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This device is to be used by patients who have a conductive hearing loss and can still benefit from sound amplification. Also indicated are patients with mixed hearing loss with average bone conduction thresholds in the indicated ear better than 45 dB HL. (Patients with bone conduction thresholds between 25 and 45 dB HL will be expected to improve, but may not achieve levels in the normal range. Patients with a bone conduction threshold where each standard measured frequency threshold is less than 25 dB HL can be expected to have restored hearing levels in the normal range.) The patients indicated for this device must also be unable to use conventional air conduction hearing aids or undergo ossicular replacement surgery because of one of the following:

1. Chronic otitis media (COM), or
2. Congenital malformation (CM) of the middle/external ear; or
3. Other acquired malfunctions of the middle or external ear canals which preclude the wearing of a conventional air conduction hearing aid.
   Additional indications to be met by perspective BAHA candidates:
4. Patients (either by themselves or with the aid of others) must be able to maintain the abutment/skin interface of the BAHA. Therefore, careful consideration must be given as to the patient's psychological, physical, emotional and developmental capabilities to maintain hygiene. In the case of children part, but not all, of that responsibility falls on the parents or guardian.
5. For children and patients with congenital malformations, sufficient bone volume and bone quality must be present for a successful fixture implantation. Alternative treatment such as conventional bone conduction hearing aids, should be considered for patients having a disease state that might jeopardize osseointegration.

The Branemark Bone-Anchored Hearing Aid (BAHA) System includes a titanium fixture which is placed in the temporal bone just behind the ear, an abutment, various accessories necessary for the placement and use of the fixture/abutment pillar, and a sound processor which is attached to the abutment. The fixture/abutment pillar is used as an anchor for the sound processor.

The provided text is related to a 510(k) submission for the Branemark Bone-Anchored Hearing Aid (BAHA™) System. This document focuses on regulatory approval and indications for use, rather than a clinical study evaluating specific performance metrics against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and performance statistics is not present in the given text.

Based on the provided information, I can offer the following:

1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or report specific device performance metrics in a way that would fit into such a table. It describes the intended use and expected outcomes (e.g., "expected to improve," "restored hearing levels in the normal range") rather than quantifiable performance thresholds.

2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of a clinical study with a specified sample size or data provenance. The information provided is for a 510(k) submission seeking clearance based on substantial equivalence to predicate devices, not a new clinical trial reporting performance data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The document does not describe a clinical study involving experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set
Not applicable. The document does not describe a clinical study with an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
Not applicable. The document does not describe an MRMC study.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Not applicable. The device described is a medical implant and sound processor, not an artificial intelligence algorithm.

7. The Type of Ground Truth Used
Not applicable in the context of an AI/algorithm performance study. The "ground truth" for the device's efficacy is implied by its ability to amplify sound and improve hearing based on its mechanism of action and prior clinical experience with similar devices, as described in the predicate products.

8. The Sample Size for the Training Set
Not applicable. The document does not describe a training set for an algorithm.

9. How the Ground Truth for the Training Set was Established
Not applicable.

In summary, the provided 510(k) document is a regulatory submission focused on the safety and effectiveness of a medical device (a bone-anchored hearing aid) and its indications for use, including an expansion to pediatric patients. It establishes substantial equivalence to previously cleared predicate devices but does not detail a new clinical study with specific performance acceptance criteria or detailed study methodologies as would be expected for demonstrating algorithm performance.

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The Nobelpharma BRANEMARK SYSTEM® - Wide Platform Accessories are intended to be used as accessories in conjunction with the Wide Platform endosseous implant system and in the exact same manner as their counterpart predicate product.

The Nobelpharma BRANEMARK SYSTEM® - Wide Platform Accessories are components used with various BRANEMARK SYSTEM® Wide Platform Fixtures. They include Abutments, Healing Abutments, Hand Instruments, Impression Copings and Machine Instruments.

This document is a 510(k) summary for a medical device submitted in 1996. It does not contain any information about acceptance criteria, device performance, results of any studies, or ground truth establishment.

