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OTC Use: Prontosan® Wound Gel is intended to cleanse and moisten the wound bed and for the management of minor cuts, abrasions, lacerations, and minor burns.

Professional Use: Prontosan® Wound Gel is intended to cleanse and moisten the wound bed and for the management of ulcers, 1st and 2nd degree burns, partial and full thickness wounds, and surgical incisions. It can be used during wound dressing changes to soften encrusted wound dressings.

Prontosan® Wound Gel is a clear, colorless and virtually odorless gel containing undecylenamidopropyl betaine, polyaminopropyl biguanide, glycerol, hydroxyethylcellulose and purified water. Prontosan Wound Gel is a nonpyrogenic solution used for wound management.

Prontosan Wound Gel will be offered in an over-the-counter (OTC) version and a professional use (Rx only) version. Prontosan Wound Gel is used to moisten the wound bed and clean the wound surface, including those that are difficult to access. Prontosan Wound Gel is aseptically filled into a 30 mL low density polyethylene squeeze bottle with a screw cap.

The provided text is a 510(k) Substantial Equivalence Determination letter from the FDA for a wound gel called Prontosan Wound Gel. This document states that the device is "substantially equivalent" to a legally marketed predicate device (Prontosan Wound Gel, K101882) and does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

The 510(k) process for this device, in particular, focuses on the manufacturer's claim that no changes have been made to the device design, packaging, manufacturing process, indications for use or the intended use. The submission is purely for labeling content changes.

Therefore, I cannot provide the requested information from this document. The document explicitly states:

• No new studies were conducted or required to demonstrate performance. The substantial equivalence is based on the device being identical to a previously cleared predicate device.
• No acceptance criteria are mentioned because the device's performance is assumed to be equivalent to the predicate, which would have already met its own performance criteria when it was initially cleared.

In summary, the provided document does not contain the information needed to answer your questions regarding acceptance criteria and a study proving the device meets those criteria.

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The IV Administration Sets with Hand Pump are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. When the hand pump component is activated to deliver only crystalloid and colloid resuscitative fluids. These devices may patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.

The IV Administration Sets with Hand Pump are single use, disposable, intravenous administration sets with a pressure pump and air guard filter used to deliver fluids from a container into a patient's vascular system rapidly through the use of the pressure pump and/or gravity flow. These sets may be comprised of various generic components which are broadly used throughout the industry such as a bag spike, drip chamber, slide clamp, roller clamp, luer access device, stopcocks, manifolds, tubing, and luer connections. Each of these needleless components have already been cleared through the 510(k) process either individually or as part of a B. Braun IV pump 510(k) which included sets. The unique components to these sets include the manual hand pump and a 15um filter integrated within the drip chamber to reduce the potential for bubble formation within the set during use. The addition of the hand pressure pump provides the capability for delivering IV fluids more rapidly by compressing the pump by hand.

This document describes a 510(k) premarket notification for the B. Braun IV Administration Set with Hand Pump and outlines the testing conducted to demonstrate its substantial equivalence to predicate devices. However, the document does not present specific acceptance criteria or reported device performance in a quantitative manner that can be organized into a table. The performance testing section broadly states that functional performance testing was completed to demonstrate that the sets perform as intended and that results of testing demonstrate that the proposed device performs similarly to the predicate device and can be used safely and effectively according to its intended use. This is a qualitative conclusion rather than a presentation of specific metrics against predefined thresholds.

Based on the provided text, here is an attempt to address your request, acknowledging the limitations of the input:

1. Table of Acceptance Criteria and Reported Device Performance

As the document does not specify quantitative acceptance criteria or precise performance metrics, the table below reflects the qualitative statements provided.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the performance or biocompatibility testing. It only mentions that "Functional performance testing was completed" and "The materials of construction...were tested."

The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the document. The testing described is primarily engineering/laboratory-based functional and biocompatibility testing, not clinical studies involving expert interpretation of results to establish a "ground truth" in the way one might for diagnostic devices.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the testing (functional and biocompatibility), an adjudication method in the context of expert consensus on clinical findings is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through functional performance and biocompatibility testing against predicate devices and relevant industry standards, not on human reader performance with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

This question is not applicable as the device is an IV administration set with a hand pump, not an AI or algorithm-driven device.

