Rapid ICH is a radiological computer aided triage and notification software in the analysis of non-enhanced head CT images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive findings of pathologies in head CT images, for IPH, IVH, SAH, and SDH Intracranial Hemorrhages (CH).

Rapid ICH uses an artificial intelligence algorithm to analyze images and highlight cases with detected ICH on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected ICH findings. Notifications include compressed preview images, which are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not is a a diagnostic device.

The results of Rapid ICH are intended to be used in conjunction and based on professional judgment, to assist with trage /prioritization of medical images. Notified radiologists are responsible for viewing full images per the standard of care.

Rapid ICH is a radiological computer-assisted triage and notification software device. The Rapid ICH module is a non-enhanced CT (NCCT) processing module which operates within the integrated Rapid Platform to provide triage and notification of suspected intracranial hemorrhage. The Rapid ICH module is an AI/ML module. The output of the module is a priority notification to clinicians indicating the suspicion of ICH based on positive findings. The Rapid ICH module uses the basic services supplied by the Rapid Platform including DICOM processing, job management, imaging module execution and imaging output including the notification and compressed image.

Here's a breakdown of the acceptance criteria and study details for the Rapid ICH device, based on the provided text:

Acceptance Criteria and Device Performance

The primary performance goals for Rapid ICH were defined by sensitivity and specificity thresholds.
Acceptance Criteria Table and Reported Device Performance:

Study Details

2. Sample Size and Data Provenance:

• Test Set Sample Size: 314 cases (148 ICH positive, 166 ICH negative).
• Data Provenance: Retrospective, multicenter, multinational study. Specific countries are not detailed, but "multinational" implies diverse geographical origins.

3. Number of Experts and Qualifications for Ground Truth:

• Number of Experts: Not explicitly stated how many individual experts established the ground truth. The document mentions "expert reader truthing of the data," suggesting one or more experts.
• Qualifications of Experts: The document states "trained radiologists" are intended users and mentions "expert reader truthing." However, specific qualifications such as years of experience, board certification, or subspecialty are not provided for the ground truth experts.

4. Adjudication Method for the Test Set:

• The document implies ground truth was established by "expert reader truthing of the data," but does not specify an adjudication method (e.g., 2+1, 3+1, consensus review process if multiple readers were involved).

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

• No, an MRMC comparative effectiveness study was NOT mentioned for evaluating human readers' improvement with AI assistance. The study focused on the standalone performance of the AI algorithm (accuracy) and the time-to-notification benefit.

6. Standalone Performance (Algorithm Only):

• Yes, a standalone performance study was done. The reported sensitivity, specificity, and AUC values directly reflect the algorithm's performance in identifying ICH presence. The study evaluated the software's performance in identifying abnormalities, and the "time to notification" indicates the speed of the algorithm's output.

7. Type of Ground Truth Used:

• Expert Consensus: The ground truth for the test set was established through "expert reader truthing of the data." This implies a clinical expert (radiologist) determined the presence or absence of ICH.

8. Sample Size for the Training Set:

• The document states that the "minor change causing this filing, is the use of additional data for training and validation," implying the training set for this iteration of the device included more data than the predicate. However, the specific sample size of the training set is not provided in the summary.

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

• Similar to the test set, the document indicates that the device was trained and validated using "retrospective case data based on expert reader truthing of the data." This suggests the ground truth for the training set was also established by expert review/diagnosis by clinical experts.

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RAPID ICH is a radiological computer aided triage and notification software indicated for use in the analysis of nonenhanced head CT images.

The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive findings of pathologies in head CT images, namely Intracranial Hemorrhage (ICH). RAPID ICH uses an artificial intelligence algorithm to analyze images and highlight cases with detected ICH on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected ICH findings. Notifications include compressed preview images, that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.

The results of RAPID ICH are intended to be used in conjunction with other patient information and based on professional judgment, to assist with triage /prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.

RAPID ICH is a clinical module which operates within the integrated RAPID Platform to provide triage and notification of suspected intra-cranial hemorrhage (ICH). The RAPID ICH module consists of the core RAPID Platform software which provides the administration and services for the RAPID; and the RAPID ICH module which functions as one of many image processing modules hosted by the platform.

