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

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

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

4. Adjudication Method for the Test Set

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

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

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

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

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

7. The Type of Ground Truth Used

The ground truth used for these studies is based on:

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

8. The Sample Size for the Training Set

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

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

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

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The BellaTek Encode Emergence Healing Abutments are intended for use as an accessory to endosseous dental implants during endosseous and gingival healing to prepare gingival tissue for acceptance of a final abutment and restoration.

The BellaTek Encode Emergence Healing Abutment is a two-piece healing abutment (abutment with a retaining screw) designed to facilitate gingival tissue healing before a final restoration is placed. It consists of an abutment and a retaining screw that are assembled and packaged together and provided sterile. Both components are machined from Titanium Alloy Ti-6Al-4V ELI (ASTM F136). They are available in pre-defined diameters, emergence profiles and heights to accommodate varying patient anatomies. The shelf life of the TSV BellaTek Encode Healing Abutment is 5 years from the date of manufacture and they are intended for single use only. The device is packaged in a blister tray with Tyvek Lid and sold sterile. The device is sterilized using the gamma irradiation method. The BellaTek Encode Emergence Healing Abutments are color anodized for aesthetic purposes.

This document is a 510(k) Premarket Notification from the FDA regarding the "BellaTek Encode Emergence Healing Abutments". It does not describe an AI/ML device, therefore the requested information regarding acceptance criteria and study details for AI/ML performance is not present.

The document focuses on demonstrating substantial equivalence to previously approved predicate devices, rather than an AI/ML device's performance.

Here's why the requested information cannot be extracted:

• No AI/ML Component: The device is a physical dental implant component (healing abutment), not a software algorithm or AI-powered system.
• Substantial Equivalence: The approval process here is based on showing that the new device is as safe and effective as a legally marketed predicate device, not on meeting specific performance metrics for an AI algorithm.
• Non-Clinical Testing: The "Non-Clinical Testing" section describes tests related to physical properties, biocompatibility, sterilization, and shelf-life, which are typical for physical medical devices. It does not mention any studies related to AI/ML performance metrics like accuracy, sensitivity, specificity, etc.

Therefore, since the input document describes a physical medical device and not an AI/ML device, it does not contain the information requested in the prompt about AI/ML acceptance criteria and study details.

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The Bella-mu is indicated for intradermal injections of FDA approved drugs for patients 18 years of age and older. The Bella-mu is to be inserted in the dermis of the suprascapular, deltoid, waist, or thigh regions.

Not Found

I am sorry, but the provided text from the FDA 510(k) clearance letter for the "Bella-mu" device does not contain information about acceptance criteria or the study that proves the device meets the acceptance criteria in the way you have described for an AI/ML medical device.

This document is a standard FDA 510(k) clearance letter, which typically confirms that a device is substantially equivalent to a predicate device and can be legally marketed. It focuses on regulatory aspects like product codes, regulations, general controls, and good manufacturing practices.

For a device like "Bella-mu" which is described as a "Hypodermic Single Lumen Needle" for "intradermal injections," the types of studies performed (e.g., biocompatibility, sterility, needle pull-off force, flow rates, sharpness, patient comfort, etc.) and their acceptance criteria are generally found in the full 510(k) submission, which is not publicly released in its entirety in this clearance letter.

Therefore, I cannot provide the detailed information requested in your prompt based on the provided text. The prompt's questions (e.g., number of experts, MRMC studies, standalone performance, training/test set sample sizes, ground truth establishment) are highly relevant for AI/ML device submissions, but not applicable to the information contained within this specific 510(k) clearance letter for a medical needle.

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The bellavista 1000/1000e ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients and optionally infant and neonatal patients by qualified, trained personnel under the direction of a physician.

Environment of use: hospitals, sub-acute care facilities and intra-hospital transfer

When used on neonatal patients: The environment of use is the Neonatal Intensive Care Unit (NICU).

bellavista is an electronically controlled pneumatic ventilation system. It is powered by AC or DC and also provided with an internal battery. The bellavista pneumatic system supplies respiratory gas whilst the electrical systems control the pneumatics and provides the power supply.

The user can enter values or parameters in the bellavista via the touch screen. These inputs entail instructions for bellavista's pneumatic system to ventilate the patient with a precisely controlled gas mixture. bellavista gathers readings from the proximal flow sensor within the ventilator.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter and summary for a medical device (ventilator). It describes the device, its intended use, a comparison to predicate devices, and the basis for substantial equivalence.

However, it does not include details about acceptance criteria, specific device performance numerical results, sample sizes for test or training sets, data provenance, expert qualifications, ground truth establishment, or any details about a multi-reader multi-case (MRMC) study or standalone algorithm performance, as these are typically part of a clinical validation study and not usually found in a 510(k) summary for a ventilator.

