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The Sentio Ti implant, in combination with Sentio 1 Mini, is indicated for the following patients:

· Patients with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL.

• Patients having a symmetrically conductive or mixed hearing loss are candidates for a bilateral fitting. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2 and 3 kHz, or less than 15 dB at individual frequencies.

· Patients who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., single sided deafness or "SSD"). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).

· Patients who are indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.

· Prior to receiving the device, it is recommended that an individual has experience with appropriately fitted air conduction or bone conduction hearing aids.

· Patients 12 years of age or older.

The Sentio system is an osseointegrating, transcutaneous active bone conduction hearing system that uses the body's natural ability to transfer sound through bone conduction, thus offering improvement of hearing for patients with conductive or mixed hearing loss whether unilaterally or bilaterally fitted, or for those with single sided deafness. A bone conduction system transmits sound directly to the cochlea independently of the function of the ear canal and middle ear.

The Sentio system primarily consists of a sound processor (Sentio 1 Mini) and an implant (Sentio Ti Implant). The two components are kept in relation to each other by means of a magnetic retention system. The sound is picked up by the microphones in the external sound processor, processed and transmitted by a transmission coil using a radio frequency (RF) link through the intact skin to an implant placed in the temporal and mastoid bone area. The receiver coil of the implant receives the signal that is converted into mechanical energy (vibrations) by the transducer. The vibrations are conveyed from the bottom of the transducer to the skull and thereafter by means of bone conduction to the cochlea. In the cochlea the vibrations are converted to signals that are transmitted to the brain through the auditory nerve.

The Sentio system is intended for improvement of hearing for patients with conductive or mixed hearing losses up to 45 dB BC. The implant has been tested and verified to allow for larger mixed hearing losses, up to an anticipated 65 dB BC.

Here's an analysis of the acceptance criteria and study detailed in the provided text:

The document describes the Sentio Active Implantable Bone Conduction Hearing System, including the Sentio Ti Implant Kit, Sentio 1 Mini, and Genie Medical BAHS. The primary study referenced for demonstrating safety and performance is Study BC101.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal "acceptance criteria" table with pre-defined thresholds for performance that the device must meet in a comparative format. Instead, it discusses performance results in context of showing meaningful improvement and equivalence to predicate devices. However, we can infer performance targets based on the documented results and comparisons to normal hearing/speech levels.

Note: PPS = Per Protocol Set, FAS = Full Analysis Set. The document clarifies that a calibration error impacted some early subjects, leading to the use of both sets for analysis.

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

• Sample Size (Study BC101): 51 adult patients (18 years or older) were included in the Full Analysis Set (FAS).
• Data Provenance (Study BC101):
  • Country of Origin: Multi-center study, including six clinics in three countries (specific countries are not named in the provided text).
  • Retrospective or Prospective: Prospective study.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the test set. Clinical studies of this nature typically involve audiologists and ENT surgeons who administer tests and evaluate outcomes, but no explicit details are provided regarding their role in establishing a "ground truth" independent of the device's own performance measurements. The "normal hearing threshold for pure tones (20 dB HL)" and "normal speech level (65 dB SPL)" serve as general external benchmarks.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). For an audiology study focused on objective measurements (e.g., dB HL, speech recognition percentages) and patient-reported outcomes, a formal adjudication process akin to image interpretation may not be necessary in the same way. The results are primarily based on quantifiable audiometric tests and standardized questionnaires.

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

An MRMC study was not conducted in the traditional sense involving multiple human readers interpreting cases with and without AI assistance. This device is a hearing aid system, not an imaging AI diagnostic tool. The "assistance" it provides is direct auditory amplification and sound processing for the patient, not a clinical interpretation aid for a human expert.

The study does compare aided performance (with the device) against unaided performance (without the device), demonstrating the effectiveness directly. For example:

• "Speech recognition in quiet is significantly improved with the Sentio system compared to unaided for patients with conductive and mixed hearing losses as well as patients with single sided deafness."
• "The study concludes that the primary end-points (improved hearing and improved speech recognition on the implanted ear) were statistically significant in favor of the Sentio when compared to reference values."

