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Found 18 results
510(k) Data Aggregation
(187 days)
SECUREPORTIV® ADVANCED Catheter Securement Adhesive is to be applied as a film forming securement and sealant at the point of vascular access catheter skin entry. The film holds the catheter to the skin to reduce catheter movement, migration, and/or dislodgment. It is used to protect the catheter skin entry site by creating a sealant that immobilizes surface bacteria, preventing them from entering into the catheter skin entry site while a moisture barrier. SECUREPORTIV® ADVANCED is intended to be used with a transparent film dressing for the securement of short-term and long-term vascular access catheters including peripheral IVs, PICCs, and CVCs.
SecurePortIV Advanced Catheter Adhesive is a sterile, professional liquid cyanoacrylatebased adhesive containing a monomeric formulation (2-octyl cyanoacrylate) and the colorant D&C Violet #2. The device is an applicator with the formulation incorporated in an ampoule housed in a tapered plastic tube. The SecurePortIV Advanced liquid is applied as a film forming securement and sealant at the point of catheter skin entry, polymerizing in minutes.
The SecurePortIV Advanced Catheter Securement Adhesive underwent various tests to demonstrate its safety and effectiveness, leading to its clearance based on substantial equivalence to a predicate device.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Catheter Adhesion to Skin | Hold BD Autoguard Catheter 1, 3, and 7 days; Hold Nexiva catheter 1 to 7 days | Pass, same as predicate device |
| Sealant of the Cannulation Site | Prevent dye penetration at 1, 4, and 7 days | Pass, same as predicate device |
| Immobilization of Surface Bacteria | Prevent bacteria from penetrating cannulation site | Pass, same as predicate device |
| Removal Time | Same removal time as predicate device | Pass, same as predicate device |
| Clinical (Securement Time) | Securement time obtained | Pass (14 seconds, compared to predicate's 143 seconds) |
| Cytotoxicity | ISO 10993-5: Tests for in vitro cytotoxicity | Pass |
| Sensitization | ISO 10993-10: Tests for irritation and skin sensitization | Pass |
| Irritation | ISO 10993-10: Tests for irritation and skin sensitization | Pass |
| Pyrogenicity | LAL Limit Screen; Current USP | Pass |
| Acute Systemic Toxicity | ISO 10993-10: Tests for irritation and skin sensitization | Pass |
| Subacute Systemic Toxicity | ISO 10993-11: Tests for systemic toxicity | Pass |
| Implantation | ISO 10993-6: Tests for local effects after implantation | Pass |
| Intracutaneous | ISO 10993-10: Tests for irritation and skin sensitization | Pass |
| Hydrolytic Degradation | for pyrogenicity). |
- Quantitative measurements: For securement time, a specific time (14 seconds) was measured and reported.
8. Sample Size for the Training Set
This question is not applicable as the device is a physical medical product, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device is a physical medical product, not an AI algorithm.
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(115 days)
The SECURE-LOCK is indicated for fixation of bone or soft tissue to bone, and is intended as a fixation device, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair such as Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) Repair and Reconstruction.
The SECURE-LOCK fixation device consists of a sterile and non-absorbable polyester and ultrahigh molecular weight polyethylene blended braid that forms a loop on a titanium alloy button. The button sits on the cortex over the exit to a bone tunnel, suspending the loop inside the tunnel to provide secure, strong fixation for ligament repair and reconstruction. The SECURE-LOCK fixation device is supplied with polyester sutures that are used to assemble and deliver the device.
The provided text describes the 510(k) summary for the SECURE-LOCK device, a suspensory fixation device for ACL/PCL repair and reconstruction. It outlines the device's characteristics, intended use, and performance data to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative table format with corresponding "reported device performance" values for clinical efficacy. Instead, it lists various performance tests conducted to demonstrate the device's mechanical properties, safety, and substantial equivalence to a predicate device. The conclusion states that the device provides "appropriate mechanical properties and is relatively safe for its use."
