100% correct results triggered by the control material when used with the instrument, which is the equivalent of "standalone" functionality for this type of product.

6. The Type of Ground Truth Used:
* Defined Composition: For quality control materials, the ground truth is the known, pre-defined composition of the control panel itself. The M239 control is designed to be positive for certain targets, and the M240 control is designed to be negative or non-reactive. The "correctness" is therefore a measure of whether the BIOFIRE FILMARRAY system, when challenged with these known controls, reports the expected results.

7. The Sample Size for the Training Set:
* Not applicable. This is a quality control material, not an AI/ML algorithm that requires a training set. The "training" for such a product implicitly involves its manufacturing and formulation process to achieve the desired composition and stability.

8. How the Ground Truth for the Training Set was Established:
* Not applicable, as there is no training set in the context of an AI/ML algorithm. For the manufacturing of the quality control material, the "ground truth" is established by the precise formulation and characterization of the synthetic RNA transcripts and other components to ensure the desired positive or negative reactivity.

Ask a specific question about this device