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Rho is a software application intended for use opportunistically with standard frontal radiographs of the lumbar spine, thoracic spine, chest, pelvis, knee, or hand/wrist performed in patients aged 50 years and older. Rho provides a notification in the form of a report to aid radiologists and/or physician interpreters in identifying patients with possible low bone mineral density (BMD) at L1-L4 or the femoral neck to prompt a clinical assessment of bone health. Rho should not be used to rule out low BMD. Radiologists and referring clinicians should follow recommended practices for screening and assessment, regardless of the absence of Rho report.

Rho is a machine learning-based software-as-a-medical device that interfaces with institutional Picture Archiving and Communications Systems (PACS) to identify patients 50 years and older undergoing x-ray with possible low bone mineral density (BMD). Eligible x-rays are frontal projections of the lumbar spine, thoracic spine, chest, pelvis, knee or hand/wrist. Rho uses the xray DICOM and DICOM tags of age and sex as inputs into a locked machine learning algorithm. The locked machine learning algorithm is trained on a patient-based dataset (True North Imaging. TNI13). The algorithm presents a binary output to indicate whether or not the patient likely has low BMD at either the femoral neck or L1-L4. A Rho Report is generated for positive cases that can be sent back to the PACS for physician interpretation or viewed through a browser-based interface.

Radiologists can choose to include this finding in their report to the referring physician. Inclusion may trigger a referring physician to conduct a clinical fracture risk assessment related to bone health.

For cases where Rho algorithm outputs a negative result, no Rho Report will be sent, and neither the radiologist nor the referring physician will receive any device output.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

• Overall:

  • TNI: 0.90 (0.88-0.92)
  • OMN: 0.93 (0.90-0.96)
  • OAI: 0.94 (0.92-0.96)

• Most subgroups (specificity generally above 0.85).

• Lowest reported specificity:

  • Hand/wrist (OMN): 0.81 (0.67-0.95)
  • 80+ (TNI): 0.71 (0.62-0.80) | Met for all datasets and all subgroups, as per statement.

• Overall:

  • TNI: 0.88 (0.88-0.90)
  • OMN: 0.85 (0.82-0.88)
  • OAI: 0.82 (0.79-0.85)

• Most subgroups (AUC generally above 0.80).

• Lowest reported AUC:

  • Hand/wrist (OMN): 0.73 (0.61-0.85)
  • 50-59 (OAI): 0.77 (0.70-0.84)
  • Hand/wrist (OAI): 0.77 (0.70-0.82)
  • 70-79 (OAI): 0.78 (0.72-0.83)
  • Males (OAI): 0.79 (0.75-0.84) | Not met for all datasets and some subgroups.

Original goal: Lower end of the two-sided 95% confidence interval of sensitivity >0.5 (for TN16 and OMN cohorts).

• Overall:
  • TNI: 0.67 (0.66-0.69) - Met
  • OMN: 0.45 (0.41-0.50) - Not Met
  • OAI: 0.36 (0.31-0.41) - Not Met
• **Specific Subgroups with Sensitivity 0.775 and lower end of the two-sided 95% confidence interval of sensitivity >0.5 for the TN16 and OMN cohorts. However, the final device performance across all analysis groups did not meet those goals." It then immediately states, "The device met its performance goals of specificity and AUC in all three datasets." This implies the final accepted performance goals were a high specificity and meeting the AUC goal, despite not fully meeting the originally proposed sensitivity goal. The approval indicates the FDA found the benefit-risk acceptable given the high specificity and AUC, and the context of use where low sensitivity is mitigated because patients continue to receive standard of care.

Study Information:

1. A table of acceptance criteria and the reported device performance: (See table above)

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

   • Total Clinical Validation Set: 4842 cases (3729 TNI6 + 522 OMN + 591 OAI).
   • Data Provenance:
     • TNI6 (Clinical Validation Set): 3729 cases from six True North Imaging centers, Canada (retrospective).
     • OMN (Clinical Validation Set): 522 US cases from OneMedNet (retrospective).
     • OAI (Clinical Validation Set): 591 US cases from Osteoarthritis Initiative, a multicenter, longitudinal, prospective observational study of knee osteoarthritis. This data was "previously acquired," suggesting it was used retrospectively for this device validation.

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

   • The text does not mention the use of experts for ground truth establishment.
   • Ground truth was established by Dual Energy X-ray Absorptiometry (DXA).

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

   • Not applicable, as the ground truth was established by DXA, not by human experts requiring 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:

   • No MRMC comparative effectiveness study was done to assess human reader improvement with AI assistance. The study described is a standalone (algorithm only) performance study against a ground truth. The device is intended to "aid radiologists and/or physician interpreters" but its direct impact on human reader performance was not evaluated in this study.