7. The Type of Ground Truth Used

For the functional performance testing, the "ground truth" would be the expected physical and mechanical performance of an IV administration set as defined by engineering specifications and industry standards (e.g., flow rates, luer connection integrity, pressure resistance). For biocompatibility, the "ground truth" is that the materials do not elicit adverse biological responses, as determined by ISO 10993-1 standard tests.

8. The Sample Size for the Training Set

This question is not applicable as the device is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable.

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The Infusomat® Space Volumetric Pump Administration Sets are intended for use on adults, pediatrics, and neonates for the intermittent or continuous delivery of parenteral fluids through clinically accepted routes of administration. These routes include, but are not limited to intra-arterial, subcutaneous, epidural, irrigation/ablation, and enteral. The sets are used for the delivery of medications including but not limited to drugs like anesthetics, sedatives, analgesics, catecholamines, anticoagulants etc., blood and blood components, Total Parenteral Nutrition (TPN), lipids, and enteral fluids. The Infusomat Space Volumetric Pump Administration Sets are intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments.

The Infusomat® Space Volumetric Infusion Pump administration sets are sterile, nonpyrogenic, single-use devices for use with the B. Braun Infusomat® Space Volumetric Infusion Pump for pump and gravity administration of fluids.

Each administration set contains a segment of silicone tubing intended to interface with the linear peristaltic mechanism of the pump. There are two connectors at each end of the pump tube segment and a line loading guide to assist the user in loading the pump segment into the pump. Each set also contains a free flow protection clamp. The clamp is specifically designed to interface with a mating receptacle in the pump and is intended to prevent free flow of fluid when the pump door is opened and the set is removed. There are multiple set configurations including basic sets, burette sets, additive sets, filtered sets, low adsorption sets, add-on sets, and blood sets.

The provided document is a 510(k) premarket notification for the "Infusomat Space Volumetric Infusion Pump Administration Sets." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where a device's performance is measured against predefined acceptance criteria for a new clinical claim.

Therefore, much of the requested information, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and details about training sets, is not available in this type of submission. This document describes performance testing conducted to show the new administration sets perform as intended and similarly to the predicate device.

Here's an attempt to extract the relevant information based on the provided text, while acknowledging its limitations for certain aspects of your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Results of the testing demonstrate that the proposed device performs similarly to the predicate device and can be used safely and effectively according to its intended use." However, specific numerical acceptance criteria and reported performance values for each test are not provided in this summary. The table below represents the types of testing performed and the general conclusion, but not specific pass/fail values or quantitative results.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: This information is not provided in the document. The phrase "functional and performance testing" is used, but no specific number of units tested is mentioned.
• Data Provenance: The testing was conducted by B. Braun Medical Inc. as part of their 510(k) submission. It's an internal test, and the data is retrospective in the sense that it was conducted before the submission, but not in the clinical trial sense. Country of origin of data is not specified beyond being part of a U.S. FDA submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• This information is not applicable to the type of engineering performance testing described. The "ground truth" for these tests would be established by engineering specifications and standards, not expert medical consensus.

4. Adjudication Method for the Test Set

• This information is not applicable. Adjudication typically refers to expert review of clinical cases. For engineering tests, results are usually measured against predefined specifications.

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?

• No, an MRMC comparative effectiveness study was not done. This document pertains to an administration set for an infusion pump, which is a hardware device, not an AI-powered diagnostic or decision support system that involves human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• This information is not applicable. The device is a physical administration set for an infusion pump, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for the performance testing of these administration sets would be based on engineering specifications and established performance standards for such medical devices (e.g., flow rate accuracy within a certain tolerance, pressure resistance, tensile strength). The document does not explicitly list these standards but implies their use through phrases like "perform as intended" and "performs similarly to the predicate device."

