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The K3900 Ultrasound Imaging System is intended for use by a qualified healthcare personnel in environments where healthcare is provided for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); and Intraoperative (abdominal, thoracic and vascular).

The K3900 Ultrasound Imaging System ("K3900") is a Track 3 general purpose ultrasound imaging system. The device generates and collects ultrasonic pulsed echo data via a transducer that is then digitized for further processing. The processing includes beamforming, image processing, and image optimization that then outputs an ultrasound image. This image may be displayed on a tablet or common displays through HDMI for general purpose radiological evaluation. The K3900 consists of an ultrasound transducer, a processing unit that manages the transducer and all data processing, and a tablet that provides the user interface to operate the device, view and analyze the ultrasound dataset, and manage patient study sessions.

The provided text is a 510(k) Summary for the MAUI Imaging K3900 Ultrasound Imaging System. It includes information about the device, its intended use, comparison to a predicate device, and performance data. However, it does not contain specific acceptance criteria, reported device performance metrics in a tabular format, information about sample size for test sets (beyond "numerous anatomical structures"), expert qualifications, adjudication methods, details of MRMC studies, or specific sample sizes for training sets.

Here's a breakdown of what can be extracted and what is missing from the provided document regarding your request:

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

• Acceptance Criteria (Implicit): The document implies that the acceptance criteria are met if the K3900 Ultrasound Imaging System demonstrates "substantial equivalence" to the predicate device (GE LOGIQ E9 K152309) and "does not raise different questions of safety or effectiveness." This is a qualitative statement, not quantitative criteria.
• Reported Device Performance: The document only states that "Side-by-side comparisons of the still images of numerous anatomical structures showed that the imaging from the subject device was substantially equivalent to the predicate." No specific metrics (e.g., sensitivity, specificity, image quality scores, quantitative measurements) are provided.

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

• Sample Size for Test Set: Not explicitly stated beyond "volunteers were recruited" and "numerous anatomical structures."
• Data Provenance: Prospective, collected in a radiology clinic. The country of origin is not specified but implied to be the US given the FDA submission.

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

• Number of Experts: One expert is explicitly mentioned: "a radiologist captured ultrasound images from both devices."
• Qualifications of Experts: Only "a radiologist" is mentioned. No details about experience level or subspecialty are provided.

4. Adjudication method for the test set

• Adjudication Method: Not specified. The comparison was described as "Side-by-side comparisons of the still images." It's unclear if there was any formal adjudication process beyond the single radiologist's assessment.

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

• MRMC Comparative Effectiveness Study: No, this was not an MRMC study and it does not involve AI assistance. The study was a comparison of two ultrasound imaging systems.

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

• This question is not applicable as the K3900 is an ultrasound imaging system, not an AI algorithm. Its performance is inherent in the image it produces for human interpretation, not as a standalone diagnostic algorithm. The comparison was about the quality of the images produced by the system.

7. The type of ground truth used

• Type of Ground Truth: The ground truth was established by "comparative ultrasound imaging data" assessed by "a radiologist." This implies a visual assessment/expert comparison rather than pathology or long-term outcomes. The predicate device (GE LOGIQ E9) serves as the reference standard for what is considered "equivalent imaging."

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. The document describes an ultrasound imaging system, not an AI/machine learning model that typically has a "training set."

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

• How Ground Truth for Training Set was Established: Not applicable (see point 8).

In summary, while the document confirms that a clinical performance study was conducted to demonstrate substantial equivalence, it lacks the specific quantitative details regarding acceptance criteria, performance metrics, and detailed study design (like sample sizes and expert qualifications) that your questions ask for.

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The K3Pro® Konus New Abutments and Implants are designed to be compatible with the K3Pro® Konus Dental Implant system and are for use in edentulous sites in the maxilla for support of a complete denture prosthesis, a final or intermediate abutment for fixed bridgework or for partial dentures, or as a single tooth replacement. Delayed loading is recommended.

The Ø7, 8, and 9mm implants are intended only for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications.

All digitally designed abutments for use with K3Pro® New Abutments and Implants are intended to be sent to an Argon validated milling center for manufacture.

The K3Pro® Konus New Abutments and Implants are components of the K3Pro® Konus Dental Implant System. The submission includes new implant bodies (7.0mm and 8.0mm diameter, 3.0mm platform, 8.0 to 11.0mm length) made of Grade 4 titanium with Osteo-Active™ surface treatment, and additional Ti-Base abutments (KSA, CG.V, and CS) in 2.0mm and 3.0mm platform diameters made of Grade 5 Ti-6Al 4V-ELI. The abutments are designed to fit and function only on previously cleared K3Pro® Konus Dental Implants (K141159, K160581) and the implants submitted in this submission. They have the same Konus connection and are screw retained. Abutment screws are made of Grade 4 titanium. All devices are for single use only. Digitally designed abutments are intended for fabrication of patient-specific abutments using FDA cleared CAD/CAM technology and manufactured by an Argon Medical Productions validated milling center. Zirconium coping and/or crown for Ti-Base abutments are made of ZrO2 and luted with an FDA cleared cement.

