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Found 7 results
510(k) Data Aggregation
(436 days)
The Arrow Epidural Catheter permits access to the administration of epidural anesthetic. The epidural catheter is intended for use up to 72 hours.
ARROW® FlexTip Plus® Epidural Catheters are single lumen catheters featuring a wire re-enforced polyurethane body with centimeter markings to facilitate placement.
This document is a 510(k) premarket notification for an ARROW FlexTip Plus Epidural Catheter (K140110). This specific submission is an update to the Magnetic Resonance (MR) Conditional statements in the Instructions for Use (IFU) for the previously cleared device (K103658).
Therefore, this document does not contain information about acceptance criteria and studies demonstrating device performance in the context of efficacy or clinical outcomes for an AI/software device. Instead, it focuses on demonstrating substantial equivalence for an updated MR safety label.
Here's an analysis of the provided text based on your request, highlighting why direct answers to some of your questions are not applicable to this type of medical device submission:
1. A table of acceptance criteria and the reported device performance
This document does not specify "acceptance criteria" and "device performance" in the context of clinical efficacy or diagnostic accuracy, as it is not an AI/software device. The performance testing mentioned is specifically for MR compatibility.
Table: MR Conditional Labeling Updates and Performance
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| MR Conditional | Safe for use under specified MR conditions (magnetic field interactions, heating, artifacts within acceptable limits). | Evaluation of Magnetic Field Interactions, Heating and Artifacts for FlexTip Plus Epidural Catheter, 19-gauge x 90-cm, Nonmagnetic SS Version. The specific results (e.g., temperature rise, artifact size, deflection angle) are not detailed in this summary but are referenced as being in Attachment C of the submission. The study aimed to provide corrected and updated MR Conditional statements in the IFU based on this testing. |
The following questions (2-9) are not applicable to this 510(k) submission because it is for a physical medical device (epidural catheter) with an update to its MR safety labeling, not a software or AI-driven diagnostic/therapeutic device. The concept of "test sets," "ground truth," "experts," "training sets," and "human-in-the-loop performance" are not relevant to demonstrating the MR compatibility of a catheter.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is not a study involving human data, but rather a physical device being tested for MR compatibility in a controlled laboratory environment.
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, in this context, refers to scientific measurement and engineering principles for MR compatibility, established by trained personnel in the testing laboratory (Shellock R&D Services).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication method is relevant for MR compatibility testing of a physical device.
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 not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI or software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" for MR compatibility is derived from standardized testing methodologies and measurements (e.g., using phantoms, thermocouples, and physical measurements) as outlined by relevant standards (e.g., ASTM F2119, F2182, F2052).
8. The sample size for the training set
- Not Applicable. There is no training set for a physical device's MR compatibility testing.
9. How the ground truth for the training set was established
- Not Applicable. There is no training set for a physical device's MR compatibility testing.
Summary of Relevant Information from the Document:
- Device: ARROW FlexTip Plus Epidural Catheter
- 510(k) Number: K140110
- Predicate Device: FlexTip Plus Epidural Catheter (K103658)
- Purpose of Submission: To update the MR Conditional statements in the Instructions for Use (IFU) based on revised magnetic resonance testing.
- Modification: Only the MR Conditional labeling was changed. The device's technological characteristics, materials, indications for use, and classification remain identical to the predicate.
- Performance Testing: "Evaluation of Magnetic Field Interactions, Heating and Artifacts for FlexTip Plus Epidural Catheter, 19-gauge x 90-cm, Nonmagnetic SS Version" by Shellock R&D Services, revised 7/15/2013. This testing was submitted to support the updated MR Conditional statements.
- Substantial Equivalence Conclusion: The updated MR Conditional labeling establishes parameters for safe use in an MRI environment, does not impact safety or effectiveness, and does not raise new questions of safety or efficacy. Substantial equivalence is based on the device being identical to its predicate in all other respects.
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(130 days)
When used with a Neptune Heated Humidifier and Hudson RCI ventilator circuits, the ConchaSmart Column provides heated humidification for patients with and without an artificial airway in place.
The ConchaSmart Column is an accessory to the Neptune Heated Humidifier (K063758 and K131912). It is a single use, disposable humidifier cartridge which is intended for neonatal, infant, pediatric, and adult patients requiring heated humidification. The ConchaSmart Column is used by inserting the column into the center of the Neptune Heated Humidifier.
