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The use of a Hummingbird HUMV-500 or HUMV-500MR by a qualified neurosurgeon is indicated when direct measurement of intracranial pressure is clinically important, when the patient may require CSF drainage in the course of their care, when data from one or more parameters may be deemed useful in providing optimum patient management and, in the case of the Hummingbird-500MR, when an MRI may be indicated.

The MPS catheter has three lumens, a drainage lumen, a thermocouple lumen and an air column lumen. An MPS catheter has a thin-wall tube termed the cage attached to its distal end. The cage holds the pressure-sensing bladder and provides the inlet holes through which CSF enters the catheter. The Continuous Pressure model eliminates the affect of clogged intet holes on the ICP reading by inserting a partition into the cage that separates cage into two compartments, an upper compartment for the sensing bladder and a lower compartment for CSF inflow. A transfer tube passing through the bladder compartment conveys CSF from the inflow compartment to the drainage lumen of the catheter. The manifold of the approved device has two probe ports. The diameter of one of the ports has been increased to allow the passage of either a flow or dialysis probe. The distal body of the manifold has been extended 1 cm to both accommodate the diameter change and improve the distal end profile for insertion into the brain. The thermocouple of the MRI Conditional catheters has been placed in a removable probe. The probe is removed prior to an MRI and replaced after. The temperature probe is placed in a polyimide tube that has been inserted into a dedicated lumen in the catheter.

This document pertains to a 510(k) premarket notification for a medical device, specifically the InnerSpace Hummingbird HUMV-500 and HUMV-500MR, which are intracranial pressure monitoring devices. It is a submission to the FDA for market clearance and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically found for AI/ML performance evaluation.

The document describes modifications to existing predicate devices and ensures the safety and effectiveness of the new models through comparison to predicate devices and testing related to MRI compatibility and physical properties. It does not involve a study with acceptance criteria in the context of diagnostic or classification performance metrics (e.g., sensitivity, specificity, AUC) that would be applicable to AI/ML devices.

Therefore, many of the requested fields cannot be populated as they are related to performance studies of AI/ML algorithms, which are not present in this regulatory submission.

Here is an attempt to address the request based only on the provided text, while acknowledging the limitations for AI/ML related questions:

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

The document does not explicitly define "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy for a diagnostic device. Instead, the submission focuses on substantial equivalence to predicate devices. The "performance" reported relates to physical characteristics and compatibility.

• MPS 8.1 Fr: 3.46 x $10^{-3}$ Sq. in. (Camino Large 2: 1.96 x $10^{-3}$ Sq. in.)
• MPS 9.0 Fr: 4.91 x $10^{-3}$ Sq. in. (Camino Large 1: 2.37 x $10^{-3}$ Sq. in.)
  (MPS catheters have a larger drainage lumen due to polyurethane construction allowing thinner walls, compared to predicate silicone catheters.)

Manifold Port Diameters:

• Modified Device Port 1: .056" (Same as Approved device Port 1)
• Modified Device Port 2: .063" (Larger than Approved device Port 2: .056")
  (Port 2 enlarged to accommodate larger flow/dialysis probes.) |
  | Material Strength | Catheter body made of polyurethane, which is "stronger than silicone." |
  | Continuous Pressure | New "Continuous Pressure" model has a modified cage design with a partition to isolate the sensing bladder from pressure changes due to clogged inlet holes, eliminating the need to stop CSF drainage for true ICP reading. |
  | MRI Compatibility | Hummingbird HUMV-500MR:
• Thermocouple placed in a removable probe to be removed prior to MRI.
• Bolted component (HUMV-500MR) found to be "MR Conditional" as defined by ASTM F2503 using 1.5T and 3.0T MR systems.
  (Catheter and manifold are plastic and MRI safe without the probe.) |
  | Indications for Use | Substantially equivalent to predicate devices, used for direct measurement of intracranial pressure, CSF drainage, and relevant parameter monitoring, with additional indication for MRI compatibility for the -MR model. |

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

Not applicable. This document describes physical device characteristics and MRI compatibility testing, not performance on a "test set" of diagnostic data. The MRI testing for the bolt (ASTM F2503) would have involved specific test methods and conditions but not a "sample size" in the context of data points for AI/ML evaluation.

