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The TotalCare® Bed System is intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either Continuous Lateral Rotation Therapy or Percussion/Vibration Therapy. The TotalCare® Bed System is intended to provide a patient support to be used in health care environments. The TotalCare® Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare® Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.

The TotalCare® Bed System, dependent upon model, is capable of supporting patient populations up to 500 lbs.

The TotalCare® Modular Therapy (Bed) System is a control unit (GUI) and frame which can house several therapeutic surfaces. The system can articulate to provide different positions for treatment, sleeping, up-in-bed, and other physician recommended positions. The Graphical Caregiver Interface/ Graphical User Interface can be set for alarms such as patient egress and head-of-bed angle.

The Hill-Rom TotalCare® Modular Therapy (Bed) System is a medical bed designed to provide patient support and therapy.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The provided summary does not mention any specific sample sizes for a test set related to clinical performance or algorithm evaluation. Instead, it explicitly states:

• "Clinical testing was not required for determination of substantial equivalence."
• "A literature review was compiled of articles related to safe patient handling and benefits of therapy surfaces and beds of this type for patients experiencing prolonged immobility."

This indicates that the device's acceptance was primarily based on non-clinical performance and substantial equivalence to predicate devices, without a dedicated clinical test set for this specific submission.

3. Number of Experts and Qualifications for Ground Truth

Given that "Clinical testing was not required," there is no mention of experts used to establish ground truth for a test set in the context of this 510(k) summary. The evaluation relied on compliance with engineering standards and comparison to existing products.

4. Adjudication Method for the Test Set

As there was no clinical test set requiring human assessment, no adjudication method is described.

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

No MRMC comparative effectiveness study was done as clinical testing was not required. The device is a medical bed, not an AI-assisted diagnostic tool for which such studies are typically performed.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study was done as the device is a medical bed and not an algorithm-based system requiring such evaluation. The evaluation focused on the physical device's compliance with safety and performance standards.

7. Type of Ground Truth Used

The "ground truth" for the device's acceptance was:

• Compliance with international engineering and safety standards: This forms the basis for the non-clinical performance summary (e.g., IEC 60601 series).
• Substantial equivalence to predicate devices: This involves comparing the new device's technological characteristics and intended use to existing, legally marketed similar devices, rather than a clinical ground truth like pathology or outcome data.

8. Sample Size for the Training Set

Since there are no indications of a machine learning or AI algorithm being developed or deployed within this device, there is no mention of a training set sample size.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a training set, the question of how its ground truth was established is not applicable.

In Summary:

The Hill-Rom TotalCare® Modular Therapy (Bed) System's acceptance was based on non-clinical performance validation against established international safety and performance standards, and demonstrating substantial equivalence to predicate medical beds. Clinical testing was not deemed necessary for this 510(k) submission, and therefore, typical metrics associated with AI device evaluation (like test set size, expert ground truth, MRMC studies, or training sets) are not present in this documentation.

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The Unity Total Knee System is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged knee joint articulation where there is evidence of sufficient sound bone to seat and support the components.

General total knee arthroplasty indications include:

• Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis
• Post-traumatic loss of knee joint configuration and function
• Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function
• Revision of previous unsuccessful knee replacement or other procedure, where soft tissue stability is adequate
• Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques
• The posterior stabilized variant is also indicated for PCL instability requiring implant bearing surface geometries with increased anterior-posterior constraint and absent or non-functioning posterior cruciate ligament

The Unity Total Knee System is indicated for cemented, single use only.

The Corin Unity Knee System is a fixed bearing total knee replacement system that consists of a femoral component, tibial insert, tibial tray and all-polyethylene patellar component for use in primary total knee arthroplasty. The Unity Knee System is provided in two variants, cruciate retaining (CR) and posterior stabilized (PS). The Unity CR Total Knee System is intended to accommodate the posterior cruciate ligament (PCL) if it is present. The Unity posterior stabilized variant is utilized when total knee replacement is indicated, and the posterior cruciate ligament is non-functioning or absent, resulting in joint instability. The Unity system patellar component is optional and is used in situations where replacement of the articular surface of the patella is required. The system also provides augment components including femoral wedges, tibial wedges, a short keel extension and stem extensions with offset connections.

The provided document describes the Unity™ Total Knee System, a medical device for knee arthroplasty. It states that "Clinical testing was not necessary to determine substantial equivalence between the Unity Total Knee System and the predicate devices." Therefore, the document does not contain information regarding acceptance criteria, reported device performance from a test set, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML-based device.

Instead, the document focuses on non-clinical testing to establish substantial equivalence to predicate devices. This type of evaluation is common for mechanical medical devices, where performance is assessed through bench testing rather than clinical trials with human subjects interacting with software.

