Search Results

Type

Special

Panel

Reference & Predicate Devices

K180623

Intended Use

The Ulthera System is intended to apply focused ultrasound energy to the body to achieve temporary changes in the physical appearance of the skin.

The Ulthera System is indicated for use as a non-invasive dermatological aesthetic treatment to:

· Lift the eyebrow

• Lift lax submental (beneath the chin) and neck tissue. which can also affect the appearance of lax tissue in the submental and neck regions

· Improve lines and wrinkles of the décolleté

· Ensure proper coupling of the transducer to the skin

· Confirm appropriate depth of treatment such as to avoid bone

Device Description

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Ulthera System (UC-1 Control Unit PRIME). The submission aims to demonstrate substantial equivalence to a predicate device (Ulthera System, K180623), primarily focusing on modifications to the console.

Based on the provided text, the device is an aesthetic device (Focused Ultrasound Stimulator System for Aesthetic Use) and NOT a diagnostic device or an AI/ML-driven device that involves human readers or complex image interpretation.

Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of diagnostic AI/ML devices (e.g., sample size, expert ground truth, MRMC studies, standalone performance) is not applicable or not detailed in this submission.

The "study" described is a series of non-clinical performance tests validating the modified console's functionality and safety, rather than a clinical study evaluating diagnostic accuracy or reader improvement.

Here's an attempt to address the points based on the available information, noting where information is not present due to the nature of the device and submission:

Acceptance Criteria and Device Performance for Ulthera System (UC-1 Control Unit PRIME)

The 510(k) submission primarily focuses on demonstrating that modifications to the Ulthera System's console do not significantly affect its clinical functionality or performance compared to the predicate device. The acceptance criteria are essentially that the modified device functions "as intended" and remains "as safe and effective" as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not a diagnostic device with specific performance metrics like sensitivity/specificity, the "acceptance criteria" relate to engineering, software, and physical performance.

Acceptance Criteria Category	Reported Device Performance/Verification
Biocompatibility	User-contacting components verified in accordance with ISO 10993-1. (Performance: Verified)
Electrical Safety and EMC	Verified in accordance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-37, and IEC 60601-2-62. (Performance: Compliant)
Software Verification & Validation	Conducted as recommended by FDA Guidance, "Content of Premarket Submissions Device Software Functions." A basic documentation level was used as a failure would not present a hazardous situation with a probable risk of death or serious injury. (Performance: Conducted, Passed; Functions as intended.)
Usability	Conducted in accordance with IEC 62366-1 and FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices." Specific checks included console's portability, GUI visibility and layout, and display responsiveness. (Performance: Clinicians able to use device in representative environment; no new risks identified.)
Mechanical Testing	Display hinge of the console verified via mechanical cyclic testing. (Performance: Verified)
Packaging, Transit, & Environmental	Packaging and transit testing per ASTM D4169 and ASTM D4332. Environmental conditioning testing conducted to verify device functionality at defined operating and storage conditions. (Performance: Verified)
Ultrasound Output Testing	Acoustic reliability verified using simulated treatment over the device's service life. Power output and imaging were verified to be within specification. (Performance: Within specification, operates as intended)
Overall Comparison (Subject vs. Predicate)	The submission states: "These non-clinical performance tests of the Ulthera System demonstrated the modified console continues to operate as intended and that it is as safe and effective as its predicate for the proposed indications for use." (Performance: Demonstrates substantial equivalence, safety, and effectiveness compared to predicate)

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

This is not a clinical study involving a "test set" of patient data in the typical sense for AI/ML. The "testing" involves engineering and software validation on the device itself. Therefore, concepts like "sample size" for patient data and "data provenance" (country, retrospective/prospective) are not applicable here.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The ground truth for this device's performance is established by engineering specifications, regulatory standards compliance, and direct verification of the device's physical and software functions. There are no "experts" establishing ground truth in the context of interpreting medical images or clinical outcomes for a test set.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" of cases requiring adjudication by multiple readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for diagnostic devices where human reader performance (with or without AI assistance) is being evaluated relative to a reference standard. This device is an aesthetic treatment system, and the submission is for console modifications, not a new diagnostic algorithm.