However, based on the tests conducted, we can infer performance areas:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Properties | |
| Implant Tensile Strength (Sufficient for fixation) | Tested (result reported as demonstrating "appropriate mechanical properties") |
| Implant Fatigue (Durability over time) | Tested (result reported as demonstrating "appropriate mechanical properties") |
| Pulling Suture Tensile Strength (Sufficient for delivery) | Tested (result reported as demonstrating "appropriate mechanical properties") |
| Suture Diameter (Meeting manufacturing specifications) | Measured (result reported as demonstrating "appropriate mechanical properties") |
| Biocompatibility & Safety | |
| Biocompatibility (No adverse biological reactions) | Tested in accordance with ISO 10993-1 (Implied to meet standards for safety) |
| Pyrogenicity (Absence of fever-inducing substances) | Bacterial endotoxin testing performed on representative devices (XTREME-LOOP and SECURE-LOOP) using Limulus Amoebocyte Lysate (LAL) method. Results met FDA requirements of and meets specification limits. Final product batch release testing for endotoxins will be carried out on the subject device in accordance with ANSI/AAMI ST72:2019. |
| MRI Compatibility (Safe for use in MR environment) | Tested (Implied to meet standards for safety in an MR environment) |
| Functional Equivalence | |
| Performance in Simulated Use Conditions (Effective function) | Formal assessment of the SECURE-LOCK design in simulated use conditions (Implied satisfactory performance) |
| Characterization of UHMWPE (Material integrity) | Tested (Implied to meet standards for material integrity) |
| Substantial Equivalence to Predicate (Overall safety/efficacy) | Concluded to be substantially equivalent to the Arthrex ACL Tightrope (K112990), with differences being minor and not raising safety/effectiveness concerns. |
Study Details
The document describes performance testing rather than a clinical study with a test set of human subjects. The assessment is based on bench testing of the device itself and its materials.
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Sample size used for the test set and the data provenance: Not applicable in the context of a clinical test set. The "test set" here refers to physical devices and materials undergoing various laboratory tests (tensile strength, fatigue, etc.). There is no mention of the specific number of devices tested for each performance test, but it is implied that representative samples were used. Data provenance is internal laboratory testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical and material properties is established by recognized engineering and material science standards and measurement techniques, not expert consensus in the diagnostic sense.
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Adjudication method for the test set: Not applicable for device performance testing against established standards. Results are compared directly to pre-defined specification limits or industry standards (e.g., ISO, USP, ANSI/AAMI).
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a device 510(k) submission focused on demonstrating substantial equivalence through bench testing and material characterization, not a comparative clinical effectiveness study involving human readers or patient outcomes, especially not in the context of AI.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is a medical device (fixation implant), not a software algorithm or AI device.
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The type of ground truth used:
- Mechanical Performance: Engineering specifications, industry standards (e.g., for tensile strength, fatigue, suture properties).
- Biocompatibility: ISO 10993-1 standards.
- Pyrogenicity: FDA requirements ( specification limits.
- MRI Compatibility: Recognized standards for safety in MR environments.
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The sample size for the training set: Not applicable. There is no training set as this is not an AI/ML device.
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How the ground truth for the training set was established: Not applicable.
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(168 days)
The Secure Wear USA™ Surgical Face Mask is intended to be worn to protect both the patient and the healtheare professional from transfer of microorganisms, body fluids, and particulate material. The surgical face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, nonsterile, disposable device.
Secure Wear USA™ Surgical Face Mask Product models: Surgical Face Mask, Ear Loop, Level 1: Surgical Face Mask, Ear Loop, Level 2: Surgical Face Mask, Ear Loop, Level 3; Surgical Face Mask, Tie-on, Level 1; Surgical Face Mask, Tie-on, Level 2; Surgical Face Mask, Tie-on, Level 3.