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

The device's core function is as a "standalone" system in its operation for the patient. While it requires clinical fitting and programming (Genie Medical BAHS software, performed by a Hearing Care professional), the performance metrics presented (e.g., aided thresholds, speech recognition, functional gain) are reflective of the device's performance as used by the patient, meaning the algorithm's output directly impacts the patient's hearing perception. There's no separate human-in-the-loop task where the algorithm assists a human to perform a diagnostic task; rather, the device is the therapeutic intervention.

7. Type of Ground Truth Used

The ground truth for evaluating the device's performance is established through a combination of:

• Objective Audiometric Measurements: This includes bone conduction thresholds, air conduction thresholds, pure tone average (PTA), functional gain, and speech intelligibility percentages. These are standard, quantifiable audiological assessments.
• Patient-Reported Outcomes (PROs): Standardized questionnaires, specifically the Glasgow Benefit Inventory (GBI), were used to assess health-related quality of life and patient satisfaction.
• Safety Data: Adverse event reporting and MRI experience questionnaires.
• Comparison to Reference Values: Performance is compared to established "normal" hearing thresholds (20 dB HL) and speech levels (65 dB SPL), and also to unaided listening conditions.

8. Sample Size for the Training Set

The document does not explicitly describe a separate "training set" for the Sentio system in the context of an AI/machine learning model. The device is a medical device (active implantable bone conduction hearing system) with specific mechanical and electrical properties, and its "programming" or "fitting" (e.g., using Genie Medical BAHS software) is based on established audiological science and algorithms, not typically on a large-scale, iterative machine learning training process with a distinct training dataset.

The clinical studies (O1, C58, BC114, BC101) described are clinical trials to evaluate the device's safety and performance in humans, not "training sets" for an AI algorithm in the conventional sense. Previous design iterations or prototypes might have undergone internal development and testing, but the text doesn't detail this as a formal "training set."

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

As noted above, the concept of a "training set" and associated ground truth is not directly applicable in the typical AI/ML sense for this device based on the provided text. The device's design, functionality, and fitting parameters are developed and refined through engineering principles, audiological research, and validation against clinical needs and outcomes (as demonstrated in the clinical studies listed).

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The Genie is an accessory to a syringe that provides a mean of sterile access to drug vials without the use of conventional needles (needleless). These devices are designed to improve user safety by reducing the exposure that health-care workers are subjected to regarding aerosolizing hazards and accidental needle sticks.

The Genie™ is intended for use as an accessory to an I.V. set. The Genie™ is used to adapt a standard medication vial for needle free access and to maintain the sterile system. In addition, the Genie™ automatically equalizes vial pressure as fluids are withdrawn and therefore reduces the risk for health-care workers for exposure to potentially hazardous drug aerosols, spills or needle sticks that can occur during the preparation, administration and dispensing process.

The provided text describes a 510(k) submission for the Genie™ vial access device, which is an accessory to a syringe. The submission focuses on establishing substantial equivalence to predicate devices rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics. Therefore, many of the requested categories for a study proving device acceptance criteria cannot be fully addressed from the provided document.

Here's a breakdown of what can and cannot be extracted from the text:

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

The document states: "The Genie™ vial access device has been tested post sterilization and passed all acceptance criteria." However, the specific acceptance criteria (e.g., maximum leakage, pressure equalization rate, sterility maintenance duration) and the quantitative results (reported device performance) are not provided in this summary.

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

This information is not provided in the document. The text only mentions that the device "has been tested," but does not detail the testing methodology, sample size, or the nature of the data (e.g., if it was from real-world usage or laboratory testing).

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)

This information is not provided as the document describes a device submission based on substantial equivalence and testing, not a study involving expert assessment or ground truth establishment in a clinical context.

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

This information is not provided.

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

This is not applicable to this device. The Genie™ is a physical accessory designed to improve user safety by reducing exposure to hazards, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.

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

This is not applicable to this device as it is a physical medical accessory, not an algorithm.

