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510(k) Data Aggregation
(22 days)
SIMS PORTEX, INC.
This device is intended for injection or aspiration of fluids utilizing a luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks. The Needle-Pro® device is not designed for use with a luer lock syringe.
This device is intended for injection or aspiration of fluids utilizing a luer slip syringe. The needle protection device is an integral component of the device as it comes 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 needle bevel by swiveling the orange arm to the desired position. After the procedure is completed, the needle is pressed into the sheath using a onehanded 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 be disposed into a sharps container. This device is not designed for use with a luer lock syringe. The device is supplied with 25G, 26G, 27G needles both with and without a syringe.
The provided text, a 510(k) summary for the "Hypodermic Needle-Pro® Needle with Needle Protection Device" and "Hypodermic Needle-Pro® Syringe & Needle with Needle Protection Device," does not include specific acceptance criteria or an analytical study detailing device performance against such criteria.
Instead, the submission relies on demonstrating substantial equivalence to a predicate device (K923127 Needle-Pro™ Cartridge) through non-clinical bench testing.
Here's an analysis of the information available in the document:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state numerical acceptance criteria for specific performance metrics. It makes a general claim:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined, but implied to be "equal or greater ability to resist static and dynamic forces, as compared to the predicate devices, while testing for needle disengagement." | "The bench test data submitted demonstrates that the proposed device has an equal or greater ability to resist static and dynamic forces, as compared to the predicate devices, while testing for needle disengagement." |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Bench test (non-clinical) data. The country of origin is not specified, but the applicant company, SIMS Portex Inc., is based in Keene, NH, USA. The data is prospective in the sense that it was generated for the purpose of this submission, but it's not clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the study was non-clinical bench testing comparing the device to a predicate, not assessing a diagnostic or predictive performance against a "ground truth" established by experts.
4. Adjudication method for the test set:
This is not applicable as the study was non-clinical bench testing, not involving human interpretation or 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 is not applicable. The device is a medical product (hypodermic needle and syringe), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical medical product, not an algorithm.
7. The type of ground truth used:
This is not applicable in the traditional sense of diagnostic accuracy. The "ground truth" for the non-clinical testing would be the established performance characteristics of the predicate device regarding its resistance to forces and needle disengagement. The goal was to prove the new device performed at least as well.
8. The sample size for the training set:
This is not applicable. There is no "training set" in the context of this 510(k) submission as it concerns a physical medical device, not a machine learning algorithm.
9. How the ground truth for the training set was established:
This is not applicable for the reasons stated above.
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(200 days)
SIMS PORTEX, INC.
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(121 days)
SIMS PORTEX, INC.
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(85 days)
SIMS PORTEX, INC.
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(185 days)
SIMS PORTEX, INC.
The Combined Spinal/Epidural Anesthesia System is indicated for the injections of local anesthetics into the spinal and epidural spaces of a patient to provide regional anesthesia. The adminsistration of the spinal anesthesia allows rapid anesthesia onset and the placement of an epidural catheter allows for bolus injections or continuous infusion of local anesthetics or other drugs into the epidural space.
The combined spinal epidural needle kit is intended for injection of local anesthetics into the intrathecal space via a spinal needle introduced through the epidural needle, and injection of local anesthetics into the epidural space via the epidural needle, or via an epidural catheter passed through the epidural needle.
Combined Spinal/Epidural Anesthesia Needles are instruments used for a spinal (subarachnoid) injection of anesthetics, followed by the placement of an epidural catheter to allow modification of the spinal analgesia if necessary, or bolus injections or continuous infusion of local anesthetics or other drugs into the epidural space for subsequent pain relief if required. The spinal needle consists of a luer hub, a stainless steel cannula with a pencil point tip, a stainless steel stylete, and a locking colar. The tuohy epidural needle consists of a luer hub, a stainless steel cannula with a Weiss tip, and a matching flange to accept the spinal needles locking colar. The needles are a matched set. The needles are provided as sterile, single use, disposable devices. They may be packaged as a set or included as a set in our regional anesthesia trays. The sizes are tabulated below:
| Spinal Needle | ||
|---|---|---|
| 26g 5 3/16" | ||
| (132 mm) | 27g 5 3/16" | |
| (132 mm) | ||
| Epidural Needle | ||
| 17g 3.5" (90 mm) | X | X |
| 18g 3.5" (90 mm) | X |
The Tuohy needle and the spinal needle have interlocking collars that enable the spinal needle to be locked into position once the dura has been pierced so that it is secured to the Tuohy needle to prevent acceidental displacement. The numbers on the Tuohy needle hub indicate the distance in millimeters that the spinal needle protrudes from the epidural Tuohy needle.