This document is a 510(k) clearance letter for a surgical face mask and does not describe acceptance criteria, a study, or device performance against such criteria. The letter confirms that the device is substantially equivalent to a legally marketed predicate device, but it does not provide information about performance studies for the device itself.
Therefore, I cannot extract the requested information from the provided text.
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(106 days)
The SECURE Screw is intended for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
The A.M. Surgical SECURE Screw is a stainless steel, cannulated, partially threaded, headless screw intended to be used for fracture fixation of small, long bones of the hands and feet. Screw threads provide compression to promote reunion of fracture fragments. The device is offered in five different lengths; 40mm, 45mm, 50mm, 55mm, and 60mm. All dimensions, excluding length, are the same among the different sizes. These varying lengths allow for personalized medical treatment of fractures geared toward each individual patient and different types of fractures. The device is manufactured out of a single piece of 316L VM (UNS-S31673) stainless steel, is provided sterile (via gamma radiation), and is not reusable or re-sterilizable. This device is intended for permanent implantation, but can also be removed. To install and remove the device from a patient, the F543 compliant T8 hexalobe drive connection on the screw head is used in conjunction with a commercially available guide wire, drill bit, and driver.
The provided text is a 510(k) summary for a medical device called the SECURE Screw, a bone fixation fastener. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where a device's performance is measured against acceptance criteria in the context of an AI/human-in-the-loop system.
Therefore, I cannot extract the acceptance criteria and study details as requested for an AI system because this document does not pertain to the evaluation of an AI-powered device.
The document describes a traditional medical device (a screw for bone fixation) and its regulatory clearance process, which relies on demonstrating substantial equivalence to an already marketed device. This process primarily involves comparing design, materials, indications for use, and performance testing against established industry standards.
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(220 days)
SecurePortIV™ catheter securement adhesive is to be applied as a film forming securement and sealant at the point of vascular access catheter skin entry. The film holds the catheter to the skin to reduce catheter movement, migration, and/or dislodgment. It is used to protect the catheter skin entry site by creating a sealant that immobilizes surface bacteria, preventing them from entering into the catheter skin entry site while also providing a moisture barrier. SecurePortV™ is intended to be used with a transparent film dressing on short-term and long-term vascular access catheters including peripheral IVs, PICCs, and CVCs.
SecurePortIV Catheter Adhesive is a sterile, professional liquid cyanoacrylate-based adhesive containing a two monomeric formulation (2-octyl cyanoacrylate and butyl cyanoacrylate) and the colorant D&C Violet #2. The device is an applicator with the formulation incorporated in an ampoule housed in a tapered plastic tube.
The SecurePortIV liquid is applied as a film forming securement and sealant at the point of catheter skin entry, polymerizing in minutes. It is intended to be used in conjunction with a transparent film dressing.
This document describes the premarket notification for the "SecurePortIV Catheter Securement Adhesive" (K170505). However, the document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report demonstrating the device meets specific acceptance criteria. The information provided is descriptive of the device and comparative to predicates.
Therefore, many of the requested elements for a study proving a device meets acceptance criteria are not explicitly present in the provided text. I will extract what I can and note where information is missing.
Here's an attempt to answer your questions based on the provided text, with clear indications where the information is not available:
1. A table of acceptance criteria and the reported device performance
The document does not present explicit "acceptance criteria" in the format of defined metrics and thresholds that the SecurePortIV device must pass. Instead, it presents a comparison table (Table 1) against predicate and reference devices, aiming to show comparable or superior performance to establish substantial equivalence. The "Acceptance Criteria" here are implicitly that the SecurePortIV performs "as well or better than" the legally marketed predicate/reference devices across various characteristics.
