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Found 14 results
510(k) Data Aggregation
(90 days)
BellaTek Bars
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.
| Acceptance Criteria Category | Description and Reported Device Performance |
|---|---|
| Intended Use | Substantially equivalent to the primary predicate device (K233083). |
| – BellaTek Bars: Indicated for attachment to dental abutments in the treatment of partially or fully edentulous jaws for restoring chewing function. Intended for attachment to a minimum of two (2) abutments and manufactured by Biomet 3i. | |
| – Predicate Device (Osteon Precision Milled Suprastructure K233083): Indicated for attachment to dental abutments in the treatment of partially or fully edentulous jaws for restoring chewing function. Intended for attachment to a minimum of two (2) abutments and manufactured by Osteon. | |
| Design Principles & Technological Characteristics | Substantially equivalent to the primary predicate device (K233083) and reference predicate device (K080864). |
| - Similar features: bar base material, bar-to-abutment connection, prosthetic platform sizes, mode of prosthetic retention. | |
| - Differences in prosthetic platform connection geometry are supported by identified predicate devices. | |
| Material and Manufacturing | Bar Material: Ti-6Al-4V ELI (ASTM F136) or Grade 4 CP Titanium (ASTM F67). |
| - Meets chemical and mechanical requirements of ASTM F136 and ASTM F67. | |
| - Packaging: Nylon pouch. | |
| - Sterilization Process: Moist heat, validated according to EN ISO 17665-1:2006 to achieve a sterility assurance level (SAL) of 10-6. | |
| Biocompatibility | Testing performed according to ISO 10993-1:2018 and ISO 10993-5:2009 on representative Biomet 3i patient-specific bar devices using the same ASTM F136 titanium alloy and ASTM F67 unalloyed titanium materials. |
| - Concluded that the material, chemical testing, and literature provide sufficient basis for demonstrating biocompatibility. | |
| MRI Safety | Non-clinical worst-case MRI review performed using scientific rationale and published literature (e.g., Woods et al., 2019). |
| - Addressed parameters per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque. | |
| - Reported Performance: BellaTek Bars have been labeled as MR conditional. | |
| Performance Bench Testing | Worst-case design validated in accordance with Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004. |
| - Demonstrates that differences from the predicate are accounted for and do not render the device not substantially equivalent. |
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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(113 days)
BellaTek Encode Emergence Healing Abutments
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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(297 days)
Bella-mu
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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(87 days)
TSV BellaTek Express and BellaTek Flex Abutments
TSV BellaTek® Express and BellaTek® Flex Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained.
All digitally designed superstructures and/or hybrid abutment crowns for use with TSV BellaTek Express or BellaTek Flex Abutments are intended to be sent to a Biomet 3i validated milling center for manufacture.
The TSV BellaTek Express Abutment and BellaTek Flex Abutment (subject devices) are Titanium-base type abutments to be used as the apical part of two-piece abutments. The coronal part of the two-piece abutment is a CAD/CAM designed and manufactured superstructure. All digitally designed superstructures manufactured in zirconia conform to ISO 13356:2015 and ISO 6872:2015. Biomet 3i recommends the use of Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436) to affix the zirconia superstructure and/or hybrid abutment crown to the Certain BellaTek Express and BellaTek Flex abutments. TSV BellaTek Express Abutment and BellaTek Flex Abutment are intended to be used with Zimmer Dental's Tapered Screw-Vent, Screw-Vent and Trabecular Metal dental implants for single and multi-unit restorations. The subject device abutments are available in hexed (single-unit) and non-hexed (multi-unit) configurations. They are available in pre-defined platform diameters, emergence profiles and heights to accommodate varying patient anatomies. They are machined from Titanium Alloy. They are intended for single use only. The device is packaged in a sealed nylon bag and sold non-sterile.
The TSV Titanium ASC screw used with the subject device is also machined from Titanium Alloy and anodized pink. The device is packaged individually in a sealed nylon bag and sold sterile. When the TSV BellaTek Express or BellaTek Flex Abutment is placed on the corresponding implant, the retaining screw will mate with the internal thread feature of the dental implant to hold the abutment in place.
The provided document is a 510(k) summary for a medical device (dental abutments) and does not describe a study involving an algorithm or AI. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and performance of an AI/algorithm-based device.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through a comparison of design, function, materials, indications for use, and non-clinical testing.