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

   • Yes, a standalone performance study was done. The described clinical performance testing directly evaluates the algorithm's Sensitivity, Specificity, and AUC as a binary classifier (yes/no low BMD) against the DXA ground truth.

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

   • Ground Truth: Dual Energy X-ray Absorptiometry (DXA).
   • Definition of Low BMD: At least one of the femoral necks or L1-L4 vertebrae having a T-Score

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Rhondium One-Visit-Crown is intended for restoration of permanent teeth with a single unit crown.

Rhondium One-Visit-Crown (OVC) is a hybrid ceramic crown consisting of a fully-cured anatomical occlusal layer and an uncured sub-layer that allows customization of the OVC to the tooth preparation. When finished, the customized OVC is bonded to a prepared natural tooth. The OVC is for restoring structurally compromised posterior teeth in cases normally restored with an onlay or a partial crown in a single dental visit. The OVC is selected based on tooth location and size and therefore no impressions are necessary. The OVC is provided in designs for the upper and lower first and second premolars and the first and second molars, and each design is provided in six (6) sizes (extra-small (XS), small (S), medium (M), large (L), extra-large (XL), and extra-extra-large (XXL)). The OVC is made from a ceramic tooth shade resin material, and is provided nonsterile for single use only.

Accessories to the OVC Device include the OVC Replica, an exact replica of the cured (occlusal layer) portion of the OVC. The OVC Replica is used to confirm that sufficient occlusal clearance was obtained during tooth preparation and to provide direct visualization of the overall 3D position of the OVC on the prepared tooth and the relationship with adjacent and opposing dentition. The OVC Replica is manufactured from vinyl polysiloxane impression material. OVC Wedges are accessories provided in four configurations (small right, large left and large right), and are placed interproximally to create a working surface and to block out undercuts of the preparation. The Wedges are manufactured from polyacetal resin. The Selector Keys are accessories that allow the clinician to measure the mesial-distal distance in order to choose the appropriate size OVC for the restoration, and are used during the curing of the uncured resin to prevent disturbing the placement of the crown. The Selector Keys are manufactured from polycarbonate resin. All accessories are provided nonsterile for single use only.

The provided document describes a 510(k) premarket notification for a dental device, the Rhondium One-Visit-Crown (OVC). This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than de novo clinical studies with acceptance criteria in the context of diagnostic performance metrics like sensitivity and specificity.

Therefore, the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not directly applicable to this document. This submission focuses on non-clinical performance and a comparison of technological characteristics to establish equivalence.

Here's a breakdown of the performance data and equivalence demonstration, addressing the relevant points from your request:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, there are no "acceptance criteria" in the sense of predefined diagnostic performance thresholds (e.g., sensitivity, specificity). Instead, the device demonstrates substantial equivalence through a series of non-clinical tests and a comparison of its technological characteristics to a predicate device.

The document lists the following performance tests and their purpose:

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

This document does not describe a "test set" in the context of diagnostic performance evaluation. The performance data discussed are from non-clinical laboratory tests. Therefore, information about sample sizes for a test set and data provenance (country of origin, retrospective/prospective) for clinical data is not applicable here.

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

This information is not applicable. The device is a physical dental restoration, not an AI/diagnostic tool requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not applicable, as there is no "test set" in the context of human interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is a physical dental material, not an AI-assisted diagnostic system.

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

This is not applicable, as the device is a physical dental restoration, not an algorithm.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, outcomes data) is not directly applicable here. For the non-clinical tests, the "ground truth" would be the scientifically established physical or biological properties of the materials as measured by standardized testing methods. For the substantial equivalence argument, the "ground truth" is the established safety and effectiveness of the predicate device (K072733).

8. The Sample Size for the Training Set

This is not applicable. The device is a manufactured product; it does not involve AI algorithms that require training sets.

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

This is not applicable for the reasons mentioned above.

In summary:

The provided document is an FDA 510(k) summary for a dental restorative device. It establishes substantial equivalence through non-clinical performance testing of the device's material properties (shelf life, biocompatibility, mechanical strength, depth of cure) and a detailed comparison of its technological characteristics with a legally marketed predicate device. The performance data demonstrate that the device meets the necessary safety and effectiveness criteria for its intended use, analogous to how an AI device would meet acceptance criteria, but through different types of evidence.

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Rhodia Bite Registration Material is intended for taking impressions of the biting surfaces of the teeth used to set gypsum casts in the correct occlusal relationship when the casts are mounted on an articulator.

The device is a two-part vinyl polysiloxane paste with an addition-cure reaction. The base and catalyst pastes are extruded from dual-barrel cartridges through a mixing tip onto a tray. The material quickly cures into a rigid impression.

