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The Autosuture™ ENDO GIA™ Staplers with ENDO GIA™ Single Use Loading Units with Staple Line Reinforcement have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and billary structures.

The Autosuture™ ENDO GIA™ Staplers with ENDO GIA™ Single Use Loading Units with Staple Line Reinforcement place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 3.5 mm or 4.8 mm Single Use Loading Unit (SULU). The ENDO GIA™ UNIVERSAL Single Use Loading Units (SULUs) with Staple Line Reinforcement are only available in the straight and articulating 45 mm and 60 mm length cartridges with the 3.5 mm or 4.8 mm staples. The staple line reinforcement material is a synthetic absorbable film prepared from synthetic polyester composed of glycolide, dioxanone, and trimethylene carbonate. The staple line reinforcement material is supplied on each SULU undyed (natural) and is secured to the anvil and cartridge with BIOSYN™ synthetic absorbable suture. Studies indicate that the staple line reinforcement material can be expected to retain measurable mechanical strength through 14 days and absorption should be complete between 90 and 110 days.

The provided text describes a 510(k) summary for the Autosuture™ ENDO GIA™ Surgical Staplers with ENDO GIA™ Single Use Loading Units with Staple Line Reinforcement. However, it does not include information about specific acceptance criteria or an explicit study that proves the device meets those criteria in the context of a typical AI/software device evaluation.

The document mainly focuses on the device description, intended use, technological characteristics, and material safety. It states: "Performance evaluations were completed to verify that the Autosuture™ ENDO GIA™ Staplers with ENDO GIA™ Single Use Loading Units with Staple Line Reinforcement are safe and effective and perform as intended." This is a general statement and does not provide the detailed information requested regarding specific acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement, which are typical for studies assessing AI device performance.

Therefore, I cannot provide the requested information from the given text. The text does not contain:

1. A table of acceptance criteria and reported device performance: No specific performance metrics or acceptance thresholds are listed.
2. Sample size used for the test set and data provenance: No information on the number of cases or the origin of data used for performance evaluation.
3. Number of experts used to establish ground truth and their qualifications: No mention of expert involvement in establishing ground truth.
4. Adjudication method for the test set: Not applicable as no ground truth creation process is described.
5. MRMC comparative effectiveness study: The document does not describe a study involving human readers with or without AI assistance.
6. Standalone (algorithm only) performance: This device is a surgical stapler, not an AI algorithm, so standalone algorithm performance is not applicable in the usual sense. Its performance is inherent to its mechanical function and material properties.
7. Type of ground truth used: Not applicable as it's a physical device and not an AI interpreting data. The "ground truth" for a physical device would relate to its mechanical integrity and biological interaction, which is assessed through various engineering and biocompatibility tests.
8. Sample size for the training set: Not applicable as this is a physical device, not an AI system that requires a training set.
9. How the ground truth for the training set was established: Not applicable for the same reason.

The "performance evaluations" mentioned in the document likely refer to laboratory testing, mechanical robustness tests, biocompatibility assessments, and potentially animal studies, which are standard for surgical devices, rather than clinical studies involving human readers or AI algorithms that would generate the kind of data you're asking for.

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COPA AMD dressings are indicated for use in management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, 1st and 200 degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds.

COPA AMD is a hydrophilic polyurethane foam that is impregnated with Polyhexamethylene Biguanide Hydrochloride (PHMB), an antimicrobial agent that protects the dressing from bacterial penetration and colonization.

The provided text from the 510(k) Premarket Notification for the COPA AMD Antimicrobial Wound Dressing describes performance data related to its antimicrobial properties. The information pertains to the device's ability to prevent bacterial penetration and colonization.

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

1. Table of acceptance criteria and the reported device performance

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

• Sample size: Not explicitly stated in terms of the number of unique dressings or tests. The tests were performed in-vitro and an animal testing was also mentioned.
• Data provenance: The tests were described as "in-vitro and animal testing," indicating laboratory and possibly animal model experiments. The country of origin for these tests is not specified, but the submission is to the US FDA.

