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The Portex® 24g Pediatric Epidural and Peripheral Block Anesthesia Catheter is designed for use primarily in pediatic applications (children under 12 years, infants and neonates) for continuous or intermittent regional anesthesia, e.g. epidural, caudal and peripheral blocks. The duration of use should not exceed 72 hours.

The Portex® 24g Pediatric Epidural and Peripheral Block Anesthesia Catherer is made of flexible, nylon tubing. The catheter is open-ended catheter with finished tip. The tipe of the catheter is marked. The catheter has a single mark at 5 cm from the tip with 1 cm increments, up to 20 cm. The 10 cm mark is indicated by two marks, 15 cm by three marks, and 20 cm by four marks.

The catherer is available in 24g (O.I). 0.022"/I.D. 0.012") size. The catheters have a nominal length of 36 inches. The catheter includes a stylet.

The catheters are provided with a catheter connector to provide a means of administration of anesthetics and/or analgesics. They are provided sterile as a component of a continuous anesthesia conduction catheter mini tray.

The provided text describes a 510(k) premarket notification for the Portex® 24g Pediatric Epidural and Peripheral Block Anesthesia Catheter. It focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study with a specific study design and data.

Therefore, most of the requested information cannot be directly extracted from this document, as it outlines a regulatory submission process based on non-clinical data and comparison to predicates.

Here's an attempt to answer based on the available information, noting where data is not present:

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

The document does not explicitly state formal "acceptance criteria" in a quantitative sense for each performance metric, as it's a 510(k) submission relying on substantial equivalence to predicate devices. Instead, it states that the device's characteristics "fall within the values of the predicate Portex catheters and the B. Braun catheter."

The "reported device performance" is essentially that it performs equivalently to predicate devices across various non-clinical tests.

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

• Sample Size: The document does not specify the sample sizes for the non-clinical tests (e.g., how many catheters were tested for flow rate, tensile strength, etc.).
• Data Provenance: The data is presented as "Non-Clinical Data" submitted by Smiths Medical ASD, Inc., located in Keene, NH, USA. The document doesn't specify if the testing was done internally or by a third-party, nor does it explicitly state the country of origin of the raw data. It is inherently prospective in the sense that the sponsor conducted these tests specifically for this 510(k) submission on the new device.

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 question is not applicable as the submission relies on non-clinical engineering and material testing data, not expert-adjudicated clinical data to establish a "ground truth" for a test set. The "ground truth" here is the performance metrics themselves, measured against engineering specifications or comparison to predicate devices, not subjective expert assessment.

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

• This question is not applicable for the same reasons as #3. There was no clinical test set requiring expert adjudication.

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 question is not applicable. This is a submission for a physical medical device (catheter), not an AI/software device. No MRMC study was conducted.

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

• This question is not applicable. This is a physical medical device, not an algorithm.

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

• The "ground truth" for this submission are the measured physical, mechanical, and material properties of the device, confirmed through standard engineering and laboratory testing, and compared against the known properties of the predicate devices. This includes dimensional characteristics, flow rate, mechanical resistances (compression, deflection), material strengths (tensile, elongation), and material compatibility (biocompatibility).

8. The sample size for the training set

• This question is not applicable. There is no "training set" in the context of this 510(k) submission, which is based on demonstrating substantial equivalence through non-clinical testing, not machine learning or AI.

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

• This question is not applicable for the same reason as #8.

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The PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula is indicated for use in providing percutaneous temporary tracheal access for airway management.

The PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula is designed to permit percutaneous insertion of a specifically designed tracheostomy tube. This single cannula Percutaneous Tracheostomy Tube has a radiopaque blue line and is constructed of biocompatible polyvinylchloride material and incorporates a tapered and beveled distal tube tip to facilitate insertion through the percutaneously dilated stoma site. The tracheostomy tube has a neck flange, an integral 15 mm connector, and a cuff which deflates to a low profile on the tube for a smooth transition during insertion. The cuff inflation line has a self sealing Luer valve. The tracheostomy tube is supplied with a disposable inner cannula of the appropriate size. The Percutaneous Tracheostomy Kit comes with the necessary components for percutaneous tracheostomy tube insertion into a stoma created by serial dilation.

