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The Quantel Medical ABSOLU is intended to be used for:

-Axial Length measurement of the eye by ultrasonic means;

-Implanted IOL power calculation, using the Axial Length measurement;

• Visualization of the interior of the eye and the orbit by A and B scans.

The ABSOLU is a high definition multifunction ophthalmic ultrasound system used for the following intended use:

• -Axial Length measurement of the eye by ultrasonic means;
• Implanted IOL power calculation, using the axial length measurements; -
• Visualization of the interior of the eve and the orbit by A and B scans. -

The Quantel Medical ABSOLU device is intended for axial length measurement of the eye, implanted IOL power calculation using axial length measurements, and visualization of the interior of the eye and orbit via A and B scans. The performance data and acceptance criteria are outlined below, primarily focusing on safety and compliance with recognized standards rather than specific diagnostic accuracy metrics of a standalone AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes tests performed for regulatory compliance (safety, EMC, usability, and ultrasonic equipment safety standards) and validation of technological changes. It does not mention a specific "test set" in the context of clinical data for diagnostic or measurement accuracy of a standalone AI algorithm. The performance data refers to instrumental performance, safety, and functional validation against standards for the device as a whole and its components (probes, software). Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set is not available in this document.

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

This information is not provided in the document, as the evaluations described are primarily for device safety, EMC, usability, and technical performance against engineering standards, not a clinical diagnostic performance study with expert-adjudicated ground truth.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not provided in the document, as the evaluations described are for device safety and technical performance, not for clinical diagnostic performance adjudicated by experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is present in the document. The device is an ultrasound system with specific measurement and visualization capabilities, and the performance data focuses on its compliance with operational, safety, and technical standards, rather than an AI-driven diagnostic accuracy study comparing human readers with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The document does not describe a standalone performance study for an AI algorithm without human intervention. The ABSOLU is described as an "ultrasonic pulsed echo imaging system" intended for use by "trained medical personnel" where "the use of the different parameters of the ABSOLU® and the predicate device are under control of the physician for the different phases of the diagnostic." This strongly suggests a human-in-the-loop system, not a standalone AI.

7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document does not detail specific "ground truth" for clinical diagnostic or measurement accuracy in the context of expert consensus, pathology, or outcomes data. The "performance data" mentioned pertains to compliance with recognized consensus standards for electrical safety, electromagnetic compatibility, usability, and ultrasonic medical device safety. These standards serve as the "ground truth" for the device's technical and safety performance.

8. Sample Size for the Training Set

No information regarding a training set sample size is provided. The document outlines a regulatory submission for an ultrasound imaging system, not an AI algorithm that typically requires a large training dataset for its development. The "software" mentioned as being revised is general device software, not an AI component trained on data.

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

Since no training set for an AI algorithm is mentioned, there is no information on how ground truth for such a set was established.

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A dual-cure, composite resin core build-up material that is usually used to restore missing tooth structure for which a dental restoration, usually a crown, is fabricated.

A dual-cure, composite resin, core build-up material that is usually used to restore missing tooth structure for which a dental restoration, usually a crown, is fabricated. It is substantially equivalent to many predicate materials that include self-, light-, and dual-cure types. This material incorporates fluoride-containing (trace amounts) glass filler particles. No Bisphenol-A or its precursors are used in the manufacturing process. The material is supplied in light-safe dual-barrel cartridges.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Parkell, Inc. Absolute Dentin II device:

Based on the provided 510(k) summary (K132115) for Absolute Dentin II, this document pertains to a dental material, specifically a composite resin core build-up material, and not an AI/ML-driven medical device. Therefore, many of the requested categories related to AI/ML device studies (like sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this submission.

The "acceptance criteria" for this type of device are primarily based on demonstrating substantial equivalence to predicate devices through biocompatibility testing and non-clinical performance testing of mechanical properties.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria (as demonstrated by testing) and Reported Device Performance:

Since this is a material rather than a diagnostic or therapeutic AI device, "acceptance criteria" are typically defined by meeting established ISO standards for biocompatibility and demonstrating comparable physical properties to predicate devices. The document lists the tests conducted and states that all tests were passed.