The RAPID platform is a software package that provides for the visualization and study of changes in tissue using digital images captured by diagnostic imaging systems including CT (Computed Tomography), CTA, XA3D and MRI (Magnetic Image Resonance), as an aid to physician diagnosis. RAPID can be installed on a customer's Server or it can be accessed online as virtual system. It provides viewing, quantification, analysis and reporting capabilities. The RAPID platform has multiple modules a clinician may elect to run and provide analysis for decision making.

RAPID ICH provides an automatic analysis of received NCCT scan data for the triage and notification of ischemic hemorrhage (ICH). The application is selected via DICOM encoding which is processed by the DICOM handler within the RAPID Platform. Once the DICOM server identifies the selected ICH processing modality, the Job Manager initiates image processing using the ICH Module.

Upon processing a case with suspicion of ICH, the clinical team is notified via messaging, the case has a suspicion of ICH. The notifications are sent to the PACS/Workstation, via email and to a mobile application. The notification provides the attending clinical team physician that suspicion of hemorrhage has been identified and immediate attention to the case should be given. The messaging provides notification and compressed image data of the case. The compressed preview is informational only and labeling identifies it as not to be used for diagnostic use and to review the data within the PACS/Workstation prior to making any diagnostic decisions. No additional information markings are added to the case.

The notifications are pop-up messages or email with the appropriate case information and suspicion or non-suspicion of ICH labelled. In all cases, the normal standard of care workflow is adhered to, this ensures the case is still reviewed when non-suspicion is determined.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for RAPID ICH:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and the Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: 336 cases
• Data Provenance: Retrospective, blinded, multicenter, multinational study.
  • Countries of Origin: US (4 Sites and 1 Multisite Study) and OUS (1 site, 1 multisite).
  • Nature of Study: Retrospective.
• Case Distribution: Approximately an equal number of positive cases (images with ICH) and negative cases (images without ICH) were included in the analysis.

3. Number of Experts and Qualifications for Ground Truth

The document states "reader truthing of the data" was used, but it does not explicitly state the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") for establishing the ground truth of the test set.

4. Adjudication Method for the Test Set

The document mentions "reader truthing," but it does not specify the adjudication method used (e.g., 2+1, 3+1, none) for the test set.

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

No MRMC comparative effectiveness study was done or reported. The study focused on the standalone performance of the AI algorithm. Therefore, there is no information on how human readers improve with AI vs without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone (algorithm only) performance study was conducted. The entire "Performance Data" section describes the RAPID ICH software's ability to identify ICH independently, reporting its sensitivity and specificity.

7. Type of Ground Truth Used

The ground truth for the test set was established through "reader truthing of the data." This implies expert consensus or expert interpretation as the basis for ground truth, rather than pathology or outcomes data.

8. Sample Size for the Training Set

The document does not explicitly state the sample size used for the training set. It only mentions that the device uses a "deep learning algorithm trained on medical images."

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

The document does not explicitly detail how the ground truth for the training set was established. It generally states the algorithm was "trained on medical images," implying that these images were annotated or labeled with ground truth information (e.g., presence or absence of ICH) by experts, but the process or expert involvement is not described.

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Cryopreservation device intended to be used to contain, vitrify and maintain human embryos and/or oocytes (MI).

Rapid-i™ Kit is a modified version of the predicate device (K140207). This device is a cryopreservation storage device intended for embryo/oocyte vitrification. Rapid-i™ Kit is provided sterile and is for single-use only. This device consists of the following items:

• Rapid-i Stick – A 80 mm long Polymethyl methacrylate (PMMA) stick with a 0.4 mm diameter hole located near the distal tip of the device. The hole on the stick is used to hold one to five embryos or oocytes for vitrification in a 30 nL drop of vitrification medium. Users suspend samples across the hole via surface tension. Therefore, the medium containing the samples only touches the periphery of the hole. The stick has one flat side that aids in correct orientation of the device during oocyte/embryo loading procedures.
• RapidStraw A 130 mm long Mediprene straw equipped with a stainless steel weight to maintain device orientation in liquid nitrogen (LN). The straw has a flared open end to allow for insertion of the Rapid-i Stick. This component functions as a protective sleeve around the Rapid-i Stick to prevent direct contact with LN during loading and after sealing the open end with an ultrasonic sealing device.
• Stainless steel rod - This 115 mm long stainless steel rod resides within RapidStraw during pre-cooling procedures in LN. It aids in keeping RapidStraw straight in LN during pre-cooling. Rod removal occurs 20-30 seconds prior to Rapid-i Stick loading into the RapidStraw.

Here is a breakdown of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided FDA 510(k) summary for the Rapid-i™ Kit (K181461).

Acceptance Criteria and Reported Device Performance

The device is a cryopreservation system for human embryos and oocytes. The acceptance criteria are implicitly tied to maintaining the viability and developmental potential of these biological materials after cryopreservation, demonstrated through various post-thaw outcomes.

Study Details:

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

   • 2PN Embryos:

     • N = 1618 vitrified 2PN embryos.
     • N = 510 embryo transfers (418 transfers for embryos cultured 1-3 days, 92 transfers for embryos cultured 4-5 days).
     • Data provenance: Not explicitly stated beyond "Data from clinical studies using the Rapid-i™ Kit were used..." This suggests it could be retrospective collection from fertility clinics where the device was in use, but without further detail, it's difficult to confirm. The document does not specify country of origin for this particular dataset.
     • Study type: Prospective or retrospective collection based on the wording "Data from clinical studies." It is not described as a controlled clinical trial.

   • Oocytes:

     • Study 1: N = 593 vitrified oocytes; N = 54 blastocyst stage embryo transfers.
     • Study 2: Data on survival, fertilization rates, and N = 40 embryo transfers. (Exact N of vitrified oocytes not stated for this study, only percentages).
     • Published Article (Gook et al. 2016): N = 413 vitrified oocytes; N = 44 embryo transfers.
     • Data provenance: Similar to 2PN embryos, "Data from clinical studies." The published article indicates a clinical setting. The Gook et al. 2016 paper is from Australia. Thus, at least some of the oocyte data likely originates from Australia.
     • Study type: Prospective or retrospective collection from clinical practice.

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

   • This is a medical device for assisted reproduction purposes. The "ground truth" (i.e., successful cryopreservation, pregnancy outcomes) is established through standard clinical and laboratory procedures performed by trained embryologists, reproductive endocrinologists, and other healthcare professionals in fertility clinics. This is not a diagnostic device where image interpretation by experts creates a "ground truth." The outcomes (survival, fertilization, pregnancy) are objective biological results.
   • Therefore, the concept of "experts used to establish ground truth" in the way it applies to AI diagnostic tools (e.g., radiologists annotating images) is not directly applicable here. The data points themselves (e.g., number of embryos surviving, number of pregnancies) are the ground truth, generated by the normal operations of an IVF clinic.

3. Adjudication method for the test set:

   • Not applicable in the context of this type of device and study design. Adjudication methods like "2+1" are typically used for establishing ground truth in diagnostic studies where there might be inter-reader variability in interpreting data (e.g., medical images). Here, the outcomes measured are direct biological results.

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:

   • No. This is not an AI-assisted diagnostic device that involves human readers interpreting output. It is a cryopreservation device. The study is evaluating the device's performance in preserving reproductive cells, not assisting human interpretation.

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

   • Not applicable. This is a physical medical device (cryopreservation kit), not an algorithm or software. Its performance is inherent to its design and material properties in facilitating the cryopreservation process. Human interaction is required for its use (loading, vitrifying, warming).

6. The type of ground truth used:

   • Clinical Outcomes and Biological Performance Markers: The ground truth is established by the observed biological outcomes of human embryos and oocytes after being processed with the device. This includes:
     • Survival rates post-warming.
     • Fertilization rates for oocytes.
     • Developmental rates (cleavage, blastulation) for embryos.
     • Clinical pregnancy rates following embryo transfer (which are typically confirmed by ultrasound).
   • For non-clinical tests, ground truth was established by laboratory standards and assays (e.g., bacterial endotoxin testing, mouse embryo assay).