This document is a 510(k) Pre-Market Notification submission for the CSEcure™ Combined Spinal/Epidural Anesthesia System with Lock. It focuses on demonstrating substantial equivalence to a predicate device rather than providing specific acceptance criteria and a detailed study report with quantitative performance metrics against those criteria.
Therefore, many of the requested details such as specific acceptance criteria for a device's performance, statistical sample sizes for test and training sets, expert qualifications, and adjudication methods are not present in this type of regulatory document.
However, I can extract the information that is available:
1. A table of acceptance criteria and the reported device performance:
This document does not provide a specific table of quantitative acceptance criteria for device performance. Instead, it relies on demonstrating equivalence to a predicate device through "comparison testing." The reported device performance is described qualitatively as:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Similar Technical Characteristics | "The device has the same technical characteristics as the predicate device marketed by Becton-Dickinson." |
| Comparable Performance | "Comparison testing between the proposed device and the predicate device... compared well." |
| Safety & Effectiveness | "There were no differences seen in performance accept for an increased flow rate of 28.6% in the 27g spinal needle. The differences in these needles are not significant and substantiate that the needles are safe and effective. The testing substantiates this claim." |
| Substantial Equivalence | "The testing performed and comparison to the predicate device demonstrate that the proposed device is safe and effective and is substantially equivalent to the predicate device." |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document only mentions "comparison testing."
- Data Provenance: Not specified, but likely internal testing performed by SIMS Portex Inc. (the manufacturer). Retrospective or prospective is not indicated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is a non-clinical study involving physical device testing (e.g., flow rate, technical characteristics), not clinical data requiring expert review for ground truth. Therefore, this information is not applicable and not present.
4. Adjudication method for the test set:
Not applicable, as this was non-clinical testing.
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. This is a medical device in the field of anesthesia, not an AI/imaging device that would involve human readers for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
The "ground truth" for this non-clinical study relied on direct measurement and comparison of technical characteristics and physical performance (e.g., flow rate) against the established characteristics and performance of the legally marketed predicate device.
8. The sample size for the training set:
Not applicable. This is a non-clinical study for a physical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable (as per point 8).
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(64 days)
SIMS PORTEX, INC.
The SIMS Portex Anesthesia Catheter is indicated for the infusion of local anesthetics or narcotics into the intraoperative site for post operative pain management and for regional anesthesia, outside of the epidural space. Routes of administration may include intraoperative or percutaneous. The catheter is not intended for intravenous or intramuscular use.
The SIMS Portex Anesthesia Catheter is made of flexible, nylon tubing. The catheter may be closed-ended with lateral eyes or an open-ended catheter with finished tip. The tip 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 catheter is available as 21g (O.D. .033"/I.D. .019"). The catheters have a nominal length of 38 inches. The catheters may include a stylete.
The catheters are provided with a catheter connector (K965017) to provide a means of administration of anesthetics, analgesics, and/or narcotics. The catheter may be used in conjunction with an infusion pump. The catheter may be used, outside of the epidural space, for up to 30 days. An insertion device may be provided to aid the placement of the catheter into the introducer needle. They are provided sterile in individual packages or as a component of a regional anesthesia procedure tray (K965017).
The provided document, K994275, describes a 510(k) premarket notification for the SIMS Portex Anesthesia Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's de novo safety and effectiveness through extensive clinical trials. Therefore, the information typically found in a study demonstrating acceptance criteria for a novel device, such as detailed performance metrics from a specific test set, expert adjudication, or MRMC studies, is not present in this document.
Instead, the document emphasizes equivalence through non-clinical data demonstrating that the new catheter performs equivalently to predicate devices for specific characteristics.