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

• Sample size: Not specified. Standard biocompatibility tests and material property tests typically use a predefined number of samples as per the relevant ISO or ASTM standards, but the exact count is not given in this summary.
• Data provenance: Not explicitly stated but assumed to be from laboratory testing as per the ISO standards mentioned.

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

• Not Applicable. This is a material testing conformity rather than a diagnostic device requiring expert interpretation of results for ground truth. Biocompatibility and mechanical property tests have objective readouts.

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

• Not Applicable. Adjudication methods are relevant for subjective interpretations, which are not involved in these types of material tests.

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-driven device.

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

• Not Applicable. This is not an AI-driven device.

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

• For biocompatibility: Ground truth is established by the specific, objective criteria defined within each ISO standard (e.g., cell viability percentages, absence of specific reactions).
• For non-clinical performance (mechanical properties): Ground truth is established by physical measurement against established material science parameters and comparison to predicate device performance.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.

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

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

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The Absolute White Light emits visible blue light in the 400 nanometer spectrum and is intended to provide a light source for bleaching teeth.

The Absolute White Light is intended for use by the end consumer. The Absolute White Light is a battery operated, hand held device that contains a hun vosible light in the 400 nanometer spectrum, which can penetrate the tooth and activate the photoactive substances within the tooth yielding a minimal amount of heat. Built in safety features include automatic light shut off after two minutes and "Light Guard" that prevents light exposure to the user's eyes.

The provided document describes the Absolute White Light, a device intended to provide a light source for bleaching teeth. However, it does not include a study that proves the device meets specific acceptance criteria in terms of efficacy or performance on human subjects for tooth whitening. Instead, the document focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and safety standards.

Here's a breakdown based on your request, highlighting what is present and what is absent:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of clinical performance (e.g., a specific percentage improvement in tooth shade) for the Absolute White Light. Instead, it relies on demonstrating that the device is "substantially equivalent" to a legally marketed predicate device (Dentovations Luster Whitening System) in terms of its intended use and technical characteristics.

The "performance data" section primarily refers to compliance with quality system regulations and safety standards, not clinical efficacy data.

Table of Comparison with Predicate Device (acting as the basis for "performance" as substantial equivalence):

Additional "Performance Data" (Compliance, not clinical efficacy):
The device is manufactured in compliance with:

• Quality System Regulations (21 CFR 820)
• DIN EN ISO13485:2003
• DIN EN ISO 9001:2000
• EN 61000-6-1 Electromagnetic compatibility (EMC) Part 6-1: Immunity standard for residential, commercial and light-industrial environments
• EN61000-6-3 Electromagnetic compatibility (EMC) Part 6-3: Emission standard for residential, commercial and light-industrial environments

Study Details (or lack thereof)

Based on the provided text, there is no specific clinical study or performance study presented that directly proves the device's efficacy in terms of tooth whitening (e.g., changes in shade). The submission relies on demonstrating substantial equivalence to a predicate device, implying that since the predicate device is already cleared for use, a device with similar characteristics and intended use is also safe and effective.

Therefore, the following points cannot be addressed with the provided text, as no such study is described:

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, no clinical test set described for efficacy.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no clinical test set described for efficacy.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, no clinical test set described for efficacy.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, this is not an AI/imaging diagnostic device. No MRMC study was conducted.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this is not an AI/imaging diagnostic device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, no clinical ground truth for efficacy was established or reported. The "ground truth" for regulatory clearance was the substantial equivalence to the predicate device based on technical specifications and safety standards.
7. The sample size for the training set: Not applicable, no machine learning model or training set is described.
8. How the ground truth for the training set was established: Not applicable, no machine learning model or training set is described.

Conclusion from the document:

The regulatory approval (K110888) was granted based on the determination of "substantial equivalence" of the Absolute White Light to the predicate device (Dentify Luster Whitening System, K042153). This means the FDA concluded that the new device has the same intended use and similar technological characteristics to a device already on the market and does not raise different questions of safety and effectiveness. The "performance data" provided focuses on manufacturing quality systems and adherence to electromagnetic compatibility (EMC) standards, not on clinical performance demonstrating tooth whitening efficacy in human subjects.