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

The concept of "ground truth" as typically applied in AI/diagnostic studies does not directly apply here. Instead, the device's performance would be judged against functional and safety standards (e.g., sterility, pressure equalization, leakage) through laboratory testing. The document implies that the "ground truth" for demonstrating safety and effectiveness was based on passing these established acceptance criteria.

8. The sample size for the training set

This is not applicable as this document does not describe an AI/算法 development process involving a training set.

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

This is not applicable as this document does not describe an AI/算法 development process involving a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

Based on the provided text, the "study" demonstrating the device meets acceptance criteria appears to be a series of "post sterilization" tests to ensure functionality, safety, and effectiveness.

• Study Type: The document describes the process as "The Genie™ vial access device has been tested post sterilization and passed all acceptance criteria." This implies a laboratory-based testing regimen and engineering verification/validation rather than a human-centered clinical trial or an AI performance study.
• Purpose: To demonstrate that the Genie™ vial access device functions as intended (providing sterile access, equalizing pressure, reducing exposure to hazards) and is safe, thereby establishing substantial equivalence to predicate devices (K001368, specifically mentioned for its pressure equalization mechanism).
• Key Finding: The device "passed all acceptance criteria" and "meets the functional claims and intended use."

The document focuses on explaining that the device is substantially equivalent to existing predicate devices due to shared intended use, indications for use, and materials, with the main difference being the internal versus external balloon for pressure equalization. The overall claim for safety and effectiveness is tied to passing these unspecified acceptance criteria.

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Sultan Genie Magic Mix™ Ultra Hydrophilic Impression Material is intended for use as a dental impression material, compatible with all techniques including dual-phase, monophase and dual impression techniques. The material is dispensed from an automatic mixing machine system and placed into dental impression trays (metal or plastic) and is used to accurately reproduce intra-oral structures (teeth & gums) to provide models for study and/or fabrication of prosthetic devices.

Not Found

I am sorry, but the provided text does not contain information about the acceptance criteria or study details for a device. The document is a 510(k) clearance letter from the FDA for a dental impression material, outlining its substantial equivalence to a predicate device and its intended use. It does not include performance metrics or study designs.

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Sultan Genie Ultra Hydrophilic Impression Material is intended for use as a dental impression material. The material is dispensed from an automatic mixing cartridge system and placed into dental impression trays (metal or plastic) and is used to accurately reproduce intra-oral structures (teeth & gums) to provide models for study and/or fabrication of prosthetic devices.

Not Found

This is a 510(k) clearance letter from the FDA for Sultan Genie™ Ultra Hydrophilic Impression Material, classifying it as substantially equivalent to a predicate device. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner typically expected for an AI/ML medical device.

The provided text pertains to a traditional dental impression material, not an AI/ML-based device. Therefore, the details requested (such as sample size for test/training sets, expert qualifications, HRMC studies, standalone performance, etc.) are not applicable to this submission.

The "acceptance criteria" and "study" mentioned in the context of this document would refer to the standards for dental impression materials (e.g., rheology, dimensional stability, tear strength, hydrophilic properties, biocompatibility) and the non-clinical bench testing or potentially limited clinical evaluations demonstrating that the Sultan Genie™ material performs comparably to the identified predicate devices for its intended use.

Based on the provided text, I cannot furnish the requested information because it is not an AI/ML device submission.

However, I can extract the relevant information from this document:

• Device Name: Sultan Genie™ Ultra Hydrophilic Impression Material
• Intended Use: As a dental impression material, dispensed from an automatic mixing cartridge system, placed into dental impression trays (metal or plastic) to accurately reproduce intra-oral structures (teeth & gums) to provide models for study and/or fabrication of prosthetic devices.
• 510(k) Number: K030414
• Regulatory Class: II
• Product Codes: ELW

To reiterate, the questions posed in your prompt (e.g., sample size for test set, expert qualifications, MRMC study, standalone performance) are designed for AI/ML device submissions, which this document is not.

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The Nucletron microSelectron HDR - GENIE Afterloading System has the same intended use as the legally marketed predicate device cited. This device is intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy.