6. If Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This is not an AI/ML diagnostic algorithm. The device has an "imaging mode" for visualization and user guidance (proper coupling, depth avoidance) but is fundamentally an energy delivery system for aesthetic treatment. Its performance is tied to its physical and software functions (power output, imaging capabilities, safety features), which were tested directly.

7. The Type of Ground Truth Used

The "ground truth" for the various tests were:

Engineering specifications and design requirements: For mechanical, electrical, and acoustic performance.
International standards (ISO, IEC, ASTM): For biocompatibility, electrical safety, EMC, usability, packaging, and transit.
FDA Guidance: For software verification and validation, and usability/human factors.
Predicate device's established safety and effectiveness: The ultimate "ground truth" for substantial equivalence is demonstrating that the modified device performs comparably to the legally marketed predicate.

8. The Sample Size for the Training Set

Not applicable. This device does not employ machine learning that would require a "training set" of data.

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

Not applicable, as there is no training set for machine learning.

Ask a Question

Ask a specific question about this device

K Number

K180623

Device Name

Ulthera System

Manufacturer

Ulthera, Inc

Date Cleared

2018-05-04

(56 days)

Product Code

OHV,IYO

Regulation Number

Type

Panel

Reference & Predicate Devices

K134032

Intended Use

The Ulthera® System is indicated for use as a non-invasive dermatological aesthetic treatment to:

· lift the eyebrow

• Ift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck regions

· improve lines and wrinkles of the décolleté

The Ulthera® System in conjunction with the Ulthera® DeepSEE transducer allows for ultrasonic visualization of depths up to 8 mm below the surface of the skin. The inaging is to visualize the dermal and subdermal layers of tissue to:

· ensure proper coupling of the transducer to the skin

· confirm appropriate depth of treatment such as to avoid bone

Device Description

The Ulthera® System consists of the Ulthera® Control Unit (with system software), a handpiece with cable, and interchangeable transducers. The device produces controlled tissue coagulation below the skin surface (epidermis) within the first few millimeters of tissue (dermis) using highly focused, low-energy ultrasound deposition. The Ulthera System directs micro-focused acoustic waves to the treatment area at desired depths without affecting or requiring a secondary action to protect the skin surface. The operator may also use the device's supplemental imaging capability to visualize the treatment area and aid in assuring full/proper skin contact of the Ulthera® System transducer to the skin in the target area.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Ulthera System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Primary Endpoint for "lifting lax submental (beneath the chin) and neck tissue": Improvement in lift, though specific quantitative metric for "improvement" is not defined, only that it refers to a lift of ≥20 mm².	- Quantitative Assessment: 51 out of 70 patients (72.9%) had an improvement of ≥20 mm² in lift.
Qualitative Assessment from Masked Evaluators: Improvement identified qualitatively.	- Qualitative Assessment: Of the 51 patients with ≥20 mm² lift, 84.3% were identified as showing improvement by masked evaluators.
Adverse Events: Mild, short-lived, and resolved without incident. No serious adverse events (SAEs) or unanticipated adverse device effects (UADEs).	- Adverse Events: Adverse events were mild, short-lived in duration, and resolved without incident. No serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) related to treatment.

2. Sample Size and Data Provenance

Test Set Sample Size: 70 patients.
Data Provenance: The document does not explicitly state the country of origin. It describes an "open-label clinical trial," which implies prospective data collection.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: The document mentions "masked evaluators" but does not specify the number of individuals.
Qualifications of Experts: Not provided. The term "masked evaluators" suggests they were independent of the treatment process.