The provided document is a 510(k) summary for the ConchaSmart Column, a respiratory gas humidifier. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria in the context of an AI/algorithm-based medical device.
Therefore, the requested information categories related to acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are largely not applicable to this type of regulatory submission. This document describes a medical device, but not an AI-powered one that would typically undergo the kind of performance evaluation requested.
However, I can extract the information that is present and indicate where the requested information is not applicable (N/A) or not provided in this document.
1. A table of acceptance criteria and the reported device performance
The document presents a comparison to a predicate device based on technological characteristics and performance specifications rather than explicit acceptance criteria and a study proving device performance against those criteria in the way an AI device would be evaluated. The "reported device performance" in this context refers to its specifications alongside those of the predicate.
| Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (ConchaSmart Column) |
|---|---|---|
| Intended Use | Same as predicate (Fisher & Paykel MR290) | When used with a Neptune Heated Humidifier and Hudson RCI ventilator circuits, provides heated humidification for patients with and without an artificial airway in place. |
| Patient Population | Neonatal, Infant, Pediatric, Adult | Neonatal, Infant, Pediatric, Adult |
| Humidification Therapies | Invasive, Non-Invasive, High Flow Nasal Cannula Therapy | Invasive, Non-Invasive, High Flow Nasal Cannula Therapy |
| Humidity Output | ISO 8185:2007 | ISO 8185:2007 |
| - Subglottic mode | ≥33mg H2O /L | ≥33mg H2O /L |
| - Supraglottic mode | ≥10mg H2O /L | ≥10mg H2O /L |
| Enthalpy Limit | < 194 kJ/kg dry gas | < 194 kJ/kg dry gas |
| Leakage | < 100 ml/min | ≤ 29 ml/min |
| Compressible Volume | 280 ml | 190 ml |
| Compliance | 0.4ml/cmH2O | 0.25ml/cmH2O |
| Connectors | ISO 5356-1:2004 compliant 22 mm connectors | ISO 5356-1:2004 compliant 22 mm connectors |
| Sterilization | Non-Sterile | Non-Sterile |
| Shelf Life | No Shelf Life (implied) | 3 year |
| Materials | Cleared as having met ISO 10993 and G-95-1 requirements | Cleared as having met ISO 10993 and G-95-1 requirements |
Study Proving Device Meets Acceptance Criteria:
The document states: "The data presented demonstrate that the device is as safe and as effective as the predicate device and therefore substantially equivalent." The comparison table and the statement "The primary differences relate to performance specifications in which the ConchaSmart Column contains less dead space, less compliance, and more stringent leak specifications" implicitly serve as the proof of meeting comparable or improved "acceptance criteria" by comparing it to an already approved device. For the ConchaSmart Column, the leakage, compressible volume, and compliance values are improvements over the predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
N/A. This is a 510(k) submission for a non-AI physical medical device. The "test set" concept as it applies to AI/algorithm evaluation is not present. The document refers to "Performance Data" but explicitly states "The change in sterility does not impact the performance characteristic of the device; therefore, no performance testing was required." This implies that the performance data for the mechanical characteristics are likely based on design specifications and engineering evaluations, not a clinical trial or a test set as understood in AI.
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)
N/A. No test set requiring expert ground truth was mentioned for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. No test set requiring adjudication was mentioned.
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
N/A. This is not an AI device, so no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
N/A. The "ground truth" for this physical device's performance relies on engineering specifications, adherence to ISO standards (e.g., ISO 8185:2007 for humidity output, ISO 5356-1:2004 for connectors), and biocompatibility testing (ISO 10993, G-95-1).
8. The sample size for the training set
N/A. This is not an AI device, so there is no training set.
9. How the ground truth for the training set was established
N/A. This is not an AI device, so there is no training set or ground truth in that context.
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(203 days)
The Conchasmart and ISO-GARD Breathing Circuits are intended for adult patients in professional healtheare facilities as a conduit for respiratory gas between a patient and includes heated wire(s) for use with the Hudson RCI Neptune Heated Humidifier. The heated wires are intended to aid in maintaining the set patient temperature and minimize condensation in the breathing circuit.
