Search Results

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.

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

The document details various bench tests (dynamic fatigue, torsion, insertion, pull-out) and validation studies (software, MRI, biocompatibility, sterilization, endotoxin, shelf-life). However, specific numerical sample sizes ("n=") for these individual tests are not provided in the summary. For example, for dynamic fatigue testing, it states "the results demonstrated that...". It doesn't specify how many implants or setups were tested.

• Data Provenance (Country of Origin): The submitter is JJGC Indústria e Comércio de Materiais Dentários S.A. (dba Neodent) based in Curitiba, Paraná, Brazil. The tests are generally conducted to international ISO standards and FDA guidance, but the location where the tests were performed is not explicitly stated for each test beyond the company's Brazilian location.
• Retrospective or Prospective: Not applicable in the context of bench testing and validation studies as described. These are laboratory-based tests rather than clinical studies on patient data.

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 and not provided in the context of this 510(k) submission. The device is a dental implant system (hardware), not an AI/software device that interprets medical images requiring expert-established ground truth for a test set. The validation processes involve standardized engineering and biological tests as opposed to expert review of clinical cases.

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

This information is not applicable and not provided. As explained above, the submission pertains to a hardware device, not an AI/software system requiring human adjudication for ground truth establishment.

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. This type of study is relevant for AI-assisted diagnostic tools, not for dental implant hardware.

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

This information is not applicable and not provided. This concept is specific to AI/software performance, not a physical dental implant system. The "software validation" mentioned is for the compatibility of milling units (CAD/CAM workflow), ensuring design parameters are respected, not for an AI algorithm interpreting dental images.

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

For the bench tests, the "ground truth" is defined by compliance with established engineering standards (e.g., ISO 14801 for dynamic fatigue) and specifications (e.g., material properties, dimensions). For biological safety, it's compliance with ISO 10993. For the CAD/CAM software, it's the accurate adherence to design parameters. This isn't "ground truth" in the diagnostic sense, but rather adherence to predefined engineering and biocompatibility specifications.

• Clinical Literature Review: A clinical literature review was conducted to support the safety of Zi Transmucosal Implant less than 7mm of length, referencing animal studies and histomorphometry evaluation. This aligns with outcomes data or pathological/histological evidence from preclinical studies, suggesting "similar osseointegration outcomes" and "ability to promote bone formation around them in a manner equivalent to titanium implants."

8. The sample size for the training set

This information is not applicable and not provided. This concept is specific to machine learning/AI models, which are not the subject of this 510(k) submission.

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

This information is not applicable and not provided. As above, this is relevant for AI/ML training data, not for a physical dental implant system.

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Custom Abutment AS Ti:
The Custom Abutment with Angled Screw Channel is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations. All abutments are only intended to be digitally designed and manufactured using specifics CAD/CAM software according to digital dentistry workflow. Custom Abutments with Angled Screw Channel are indicated for screw-retained single restorations or cemented retained single or multiple restorations. All digitally designed abutments for use with the Custom Abutment Ti with Angled Screw Channel are intended to be sent to Straumann for manufacturing at a validated milling center.

ASC 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.

This premarket notification includes new digital abutments to the Neodent Implant System (GM, NGM and HS prosthetic interfaces). The abutments proposed on this submission are identical to devices already cleared in previous submissions of Neodent Implant System, according to predicate devices described above, being the only difference between them the introduction of a new angled channel solution. This submission intends to expand the portfolio of Neodent Implant System. The Custom Abutments AS Ti are composed of a unique body with two different regions: the upper region, which is the customizable portion, and the end region presents the prosthetic interface that fits with the implant, which does not allow customization. They must be sent to a Straumann Validated Milling

This document describes the Neodent Implant System - Custom Abutments and its FDA 510(k) clearance (K250614). The information provided is primarily focused on demonstrating substantial equivalence to a predicate device, rather than detailed performance study results with specific acceptance criteria and performance metrics for a novel AI/software device.

Based on the provided text, the device is a physical medical device (dental implant abutment) and not an AI/software device. Therefore, the questions related to AI/software performance studies, such as sample size for test sets, expert adjudication, MRMC studies, standalone algorithm performance, and training set details, are not applicable to this submission.

The "Performance Testing" section primarily describes bench testing (dynamic fatigue and torsion tests), biocompatibility testing, and sterilization validation, which are standard for physical medical devices.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the format typically seen for performance metrics of a diagnostic device. Instead, it describes general compliance with standards and the determination of "not a new worst case" for dynamic fatigue.