4. Adjudication Method

The document mentions "masked evaluators" identifying improvement. It doesn't detail a specific adjudication method like 2+1 or 3+1 for resolving discrepancies, implying a single assessment per evaluator or a simple consensus if multiple evaluators were involved.

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

No MRMC study described for human readers with and without AI assistance. This study focuses on the device's direct clinical effect on patients. The device itself uses imaging as an aid for the operator, but the clinical trial evaluates the treatment outcome, not the efficacy of the AI component in guiding human readers.

6. Standalone (Algorithm Only) Performance Study

Not applicable/Not done. The Ulthera System is a therapeutic device that involves human operation. The performance assessed here is the clinical outcome of the treatment when performed by an operator, not a standalone algorithmic output. The "imaging" component is a visualization aid for the operator, not a diagnostic algorithm with standalone performance metrics.

7. Type of Ground Truth Used

Clinical Outcomes/Quantitative Measurement: The primary ground truth for the effectiveness of "lifting lax submental and neck tissue" was a quantitative assessment of lift (≥20 mm² improvement) and qualitative assessment by masked evaluators. Adverse events were also monitored as part of the safety profile.

8. Sample Size for the Training Set

Not applicable/Not provided. This document describes a clinical trial for an aesthetic treatment device. The "Ulthera System" itself is a device that generates focused ultrasound; it's not explicitly described as having an AI component that is "trained" in the typical machine learning sense to perform a task. If the "system software" (Version 1700) has an AI component that processes data and learns, the training set size is not disclosed in this document. The clinical study detailed is a validation study for the device's clinical efficacy for a new indication, not an AI model training or validation set.

9. How Ground Truth for Training Set Was Established

Not applicable/Not provided. As stated above, the document does not discuss the training of an AI model.

Ask a Question

Ask a specific question about this device

K Number

K134032

Device Name

Manufacturer

Date Cleared

2014-06-20

(171 days)

Product Code

OHV,IYO

Regulation Number

Type

Panel

Reference & Predicate Devices

K132028

Intended Use

The Ulthera® System is indicated for use as a non-invasive dermatological aesthetic treatment to:

lift the eyebrow
lift lax submental (beneath the chin) and neck tissue
improve lines and wrinkles of the décolleté

The Ulthera System in conjunction with the Ulthera DeepSEE transducer allows for ultrasonic visualization of depths up to 8 mm below the surface of the skin. The indicated use of the imaging is to visualize the dermal layers of tissue to:

ensure proper coupling of the transducer to the skin
confirm appropriate depth of treatment such as to avoid bone

Device Description

The Ulthera® System consists of the following components:
• Ulthera® Control Unit
• Handpiece
• Transducers

AI/ML Overview

The Ulthera® System, which uses focused ultrasound for aesthetic treatment, was evaluated for an expanded indication to improve lines and wrinkles of the décolleté.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and the Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Primary Endpoint: Improvement in lines and wrinkles of the décolleté as evaluated by a masked assessment of pre and post-treatment photographs. (Note: No pre-specified success criteria were established for this primary endpoint at the beginning of the trial due to issues with the initial Fabi-Bolton Scale validation).	36 out of 54 evaluable subjects (~67%) showed improvement by masked assessment of pre- and post-treatment photographs at 180 days post-treatment.
Safety: No serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) related to the treatment.	No SAEs or UADEs related to treatment were reported. All adverse events were mild, with the exception of two moderate events (one of which was not device-related), and all resolved.
Treatment Efficacy at Specific Energy Levels: Efficacy achieved at Level 4 for 7-3.0 and 4-4.5 transducers, and Level 3 for 10-1.5 transducer.	Treatment efficacy was achieved at the pre-set energy levels: Level 4 for the 7-3.0 and 4-4.5 transducers, and Level 3 for the 10-1.5 transducer.