The document discusses the ventilatory support capabilities and patient populations for which the device is intended, but not the kind of detailed performance metrics usually required for AI/algorithm-based diagnostic devices.

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The bellavista 1000 ventilator is intended to provide positive pressure ventilator support to adults and pediatrics (IBW greater than 6 kg).

Environment of use: hospitals, sub-acute care facilities and intra-hospital transfer

It is intended for use by qualified, trained personnel under the direction of a physician.

The bellavista 1000 ventilator (hereafter referred to as "bellavista") is designed for continuous ventilation of adult and pediatric patients.

The bellavista ventilator is a positive pressure ventilator for intubated patients and patients with mask ventilation. Its pneumatic power is provided by an internal turbine. Supplemental oxygen is provided by an auxiliary oxygen source.

The following modes of ventilation are available

• Adults: CPAP, PCV, P-A/C, PC-SIMV, PSV, S, S/T, T, beLevel, APRV, VCV, ● V-A/C, VC-SIMV.
• Pediatrics the following modes of ventilation are available: CPAP, PCV, P-A/C, ● PC-SIMV, S, T, beLevel, APRV, VCV, V-A/C, VC-SIMV

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "bellavista 1000" ventilator. It is a letter confirming the device's substantial equivalence to legally marketed predicate devices.

Crucially, this document does NOT describe the acceptance criteria and study that proves the device meets the acceptance criteria in the way you are asking.

The 510(k) process for substantial equivalence (SE) reviews a new device against a predicate device. It demonstrates that the new device is as safe and effective as a legally marketed device, not that it independently "meets acceptance criteria" through clinical trials for novel devices.

Therefore, many of the specific points you requested (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set information) are not applicable to this type of regulatory submission because clinical performance studies, as you've outlined, are generally not required for a 510(k) unless significant differences or new questions of safety/effectiveness arise.

The document states:

• "No clinical testing was conducted or required in support of this premarket notification." (Page 17)
• The comparison is primarily against a predicate device (HAMILTON-C2, K121225) and some reference devices (HAMILTON-G5, COVIDIEN-PB 840, DRAEGER-Oxylog 3000 plus).

Instead of clinical study data, the document relies on:

• Performance Testing:
  • Tests according to IEC 60601-1:2005+A1:2012, IEC 60601-1-2:2007, ISO 80601-2-12:2011, IEC 60601-1-8:2006+A1:2012, ISO 80601-2-55:2011.
  • Reliability testing as described in ASTM F1100-90.
  • Validation testing with "wide range of System Acceptance Tests (SAT)".
  • Biocompatibility testing according to ISO 10993-1, with certain scientific methodologies within ISO 18562-3.
• Comparison of Technical Specifications: Detailed tables comparing settings, alarms, monitoring parameters, and accuracy controls with the predicate device.
• Usability: Summative usability tests performed with a user group of respiratory therapists.

Given this, I will answer the applicable parts of your request based on the provided document and clarify why other points are not present.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence to Predicate)

The "acceptance criteria" in this context are primarily demonstrating equivalence to the predicate device (HAMILTON-C2, K121225) and compliance with relevant performance standards. The "reported device performance" is presented through detailed comparisons.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. This is a 510(k) premarket notification relying on technical specifications and performance testing against standards and a predicate device, not a clinical study with patient samples.
• Data Provenance: The document does not specify the country of origin for the internal testing data, but the submitter is IMTMEDICAL AG, Switzerland. The testing is non-clinical (laboratory/bench testing) rather than retrospective or prospective patient data.

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

• Not Applicable. Ground truth in the context of clinical expert consensus would be relevant for devices involving image interpretation or diagnosis. For a ventilator, "ground truth" for performance is established through internationally recognized performance standards (e.g., ISO, IEC, ASTM) and physical measurements using test lungs and calibrated sensors.
• The usability testing was conducted with a user group reported as "respiratory therapists," but no number or detailed qualifications are provided.

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

• Not Applicable. This is a method used in clinical studies, particularly for diagnostic devices where subjective interpretation (e.g., by radiologists) needs consensus. It does not apply to the technical performance testing of a ventilator.

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

• No. An MRMC study is a type of clinical study for diagnostic devices, especially those using AI, to assess the impact of AI on human reader performance. This document concerns a ventilator, which is a therapeutic device, and explicitly states "No clinical testing was conducted or required."

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

• Yes, in spirit, for certain aspects. The performance testing (e.g., accuracy of controls, alarm limits, monitoring parameters) represents the "standalone" or "algorithm only" performance of the ventilator's internal systems against engineering specifications and international standards. This is not "AI algorithm only" but "device functionality only." The document does not detail specific "algorithms" for AI, as this is a traditional ventilator.