The entry-level microSelectron®HDR - GENIE Afterloading System concerns a microSelectron-HDR (V2) with only three treatment channels. The operators console of the microSelectron®HDR - GENIE Afterloading System concerns a PC running dedicated Treatment Console Software which is similar as in the predicate device microSelectron-HDR (V2). In the microSelectron®HDR - GENIE Afterloading System there is on the operators console a second completely independent software program for radiotherapy treatment planning. Treatment plans are transferred from the radiotherapy treatment planning software to the Treatment Console Software by file transfer. It is the same as in the predicate device where treatment plans are transferred to the Treatment Console Software from radiotherapy treatment planning software running on a separate computer. The radiotherapy treatment planning software is covered by a separate 510(k) submission. Applicators and Transfer Tubes as available for microSelectron-HDR (V2) are also applicable for the microSelectron®HDR - GENIE Afterloading System. The entry-level microSelectron®HDR - GENIE Afterloading System is a standalone device. Connection to a LAN is only for the purpose of File Transfer of Treatment Plan Files.

The provided text describes a 510(k) premarket notification for a medical device called the "microSelectron®HDR - GENIE Afterloading System". This document focuses on demonstrating substantial equivalence to a previously cleared predicate device (microSelectron-HDR V2, K953946), rather than presenting a study with acceptance criteria and device performance metrics in the way one would for a novel AI/software medical device.

Therefore, many of the requested categories related to studies, sample sizes, ground truth, and expert evaluation are not directly applicable or present in this specific 510(k) summary. The information provided is primarily about the device's technical description, intended use, and its relation to a predicate device.

Here's an attempt to address the points based only on the provided text, noting where information is not available:

Acceptance Criteria and Device Performance (Not Applicable - Substantial Equivalence Submission)

This submission is for a medical device (a remote-controlled afterloading system for radiation therapy) that is demonstrating substantial equivalence to a predicate device (microSelectron-HDR V2). It is not presenting a performance study against predefined acceptance criteria for accuracy or efficacy in the same way a software or AI device submission would. The "acceptance" is based on the FDA's determination of substantial equivalence.

Therefore, a table of acceptance criteria and reported device performance, in the context of a new performance study, cannot be generated from this document. The performance is implicitly deemed acceptable because it is substantially equivalent to a device already on the market.

Additional Requested Information (Based on provided text)

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

   • N/A. As explained above, this document is a 510(k) for substantial equivalence, not a performance study against novel acceptance criteria.

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

   • Not provided. This type of information is typically associated with performance studies, which are not detailed in this 510(k) summary. The submission focuses on the technical characteristics and intended use being similar to a predicate 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 provided. This information is relevant for performance studies involving expert review, which is not described here.

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

   • Not provided. This is relevant for performance studies involving expert review, which is not described here.

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 device is a "Remote Controlled Afterloading System" for radiation therapy, not an AI or imaging diagnostic device that would involve human readers interpreting cases. Therefore, an MRMC study is not applicable in this context.

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

   • Yes, to some extent. The document states: "The entry-level microSelectron®HDR - GENIE Afterloading System is a standalone device." While this refers to the hardware system, the core of the submission (and the "study" in a very broad sense) is about the technical specifications of the device itself, functioning independently of real-time human interpretation or decision-making in a diagnostic sense. It's a control system for radionuclide application.

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

   • Not applicable in the typical sense of a diagnostic or AI device. The "ground truth" for this submission is implicitly the functional and safety performance of the predicate device (microSelectron-HDR V2). The new device is asserted to be substantially equivalent in its design and intended use. The "truth" being established is that the device safely and effectively performs its stated function of applying a radionuclide source, similar to the predicate.

8. The sample size for the training set:

   • Not applicable. This device is not an AI/machine learning model and therefore does not have a "training set" in that context.

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

   • Not applicable. As above, there is no "training set" for this type of device.

Summary of the "Study" and "Acceptance Criteria" for K021286:

The document K021286 is a Special 510(k) Premarket Notification for the Nucletron microSelectron®HDR - GENIE Afterloading System. The "study" presented here is a demonstration of substantial equivalence to a previously cleared predicate device, the microSelectron-HDR V2 (K953946).