8. The Sample Size for the Training Set

• This information is not applicable. There is no "training set" as this is not a machine learning or AI device. The testing described is verification and validation of a physical medical device.

9. How the Ground Truth for the Training Set was Established

• This information is not applicable for the reasons stated above.

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The Caresite Luer Access Device (LAD) is a needleless connector intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. The Caresite Luer Access Device (LAD) may be used with power injectors at a maximum pressure of 400 psi and a maximum flow rate of 15 mL/sec.

The Caresite Luer Access Device (LAD) is a positive displacement needleless connector intended to provide needle-free access to IV gravity sets, extension sets and catheters for the administration of IV fluids and blood. The Caresite Luer Access Device (LAD) is a 3-piece assembly containing an elastomeric piston with a slit septum, which is housed within a clear, rigid body. The Caresite Luer Access Device (LAD) requires swabbing to disinfect prior to insertion of a male luer connector. The Caresite Luer Access Device (LAD) does not require a specific clamping sequence or technique in order to be used safely. The Caresite Luer Access Device (LAD) may be used with power injectors with a maximum pressure rating of 400 psi and a maximum flow rate of 15mL/sec. The Caresite Luer Access Device (LAD) is individually packaged and is supplied as a sterile, non-pyrogenic, single use, disposable device.

The input document describes a 510(k) submission for a medical device (Caresite Luer Access Device), which is a premarket notification to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission relies on demonstrating substantial equivalence, meaning the new device is as safe and effective as a legally marketed device that is not subject to premarket approval (PMA).

Crucially, a 510(k) filing for a device like a needle-free luer access device typically does NOT involve the kind of elaborate clinical studies (MRMC, expert consensus for AI training/testing, etc.) that would lead to the specific information requested in your prompt. These studies are far more common for novel, high-risk devices, or AI-driven diagnostic/therapeutic tools.

The document states:

• "Performance testing was performed to demonstrate safety and effectiveness."
• "Based on the results of biocompatibility and performance testing, the proposed B. Braun Medical Caresite Luer Access Device (LAD) is considered substantially equivalent to the predicate device and is safe and effective for its intended use."

The performance testing mentioned here likely refers to bench testing, engineering verification, and perhaps some in-vitro studies to confirm properties like:

• Pressure resistance (e.g., 400 psi)
• Flow rate (e.g., 15 mL/sec)
• Durability (e.g., number of activations)
• Leakage prevention
• Microbial ingress prevention
• Biocompatibility (in accordance with ISO 10993-1)

Therefore, many of your requested points cannot be directly answered from the provided text. The document is for a physical medical device, not an AI/algorithm-driven one, hence the absence of metrics like "effect size of how much human readers improve with AI vs without AI assistance" or "number of experts used to establish ground truth."

Here's an attempt to address your prompt based on the provided text, and explicitly stating where the information is not applicable (N/A) or not provided (N/P) given the nature of a 510(k) for this type of device:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Principle)

The acceptance criteria for a 510(k) submission like this are primarily to demonstrate substantial equivalence to a predicate device in terms of:

1. Indications for Use: The Caresite Luer Access Device has similar indications for use to the predicate device.
2. Technological Characteristics: Similar physical and technical characteristics, materials, and components as the predicate.
3. Performance: Safety and effectiveness demonstrated through performance testing, showing it performs at least as well as the predicate for its intended use, and meets specific functional requirements.

Given the absence of specific quantitative acceptance thresholds in the provided text for "performance testing," the table below reflects what can be inferred or is explicitly stated as characteristics of the device. The "acceptance criteria" here are implied by the device's functional specifications and the successful 510(k) clearance, meaning it performs acceptably for its intended use compared to the predicate.

Study Details (As Applicable for this Device Type)

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • N/P. For a physical device of this nature, "test set" would refer to the number of devices tested during performance (bench) and biocompatibility testing. This information is not typically detailed in the 510(k) summary provided, but would be in the full submission. The data provenance would be from manufacturing/testing facilities, likely in the US (where the applicant is based). These would be prospective tests.