Here's a breakdown of the available information relevant to product acceptance, though it's for a physical medical device, not an algorithm:
1. A table of acceptance criteria and the reported device performance:
The document primarily demonstrates substantial equivalence through comparisons with predicate devices and adherence to relevant standards. It doesn't present a table of specific performance acceptance criteria in the way one would for an AI model's metrics (e.g., sensitivity, specificity).
Instead, "performance" here refers to the physical and biological characteristics of the dental abutment and its components:
| Characteristic/Test | Acceptance Criteria (Implied by Standards/Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Sterilization Validation (Steam) | Conformance to ISO 17665-1 | Successfully validated (SAL of 10^-6) |
| Sterilization Validation (Gamma) | Conformance to ISO 11137-1 and ISO 11137-2 | Successfully validated (SAL of 10^-6, 25-38 kGv exposure dose, VDmax35 method) |
| Biocompatibility | Conformance to ISO 10993-1 | Acceptable biocompatibility demonstrated by reference to predicate device K183138 |
| Magnetic Resonance (MR) Conditional | Demonstrated as MR Conditional | Demonstrated as MR Conditional by reference to K150571 |
| Aging/Shelf-Life (Abutment) | Not applicable (supplied non-sterile) | N/A |
| Aging/Shelf-Life (Retaining Screw) | 5-year shelf-life | Maintaining a 5-year shelf-life |
| Packaging Integrity (Retaining Screw) | Withstand shipping/vibration; maintain sterile barrier; meet dye penetration & seal strength criteria (ISO 11607-1) | Met acceptance criteria for dye penetration and seal strength after accelerated and real-time aging, and shipping/distribution tests. |
| Material (Abutment) | Titanium Alloy (Ti-6Al-4V ELI) and Zirconia | Titanium Alloy (Ti-6Al-4V ELI) and Zirconia |
| Material (Retaining Screw) | Titanium Alloy (Ti-6Al-4V ELI) | Titanium Alloy (Ti-6Al-4V ELI) |
| Design/Function/Intended Use | Substantially equivalent to predicate devices | Aligned with predicate devices K183138 and K133551 |
Regarding the other points you requested (2 through 9), they are not applicable as this document discusses a physical medical device, not an AI/algorithm:
- 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 for this type of device. The "tests" mentioned are non-clinical (e.g., sterilization, biocompatibility, packaging), not an evaluation of an algorithm on a dataset.
- 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 review, is not relevant to the non-clinical testing performed for dental abutments.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 document explicitly states, "No clinical data was included in this submission."
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a physical device's performance relies on adherence to material specifications, engineering standards, and biological compatibility.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, this document is a regulatory submission for a physical medical device, not an AI or algorithm. Therefore, the specific details you requested regarding AI model evaluation are not present.
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(283 days)
Bellavista
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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(231 days)
Certain BellaTek Express and BellaTek Flex Abutments
Certain BellaTek® Express and BellaTek® Flex Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained.
All digitally designed superstructures and/or hybrid abutment crowns for use with Certain BellaTek Express or BellaTek Flex Abutments are intended to be sent to a Biomet 3i validated milling center for manufacture.
The Certain BellaTek Express Abutment and BellaTek Flex Abutment (subject devices) are Titanium-base type abutments to be used as the apical part of two-piece abutments. The coronal part of the two-piece abutment is a CAD/CAM designed and manufactured superstructure. All digitally designed superstructures manufactured in zirconia conform to ISO 13356:2015 and ISO 6872:2015. Biomet 3i recommends the use of Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436) to affix the zirconia superstructure and/or hybrid abutment crown to the Certain BellaTek Express and BellaTek Flex abutments. Certain BellaTek Express Abutment and BellaTek Flex Abutment are intended to be used with Biomet 3i Certain (Internal Hex) dental implants for single and multi-unit restorations. The subject device abutments are available in hexed (single-unit) and nonhexed (multi-unit) configurations. They are available in pre-defined platform diameters, emergence profiles and heights to accommodate varying patient anatomies. They are machined from Titanium Alloy. They are intended for single use only. The device is packaged in a sealed nylon bag and sold non-sterile.
This document pertains to the 510(k) premarket notification for Certain BellaTek® Express and BellaTek® Flex Abutments, K183138. It describes dental implant abutments and does NOT describe an AI/ML medical device. Therefore, the information requested regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device cannot be extracted from this document.