The manufacturer, Portex, Inc., submitted a 510(k) premarket notification (K031057) for their PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula. The submission includes a summary of nonclinical and clinical tests that support the device's substantial equivalence to predicate devices and its safety and effectiveness.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The clinical user evaluation involved 28 subjects in the control group and 26 subjects in the two study groups. This totals 54 subjects for the clinical test set.
• Data Provenance: The study was a prospective clinical user evaluation conducted at St. John's Mercy Medical Center. The country of origin is not explicitly stated but can be inferred as the United States (given the submission to the FDA and the U.S. location of the manufacturer and study site).

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

The document does not specify the number of experts used to establish the ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). It refers to a "clinical user evaluation," which implies participation from medical professionals. The study was conducted at "St. John's Mercy Medical Center," suggesting that the evaluation was carried out by healthcare professionals at that institution who are experienced in performing tracheostomies and managing tracheostomy patients.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical user evaluation. It presents the findings as conclusions from the evaluation without detailing the consensus or disagreement resolution process.

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 conducted, nor is this device an AI-assisted device. The study was a clinical user evaluation comparing a new medical device to existing (predicate) devices, focusing on clinical outcomes directly related to the device itself, not AI interpretation or human reader performance with or without AI.

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

No, a standalone algorithm performance study was not done. This device is a physical medical device (tracheostomy kit), not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used in this study would be based on clinical observation and assessment of patient outcomes. This would include:

• Clinical Assessment: Direct observation by healthcare professionals during tube insertion for "trauma or difficulty."
• Patient Outcomes/Monitoring: Data collected on the "incidence of occlusion of the tracheostomy tube" over time for the study subjects.
• Expert Clinical Judgement: The expertise of the clinicians performing the procedures and evaluating the patients would form the basis of the "ground truth" for success or failure regarding safety and effectiveness.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of this device. As a physical medical device, there isn't a "training set" in the sense of data used to train a machine learning model. Instead, the design and development of the device would have involved internal testing and refinement (e.g., engineering tests, bench testing, animal studies, or earlier human factors analysis) which are not detailed as a "training set" in this summary.

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

Since there is no "training set" in the context of an algorithm or machine learning for this device, the concept of establishing ground truth for a training set does not apply. The development process for the physical device would have involved standard medical device design control procedures, where design inputs are translated into design outputs, and verification/validation activities ensure the device meets its requirements. Any "ground truth" during development would stem from engineering specifications, material testing standards, and preclinical (e.g., animal, bench) study results.

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The 1st Response Pediatric Manual Resuscitator is a pulmonary-assist device intended to provide respiratory support to patients suffering from respiratory distress. It is intended for use on patients with a body mass of between 10 kg (22 lbs) and 40 kg (88 lbs).

The 1st Response Pediatric manual resuscitator is a disposable, single use emergency manual ventilator. It is intended for single patient use only. Each device consists of a plastic compressible ventilator bag fitted with control valves at each of the two ends. The inlet valve, opposite the patient end, allows entry of fresh gas into the compressible ventilator bag. The valve blocks escape of fresh gas from the ventilator bag during its compression. Attached to this valve are one of two types of reservoirs; bag reservou or tube reservoirs serve to collect an overflow of oxygen when a supplemental oxygen supply is used. The patient end of the ventilator bag is fitted with a second valve assembly. This valve consists of a 15 mm ID x 22 mm OD patient connector, exhalation port, manometer port and a pressure-limiting valve (PLV). The patient port has a swivel feature to allow the care provider to move the bag around the patient, as needed. Standard configurations of the device are provided with or without a face mask. Special configurations are available which include a disposable manometer, PEEP valve with adapter, or exhalation filter.

This document describes a 510(k) premarket notification for the "1st Response Pediatric Manual Resuscitator." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new device's efficacy through extensive clinical trials. Therefore, the information requested in your prompt regarding acceptance criteria, study details, expert involvement, and training set information is not typically found in this type of regulatory submission.