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 not an AI/ML device requiring expert ground truth for a diagnostic test set.

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

Not applicable. This is not an AI/ML device evaluation.

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 not an AI-assisted diagnostic device.

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

Not applicable. This is a physical medical device, not an algorithm.

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

Not applicable. Ground truth, in the context of AI/ML, refers to definitively correct labels for data. For this device, "ground truth" would be the physical properties measured against engineering specifications or established standards (e.g., ASTM F2503 for MRI compatibility).

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm that undergoes a "training set."

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

Not applicable.

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The Vectors Temporary Anchorage System is a threaded titanium dental implant screw intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment. The screw is sterile and is intended for single use only.

The Vectors Temporary Anchorage System consists of sterile, single-use titanium screws that are available in 6, 8, 10, and 12mm lengths which are designed to aid in dental movement by providing a rigid skeletal fixation point. They are inserted into the bone and serve as a temporary anchor for various orthodontic tooth movements. The selfdrilling thread design allows for easy insertion and removal with the use of the system's driver. The product is sterilized using gamma radiation.

The provided text is a 510(k) summary for the Sybron Dental Specialties Vectors Temporary Anchorage System. This document focuses on establishing substantial equivalence to existing legally marketed devices, rather than presenting a study with specific acceptance criteria and performance data for the device itself.

Therefore, many of the requested items (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable (N/A) because the regulatory pathway chosen (510(k)) does not require such studies for this type of device.

The core of this submission is to demonstrate that the new device is as safe and effective as pre-existing, legally marketed devices. This is typically done by comparing materials, design, intended use, and general performance characteristics, not through new clinical trials with detailed performance metrics.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size (Test Set): Not Applicable (N/A) - No specific test set for performance evaluation is described.
• Data Provenance: Not Applicable (N/A) - The submission is based on comparison to existing predicate devices, not on new data from a test set.

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

• Number of Experts: Not Applicable (N/A)
• Qualifications of Experts: Not Applicable (N/A)

4. Adjudication Method for the Test Set:

• Adjudication Method: Not Applicable (N/A)

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

• Was an MRMC study done? No.
• Effect size of human readers with AI vs. without AI assistance: Not Applicable (N/A) - This device is a physical implant, not an AI-assisted diagnostic or therapeutic tool.

6. Standalone (Algorithm Only) Performance Study:

• Was a standalone study done? No. This device is a physical implant, not an algorithm.

7. Type of Ground Truth Used:

• Type of Ground Truth: Not Applicable (N/A) - The "ground truth" in a 510(k) for this type of device is the safety and effectiveness of the predicate devices to which equivalence is claimed.

8. Sample Size for the Training Set:

• Sample Size (Training Set): Not Applicable (N/A) - No training set is relevant for this type of device submission.

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

• Ground Truth Establishment: Not Applicable (N/A) - No training set is relevant for this type of device submission.

Summary of Relevant Information from the Document:

While the document doesn't provide the requested study details, it does contain the following pertinent information:

• Device Name: Vectors Temporary Anchorage System
• Intended Use: To serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment. The screw is sterile and is intended for single use only.
• Predicate Devices:
  • Medicon eG. Aarhus Anchorage System
  • Dentaurum, Tomas Pin
  • Imtec Corporation, Ortho Implant
  • Mondeal Medical Systems, Lomas Quattro
• Substantial Equivalence Claim: The Vectors Temporary Anchorage System is composed of the same material (titanium) and is substantially equivalent in application and function to the listed predicate devices.

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The EsteLuxTM System with the LuxVTM handpiece is intended for the treatment of inflammatory acne (acne vulgaris).

The EsteLux Pulsed Light System with the LuxVTTM handpiece accessory is a light-based medical device designed for treatment of inflammatory acne.

The provided text focuses on the 510(k) summary for the Palomar LuxV™ Handpiece, outlining its classification, intended use, and substantial equivalence to predicate devices for the treatment of inflammatory acne. However, it does not contain information about acceptance criteria, specific study designs, sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC studies. The document primarily serves as a regulatory submission for market clearance based on substantial equivalence, rather than a detailed report of a performance study with specific acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them because the necessary information is not present in the provided text.