2. 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. This device is not an AI/diagnostic imaging device, so the concept of "experts establishing ground truth" in the context of clinical images or algorithmic output is not applicable. The "truth" here is engineering specification, material safety, and functional performance as observed in bench tests.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • N/A. Adjudication methods are relevant for subjective interpretations of data (e.g., radiological reads) or clinical outcomes. Not applicable for this physical device's performance testing.

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:

   • N/A. This is a physical medical device, not an AI/diagnostic tool. MRMC studies are not relevant for its clearance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • N/A. This is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For this type of device, "ground truth" would be established through:
     • Engineering Specifications/Standards: Performance measured against predefined industry standards (e.g., ISO for biocompatibility) and engineering design specifications (e.g., pressure, flow rates).
     • Predicate Device Performance: The predicate device's established performance serves as a benchmark for substantial equivalence.
     • Biocompatibility Standards: Adherence to ISO 10993-1.

7. The sample size for the training set:

   • N/A. There is no "training set" as this is not an AI/machine learning device.

8. How the ground truth for the training set was established:

   • N/A. There is no "training set" as this is not an AI/machine learning device.

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Rx: Prontosan® Wound Gel X is indicated for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 14 and 2nd degree burns, partial and full thickness wounds, large surface area wounds and surgical incisions.
OTC: Prontosan Wound Gel X is indicated for the management minor cuts, minor lacerations, minor burns (131 degree burns), and abrasions.

Prontosan Wound Gel X is a ready to use, clear, odorless, amorphous hydrogel wound dressing that helps maintain a clean, moist wound environment. It is intended as a barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. The gel matrix includes the preservative, polyhexanide, a viscosity modifying agent and a betaine surfactant. GelX is supplied sterile in blind ended, heat sealed polyfoil 250g tubes fitted with PP screw caps.

The document describes the Prontosan® Wound Gel X, a wound dressing, and its substantial equivalence to predicate devices. It mentions that performance testing was conducted to support this claim.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide specific details on the sample sizes used for the biocompatibility, USP <51>, or Strike Through Barrier tests. It also does not specify the provenance of the data (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided. The testing described appears to be laboratory-based performance and biocompatibility testing, not studies requiring expert interpretation of results to establish ground truth in the context of medical imaging or diagnostic devices.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The testing described does not involve adjudication as it's not a study where human readers or algorithms interpret data against a ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The document focuses on demonstrating substantial equivalence through biocompatibility and performance testing, not on comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as Prontosan® Wound Gel X is a wound dressing, not an algorithm or AI device. The studies mentioned are traditional medical device performance tests.

7. Type of Ground Truth Used

The ground truth for the performance tests (Biocompatibility, USP <51>, Strike Through Barrier Test) would be established by the defined standards and protocols of these specific tests. For example, for biocompatibility, the ground truth is adherence to the requirements of ISO 10993-1. For USP <51>, it likely refers to antimicrobial effectiveness testing against predefined microorganisms and reduction criteria.

8. Sample Size for the Training Set

This is not applicable and not provided. Prontosan® Wound Gel X is a medical device (wound dressing), not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as above; there is no training set for this type of medical device.

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The Sterican™ Cannula is intended for the aspiration of fluids for fluid transfer and may be used with a syringe for transferring fluids from stoppered vials, glass or plastic ampoules. The Sterican™ Cannula is intended for drug admixture only.

The Sterican™ Cannula is a semi blunt, 18G (1.20mm) x 1½ inch (40 mm) cannula configuration with a single cut bevel (40°). The hub can be used to establish either slip fit or locking type connections to male 6% (Luer) taper slip fit or locking type adapters.

The provided document is a 510(k) premarket notification for a medical device (Sterican™ Cannula) and does not contain detailed information about acceptance criteria or a study with specific performance metrics in the format requested.

The document indicates that "Biocompatibility and performance testing was performed with Sterican™ Cannula to support substantial equivalence to the predicate device." However, it does not provide specific acceptance criteria or the results of these performance tests in a quantitative manner.