The document discusses substantial equivalence to predicate devices based on:
- Intended Use: Similar, supporting prosthetic devices in edentulous patients.
- Operating Principle: Attaching to dental implants to restore chewing function.
- Identical Materials: Titanium Alloy (Ti-6Al-4V ELI) and Zirconia for abutments.
- Similar Fundamental Design: Including platform diameters, screw or cement retention options.
Performance Data (Non-clinical):
- Sterilization Validation: Per FDA Guidance and ISO 17665-1 and ISO 17665-2, demonstrating a sterility assurance level (SAL) of 10^-6.
- Biological Evaluation: In accordance with FDA Guidance and ISO 10993-1, demonstrating acceptable biocompatibility.
- MR Testing Data: Leveraged, and the device is labeled as MR conditional.
- Design & Development: In accordance with FDA Guidance Document for Root-form Endosseous Dental Implants and Abutments.
No clinical data was included in this submission.
Therefore, I cannot provide the information requested in the format of an AI/ML device acceptance criteria and study.
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(47 days)
TSV BellaTek Encode Healing Abutments
The TSV™ BellaTek® Encode® 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 purpose of this submission is to obtain 510(k) premarket clearance for the TSVIM BellaTek® Encode® Healing Abutments compatible with Tapered Screw-Vent® and Trabecular Metal implant systems. Abutments sizing is based on implant platform diameter.
TSV™ BellaTek® Encode® Healing Abutments are designed to aid in soft tissue contouring during the healing period after implant placement, creating an emergence profile for the final prosthesis. They have the added design feature of machined markings for identification when taking an abutment level impression or an intraoral scan/digital impression. The occlusal surface of the device include markings that provide information about the mating implant's position and orientation.
The principal of operation and Encode "Coding Scheme of the same as the primary predicate device. The pattern of the markings for the subject device is specific to the Tapered Screw-Vent", and Trabecular Metal implant lines.
The provided text does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria. Instead, it is a 510(k) summary for a medical device (TSV™ BellaTek® Encode® Healing Abutments) demonstrating substantial equivalence to a predicate device.
The document explicitly states: "No clinical data were included in this submission." and relies on non-clinical testing data and equivalence to a predicate device.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth, expert opinions, or MRMC studies, as this information is not present in the provided text.
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(261 days)
Eztetic BellaTek Encode Healing Abutments
The Eztetic™ BellaTek® Encode® 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 Eztetic™ BellaTek® Encode® Healing Abutment is a healing abutment designed to facilitate gingival tissue healing. It consists of an abutment and a retaining screw that are assembled together. Both components are machined from Titanium Alloy (Ti-6AL-4V ELI). The shelf life of the Eztetic™ BellaTek® Encode® Healing Abutment is 5 years and they are intended for single use only. The device is packaged in a sealed nylon bag and sold sterile. The device is sterilized using gamma irradiation method.
This document, a 510(k) summary for the Eztetic™ BellaTek® Encode® Healing Abutments, describes non-clinical testing performed to establish substantial equivalence to predicate devices, rather than a clinical study evaluating the device's performance against specific acceptance criteria.
Therefore, I cannot provide the information requested regarding acceptance criteria and a study proving the device meets those criteria, as these are typically associated with clinical performance studies, which are not detailed in this document.
However, I can extract information about the non-clinical testing performed to demonstrate substantial equivalence:
Non-Clinical Testing Information:
Since this is a non-clinical evaluation for substantial equivalence, the concepts of "acceptance criteria," "reported device performance," "sample size for test set," "data provenance," "number of experts," "adjudication method," "MRMC study," "standalone study," "type of ground truth," "sample size for training set," and "how ground truth for training set was established" are not directly applicable in the way they would be for a clinical efficacy or safety study.
Instead, the document describes tests conducted to ensure the new device is comparable to existing, legally marketed devices.