Specifically, for this 510(k) K023793:

1. Acceptance Criteria and Reported Device Performance:

   • The document states that "Performance and specifications of the modified device are consistent with all requirements for this device type specified by: ASTM 920; Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use with Humans, ISO 8382:1988 (E) Resuscitators intended for use with humans, and ISO 5356-1: 1987 - Anaesthetic and respiratory equipment - Conical connectors - Part 1; Cones and sockets."
   • Interpretation: The acceptance criteria are defined by compliance with these established national and international standards for manual resuscitators. The reported device performance is implicitly stated as meeting these standards, as the submission concludes substantial equivalence. However, no specific performance metrics are provided in a table format in the document to directly compare against numerical acceptance criteria.

2. Sample Size used for the test set and the data provenance: Not applicable. This is a non-clinical submission relying on engineering and performance standards compliance, not a clinical study with a test set of patients/data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth was established by experts for a test set.

4. Adjudication method for the test set: Not applicable. No clinical test set was used.

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 manual resuscitator, not an AI-assisted diagnostic tool or imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's safety and effectiveness determination is established by its adherence to recognized industry standards (ASTM and ISO as listed above) and by demonstrating substantial equivalence to predicate devices that have previously met regulatory requirements.

8. The sample size for the training set: Not applicable. There is no "training set" in the context of an AI/machine learning device. The design and testing are based on engineering principles and regulatory standards.

9. How the ground truth for the training set was established: Not applicable.

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The 1st Response Manual Resuscitator is a pulmonary-assist device intended to provide respiratory support to patients suffering from respiratory distress. It is intended for use on patients with a body mass of 25 kg (55 lbs) or more.

The 1st Response manual resuscitator is a disposable, single use emergency manual ventilator. It is intended for single patient use only. Each device consists of a plastic compressible ventilator bag fitted with control valves at each of the two ends. The inlet valve, opposite the patient end, allows entry of fresh gas into the compressible ventilator bag. The valve blocks escape of fresh gas from the ventilator bag during its compression. Attached to this valve are one of three types of reservoirs; bag reservoir, expandable tube reservoir, or flexible length tube reservoir. These reservoirs serve to collect an overflow of oxygen when a supplemental oxygen supply is used. The patient end of the ventilator bag is fitted with a second valve assembly. This valve consists of a 15 mm ID x 22 mm OD patient connector and exhalation port. The patient port has a swivel feature to allow the care provider to move the bag around the patient, as needed. Standard configurations of the device are provided with or without a breathing mask and with or without a PEEP valve. Special configurations are available which could include; pre-attached components, exhalation filter, varying lengths of oxygen lines, varying sizes of breathing masks, and oropharyngeal airways (Berman and Guedel). The breathing mask consists of a clear flexible cone that features a 22 mm ID port and a clear tacky cushion that contacts the patient's face. The PEEP valve features a 30 mm ID port and a knob to allow the care provider the ability to adjust the amount of PEEP. The PEEP valve can be adjusted from 5-20 cm H2O and uses two springs and a silicone rubber diaphragm to regulate the exhaust pressure.

This document describes a 510(k) submission for a manual resuscitator, which primarily relies on substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria, sample sizes, and expert review as typically seen in submissions for AI/ML devices or novel technologies. Therefore, many of the requested details are not applicable or explicitly stated in this type of submission.

Here's an analysis based on the provided text, addressing the points where information is available or can be inferred:

Acceptance Criteria and Device Performance

The submission focuses on establishing equivalence to a predicate device (Portex, Inc., 1st Response Manual Resuscitators, K992057). The "acceptance criteria" are implied by adherence to recognized standards and the demonstration that the new device has "the same technical characteristics" as the predicate.

Study Details

Given this is a 510(k) for a manual resuscitator based on equivalence to a predicate, a "study" in the sense of a clinical trial or a performance validation for an AI/ML device is not described. The "study" here refers to the non-clinical data assessment and comparison.

1. Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI/ML algorithm evaluation. The document refers to non-clinical data related to product specifications and standards adherence.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a traditional device like a manual resuscitator is not established by expert consensus on data interpretation, but by engineering specifications and physical testing against standards.
3. Adjudication method for the test set: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, a MRMC study was not done. This type of study is typically for evaluating diagnostic or imaging devices where human readers interpret results, often with AI assistance. This device is a manual resuscitator.
5. 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.
6. The type of ground truth used: For a manual resuscitator, "ground truth" would be objective measurements against performance standards (e.g., flow rates, pressures, valve function) and material specifications, as outlined by ASTM and ISO standards. The submission states that the device's performance and specifications are "consistent with all requirements for this device type" as specified by these standards.
7. The sample size for the training set: Not applicable. There is no concept of a "training set" for this type of medical device submission.
8. How the ground truth for the training set was established: Not applicable.

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This device is intended for injection of insulin. The needle protection device covers the needle after use to help prevent needle sticks.

This device is intended for injection of insulin. The needle protection device is an integral pre-attached to the needle. Once the needle/needle protection device is attached to a syringe, the collar hoop hinders removal of the needle protection device from the needle. The Needle-Pro® sheath may be adjusted relative to the desired position. After the procedure is completed, the needle is pressed into the sheath using a one-handed technique. As the needle enters the protective sheath, the needle protection device engages and the needle is contained within the sheath. The device should be immediately disposed into a sharps container. The device is supplied with 26G and 27G needles.

The provided text is a 510(k) summary for a medical device (Hypodermic Needle-Pro® Insulin Syringe & Needle with Needle Protection Device). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically seen in performance studies for diagnostic or AI-driven devices.

Here's a breakdown of the requested information based only on the provided text, highlighting what is missing:

Acceptance Criteria and Device Performance Study

The provided document does not describe an acceptance criteria table or a study designed to prove the device meets specific performance criteria in the way requested (e.g., sensitivity, specificity, or similar metrics for diagnostic tools). This document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel performance against predefined metrics.

The document states:

• "NON-CLINICAL DATA: The descriptive characteristics of this device are precise enough to ensure equivalence."
• "CLINICAL DATA: Not applicable"
• "CONCLUSION: The comparison to the predicate devices demonstrates that the proposed device is safe and effective and is substantially equivalent to the predicate device."

This indicates that the "study" conducted for this 510(k) was primarily a comparative analysis of the device's characteristics against a predicate device to establish substantial equivalence. Performance criteria related to safety and effectiveness are inferred through this equivalence, rather than direct measurement against numerical targets.

Breakdown of Requested Information:

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

   • Not provided. The document does not define specific quantitative acceptance criteria or report performance metrics in this format. The basis for approval is substantial equivalence to a predicate device.

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 / Not provided. Since no specific clinical or performance study with a "test set" was described, this information is absent. The assessment relied on comparison with a predicate device.

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 / Not provided. No ground truth establishment by experts for a test set is mentioned.

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

   • Not applicable / Not provided. No test set or adjudication method 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

   • Not applicable / Not provided. This device is an insulin syringe with a needle protection mechanism, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.

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

   • Not applicable / Not provided. This device is a physical medical instrument, not an algorithm.

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

   • Not applicable / Not provided. For this type of device and submission, "ground truth" as typically understood in performance studies (especially for diagnostics) is not used. The "truth" or benchmark is the predicate device's substantial equivalence in design, materials, and intended use.

8. The sample size for the training set

   • Not applicable / Not provided. No training set, as understood for AI or complex statistical models, is mentioned.

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

   • Not applicable / Not provided. No training set or ground truth establishment for it is mentioned.

Summary of the Document's Approach to Demonstrating Safety and Effectiveness:

The document leverages the concept of substantial equivalence to a predicate device (K011925 Hypodermic Needle-Pro® Syringe & Needle with Needle Protection Device). Instead of conducting a new study with explicit performance criteria, the manufacturer demonstrates that their proposed device is:

• Comprised of identical or similar components and materials as the predicate device.
• Has the same intended use (injection of insulin; needle protection after use).
• Has similar technical characteristics.
• Doesn't raise new questions of safety or effectiveness.

This approach, common for Class II medical devices in 510(k) submissions, assumes that if a new device is sufficiently similar to a previously cleared device, it is also safe and effective. No clinical data, performance studies with acceptance criteria, or expert evaluations for a test set were deemed necessary or were documented in this summary.

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