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The Absolute® Pro .035 Biliary Self-Expanding Stent System is intended for palliation of malignant strictures in the biliary tree.

The Absolute® Pro .035 Biliary Self-Expanding Stent System includes a selfexpanding nickel titanium stent that is pre-mounted on an over-the-wire Delivery System. A total of 12 (6 at each end) radiopaque markers made of a radiopaque nickel titanium alloy are located at the ends of the stent. The Absolute Pro .035 Biliary Self-Expanding Stent System utilizes a 0.035" (0.89 mm) guide wire. The system includes radiopaque markers that identify the stent location.

The catheter comprises a retractable sheath that covers the stent during delivery. a radiopaque tip, an I-Beam to support the stent during deployment with an internal guide wire lumen, a detachable outer jacket, and a handle assembly with a safety lock and retraction features. With the handle in the unlocked position, rolling back the thumbwheel deploys the stent.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Absolute® Pro .035 Biliary Self-Expanding Stent System:

Summary of Acceptance Criteria and Device Performance for Absolute® Pro .035 Biliary Self-Expanding Stent System

This 510(k) submission (K072708) relies on demonstrating substantial equivalence to predicate devices rather than meeting specific quantifiable performance acceptance criteria for a novel AI device. The "device performance" reported is that the new device is equivalent to its predicates based on various tests.

Study Information (Based on the provided text):

The provided text describes a 510(k) submission for a medical device (a biliary stent system), not an AI/ML diagnostic or prognostic device. Therefore, many of the typical AI study parameters (sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance) are not applicable to this type of submission.

Here's an attempt to address the points based on what's available and an understanding of traditional medical device submissions:

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

   • See the table above. The "acceptance criteria" are effectively the demonstration of substantial equivalence to the predicate devices based on intended use, technological characteristics, and performance data (primarily in vitro).

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 in the AI sense. This submission is for a physical medical device. The "test set" would be the units of the device subjected to in vitro bench testing. The text does not specify the number of samples used for these bench tests.
   • Data Provenance: The data would be derived from internal laboratory testing conducted by Abbott Vascular. The country of origin for the data is implicitly the USA (Abbott Vascular, Santa Clara, CA). This is generally prospective testing of the manufactured device.

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 in the AI sense. For a physical device like a stent, "ground truth" is established through engineering specifications, material science standards, and established medical device testing methodologies. The "experts" would be the R&D engineers, metallurgists, and quality control professionals who design and test the device against these standards. Their qualifications are not specified but are presumed to be appropriate for medical device engineering and testing.

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

   • Not applicable in the AI sense. The "adjudication method" for traditional device testing involves adherence to predefined test protocols, acceptance limits, and quality control procedures. It's not a consensus-based review by experts of clinical cases.

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. This is a physical device, not an AI diagnostic tool. MRMC studies are not relevant here.

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

   • Not applicable. This is a physical device.

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

   • For the in vitro performance data, the "ground truth" would be the engineering specifications and performance characteristics of the predicate devices, as well as relevant industry standards and design requirements for biliary stents (e.g., radial force, fatigue resistance, deployment accuracy, material biocompatibility, etc., though not detailed in this summary). The goal is to demonstrate that the new device meets or exceeds these established performance benchmarks found in the predicates.

8. The sample size for the training set:

   • Not applicable in the AI sense. There is no "training set" for a physical device in this context. The design and manufacturing process would involve extensive engineering studies and prototypes, but not a "training set" like that used for machine learning.

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

   • Not applicable in the AI sense. See point 8.

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Absolute America is a dental operative unit intended as an operative tool for therapeutic use on people by personnel highly skilled in dental practices, such as dentists, dental assistants and dental hygienists.

