Search Results
Found 5 results
510(k) Data Aggregation
(74 days)
The VENX REVOLUTION™ is a manual surgical instrument intended for use in the destruction of spider veins in the lower extremities of the body.
The VENX REVOLUTION™ is a sterile, disposable, single patient use surgical instrument for the disruption and destruction of spider veins located in the lower extremities of the body. The device is made available in several sizes to accommodate a range of veins that form in the lower body. The VENX REVOLUTION™ consists of a thermoplastic handle containing a lever actuated rack and gear mechanism for rotating a shaft extending from the handle. At the end of the shaft are stainless steel, needle-like tines sharpened and spaced appropriately to straddle veins located just below the surface of the skin. Once the tines are in place straddling the vein, the levers are actuated causing the shaft to rotate approximately 360° or more. Actuating the levers causes internal springs to compress. Once the levers have rotated the shaft 360° and the tines have disrupted the vein, releasing the levers allows the compressed springs to return the tines to their original position. The device is then withdrawn and re-inserted at another position within the clinician-selected area to repeat the operation on the same vein or on another vein. The procedure is repeated until all veins within the selected area have been treated.
The VENX REVOLUTION is a manual surgical instrument for the disruption and destruction of spider veins in the lower extremities. The device incorporates a lever-actuated mechanism to rotate tines a minimum of 360 degrees.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Supporting Performance |
|---|---|---|---|
| Functional Equivalence | Ability to disrupt and destruct spider veins | Performed as intended and equivalent to the predicate device | Bench testing under simulated actual use conditions |
| Device Integrity/Durability | Tine deformation | Not explicitly detailed as a separate criterion, but included in "Testing" | Bench testing |
| Device Functionality | Cycle life | Not explicitly detailed as a separate criterion, but included in "Testing" | Bench testing |
| Mechanical Operation | Rotating mechanism operation | Not explicitly detailed as a separate criterion, but included in "Testing" | Bench testing |
2. Sample size used for the test set and the data provenance:
The provided document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The testing described is "Bench testing... using simulated actual use conditions," which suggests in-vitro testing rather than human subject data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not mention the use of experts to establish ground truth for the test set. The evaluation was done through "Bench testing," likely involving engineering and technical assessment rather than clinical expert consensus.
4. Adjudication method for the test set:
No adjudication method is mentioned as there were no human subjects or expert assessments involved in the "Bench testing."
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. The testing described is bench testing, not a clinical study involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The concept of "standalone performance" typically applies to AI algorithms. Since this is a manual surgical instrument, this question is not directly applicable. The device itself is a "standalone" mechanical tool, and its performance was assessed in isolation through bench testing.
7. The type of ground truth used:
Given that the study involved "Bench testing using simulated actual use conditions," the "ground truth" would likely be based on physical measurements and engineering specifications related to the device's ability to disrupt simulated veins and its mechanical integrity, rather than expert consensus, pathology, or outcomes data from human subjects. For example, successful disruption of a simulated vein might have been a measurable outcome against a predefined physical standard.
8. The sample size for the training set:
There is no training set as this is a mechanical device undergoing bench testing, not an AI or algorithmic system that requires training data.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device and study.
Ask a specific question about this device
(55 days)
Ask a specific question about this device
(297 days)
The Template System will be used solely for hair restoration. The device will first create slits in a recipient site in the scalp, and then insert hair grafts into these slits. Cartridges preloaded with hair grafts will facilitate insertion in an efficient manner.
The Template System will be used solely for hair restoration. The device will first create slits in a recipient site in the scalp, and then insert hair grafts into these slits. Cartridges preloaded with hair grafts will facilitate insertion in an efficient manner.
I apologize, but the provided text from the FDA 510(k) letter for the Markman Template System does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.
This document is solely an FDA clearance letter indicating that the device has been deemed "substantially equivalent" to a predicate device and can be marketed. It outlines regulatory requirements but does not delve into the technical details of device validation.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the other specific questions you posed based on the given input.
Ask a specific question about this device
(81 days)
The RAPID FIRE HAIR IMPLANTER CAROUSEL™ is in ended to be used for hair transplantation on the scalp. The RAPID FIRE HAIR IMPLANTER CAROUSEL™ is indicated where patients require one or more hair grafting sessions during which multiple grafts have to be implanted.
The RAPID FIRE HAIR IMPLANTER CAROUSEL™ (Carousel) is a disposable mechanical device designed to facilitate a hair transplant. It consists of a circular Carousel designed to house hair grafts, a sharp end designed to create an opening in the skin of the scalp and a button end that activates the moving parts within the Carousel. The CAROUSEL consists of a stainless steel blade and the body composed of Lustran 348 resin.