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

• The "ground truth" for the device's technical performance is the relevant international performance standards (e.g., IEC, ISO, ASTM) and the measured performance of the legally marketed predicate device. These standards define acceptable ranges for parameters like accuracy, flow, pressure, etc.

8. The sample size for the training set

• Not Applicable. This is a traditional medical device (ventilator). The document does not describe the use of machine learning or AI models requiring a "training set" of data. Its design and validation rely on engineering principles, known predicate device performance, and adherence to established standards.

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

• Not Applicable. See point 8.

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The BellaFuse™ is an implant intended to fill bony voids or gaps of the skeletal system, i.e. posterolateral spine. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Bellafuse™ resorbs and is replaced with bone during the healing process.

Device Identification and Materials of Use:
BellaFuse™ is a resorbable bone void filler, combining Human Demineralized Bone Matrix (DBM) with gelatin. The primary component of this BVF product is demineralized particle bone, which is derived from human donor cortical bone. The additional porcine gelatin is a biocompatible component which maintains the shape and enhances flexibility.
Device Characteristics:
This product is provided in several flexible sheet sizes ranging from 10x10x2.5mm to 50x100x5.0mm. It is supplied sterile for single patient use.
Body Contact:
BellaFuse™ is a permanent resorbable device, implanted in bone tissue.

I am sorry, but the provided text does not contain the detailed information necessary to complete the table and answer the questions regarding acceptance criteria, device performance, and study specifics as outlined in your request.

The document is a 510(k) premarket notification summary for a medical device called BellaFuse™. It discusses the device's intended use, description, mechanism of action, and a summary of testing for serological, biocompatibility, osteoconduction, and osteoinductive potential. However, it does not provide:

• Specific numerical acceptance criteria for performance. It states the device "was tested successfully to fully assess the performance to grow bone" and "was shown to have osteoinductive potential," but doesn't quantify these successes with specific metrics or thresholds.
• Detailed reported device performance outcomes. While it mentions new bone growth, it doesn't provide statistical results like sensitivity, specificity, accuracy, or quantitative measures of bone growth in the context of specific acceptance criteria.
• Sample sizes for test sets, training sets, or data provenance. Only a sample size of "nude rat muscle pouch model" (n=?) is mentioned for osteoinductive potential, and no other sample sizes are given.
• Information about experts, ground truth establishment, adjudication methods, or MRMC studies.
• Specifics on how the ground truth for training or test sets was established.

Therefore, I cannot populate the table or answer most of the questions based on the provided text.

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Compression Class I Mild swelling, tired aching legs, thrombosis prophylaxis, minor varices, post surgery

Compression Class II Primary varices, varices with edema, varices with pregnancy; post-sclerotherapy; post venous ulceration

Compression class III Secondary varices; severe varices with edema; post-phlebitic syndrome; chronic venous insufficiency; phiebitis; thrombophlebitis and edema

Not Found

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical support stocking (Bellavar, Custom Seamless Soft). It confirms the device's substantial equivalence to a predicate device and lists its indications for use.

However, the letter does not include any details about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any comparative effectiveness studies. These types of details are typically found in the 510(k) submission itself or in separate study reports, not in the clearance letter from the FDA.

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The intended use of the product is to remove the cold from the bucky by placing this sheet between the patient's breast and the imaging receptor plate allowing the patient to feel more comfortable and less cold without interfering with image quality.

Indications for Use: To be applied to the mammography receptor plate, one per patient

Bella is to be used on the bucky or the imaging receptor plate of mammography imaging equipment where the breast is placed for mammograms. The purpose of the product is to remove the cold from the bucky by placing this sheet between the patient's breast and the imaging receptor plate allowing the patient to feel more comfortable and less cold without interfering with image quality.

Bella is designed to include a non-woven fabric type material that will feel like fabric on the skin. The material is non-compressable and the sizes are to include all leading mammography equipment for small and large buckies. Bella includes printed graphics to aid in the mental comforting of the patient. There is adhesive backing to Bella which allows easy application and removal from the bucky. The material and adhesive do not affect imaging.

Here's a breakdown of the acceptance criteria and study information for the Bella device, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The core acceptance criteria for Bella revolve around its intended use and comparison to the predicate device (MammoPad). Both devices aim to increase patient comfort during mammography without compromising image quality.

Study Information

This 510(k) summary describes a series of non-clinical and clinical tests for Bella, primarily focused on proving substantial equivalence to the MammoPad predicate device by demonstrating no interference with image quality.

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