Therefore, I cannot directly extract the table of acceptance criteria and reported device performance, nor can I answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from the provided text.

The document is primarily a regulatory filing demonstrating "substantial equivalence" to a predicate device (K944931: Becton Dickinson Blunt Steel Cannula) based on similar indications for use, technological properties, and performance, along with biocompatibility testing (ISO 10993-1). It concludes that the device is "safe and effective for its intended use" based on these tests, but the detailed results and criteria are not presented in this summary.

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The Contiplex C Continuous Peripheral Nerve Block Needle is intended for use in regional anesthesia and pain therapy to locate peripheral nerves by transferring electrical impulses from a nerve stimulator or by ultrasound visualization of the device. The needle is used to inject and facilitate the continuous administration of local anesthetics or analgesics to the targeted nerve bundle in general and orthopedic surgery.

In set configuration, the B. Braun Contiplex C Continuous Peripheral Nerve Block Set, consisting of the peripheral nerve block needle, catheter, and related peripheral nerve block procedural accessories, is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management during pre-operative, perioperative and post-operative periods associated with general and orthopedic surgery. The catheter may remain indwelling for up to 72 hours.

The Contiplex C Continuous Peripheral Nerve Block Needle is a needle comprised of an open tip catheter over an insulated needle with a positioning component, a needle hub with integrated injection tubing and cable, and connection tubing.

This is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore, the typical acceptance criteria and study designs associated with AI/ML performance (e.g., sensitivity, specificity, AUC, human reader studies, ground truth establishment with experts) are not applicable here.

This submission focuses on demonstrating substantial equivalence to a predicate device through biocompatibility and performance testing to ensure the device's safety and effectiveness for its intended use.

Here's an analysis of the provided text in the context of device acceptance, though it won't align perfectly with the AI/ML specific questions due to the nature of the device:

1. A table of acceptance criteria and the reported device performance

Since this is a traditional medical device (a nerve block needle), the "acceptance criteria" are compliance with established performance standards and the "reported device performance" is that the device met these standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated for each test. For medical device performance testing, sample sizes are typically determined by statistical methods or industry standards relevant to the specific test (e.g., number of units tested for kink resistance, bond strength, etc.).
• Data Provenance: Not specified. Standard testing for medical devices is usually performed in-house by the manufacturer or by certified contract laboratories, generally under controlled conditions. It is prospective testing of manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. For this type of device, "ground truth" relates to objective physical and biological properties measured against established standards, not interpretation by human experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or subjective assessment. For objective device performance testing, results are typically binary (pass/fail) or quantitative measurements compared against a specification.

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/ML device or a diagnostic device where human reader studies are generally performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's acceptance is adherence to international and national consensus standards (ISO 10993-1, ISO 594-1, ISO 594-2, ISO 7864, ISO 9626, EN 13868) for biocompatibility and functional performance. The device's physical and material properties, and its functional characteristics, are measured against these objective standards.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML product.

9. How the ground truth for the training set was established

Not applicable. There is no "training set" for this product.

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The Dual Spike Transfer Device is intended for the direct transfer of fluid/medication from one rubber-stoppered container to another.

The Dual Spike Transfer Device is a device containing two opposing spikes. Each spike contains a second lumen (adjacent to the spike). which facilitates direct flow of fluid/medication from one container (glass or flexible comainer) to another (glass or flexible container).

The proposed device is designed for, use by healthcare professionals during medication preparation, admixture, or fluid transfer. When the Dual Spike Transfer device is attached to the additive container, only air within the vial or flexible container is released into the recipient container. Once fluid transfer is complete, the transfer device attached to the additive container is discarded. This device is intended for admixture only.

The Dual Spike Transfer Device is individually packaged with two guards placed on each spike that provide protection to the spike ends of the device and prevent touch contamination.

The provided text describes a 510(k) premarket notification for a medical device called the "Dual Spike Transfer Device." However, it does not include information about acceptance criteria or a study proving the device meets said criteria in the way typically expected for an AI or diagnostic device.