The provided text describes a 510(k) notification for Rhodia Bite Registration Material, a dental impression material. It does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document focuses on:

• Device Identification: Proprietary name, common name, product code, manufacturer, and contact information.
• Device Description: Two-part vinyl polysiloxane paste for taking impressions of biting surfaces to set gypsum casts.
• Substantial Equivalence Claim: The device is claimed to be substantially equivalent to preamendment vinyl polysiloxane dental impression materials and was tested according to existing guidance.
• FDA Clearance Letter: Confirmation of 510(k) clearance and the regulatory framework.
• Indications for Use: The intended purpose of the device.

Therefore, I cannot fulfill your request for the following sections as the information is not present in the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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Rhodia Putty Dental Impression Materials are intended for use for first impression in the technique of double impression.

Rhodia Putty is used for first impression in the technique of the double impression. It can be used with perforated and non-perforated trays constructed of metal or plastic. The device is a two-part vinyl polysiloxane putty with an addition-cure reaction. The base and catalyst components are mixed together prior to creating an impression.

The provided text describes a 510(k) premarket notification for a dental impression material, Rhodia Dental Putty Impression Material. However, it does not contain the specific details required to answer your questions regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

The document states that the device "has been tested according to the criteria established in the Guidance Document, 'Dental Impression Materials-Premarket Notification'". This implies that there are established performance standards and testing methodologies for dental impression materials that the device has met. However, the document does not elaborate on what those criteria are, what the reported performance was, or any of the specific details about the study.

Therefore, I cannot provide the requested table, sample sizes, expert details, or ground truth information from this document. The information focuses on regulatory approval and substantial equivalence to pre-amendment devices, rather than a detailed performance study report.

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Rhodia hydrophilic dental impression materials are intended for use with PUTTY set for second impression (impression of correction) in the technique of double impression.

Rhodia hydrophilic dental impression material is intended for use for making intra-oral impressions. The device is a two-part vinyl polysiloxane paste with an addition-cure reaction. The base and catalyst pastes are extruded from dual-barrel cartridges through a mixing tip onto the surfaces of the teeth or onto a tray. The material quickly cures into a rigid impression. The hydrophilic property of the dental impression material helps to capture and reproduce perfect detail even in a moist environment.

This document is a 510(k) summary for the Rhodia Hydrophilic Dental Impression Material. It does not contain the detailed study information generally required to describe acceptance criteria and device performance in the way you're requesting for a medical device that claims diagnostic or prognostic capabilities based on specific performance metrics like accuracy, sensitivity, or specificity.

Dental impression materials are typically evaluated against physical and chemical properties and their ability to accurately replicate oral structures. The provided text indicates the device has been tested according to the criteria established in the Guidance Document, "Dental Impression Materials-Premarket Notification". However, it does not list specific acceptance criteria or report device performance data in terms of those criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details on sample sizes, ground truth establishment, expert involvement, or comparative effectiveness studies related to diagnostic accuracy, as this information is not present in the provided 510(k) summary.

The 510(k) process for this type of device primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device based on its intended use, technological characteristics, and safety and effectiveness, often through adherence to recognized standards for materials.

Based on the provided text, the following information can be extracted:

• Device Name: Rhodia Hydrophilic Dental Impression Material
• Intended Use: For making intra-oral impressions, specifically for "PUTTY set for second impression (impression of correction) in the technique of double impression."
• Device Type: Two-part vinyl polysiloxane paste with an addition-cure reaction.

The following information cannot be extracted from the provided text, as it's not relevant to this type of device's 510(k) submission or is simply not present:

• A table of acceptance criteria and reported device performance (in terms of specific quantitative metrics like accuracy, sensitivity, etc., which are not typically defined for impression materials in a 510k summary).
• Sample sizes used for a "test set" in the context of diagnostic accuracy.
• Data provenance.
• Number of experts used to establish ground truth.
• Qualifications of experts.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study information.
• Standalone (algorithm only) performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

Summary of what can be gleaned about the study/testing:

The submission states: "Rhodia dental impression material is substantially equivalent to preamendment vinyl polysiloxane dental impression materials and has been tested according to the criteria established in the Guidance Document, "Dental Impression Materials-Premarket Notification"."

This indicates that testing was performed to demonstrate compliance with a recognized guidance document for dental impression materials. This testing would typically involve evaluating physical and chemical properties relevant to impression materials (e.g., tear strength, dimensional stability, working time, setting time, contact angle for hydrophilicity), rather than diagnostic accuracy. The specific results of these tests and the acceptance criteria are not detailed in this 510(k) summary.

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