The document is a pre-market notification that primarily focuses on:

• Device Name and Manufacturer: Nobelpharma USA, Inc.
• Device Description: Accessories for the BRANEMARK SYSTEM® - Wide Platform Fixtures (e.g., Hand Instruments, Healing Abutments, Impression Copings, Machine Instruments).
• Predicate Product: Other existing components marketed by Nobelpharma.
• Intended Use: To be used as accessories with the Wide Platform endosseous implant system, in the same manner as predicate products.
• Comparison of Technological Characteristics: States that the technological characteristics are "identical" to the corresponding predicate products.

Therefore, I cannot provide the requested information as it is not present in the provided text.

To answer your questions, I would need a document that describes the design verification and validation testing performed for the device, including:

• Specific acceptance criteria (e.g., tensile strength, dimensional accuracy, sterilization efficacy).
• Results of tests demonstrating compliance with these criteria.
• Details about the study design (e.g., sample sizes, methods for establishing ground truth, expert qualifications, adjudication methods).

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The BRANEMARK Bone-Anchored Hearing Aid (BAHA™) System is intended to be used as a bone-anchored, bone-conduction hearing aid. The device is indicated for use in patients requiring hearing amplification and with the following conditions:

• Otological 1)
• . congenital malformations of the external ear or microtia
• . chronically draining ear which does not allow use of an air conduction hearing aid (e.g. external otitis, draining mastoid cavity)
• other acquired malformations of the middle or external ear which . preclude the wearing of a conventional hearing aid
• patients presently wearing, but dissatisfied with, traditional bone . conduction hearing aids or patients who are satisfied with their bone conduction aids but could benefit from the features of the BAHA-type device.
• patients with conductive hearing loss due to ossicular disease and ● not appropriate for surgical correction or unable to be aided by conventional air conduction hearing devices.
• 2. Audiological
• . Pure tone average bone conduction threshold of the indicated ear better than or equal to 45 dB HL for model, Classic 300 and 60 dB HL for model HC-220 (average 500, 1k, 2k and 3k Hz); and a speech discrimination score better than 60% or reasonably good speech discrimination as evaluated by a qualified audiologist, based on the patient's particular needs.
• 3. Psychosocial
• patients (either by themselves or with the aid of others) must be ● able to maintain the abutment/skin interface of the BAHA. Therefore, careful consideration must be given as to the patient's psychological, physical, emotional and developmental capabilities to maintain hygiene. Patients should be at least 3 years of age.
• Anatomical and Biological 4)
• Biologically, titanium implants can be installed in most patients. ● Sufficient bone volume and bone quality should be present for a successful fixture implantation. Alternative treatments should be considered for patients having a disease state that might jeopardize osseointegration.

The BRANEMARK Bone-Anchored Hearing Aid (BAHA™) System includes a titanium fixture which is placed in the temporal bone just behind the ear, an abutment, various accessories necessary for the placement and use of the fixture/abutment pillar, and a sound processor which is attached to the abutment. The fixture/abutment pillar is used as an anchor for the sound processor.

The provided text describes a medical device, the BRANEMARK Bone-Anchored Hearing Aid (BAHA™) System, and its intended use. However, it does not contain information about acceptance criteria, specific studies proving the device meets acceptance criteria, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document primarily focuses on:

• Device Name and Manufacturer: Nobelpharma USA, Inc., BRANEMARK Bone-Anchored Hearing Aid (BAHA™) System.
• Predicate Products: BRANEMARK SYSTEM® - Bone-Anchored Craniofacial Prosthetic Attachment System (K945154), Audiant Bone Conduction Hearing Aid (K861971, K872168 and K841432), and other bone conduction hearing aids.
• Device Description: A titanium fixture placed in the temporal bone, an abutment, accessories, and a sound processor.
• Intended Use: Bone-anchored, bone-conduction hearing aid for patients with specific otological, audiological, psychosocial, and anatomical/biological conditions.
• Comparison to Predicate: Stated that technological characteristics are "substantially identical and no additional questions regarding safety and effectiveness exist."

Therefore, I cannot fulfill your request for the specific details outlined in your prompt based on the provided text. The document is a "Summary of Safety and Effectiveness" from a 1995 FDA submission (K955713), which typically provides a high-level overview rather than detailed study results or performance data.