ConchaSmart and ISO-GARD breathing circuits provide a conduit for respiratory gases between the patient and the ventilator/Hudson RCI Neptune Heated Humidifier. The heated wires inside the breathing circuits are used to minimize condensation in the circuit and to aid in maintaining the designated humidity and temperature of the respiratory gas. ConchaSmart and ISO-GARD breathing circuits are intended for use with adult patient populations in professional healthcare environments. These devices are made of corrugated tubing (22 mm in diameter) which house the heated wires and are kitted with various adaptors and connectors to aid the respiratory care clinician in system configuration.
Here's an analysis of the provided text in relation to acceptance criteria and study details, presented as requested:
Device Name: ConchaSmart and ISO-GARD Breathing Circuits
Regulation Name: Respiratory Gas Humidifier
Product Code: BTT
1. Table of Acceptance Criteria and Reported Device Performance
The document describes performance testing rather than explicitly stating quantitative "acceptance criteria" and "reported device performance" in a direct numerical comparison format that is typical for diagnostic tools. Instead, it focuses on compliance with standards and compatibility.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ISO 5367 (Breathing tubes intended for use with anaesthetic apparatus and ventilators) | The proposed devices were tested to ensure compliance to ISO 5367. |
| Compliance with ISO 5356-1 (Anesthetic and respiratory equipment -- Conical connectors -- Part 1: Cones and sockets) | The proposed devices were tested to ensure compliance to ISO 5356-1. |
| Compatibility with the Hudson RCI Neptune Heated Humidifier | Testing was performed to ensure compatibility with the Hudson RCI Neptune Heated Humidifier. |
| Useful life of 30 days | Testing was performed to ensure a useful life of 30 days. |
| Biocompatibility of patient contacting materials (Cytotoxicity, Sensitization, Irritation, Genotoxicity, Implantation) | Cytotoxicity, sensitization, irritation, genotoxicity, and implantation testing were performed to demonstrate biocompatibility of the patient contacting materials. |
2. Sample size used for the test set and the data provenance
The document does not provide specific sample sizes for the testing described. It broadly states that "testing was performed."
The data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective). However, given the context of a 510(k) summary, the testing would have been conducted by the manufacturer (Teleflex Medical, Incorporated, USA) to support their submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The testing described (compliance with ISO standards, compatibility, useful life, biocompatibility) typically relies on laboratory measurements and established protocols rather than expert clinical interpretation for "ground truth" in the way it might be for a diagnostic AI device.
4. Adjudication method for the test set
This information is not applicable and not provided in the document. The testing involved objective measurements and compliance checks against established standards, not human expert adjudication of subjective results.
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
This information is not applicable and not provided in the document. The device is a breathing circuit, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers or AI assistance are not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided in the document. The device is a physical breathing circuit, not an algorithm.
7. The type of ground truth used
The "ground truth" for the performance evaluation in this context refers to established international standards (ISO 5367, ISO 5356-1), manufacturer specifications (compatibility with Hudson RCI Neptune Heated Humidifier, 30-day useful life), and biocompatibility testing protocols for patient-contacting materials. It is not based on expert consensus, pathology, or outcomes data in the way it would be for a diagnostic device.
8. The sample size for the training set
This information is not applicable and not provided in the document. The device is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable and not provided in the document, as there is no "training set" for this type of device.
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(253 days)
ConchaTherm Neptune Heated Humidifier: The ConchaTherm® Neptune TM is a respiratory humidifier designed to heat and humidify respiratory gases delivered via endotracheal tubes, nasal cannula or face masks to adult, pediatric, infant and neonatal patients. This system may be used with either conventional (non-heated wire) breathing circuits or compatible (21-volt) Hudson Respiratory Care Incorporated (RCI) heated-wire circuits. The ConchaTherm® NeptuneTM can be used with ventilators, continuous flow systems, oxygen diluters and blenders, adjustable nebulizer adapters for aerosol therapy, or nonflammable anesthesia gases to help maintain patient body temperature.
ConchaSmart Column: When used with the Hudson RCI ConchaTherm Neptune Heated Humidifier and Hudson RCI ventilator circuits, the ConchaSmart Column provides heated humidification for patients with and without an artificial airway in place.
Comfort Flo Humidification System: To provide a continuous flow of heated and humidified gas to spontaneously breathing patients.
