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510(k) Data Aggregation
(618 days)
Feeltech Co., Ltd.
FEELject LDV(Low dead volume) Syringe is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin.
A Disposable Syringe with Needle is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a hypodermic single lumen needle which is permanently attached. The device is used to inject fluids into, or withdraw fluids from, the body. It is made of plastic and silicone materials that allows for smooth plunger movement, and manually operated. This is a single-use device. This product is packed by sterile paper and sterilized by E.O gas.
The provided text describes the 510(k) summary for the FEELject LDV (Low dead volume) Syringe, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new medical device meets specific acceptance criteria through a clinical study or AI performance evaluation.
Therefore, the information required to answer your specific questions about acceptance criteria, AI performance, ground truth establishment, sample sizes for training/test sets, expert adjudication, or MRMC studies for an AI/device is not available in this document.
The document discusses bench testing and biocompatibility testing to show that the device performs in a substantially equivalent manner to the predicate device. These tests demonstrate the physical and biological properties of the syringe, not the performance of an AI algorithm or a diagnostic device.
Here's a breakdown of what can be extracted from the document, and why the other requested information is absent:
Information Available from the Document:
This document is a 510(k) summary for a medical device (syringe), not an AI algorithm. Therefore, the requested information about AI-related acceptance criteria, study design (MRMC, standalone), ground truth establishment for AI, and sample sizes for AI training/test sets is not applicable and not found in this text.
The closest equivalent to "acceptance criteria" here is compliance with ISO standards and passing various bench tests and biocompatibility tests to show substantial equivalence to the predicate device.
1. A table of acceptance criteria and the reported device performance
While not "AI performance" criteria, the document lists various requirements/tests for the syringe and their results (Pass). These serve as the "acceptance criteria" for the syringe's physical and biological properties.
| Requirement - Test (ISO 7886-1) | Reported Device Performance (Result) |
|---|---|
| Limits for extractable metals | Pass |
| General | Pass |
| Limits for acidity or alkalinity | Pass |
| Conical fitting | Pass |
| Position of nozzle on end of barrel | Pass |
| Tolerance on graduated capacity | Pass |
| Scale | Pass |
| Numbering of scales | Pass |
| Overall length of scale to nominal capacity line | Pass |
| Position of scale | Pass |
| Barrel flanges | Pass |
| Plunger stopper/plunger assembly | Pass |
| Dead space | Pass |
| Freedom from air and liquid leakage past plunger stopper | Pass |
| Force to operate the piston | Pass |
| Fit of plunger stopper/plunger in barrel | Pass |
| Unit packaging and self-contained syringe units | Pass |
| Quantity of silicone oil | Pass |
| Requirement - Test (ISO 7864) | Reported Device Performance (Result) |
|---|---|
| Cleanliness | Pass |
| Tolerances on length | Pass |
| Needle Point, needles with sharp tip only | Pass |
| Bond between hub and needle tube | Pass |
| Patency lumen | Pass |
| Requirement – Test (ISO 9626) | Reported Device Performance (Result) |
|---|---|
| Stiffness | Pass |
| Resistance to breakage | Pass |
| Resistance to corrosion | Pass |
| Requirement - Test (USP 788) | Reported Device Performance (Result) |
|---|---|
| Particulate matter injections | Pass |
| Biocompatibility Test Item | Test Method / Test Criteria | Reported Device Performance (Result) |
|---|---|---|
| Cytotoxicity | ISO 10993-5 Tests for in vitro cytotoxicity | Pass |
| Skin Sensitization Test | ISO 10993-10 irritation and skin sensitization | Pass |
| Intracutaneous Reactivity Test | ISO 10993-10 Test for irritation and skin sensitization, maximization test for delayed hypersensitivity | Pass |
| Acute Systemic Toxicity Test | ISO 10993-11 Test for systemic toxicity - Acute Systemic Toxicity | Pass |
| Pyrogen Test | ISO 10993-11 Tests for systemic toxicity, Annex(F) Information on material-mediated pyrogens. | Pass |
| Hemolysis Test | ISO 10993-4 Selection of tests for interactions with blood | Pass |
| Sterility and LAL Test Item | Test Standard | Reported Device Performance (Result) |
|---|---|---|
| LAL test (Bacterial Endotoxins) | USP39 (Unit : EU/Device) | Pass |
| Sterility test | According to ISO 11737-2 | Pass |
| E.O Residual | Under the conditions of ISO 10993-7:2008, Ethylene oxide sterilization residuals | Pass |
Information Not Applicable or Not Present:
The following information is specifically requested for AI/Software as a Medical Device (SaMD) performance studies, which are not described in this 510(k) summary for a physical medical device (syringe). Therefore, the answers are "Not Applicable" or "Not Provided" in this context.