Here's a breakdown of the non-clinical testing mentioned:
1. Acceptance Criteria and Reported Device Performance (Non-Clinical Equivalence):
| Non-Clinical Test / Characteristic | Acceptance Criteria (Implied by Equivalence) | Reported Performance (Implied by Conclusion of Substantial Equivalence) |
|---|---|---|
| MR Compatibility | Device is MR conditional (same as previously tested Biomet 3i devices). | The subject devices, having less surface area and volume and made of identical materials as previously tested MR-compatible Biomet 3i devices, are considered MR conditional. |
| Biocompatibility | Biologically compatible (same as primary predicate devices). | The subject devices, made of identical materials and manufactured under identical conditions as primary predicate devices, leverage the predicate's biocompatibility data. |
| Sterilization Efficacy | Minimum Sterility Assurance Level (SAL) of 10⁻⁶; compliance with ISO 11137-1 and ISO 11137-2. | Sterilization validated at 25-38 kGy using gamma irradiation, achieving a SAL of 10⁻⁶, consistent with ISO standards. Quarterly dose audits are conducted. |
| Shelf-Life | Maintain structural integrity and performance for 5 years. | Substantiated 5-year shelf-life based on material stability (Ti-6Al-4V ELI) and successful accelerated/real-time aging studies of packaging. |
| Packaging Integrity | Maintain sterile barrier over labeled shelf life; withstand shipping/vibration conditions without compromise to sterility. | Met acceptance criteria for dye penetration and seal strength after accelerated/real-time aging and shipping/distribution testing (per ISO 11607-1, ASTM D4169). |
| Torque to Failure | Withstand recommended torque (similar to primary predicate devices). | Performance demonstrated to be substantially equivalent to predicate devices. (Specific values not provided, but passed). |
| Physical Fit Check | Device fits correctly with the mating implant (similar to primary predicate devices). | Performance demonstrated to be substantially equivalent to predicate devices. (Specific details not provided, but passed). |
| Tolerance Analysis | Entire tolerance range meets design input (similar to primary predicate devices). | Performance demonstrated to be substantially equivalent to predicate devices. (Specific details not provided, but passed). |
| Print Verification | Properly constrained and accurately describes intended original design (similar to primary predicate devices). | Performance demonstrated to be substantially equivalent to predicate devices. (Specific details not provided, but passed). |
2. Sample Size for Test Set and Data Provenance:
- Sample Size: Not explicitly stated for any of the non-clinical tests.
- Data Provenance: The data is primarily derived from "leveraged" data from previously tested Biomet 3i devices and predicate devices, as well as new bench testing. There is no mention of country of origin as it's non-clinical lab testing. All testing appears to be prospective in the sense that the tests were conducted for this submission, although some rely on retrospective leveraging of prior data.
3. Number of Experts and Qualifications (for Ground Truth):
- This concept is not directly applicable to the non-clinical tests described. The "ground truth" here is adherence to engineering specifications, material properties, and regulatory standards, evaluated by qualified personnel within the company and verified by regulatory bodies.
4. Adjudication Method for Test Set:
- Not applicable as these are non-clinical engineering and material tests, not expert-adjudicated clinical data.
5. MRMC Comparative Effectiveness Study:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is for evaluating human performance, often with AI assistance, in interpreting medical images or data. The device in question is a physical dental healing abutment, not an AI diagnostic tool.
6. Standalone Study (Algorithm Only Without Human-in-the-Loop Performance):
- No, a standalone study in this context (algorithm performance) was not done as the device is a physical medical device, not an algorithm or software. The "standalone" performance here refers to the physical and material characteristics themselves, which are addressed by the non-clinical bench testing.
7. Type of Ground Truth Used:
- For the non-clinical tests, the "ground truth" is based on:
- Regulatory Standards: ISO 11137-1, ISO 11137-2, ISO 11607-1, ASTM D4169, ASTM F 136.
- Engineering Specifications: Design inputs, tolerance ranges, recommended torque values.
- Material Science Properties: Known characteristics of Ti-6Al-4V ELI.
- Prior Validated Test Data: From predicate and previously tested Biomet 3i devices (e.g., for MR compatibility, biocompatibility).
8. Sample Size for the Training Set:
- Not applicable. This is not an AI/machine learning device that would have a "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable.