| Characteristic | Implicit Acceptance Criteria (based on comparison) | Reported Device Performance (SecurePortIV) |
|---|---|---|
| Indications for Use (IFU) | Comparable functionality to predicate/reference device, with specific claims. | Film forming securement and sealant at vascular access catheter skin entry. Holds catheter to skin to reduce movement/migration/dislodgement. Protects skin entry site by creating sealant that immobilizes surface bacteria, prevents entry, and provides moisture barrier. Intended for use with transparent film dressing on short-term and long-term vascular access catheters (peripheral IVs, PICCs, CVCs). |
| Adhesion Strength/Securement | Statistically equal or significantly greater than commercial transparent adhesive dressings; no pullout failures under challenge. | In vitro: Adhesion strength values statistically equal or significantly greater than several commercially available transparent adhesive dressings from 3 minutes to 7 days. |
| In vivo (dog study): Presented significant shear pull out force challenge (100g) with no pullout failures in any test point for 6 hours (SecurePortIV alone and in combination with transparent film dressing). | ||
| Moisture Barrier | Provides a film barrier to moisture penetration, comparable to predicate. | Provides a film barrier to moisture penetration. Activity shared with reference product (seal repellant). |
| Anti-bacterial Activity | Immobilization of bacteria, equivalently effective against gram positive and gram negative bacteria (compared to predicates). | Immobilization of bacteria. Identical to primary predicate; different anti-bacterial to secondary predicate, but all equivalently effective against gram positive and gram negative bacteria. |
| Protection Duration | 5 days to skin sloughing, comparable to predicate. | 5 days to skin sloughing. (Identical to predicate). |
| Packaging Material | Identical to predicate. | Primary - Barex. Identical ampoule material reservoir to predicate. |
| Viscosity |
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(89 days)
The SECURE-LOOP is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as anterior cruciate ligament (ACL) reconstruction.
The SECURE-LOOP fixation device consists of a polyester continuous loop captured on a titanium alloy button. The button sits on the exit to a bone tunnel on the cortex, suspending the continuous loop inside the tunnel to provide secure, strong fixation for ligament reconstruction. The SECURE-LOOP fixation device is supplied with sutures that are used to pull the graft assembly into place and then flip the button allowing ligament reconstruction to be performed arthroscopically.
The provided text describes the SECURE-LOOP device and its substantial equivalence to a predicate device, the Smith & Nephew Endobutton Continuos Loop (ECL) K980155. It focuses on comparing the technological characteristics and performance of the SECURE-LOOP with the predicate device rather than presenting specific acceptance criteria and a study to prove they are met in a traditional sense.
Instead of a typical AI/ML device study, the document describes a device equivalency study based on pre-clinical testing for a medical fastener.
Here's an analysis based on the information provided, formatted to answer your questions where applicable:
Acceptance Criteria and Device Performance
The document does not explicitly state "acceptance criteria" in terms of specific performance metrics with numerical thresholds. Instead, the criterion for the SECURE-LOOP device is substantial equivalence to the predicate device (Smith & Nephew Endobutton Continuos Loop (ECL) K980155) across several performance characteristics.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (SECURE-LOOP vs. Predicate) |
|---|---|
| Stiffness equivalence | Determined to be substantially equivalent to Endobutton Continuous Loop (ECL) |
| Tensile strength equivalence | Determined to be substantially equivalent to Endobutton Continuous Loop (ECL) |
| Cyclic fatigue testing equivalence | Determined to be substantially equivalent to Endobutton Continuous Loop (ECL) |
| Functional testing equivalence | Determined to be substantially equivalent to Endobutton Continuous Loop (ECL) |
| No new issues of safety and efficacy | Testing demonstrated that differences do not raise any new issues of safety and efficacy. |
| Similar safety and effectiveness profile | Based on pre-clinical testing, found to have a safety and effectiveness profile similar to predicate device |
Study Details:
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Sample size for the test set and data provenance:
The document does not specify the exact sample sizes (i.e., number of devices or test repetitions) used for the stiffness, tensile strength, cyclic fatigue, and functional testing.