Specifically, the document states: "The differences in the specifications of the EsteLux LuxVIM and the ClearTouch do not result in different performance or raise new questions of safety or efficacy. In addition, clinical data was provided to support the safety and efficacy of the LuxV handpiece." This indicates that clinical data was provided, but the details of that data, including the points you've requested, are not included in this 510(k) summary.

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The MAS® chemTRAK® · H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include MAS® chemTRAK .. II with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges us a means of assuring consistent performance of reagent and instrument.

The DADE® Moni-Trol® • H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include DADE® Moni-Trolf · H with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

The OLYMPUS Chemistry Control is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include Chemistry Control with patient serum specimens when assaying for any of the listed consititients. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

Not Found

The provided document is a 510(k) clearance letter from the FDA for several chemistry control materials (MAS® chemTRAK® H, DADE® Moni-Trol® H, and OLYMPUS Chemistry Control). This type of device is a "Quality control material (assayed and unassayed)" and is classified as Class I.

The purpose of this submission is to demonstrate substantial equivalence to a predicate device, not to prove clinical efficacy or diagnostic performance in the way a medical diagnostic AI might. Therefore, the questions related to acceptance criteria for diagnostic performance, study design with test sets, ground truth establishment, expert adjudication, or MRMC studies are largely not applicable in the context of this specific regulatory document.

Here's how to address the questions based on the provided FDA letter:

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

• Acceptance Criteria: The primary "acceptance criteria" for a 510(k) submission of a Class I quality control material is demonstrating substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device has the same intended use, technological characteristics, and safety and effectiveness profile as the predicate. For quality control materials, this would involve comparing their physical and chemical properties, stability, and control ranges to that of established controls. The specific quantitative acceptance criteria (e.g., within certain percentage of known values, specific coefficient of variation) are not detailed in this FDA letter but would have been part of the 510(k) submission.
• Reported Device Performance: The FDA letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This is the reported "performance" in the context of regulatory clearance – the device met the criteria for substantial equivalence to a predicate. The specific performance data (e.g., assay values, stability data, precision data) for these specific controls are not detailed in the public FDA letter but would be in the confidential 510(k) submission. The "Indications for Use" section mentions that "Assay values are provided for the specific systems listed" and that users can "compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument." This implies that the controls provide known, consistent values.

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

• Not applicable in this document. A "test set" in the context of diagnostic AI algorithms is for evaluating performance on unseen data. For a Class I quality control material seeking 510(k) clearance for substantial equivalence, the "testing" involves demonstrating the product's consistency, stability, and ability to provide known control values. The document does not specify sample sizes for such internal validation studies for these control materials. Data provenance (country of origin, retrospective/prospective) is also not specified.

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

• Not applicable in this document. "Ground truth" in the context of a diagnostic algorithm refers to a definitive diagnosis or finding. For a quality control material, the "ground truth" or "known concentration" is established through analytical methods and manufacturing processes, not typically by expert interpretation of patient data.

4. Adjudication method for the test set

• Not applicable in this document. Adjudication methods (e.g., 2+1, 3+1) are common in clinical studies for establishing ground truth for diagnostic devices, especially those involving image interpretation. This is not relevant for the clearance of liquid chemistry control materials.

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. MRMC studies are used to evaluate the impact of a diagnostic tool (like AI) on human reader performance. This device is a quality control material, not a diagnostic tool that assists human readers.

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

• Not applicable. This device is a chemical control; it's not an algorithm, so "standalone performance" of an algorithm is not relevant.

7. The type of ground truth used

• For quality control materials, the "ground truth" refers to the assigned values or expected ranges for various analytes (e.g., glucose, cholesterol) within the control material. These values are established through rigorous analytical testing and calibration processes during the manufacturing and initial validation of the control material, often against reference methods or certified reference materials. It's not "expert consensus," "pathology," or "outcomes data" in the diagnostic sense.

8. The sample size for the training set

• Not applicable. "Training set" is a concept for machine learning models. This device is a manufactured chemical product, not an AI algorithm.

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

• Not applicable. As explained in point 8, there is no "training set" in the context of these quality control materials. The establishing of "known concentrations" for the control materials themselves is through analytical validation, as described in point 7.

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