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

• Sample Size for Bench Testing (Dynamic Fatigue and Torsion): Not
  explicitly stated. The document mentions "a worst case analysis determined that the subject devices are not a new worst case compared to those devices tested for the primary predicate." This implies that testing was performed on a sufficient number of samples to make this determination, likely following the requirements of ISO 14801.
• Data Provenance: Not explicitly stated, but these are typically laboratory-based bench tests performed by the manufacturer or a contracted testing facility.

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

• Not Applicable. This is a physical device, and the testing involves objective measurements (e.g., force, torque, material properties) rather than expert interpretation of data for ground truth establishment.

4. Adjudication Method for the Test Set

• Not Applicable. As above, the tests are objective physical measurements.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

• Not Applicable. This is a physical device, not an AI-assisted diagnostic or decision support system.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not Applicable. This is a physical device. While it involves digital design using CAD/CAM software, the 'device' itself is the physical abutment, and its performance is evaluated through physical and material tests, not software algorithm performance.

7. The Type of Ground Truth Used

• Physical/Material Standards and Engineering Specifications. For dynamic fatigue and torsion tests, the "ground truth" or acceptance criteria are derived from established engineering principles, material properties (ASTM F136 for titanium alloy), and international standards (ISO 14801). For biocompatibility, it's compliance with ISO 10993 series.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical device; there is no "training set" in the context of machine learning or AI models.

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

• Not Applicable. As above, no training set for an AI/ML model for this physical device.

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The Fibers are indicated for use in general surgical applications for incision, vaporization, ablation, hemostasis or coagulation of soft tissue. It is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated. The neoLaser Laser Surgery Fibers have a wavelength range of 450 nm to 2100 nm, can be used in contact mode and are indicated for use in general surgery, urology, gastroenterology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT and endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with a cleared compatible laser marketed for the mentioned intended uses and using an SMA 905 connector.

The neoLaser Laser Surgery Fibers are sterile, single use, laser delivery devices intended for medical applications in various fields of laser surgery. They are intended to deliver energy to soft tissue in contact and non-contact mode during various surgical applications, including via endoscopes and cytoscopes. The fibers are designed to transmit energy from the laser system to the treatment site, as well as to transmit a low power laser aiming beam to assist in the visibilty of the target tissue.

The provided text is a 510(k) summary for the neoLaser Laser Surgery Fibers. It describes a medical device and its substantial equivalence to a predicate device, BeaMed Laser Surgery Fibers (K232769). This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy from scratch.

Therefore, the document does not outline acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-based medical device performance study. Instead, it focuses on demonstrating equivalence through comparison of technical characteristics and performance bench testing.

Here's why the requested information cannot be extracted from this document:

• The device is a physical medical instrument (laser surgery fibers), not an AI/algorithm-based device. The questions about MRMC studies, human reader improvement with AI, standalone algorithm performance, and ground truth establishment for training/test sets are relevant to AI/ML medical devices, not simple surgical tools.
• The 510(k) pathway for this device is based on "substantial equivalence" to a predicate device. This means the manufacturer proves the new device is as safe and effective as an already cleared device through comparison of specifications, materials, and bench testing, not through new clinical performance studies against defined acceptance criteria for a novel technology.
• The document explicitly states: "Animal or clinical studies: None." This confirms that performance studies in the way you've outlined for AI/ML models (with test sets, ground truth, expert readers, etc.) were not conducted or required for this 510(k) submission.

However, I can extract information regarding the device's characteristics and the types of "performance" assessments that were deemed sufficient for this 510(k) clearance, even though they don't align with the typical AI/ML study framework you've described.

Based on the provided document, here's an attempt to address the prompt's points, reinterpreting them for a physical medical device clearance based on substantial equivalence:

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

The "acceptance criteria" for a 510(k) submission for a physical device like this are primarily demonstrated through substantially equivalent technical specifications and material properties to a predicate device, along with successful bench testing to ensure safety and functionality. The document presents a comparative table rather than an acceptance criteria table.