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The Nobelpharma BRÅNEMARK SYSTEM - MK II Self-Tapping Fixtures are intended to be used in edentulous and partially edentulous patients to restore chewing functions.

The Nobelpharma BRÅNEMARK SYSTEM - Mk II Self-Tapping Fixture is a line of endosseous implants, varying in diameter, which are implanted in the upper and lower jaw bone to be used to support prosthetic devices to help restore chewing functions of edentulous patients. The device has been cleared for sizes 3.75, 4.0, 4.4, 5.0 and 5.5mm diameters. The only modification is to the 5.0 and 5.5mm diameter fixtures. This modification of the 5.0mm and 5.5mm diameter fixtures entails 1) an increased internal thread diameter for insertion of appropriate abutment screws and 2) an increased hexagonal dimension for the hex portion of the fixture to facilitate accurate seating of appropriate abutments. An additional minor modification to the flange (a 0.4mm increase of diameter) and to the apex (a 0.3mm increase in diameter) is being made to the 5.5mm fixture to accommodate the surgical and prosthetic components of the system.

This request cannot be fulfilled. The provided text describes a medical device (an endosseous implant) and its specifications, but it does not contain information about acceptance criteria, device performance studies, or AI/software validation. The document is a 510(k) summary from 1996 for a physical implant device, not a diagnostic or AI-powered medical device that would involve the type of study details you're asking for.

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Intended to be used in edentulous patients as an anchor to support a prosthesis.

The Nobelpharma 17° Angulated Abutment is an abutment used with an endosseous implant. The abutment sits upon the implanted fixture and is used to support prosthetic devices and restore chewing functions in edentulous patients. The only modification is the narrowing of the base and external diameter of the abutment; and narrowing of the diameters of the abutment screws, adding one series of abutments to fit the smaller diameter fixtures previously cleared.

This document is a 510(k) Pre-Market Notification for a medical device called the "BRANEMARK SYSTEM® 17° Angulated Abutment." This submission is a modification of an already cleared device, K944962. The key information for your request is largely absent because this is a 510(k) submission for a modification to an existing device, and the documentation focuses on demonstrating substantial equivalence rather than presenting new performance study data with acceptance criteria for a novel device.

Here's an analysis based on the provided text, highlighting what is and isn't available:

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

• Not provided. The document states that the "technological characteristics between the modified version of the 17° Angulated Abutment and the earlier version are identical." The changes are described as "minor dimensional changes to the diameter of the abutment and abutment screw." For a 510(k) for a minor modification, extensive performance testing with defined acceptance criteria is typically not required if the changes are deemed to not affect the safety or effectiveness. The submission relies on the predicate device's established safety and effectiveness.

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

• Not applicable/Not provided. No new performance testing data (and therefore no test set sample size or provenance) is mentioned, as the device is a minor modification of an already cleared product.

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/Not provided. As no new performance studies are described, there's no mention of experts establishing a ground truth for a test set.

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

• Not applicable/Not provided. No new performance studies are described, so no adjudication method is mentioned.

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 describes a dental implant abutment, not an AI-powered diagnostic device. Therefore, MRMC comparative effectiveness studies or human-in-the-loop performance details are irrelevant and not present.

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

• Not applicable. This pertains to an abutment for an endosseous implant, which is a physical medical device, not an algorithm or software.

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

• Not applicable/Not provided. Since no new performance studies are detailed, there is no mention of how "ground truth" was established. The effectiveness of the device is inferred from the predicate device through substantial equivalence arguments.

8. The sample size for the training set

• Not applicable. As this is a physical medical device and not an AI/ML algorithm, there is no concept of a "training set."

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

• Not applicable. As this is a physical medical device and not an AI/ML algorithm, there is no concept of a "training set" or establishing ground truth for it.

Summary of Device and 510(k) Context:

• Device: BRANEMARK SYSTEM® 17° Angulated Abutment, an abutment for endosseous dental implants.
• Modification: Narrowing of the base and external diameter of the abutment, and narrowing of the diameters of the abutment screws, to fit smaller diameter fixtures.
• Predicate Device: The previous version of the same device, K944962.
• Basis for Clearance: Substantial equivalence to the predicate device, based on the argument that the "technological characteristics... are identical" and the changes are "minor dimensional changes" that do not affect safety or effectiveness.
• Intended Use: To be used in edentulous patients as an anchor to support a prosthesis.

