Search Results

The STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Devices are indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.

STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Devices are antibacterial monofilament, synthetic absorbable devices consisting of dyed (violet) polyester, poly(p-dioxanone), the empirical molecular formula of which is (C4H6O3)X. The devices contain IRGACARE® MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 μg/m. The pigment for the violet dye is D&C Violet No. 2. Polydioxanone polymer has been found to be nonallergenic, nonpyrogenic and elicits only a slight tissue reaction during absorption.

The STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Devices are available in Unidirectional and Bidirectional forms:

• The STRATAFIX™ Spiral PDS™ Plus Unidirectional Knotless Tissue Control Devices consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The STRATAFIX™ Spiral PDS™ Plus Unidirectional Knotless Tissue Control Device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. Barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.

• The STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device consists of barbed suture material, armed with a surgical needle on each end. The device also contains an un-barbed center transition zone that facilitates the initiation of the device use. The barbs allow for tissue approximation without the need to tie surgical knots.

While the formation of barbs in the STRATAFIX™ Spiral PDS™ Plus Devices reduce the tensile strength relative to non-barbed suture material of the same size, tying of knots in non-barbed suture materials also reduces their effective strength. For this reason, the strength of the STRATAFIX™ Spiral PDS™ Plus Devices can be compared to USP knot strength of non-barbed sutures. Additionally, USP designations for diameter are used to describe the STRATAFIX™ Spiral PDS™ Plus Devices suture material after barbing, except for minor variation in suture diameter with a maximum overage of 0.1 mm.

N/A

Ask a specific question about this device

PDS™ Plus Suture is indicated for use in general soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur. PDS™ Plus Suture is not indicated in adult cardiovascular and neurological tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to 6 weeks) is desirable.

PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture is a sterile synthetic absorbable monofilament suture made from the polyester poly (p-dioxanone). The empirical molecular formula of the polymer is (C₄H₆O₃)ₙ.

PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture is available undyed and dyed with D&C Violet No. 2.

PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture contains Triclosan, a broad spectrum antibacterial agent, ranging between 42 – 2360 µg of Triclosan per meter of suture. The maximum of 2360 µg/m falls well below literature values for toxicity of Triclosan based on a single worst-case dose.

The lower specification limit is set at a value where claims for in-vitro antibacterial activity can be supported across all product variants throughout their shelf-life.

N/A

Ask a specific question about this device

The Miracu™ Absorbable Polydioxanone Suture with Needle (MONO) 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 absorbable PDO suture with needle is made of polydioxanone. 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 no barbs along the long axis of the suture monofilament with needle attachment. The Miracu™ Synthetic Absorbable PDO suture with needle (No Barb) approximates tissue is equivalent in form and function to the predicate device DemeDIOX (K181582).

The proposed suture is available in 4-0, 5-0, 6-0 suture sizes, which are the sizes identified in the currently recognized United States Pharmacopeia, and is equivalent to sizes available in the PDREX reference device (K173779).

The formation of barbs in the Miracu™ reduces the tensile strength relative to non-barbed suture material of the same size. Therefore, the suture tensile strength for the Non Barbed is not compromised and is equal or stronger than the barbed reference configuration. The Miracu™ non-barbed suture is made from the same material, sterilized in the same manner, and packaged as the barbed reference device Miracu™ (K172602).

The strength of the Miracu™ (non Barbed) can be compared with, and is substantially equivalent to, the publicly available information for the PDS Plus (K212380).

N/A

Ask a specific question about this device

The V-Soft Line™ barbed device 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.

The V-Soft Line™ synthetic absorbable PDO suture with needle is made of polydioxanone. The pigment for the violet dye is D&C Violet No.2. The V-Soft Line™ is available sterile after ethylene oxide (EO) gas sterilization and degrades or dissolves over time in tissue. The barbed sutures are pre-loaded and are not attached to the needle.

Each dyed (violet) suture has bi-directional barbs along the long axis of the suture monofilament with needle attachment. The V-Soft Line™ Synthetic Absorbable PDO suture with needle approximates 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 proposed suture is available in 2, 2-0, and 3-0 suture sizes, which are the sizes identified in the currently recognized Unites States Pharmacopeia.

The V-Soft Line™ is barbed to two sections on suture and the barbs on each section are opposite direction each other. The reason that this suture has each opposite barb direction is not to slide and move to forth and back and to fix well. Therefore, the effectiveness of suture for treatment can be improved.