• Acceptance Criteria (Implicit for Substantial Equivalence): The primary acceptance criterion for a 510(k) is that the new device has the same intended use as a legally marketed predicate device and has technological characteristics that are sufficiently similar to the predicate device that it can be determined to be as safe and effective as the predicate device. Minor differences in technological characteristics must not raise different questions of safety and effectiveness.
• Reported Device Performance (Implicit): The functional performance is asserted to be equivalent to the predicate device. The description highlights that the new system is an "entry-level" version with only three treatment channels and uses similar software and applicators as the predicate. The statement "The Nucletron microSelectron®HDR - GENIE Afterloading System concerns a microSelectron-HDR (V2) with only three treatment channels" and "The operators console ... concerns a PC running dedicated Treatment Console Software which is similar as in the predicate device" serves as the core of this claim.
• Proof: The entire 510(k) submission, by outlining the similarities in intended use, technological characteristics, and specifications, serves as the "proof" for substantial equivalence. The FDA's letter (pages 2-4) confirms that they found the device to be substantially equivalent.

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The Genie Cup™ Integrated Screening Device is a professional use, rapid, multiple immunoassay tool for the qualitative detection of the major metabolites of the following drugs of abuse in urine at the SAMHSA specified (except for methamphetamines) cutoff concentrations.

Not Found

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving a device meets them. The document is a 510(k) clearance letter from the FDA for the "Genie Cup™ Integrated Screening Device."

While it mentions the intended use and cutoff concentrations for certain substances, it does not include:

• A table of acceptance criteria and reported device performance. It lists cutoff concentrations but not the performance metrics against those cutoffs (e.g., sensitivity, specificity).
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth establishment.
• Adjudication method.
• Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
• Details about standalone algorithm performance.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample size and ground truth establishment for the training set.

The document primarily focuses on the FDA's determination of substantial equivalence to a legally marketed predicate device, allowing the manufacturer to market the device. It refers to "established economics of the major metabolites of Sep" and SAMHSA specified cutoff concentrations, suggesting that the device's design aligns with existing standards, but it doesn't present the specific rigorous study data you're asking for.

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Genie P&R is designed to display and process data acquired by nuclear medicine cameras for review by physicians. Genie P&R can retrieve data from nuclear imaging systems and archive the data.

Genie P&R is a computer workstation used for the retrieval, archival, processing, analysis and management of nuclear medicine images (data). It consists of a UNIX based workstation (high resolution color monitor, keyboard, mouse, CD ROM), ethernet network connection and system software. Optional optical disk archive and laser filming/color hardcopy are available.

This document describes a legacy device, the GE Medical Systems Genie Processing and Review Workstation, cleared in 1997. As such, the information provided is typical of the regulatory submissions from that era and does not contain the detailed study information (e.g., acceptance criteria, detailed performance metrics, ground truth establishment, sample sizes, MRMC studies) that are now standard for AI/ML-based devices. The submission primarily focuses on substantial equivalence to a predicate device rather than comprehensive performance studies with predefined acceptance criteria.

Therefore, many of the requested data points are not explicitly available or described in the provided text.

Acceptance Criteria and Reported Device Performance

The submission does not explicitly define acceptance criteria in terms of quantitative performance metrics for the device itself. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device. The performance is assessed by comparing its functionalities to those of the predicate device.

Study Information (Based on Provided Text)

1. Sample size used for the test set and the data provenance: Not specified. The document states "Summary Of Studies" but then only describes the device's capabilities without detailing any specific performance studies with test sets.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified.
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: An MRMC comparative effectiveness study was not conducted or reported. This type of study is typically for evaluating the impact of AI on human reader performance, which is not relevant for this device which functions as a processing and review workstation.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a 'Processing And Review Workstation', implying human-in-the-loop for image review. No standalone algorithm-only performance is described as the device's purpose is to facilitate human review.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not specified.
7. The sample size for the training set: Not applicable/not specified. This device is described as a workstation for processing and review, not an AI/ML algorithm that would typically require a training set in the modern sense.
8. How the ground truth for the training set was established: Not applicable/not specified.

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