The provided submission describes limited studies to support the device. Here's a breakdown based on the information provided and how it aligns with your requested criteria:
Device: RAPID FIRE HAIR IMPLANTER CAROUSEL™ (Carousel)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Device does not overtly harm tissue or patient compared to predicate/manual method. | In vitro: No difference in gross morphology, intact and undamaged implants, no significant histological difference (Carousel resulted in more uniform depth). In vivo (human): No reported adverse events, "much less bleeding by the Carousel method" (implying less trauma), "no difference between those made with the Carousel and those made with the conventional appeared" (referring to post-operative wounds). |
| Effectiveness/Functionality: Device facilitates hair transplantation. | In vitro: Successfully implanted grafts. In vivo (human): Successfully implanted grafts, "much shorter time needed for graft placement" with Carousel (compared to manual), "no difference in the rate of growth or the number of hairs" between Carousel and manual methods. |
| Substantial Equivalence: Device is equivalent to predicate devices in terms of safety and effectiveness. | Performance tests validated its safety and effectiveness and support the claim of substantial equivalence to the Calivitron Hair Transplant System and Padgett Hair Transplant Punch. The Carousel's differences (carousel feature for graft storage and speed) do not impact safety and effectiveness negatively. |
2. Sample size used for the test set and the data provenance
- In vitro study: Not explicitly stated, but involved "biopsy specimens of groups implanted manually and with the Carousel under loop magnification".
- In vivo (human) study: One (1) human subject.
- Data Provenance: Not explicitly stated, but the human study involved a patient. Given the context of a 510(k) submission to the FDA, it is retrospective in nature (reporting on completed studies). The country of origin is not specified but is likely the U.S. as it's an FDA submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not explicitly stated. The "visual inspection" and "histologic evaluation" were likely performed by medical professionals, but their number, qualifications, and role in establishing ground truth (e.g., comparing to a gold standard) are not detailed.
4. Adjudication method for the test set
Not applicable/not explicitly stated. The studies describe observations and evaluations, but not a process of adjudicating differing expert opinions on a specific outcome (e.g., presence of a disease).
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 surgical instrument, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manual surgical instrument.
7. The type of ground truth used
- In vitro study: Gross morphology and histological evaluation of porcine skin biopsy specimens. The comparison was against manually implanted grafts.
- In vivo (human) study: Clinical observations of bleeding, operative time, post-operative wound appearance, rate of hair growth, and number of hairs. The comparison was against a manual implantation method (Nokor needle and manual forceps).
8. The sample size for the training set
Not applicable. This device is a physical surgical instrument, not a learned algorithm. There is no concept of a "training set" in the context of this submission.
9. How the ground truth for the training set was established
Not applicable. See point 8.
Ask a specific question about this device
(86 days)
The Navigator (stylet) is a stainless steel wire rod, inserted into the catheter to assist with insertion and placement of the catheter in the peritoneum.
Stainless steel wire rod intended to aid in the manipulation of or insertion of the catheter for placement in the peritoneum.
The provided document is a 510(k) summary for a medical device called "Navigator (stylet)". This document describes the device, its intended use, and biocompatibility testing. It is a premarket notification for a medical device and therefore does not contain information related to software algorithm performance, such as acceptance criteria for diagnostic accuracy, sample sizes for test sets in an AI context, or ground truth establishment by experts.
This document describes a physical medical device (a stainless steel wire rod or stylet), not a software algorithm or an AI-powered diagnostic tool. The "acceptance criteria" discussed are related to the physical properties and biological compatibility of the device, not its performance in a diagnostic or analytical capacity. Therefore, the questions related to AI/algorithm performance, ground truth, expert consensus, and comparative effectiveness studies are not applicable to the content provided.
Here's an attempt to answer the relevant questions based on the provided text, and to explicitly state when information is not applicable or available:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Cytotoxicity Study | Non-cytotoxic | Pass |
| Hemolysis Study | Non-hemolytic | Non-Hemolytic |
| Dimensional Equivalence | Equivalent to Quinton's stylet | Dimensionally equivalent |
| Material Equivalence | Stainless steel | Manufactured from stainless steel |
| Sterilization | Sold sterile | Sold double pouched and sterile |
Note: The acceptance criteria for "Pass" in the cytotoxicity study and "Non-Hemolytic" in the hemolysis study are directly stated or directly implied by the result.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. The document describes a physical device, not an algorithm tested with a data set of images or patient data. Biocompatibility studies are typically performed on samples of the device material, not a "test set" in the context of an algorithm.
- Data Provenance: Not applicable.
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. Ground truth as typically defined for algorithms (e.g., disease presence/absence based on expert consensus) is not relevant for the assessment of a physical stylet's biocompatibility or dimensional equivalence. The "ground truth" for biocompatibility is established by standardized laboratory tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically used to resolve discrepancies in expert interpretation of diagnostic data for algorithm training/testing, which is not relevant here.
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 physical stylet, not an AI-powered diagnostic tool. MRMC studies evaluate the impact of AI on human reader performance, which is not relevant for this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical device, not a standalone software algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable in the context of an algorithm's diagnostic performance. For biocompatibility, the "ground truth" is provided by the results of standardized biological assays (cytotoxicity and hemolysis tests) and physical/material comparisons against predicate devices.
8. The sample size for the training set
- Not applicable. This device does not involve a training set for an algorithm.
9. How the ground truth for the training set was established
- Not applicable. This device does not involve a training set or ground truth establishment in the context of an algorithm.
Ask a specific question about this device
Page 1 of 1