Here's why and what can be extracted from the document given its nature:

• Nature of the Device: The Dual Spike Transfer Device is a fluid transfer device, not an AI or diagnostic tool. Its performance is assessed through safety and functional testing, not statistical metrics like sensitivity, specificity, or AUC, or a clinical study with human readers.
• 510(k) Process: A 510(k) submission primarily focuses on demonstrating "substantial equivalence" to a predicate device. This often involves comparing technological characteristics, intended use, and performance testing to show that the new device is as safe and effective as the legally marketed predicate. It's not typically a full-scale clinical trial with complex statistical analysis.

Given these points, I will extract what is available regarding performance testing and interpret the "acceptance criteria" in the context of a 510(k) for a physical transfer device.

Acceptance Criteria and Study for the Dual Spike Transfer Device

Based on the provided 510(k) summary, the "acceptance criteria" for the Dual Spike Transfer Device are implicitly met by demonstrating its safety and functional performance, and by demonstrating substantial equivalence to a predicate device. The "study" in this context refers to the safety and functional testing conducted.

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample size used for the safety and functional testing. It only states "Safety and functional testing were conducted."
• Data Provenance: Not explicitly stated, but assumed to be internal testing conducted by B. Braun Medical Inc. It would be prospective testing on manufactured devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• This question is not applicable to this type of device and submission. The "ground truth" for a fluid transfer device's function is its physical ability to perform the transfer without leaks, contamination, or damage. This is assessed through engineering and quality control testing, not expert consensus in a clinical setting.

4. Adjudication Method for the Test Set

• This question is not applicable. Adjudication methods (like 2+1) are used for resolving disagreements in expert opinions, typically in diagnostic imaging studies. The performance of this physical device is determined by objective functional and safety tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret data (e.g., medical images) and AI might assist them. The Dual Spike Transfer Device is a mechanical fluid transfer device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• No, this is not applicable. The device is a physical product, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established through objective engineering and safety testing against predefined specifications for:
  • Material compatibility
  • Sterility
  • Fluid transfer efficiency and integrity (no leaks, proper flow)
  • Spike integrity and protection mechanisms
  • Biocompatibility (implied by material safety and non-pyrogenicity)
• It is not based on expert consensus, pathology, or outcomes data in the clinical diagnostic sense.

8. The Sample Size for the Training Set

• Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set."

9. How the Ground Truth for the Training Set was Established

• Not applicable. As above, there is no training set for this type of device.

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The B. Braun Contiplex® FX Continuous Nerve Block Set is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management. The Contiplex FX catheter may remain indwelling for up to 72 hours.

The B. Braun Continuous Nerve Block Set consists of one 17 gauge Tuohy needle, one 19 gauge springwound catheter with threading assist guide, one sideport valve assembly, and one clamp style catheter connector. The set is used to facilitate the continuous delivery of anesthetics or analgesics to the patient for pain management during regional anesthesia procedures.

The provided text is a 510(k) Premarket Notification for the B. Braun Contiplex FX Continuous Nerve Block Set. It describes the device, its intended use, and indicates that performance testing and biocompatibility testing were conducted to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for performance or biocompatibility testing. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be primarily benchtop/laboratory-based for device characteristics rather than clinical data from human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this submission. The "ground truth" for this medical device's performance is established by its adherence to internationally recognized engineering and biocompatibility standards, rather than expert consensus on clinical images or diagnoses.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation relies on objective measurements against engineering standards, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is a medical instrument (nerve block set), not an AI diagnostic tool or imaging system that would typically undergo such a study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is a physical medical tool, not an AI algorithm. Its performance is evaluated through physical and material testing, not algorithmic output.

7. The Type of Ground Truth Used

The "ground truth" for establishing the safety and effectiveness of the Contiplex FX Continuous Nerve Block Set is adherence to international consensus standards for medical device design, manufacturing, and biocompatibility. This includes:

• Engineering standards (e.g., ISO 9626, ISO 7864, ISO 594-1, ISO 594-2, EN 1618) for physical properties and functional performance of the needle and catheter components.
• Biocompatibility standards (ISO 10993-1) for the materials used.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of this device's evaluation, as it's not an AI/machine learning product. The testing is based on device characteristics against predetermined standards.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated in point 8.