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(265 days)
bellavista 1000
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
| Feature/Parameter | Acceptance Criteria (Demonstrated Equivalence / Standard Compliance) | Reported bellavista 1000 Performance (vs. Predicate/Reference) |
|---|---|---|
| Indications for Use | Substantially equivalent to predicate HAMILTON-C2 (K121225). | "Intended to provide positive pressure ventilator support to adults and pediatrics (IBW greater than 6 kg)." (Similar to predicate) |
| Patient Population | Substantially equivalent to predicate. | "Adults and pediatrics (IBW greater than 6 kg)." (Predicate has broader population including infants and neonates, but this "does not change the intended use.") |
| Environment of Use | Substantially equivalent to predicate. | "Hospitals, sub-acute care facilities and intra-hospital transfer." (Same as predicate) |
| Technology / Design | Similar system architecture, gas source, flow measurement, power supply, exhalation method to predicate. Compliance with relevant standards. | System Architecture: 2 microprocessors + alarm controller (Predicate: 1 microprocessor + alarm controller) |
| Gas Source: Blower + high pressure O2 (Similar) | ||
| User Interface: Touch screen (Predicate: touchscreen + keys + press-and-turn knob) | ||
| Flow Measurement: Proximal flow sensor (Similar) | ||
| Power Supply: AC, DC or battery (Similar) | ||
| Exhalation: Membrane valve towards ambient (Similar) | ||
| Ventilation Modes | Similar to predicate and reference devices. | Lists various modes for adults and pediatrics (e.g., CPAP, PCV, VCV). Most are similar to the predicate or specific reference devices. PSV and S/T not available for pediatrics. |
| Setting Ranges | Bellavista setting is a maximum of 10% outside the range of the predicate device's setting (for ventilation modes). | CPAP: 4-30 mbar (Predicate: 0-35 mbar – narrower range, but acceptable) |
| Exp Trig: 5-90% (Predicate: 5-80% – higher available range) | ||
| FiO2: 21-100% (Similar) | ||
| PEEP: 0-40 mbar (Predicate: 0-35 mbar – similar to reference G5) | ||
| VtInsp/Vt: 40-2500 mL (Predicate: 20-2000 ml – similar to reference PB840) | ||
| Alarm Limits | Bellavista setting is a maximum of 10% outside the range of the predicate device's setting. Compliance with ISO 60601-1-8. | Apnea Time: 2-60s (Predicate: 15-60s) |
| FiO2: Upper 24-100%, Lower 18-80% (Similar) | ||
| MVInsp: 0.1-60 L/min (Similar) | ||
| PPeak: Upper 7-65 mbar, Lower 1-55 mbar (Similar) | ||
| Rate: 1-130 bpm (Similar) | ||
| VtExp: 40-3000 mL (Similar) | ||
| Leak%: 5-95%, Off (Predicate: n/a - new feature, informative only) | ||
| Monitoring Parameters | Bellavista measuring range maximum 20% outside predicate; compliance with ASTM F 1100-90 (indicators within 10%, freq. within 1 bpm or 10%). | %Spont: 0-100% (Similar) |
| AutoPEEP: 0-100 mbar (Similar) | ||
| CStat: 0-1000 mL/mbar (Predicate: 0-200 mL/mbar – higher range, but minor difference) | ||
| FiO2: 18-100 Vol% (Similar) | ||
| MVExp: 0-250 L/min (Predicate: 0-99.9 L/min – higher range, related to higher peak flows) | ||
| PEEP/PMean/PPeak/PPlateau: Similar ranges and accuracies. | ||
| Accuracy of Controls | Bellavista setting within 10% of predicate range. | Volume: ± (5 mL + 6%) (Predicate: ±10% or ±10 ml) (Similar) |
| Inspiratory pressure: ± (0.8 mbar + 4%) (Predicate: ± (1.6 mbar + 4%)) (Similar) | ||
| PEEP: ± (0.5 mbar + 1%) (Predicate: ± (1.6 mbar + 4%)) (Similar) | ||
| Oxygen: ± (3.5% FiO2 + 5% of actual reading) (Similar to reference Dräger Oxylog 3000) | ||
| Biocompatibility | Materials in gas pathway evaluated per ISO 10993-1 and ISO 18562-3, acceptable for intended use. | VOC (gas emission), CO, CO2, Ozone and PM25 testing performed. Materials found acceptable. |
| Electrical Safety/EMC | Compliance with IEC 60601-1:2005+A1:2012, IEC 60601-1-2:2007. | Performed and demonstrated compliance. |
| Reliability | Performed as described in ASTM F1100-90. | Testing performed. |
| Software Validation | System Acceptance Tests (SAT). | Testing performed. |
| Usability | Summative usability tests performed with representative user group. | Performed with a user group of respiratory therapists. |
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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(303 days)
BellaFuse
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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