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510(k) Data Aggregation
(55 days)
The EndoVive™ Standard Replacement Gastrostomy Tube is indicated in adult and pediatric populations for use in percutaneous placement of an Enteral feeding tube for feeding and/or administration of medication in conjunction with an established GI stoma tract. Typical uses include the replacement of existing gastrostomy feeding tubes. In addition, the 20F tube is also used for the replacement of initial placement jejunostromy feeding tubes. The replacement tube may also be used for decompression. Note: Only the 20F tube is indicated for jejunal replacement.
The EndoVive™ Standard Replacement GastrostomyTube is constructed primarily of silcone. The device consists of a tri-port funnel which is overmolded onto a previously extruded bi-lumen shaft. A retention bolster is molded separately and placed over the shaft. At the proximal end, a silicone balloon is bonded to the shaft using a silicone RTV. The shaft is filled with a radiopague banum RTV. In use, the balloon end of the catheter is inserted into an established stoma, the balloon inflated with 3 mL saline, and the bolster slide down to the skin to secure the device in place. There are two versions of the bolster, a straight version and a right angle
The provided text describes a 510(k) summary for the "EndoVive™ Standard Replacement Gastrostomy Tube." This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.
The submission relies on bench test results to demonstrate that "there was no difference in the performance, safety, or effectiveness between the EndoVive™ Standard Replacement Gastrostomy Tube and the specified predicate devices." This is a common approach for devices seeking 510(k) clearance where the new device is technologically similar to previously cleared devices.
Therefore, many of the requested details about acceptance criteria, clinical study specifics, and expert involvement are not explicitly stated or applicable in the context of this 510(k) submission as it's presented.
Here's a breakdown based on the provided information, noting where details are not available:
1. Table of Acceptance Criteria and Reported Device Performance
As the submission relies on bench testing for substantial equivalence, specific numerical "acceptance criteria" and "reported device performance" in terms of clinical outcomes or diagnostic accuracy are not provided. The acceptance criterion is implied as "no difference in performance, safety, or effectiveness" compared to predicate devices based on bench testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| No difference in performance compared to predicate devices | Bench tests demonstrated no difference in performance. |
| No difference in safety compared to predicate devices | Bench tests demonstrated no difference in safety. |
| No difference in effectiveness compared to predicate devices | Bench tests demonstrated no difference in effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The submission refers to "bench test results," which typically involve a limited number of device samples rather than human subjects.
- Data Provenance (e.g., country of origin, retrospective/prospective): Not specified. Bench testing is conducted in a laboratory setting, not typically patient-based.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. For bench testing comparing physical device characteristics and performance, "ground truth" as established by medical experts for diagnostic accuracy is not relevant. The "ground truth" would be engineering specifications and predicate device performance.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for evaluating human expert disagreements in image interpretation or clinical diagnosis. This submission describes bench testing of a physical medical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement with AI vs. Without AI Assistance
- MRMC Study: No, an MRMC study was not done.
- Effect Size of AI Assistance: Not applicable. This device is a gastrostomy tube, not an AI-powered diagnostic or assistive technology.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the "bench test results," the ground truth would be established engineering specifications, material properties, and the known performance characteristics of the legally marketed predicate devices (Microvasive Balloon Gastrostomy Tube Kit, K962375, and EndoVive™ Low Profile Button Replacement Gastrostomy Tube, K014297).
8. The Sample Size for the Training Set
Not applicable. The concept of a "training set" is relevant for machine learning algorithms. This submission describes a physical medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As described above, the concept of a training set and its ground truth is not relevant to this device's premarket submission.
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(136 days)
The Actigraph is a small, limb-worn activity monitor, typically placed on the wrist or ankle, designed for documenting physical movement associated with applications in physiological monitoring. The device is intended to monitor limb activity associated with movement during sleep. The Actigraph can be used to assess activity in any instance where quantifiable analysis of physical motion is desirable.
The ActiGraph is a compact wrist, waist, or ankle worn, battery-operated activity monitor whose physical characteristics are similar to a wristwatch. The monitor consists of the activity monitor itself and a disposable wrist strap, belt clip, or nylon pouch. The ActiGraph is intended for the measurement, storage, and analysis of body activity. The ActiGraph can be attached to the subject's limb or torso, and through the use of an accelerometer, motion measured, the activity stored within the activity monitor. A computer program is used to set up the ActiGraph to collect data. This program is called Actisoft and runs on an IBM-compatible personal computer (PC) having a WINDOWS OS. The major functions of Actisoft are to program the device to collect data, retrieve the data from the activity monitor, display the data, and rename and store the data for storage for future reference and comparison. The ActiGraph's Reader Interface Unit is a compact interface device that provides a communications link between the ActiGraph and the PC. The ActiGraph Reader is connected to the serial communications port of the PC via a standard 9-conductor RS-232 cable or an USB adapter. The ActiGraph utilizes a motion sensor known as an "accelerometer" to monitor the occurrence and degree of motion. This type of sensor integrates the amplitude and speed of motion and produces a small signal whose magnitude and duration depend on the amount of motion. The activity signals are amplified, filtered, and digitized by the on-board electronics. This information is stored in memory on board the device as activity counts.
The Manufacturing Technology, Inc. ActiGraph device is an activity recording device that uses an accelerometer to monitor movement. The acceptance criteria and the study that proves the device meets these criteria are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sensitivity to motion: 0.75 Hertz peak sensitivity, output within 2% of response standard. | All ActiGraphs must be within 2% of the response standard at 0.75 Hertz. The document states that this is the primary criterion, and it is implied that the device meets this standard. |
| Variation between devices: Small differences in activity counts. | Movement acceleration in the range of 1G at 0.75 Hertz is where the ActiGraph has its smallest variation between devices. The differences have been measured for a sample of ten devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document explicitly states that variations between devices have been measured for a sample of ten devices.
- Data Provenance: The data appears to be generated internally by Manufacturing Technology, Inc. as part of their device development and testing. There is no information regarding the country of origin of the data or whether it was retrospective or prospective, though it is implied to be a prospective internal device validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of external experts or any ground truth established by experts for this specific performance characteristic test (sensitivity to motion and variation between devices). The "response standard" likely refers to an internal engineering specification or calibration standard rather than a clinical ground truth established by experts.
4. Adjudication Method for the Test Set
No adjudication method is described for the test set. The performance evaluation seems to be based on direct instrument measurements and comparison to a predefined standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of an MRMC comparative effectiveness study being performed, nor is there any data on human reader improvement with or without AI assistance. This device is an activity monitor, not an AI-assisted diagnostic tool.
6. Standalone Performance Study
Yes, a standalone performance study was done for the device itself. The core of the performance testing described is the evaluation of the ActiGraph's sensitivity to motion and variation between devices, which assesses the algorithm's (or device's) ability to accurately measure and record activity counts independently.
7. Type of Ground Truth Used
The ground truth used for evaluating the device's sensitivity appears to be an engineering response standard or calibration standard for motion. For the variation between devices, the "ground truth" for comparison is the measurement of activity counts across multiple devices under controlled conditions. This is not a clinical ground truth (e.g., pathology, outcomes data, or expert consensus on a clinical condition) but rather a technical performance benchmark.
8. Sample Size for the Training Set
The document does not provide information about a training set. This is not a machine learning or AI-driven device in the context of typically understood "training sets" for such technologies. Its function is based on direct physical measurement via an accelerometer and pre-programmed algorithms.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set in the context of machine learning, there is no information on how a ground truth for a training set was established. The device relies on fundamental physics and engineered specifications for its operation.
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