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The Pencan spinal needles with or without introducer are intended for the injection of local anesthetics into the subarachnoid space to provide spinal anesthesia for pain management or to facilitate CSF sample collection for diagnostic purposes (lumbar puncture). The needles are intended for use in any target population with consideration given to the anatomy of the patient.

The Spinocan spinal needles with or without introducer are intended for the injection of local anesthetics into the subarachnoid space to provide spinal anesthesia for pain management or to facilitate CSF sample collection for diagnostic purposes (lumbar puncture). The needles are intended for use in any target population with consideration given to the anatomy of the patient.

The B. Braun Pencan Spinal Needle consists of a polycarbonate hub bonded to a stainless steel cannula with pencil-point tip. The hub of the Pencan spinal needle incorporates a viewing window for visualization of cerebrospinal fluid. The needles are provided with a stylet with color-coded hub that corresponds to the needle gauge. The needles will be offered in gauges ranging from 22 Ga. to 27 Ga. Needles that are 24 Ga .- 27 Ga. may be used with an individually packaged 20 Ga. or 22 Ga. introducer needle.

The B. Braun Spinocan Spinal Needle consists of the same polycarbonate hub as the Pencan needles. The hub is bonded to a stainless steel cannula with Quincke bevel. The needles are provided with a stylet with color-coded hub that corresponds to the needle gauge. The needles will be offered in gauges ranging from 18 Ga. to 27 Ga. Needles that are 25 Ga. - 27 Ga. may be used with an individually packaged 20 Ga. or 22 Ga. introducer needle.

Here's an analysis of the provided text regarding the acceptance criteria and study for the B. Braun Medical Inc. Pencan, Spinocan Spinal Needles and Spinal Introducer Needles:

Based on the provided 510(k) summary (K112515), the device in question is a medical needle, not an AI/ML powered device. Therefore, many of the requested criteria related to AI/ML device studies (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this submission.

The acceptance criteria and study focus on demonstrating substantial equivalence to predicate devices through performance testing against established international standards and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

This is not an AI/ML device study. The "testing" refers to physical and material performance evaluations against established standards, not a clinical trial with patient data. Therefore, concepts like "test set" or "data provenance" in the context of clinical data are not applicable here. The data provenance would be the internal testing laboratories of B. Braun Medical Inc. or contracted testing facilities that conducted the performance and biocompatibility tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable for this type of medical device submission. Ground truth for physical device performance is established by objective measurements against engineering and material science standards (e.g., tensile strength, flow rate, biocompatibility assays), not expert clinical consensus.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or clinical outcomes where there might be disagreement. For a physical device demonstrating compliance with standards, the results are objectively measured.

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/ML device and therefore no MRMC study involving human readers with AI assistance was conducted.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI device. Its performance is inherent to its physical design and materials.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by the international standards themselves (ISO 9626, ISO 7864, ISO 594-1, ISO 594-2, ISO 10993-1). The device must meet the specified test methods and criteria outlined in these standards. For biocompatibility, the chemical and biological properties of the materials, as tested according to ISO 10993 guidelines, serve as the ground truth.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device and does not involve a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. This is not an AI/ML device and does not involve a training set.

In summary, for K112515, the "study" demonstrating the device meets acceptance criteria consists of:

• Performance testing against established international standards (ISO).
• Biocompatibility testing in accordance with ISO 10993-1.
• Comparison to predicate devices to demonstrate substantial equivalence based on similar design, materials, and intended use, and successful performance against the aforementioned standards.

The B. Braun Pencan and Spinocan Spinal Needles and Spinal Introducer Needles are traditional medical devices, and their regulatory pathway focuses on demonstrating safety and effectiveness through compliance with recognized standards and substantial equivalence to legally marketed predicate devices, rather than through AI/ML-specific validation studies.

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