The ConchaTherm Neptune Heated Humidifier is an active heated humidifier designed to provide heat and moisture to the medical gases delivered to a patient through continuous flow, invasive ventilation or non-invasive ventilation. The ConchaSmart Column is an accessory to the ConchaTherm Neptune Heated Humidifier. It is a single use, disposable humidifier cartridge which is intended for neonatal, infant, pediatric, and adult patients requiring heated humidification. The ConchaSmart Column is used by inserting the column into the center of the ConchaTherm Neptune. The Comfort Flo Humidification System is intended to deliver heated and humidified respiratory gases to spontaneously breathing patients. The Comfort Flo Humidification System is designed to be used in conjunction with the ConchaTherm Neptune Heated Humidifier for neonate/infant, pediatric, and adult populations. The Comfort Flo Humidification System includes a Heated Wire Breathing Circuit, a ConchaSmart Column, and various Class I exempt accessories.
The provided document is a 510(k) summary for a medical device (Teleflex Medical's ConchaTherm Neptune Heated Humidifier, ConchaSmart Column, and Comfort Flo Humidification System). It focuses on demonstrating substantial equivalence to predicate devices, primarily through technological characteristics and performance data related to safety standards.
It does not contain any information about acceptance criteria and studies related to AI/algorithm performance, human reader studies, ground truth establishment, or sample sizes for training/test sets for an AI device. The document is for a physical medical device (humidifier) and not an AI/ML software device.
Therefore, I cannot extract the requested information from the provided text.
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(57 days)
This product is to assist in the introduction of diagnostic or therapeutic devices into a vessel.
Teleflex Medical OEM's Percutaneous Introducer and Kit is used to assist in the introduction of diagnostic or therapeutic devices into a vessel. These devices will be marketed in two configurations:
- Percutaneous Introducer only, or
- Percutaneous Introducer. Needle, Kit including Introducer Syringe and Guidewire
A description of each individual component is provided below:
Guidewire
The guidewire is designed to allow ease of movement through the vessels of the bodv.
18 Ga Needle
The 18 Ga Needle design allows the syringe to be attached to it and for the guidewire to be inserted through it.
Syringe
The 10ml syringe design allows for insertion into the needle.
Percutaneous Introducer
The Percutaneous Introducer uses a secure locking luer collar hub design and also incorporates an ergonomic handle design. This protects against separation of the dilator and sheath assembly during insertion. The introducer is designed to allow the dilator to be advanced over the guidewire into the vessel thus facilitating the introduction of the sheath into the vessel. This device design is such that after advancement into the vessel the dilator can be removed to allow access through the sheath of the customer's chosen device. For easy removal, the split sheath can be removed by breaking the hub and removing the two halves of the sheath while still within the vessel. The sheath hub is designed to snap cleanly. The sheath peels easily and evenly, thus reducing complications during the procedure.
The provided text describes a 510(k) summary for a medical device, the Teleflex Medical Percutaneous Introducer and Kit. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of the device meeting specific acceptance criteria in the manner typically associated with an AI/algorithm-driven device.
Therefore, many of the requested elements (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone performance) are not applicable as this submission pertains to a traditional medical device, not an AI medical device.
Here's the information that can be extracted and a summary of why other points are not relevant based on the provided document:
Acceptance Criteria and Reported Device Performance
The document states that the device was subjected to performance testing with pre-determined acceptance criteria, and it met all acceptance criteria. However, it does not provide an explicit table of these criteria or specific quantitative results for each. It lists general categories of tests.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional | Met all acceptance criteria |
| Tensile | Met all acceptance criteria |
| Radiopacity | Met all acceptance criteria |
| Corrosion Resistance | Met all acceptance criteria |
| Leakage | Met all acceptance criteria |
| Other (not specified) | Met all acceptance criteria |
Study Proving Device Meets Acceptance Criteria:
The study consisted of "a full battery of performance testing." The document does not provide a specific name or detailed protocol for this study but indicates it was conducted by Teleflex Medical OEM.
Non-Applicable Information for this Device (as per the provided text):
Since this is a submission for a traditional medical device (percutaneous introducer kit) and not an AI/algorithm-driven device, the following points are not directly addressed or are not relevant to this type of 510(k) submission based on the provided document:
- Sample size used for the test set and the data provenance: Not applicable. Performance testing for this type of device typically involves laboratory-based tests on device samples, not patient data in the context of an AI model.
- 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 test set is not relevant here.