The provenance of the data (country of origin, retrospective/prospective) is not mentioned beyond stating "pre-clinical testing." -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the study involves device performance testing against a predicate, not human expert interpretation for ground truth establishment. -
Adjudication method for the test set:
Not applicable, as it is a physical device performance comparison, not a ground truth establishment process involving multiple experts. -
If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
No, an MRMC study was not done. This type of study is typically for diagnostic imaging devices involving interpretation by multiple human readers, which is not relevant for this orthopedic fixation device. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is generally relevant for AI/ML algorithms. For this physical device, the "standalone performance" is implicitly what was measured in the pre-clinical tests (stiffness, tensile strength, cyclic fatigue, functional testing) where the device's properties were characterized without human intervention in its function. -
The type of ground truth used:
The "ground truth" in this context is the established performance characteristics of the predicate device which the SECURE-LOOP device is attempting to demonstrate equivalence to. The performance parameters (stiffness, tensile strength, cyclic fatigue, functional performance) of both the SECURE-LOOP and the predicate device are determined through laboratory-based physical/mechanical testing. -
The sample size for the training set:
The concept of a "training set" is not applicable here as this is not an AI/ML device. The testing described is for performance validation, not for training a model. -
How the ground truth for the training set was established:
Not applicable, as there is no training set for an AI/ML model.
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(149 days)
Cardinal Health Secure-Gard® surgical and procedure masks are intended to be worn by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health Secure-Gard® surgical and procedure masks are single use, disposable devices provided non-sterile.
The Cardinal Health Secure-Gard® surgical and procedure masks are all the same four-layer masks constructed of 1 layer of nonwoven cellulose (inner facing), 1 layer of nonwoven polvolefin melt blown (media). 1 laver of nonwoven polyester/polvethylene blends (media), and 1 layer polyolefin spunbond material (outer facing). The four layers of the mask body are collated and sonically welded around the edges to enclose the filter media. The mask is provided with nonwoven polyolefin ties or polyester-spandex earloops (both attached by ultrasonic welding). A malleable nosepiece is placed within the binding for comfort and individualized fit around the wearer's nose. The surgical masks will be provided with or without an eye shield. Cardinal Health surgical and procedure masks are a single use, disposable device provided non-sterile.
Here's an analysis of the acceptance criteria and study detailed in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria per ASTM F2100-11 Level 3 (AQL = 4.0%) | Reported Device Performance (Current device test results) | Average Performance |
|---|---|---|---|
| ASTM F1862 Synthetic Blood (Resistance to Penetration) | 160 mmHg | 32/32 Pass | Not Applicable |
| ASTM F2101 BFE (Bacterial Filtration Efficiency) | ≥ 98% | 32/32 Pass | 99.4 - 99.7% |
| ASTM F2299 PFE at 0.1 micron (Particle Filtration Efficiency) | ≥ 98% | 32/32 Pass | 98.6 - 99.1% |
| Mil-M-36954C Delta P (Differential Pressure / Breathability) |
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(134 days)
Secure Implant System(2.5/3.0mm) is designed for use in dental implant surgery and is intended for use in a manner in which the implants integrate with the bone(osseointegration). It is intended to provide immediate transitional splinting stability or intrabony long-term fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients
Sccure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy. The implant is produced by machining process, followed by grit blasting and cleaning. It is available in diameters 2.5 and 3.0mm, and lengths from 8mm to 16mm.
The provided text describes a 510(k) submission for the "Secure Implant System (2.5/3.0mm)", which is an endosseous dental implant system. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than for proving efficacy through clinical studies with acceptance criteria and device performance metrics in the way a new drug or novel medical device might.
Therefore, the document does not contain information on:
- Acceptance criteria tables with reported device performance: This submission relies on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use, rather than meeting specific performance metrics derived from a clinical study.