Performance Bench Testing included in the submission (serving as "proof"):

• Packaging seal strength
• Dye penetration test
• Packaging microbial barrier
• Shelf-life validation summary
• Sterilization process validation plan
• Sterilization process validation protocol
• Sterilization process validation report
• Sterility Assurance Level (SAL)
• EO-ECH residuals report
• LAL Endotoxin test
• Bioburden bare fibers test / Bioburden capped fibers tests
• Biocompatibility tests protocols & reports
• Thermal safety validation

The success of these tests (implicitly, meeting pre-defined thresholds for each) serves as the "reported device performance" that proves the device's safety and functionality for a 510(k) submission based on 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)

Not applicable. This is for a physical device, and the submission explicitly states "Animal or clinical studies: None." The "tests" mentioned are bench tests on the device itself or its packaging/materials, not performance studies with human data. Therefore, concepts like sample size for a test set of patient data or data provenance (country, retrospective/prospective) are not relevant here.

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

Not applicable. No "ground truth" was established in the context of an AI/ML algorithm's performance against human expert interpretations or pathology. The evaluation is based on engineering and material specifications, and physical bench testing results.

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

Not applicable. There was no 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

Not applicable. This device is not an AI/ML algorithm that assists 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 AI/ML algorithm.

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

Not applicable. The "ground truth" for this device's clearance is its conformity to engineering specifications, material standards, and successful completion of bench tests (e.g., sterilization efficacy, biocompatibility).

8. The sample size for the training set

Not applicable. There is no AI/ML training set for this physical device.

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

Not applicable. There is no AI/ML training set or associated ground truth.

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Neonav is indicated for navigation and positioning of central venous access devices (CVADs) of at least 1Fr in size. Neonav provides real-time catheter tip location information by using the patient's cardiac electrical activity. Neonav is indicated for use as an alternative method to chest X-ray and fluoroscopy for all central venous access device tip placement confirmation.

In adult patients and in adolescents (greater than 12 through 21 years of age), Neonav can be used with CVADs such as peripherally inserted central catheters (PICCs), centrally inserted central catheters (CICCs), implantable ports, and hemodialysis catheters; in children (greater than 2 to 12 years of age), Neonav can be used with CICCs; in infants (greater than 1 month to 2 years of age) and in neonates (from birth to 1 month of age), Neonav can be used with PICCs and CICCs. In each specific age group, the CVAD type and size must be chosen and the CVAD must be used according to the CVAD's indications and instructions for use.

Limiting but not contraindicated situations for use of the Neonav are in patients where alterations of cardiac rhythm change the presentation of the P wave as in atrial flutter, severe tachycardia, and pacemaker driven rhythm. In such patients, who are easily identifiable prior to central venous access device insertion, the use of an additional method is required to confirm catheter tip location.

The Neonav ECG Tip Location System (Neonav) is a non-invasive medical device that analyzes electrocardiographic signals (ECG) to track the location of central venous access devices (CVADs) in patients' blood vessels during placement in real time via a display.

Catheter position in the vasculature is analyzed based on the patient's intravascular ECG (I-ECG). An I-ECG is recorded via the catheter tip from within the blood vessels of a patient. For the conductive fluid method, the sterile Neonav ECG Adapter Cable are used whereas for guidewire/stylet method, the sterile Neonav ECG clip cable is used. These components allow the electrical impulses detected at the catheter tip to be recorded by a non-sterile Acquisition Unit and analyzed by the Neonav Console to assist in determining the catheter tip position. The Neonav Controlled via a touch screen interface or a Remote enclosed in a sterile cover. The Neonav Console displays real-time surface ECG and I-ECG signals, highlighted QRS complex, max measured P-wave, the patient's heart rate, and other device performance indicators. A surface electrode is placed on the subject to act as a reference electrode. A second surface electrode is placed on the subject for noise reduction.

Neonav components are designed to attach easily to standard catheter and IV therapy components via standard luer lock connections. The only patient contacting component of the ECG Adapter. It has indirect contact with the patient via fluids and is composed of biocompatible polycarbonate and stainless steel.

The Neonav ECG Tip Location System is intended for navigation and positioning of central venous access devices (CVADs). The acceptance criteria and supporting study details are outlined below based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not explicitly state a specific sample size for a clinical test set used to prove the device meets acceptance criteria related to its primary function of tip location accuracy. The document primarily references non-clinical bench tests and compliance with various standards.

There is a mention of "most current literature and effectiveness of PICCs in infants and neonates" supporting expanded indications, but this is not described as a direct device performance study.