Here’s an analysis based on the provided text, addressing the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Demonstrated Equivalency to Predicate) | Reported Device Performance |
|---|---|---|
| Dimensional Characteristics | Identical design and materials to current catheter for: |
- Inner Diameter (ID)
- Outer Diameter (OD)
- Length | Demonstrated equivalency to predicate devices. |
| Functional Characteristics | - Flow Rate - Leakage
- Eye Patency
- Tensile Strength
- Percentage Elongation
- Luer Taper
- Security of Connection of the catheter to the catheter connector
- Hub/Catheter Detachment | Demonstrated equivalency to predicate devices. |
| Material Safety | - ETO residuals (Ethylene Oxide sterilization residuals) - Biological Safety per ISO 10993 | Data submitted covers ETO residuals and biological safety per ISO 10993. |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" in the way one would for a clinical study with patients or a specific set of images for an AI algorithm. The performance evaluation was based on non-clinical data comparing the new device's characteristics against predicate devices. The exact sample sizes for each physical or material test (e.g., number of catheters tested for flow rate, tensile strength, etc.) are not provided in this summary.
Data provenance (country of origin, retrospective/prospective) is not applicable in the context of these non-clinical, bench-top type tests. The tests would likely have been conducted in a lab setting by the manufacturer (SIMS Portex Inc., likely in Keene, NH, USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the evaluation was based on objective, quantifiable physical and material tests against manufacturer specifications and predicate device characteristics, not subjective interpretations by experts to establish a "ground truth" in a clinical diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the non-clinical, bench-top tests conducted.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an anesthesia catheter, not an AI-assisted diagnostic tool.
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 anesthesia catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to the established specifications and performance characteristics of the predicate devices and recognized industry standards (e.g., ISO 10993 for biological safety). The new device's performance in dimensional, functional, and material safety tests was compared directly to these objective benchmarks to demonstrate substantial equivalence.
8. The sample size for the training set
This question is not applicable. The device is an anesthesia catheter and does not involve a training set as would be used for machine learning.
9. How the ground truth for the training set was established
This question is not applicable for the reasons stated above.
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(231 days)
SIMS PORTEX, INC.
Infant Manual Resuscitator: The 1st Response Infant Manual Resuscitator is a pulmonary-assist device intended to provide respiratory support to infant patients suffering from respiratory distress. It is intended for use on patients with a body mass of 10 kg (22 lbs) and
The 1st Response infant and pediatric manual resuscitators are disposable, single use emergency manual ventilators. 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 reservoir or 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 15mm ID x 22 mm OD patient connector, exhalation port, manometer port, and a pressure limiting valve (PLV).
The device is provided with or without a face mask. Special configurations are available which include a disposable manometer, PEEP valve with adapter, or exhalation filter.
The provided document describes a 510(k) premarket notification for the SIMS Portex Inc. 1st Response Infant and Pediatric Manual Resuscitator. This is a submission for a medical device that demonstrates substantial equivalence to existing predicate devices, rather than a study proving the device meets acceptance criteria through clinical trials or performance metrics that would typically be described with the requested information.
Therefore, the specific information requested about acceptance criteria, detailed study design, sample sizes, expert involvement, and ground truth establishment (which are common for AI/software-based medical devices or novel medical devices requiring extensive performance studies) is not applicable in the context of this 510(k) submission for a manual resuscitator.
Here's how the available information relates to your request:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable. The document does not present specific quantitative acceptance criteria or reported device performance in a table format as would be typical for a clinical or performance study of a novel device. Instead, the "acceptance" in this context is based on demonstrating substantial equivalence to predicate devices, meaning it meets the same standards and performs similarly to devices already on the market.
The document states:
- "Performance and specifications of the modified device are consistent with all requirements for this device type specified by 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." (Page 2)
This indicates that the device meets existing international standards for medical resuscitators, which serve as the implicit "acceptance criteria" for its design and manufacturing.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable. This submission is for a physical medical device (manual resuscitator) and relies on "non-clinical data" (Page 2), primarily engineering and design specifications, and comparison to predicate devices, rather than a "test set" of patient data as might be used for an AI algorithm or a diagnostic device. There is no mention of a test set, data provenance, or patient data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. There was no "test set" in the context of patient data where ground truth would be established by experts. The determination of substantial equivalence is made by regulatory bodies (FDA) based on the submitted technical documentation and comparison to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. As no test set of patient data was used, no adjudication method for ground truth establishment was necessary or performed.
