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Kii Structural Balloon Access System is indicated for use in patients undergoing laparoscopic surgery requiring a path of entry and/or tissue retraction of the extraperitoneal space.

Applied Medical's Kii Structural Balloon Access System provides a path of entry and/or tissue retraction for laparoscopic procedures in the extraperitoneal space. The system is provided sterile.

The system is composed of four main components:

• An obturator that facilitates insertion of the system through an incision.
• A cannula with bolster and attached balloon, encased within a perforated sheath.
• A seal which maintains insufflation.
• An inflation bulb that is used to manually inflate and deflate the balloon.

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The Kiwi Complete Vacuum Delivery System (Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)) is indicated for use in the following conditions:

• Prolonged second stage of labor (arrest of descent) where fetopelvic relationships are adequate
• Presumed fetal jeopardy that is not considered to be severe
• Elective shortening of the second stage for selected maternal or fetal conditions

The subject device is a fetal vacuum extractor (Kiwi® Complete Vacuum Delivery System) that includes four different models: OmniCup® (VAC-DUAL M); OmniCup® with Traction Force Indicator (VAC-DUAL MT); OmniC Cup® for Cesarean Section (VAC-DUAL C); ProCup® (VAC-DUAL S). All models use the same pump assembly, which allows the user to generate vacuum by squeezing the handle repeatedly. The pump/handle assembly includes a vacuum gauge that is color-coded to indicate safe operating pressures for the device. Models M and MT differ only in the inclusion of a traction force indicator (MT). Model C differs from models M/MT in the cup design, which has a lower profile cup with finger grooves to facilitate use in cesarean sections, as well as a baffle instead of an inner filter. The model S design is suggested for use in vaginal births and includes a combined tube and cup portion that is flexible and fits over the fetal head.

For vaginal delivery, the device is operated by inserting the cup into the vagina and placing the cup at the flexion point on the fetal skull. The Omni-C is designed specifically for the confined abdominal space of C-section deliveries. It is designed with a slimmer cup profile, finger grooves and baffle filter on the inside. For cesarean delivery, the cup is inserted into the incision over the flexion point.

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KALA MINI 2.0 (Model: KALA-04) (Mode 1) is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.

KALA MINI 2.0 (Model: KALA-04) (Mode 2) is an over-the counter device intended for the treatment of full-face wrinkles.

The KALA MINI 2.0 (Model: KALA-04) is a home use light-emitting diode phototherapy device with four proven wavelengths of red light: 630nm, 660nm, and near infrared red light: 830nm, 850nm, the red light (630nm, 660nm) are known to treat the wrinkles and the NIR light (830nm, 850nm) to provide topical heating to elevate tissue temperature for the temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain or muscle spasms and to provide a temporary increase in local blood circulation.

The equipment is a panel that contains LEDs. There are two buttons, one LED display screen on this panel: the button used to control the treatment time and the irradiance of the device; the LED display screen will show the remaining treatment time. Beside the buttons, there are power indicator which will indicate the remaining battery power.

There are fixed straps on the back of the panel, which you can use to hold the panel in your hand. The surfaces patients will contact with hand are constructed of silicone.

The controller contains a rechargeable Lithium battery, the power supply (adaptor) is used to charge the Lithium battery and be connected to a suitable mains outlet via a 2 or 3 pin input socket and wall plug. The KALA MINI 2.0 (Model: KALA-04) cannot be operated while charging. The cable for connecting with the controller is detachable.

The device is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The device does not require checks on the light output as the LEDs do not dim with age to any practical extent.

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The Kinos Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The Kinos Total Ankle System is additionally indicated for patients with failed previous ankle surgery. The Kinos Total Ankle System is intended for cement use only.

