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The CT Injectable Safety Huber Needle is a device used to administer fluids from a container to a patient's vascular system through an implanted port. The CT Injectable Safety Huber Needle incorporates an active safety feature that aids in the prevention of accidental needle sticks.

The CT Injectable Safety Huber Needle is a safety needle designed with an anti-coring needle tip configuration. The primary use for Huber Needles is to deliver solutions to implanted ports. The safety feature is designed to protect the practitioner from accidental needle sticks.

The CT Injectable Safety Huber Needle is compatible with power injection procedures up to 300 psi.

The CT Injectable Safety Huber Needle is composed of a sharpened anticoring Huber style needle for port septum access having a safety feature which is manually operated and will prevent accidental needle sticks when advanced which is connected to a conventional style extension set for attachment to standard IV/Drug infusion line sets.

The proximal end of the needle cannula is adhesively sealed to the molded housing which contains a glue well and fluid thru hole. The fluid thru hole leads to the distal end of the extension line set that is also adhesively bonded in the molded housing. The distal end of the extension tubing contains a female luer connector with removable dust cap on the proximal end creating a fluid path from the needle tip thru the female luer. The infusion set is also offered in a configuration where the extension tubing contains a Y-Site connector with removable dust cap placed midway between the needle and the female luer connector. The extension tubing contains purple pigment to indicate its use for high pressure. The Y portion of the connector is a molded female luer that is sealed with a removable dust cap. A non-removable pinch clamp is located between the female luer and needle cannula. On line sets with a Y-Site connector, two pinch clamps are present located between the female luer and the Y-Site and the Y-Site and the needle cannula. The pinch clamps are designed that when engaged, fluid flow is restricted thru the extension tubing.

The needle cannula is constructed with a Huber style anti-coring needle tip. The cannula is stainless steel and is shielded by a removable star needle quard of plastic construction.

The molded wing housing is of plastic construction and contains rigid protruding wings. The under side of the wings contain a foam comfort pad. The comfort pad is constructed with an adhesive backing which is secured to the wing housing.

The molded wing housing is snap fitted into the molded housing via a securement post. The wing housing is of plastic construction with a protruding wing designed flush with the under surface of the housing. The wing housing contains a thru hole that easily slides over the needle cannula. The wing housing contains a torsion spring that is positioned on a post and is orientated in a positioning channel. The torsion spring is in a compressed state until the molded housing is removed from the winq housing at which time the torsion spring is automatically activated. The winq housing consists of a base to which the securement bag is adhesively bonded.

The molded housing is connected to the wing housing via the securement bag. The securement bag (a polyester film lamination) is adhesively bonded to the molded housing and the wing housing. The securement bag is compressed (accordion style) between the molded housing and wing housing and is of length sufficient to activate the torsion spring and to prevent the needle tip from entering the securement bag area.

In normal operation, the molded housing is activated during removal of the needle from the patient. The wing housing is held firmly in place while the molded housing is disengaged. The molded housing is disengaged from the wing housing by grasping the elevated portion of the molded housing and sliding the molded housing in an upward direction. The molded housing will disengage from the wing housing and will advance until the torsion spring is past the needle tip at which time the torsion spring will snap over the needle access hole. Upon spring activation, there will be an audible click sound as the spring snaps against the wing housing. The securement bag prevents the molded housing from advancing off the needle cannula and the torsion spring prevents the needle from advancing out of the housing.

Prior to use, the exposed portion of the needle cannula, including the sharpened needle tip area, is coated with a silicone fluid to render the needle lubricious and to reduce the insertion (penetration) and drag force to industry acceptable values.

Each needle size has I.D. Rings located within the pinch clamp to identify the appropriate infusion rate for the noted needle gauge size. Components will be assembled by the manufacturer into standard configurations with or without the "Y-Site" and packaged.

The provided text describes a 510(k) premarket notification for a medical device called the "CT Injectable Safety Huber Needle." This application primarily relies on substantial equivalence to a predicate device rather than extensive new studies proving acceptance criteria for the new device itself.

Here's a breakdown of the requested information based on the provided text, heavily noting what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document states: "Clinical studies were not deemed necessary since no changes have been made to the design, packaging, sterilization or indications for use that would have any effect on the safety and effectiveness of the device when compared to the legally marketed predicate device."
• This indicates that no formal test set (in the context of clinical studies) was used for proving acceptance criteria for this specific device as directly presented in the submission. The acceptance is based on substantial equivalence to the predicate device.
• Data Provenance: Not applicable for new clinical data on this specific device. The reliance is on existing data and regulatory clearances of the predicate device and the materials used.