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

The document does not specify the number of experts or their qualifications for establishing ground truth for any performance study.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it quantify any improvement in human reader performance with or without AI assistance. The Neonav system "displays the intravascular ECG to the user makes their own decision regarding catheter navigation of the real-time intravascular ECG signal," suggesting it's an assistance tool rather than a fully automated AI interpretation.

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

The document does not explicitly describe a standalone performance study of the algorithm without human-in-the-loop. The description of Neonav states it "displays the intravascular ECG to the user makes their own decision regarding catheter navigation of the real-time intravascular ECG signal," implying a human-in-the-loop operation. "Neonav does not provide computation of ECG signal for navigation. Neonav displays the intravascular ECG to the user makes their own decision regarding catheter navigation of the real-time intravascular ECG signal."

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for performance evaluation. Given the device's function and the comparison to X-ray and fluoroscopy, it is highly probable that ground truth in any clinical validation would involve imaging modalities (e.g., chest X-ray or fluoroscopy confirmation) or direct physician assessment of catheter tip position, but this is not explicitly detailed in the provided text.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size for a training set.

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

The document does not provide any information on how ground truth was established for a training set.

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NEO Pedicle Screw System™

The NEO Pedicle Screw System™, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The system is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (scoliosis, kyphosis), tumor, pseudarthrosis, and/or failed previous fusion.

When used in conjunction with BonOs® Inject Cement, the NEO Pedicle Screw System™ is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use with 5 mm to 8 mm screw diameters at spinal levels (thoracic and lumbar T1 to L5) where the structural integrity of the spine is not severely compromised.

BonOs® Inject

BonOs® Inject bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using vertebroplasty or balloon kyphoplasty procedure.

When used in conjunction with NEO Pedicle Screw System™ BonOs® Inject is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

1. BonOs® Iniect

BonOs® Iniect is a radiopaque, iniectable bone cement for use in spine surgery like percutaneous vertebral augmentation during vertebroplasty or kyphoplasty. It is a twocomponent system consisting of a powder and a liguid. Methylmethacrylate polymer is the primary constituent of the powder component. Zirconium dioxide is added as radiopacifier. Methylmethacrylate monomer is the primary constituent of the liquid component. Mixing the two separate sterile components, initially an injectable paste is produced which can be transferred into a syringe and which then can be injected under slight pressure into the vertebral body. After curing of the bone cement by exothermic polymerization it stabilizes the vertebral lesions and vertebral compression fractures.

2. NEO Pedicle Screw System™

The NEO Pedicle Screw System™ has been optimized and consists of 27 pedicle and 8 iliac screws, rods and connectors which are available in different sizes. The system includes a reduced optimized trav of instruments providing options for open and MIS surgical techniques. The implants are all delivered sterile and ready to use. The relevant instruments are mainly delivered as single use, disposable and delivered sterile, just a few optional instruments are reusable and delivered non-sterile.

All the system components are made of materials compliant with ASTM and/or ISO standards. Screws and rods are made of titanium-alloy (Ti-6AI-4VELI) and comply with ISO 5832-3 or ASTM-F136. The screws are made out of a titanium alloy and delivered pre-mounted to a screw extender including a tissue dilator and sterile. The rods are made out of a titanium alloy or cobalt chrome alloy CoCrMo (ISO 5832-12, ASTM F1537) and delivered sterile, Connectors are made out of titanium alloy and delivered sterile.

The pedicle screws are offered in diameters of 4.5 – 8.0 mm and lengths of 25 - 55 mm. Illiac screws are offered in diameters of 8.0 mm and 10.0 mm and lengths of 70 – 100 mm. Three different types of rods are available: pre-bent, straight or special bent rod for S1/L5. All rods have a diameter of 5.5 mm. Pre-bent rods are offered in lengths of 35 – 100 mm, straight rods in lengths from 30 - 500 mm and the special-bent rod in either 30 or 40 mm length.

The NEO Pedicle Screw System™ provides immobilization and stabilization of spinal seqments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system can be used via an open or minimally invasive posterior approach. lliac screws shall be placed via Sacral Alar Iliac (SAI) and/or Posterior Superior Illiac Spine (PSIS) approach. The size and form of the device is adjusted to the morphology of the body and the surgical technique.

The provided text is an FDA 510(k) clearance letter and a 510(k) summary for a medical device called the "NEO Pedicle Screw System™" and "BonOs® Inject Bone Cement." This document details the administrative information, device description, indications for use, and a summary of performance data to support substantial equivalence to a predicate device.