The subject Kinos Total Ankle System consists of implant and instrument components designed to preserve motion in patients with ankle arthritis or previously failed ankle surgery. The device is a fixed bearing and semi-constrained implant construct, intended for replacement of the articulating surfaces of the ankle that have been affected by a disease state or injury. The subject device provides limited mobility to a patient by restoring alignment of the articulating surfaces, reducing pain, and providing flexion-extension movement within the ankle joint. The tibial and talar implants are intended to be used with bone cement. The subject Kinos Total Ankle System consists of three implant components – a tibial implant affixed to the tibia, a bearing implant assembled to the tibial implant and a talar implant affixed to the talus. The tibial implant and bearing implant, assembled intraoperatively, function together and articulate with the talar implant to create a fixed bearing prosthesis, replacing the articulating surface of the tibiotalar joint. The subject line extension includes additional intermediate sizes for the tibial implants. Additionally, the line extension introduces steam (moist heat) sterilization for the tibial implants for sterilization on-site at the hospital.

The Kinos Total Ankle Tibial Implants subject of this 510(k), are compatible with:

• All Kinos Axiom Total Ankle System Talar and Bearing Components and associated instrumentation cleared via K192778
• All Kinos Axiom Total Ankle System r3 Talar and Vitamin E Bearing Components and associated instrumentation cleared via K240591

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The KnoxFog Anti-fogging Device is a temporary anti-fog coating and therein inhibits fogging on optical lenses. It is a laparoscopic accessory intended to facilitate intraoperative defogging of laparoscope lenses, thereby maintaining visualization of the surgical site and closed body cavity.

KnoxFog™ is intended for use as an anti-fog solution applied to rigid endoscope lenses prior to insertion into the body to maintain optical clarity during endoscopic procedures.

KnoxFog™ is a semi-sol gel anti-fog coating designed to prevent condensation on endoscopic lenses during surgical procedures. The device is supplied as a sterile solution in single-use containers for application immediately prior to endoscopic procedures. When applied to the endoscope lens, KnoxFog™ forms a transparent hydrophilic coating that prevents fog formation by maintaining optical clarity in high-humidity environments. The product is terminally sterilized using gamma radiation to ensure safety for use in surgical environments.

The provided FDA 510(k) clearance letter for the KnoxFog Anti-fogging Device focuses on the device's technical specifications and substantial equivalence to a predicate device, VitreOx™. However, it does not contain information typically associated with studies proving a device meets acceptance criteria for an AI/ML medical device, which would involve aspects like expert ground truth, multi-reader studies, or large data sets.

The document describes bench testing for an anti-fogging solution, not an AI/ML algorithm. Therefore, many of the requested points regarding AI/ML device studies (e.g., ground truth establishment, training sets, MRMC studies, standalone performance) are not applicable to the information provided.

I can, however, extract the acceptance criteria and performance data for the anti-fogging device based on the provided text.

Acceptance Criteria and Device Performance (KnoxFog Anti-fogging Device)

Based on the provided document, the "acceptance criteria" appear to be implicitly defined by the comparative performance against the predicate device, VitreOx™, specifically in terms of time-to-fog. Other tests (transportation, accelerated aging, biocompatibility) are also performance indicators but without explicit numerical acceptance thresholds provided beyond general "stability," "shelf-life claims," and "biocompatible."

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Note on "Acceptance Criteria": The document doesn't explicitly state numerical acceptance criteria for "Transportation Stability," "Accelerated Aging," or "Biocompatibility." Instead, it states that the tests verified stability, confirmed shelf-life claims, and demonstrated biocompatibility in accordance with standards. The time-to-fog analysis is the most quantitative comparative criterion mentioned.

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

• Sample Size: Not explicitly stated for any of the tests (Time-to-Fog, Transportation, Accelerated Aging, Biocompatibility). The text just mentions "comparative testing" and "studies."
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be bench testing performed by the manufacturer, UV ONE Hygienics, Inc. The document does not indicate if the data was retrospective or prospective in the medical context, as it's a materials science/engineering evaluation rather than a clinical study.

