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FASTResponder™ Sternal Intraosseous Device is indicated for use in establishing a sternal intraosseous access route in adult and adolescent patients (12 years of age and older) requiring vascular administration of drugs or fluids to facilitate emergency resuscitation.

FASTRESPONDER™ Sternal Intraosseous Device has been designed to provide an alternative to intravenous infusion access of the circulatory system. It utilizes intraosseous infusion in order to facilitate emergency resuscitation through the use of fluids and drugs. The device has been designed for use on the manubrium, the upper (superior) portion of the sternum. The FASTRESPONDER™ Sternal Intraosseous Device consists of an introducer handle with target foot which allows the user to target the recommended insertion site and place the infusion tube bone portal into the manubrium. On withdrawing the introducer handle, the infusion tube bone portal is left firmly placed in the manubrium, the infusion tube luer lock can be connected to a source such as an IV line or standard syringe for infusion of emergency drugs or fluids. The target foot separated from the handle is adhered to the skin over the insertion site providing protection; the infusion tube strain relief hook is clipped to the target foot for strain relief. The protective dome is placed over the target foot insertion site providing additional protection from external forces.

The provided text describes a 510(k) summary for the FASTResponder™ Sternal Intraosseous Device. It outlines the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain any information about acceptance criteria, device performance, a specific study proving acceptance, sample sizes for test or training sets, ground truth establishment, expert involvement, adjudication methods, or MRMC studies.

The section "Safety & Effectiveness VII." mentions that "Bench tests, functional testing, and validation studies were conducted," and refers to compliance with various ISO standards and USP guidelines for specific aspects like risk analysis, biocompatibility, sterilization, and pyrogen studies. However, it does not provide details on the actual results of these studies or specific performance metrics that would be considered acceptance criteria.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about a study proving the device meets acceptance criteria, as this information is not present in the provided document.

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FASTx™ Sternal Intraosseous Device is indicated for use in establishing a sternal intraosseous access route in adult and adolescent patients (12 years of age and older) requiring vascular administration of drugs or fluids to facilitate emergency resuscitation.

FASTx™ Sternal Intraosseous Device has been designed to provide an alternative to intravenous infusion access of the circulatory system. It utilizes intraosseous infusion in order to facilitate emergency resuscitation through the use of fluids and drugs. The device has been designed for use on the manubrium, the upper (superior) portion of the sternum. The FASTx™ Sternal Intraosseous Device consists of an introducer handle with target foot which allows the user to target the recommended insertion site and place the infusion tube bone portal into the manubrium. On withdrawing the introducer handle, the infusion tube bone portal is left firmly placed in the manubrium, the infusion tube luer lock can be connected to a source such as an IV line or standard syringe for infusion of emergency drugs or fluids. The target foot separated from the handle is adhered to the skin over the insertion site providing protection; the infusion tube strain relief hook is clipped to the target foot for strain relief. The protective dome is placed over the target foot insertion site providing additional protection from external forces.

The provided document is a 510(k) summary for the FASTx™ Sternal Intraosseous Device, seeking substantial equivalence to a predicate device (FAST1® Intraosseous Infusion System cleared under K080865). This type of submission focuses on demonstrating equivalence rather than proving novel effectiveness through clinical studies with specific acceptance criteria and performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria for a new device, a study proving the device meets those criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document states that the FASTx™ Sternal Intraosseous Device has "the same intended use and similar technological characteristics as the predicate devices." It outlines the safety and effectiveness review based on:

• Bench tests, functional testing, and validation studies.
• The infusion needle tubing and portal tip being the same as the predicate device.
• Risk analysis conducted according to ISO 14971:2007.
• Biocompatibility testing according to ISO 10993-1.
• Sterilization validation study according to ISO 11137.
• Pyrogen study according to USP guidelines.
• Packaging validation according to ISO 11607.

These are standard regulatory assessments for demonstrating safety and performance equivalence to a legally marketed predicate device, not a study designed to establish novel acceptance criteria or compare performance against a specific clinical benchmark for a new, non-predicate-based claim.

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The FAST1™ Intraosseous Infusion System is indicated for use in establishing a sternal intraosseous access route in adult and adolescent patients (12 years of age and older) requiring vascular administration of drugs or fluids to facilitate emergency resuscitation.

The FASTI™ Intraosseous Infusion System has been designed to provide alternative access of the circulatory system to intravenous infusion. It utilizes intraosseous infusion in order to facilitate emergency resuscitation through the use of fluids and drugs. The device has been designed for use on the manubrium, the upper (superior) portion of the sternum.

The provided text is a 510(k) summary for the FAST1™ Intraosseous Infusion System. It details an expansion of the intended use population to include adult and adolescent patients (12 years and older).

Based on the provided text, there is no study described that proves the device meets specific acceptance criteria in terms of quantitative performance metrics. The submission primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with defined acceptance criteria and results.