Here's a breakdown of what the document does provide regarding the device's evaluation, as per your request related to acceptance criteria, but reinterpreted for a mechanical device:

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

Explanation: The "acceptance criteria" here are implied by adherence to industry standards, specifically ASTM F2083, which outlines specifications for total knee prostheses. The "reported device performance" is a general statement that the device met these criteria, thus deeming it "safe and effective for the proposed indications and substantially equivalent to the predicate devices."

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

• Sample Size: Not applicable in the context of clinical data for AI/ML. For mechanical bench testing, the "sample size" would refer to the number of device components tested (e.g., number of femoral components, tibial trays, inserts). This information is not specified in the provided text, but it would typically be defined within the test protocols conforming to ASTM F2083.
• Data Provenance: Not applicable in the context of clinical data. The tests were performed "in accordance with ASTM F2083 Standard Specification for Total Knee Prosthesis." This implies controlled laboratory conditions for mechanical testing rather than patient data collection.

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

• Not applicable as the evaluation was based on mechanical bench testing against engineering standards, not expert interpretation of clinical data.

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

• Not applicable as the evaluation was based on mechanical bench testing against engineering standards, not expert adjudication of clinical findings.

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 mechanical total knee system, not an AI/ML diagnostic or assistive tool. Therefore, a MRMC study for AI assistance is not relevant to its evaluation.

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

• No. This device is a mechanical total knee system.

7. The type of ground truth used:

• Engineering Standards and Specifications: The "ground truth" for this device's performance is established by the requirements and test methods outlined in ASTM F2083 Standard Specification for Total Knee Prosthesis. Compliance with these established industry standards (e.g., specific deflection limits, fatigue life, wear rates, constraint magnitudes) serves as the basis for determining the device's mechanical integrity and functional performance.

8. The sample size for the training set:

• Not applicable. This device is a mechanical knee prosthesis, not an AI/ML system that requires a "training set."

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

• Not applicable. This device is a mechanical knee prosthesis.

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The Simpler Toadstool Abutment consists of a pre-manufactured flattened ball which is directly screwed into a Simpler endosseous dental implant. The design allows for a lower profile height for a soft tissue supported overdenture. The prosthetic device is indicated for retention of soft tissue supported overdentures only and NOT for implant supported prostheses such as crowns and bridges.

The Toadstool abutment is a restorative prosthesis that threads into an already integrated dental implant. A rubber O ring snaps into a metal keeper, both of which are imbedded into a denture base. When in use, this rubber ring/keeper combination attaches the denture to the abutment preventing the movement of the denture while providing a cushioning affect to the implant.

It has a flattened ball at the top giving the retention area an ovoid appearance in profile. The external hexagonal portion of the abutment that allows the abutment to be torqued into the implant has been moved from below the ball at gingival level to the be part of the ovoid retention portion

The provided document is a 510(k) summary for the "Simpler Toadstool Abutment," a dental implant component. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a comprehensive clinical study with detailed performance metrics.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set specifics.

Here's a breakdown of why the requested information is absent:

• Acceptance Criteria and Reported Device Performance (Table 1): The document does not define specific clinical acceptance criteria (e.g., success rates, complication rates, retention force ranges) for a clinical trial and does not report performance against such criteria. It states that the device has "proven safe and effective" by reference to predicate devices but doesn't provide new performance data. The only "test" mentioned is a non-clinical torquing load test, which is an engineering specification, not a clinical performance metric.
• Sample Size for Test Set and Data Provenance (2): No clinical test set is described. The "non clinical tests" mentioned involve the device itself, not human subjects or patient data.
• Number of Experts and Qualifications for Ground Truth (3): Ground truth is not established in the context of clinical performance as no clinical study or expert review of clinical outcomes is described.
• Adjudication Method (4): Not applicable, as there's no clinical test set requiring adjudication.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study (5): Not applicable. This type of study would compare human performance with and without AI assistance, which is not relevant to a dental abutment's mechanical evaluation.
• Standalone Performance (6): The device's "performance" is primarily mechanical and related to its design modifications. It's not an AI algorithm with standalone performance in the typical sense. The torquing load test result could be considered a standalone mechanical performance, but it's not a comprehensive clinical performance metric.
  • Reported performance (from "NON CLINICAL TESTS"): The abutments were tested to a breaking limit of 113 to 120 NCm. This is well in excess of the recommended maximum torquing load of 30 NCm for insertion.
• Type of Ground Truth Used (7): For the non-clinical test, the "ground truth" is the physical measurement of the breaking limit under controlled laboratory conditions. There is no clinical ground truth established or needed for this type of submission.
• Sample Size for Training Set (8): Not applicable. There is no AI model or algorithm being "trained."
• How Ground Truth for Training Set was Established (9): Not applicable.