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

• Not Applicable. This device is an anti-fogging solution, not an AI/ML diagnostic or image interpretation device. The "ground truth" would be objective measurements of fogging, material stability, and biological reactions, not expert consensus on medical images.

4. Adjudication Method for the Test Set

• Not Applicable. As above, this is for assessment of an anti-fogging solution, not human interpretation of data requiring adjudication.

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

• No. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in interpreting medical images. This device is a topical anti-fogging agent. The "Performance Data" section details bench testing comparing the device's technical performance (time-to-fog, stability) to a predicate, not how it affects human readers.

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

• Not Applicable. This is not an algorithm. The performance data presented (time-to-fog, stability, biocompatibility) are inherently "standalone" in the sense that they measure the physical properties of the device itself.

7. The Type of Ground Truth Used

• Objective Measurements/Material Science:
  • For "Time-to-Fog Analysis": The ground truth is the measurable time until fog formation on the endoscope lens under specific conditions.
  • For "Transportation Testing": The ground truth relates to the physical integrity and continued functionality of the product after simulated transport.
  • For "Accelerated Aging": The ground truth is the product's stability and efficacy over time, extrapolated from accelerated conditions.
  • For "Biocompatibility Testing": The ground truth is established through standardized in vitro and in vivo biological tests (e.g., cytotoxicity, irritation) according to ISO 10993 standards.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. As above, no training set for an AI/ML algorithm is involved.

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The KLS Martin Ixos system is indicated for use in forearm fractures, osteotomies, and arthrodeses. This system is intended for adults, as well as adolescents (12-21 years) and children (2-12 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.

The KLS Martin Ixos System consists of metallic plates used in conjunction with bone screws and locking pins intended for the internal fixation, alignment, stabilization, and reconstruction of the distal radius and/or ulna. Plates are manufactured from Ti-6Al-4V and are available in various shapes and dimensions. The system also includes the necessary instruments to facilitate placement of the implants. The manufacturing process, sterilization methods, materials and packaging are identical to those of the cleared predicate device, KLS Martin LINOS Wrist System (K222624).

The provided FDA 510(k) clearance letter for the KLS Martin Ixos System does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria for an AI/software device.

This document describes a metallic bone fixation appliance, not a software or AI medical device. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states "Clinical Performance Data: Not Applicable" and details mechanical performance testing (in accordance with ASTM F382) and MR compatibility testing (per various ASTM standards). These are standard tests for orthopedic implants to demonstrate their static and dynamic strength, and safety in an MRI environment.

Therefore, I cannot extract the following information as it is not present in the provided text:

• A table of acceptance criteria and the reported device performance (for AI/software).
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth
• Adjudication method
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc)
• The sample size for the training set
• How the ground truth for the training set was established

The document focuses on demonstrating substantial equivalence to predicate orthopedic implants based on:

• Same intended use/indications for use.
• Similar technological characteristics: manufactured from the same materials (Ti-6Al-4V), using the same manufacturing methods, and having similar principles of operation.
• Performance data: Non-clinical comparative static and dynamic mechanical performance testing against a secondary predicate (Stryker VariAx 2 distal radius plates) and MR compatibility testing.

In summary, the provided document is a 510(k) clearance for a physical medical device (bone plate system), not an AI/software device, and thus does not include the type of performance evaluation details (e.g., ground truth, reader studies, training data) relevant to AI/software.

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Telescopes for adults
KARL STORZ HOPKINS Telescopes for Urology when used with sheaths, obturators, accessories, and instruments are intended to provide visualization and operative access during diagnostic and therapeutic urological procedures in adults.

Telescopes for adults and pediatrics
KARL STORZ HOPKINS Telescopes for Urology when used with sheaths, obturators, accessories, and instruments are intended to provide visualization and operative access during diagnostic and therapeutic urological procedures in adults and pediatrics.