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 a manual resuscitator, not an AI or diagnostic imaging device. Therefore, no MRMC study or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical medical device; there is no algorithm involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not Applicable. For this type of device submission, the "ground truth" or basis for approval is adherence to established industry standards (ISO 8382:1988 (E) and ISO 5356-1: 1987) and demonstrated substantial equivalence in technical characteristics, indications for use, and safety/effectiveness to previously cleared predicate devices.
8. The sample size for the training set
Not Applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not Applicable. There is no "training set" or associated ground truth.
Summary of the Study/Justification Presented in the Document:
The "study" in this context is a non-clinical comparative analysis demonstrating an equivalence to legally marketed predicate devices.
- Objective: To demonstrate that the 1st Response Infant and Pediatric Manual Resuscitator is substantially equivalent to existing predicate devices in terms of safety and effectiveness.
- Methodology: Comparison of technical characteristics, indications for use, and performance against established international standards (ISO 8382:1988 (E) and ISO 5356-1: 1987).
- Predicate Devices:
- Hudson Respiratory Care Inc., Neonate Manual Resuscitator, Cat. No. 5360 and Pediatric Manual Resuscitator, Cat. No. 5365.
- SIMS Portex Inc., 1st Response Infant Manual Resuscitator, Cat. No. 008027MP and 1st Response Pediatric Manual Resuscitator Cat. No. 008120.
- Conclusion: "The comparison to the predicate devices demonstrate that the proposed devices are safe and effective and are substantially equivalent to the predicate devices." (Page 2)
This type of submission focuses on regulatory compliance and equivalence rather than detailed clinical trial data with specific acceptance criteria and performance metrics for a novel technology.
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(88 days)
SIMS PORTEX, INC.
The SIMS Portex Epidural Catheter is indicated for the injection of local anesthetics into the epidural space.
The SIMS Portex Epidural Catheter is made of flexible, nylon tubing. The catheter may be closed-ended with lateral eyes or an open-ended catheter with finished tip. The tip 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 catheter is available in 20g (O.D. .042"/I.D. .023") or 21g (O.D. .033"/I.D. . 019") sizes. The catheters have a nominal length of 38 inches. The catheters may include a stylete. The catheters are provided with a catheter connector (K965017) to provide a means of administration of anesthetics and/or analgesics. They are provided sterile in individual packages or as a component of a continuous epidural procedure tray (K965017).
The provided 510(k) summary for the SIMS Portex Epidural Catheter indicates that no clinical data was submitted to demonstrate the device meets acceptance criteria. Instead, the submission relies on non-clinical data to establish substantial equivalence to a predicate device.
Therefore, many of the requested sections regarding clinical study design, ground truth, expert adjudication, and MRMC studies are not applicable or cannot be extracted from this document.
Here's the information that can be extracted and a clear indication where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional Characteristics | Performs equivalently to predicate device |
| Flow Rate | Performs equivalently to predicate device |
| Compression Resistance | Performs equivalently to predicate device |
| Hub/Catheter Detachment | Performs equivalently to predicate device |
| Deflection Resistance | Performs equivalently to predicate device |
| Modulus of Elasticity | Performs equivalently to predicate device (with an increase in percent elongation compared to predicate due to material change, but this has "no affect on performance criteria"). |
| Tensile Strength | Performs equivalently to predicate device |
| Elongation | Performs equivalently to predicate device (with an increase in percent elongation compared to predicate due to material change, but this has "no affect on performance criteria"). |
| ETO Residuals | Data submitted (implies acceptable levels) |
| Biological Safety (per ISO 10993) | Data submitted (implies acceptable levels based on ISO 10993 standards) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No clinical test set. Non-clinical data was used.
- Data Provenance: Not applicable. Non-clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable. No clinical test set requiring expert ground truth.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No.