Summary of what is provided regarding testing:

The document mentions non-clinical tests directly related to the mechanical properties of the abutment:

• Test: Torquing load on abutments during insertion.
• Acceptance Criterion (implicit): The device should withstand torquing loads significantly higher than the recommended insertion torque.
• Reported Performance: The abutments were tested to a breaking limit of 113 to 120 NCm.
• Conclusion: This breaking limit is well in excess of the recommended torque load of 30 NCm.

This information demonstrates the structural integrity of the abutment under a specific loading condition but does not involve clinical performance, human subjects, or AI evaluations. The primary argument for substantial equivalence relies on the device's design similarities to already approved predicate devices and the fact that its modifications (flattened ball, hex relocation) do not raise new questions of safety or effectiveness.

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The Simpler Toadstool Mini Implant is intended to be used as an artificial root to provide immediate long term or transitional support for overdentures.

The Simpler Toadstool Mini Implants and the Simpler HA Toadstool Mini Implants are intended to provide long term intra-bony applications for Soft Tissue Supported Over Dentures only. They are designed for immediate loading when there is good primary stability and an appropriate occlusal load. These implants may also be used for temporary soft tissue overdenture support for partial and fully edentulous restoration in the mandible and maxilla. They may be used as a minimally invasive surgical technique option for full or partial edentuloism as an alternative to more invasive surgery involving conventional implants.

The Simpler Toadstool Minis and the Simpler HA Toadstool Minis are Narrow Diameter implants. They are manufactured using 6/4 Titanium alloy 90% titanium 6% aluminum and 4% vanadium for strength. All implants are arit blasted and also acid etched and are available uncoated or coated with hydroxylapatite only on the threaded part of the implant. The diameter is 2.5mm and the lenaths are 10mm. 13mm, 15 mm and 18 mm in both the coated and uncoated implants. The implants are designed as one piece with a flattened toadstool shaped abutment with a hexagonal outline at the top of the implant. The flattened, hex ball fits into a keeper with a rubber o-ring placed in the prosthesis to reduce loading and to help with retention.

The provided document describes a 510(k) premarket notification for an endosseous dental implant. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance criteria through clinical studies as often seen for AI/ML devices. Therefore, much of the requested information regarding acceptance criteria, sample sizes for test/training sets, expert consensus, and comparative effectiveness studies is not applicable or cannot be extracted from this document.

However, I can extract the relevant information from the provided text based on the nature of this submission.

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

For a 510(k) submission concerning an endosseous dental implant, "acceptance criteria" are typically related to material properties, mechanical performance, and substantial equivalence to predicate devices, rather than clinical efficacy metrics like sensitivity or specificity.

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

This submission does not describe a clinical "test set" in the context of an AI/ML algorithm evaluation. It's a 510(k) for a physical medical device (dental implant). The "Summary of Testing" section indicates that "Simpler Toadstool Mini Implants do not introduce new issues for materials, surface treatment, fatigue testing and risk management that have not been addressed in all other approved Simpler Implants." This implies equivalence through comparison to existing data and established parameters of the predicate devices. There is no mention of a specific new clinical study with a test set of human subjects described in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a physical dental implant, not an AI/ML device requiring expert ground truth for a test set.

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

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is about a physical implant, not an AI/ML system assisting human readers.

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

Not applicable. This is not an algorithm.

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

The "ground truth" for this device's safety and effectiveness essentially relies on:

• Established engineering and material science principles: for the titanium alloy, surface treatment, and design.
• Performance of predicate devices: The primary "truth" for a 510(k) is the established safety and effectiveness of the legally marketed predicate devices. The new device demonstrates substantial equivalence to these.
• Existing knowledge of dental implant outcomes: The contraindications and complications listed are general to dental implants, implying a reference to broad clinical experience.

8. The sample size for the training set

Not applicable. This is not an AI/ML algorithm that requires a training set.

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

Not applicable.

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The intended use for the Nasal Mask Oral Appliance Holder is that is may be used with or without the complete Oral Appliance approved for Snoring and OSA to serve as an accessory to hold a Nasal Mask on a patient's face. The designed attachment can be fitted to hold the nasal mask in place via an oral appliance secured by the upper teeth of the patient. The accessory will have the same indications for use as those of the equipment to which it is an accessory.