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set. The "training" for such a device would be its iterative design and manufacturing process, combined with quality control and verification, rather than a data-driven training set in the AI sense.

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

   • Not applicable, as no training set was used for an AI/machine learning model.

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The Rapid-i™ Kit is a cryopreservation device designed to contain 4-8 cell and blastocyst stage human embryos.

Rapid-iTM Kit, a cryopreservation device designed to contain, vitrify and maintain 4-8 cell and blastocyst stage human embryos, consists of the following three items:
• 80 mm PMMA stick (Rapid-iTM)
• 135 mm Mediprene straw equipped with a stainless steel weight, (RapidStraw)
• 115 mm stainless steel rod inserted in the RapidStraw

Here's an analysis of the acceptance criteria and supporting studies for the Rapid-i™ Kit, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

*   **Sterilization:** No specific sample size given, but validation was performed according to ISO 11737-2:2009. (Page 5)
*   **Data Provenance:** Likely internal lab studies by Vitrolife Sweden AB, prospective.

• Design Validation (Comparative Studies, predicate device K090832):

  • "Effects of sealing before and after vitrification": Compared post-seal Rapid-i™ (predicate), pre-seal Rapid-i™ and HSV straw. No specific sample counts for embryos, but compared "different non-liquid nitrogen (LN2) contact vitrification methods of previously frozen day 1 embryos." (Page 8)
  • "A comparative mouse study": Compared post-seal Rapid-i™ (predicate), pre-seal Rapid-i™ and HSV straw, using "fresh F1 mouse embryos." (Page 8)
  • "A comparative Swiss outbred study": Compared post-seal Rapid-i™ (predicate) and pre-seal Rapid-i™ using "Swiss outbred mice." (Page 8)
  • "A vitrification study": No embryos used; visually verified vitrification of media. (Page 8)
  • Data Provenance: These were studies related to the predicate device (K090832) for design validation and likely conducted by or for Vitrolife. The nature of the studies suggests prospective experimental designs.

• Clinical Testing (Blastocyst Vitrification):

  • Patients: 426 patients with embryo transfer. (Page 10)
  • Data Provenance: Conducted at four sites. It appears to be retrospective collection of results from historical clinical use, stating "The clinical pregnancy rates range between 32% and 47%, and to date, birth of 124 children." and "Clinical blastocyst vitrification was conducted at four sites..." (Page 10)

3. Number of Experts and Qualifications for Ground Truth

• Nonclinical & Shelf-Life Testing (MEA, Endotoxin, Sterilization): No independent experts are explicitly mentioned for establishing ground truth for these tests. These are standard laboratory assays with predefined control samples and acceptance criteria.
• Design Validation (Comparative Studies on Mice/Embryos): No external experts are mentioned. Ground truth was based on defined measurable outcomes like blastocyst development, cell count, and visual assessment of vitrification.
• Clinical Testing: This section references "standard procedures" for embryo assessment and "clinical pregnancy rates" and "birth of 124 children." While embryologists and clinicians are inherently experts, the document does not specify how many or their specific qualifications for establishing ground truth in terms of a consensus panel for this specific submission. The "ground truth" here is objective clinical outcomes (pregnancy, live birth, survival rates) as reported by the clinics.

4. Adjudication Method

• There is no mention of an adjudication method (e.g., 2+1, 3+1) in the document. This type of adjudication is typically for subjective assessments (e.g., image interpretation). Given the nature of these tests (laboratory assays, survival rates, clinical outcomes), such a method would not commonly be applied.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done for this device. This type of study is more common for diagnostic imaging devices where human readers interpret data, and the comparison is how AI assistance changes their diagnostic accuracy. The Rapid-i™ Kit is a cryopreservation device, not a diagnostic tool requiring human interpretation for its primary function.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone (algorithm only) performance study was not done. The Rapid-i™ Kit is a hardware device for cryopreservation, not an algorithm. Therefore, "algorithm only" performance is not applicable.