N/A

Ask a specific question about this device

The Suture-TOOL System is intended for abdominal wall closure after laparotomy in patients 18 years old and older.

The Suture-TOOL System is a single-use, sterile, suture applicator with a polydioxanone resorbable suture pre-mounted to the needle. The polydioxanone monofilament synthetic absorbable sutures are prepared from polyester, poly(p-dioxanone). The empirical molecular formula of the polymer is as follows: -(0-CH2-CH2-O-CH2-CO)n- The sutures are dyed with D&C Violet No. 2 (21CFR§ 74.3602) and are available in size 2. The Suture-TOOL System includes the following: - Polydioxanone resorbable suture pre-mounted on the needle -1020S (Suture&Needle). - Suture-TOOL 1018S (suture applicator) Before use, the user must follow the instructions to attach the needle, preloaded with the suture, to the applicator.

The provided text describes the regulatory clearance of a medical device, the "Suture-TOOL System," and compares it to predicate and reference devices. However, it does not contain the specific information required to answer the questions about acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/human-in-the-loop study.

This document focuses on the substantial equivalence of a physical surgical device (suture and applicator) based on material properties, performance testing (tensile strength, diameter, needle attachment), biocompatibility, and human factors testing related to its physical use. It does not describe an AI medical device or a study involving human readers and AI assistance for diagnostic or interpretative tasks.

Therefore, I cannot provide the requested information from the given text. The text does not provide:

1. A table of acceptance criteria and reported device performance: While it mentions USP criteria were met or exceeded for physical tests, it doesn't present these as specific acceptance criteria in a table format.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study effect size, standalone performance, type of ground truth, training set size, or how ground truth for training was established. These are all concepts relevant to AI/diagnostic studies, which are not described in this regulatory submission for a physical surgical device.

The study referenced ("Börner and Montgomery, 2020; and Börner et al., 2022") appears to be a nonclinical performance study related to the physical surgical technique (SL/WL ratio, reducing needle stick injuries), not an AI performance study measuring diagnostic accuracy.

Ask a specific question about this device

Secret Line up and i-Thread (Sterile single use absorbable polydioxanone suture with needle) comprised of dyed polydioxanone suture with a sterile needle. It is indicated for use in soft tissue approximation where use of absorbable suture is appropriate. The suture is not intended for body cavity applications, nor is it intended for lifting and supporting tissues; it is intended for dermatological use only.

Secret Line up and i-Thread (Sterile single use absorbable polydioxanone suture with needle) consist of a cannula type needle which is straight and hollow (pre-loaded on the suture), a needle cap, a hub, a sponge and polydioxanone (PDO) suture which is sterilized by ethylene oxide (EO) gas. The pigment for the violet dye is D&C Violet No.2. PDO Sutures are characterized by their bidirectional barbs along axis of the monofilament. The bidirectional barbs of barbed suture are precisely lodged in tissue, making it feasible to anchor in the tissue and prevent movement in both directions without the need for a surgical knot. As a result, the barbed suture improves the effectiveness of treatment.

The provided document is a 510(k) premarket notification for a medical device called "Secret Line up" and "i-Thread," which are absorbable polydioxanone sutures with needles. The document asserts that the subject device is substantially equivalent to a previously cleared predicate device (K240389).

However, the document does not contain any acceptance criteria or study results that prove the device meets specific performance criteria related to AI or algorithm-only performance. This is because the device described is a physical surgical suture, not an AI/algorithm-driven device.

Therefore, I cannot fulfill the request for information regarding AI/algorithm acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies, as these types of studies are not applicable to the non-AI medical device described in the input.

The document primarily focuses on demonstrating substantial equivalence of the subject suture to a predicate suture based on material, manufacturing, sterilization, and physical performance tests, not on any AI or software-related functional performance.

Therefore, many parts of your request for information related to AI/algorithm performance studies cannot be answered based on the provided document.

Here’s what can be extracted and inferred from the document regarding the physical medical device:

Acceptance Criteria and Device Performance (Not for AI, but for the physical suture)

The document does not present a formal table of "acceptance criteria" for the device's main performance as a suture with corresponding "reported device performance" in a quantitative manner as one might expect for an AI algorithm. Instead, it lists the types of performance tests conducted and states that they "Pass." The acceptance criteria are implicitly the successful completion of these tests as per relevant standards.