- Sample sizes used for a test set or data provenance
- Number or qualifications of experts for ground truth establishment
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study
- Standalone (algorithm-only) performance
- Type of ground truth used (e.g., expert consensus, pathology, outcomes data)
- Sample size for the training set
- How ground truth for the training set was established
The study section of the document states: "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." This indicates that testing was performed internally by the manufacturer to ensure the device met its design specifications and performed as intended, which is standard for medical device development. However, specifics of this laboratory testing (e.g., acceptance criteria, test results) are not detailed in the provided 510(k) summary.
The primary method for demonstrating "device meets acceptance criteria" in this context is through substantial equivalence to predicate devices. The table provided in Section 14-12, "Substantial Equivalence Comparison," outlines the characteristics of the subject device (Secure Implant System) against two predicate devices (IntermezzoTM Plus and Zimmer One-Piece Implant System, though only IntermezzoTM Plus is detailed in the table). This comparison acts as the "study" proving the device's acceptability by showing it is similar enough to already-approved devices, rather than a clinical trial with specific performance metrics.
Summary of available information:
| Category | Information from Document |
|---|---|
| Acceptance Criteria & Reported Device Performance Table | Not applicable in the context of this 510(k) summary. The "acceptance criteria" here is substantial equivalence to predicate devices. The "performance" is implied by the similarity in design and materials. The document states: "Laboratory testing was conducted to determine device functionality and conformance to design input requirements," but does not provide specific criteria or results of this testing. |
| Sample Size (Test Set) & Data Provenance | Not applicable. There is no mention of a clinical test set in the provided text. The device is cleared based on substantial equivalence to predicate devices and laboratory testing to design inputs. |
| Number & Qualifications of Experts for Ground Truth | Not applicable. |
| Adjudication Method | Not applicable. |
| Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study | No MRMC study was conducted or reported. |
| Standalone Performance | The document mentions "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." This is typically a standalone assessment against predetermined design specifications, but no specific performance results are provided in this summary. |
| Type of Ground Truth Used | Not applicable in the context of clinical performance evaluation. The "ground truth" for a 510(k) is the established performance and safety of the predicate device(s). |
| Sample Size for Training Set | Not applicable. This is not an AI/Machine Learning device. |
| How Ground Truth for Training Set Was Established | Not applicable. |
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(79 days)
SEcure Adhesive Dental Cement is a dual-cure, self-etching, adhesive dental cement system. It is intended for indirect cementation of porcelain, ceramic, resin, and metalbased inlays, onlays, crowns, bridges, veneers and posts.
SEcure is a dual-cure, self-etching, adhesive dental cement system consisting of a self-etching primer and a two-part dental cement. The self-etching primer is supplied in a single bottle, while the dental cement is supplied in a double-barrel auto-mix syringe. The cement system does not require acid etching of tooth surfaces, and can be cured with any available curing light.
I am sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) summary for a dental cement, focusing on its description, intended use, and substantial equivalence to predicate devices for regulatory approval. It does not include details about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as typically found in a clinical study report or performance evaluation chapter.
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(37 days)
The SECURE® Arterial Blood Sampling Set is a hemodynamic pressure monitoring and blood gas sampling system designed to allow easy withdrawal of blood samples from an arterial pressure monitoring line while maintaining a completely closed system.
The SECURE® Arterial Blood Sampling Set is a hemodynamic pressure monitoring and blood gas sampling system.
I am sorry, but based on the provided text, there is no information available regarding the acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria.
The document is an FDA 510(k) clearance letter for the "SECURE® Arterial Blood Sampling Set." This letter primarily:
- Acknowledges the review of the premarket notification.
- States that the device is substantially equivalent to legally marketed predicate devices.
- Outlines general regulatory requirements and responsibilities for the manufacturer.
- Includes the "Indications for Use" statement for the device.
It does not contain:
- A table of acceptance criteria or reported device performance.
- Details about sample sizes for test or training sets.
- Information about experts used for ground truth or adjudication methods.
- Any mention of MRMC comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used or how it was established.
Therefore, I cannot provide the requested information.
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