- Adjudication method for the test set: Not applicable.
- 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 not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device's performance would be the specifications and standards it must meet (e.g., material strength, dimension tolerances).
- The sample size for the training set: Not applicable. This device does not use an AI model that requires a training set.
- How the ground truth for the training set was established: Not applicable.
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(41 days)
Continuous nerve block kit and set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.
The Arrow Continuous Peripheral Nerve Block Catheter set and kit is comprised of components and accessories which have already been cleared for the same indications for use under earlier 510(k)s. This submission is intended to clarify that the catheter and the associated components and accessories, which we refer to as kits and sets, may be used for non-stimulating procedures. Many of the components and accessories of these kits and sets are already cleared for use in PNB stimulating procedures as well. It is the option of the clinician as to whether they would or would not use stimulation. A typical basic Peripheral Nerve Block ("PNB") set / kit includes the following components. The primary components of any PNB set or kit are: Catheter with stylet, Anesthesia Conduction ("AC") Needle, SnapLock™.
The provided 510(k) summary for the "Continuous Peripheral Nerve Block Catheter Kit and Set" (K121403) states that this medical device submission is intended to clarify that the device, which includes components already cleared for stimulating procedures, may also be used for non-stimulating procedures. The submission explicitly states that no additional bench testing is required because the clarification for non-stimulating use does not change the cleared indications for use and does not introduce any new safety or efficacy concerns compared to the predicate devices. Therefore, the device does not rely on a new study to prove it meets acceptance criteria, but rather on demonstrating substantial equivalence to existing predicate devices.
Based on the provided document, here's the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) submission does not present specific acceptance criteria or performance data for the proposed device from a standalone study because it is claiming substantial equivalence based on the device's components being identical to already cleared predicate devices. The "performance" assessment is comparative to the predicate.
| Acceptance Criteria (based on predicate device characteristics) | Reported Device Performance (Proposed Device) |
|---|---|
| Indications for Use: Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours. | Identical: Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours. |
| Technology: Components of predicate devices (K030937, K021567, K001587) | Identical: Components are identical to the predicates. Including catheter with stylet, Anesthesia Conduction (AC) Needle, SnapLock™. |
| Materials: Materials used in predicate devices (K001587, K021567, K030937) | Identical: All materials in all components are identical to the predicates. |
| Environment of Use: Hospital, sub-acute facilities, pain clinics, physician offices. | Identical: Hospital, sub-acute facilities, pain clinics, physician offices. |
| Patient Population: Patients requiring peripheral nerve block procedures including upper extremity, lower extremity, abdominal and paravertebral locations. | Identical: Patients requiring peripheral nerve block procedures including upper extremity, lower extremity, abdominal and paravertebral locations. |
| Contraindications: Pre-existing nerve injury, neuritis or plexitis; skin/systemic sepsis; bleeding tendencies/anticoagulants. | Identical: Pre-existing nerve injury, neuritis or plexitis; skin/systemic sepsis; bleeding tendencies/anticoagulants. |
| Catheter Specifications (K030937): Effective length (30-90 cm), Gauge (19 Ga, 20 Ga), Material (SS spring core in polyurethane), Echogenic, Color (White/19Ga, Blue/20Ga), Length markings, Exposed length at tip (5mm/19Ga, 6mm/20Ga). | Identical: Meets all specified catheter specifications of the predicate (K030937). |
| AC Needle Specifications (K030937): Length (38-152mm), Gauge (17 Ga, 18 Ga), Geometry (5mm/17Ga, 6mm/18Ga), Exposed Length at Distal needle (5mm/17Ga, 6mm/18Ga). | Identical: Meets all specified AC needle specifications of the predicate (K030937). |
| SnapLock™ Connector (K001587 for non-stimulating, K030937/K021567 for stimulating): Designed for non-stimulating and stimulating procedures. | Identical: Connector for non-stimulating procedures (K001587). Integral wire (K030937), Connection Tab (K021567) for stimulation. |
2. Sample size used for the test set and the data provenance
Not applicable. No new test set or data was generated for this 510(k) submission. The submission relies on demonstrating substantial equivalence to already cleared devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No new test set requiring expert ground truth establishment was conducted. The device's safety and effectiveness relies on its similarity to previously cleared devices.
4. Adjudication method for the test set
Not applicable. No new test set requiring an adjudication method was conducted.