The provided text does not describe acceptance criteria for a device's performance, nor does it detail a study that proves the device meets such criteria.

Instead, the document is a 510(k) premarket notification letter from the FDA regarding the K3Pro® Konus New Abutments and Implants. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing new performance criteria or conducting studies to meet specific acceptance thresholds.

The document discusses:

• Indications for Use: What the device is intended for.
• Technological Characteristics: How the device is similar to predicate devices in terms of materials, design, and manufacturing.
• Non-Clinical Testing: A list of tests performed (e.g., sterilization validation, biocompatibility, fatigue testing) to show that the new device performs similarly and safely to the predicate devices. These are equivalence tests, not performance tests against specified acceptance criteria.

Therefore, I cannot provide the requested information as it is not present in the given text. The document explicitly states: "No animal testing or human clinical trials have been conducted." and focuses on "similarities between the predicate and proposed devices" and "non-clinical performance to the predicates listed" to support substantial equivalence.

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K3 is intended to supply power to and serve as a base for dental devices and accessories. This device includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants.

A Dental Unit and Chair K3 (ver 1.2) is designed for dental treatment of children and adults. It is a dental treatment unit in accordance with IEC 80601-2-60. The 3-way syringe is a dental instrument in accordance with EN 1639. It aids the dental application in the mouth of the patient by supplying air, water or spray. This product is designed for use in dentistry only and may only be used by trained medical personnel. K3 is similar to other commercially available products based on the intended use, the technology used, the claims, the electrical power and performance characteristics. It is substantially equivalent in design, function and intended use to the predicate device.

The provided text describes a 510(k) premarket notification for a dental operative unit and accessories (device K3, version 1.2). The submission aims to establish substantial equivalence to a predicate device (K3, version 1.1).

It is important to note that this document does not describe acceptance criteria or a study proving the device meets those criteria in the typical sense of a diagnostic or AI-powered medical device. The K3 is a physical dental unit, not an AI or diagnostic device that would have performance metrics like sensitivity, specificity, or image analysis accuracy.

Instead, the document details non-clinical tests performed to demonstrate that K3 (ver 1.2) is safe and effective and substantially equivalent to its predicate. These tests focus on aspects like biocompatibility, cleaning/sterilization validation, electrical safety, electromagnetic compatibility, and software verification/validation.

Therefore, many of the requested points regarding acceptance criteria and studies (especially those related to AI, ground truth, expert readers, and sample sizes for diagnostic performance) are not applicable to this type of device submission.

Here's a breakdown of the relevant information from the document:

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

Since this is a physical dental operative unit, the "acceptance criteria" are compliance with various safety and performance standards rather than diagnostic accuracy metrics. The "reported device performance" is the conclusion that the device complies with these standards.

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

• Sample Size: Not specified for each test, but general statements like "Components of the K3" and "A representative sample of the 3-Way syringe components" are used. For standards compliance, the "sample" is typically the device itself or representative parts/units of the device.
• Data Provenance: The tests would have been performed by the manufacturer (OSSTEM IMPLANT Co., Ltd. located in Seoul, Korea) or accredited testing facilities on behalf of the manufacturer. The data is prospective in the sense that these tests were conducted specifically for this submission.

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. This is a physical dental unit, not a diagnostic device requiring expert interpretation of results to establish ground truth. Compliance with engineering, safety, and sterilization standards is assessed by qualified engineers and microbiologists, not medical experts establishing a "ground truth" for a medical condition.

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

• Not Applicable. As there's no ground truth established by human experts in the context of diagnostic performance, no adjudication method is relevant. Compliance with standards is typically a pass/fail determination based on objective measurements and testing protocols.

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 is not an AI-powered or diagnostic device. No such study was conducted.

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

• Not Applicable. This is a physical dental operative unit. It does not have a standalone algorithm for diagnostic performance.

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

• Not Applicable in the traditional diagnostic sense. The "ground truth" for this device is the established safety and performance requirements codified in the cited international and national standards (e.g., IEC 60601-1, ISO 10993-1). The tests aim to demonstrate that the device's characteristics (e.g., electrical leakage, sterilization efficacy, material cytotoxicity) meet the predefined "truth" of these standards.

8. The sample size for the training set

• Not Applicable. This is not a machine learning or AI device that requires a "training set."

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

• Not Applicable. As there is no training set.

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K3 is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The dental treatment unit is intended for use in the dental clinic environment and is used by trained dentists and/or dental assistants.

K3, Dental Unit and Chair, is designed for dental treatment of children and adults. It is a dental treatment unit in accordance with ISO 7494-1, ISO 7494-2 and ISO 6875. The 3way syringe is a dental instrument in accordance with EN 1639. It aids the dental application in the mouth of the patient by supplying air, water or spray. This product is designed for use in dentistry only and may only be used by trained medical personnel K3 is similar to other commercially available products based on the intended use, the technology used, the claims, the electrical power and performance characteristics. It is substantially equivalent in design, function and intended use to the predicate devices.