- Effect Size of Human Readers with/without AI assistance: Not applicable, as this is neither an AI device nor was an MRMC study performed.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? Not applicable. This is not an AI algorithm. The device is a physical epidural catheter.
7. Type of Ground Truth Used
- For Non-Clinical Data: Engineering specifications, material science standards (e.g., ISO 10993 for biological safety), and comparative measurements against the predicate device.
8. Sample Size for the Training Set
- Not applicable. This is not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This is not an AI algorithm requiring a training set or ground truth establishment for training.
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(87 days)
SIMS PORTEX, INC.
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. 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 reservoir or 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. A manometer port is optional. The device is provided with or without a facemask. Special configurations are available which include a disposable manometer, PEEP valve with adapter, or exhalation filter.
The document provided is a 510(k) summary for a medical device called the "1st Response Manual Resuscitator." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a new study.
Therefore, the document does not contain the information requested regarding acceptance criteria, a specific study proving the device meets those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about training and ground truth for an AI-powered device.
The document states:
- "Performance and specifications of the modified device are consistent with all requirements for this device type specified by 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."
- "The comparison to the predicate devices demonstrate that the proposed device is safe and effective and is substantially equivalent to the predicate devices."
This indicates that the device's characteristics were compared against established standards (ISO) and existing predicate devices, rather than being subjected to a novel clinical study with explicit acceptance criteria for a new device's performance.
In summary, this document does not support the generation of the requested table and details.
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(88 days)
SIMS PORTEX, INC.
Spinal needles are indicated for the injection of local anesthetics into a patient to provide regional anesthesia.
A spinal needle is an instrument used for the injection of local anesthetics into a patient to provide regional anesthesia. The needle consists of a luer hub, a stainless steel cannula, and a stainless steel stylete. The needles are provided as sterile, single use, disposable devices. They may be packaged individually or included in our regional anesthesia trays. The spinal needles are provided in three styles; Lancet Point (Quincke), Pencil Point (Whitacre), and European Style (Sprotte). The introducer needle is a simple hypodermic needle, either 18g or 20g, to make the initial puncture through the skin to aid in the placement of the spinal needle.
The provided document is a 510(k) Summary for Spinal Anesthesia Needles. It describes the device, its intended use, technical characteristics, and non-clinical data. It does not present acceptance criteria or a study designed to prove the device meets specific acceptance criteria as would be typical for an AI/ML medical device.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices through comparison testing of physical characteristics and performance attributes (like flow rate and penetration force). This is a regulatory pathway for traditional medical devices, not for AI/ML algorithms.
Therefore, for your request, I must state that the information you are asking for (acceptance criteria, specific study design, performance metrics, ground truth, expert involvement, MRMC studies, standalone performance, training set details) is not available in this document because it pertains to a different type of device evaluation (traditional medical device vs. AI/ML medical device).
The document's "study" is a comparison test, not a performance study against predefined acceptance criteria in the context of an AI/ML algorithm.
Here's a breakdown of why each specific point you asked for cannot be extracted from this document:
-
A table of acceptance criteria and the reported device performance: This document does not establish explicit "acceptance criteria" for the device in the way an AI/ML device would, nor does it report performance against such criteria. Instead, it compares characteristics like "increased inside diameter" and "reduced outside diameter" to predicate devices, stating that the proposed device "compared well" and that the differences are "not significant."
-
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The document mentions "comparison testing between the proposed device and the predicate devices" and "unisis needles tested." However, it does not specify sample sizes for this testing, nor does it provide details on data provenance (e.g., country of origin, retrospective or prospective nature of the test data).
-
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): Since this is a physical medical device and not an AI/ML system, the concept of "ground truth" established by experts for a test set is not applicable in the way it would be for an AI/ML device. The "truth" here is based on physical measurements and mechanical performance.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a physical medical device comparison test.
-
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 document is about spinal needles, not an AI system.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc): The "ground truth" in this context would be the physical properties and performance characteristics of the needles themselves (e.g., measured flow rates, penetration force), rather than clinical outcomes or expert consensus on interpretations.
-
The sample size for the training set: Not applicable. This device is not an AI/ML algorithm that requires a training set.
-
How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.
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