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

Not applicable. The performance data is based on laboratory (in-vitro) and animal testing, which typically relies on established microbiological and scientific protocols rather than expert consensus on subjective observations.

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

Not applicable. This type of adjudication is relevant for studies involving human interpretation (e.g., image reading), not for laboratory or animal testing results.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a wound dressing, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

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

Not applicable. This device is a physical wound dressing and does not involve an algorithm or AI.

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

The ground truth was established through microbiological assays (quantifying bacterial kill) for the in-vitro tests and likely biological endpoints related to infection or wound healing for the animal testing.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The "testing" referred to is for device performance, not algorithm training.

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

Not applicable, as there is no training set for this device.

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The proposed catheters are intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals. General drainage is accomplished by inserting the catheter through the urethra and into the urine bladder. The catheter is retained in the bladder by inflation of balloon. Drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.

Not Found

Please note that the provided document is a 510(k) clearance letter from the FDA for a medical device (a Foley catheter with a temperature sensor). This type of document does not contain the detailed study information, acceptance criteria, or performance metrics that would be generated by a clinical or performance study.

The FDA 510(k) process is primarily about demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel performance against specific acceptance criteria. Therefore, most of the requested information regarding study details, ground truth, and sample sizes will not be present in this document.

However, I can extract the following relevant information and explain why other requested details are not available:

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

This document does not specify quantitative acceptance criteria or detailed reported device performance in this format. The FDA 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device. This typically involves showing that the new device has the same design, materials, and intended use, and performs as safely and effectively as the predicate. Performance data, if submitted, would be intended to support this equivalence, not necessarily to meet pre-defined, publicly disclosed acceptance criteria in the manner one might find for a novel drug or a high-risk device requiring a PMA.

The closest to "performance" mentioned is in the "Indications for Use" section (Page 3), which states: "The proposed catheters are intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals." This is a statement of intended function, not a quantitative performance metric.

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

This information is not available in the provided document. The 510(k) clearance letter itself does not include details about specific test set sample sizes or data provenance. Such information would be part of the predicate device's historical data or a new device's performance testing reports, which are part of the full 510(k) submission, but not typically summarized in the clearance letter.

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 therefore not available in the provided document. This device is a physical medical device (Foley catheter with temperature sensor), not an AI or diagnostic imaging device that would require expert-established ground truth for a test set. Its performance relies on physical specifications, material compatibility, and temperature sensing accuracy, not on interpretations of complex data by experts.

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

This information is not applicable and therefore not available. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation, often in diagnostic imaging or clinical trials where multiple experts assess the same cases. This is not relevant for a physical device like a Foley catheter.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and therefore not available. An MRMC study is relevant for diagnostic performance, particularly with AI assistance, where different readers analyze cases. This device is a physical catheter, not an AI diagnostic tool.

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

This information is not applicable and therefore not available. A "standalone algorithm" is not relevant for a physical medical device like a Foley catheter.

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

Again, the concept of "ground truth" as it applies to AI diagnostics or complex clinical endpoints is not directly applicable to this device in the context of this 510(k) letter. For a Foley catheter with a temperature sensor, "ground truth" would be related to:

• Physical measurements: Accuracy of the temperature sensor against a calibrated standard.
• Biocompatibility: In vitro and in vivo testing for material safety.
• Mechanical integrity: Tensile strength, balloon inflation/deflation, tip integrity, etc.
• Sterility: Confirmation of sterility.
  These types of "ground truth" are established through engineering testing, laboratory standards, and biocompatibility assessments, not typically through expert consensus on clinical cases or pathology. The document does not detail these specific test methods or their "ground truth" establishment.

8. The sample size for the training set

This information is not available in the provided document and likely not applicable in the context of this device. Training sets are relevant for machine learning algorithms. This device is a conventional medical device, not an AI/ML product.