However, the document specifies that "No clinical studies were conducted." This means that the information requested regarding acceptance criteria for a study proving device performance (especially for AI/algorithm-based devices), sample size for test and training sets, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment cannot be provided from this document.

The performance data mentioned in the document are limited to non-clinical testing, primarily focusing on mechanical performance, biological evaluation, and MRI compatibility. These types of tests are used to demonstrate that changes to the device (like new components or size extensions) do not negatively impact its existing, cleared performance characteristics, and that it is substantially equivalent to the predicate device.

Therefore, I cannot populate the requested table or answer the specific questions related to the acceptance criteria and study that proves the device meets the acceptance criteria in the context of an AI/algorithm-driven device's performance study, as this submission is for a physical orthopedic implant system, not a software or AI product requiring such a study.

Here's what can be inferred from the document regarding "acceptance criteria" and "proof" in the context of this device:

The "acceptance criteria" for the modifications introduced in this 510(k) submission are implicitly met if the device demonstrates substantial equivalence to its predicate device. This is primarily demonstrated through:

• Mechanical Performance: Meeting the requirements for pedicle screw spinal systems according to relevant ASTM and ISO standards (e.g., ASTM F1717 for dynamic compression bending). The document states: "Non-clinical performance testing demonstrate that the NEO Pedicle Screw System™ meets the requirements for Pedicle screw spinal systems according to Spinal System 510(k)s Guidance for Industry and FDA Staff Document issued on: May 3, 2004 and is substantially equivalent to its predicate devices."
• Biological Evaluation: Compliance with ISO 10993-1 series for the new components.
• MRI Compatibility: Meeting standards like ASTM F2052-15, ASTM F2182-11a, and ASTM F2119-07 (R2013).
• Functionality: Internal validation confirming new components function as intended.

Table of Acceptance Criteria (Implicit for a Mechanical Device) and Reported Performance:

Regarding the specific questions about an AI/algorithm performance study:

1. Sample size for the test set and data provenance: Not applicable. No clinical or external algorithm performance test set was used.
2. Number of experts used to establish the ground truth and qualifications: Not applicable.
3. Adjudication method for the test set: Not applicable.
4. MRMC comparative effectiveness study: Not applicable.
5. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable.
6. Type of ground truth used: Not applicable. Ground truth for a physical device is often demonstrated by meeting design specifications and performance under defined test conditions (e.g., material strength and fatigue testing).
7. Sample size for the training set: Not applicable. This is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is for a traditional mechanical medical device, not an AI/ML powered one. Therefore, the specific criteria and study details requested, which are pertinent to AI/ML device evaluations, are not present in this submission. The "proof" for this device's acceptance rests on its demonstration of substantial equivalence to a predicate device through non-clinical laboratory testing.

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NeoConvert Solution: 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. The NeoConvert Solution may be used with single-stage or two-stage procedures, for temporary multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Direct Screw to MUA: 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. The Direct Screw to MUA may be used with single-stage or two-stage procedures, for screw-retained multi-unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. All digitally designed personalized copings to be used with the Direct to Multi Unit Abutment Screw are intended to be sent to Straumann for manufacture at a validated milling center.

GM Attachment TiN 30°: 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. The GM Attachment TiN 30° may be used with single-stage or two-stage procedures, for multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

This premarket notification includes the following additions to the Neodent Implant System: NeoConvert Solution, Direct Screw to MUA, GM Attachment TiN 30°. The Neodent Multi-Unit Abutments proposed on this submission are similar to devices already cleared in previous submissions of Neodent Implant System, according to predicate devices described above. This submission intends to expand the portfolio of Neodent Abutments with these new solutions for multi-unit restorations, to provide more treatment options to customers. The NeoConvert Solution is a technique comprised by some abutments (not subject of this submission) used for converting removable temporary prosthesis into a screw-retained fixed temporary prosthesis. The Direct Screw to MUA is a prosthetic component designed to fix planned and digitally designed multi-unit milled restorations directly onto mini or micro abutments, eliminating the need for using the passive seating cylinder to restore chewing function. The GM Attachment TiN 30° is a prosthetic component used to stabilize implant-mucosa-supported removable full prosthesis (retained on the implant and supported on the mucosa), on implants installed in the maxilla or mandible. Although all these three new solutions are compatible with the same implants and components of Neodent Implant System and used for multiple unit rehabilitation, they are not used in conjunction with each other.