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

Sample Size for Test Set:
- Initial Enrollment: Up to 130 female subjects.
- Subjects Completing Protocol: 108 subjects.
- Evaluated Photo Sets (Test Set): 54 subjects. This subset was chosen as their day 180 photos were identified as "most consistent in photo quality" after excluding 54 photos with inconsistencies.
Data Provenance: The study was a prospective safety and efficacy study. The document does not specify the country of origin of the data, but the submission is to the US FDA, implying it was conducted to meet US regulatory requirements.

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

The document mentions "masked assessment of pre and post treatment photographs" but does not specify the number or qualifications of the experts who performed this masked assessment. It also states that the initial Fabi-Bolton Scale, a published validated scale, could not be successfully validated during the clinical trial due to low kappa scores for both intra-rater and inter-rater reproducibility, leading to the change in primary endpoint to a post-hoc masked assessment.

4. Adjudication Method for the Test Set:

The document mentions "masked assessment," which implies multiple raters, but it does not explicitly state the adjudication method used to arrive at the final assessment (e.g., 2+1, 3+1, majority vote, etc.). The mention of inter-rater reproducibility issues with the Fabi-Bolton scale suggests that inter-rater agreement was a consideration, but the method for resolving discrepancies in the masked assessment is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not conducted or reported. This study evaluates the device's direct clinical effect on patients, not the performance of an AI algorithm assisting human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. The Ulthera® System is a medical device for treatment, not an AI algorithm for diagnostic interpretation in a standalone context. The "performance data" refers to the clinical outcomes of patients treated with the device.

7. The Type of Ground Truth Used:

The ground truth for the expanded indication of improving lines and wrinkles on the décolleté was established through:

Expert Consensus (implied): "Masked assessment of pre and post treatment photographs." While not explicitly stated as "consensus," this type of assessment by presumably trained evaluators serves as the "ground truth" for visual improvement.
Clinician Global Aesthetic Improvement Scores (CGAIS): An unmasked assessment performed by clinicians.
Patient Satisfaction Questionnaires: Patient-reported improvement.

The primary endpoint shifted to the masked assessment due to issues with the initial validated scale.

8. The Sample Size for the Training Set:

This information is not provided in the document. The study described is a clinical trial to evaluate the device's effectiveness, not an AI model's development. Therefore, there isn't a "training set" in the context of machine learning. The "training" for this device would refer to the development and engineering process, which is not detailed in terms of data sets.

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

Not applicable, as there is no mention of a "training set" for an AI algorithm in this context. The study focuses on evaluating the clinical performance of the Ulthera® System treatment itself.

Ask a Question

Ask a specific question about this device

K Number

K132028

Device Name

Manufacturer

Date Cleared

2013-12-11

(163 days)

Product Code

OHV,IYO

Regulation Number

Type

Panel

Reference & Predicate Devices

K121700,K983945

Intended Use

The Ulthera System is indicated for use as a non-invasive dermatological aesthetic treatment to:

lift the eyebrow .
lift lax submental (beneath the chin) and neck tissue .

. ensure proper coupling of the transducer to the skin
confirm appropriate depth of treatment such as to avoid bone .

Device Description

The Ulthera System consists of the following components:

. Ulthera Control Unit
Handpiece .
Transducers .

AI/ML Overview

The provided text describes an FDA 510(k) summary for the Ulthera® System. However, it explicitly states:

"No new performance testing was performed to support the new Performance Data: indications. There have been no changes to previously cleared device (K121700, Ulthera® System) that would result in a new 510(k). Imaging capabilities of the Ulthera® System have been included in the device's profile since the original clearance. Clinical literature and ultrasound images were provided."
"There have been no changes to previously cleared Ulthera® System Conclusion: (K121700) that would result in a new 510(k)."

This means that this specific submission (K132028) did not conduct a new study to prove acceptance criteria because it's a re-submission for minor changes or clarifications, not new performance claims. The device relies on its previous clearances (K121700 and K072505 for the Ulthera System, and K983945 for the predicate device DermaScan C) for performance data.