- 2. Sample sized used for the test set and the data provenance: Not applicable. The tests are bench tests of physical characteristics, not data-driven AI test sets with specific sample sizes from a clinical population.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not established for a physical syringe.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is for AI performance 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 for AI performance evaluation.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI performance evaluation. The device is a physical syringe.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. This is for AI performance evaluation. The "ground truth" for the syringe is its compliance with specified physical and biological standards.
- 8. The sample size for the training set: Not applicable. There is no AI training set for a syringe.
- 9. How the ground truth for the training set was established: Not applicable. There is no AI training set for a syringe.
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(441 days)
Feeltech Co., Ltd.
The Miracu™ barbed surgical suture is comprised of dyed polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate. The anatomical location(s) of use are on the skin for dermatological applications only. The suture is not intended for interior body cavity applications and the suture is not intended for lifting and supporting tissues.
Miracu™ synthetic barded surgical absorbable polydioxanone (PDO) suture with needle is straight, hollow, cannula and is pre-loaded onto the suture. The pigment for the violet dye is D&C Violet No.2. The Miracu™ is available sterile after ethylene oxide (EO) gas sterilization and degrades or dissolves over time in tissue. Each dyed (violet) suture has bi-directional barbs along axis of the suture monofilament. The Miracu™ Synthetic Absorbable PDO suture with needle approximate tissue without the need to tie surgical knots, by using the opposing barbs on the surface to embed in the tissues after the surgeon precisely places the suture within the tissues. The suture is available in 4-0, 3-0, and 0, suture sizes, which are the sizes identified in the currently recognized United States Pharmacopeia (USP). The Miracu™ is barbed to two sections on suture and the barbs on each section are opposite direction each other.
The provided document is a 510(k) premarket notification for a medical device called "Miracu™ barbed surgical suture." It details the device's characteristics, intended use, and a comparison to a predicate device ("TranQuill Barbed Device"). However, the document does not describe a study involving an AI-powered device, nor does it provide details on acceptance criteria and performance metrics for such a device. The device in question is a physical surgical suture.
Therefore, I cannot fulfill the request to describe the acceptance criteria and study that proves an AI device meets those criteria, as the provided text pertains to a physical surgical suture.
The document mainly focuses on proving the substantial equivalence of the Miracu™ suture to a predicate device through:
- Bench Testing (Mechanical Testing): This involved tests for dimension, tensile strength, and bend testing of needles, conducted in accordance with USP 37-NF 32:2014 and ASTM F1874-98.
- Biocompatibility Testing: Performed in accordance with ISO 10993-1:2009, covering intracutaneous, acute systemic toxicity, cytotoxicity, bacteria reverse mutation, implantation, subchronic, sensitization, bacterial endotoxin, and material-mediated pyrogen tests.
- Animal Studies: An in-vivo biodegradation study comparing Miracu™ to the predicate device in Sprague-Dawley rats, evaluating barb holding forces, residual tensile strength, and absorption over 12 weeks.
Since the original request is specifically about an "AI-powered device" and the provided text is about a "surgical suture," it's impossible to extract the requested information as it does not exist within the given document.
If you have a document describing an AI medical device, please provide it, and I will be happy to answer your questions based on that information.
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