1. The Universal Nasal Mask Oral Appliance Holder includes the Extension Bracket with Mask Flange which attaches to the upper tray of the Oral Appliance, approved under K972061. This device would be considered an accessory to the Nasal Mask and is designed to hold the Nasal Mask in place. It is an alternative to the use of standard headgear. It is adaptable to several different nasal masks styles.
2. In combination with the already approved, K972061, Oral Appliance which has both an upper and lower tray. The upper tray has a fitting which permits the attachment of the Extension Bracket with Mask Flange. This combined device permits therapy for OSA and snoring by an oral device and a positive airway pressure delivery device.

The provided text describes a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a clinical study with statistical endpoints. Therefore, many of the requested elements (sample size, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not typically included in this type of submission and are not present in the provided document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not outline specific numerical acceptance criteria or present quantitative performance data. Instead, it relies on a comparison of attributes and the assertion that "There is no significant difference" in performance relevant to safety and effectiveness compared to predicate devices. The "Performance Testing" section explicitly states "None applicable under Section 514" and "Equivalent leak rates," indicating that specific performance tests for this type of accessory device were not considered necessary beyond demonstrating functional equivalence.

2. Sample Size and Data Provenance for Test Set

Not applicable. The document does not describe a clinical test set with a specific sample size. The demonstration of equivalence is based on a comparison of design attributes and intended uses with predicate devices.

3. Number and Qualifications of Experts for Ground Truth

Not applicable. No ground truth establishment by experts is described, as this is a regulatory submission for device equivalence, not a performance study requiring ground truth.

4. Adjudication Method

Not applicable. There is no mention of adjudication, as this is not a study involving expert review or conflict resolution.

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

Not applicable. No MRMC study was conducted or referenced. This type of study is more common for diagnostic or AI-driven devices where human interpreter performance is being evaluated.

6. Standalone Performance Study

Not applicable. No standalone performance study (algorithm only, without human-in-the-loop performance) was conducted or described. The device is a physical accessory, not an algorithm.

7. Type of Ground Truth Used

Not applicable. The submission relies on establishing substantial equivalence to existing, legally marketed predicate devices rather than validating performance against an independent "ground truth." The implicit "ground truth" is the established safety and effectiveness of the predicate devices.

8. Sample Size for the Training Set

Not applicable. This is a submission for a physical medical device accessory, not an AI or algorithm-driven device that typically requires a training set.

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

Not applicable, as there is no training set for this device.

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The TOA is intended to reduce or alleviate night time snoring and obstructive sleep apnea, OSA.

The TOA Anti-snoring device is comprised of -

• Lower tray fitted over the lower teeth.
• Upper tray fitted over the upper teeth.
• Impression material
• Hook mechanism to attach lower tray to upper tray

Here's an analysis of the provided text regarding the TOA Anti-snoring device, focusing on acceptance criteria and supporting studies, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in the typical sense of numerical thresholds that the new device must meet to demonstrate safety and effectiveness. Instead, it relies on substantial equivalence to predicate devices. The "Performance Testing" section in the comparison table is the closest equivalent to reporting on device performance relative to a defined metric.

2. Sample Size for Test Set and Data Provenance

The provided summary does not contain information about a specific test set or clinical study conducted for the TOA device itself to establish the 72% AHI reduction. The 72% figure appears to be directly copied from the performance claimed by the predicate device, NPB TAP (K962516), implying that if the TOA device is "substantially equivalent" in design and intended use, its performance would also be substantially equivalent.

Therefore, there is no direct information on:

• Sample size used for a test set.
• Data provenance (country of origin, retrospective/prospective).

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

Since no specific study for the TOA device is described, there's no information on experts used to establish ground truth or their qualifications. The performance metric of "reduced AHI" is a quantifiable physiological measurement typically derived from polysomnography studies, not expert consensus in the way a diagnostic image might be.

4. Adjudication Method for the Test Set

Not applicable, as no specific test set or study for the TOA device is described.

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

No, an MRMC comparative effectiveness study was not done or described in this submission. The device is not a diagnostic tool where "human readers" would be involved in interpreting outputs. It's a therapeutic device for a physiological condition.

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

This is not applicable to an anti-snoring oral appliance. The device itself is the intervention, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the reported performance (72% AHI reduction) would be physiological measurements from polysomnography (PSG) studies that quantify snoring events and apneas/hypopneas. However, this "ground truth" data is attributed to the predicate device (NPB TAP), not presented as directly generated by a study on the TOA device.

8. Sample Size for the Training Set

Not applicable. The TOA is a physical medical device, not an AI/algorithm-based system that requires a "training set."

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

Not applicable, as there is no training set for this type of device.

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