Here's a breakdown of the requested information based on the provided text, with "N/A" where the information is not present:

1. Table of acceptance criteria and the reported device performance:
   • Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a new study. The acceptance criterion for this 510(k) appears to be "Substantial Equivalence" to predicate devices.
   • Reported Device Performance: The primary "performance" reported is that the device has the "same intended use and the same or similar technological characteristics as the predicate devices." (Section VII)

2. Sample size used for the test set and the data provenance: N/A. No specific test set or data from a performance study is described. The submission relies on the substantial equivalence to previously cleared devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. No ground truth establishment by experts for a test set is described.
4. Adjudication method for the test set: N/A. No test set requiring adjudication is described.
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 device is not an AI-assisted diagnostic tool, but a medical device for intraosseous infusion. Therefore, an MRMC study as typically performed for AI products is not applicable here.
6. 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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A. No ground truth is described in the context of a new performance study. The ground for decision-making is substantial equivalence.
8. The sample size for the training set: N/A. No algorithm training is described.
9. How the ground truth for the training set was established: N/A. No algorithm training or corresponding ground truth establishment is described.

Summary of the study that proves acceptance criteria (as per the document):

The "study" presented is a substantial equivalence argument. The manufacturer asserts that the FAST1™ Intraosseous Infusion System (with expanded intended use population) is substantially equivalent to two predicate devices:

• The original FAST1™ Intraosseous Infusion System cleared under K072487.
• The EZ-IO Intraosseous Infusion System from Vidacare Corporation cleared under K052195.

The basis for this "proof" is that the modified device has the "same intended use and the same or similar technological characteristics" as the predicate devices. The document explicitly states: "The differences in technological characteristics between the modified and the predicate devices do not raise issues with the safety and effectiveness of the modified FAST1™ Intraosseous Infusion System." This implies that prior safety and effectiveness data for the predicate devices, and the inherent similarities, are considered sufficient evidence for accepting this expansion of intended use. There is no new clinical or performance study detailed in this 510(k) summary to establish novel acceptance criteria or performance metrics.

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The FAST1™ Intraosseous Infusion System is indicated for use in establishing a sternal intraosseous access route in adult patients requiring vascular administration of drugs or fluids to facilitate emergency resuscitation

The modified FASTI™ Intraosseous Infusion System is very similar to the FAST1™ Intraosseous Infusion System previously cleared under 510(k) K970380. It consists of a primary component - the infusion tube, and secondary components - the introducer for placing it through the sternum of the patient, the target/strain-relief patch, protector dome and sharps plug. The minor difference is that the infusion tube of the modified FAST1™ Intraosseous Infusion System can be removed from the patient's sternum by directly pulling on the infusion tubing, whereas the predicate device utilizes a remover tool to remove the infusion tube from the patient's sternum.

Both products are single use, hand-held, manually operated passive devices, (it has no internal energy source). Both products have an infusion tube with a sharp stainless steel tip, a flexible shaft and a standard Luer connector. For both products the user grasps an introducer handle attached to the infusion needle, and pushes the needle tip through the skin and overlying tissue into the sternum of the subject. Fluids or drugs are delivered through the needle to the marrow space of the sternum, and flow out the emissary veins of the sternum into the venous circulation.

Both devices use the same pusher handle and method to insert the infusion needle to the correct penetration depth in the sternum; a mechanism inside the introducer handle disconnects the handle from the infusion needle, preventing the user from pushing the needle any further. The principal of the mechanism is identical for both devices in that it detects the position of the anterior surface of the cortical bone of the sternum, and relates the position of the tip of the infusion needle to the surface of the cortical bone.

Both devices utilize the same adhesive patch which is applied to the top of the patient's chest which the user aligns with the supra-sternal notch of the patient. The position of the recommended insertion site is the same for both devices and is marked on the patch to aid in land marking. Also, the same patch and an associated cover for both devices provide protection and strain-relief to the site and the installed Infusion Tube.

The provided text is a 510(k) summary for the FAST1™ Intraosseous Infusion System. This document focuses on demonstrating substantial equivalence to a predicate device, specifically highlighting a minor modification related to the removal mechanism of the infusion tube. It does not contain specific acceptance criteria, a detailed study description with performance metrics, or information related to AI or ground truth establishment in the context of medical device performance studies.

Therefore, many of the requested details cannot be extracted from the provided input. The document is primarily a regulatory submission for a device modification, not a standalone performance study report.

Here's a breakdown of what can be inferred and what is missing, based on the provided text:

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

• Acceptance Criteria: Not explicitly stated. The document focuses on demonstrating substantial equivalence to a predicate device, which implies the modified device should perform at least as safely and effectively as the predicate.
• Reported Device Performance: Not quantified. The study conclusion states "The verification and validation conducted and conclusions demonstrate that the modified FAST1™ Intraosseous Infusion System is as safe and effective as the predicate device K970380." This is a qualitative statement of equivalence, not a report of specific performance metrics.