This FDA 510(k) summary describes the K3 dental unit, which is a dental operative unit and accessories, including a dental chair. The submission aims to establish substantial equivalence to a predicate device, the Sirona C8 (K983242).

Here's the breakdown of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) that the device must meet for a particular clinical task. Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing technical specifications, safety standards, and intended use. The "reported device performance" is largely framed within compliance with various international standards and the comparison table.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Study Details:

This document is a 510(k) summary for a Class I medical device (Dental Operative Unit and Accessories). For such devices, clinical studies and elaborate performance evaluations focusing on diagnostic accuracy (like those for AI/ML devices) are typically not required. The primary mechanism for clearance is demonstrating substantial equivalence to a legally marketed predicate device through non-clinical performance testing and comparison of technical specifications and intended use.

Therefore, many of the requested details about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device (e.g., sample sizes for test sets, ground truth establishment, MRMC studies) are not applicable to this submission.

Here are the answers based on the provided text, indicating "Not Applicable" where appropriate for this type of device submission:

1. A table of acceptance criteria and the reported device performance: See the table above based on inferred criteria and the comparison tables in the document.

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

   • Sample Size for Test Set: Not applicable. The document describes non-clinical engineering and safety compliance testing (e.g., electrical safety, EMC, biocompatibility, sterilization, cleaning validation) rather than testing on a "test set" of patient data as would be used for an AI/ML diagnostic device. These tests are performed on either components or the assembled device.
   • Data Provenance: Not applicable. The tests are laboratory-based and standard compliance tests. The manufacturer is Osstem Implant Co. Ltd. from Seoul, Republic of Korea.

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):

   • Number of Experts: Not applicable. Ground truth as typically defined for diagnostic performance is not relevant here. Compliance with standards and technical specifications is verified by testing facilities and potentially by internal engineering teams.

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

   • Adjudication method: 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:

   • MRMC Study: No. This is a physical dental unit, not an AI/ML diagnostic or assistive device that would involve human readers.

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

   • Standalone Performance: No. This is not an algorithm; it's a dental chair and associated components.

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

   • Type of Ground Truth: Not applicable. The "ground truth" here is compliance with established international standards (e.g., IEC, ISO, EN) for safety, electrical characteristics, biocompatibility, cleaning, and sterilization.

8. The sample size for the training set:

   • Sample Size for Training Set: Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.

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

   • Ground Truth for Training Set: Not applicable.

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K3Pro Konus Additional Abutments and Implants are designed to be compatible with the K3Pro Konus Dental Implant system and are for use in edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a final or intermediate abutment for fixed bridgework or for partial dentures, or as a single tooth replacement. Delayed loading is recommended. The prosthesis may be secured to the abutment by the use of adhesives or mechanically by the use of a screw.

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The provided text is a 510(k) Clearance letter from the FDA for a dental implant system. It does not contain any information about a study that proves a device meets acceptance criteria, an AI/ML powered device, or any performance metrics. Therefore, I cannot generate the requested information based on the input.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for 510(k) clearance, rather than requiring performance data against specific acceptance criteria as would be needed for a novel device or AI/ML product.

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The indications for use of the K3 Bone Screw System™ are fixation/stabilization of small bones in hand or small bones in mid and forefoot fractures.

The KMI K3 Bone Screw System'™ will be offered in Ti-6AI-4V ELI. It will be available in common styles and assorted lengths for bone fracture fixation and stabilization. Initially, a range of fifthteen screw lengths will be made available in 3.5 mm diameter (12-50 mm), and eight screw lengths will be made available in the 3.5 mm solid (12-26 mm) diameter screw. Both screw types are implantable using a standard (e.g. American Orthopedic) hexhead screwdriver, which is cannulated at center.

The provided text describes the K3 Bone Screw System™ and details its intended use, regulatory standing, and comparison to existing devices. However, the document does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria.

Instead, the document focuses on:

• Substantial Equivalence: The primary "proof" offered is that the K3 Bone Screw System™ is substantially equivalent to other orthopedic screws already on the market and approved by the FDA. This is a regulatory pathway for devices that are very similar to already legally marketed devices.
• Voluntary Standards: The material (titanium alloy 6AL-4V ELI) used to manufacture the screws meets chemical and mechanical requirements specified in voluntary standards established by the American Society for Testing and Materials (ASTM F136-84, ASTM B348-83, F136-84, F67-88). The instruments are manufactured from stainless steel meeting ASTM F899-84 standards.
• Clinical History: It highlights that bone screw systems in general have been used for many years, and their clinical performance is well known and documented over 75 years of clinical evaluation.

Therefore, I cannot fill out the requested table and answer the study-specific questions as the document does not contain that information. It does not describe a performance study with specific acceptance criteria, sample sizes, expert involvement, or comparative effectiveness.

The document's purpose is to satisfy an FDA Notification for a Summary of Safety and Effectiveness Information, primarily by demonstrating substantial equivalence, not by presenting a performance study with specific, quantifiable acceptance criteria and results.

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