Table of Acceptance Criteria (Inferred from standards and tests listed) and Reported Device Performance (Summary)

Information Not Applicable or Not Found (Relevant to AI/Algorithm Studies):

1. Sample sizes used for the test set and data provenance (e.g., country of origin of the data, retrospective or prospective): This information is not provided as the tests are for a physical device, not an AI algorithm. The document mentions "in vivo testing in Sprague-Dawley Rat" for animal studies, but doesn't specify sample sizes for these, nor does it detail human subject data for an AI test set.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical suture's performance (e.g., tensile strength) is established by direct measurement and compliance with engineering standards, not by expert consensus on interpretations of data.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This pertains to expert review for AI ground truth.
4. 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 surgical suture, not an AI assistance tool for human readers. The document explicitly states "no Clinical Studies were performed nor required."
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this physical device is established by bench testing against ISO, USP, and ASTM standards, and animal studies for in-vivo performance (absorption, barb holding, tensile strength over time).
7. The sample size for the training set: Not applicable, as this is not an AI device with a training set.
8. How the ground truth for the training set was established: Not applicable, as this is not an AI device.

In summary, the provided document is a 510(k) submission for a traditional physical medical device (a surgical suture) and, therefore, does not contain any of the specific information requested regarding acceptance criteria and study designs pertinent to AI/algorithm performance. The 'acceptance criteria' for this device are implicitly derived from the successful execution of a range of standard physical, chemical, biological, and sterilization tests.

Ask a specific question about this device

The Cypris eXact Suture Placement Device is indicated for use in general soft tissue approximation when used with sutures.

The Cypris eXact Suture Placement Device is for use in general soft tissue approximation by surgeons, and it is single-use and provided sterile. It is a hand-held device used for the placement of a surgical suture, and the device consists of a handle, needle driver, and tissue capture port. The handle is designed for manual manipulation of the suture placement device, allowing the surgeon to advance the device to the desired deployment site. The needle driver functions to pass the suture when it is advanced and retracted. The tissue capture port consists of a capture chamber, needle, and hook assembly, and holds the tissue to be sutured during either manual palpation or vacuum-assisted palpation of tissue into the tissue capture port. Suture placement is achieved by advancing and retracting the needle driver.

{
"1. A table of acceptance criteria and the reported device performance": {
"Acceptance Criteria": [
"Biocompatibility endpoints evaluated (cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogenicity)",
"Integrity of the sterile barrier and functionality of the device after 3 years of real-time aging",
"Performance as expected",
"Use of vacuum-assisted palpation equivalent to manual palpation by the predicate device",
"Peak suction force measurement at 25.0 inHg"
],
"Reported Device Performance": [
"Device underwent testing for cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogenicity.",
"Testing demonstrated integrity of the sterile barrier and functionality after 3 years of real-time aging (shelf-life is 3 years).",
"Testing demonstrated that the subject device performs as expected.",
"Testing demonstrated that the use of vacuum-assisted palpation is equivalent to the use of manual palpation by the predicate device.",
"At a vacuum level of 25.0 inHg, the minimum, maximum, and average measured peak suction force achieved was 0.753 lbf, 1.052 lbf, and 0.904 lbf, respectively."
]
},
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The provided text describes non-clinical testing. It does not mention specific sample sizes for a test set in the context of clinical data or human subjects. The data provenance is not specified, but the testing appears to be laboratory-based (non-clinical).",
"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. This is a non-clinical study for a manual surgical instrument, not an AI/imaging device requiring expert ground truth establishment for a test set.",
"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable. This is a non-clinical study for a manual surgical instrument, not an AI/imaging device requiring an adjudication method.",
"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 a non-clinical study for a manual surgical instrument, not an AI/imaging device. No MRMC study was conducted or mentioned.",
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Not applicable. This is a non-clinical study for a manual surgical instrument. No algorithm or standalone performance testing was mentioned.",
"7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "Not applicable. For this non-clinical study, ground truth was established by adherence to performance specifications and established biocompatibility standards.",
"8. The sample size for the training set": "Not applicable. This is a non-clinical study for a manual surgical instrument, not an AI/machine learning device requiring a training set.",
"9. How the ground truth for the training set was established": "Not applicable. This is a non-clinical study for a manual surgical instrument, not an AI/machine learning device. No training set was used or ground truth established for one."
}

Ask a specific question about this device