Eurodent dental operative unit is an electrical device with air and water connections. It is composed from:

• A patient treatment chair moved electrically -
• an hydric group with cuspidor and inside all suction , water, air and electrical circuits ・
• a dentist's instrument board -
• an assistant board -
• an electrical footswitch that controls same unit functions -
• a dental light

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document is a 510(k) summary for a dental operative unit, and it primarily focuses on:

• Device Description: What the device is composed of.
• Intended Use: How the device is meant to be used and by whom.
• Summary of Substantial Equivalence Comparison: Comparing the device to legally marketed predicate devices, stating they use similar components, design, technical characteristics, and mode of operation.
• FDA Communication: A letter from the FDA confirming the substantial equivalence determination, allowing the device to be marketed, and outlining regulatory requirements.
• Indication for Use form: Reiteration of the intended use.

This type of submission (510(k)) for a Class I device often relies on demonstrating substantial equivalence to a predicate device rather than extensive clinical studies with specific performance metrics and acceptance criteria as one might find for a Class II or Class III device. Therefore, the detailed study information you are asking for is not present in this document.

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The ABSOLUTE™ .035 Biliary Self-Expanding Stent System is intended for palliation of malignant strictures in the biliary tree.

The ABSOLUTE™ Biliary Self-Expanding Stent System is comprised of the ABSOLUTE™ stent pre-mounted on an over-the-wire delivery system. The delivery catheter consists of three coaxial members (an inner member, a retractable outer member, and an outer, outer member), a guide wire lumen, a distal soft tip and a proximal handle with retraction and locking features. The distal section of the outer member constrains the stent on the inner member. Deployment of the ABSOLUTE™ stent occurs when the outer member is retracted by activating the retraction features in the handle.

The provided text is a 510(k) Summary for the Guidant ABSOLUTE™ .035 Biliary Self-Expanding Stent System. It declares substantial equivalence to predicate devices based on technological characteristics and performance data. However, it does not contain the detailed information required to fill out the requested table and study details.

Specifically, the document states:

• "The results of the in vitro bench tests and analyses demonstrated the safety and effectiveness of the ABSOLUTE™ .035 Biliary Self-Expanding Stent System."

This is a general statement and does not provide:

1. A table of specific acceptance criteria.
2. Reported device performance against those criteria (e.g., specific measurements, thresholds, or statistical results).
3. Details about the study design (sample sizes, data provenance, ground truth establishment, expert qualifications, etc.).
4. Information on MRMC studies or standalone algorithm performance.

Therefore, I cannot extract the requested information from the provided text. The document focuses on demonstrating substantial equivalence through a summary of technological characteristics and a general assertion of safety and effectiveness from bench tests, rather than providing the detailed clinical or performance study data one would expect for an AI/device performance study with specific acceptance criteria.

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The 11mm & 12mm Absolute™ Absorbable Interference Screws are intended for fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.

The Absolute™ Absorbable Interference Screw is a biodegradable interference screw intended for interference fit fixation of soft tissue grafts or bone-tendonbone grafts during cruciate ligament reconstruction surgeries of the knee. The device is offered in 11mm and 12mm diameters and 30mm in length.

The provided text describes a 510(k) premarket notification for the Innovasive Absolute™ Absorbable Interference Screw. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set (e.g., number of screws tested). It mentions "Bone Model Testing," implying in-vitro mechanical testing rather than human subject data. Therefore, data provenance such as "country of origin" or "retrospective/prospective" is not applicable in the traditional sense of clinical studies.

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

Not applicable. The ground truth for this type of device (mechanical performance) is established through physical measurement and engineering principles, not expert medical opinion.

4. Adjudication Method for the Test Set

Not applicable. This is a mechanical performance study, not one requiring expert human adjudication.

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

Not applicable. This document describes a medical device (an interference screw), not an AI-powered diagnostic or assistive technology.

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

Not applicable. This is a medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used was physical measurement in a bone model for ultimate holding strength, insertion force, and stripping force.

8. The Sample Size for the Training Set

Not applicable. This is a mechanical performance study of a physical device, and the concept of a "training set" is not relevant.

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

Not applicable, as there is no training set mentioned or implied for this type of device testing.

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