In essence, this 510(k) submission for K961736 is for a minor modification of an already cleared device. The "study" proving it meets acceptance criteria is the argument of substantial equivalence to the predicate device, rather than new, extensive performance testing with explicit acceptance criteria. The FDA's clearance letter (SEP 17 2010) confirms the device's substantial equivalence to legally marketed predicate devices.

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The Nobelpharma CeraOne Abutment System is intended to be used to anchor single tooth prostheses in partially edentulous patients.

The Nobelpharma CeraOne Abutment System is an abutment used with an endosseous implant which is implanted in the upper or lower jaw bone. The CeraOne System allows the prosthesis to be cemented directly to the abutment rather than requiring an additional screw connection. The modifications to the device are the broadening and narrowing of the base and external diameters of the abutments; and broadening and narrowing of the diameters of the abutment screws, adding two series of abutments fitting to larger and smaller diameters of fixtures previously cleared.

This document is a 510(k) summary for a pre-market notification of a dental implant abutment system. It describes modifications to an existing device, primarily dimensional changes. It does not contain information about acceptance criteria or a study that proves the device meets acceptance criteria related to a diagnostic or AI-driven medical device.

Therefore, I cannot provide the requested table or information regarding sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details as this document is not about a performance-measuring study for such a device.

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Intended to be used in edentulous patients as an anchor to support a prosthesis.

The Nobelpharma MirusCone Abutment System is an abutment used with an endosseous implant which is implanted in the upper or lower jaw done. The abutment has a lower profile (vertical height) for use when the dentist desires a lower profile abutment. The only modifications to the device are the broadening and narrowing of the base and external diameters of the abutments; and broadening and narrowing of the diameters of the abutment screws, adding two series of abutments fitting the larger and smaller discussion in of fixture previously cleared.

The provided text is a 510(k) summary for a premarket notification for a dental device, specifically an abutment for an endosseous implant. It does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment for an AI/ML device.

This document describes a modification to an existing device (K944964), stating that the technological characteristics between the modified and earlier versions are "identical," with only minor dimensional changes. The basis for substantial equivalence is the predicate device itself, implying that no new performance testing to specific acceptance criteria was required beyond demonstrating that the dimensional changes did not alter the fundamental safety and effectiveness of the device as compared to its predicate.

Therefore, the requested information regarding acceptance criteria and a study to prove the device meets these criteria cannot be extracted from this document, as it pertains to a different type of device and regulatory submission.

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The Nobelpharma BRANEMARK SYSTEM® Abutment Selection Kit is intended to be used by practitioners to select the proper abutment.

The Nobelpharma BRANEMARK SYSTEM® Abutment Selection Kit consists of trial models of various abutments which are used by the practitioner to select the proper abutment. It can be used in two situations: in a patient's mouth and/or on a plaster model. The abutment selection system is used in a patient's mouth for only 5-10 minutes so that the clinician can determine the proper abutment type and length.

This document is a 510(k) summary for a medical device called the "BRANEMARK SYSTEM® Abutment Selection Kit." It's a pre-market notification from 1996.

Based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on:

• Device Identification: Name, address, contact person, product name.
• Predicate Device: K944963 (another abutment selection kit).
• Device Description: Trial models of abutments for selection, used in a patient's mouth for 5-10 minutes or on a plaster model.
• Intended Use: To select the proper abutment.
• Comparison of Technological Characteristics: Stating that the characteristics are "identical" to the predicate, with the only notable difference being a "proposed colorant method... to provide a bright color distinction between the 'trial' abutments and the abutments intended for long-term use."

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth, expert qualifications, or MRMC studies because this document does not contain that type of data.

This document is a regulatory submission for a simple, non-active, non-diagnostic device (trial models for fitting) that is being compared to a substantially equivalent predicate. The type of rigorous performance studies and detailed acceptance criteria typically associated with AI/diagnostic devices (which your questions are geared towards) are not relevant or present in this context.

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