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

This information is not applicable and therefore not available, for the same reasons as point 8.

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The Kendall Antimicrobial Drain Dressing is intended for OTC use. It is used as a primary dressing around drains, IV sites, and tracheotomies.

The Kendall Antimicrobial Drain Dressing for OTC use is a sterile, single use wound dressing consisting of a rayon/polyester nonwoven material treated with polyhexamethylene biguanide hydrochloride (0.2%), and is available in sponge form.

I am sorry, but without a dedicated study section detailing acceptance criteria and performance results, I cannot fulfill your request for a table of acceptance criteria and reported device performance.

The provided text {0}-{4} is a 510(k) summary for a medical device (Kendall Antimicrobial Drain Dressing). It focuses on demonstrating substantial equivalence to a predicate device for OTC marketing, not on establishing specific performance criteria for the new device.

Here's what I can extract based on the provided text, and why I cannot complete most of your request:

• No specific acceptance criteria or quantitative performance measures are mentioned for the Kendall Antimicrobial Drain Dressing itself. The document primarily asserts "substantial equivalence" to a predicate device.
• No new study is described to "prove the device meets acceptance criteria." Instead, it references prior biocompatibility testing of the predicate device and states the current device "is identical to the predicate device with the exception of OTC labeling."

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance. No such criteria or performance data for this specific device are presented.
2. Sample size used for the test set and data provenance. No new test set or study for this device's performance is detailed.
3. Number of experts used, qualifications, or adjudication method for ground truth for a test set. Not applicable, as no new performance study is described.
4. MRMC comparative effectiveness study or human reader improvement. This type of study is not relevant to a drain dressing and is not mentioned.
5. Standalone (algorithm only) performance. The device is a physical dressing, not an algorithm.
6. Type of ground truth used. Not applicable, as no new performance study is described.
7. Sample size for the training set. Not applicable, as no training set for an algorithm is involved.
8. How ground truth for the training set was established. Not applicable.

The closest information provided related to testing is in section 7:

• "Biocompatibility testing of the predicate Kendall Excilon AMD Antimicrobial Drain Sponge, (predicate device), has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1."
  • This indicates that the predicate device met certain biocompatibility standards.
  • It does not provide specific acceptance criteria values or detailed performance results for this new device.

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Over the counter use as a primary or secondary dressing for light to moderate draining wounds.

The Kendall Kerlix AMD Antimicrobial Gauze Dressing is a sterile, single use, wound dressing consisting of gauze treated with polyhexamethylene biguanide hydrochloride, and is available in both sponge and roll form.

The provided text describes a 510(k) premarket notification for a medical device called the "Kendall Kerlix AMD Antimicrobial Gauze Dressing (OTC)". This notification focuses on substantial equivalency to a previously cleared device, rather than providing a detailed study proving performance against pre-defined acceptance criteria in the way one might expect for a novel AI/software medical device.

Therefore, many of the requested sections regarding a study proving acceptance criteria cannot be directly extracted from the provided text. The submission relies on the established performance and safety of the predicate device.

Here's an analysis based on the provided document:

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

The submission does not define specific quantitative "acceptance criteria" in the traditional sense of a performance study for a novel device. Instead, the core "acceptance criteria" for this 510(k) submission are based on demonstrating 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. This submission relies on substantial equivalence to a predicate device. There is no new clinical performance study for this specific device described in the provided text. The biocompatibility testing mentioned refers to the 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. This information is not provided because there was no new clinical performance study with a test set.

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

Not applicable. 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. This is not an AI device, and no MRMC study 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/AI device.

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

Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate device through its prior clearance and the testing it underwent (e.g., biocompatibility consistent with ISO 10993-1).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

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The device is indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.

Polysorb* Synthetic Absorbable Suture with Modified Packaging shall remain identical to the predicate device, an absorbable poly(glycolide/L-lactide) surgical suture. with the addition to the packaging of an injection port to the inner foil pouch.