7. Type of Ground Truth Used

• Nonclinical & Shelf-Life Testing: Objective laboratory measurements (e.g., growth in MEA, endotoxin levels, sterility confirmation).
• Design Validation: Objective experimental outcomes (e.g., blastocyst development rate, cell count, visual assessment of vitrification).
• Clinical Testing: Objective clinical outcomes (embryo survival rate, clinical pregnancy rate, live birth). This is a form of outcomes data.

8. Sample Size for the Training Set

• The concept of a "training set" is not applicable here as the Rapid-i™ Kit is a medical device (hardware) rather than an AI/ML algorithm that requires training data. The studies performed are for validating the product's functional performance and safety.

9. How Ground Truth for the Training Set Was Established

• As the device is not an AI/ML algorithm, there is no "training set" or ground truth for it in that context. The "ground truth" for evaluating the device's performance as a cryopreservation tool is established through the objective measurements and clinical outcomes described above.

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Rapid-i™ is a cryopreservation device indicated to be used to contain, vitrify and maintain 4-8 cell stage embryos

Rapid-i™ is a device intended for the vitrification of 4-8 cell stage embryos through vitrification. Rapid-iTM consists of the following two items:

• . A Polymethyl Methacrylate (PMMA) stick, 80 mm long and 2 mm in diameter
• A Polyvinyl Chloride (PVC) straw, 165 mm long and 3 mm in . diameter, equipped with a stainless steel weight
• The two parts are packed in a TYVEK® bag and sterilised by ionizing radiation

I cannot provide acceptance criteria and study details as the input document is a 510(k) premarket notification summary for a medical device (Rapid-i™ cryopreservation container and microtool). This type of document declares substantial equivalence to a predicate device and does not typically include detailed performance studies with acceptance criteria in the manner you've requested for typical AI/ML-based device evaluations. The document focuses on demonstrating that the new device has similar intended use and technological characteristics to an already approved device.

Here's why the information you're asking for is not present or applicable in this context:

• Acceptance Criteria & Reported Device Performance (Table 1): The document affirms that the Rapid-i™ has "similar intended use as the predicate device... and similar technological characteristics related to safety and effectiveness." It doesn't present specific performance metrics (e.g., sensitivity, specificity, accuracy, or a quantitative measure of embryo viability/survival rate) with predefined acceptance criteria. Instead, it relies on the established safety and effectiveness of the predicate device.
• Sample Size, Ground Truth, Adjudication, MRMC, Standalone Studies, Training Set Details (Points 2-9): These points are highly relevant for modern AI/ML-based medical devices or devices undergoing rigorous clinical performance trials. This 510(k) pertains to a physical microtool used in assisted reproduction. The "study" here is primarily a comparison of material properties, design, and intended use against a legally marketed predicate, rather than a clinical trial generating novel performance data against a ground truth.

What the document does convey regarding "performance" is:

• Substantial Equivalence: The core "finding" or "proof" is the FDA's determination that the Rapid-i™ is substantially equivalent to the predicate device (CryoTip™ K041562). This implies that its performance, as it relates to safety and effectiveness for its intended use, is considered equivalent to a device already on the market.
• Safety Considerations: The document discusses the likelihood of contamination from liquid nitrogen being "very small" due to the device's design (distance from liquid nitrogen surface, air pocket, liquid nitrogen transition to gas). It also states that "samples can not thaw when the straw is sealed after placement in liquid nitrogen if the instructions in the Package Insert are followed." These are statements related to the design features meant to ensure safety and maintain expected performance rather than measured performance results from a study.
• Maintenance of Embryos: The intended use states the device is "intended to be used to contain, vitrify and maintain 4-8 cell stage embryos." The "performance" in this context is the successful vitrification and maintenance of embryos, which is assumed to be equivalent to the predicate device.

In summary, this document is a regulatory submission for a physical medical device demonstrating substantial equivalence, not a performance study for an AI/ML algorithm or a device requiring detailed clinical efficacy data against a ground truth.

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