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 mentioned.
• Data Provenance: Not mentioned.
• Retrospective/Prospective: Not mentioned.

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)

• This information is not applicable and not provided. The study is a comparison of a modified mechanical device to a predicate device, not an assessment of diagnostic performance requiring expert interpretation or ground truth establishment in that typical sense.

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

• Not applicable and not provided.

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

• MRMC Study: No, an MRMC study was not done. The device is a direct-use medical device, not a diagnostic or AI-assisted tool involving human readers.
• AI Improvement Effect Size: Not applicable, as the device does not involve AI.

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

• Not applicable, as the device is not an algorithm.

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

• Not applicable in the typical sense. The "ground truth" for this device's performance would likely involve mechanical testing, simulated insertion/removal tests, and potentially human factors assessments to confirm the modified removal mechanism's efficacy and safety. These details are not provided.

8. The sample size for the training set

• Not applicable, as this device does not use machine learning or AI that would require a training set.

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

• Not applicable.

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The F.A.S.T. 1™ Intraosseous Infusion System is intended for intraosseous infusion as an alternative to intravenous access to facilitate emergency resuscitation through the use of drugs and fluids.

The F.A.S.T. 1™ Intraosseous Infusion System has been designed to provide a means, as an alternative to intravenous infusion, for facilitating emergency resuscitation of adults through the administration of fluids and drugs. The F.A.S.T. 1™ Intraosseous Infusion System has been designed for use on the adult sternum. It consists of a primary component - the infusion tube, and secondary components - the introducer for placing it through the skin into the sternum of the patient, the target / strain-relief patch, and a protector dome. There is also an infusion tube removal tool.

The provided 510(k) summary for the F.A.S.T. 1™ Intraosseous Infusion System does not contain specific acceptance criteria with numerical performance targets or a detailed study section with reported device performance metrics against those criteria. Instead, it offers a general overview of testing and a qualitative comparison to predicate devices, asserting substantial equivalence.

Therefore, I cannot populate a table with acceptance criteria and reported device performance as requested.

However, I can extract information related to the study design and ground truth as available in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated for specific test sets. Data was acquired from:
  • Excised human sternums
  • Human cadavers
  • Live human subjects (volunteers) in simulations/simulated clinical trials
• Data Provenance: The document states "Data have been obtained from tests conducted by or for Pyng Medical Corp., and from published literature." It does not specify the country of origin, but Pyng Medical Corp. is based in Vancouver, B.C., Canada. The nature of the studies involving cadavers and excised sternums implies a retrospective element in the use of biological material, while live human volunteer simulations would be prospective in nature.

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

• Number of Experts: Not specified.
• Qualifications of Experts: The document mentions that the device was "evaluated by both civilian and military paramedics." It does not provide further details on the number or specific qualifications (e.g., years of experience) of these individuals in establishing a formal ground truth for data evaluation.

4. Adjudication method for the test set:

• Adjudication Method: Not specified.

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:

• MRMC Study: Not applicable. The device described is a physical medical device (intraosseous infusion system), not an AI-assisted diagnostic or imaging tool involving human "readers." The "evaluations" mentioned were likely related to user experience and performance of the physical device by paramedics.

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

• Standalone Performance: Not applicable. This is a physical, manually operated device, not an algorithm. The device itself (mechanism for depth control, patch, etc.) has "standalone" characteristics in terms of its mechanical function, which were tested.

7. The type of ground truth used:

• The concept of "ground truth" as typically applied to AI/diagnostic studies is not directly transferable to this device submission. However, the closest equivalents to establishing "truth" about the device's performance involved:
  • Direct observation and measurement: Mechanical tests (masses, forces, strengths).
  • Physiological outcomes/anatomical assessment: Testing with excised human sternums, human cadavers to confirm penetration depth into the marrow space, and effectiveness of fluid delivery.
  • User feedback/expert evaluation: Simulated clinical trials with human volunteers and assessments by civilian and military paramedics for aspects like ease of use, successful insertion, and overall ratings.
  • Adherence to standards: Compliance with biocompatibility, sterilization, and mechanical performance standards (ISO, ANSI).

8. The sample size for the training set:

• Training Set Sample Size: Not applicable in the context of device development as described. The document refers to "development" and "testing" but does not delineate a formal machine learning "training set." Device refinement would have occurred iteratively based on engineering tests and feedback from the various test environments.

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

• Training Set Ground Truth Establishment: Not applicable as a formal "training set" for an algorithm is not described. The "truth" about the device's design effectiveness and safety during its development would have been established through a combination of engineering specifications, direct observation of performance in various test environments (simulators, cadavers, excised sternums), and iterative design improvements based on these findings.

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