The provided text describes a 510(k) premarket notification for the "Neodent Implant System," focusing on the NeoConvert Solution, Direct Screw to MUA, and GM Attachment TiN 30°. This document details the device's technical characteristics, intended use, and its substantial equivalence to previously cleared predicate devices.

However, the provided text does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device submission. The document is a traditional 510(k) submission for dental implants and abutments, which are physical medical devices, not AI/ML software. Therefore, the specific requirements for an AI/ML device study (such as sample sizes for test and training sets, expert qualifications for ground truth, MRMC studies, or standalone performance) are not applicable or present in this document.

The "Performance Testing" section (pages 15-16) describes bench testing (dynamic fatigue, torsion, SEM images), MRI compatibility testing, biocompatibility testing, sterilization validation, and shelf-life testing for the physical dental implant components. These are standard performance tests for this type of physical device, not AI/ML algorithm validation.

Therefore, I cannot provide a table of acceptance criteria and a study proving the device meets acceptance criteria as typically outlined for an AI/ML medical device, as this information is not present in the provided document. The document focuses on demonstrating substantial equivalence of a physical dental device to predicate devices through engineering and material testing.

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The device is indicated to be used for:

• Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.

· Strengthening, Toning and Firming of buttocks and thighs.

·Improvement of muscle tone and firmness, for strengthening muscles in arms.

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a 510(k) clearance letter from the FDA for the medical device "Neo Sculptor (OF-NEO001)". It states that the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use.

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, or the number/qualifications of experts used for a test set.
• Information on adjudication methods, MRMC studies, or standalone algorithm performance.
• The type of ground truth used, or details about the training set size or how its ground truth was established.

The letter primarily focuses on regulatory clearance, general controls, and compliance requirements rather than specific performance study data or acceptance criteria.

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The neo315 is a magnetic resonance diagnostic device which is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear resonance. Other physical parameters derived from the images and/or spectra may also be produced.

The device includes hydrogen-1 (proton) imaging, hydrogen-1 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information). The intended group of patients for the neo315 can be found in the pediatric environment. The exclusion of patients is determined by the dimensions of the patient bed and excludes patients that exceed a 120 cm length and a diameter of 26 cm. The weight of the patient shall not exceed 18 kg.

The neo315 is a conductively cooled 1.5T whole body magnetic resonance diagnostic device (MRDD) which generates images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Its intended group of patients for the neo315 can be found in the pediatric environment. The neo315 consists of the Field Generating Unit (FGU), two technical cabinets (consoles) and gets operated via the operating software ScanUI.

The provided text does not contain information about specific acceptance criteria, device performance results, sample sizes for test or training sets, ground truth establishment, expert qualifications, or multi-reader multi-case studies for the neo315 device.

The document primarily focuses on the FDA's 510(k) clearance for the neo315, stating its substantial equivalence to a predicate device (Siemens MAGNETOM Avanto syngo MR B19A). It outlines the device's indications for use, technological comparison, and compliance with recognized standards.

Therefore, I cannot fulfill all parts of your request based on the provided text. I can only extract information related to the device's general intended use and the standards it complies with.

Here's what can be inferred from the text, though it doesn't meet the specific requirements of your request regarding detailed study results:

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

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in terms of metrics like sensitivity, specificity, accuracy, or specific imaging quality parameters. It generally asserts that "The performance testing results demonstrate the safety and performance as expected."

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

No information is provided regarding the sample size used for any test set or the provenance of data (e.g., country of origin, retrospective/prospective). The document mentions "performance testing results" but does not detail the methodology or datasets used.

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):

No information is provided about the number or qualifications of experts used to establish ground truth.

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

No information is provided about any adjudication method.

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:

The document does not mention an MRMC study or any assessment of human reader improvement with or without AI assistance. The neo315 is described as a Magnetic Resonance Diagnostic Device, not an AI-assisted diagnostic tool.

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

The document doesn't detail performance studies of the device in isolation or as part of an algorithm. It focuses on the substantial equivalence of the hardware.

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

No information is provided regarding the type of ground truth used.

8. The sample size for the training set:

No information is provided regarding the sample size of any training set.

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

No information is provided on how ground truth was established for any training set.

Summary of available information related to performance and standards:

The document states that the neo315 is claimed to comply with several applicable FDA recognized standards, which implicitly define "acceptance criteria" in terms of technical performance expected of an MR diagnostic device. These standards establish various performance benchmarks for MR systems.