Therefore, a detailed table of acceptance criteria and reported device performance from this specific document against a new study is not available. The document asserts substantial equivalence to predicate devices based on design, materials, principle of operation, and intended use, and provides no new performance data or study details for the current submission.

Summary based on the provided document:

Table of Acceptance Criteria and Reported Device Performance: This document does not present new acceptance criteria or reported device performance data from a new study. It relies on the performance proven for the predicate devices and prior clearances of the Ulthera System.
Sample Size and Data Provenance for Test Set: Not applicable for this submission as no new performance testing was conducted.
Number and Qualifications of Experts for Ground Truth: Not applicable for this submission as no new performance testing was conducted.
Adjudication Method for Test Set: Not applicable for this submission as no new performance testing was conducted.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable for this submission. The document doesn't mention any MRMC study.
Standalone Performance Study: Not applicable for this submission as no new performance testing was conducted.
Type of Ground Truth Used: Not applicable for this submission as no new performance testing was conducted.
Sample Size for Training Set: Not applicable for this submission as no new machine learning algorithm development requiring a training set is described.
How Ground Truth for Training Set Was Established: Not applicable for this submission.

Conclusion from the document:
The Ulthera System's imaging subsystem is considered equivalent to the predicate device, DermaScan C (K983945), in terms of "patient contact material biocompatibility, electromagnetic compatibility, and medical electrical safety standards" as well as "general specifications, device settings and intended use." This equivalence forms the basis of its clearance for the stated indications without the need for new performance studies in this specific 510(k) submission.

Ask a Question

Ask a specific question about this device

K Number

K121700

Device Name

Manufacturer

Date Cleared

2012-10-02

(117 days)

Product Code

OHV

Regulation Number

Type

Panel

Reference & Predicate Devices

K072505

Intended Use

The Ulthera® System is indicated for use as a non-invasive dermatological aesthetic treatment to:

lift the eyebrow .
lift lax submental (beneath the chin) and neck tissue .

Device Description

The Ulthera System consists of the following components: Ulthera® Control Unit . Handpiece . . Transducers

AI/ML Overview

The Ulthera System was evaluated in an open-label clinical trial to support an expanded indication for lifting lax submental (beneath the chin) and neck tissue.

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

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Metric	Reported Device Performance
Improvement in lift	51 out of 70 patients (72.9%) had an improvement of ≥20 mm² in lift. Among these, 84.3% were identified as showing improvement by masked evaluators.
Safety	Adverse events were mild, short-lived, and resolved without incident. No serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) were reported.
Patient Satisfaction (Qualitative Assessment)	Used as an evaluation method, but specific performance metrics are not detailed in the provided text.

Important Note: The provided document is a 510(k) summary, which often provides a high-level overview. A full clinical study report would contain more detailed acceptance criteria and specific statistical thresholds for primary and secondary endpoints. For example, it's not explicitly stated what percentage of patients with ≥20 mm² lift was required for acceptance; only the observed performance is given.

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

Sample Size: 70 patients.
Data Provenance: The document does not explicitly state the country of origin. It indicates it was an "open-label clinical trial," which implies a prospective study.

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

Number of Experts: Not explicitly stated. The document mentions "masked evaluators" identified improvement in 84.3% of patients with ≥20 mm² lift. The exact number of these evaluators and their qualifications (e.g., dermatologists, plastic surgeons, years of experience) are not provided in this summary.

4. Adjudication Method for the Test Set

The document mentions "masked evaluators" were used, but it does not specify an adjudication method (e.g., 2+1, 3+1, none) for disagreements among these evaluators. This detail would typically be in a full clinical study protocol.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study that assesses human readers' improvement with AI vs. without AI assistance was not conducted. This study is evaluating the device's direct clinical effect, not an AI's impact on human interpretation.