The provided document is a 510(k) summary for a medical device, specifically an absorbable surgical suture. It describes the device, its intended use, and its equivalence to a predicate device. It does not present a study that establishes acceptance criteria for new functionality or a new AI/software-driven device. Instead, it refers to "in-vitro studies" to demonstrate substantial equivalence to a predicate device for an existing product with a modified packaging.

Therefore, many of the requested categories are not applicable to the information provided in this 510(k) summary. I will fill in the applicable information and note when a section is not applicable.

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

The document does not specify quantitative acceptance criteria. It states that "In-vitro studies were performed...to demonstrate that the functional performance of the suture is substantially equivalent to the predicate device when pre-wetted with sterile saline (0.9% NaCl) using the injection port for up to 12 hours at room temperature prior to use." This implies that the performance after pre-wetting should be comparable to the 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)

• Sample size: Not specified in the provided 510(k) summary.
• Data provenance: Not specified, but the studies were "in-vitro."

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. This device is a surgical suture, and the studies were "in-vitro" to assess physical properties and performance, not diagnostic interpretations requiring expert ground truth establishment.

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

Not applicable. See point 3.

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/software-driven device.

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

Not applicable. This is not an AI/software-driven device.

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

Not applicable. The equivalence was based on "functional performance" in "in-vitro studies," likely involving mechanical testing or other objective physical measurements, rather than clinical ground truth as understood in diagnostic AI.

8. The sample size for the training set

Not applicable. This is not an AI/software-driven device, so there is no "training set."

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

Not applicable. See point 8.

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The device is intended for the delivery of U-100 insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.
The device is intended for the delivery of Tuberculin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.

The proposed device consists of a sterile syringe, labeled for either U-100 Insulin or Tuberculin, with a permanently attached single lumen needle, and an attached safety shield. The segmented safety shield is designed to be extended over the needle and locked. Activation is performed by a finger-tip or thumb operation or by pressing the shield. Once activated, the safety shield is securely and permanently locked.

The provided text is a 510(k) summary for the Kendall Monoject® Safety Syringe. It describes the device, its intended use, and its substantial equivalence to a previously marketed device. However, the document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria for performance, such as diagnostic accuracy or clinical outcomes.

The nonclinical testing mentioned (Biocompatibility testing) only states that the device meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1. This is a general safety standard, not a performance study.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and performance studies based on the provided text. The document focuses on regulatory approval through substantial equivalence, primarily by comparing the new device's design and intended use to a predicate device and confirming biocompatibility, rather than providing detailed performance data against specific acceptance criteria.

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The Palindrome Emerald 14.5 fr Cuffed catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. The performance of the heparin coating on this catheter in reducing platelet adhesion on the catheter surface for up to 720 hours of dialysis treatment is supported by bench and animal testing. It may be inserted either percutaneously or by cutdown.

The Palindrome™ Emerald™ 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The distal end of the catheter extends to a symmetrical tip. The proximal end of the catheter shaft contains a polyurethane hub assembly and silicone extension sets. The catheter contains a heparin coating on its surface, from the tip of the catheter to the cuff on the external surface, and throughout the entire length on the internal surface (tip to luer adapters), for the purpose of reduction of platelet adhesion. Results of in-vitro studies using bovine blood against an uncoated catheter demonstrate a 60% reduction in platelet adhesion along the catheter surface of the proposed device.

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

Device: Palindrome™ Emerald™ 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating

Acceptance Criteria and Reported Device Performance:

Detailed Study Information:

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

   • In-vitro circulating blood loop test: Not explicitly stated, but the test involved comparing a coated catheter to an uncoated control.
   • Coating durability test: Involved one catheter subjected to simulated dialysis conditions for 720 hours, with measurements taken periodically.
   • In-vivo ovine model: 6 sheep were used. Each sheep had both a coated and non-coated catheter implanted.
   • Data Provenance: The studies were conducted as bench (in-vitro) and animal (in-vivo) testing. The animals used were sheep (ovine model). The origin of the in-vitro blood (bovine blood) is mentioned.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here is objective measurement data from experiments (e.g., platelet count, thrombus weight, heparin activity), not expert interpretation of images or observations requiring multiple human readers.