Conclusion from available text:

The provided document asserts that the neo315 meets the "safety and performance as expected" by complying with a list of recognized industry standards for Magnetic Resonance Imaging devices. However, it does not provide granular details about the specific quantitative acceptance criteria or the numerical results of performance testing that would directly fulfill the detailed requirements of your prompt. The FDA's 510(k) clearance process often relies on substantial equivalence to predicate devices and compliance with recognized standards without requiring novel clinical performance studies unless significant differences or new risks are identified.

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NeoBeat and NeoBeat Mini are indicated to continuously measure and display the heart rate of neonates using dry electrodes on the torso during transition, stabilization and/or resuscitation. The devices are intended to be used in healthcare facilities. NeoBeat is intended for use on newborns approximately 1.5-5 kg. NeoBeat Mini is intended for newborns approximately 0.5-2 kg.

The NeoBeat Newborn Heart Rate Meter is a battery-powered device placed on the torso of a newborn, indicated to measure the heart rate. NeoBeat does not store, display or output an ECG signal. The device is placed around the torso of the neonate such that the ECG dry electrodes contact the neonate's skin. It can be oriented caudally or cranially. In normal operation, the LED display presents the heart rate in large numerals. The display can also present other information, such as signal quality and error codes. The device comes with a charging stand.

Here's a breakdown of the acceptance criteria and study information for the NeoBeat/NeoBeat Mini device based on the provided text:

Acceptance Criteria and Device Performance

Study Information

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: 19 clinical cases representing over 4 hours of ECG data.
   • Data Provenance: The 19 cases were randomly selected from a large database containing newborn ECGs from four countries outside the United States.

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

   • Number of Experts: 2
   • Qualifications: An ICU physician and a scientific expert in ECG signal processing and analysis.

3. Adjudication method for the test set:

   • Not explicitly stated, but it implies a consensus given "Heart rate based on expert annotation was considered 'ground truth'." This suggests the two experts either agreed directly or their combined annotation formed the ground truth.

4. 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 MRMC comparative effectiveness study was done. This study focused on the algorithm's standalone performance compared to expert-annotated ground truth, not on human reader improvement with or without AI assistance.

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

   • Yes, a standalone performance study was done. The study compared "Heart rate based on NeoBeat's algorithm" to the "ground truth" heart rate established by experts.

6. The type of ground truth used:

   • Expert consensus (specifically, expert annotation of QRS complexes).

7. The sample size for the training set:

   • Not explicitly stated. The document mentions a "large database containing newborn ECGs from four countries outside the United States" with "over 1000 cases of ECGs" collected from researchers. While this database was used to select the test cases, it is strongly implied that this database would have been used for training/development, but the exact size of the training set is not specified separately from the total database.

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

   • Not explicitly stated for the training set. For the test set, it was established by expert annotation of QRS complexes by an ICU physician and a scientific expert. It is reasonable to infer a similar method for the training set, given the nature of the data and the use of expert annotation for the test set.

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The NeoSpan® Compression Implant System is a nitinol implant intended to provide fixation of fractures, fusions, or osteotomies of the hand and foot.

In2Bones NeoSpan® Compression Implant System (CIS) is a product expansion of the existing NeoSpan Compression Staple Implant w/ Instruments (K161426). The NeoSpan® Compression Implant System consists of implants offered in various configurations from 2 and 3 legs with no hole or 1-to-3 holes intended for bone screw assembly for additional fixation. The fixed-leg implants are comprised of Nitinol per ASTM F2063. The devices are sterile implants intended to provide fixation of fractures, fusions, or osteotomies of the hand and foot.

Bone screw options for the NeoSpan® Compression Implant System are previously cleared 3.0mm and 3.5mm locking and non-locking screws in lengths 10-30mm made from titanium alloy.

The provided text is a 510(k) summary for the NeoSpan® Compression Implant System, describing a medical device used for bone fixation. It does NOT contain any information about a study proving the device meets acceptance criteria for an AI/software-based medical device.

The document primarily focuses on demonstrating substantial equivalence of the physical implant system to previously cleared predicate devices through performance testing related to mechanical properties (e.g., static bending, fatigue bending, pull-out, corrosion) and biological/sterilization properties, not performance of an AI algorithm.

Therefore, I cannot provide the requested information about acceptance criteria for an AI device or a study proving an AI device meets those criteria, as the input document is about an implantable hardware device.

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