Search Results

The Featherlift silhouette Suture is indicated for use in mid-face suspension surgery to fixate the cheek sub dermis in an elevated position.

Not Found

This document is a 510(k) premarket notification decision letter from the FDA for the "Featherlift Silhouette Suture." It confirms that the device is substantially equivalent to a legally marketed predicate device. This type of regulatory document does not contain acceptance criteria or a study describing device performance.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval rather than technical performance data.

Ask a specific question about this device

The Featherlift™ Extended Length Aptos Thread is indicated for use in midface suspension surgery to fixate the cheek sub dermis in an elevated position.

Not Found

This document is a marketing clearance letter from the FDA for a medical device. It does not contain information about acceptance criteria, study details, or performance data for the device. Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device

The indication for use for the K.M.I. Kolster Methods Inc. Stars2000 power cannula device is for situations requiring the removal of tissue or fluids from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a device called "Stars2000 Power Cannula," a suction lipoplasty system. It does not contain information about acceptance criteria, study details, or device performance metrics.

The letter primarily focuses on:

• Notifying the applicant of an administrative change (new product code).
• Confirming the substantial equivalence determination made in 2001.
• Outlining the regulatory requirements for marketing the device.
• Stating the intended use of the device.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth information, MRMC study, or standalone performance) from the provided text. This type of information would typically be found in the 510(k) submission itself, not in the clearance letter.

Ask a specific question about this device

Ask a specific question about this device

The K.M.I. SSW Sterile Solution Warmer is intended for the administration of sterile solutions at a controlled temperature drawn from containers using K.M.I. DIK system administration set. The "K" pump is also used in conjunction with this device.

Not Found

This is a 510(k) premarket notification letter from the FDA to Kolster Methods, Incorporated, regarding their SSW-Sterile Solution Warmer. The letter confirms that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications as requested in the prompt. It is a regulatory approval letter based on a declaration of substantial equivalence, not a detailed study report.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study proving the device meets them from the provided text.

Ask a specific question about this device

The K.M.I. Irrigation or Infusion pump "K" Pump is intended for the administration of sterile solutions drawn from containers using standard sterile administration sets with a 3/8 diameter silicone peristaltic section. The "K" Pump is intended for the rapid introduction of sterile fluids into the wound site for wound irrigation. The "K" pump may also be used with K.M.I.'s DIK Irrigation System.

Not Found

Based on the provided text, the document is an FDA 510(k) clearance letter for the "K" Pump, an irrigation or infusion pump. This type of document primarily confirms that a new medical device is substantially equivalent to a previously cleared device, meaning it has the same intended use and technological characteristics as a predicate device, or has different technological characteristics but does not raise different questions of safety and effectiveness.

Crucially, this document does not contain information about specific acceptance criteria or a study that proves the device meets those criteria in the way a performance study report would.

Therefore, I cannot provide the requested information in the table format because the details are not present in the provided text.

Here's why and what's missing:

• Acceptance Criteria & Reported Performance: The letter only states that the device is "substantially equivalent" to a predicate device. It does not list specific performance metrics (e.g., accuracy, flow rate, pressure limits) for the "K" Pump, nor does it provide data from a study demonstrating achieved performance against those criteria.
• Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set, Ground Truth Establishment: These are all elements typically found in detailed clinical or performance study reports, which are not included in this FDA clearance letter. The letter refers to a 510(k) notification, which would have contained some technical and performance data, but that notification itself is not provided here.

In summary, the provided document (an FDA 510(k) clearance letter) is a regulatory approval and does not contain the detailed study information, acceptance criteria, or performance data you are requesting.

Ask a specific question about this device