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

Yes, in a sense, a standalone evaluation was done for the device's direct clinical effect. The "Improvement was evaluated through quantitative assessment, qualitative assessment and patient satisfaction questionnaires." This is an assessment of the device's performance in situ on patients, which is analogous to a standalone performance from the device's perspective, without requiring human interpretation of output from the device. However, it's not an AI algorithm being evaluated in isolation.

7. The Type of Ground Truth Used

The ground truth was established through a combination of quantitative assessment (≥20 mm² in lift, likely measured objectively by a physician or imaging) and qualitative assessment by "masked evaluators." This suggests a blend of objective measurement and expert visual assessment. Patient satisfaction questionnaires also contributed to the overall evaluation of improvement.

8. The Sample Size for the Training Set

Not Applicable / Not Provided. This study describes a clinical trial evaluating the therapeutic effect of the Ulthera System, not the performance of an AI algorithm that would typically require a training set. The Ulthera System is a focused ultrasound stimulator, not an AI diagnostic tool.

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

Not Applicable / Not Provided. As this is not an AI algorithm study, there is no "training set" or ground truth establishment method for a training set described.

Ask a Question

Ask a specific question about this device

K Number

K122528

Device Name

Manufacturer

Date Cleared

2012-08-28

(8 days)

Product Code

OHV

Regulation Number

Type

Panel

ULTHERA SYSTEM, MODEL 8850-0001

Reference & Predicate Devices

K072505

Intended Use

The Ulthera" System is indicated for use as a non-invasive dermatological aesthetic treatment to: lift the eyebrow.

Device Description

The Ulthera® System consists of the following components:
● Ulthera® Control Unit
● Handpiece
● Transducers

AI/ML Overview

The Ulthera® System, K122528, is indicated for use as a non-invasive dermatological aesthetic treatment to lift the eyebrow. The submission discusses an accelerated aging study to support the extension of the shelf life for the Ulthera® System Transducers from six months to one year. This study aimed to demonstrate that the transducers would continue to meet performance criteria over the extended shelf life.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Maintain "technological characteristics" over 12 months	Transducers met predetermined acceptance criteria in performance testing after accelerated aging.
Maintain "performance criteria" over 12 months	Transducers met predetermined acceptance criteria in performance testing after accelerated aging.
No detrimental effect on transducer functionality over 12 months	Twelve-month shelf life study demonstrated no detrimental effect on transducer functionality.
No detrimental effect on patient safety over 12 months	Twelve-month shelf life study demonstrated no detrimental effect on patient safety.
No detrimental effect on efficacy over 12 months	Twelve-month shelf life study demonstrated no detrimental effect on efficacy.

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

The document mentions an "accelerated aging study (per ASTM Standard F 1980 (2011))" and "performance testing protocol," but does not specify the sample size of transducers tested or the number of units used in the accelerated aging study.
The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective, beyond being a study conducted to support the shelf life extension.

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

This information is not provided in the document. The study described is a technical performance test of the device's shelf life, not a clinical study involving human assessment of ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable as the relevant study is a technical performance test, not a clinical study requiring human adjudication for ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The provided document concerns a shelf life study for device transducers, not an assessment of human reader performance with or without AI assistance.

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

Not applicable. This is a shelf life study for a physical device (transducers), not an algorithm.

7. The Type of Ground Truth Used:

For the shelf-life study, the "ground truth" was the predetermined acceptance criteria identified in the performance testing protocol. These criteria would likely be objective measurements related to the transducers' physical and functional characteristics (e.g., ultrasonic output, structural integrity, electrical performance) that are defined in technical specifications rather than based on expert clinical consensus, pathology, or outcomes data, which are typical for diagnostic or therapeutic efficacy studies.

8. The Sample Size for the Training Set:

Not applicable. The provided information relates to a device's shelf life, not a machine learning algorithm that requires a training set.

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

Not applicable. As above, this document does not describe a machine learning study.

Ask a Question

Ask a specific question about this device

K Number

DEN080006

Device Name

Manufacturer