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

• Not applicable. No clinical test set data was generated for the new device.

4. Adjudication method for the test set

• Not applicable. No clinical test set data was generated for the new device.

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 device is a manual medical instrument (Huber needle), not an AI-powered diagnostic tool.

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

• Not applicable. This device is a manual medical instrument.

7. The type of ground truth used

• The "ground truth" for this submission is substantial equivalence to the predicate device (PFM Medical, EZ Huber Safety Infusion Set, K071846) as demonstrated through design, materials, and intended use comparison.
• For the pressure testing, the ground truth would be established by physical measurements against a specified pressure value (e.g., 300 psi), but the detailed results of this testing, including methodology and specific values, are not provided in this summary.

8. The sample size for the training set

• Not applicable as this is not an AI/algorithm-based device and no new clinical studies were performed. The "training set" for the predicate device's clearance would have been its own testing and clinical data, which is referenced indirectly through the substantial equivalence claim.

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

• Not applicable for a training set for this specific device. For the predicate device, its ground truth would have been established through its own regulatory clearance process, likely involving engineering bench testing, material biocompatibility, and potentially clinical studies or historical device performance data.

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Sunrise scooters empower physically challenged persons by providing a means of mobility.

The Three Wheeled mid Range Scooter is a medium duty, conventional, rear whech drive, rigid frame power Vehicle. The armrests of the sear are adjustable. The seat may be repositioned from from to back and chair height can be adjusted up and down. There are many kinds of accessories that are commonly sold after market. These accessories include canopies, crutch holders, cup holders, baskers etc.

Like most scooters, the tiller and throttle controls are the user interface. They transfer the rider's intentions to command the device. When the control is activated, or moved out of neutral position, the motor brake is energized and released, allowing the scooter to move in the appropriate direction. When the activation device is released, the scooter slows to a stop and the motor brake is automatically reengaged. These dynamic "on command" brakes allow the user to stop by letting go of the activation device.

If the scooter looses power, the motor brake is automatically engaged and the scooter comes to a stop. To prevent the rider from becoming stranded, the scooter may be pushed. The design incorporates a "free wheel" device motor lock disengagement device. This device allows the drive train to be manually disengaged, enabling the scooter to be pushed. It should be noted that the scooter would not have electronic brakes when in the "free wheel" mode.

The controller is microprocessor based and program-able. It is pro-programmed at the manufacturer to meet Sunrise specifications. This controller is currently used on selected models of the Sunrise scooters under K880425. Drive characteristics that are pre set are:

forward/reverse acceleration forward speed

forward/reverse deceleration reverse speed

The controller also has manual reset circuit breakers. These adjustments and features are similar to all standard scooter controllers.

The provided text describes a 510(k) submission for a medical device, specifically a mobility scooter. However, it does not include the typical information one would expect for demonstrating the acceptance criteria and performance of an AI/ML device in a clinical study.

The document is a K981885 submission for a "Sunrise 3 Wheel Scooter" in 1998, which is a physical device, not an AI/ML software device. The "testing" section refers to engineering standards like ISO 7176 and RESNA for wheelchairs, covering aspects like stability, brakes, energy consumption, and EMC. The "efficacy" section refers to articles about power wheelchairs in general, not specific studies on this particular device's clinical efficacy in a statistical sense.

Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving the device meets those criteria, as the provided input does not contain information relevant to an AI/ML device's clinical performance assessment.

Here's a breakdown of why each requested point cannot be addressed with the given document:

1. A table of acceptance criteria and the reported device performance: The document lists engineering tests (e.g., Static Stability, Dynamic Stability, Effectiveness of Brakes) and states that the device was tested to these standards. It doesn't present specific acceptance criteria values (e.g., "must stop within X feet at Y speed") and then reported performance values against them in a table format. These are design and safety standards, not clinical performance metrics for an AI/ML diagnosis/prediction.
2. Sample sized used for the test set and the data provenance: Not applicable. This refers to engineering tests, not a clinical study on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth is established for patient data.
4. Adjudication method 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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the regulatory submission for a physical medical device (a scooter) and focuses on engineering safety standards and comparisons to predicate devices, not on the clinical performance validation of an AI/ML algorithm.

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