3. Adjudication method for the test set: Not applicable, as there was no subjective assessment requiring adjudication. Outcomes were determined by quantitative measurements. In the in-vitro test, retrieved catheters were visually inspected and then placed in a gamma counter for quantification. In the in-vivo test, gravimetric analysis was performed.

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: Not applicable. This is a medical device for direct patient contact/treatment, not an AI diagnostic or interpretive tool.

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

6. The type of ground truth used: Experimental measurement data:

   • Quantification of radiolabeled platelet adhesion via gamma counter.
   • Gravimetric analysis of thrombus weight.
   • Measurement of heparin activity levels.

7. The sample size for the training set: Not applicable. This is not a machine learning model, so there is no training set. The term "training set" is usually reserved for AI/ML contexts.

8. How the ground truth for the training set was established: Not applicable. See point 7.

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The Kendall Genius 2 Infrared Tympanic Electronic Thermometer is intended for use in patients in Acute and Alternate care settings to provide temperature measurements from the tympanic membrane and equivalent measurements of core, oral, rectal, and axillary temperature based on the tympanic reading.

The Genius 2 is a new infrared tympanic electronic thermometer comprised of a battery operated handheld thermometer unit tethered to a base station. This Class II device is an electronic clinical thermometer that measures temperature by sensing infrared emmisions from the tympanic membrane in the ear canal. Through offest adjustments, equivalent site temperatures can be displayed for oral, rectal, core, and axillary temperatures based on the tympanic reading. This clinical electronic thermometer offers a streamlined graphical user interface that walks the user through temperature measurement.

The provided text is a 510(k) summary for the Kendall Genius 2 Infrared Tympanic Electronic Thermometer. While it states that "Performance data for the Kendall Genius 2 Infrared Tympanic Electronic Thermometer is compared to that of the predicate device... Results of verification / validation demonstrate that the modified device is substantially equivalent to the legally marketed device," it does not actually include the detailed performance data or a specific study proving the device meets acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions 2 through 9 based on the provided text. The document focuses on establishing substantial equivalence to a predicate device (Kendall FirstTemp Genius Tympanic Thermometer, K920713) based on intended use, materials, physical characteristics, and performance characteristics, but it does not present the specific data from such performance comparisons.

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Kendall Monoject PreFill™ ADVANCED™ 0.9%Sodium Chloride Flush Syringes for Sterile Delivery is indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.

The proposed device is an extension to the Kendall Monoject PreFill™ ADVANCED™ Flush Syringe line is to include one or more PreFill syringe configurations equivalent to those already marketed by Tyco Healthcare with the syringe delivered to the customer in a package that will maintain the sterility of the syringe exterior surface.

The provided text is a 510(k) summary for a medical device: "Kendall Monoject PreFill™ ADVANCED™ 0.9%Sodium Chloride Flush Syringes for Sterile Delivery." This document describes the device, its intended use, and its substantial equivalence to a legally marketed predicate device.

However, the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria in the context of an algorithm or AI performance. The document is for a physical medical device (pre-filled syringes) and a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device, primarily through nonclinical testing (like biocompatibility) and comparison of technological characteristics.

Therefore, I cannot provide the requested information, such as:

• A table of acceptance criteria and reported device performance (for an algorithm).
• Sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, type of ground truth used, or training set details.

The nonclinical testing mentioned in the document is:

Nonclinical Testing:

• Biocompatibility testing against ISO Standard 10993, Part 1 and FDA modified matrix (G95-1).

This testing is relevant to the safety and compatibility of the physical syringe and its contents with the human body, not to the performance of any AI or algorithmic component.

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