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 medical device (catheter kit), not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" in this context is the established safety and effectiveness of the predicate devices based on their prior 510(k) clearances. The current submission argues that the proposed device is identical in design, materials, and intended use (with clarification for non-stimulating procedures) to these predicates.
8. The sample size for the training set
Not applicable. This device is a physical medical device, not an AI/algorithmic device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is a physical medical device and does not involve a training set as would be used for an AI/algorithmic device.
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(518 days)
The Arrow Epidural Catheter permits access to the epidural space for the administration of epidural anesthetic. The epidural catheter is intended for use up to 72 hours.
The FlexTip Plus Epidural Catheter has the following characteristics:
- 19 Ga. single lumen 900 mm
- Available in open or closed tip
- Internal radiopaque, echogenic coiled reinforced wire
- Catheters are provided in sterile kit configurations
The provided document is a 510(k) summary for a medical device (Arrow FlexTip Plus Closed Tip Epidural Catheter) and focuses on demonstrating substantial equivalence to a predicate device. It primarily details non-clinical laboratory testing rather than a clinical study with acceptance criteria and device performance in a human context.
Therefore, the requested information cannot be fully provided from the given text as it does not describe a clinical study in humans to prove device performance against acceptance criteria typically associated with such studies (e.g., sensitivity, specificity, accuracy for a diagnostic device, or effect size for an intervention).
However, I can extract the information related to the non-clinical testing that was performed to demonstrate substantial equivalence.
Here's the information based on the provided text, with an explanation for elements that are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criteria (Non-Clinical) | Reported Device Performance (Non-Clinical) |
|---|---|
| Tensile Strength | The results of the performance testing (including tensile strength) demonstrate that the FlexTip Plus Closed Tip Epidural Catheter is as safe, as effective, and performs comparably to the predicate Epidural catheter. |
| Column Strength | The results of the performance testing (including column strength) demonstrate that the FlexTip Plus Closed Tip Epidural Catheter is as safe, as effective, and performs comparably to the predicate Epidural catheter. |
| Flow Rate | The results of the performance testing (including flow rate) demonstrate that the FlexTip Plus Closed Tip Epidural Catheter is as safe, as effective, and performs comparably to the predicate Epidural catheter. |
| Biocompatibility (In vivo) | Pre-clinical evaluations have been conducted on the catheter and extracts thereof. No adverse effects were observed in any in vivo study conducted. |
| Biocompatibility (E&L Studies) | Extractable and Leachable (E&L) studies were performed using Bupivacaine, Naropin, Polocaine, Hydromorphone, Morphine, Meperidine, and Fentanyl. The toxicity of the relevant leachable chemicals relating to these drugs was reviewed and addressed. A comparative chemical analysis study was conducted to assess potential differences in the E&L profile between devices that were EO sterilized after one cycle versus devices that were processed with two EO cycles. There were no appreciable qualitative differences in the extractable profiles for the one-time vs. two-time EO-sterilized devices. The relevant patient contacting components meet the requirements of applicable ISO 10993 Guidelines. There was no evidence of significant risk of acute toxicity under the proposed conditions and duration of clinical use based on review of available toxicological data for a surrogate leachable chemical. |
2. Sample Size Used for the Test Set and Data Provenance:
This document describes non-clinical engineering and biocompatibility testing. It does not refer to a "test set" in the context of human data or AI performance. The tests were performed on the device itself and its extracts in a laboratory setting. No country of origin for human data is applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
Not applicable. This was non-clinical lab testing; there was no "ground truth" established by human experts in the context of a clinical study. Biocompatibility and performance testing would follow established international standards (like ISO 10993) and internal protocols, with analysis performed by qualified lab personnel.
4. Adjudication Method for the Test Set:
Not applicable. There was no clinical test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This is a 510(k) submission for an epidural catheter, not an AI or diagnostic device. Therefore, no MRMC study was conducted, and the concept of "human readers improving with AI vs. without AI assistance" is not relevant here.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
No. This is a physical medical device, not an algorithm or AI product.
7. Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" was based on established industry standards, engineering specifications, and validated laboratory methodologies for physical properties (tensile strength, column strength, flow rate) and chemical analysis (extractables and leachables).
8. Sample Size for the Training Set:
Not applicable. This is not an AI or machine learning device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
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