The KARL STORZ HOPKINS Telescopes for Urology are rigid cystoscope systems, which provide visualization and operative access during urological procedures in adults and pediatrics. Urological devices consist of sheaths, obturators, accessories, and instruments, which are combined into a cystoscope system for diagnostic or therapeutic procedures in the lower urinary tract such as prostate, bladder, and urethra. The sheath provides a working channel for therapeutic instruments, as well as ports for irrigation and aspiration. The obturator is inserted through the sheath for atraumatic insertion to the surgical site, then removed after placement. The telescope is inserted through the sheath for visualization of the surgical site. All instruments subject to this submission are optical instruments, and compatible with telescopes; the optical instruments are only compatible with adult systems. Compact telescopes are all-in-one cystoscopes with built-in sheaths, obturators, and optics, they do not require device compilation for use.

The provided text is an FDA 510(k) clearance letter and its accompanying summary for the KARL STORZ HOPKINS Telescopes for Urology. This document details the regulatory pathway for a medical device, specifically rigid endoscopes, not an AI software or system. Therefore, most of the questions regarding acceptance criteria and study design for AI performance are not applicable.

Here's an analysis of the provided information:

Analysis of Acceptance Criteria and Study for a Medical Device (Endoscope):

Given that this is a medical device (endoscope), the "acceptance criteria" are typically related to meeting established performance standards for such devices. The "study" refers to non-clinical bench testing to demonstrate compliance with these standards and substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of acceptance criteria with specific numerical performance targets and reported values in the way you might see for an AI algorithm's accuracy or sensitivity/specificity. Instead, the acceptance criteria are implicit in the adherence to international and national standards for medical devices, particularly endoscopes. The reported device performance is that it complies with these standards.

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

• Sample Size: Not applicable in the context of an endoscope's non-clinical bench testing. The "test set" here refers to the actual device prototypes or representative samples tested in a laboratory setting to verify compliance with engineering and safety standards. The number of units tested isn't specified but typically involves a sufficient number to ensure reproducibility and meet statistical requirements for the specific test (e.g., several samples for biocompatibility, multiple cycles for reprocessing).
• Data Provenance: The testing is non-clinical bench testing, meaning it does not involve human subjects or real-world patient data. It is performed in a controlled laboratory environment by the manufacturer (KARL STORZ SE & Co. KG), likely in Germany given their address.

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

• Experts for Ground Truth: Not applicable. For a rigid endoscope, "ground truth" is defined by established engineering specifications and compliance with recognized national and international standards. The "truth" is whether the device performs according to these measurable standards, not a subjective interpretation by experts.
• Qualifications of Experts: Not applicable. The "experts" involved are likely engineers, quality assurance personnel, and regulatory specialists within Karl Storz and external testing laboratories who are qualified to conduct and interpret the specified tests according to the standards.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in medical image diagnosis). For physical device testing, the results are typically quantitative measurements that either pass or fail against predefined criteria in the standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

• MRMC Study: No. MRMC studies are used to evaluate the impact of a new diagnostic aid (like an AI system) on human reader performance across multiple readers and cases. This is not relevant for a rigid endoscope, which is a physical visualization and access tool.

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

• Standalone Performance: Not applicable. This device is a physical endoscope, not an AI algorithm. Its function is to provide visualization, which inherently involves a human user (the clinician) in the loop.

7. The type of ground truth used:

• Type of Ground Truth: The "ground truth" is adherence to established engineering specifications, safety standards (e.g., thermal safety), optical performance metrics (e.g., field of view, resolution), biocompatibility requirements, and validated reprocessing protocols as defined by the numerous ISO, IEC, AAMI, ASTM, and ANSI standards listed. It is a technical and regulatory compliance "ground truth."

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This is a physical medical device, not an AI algorithm that undergoes training.

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

• Training Set Ground Truth: Not applicable. As this is not an AI device, there is no "training set" or "ground truth for the training set."

In summary, the provided document is a regulatory submission for a physical medical device (an endoscope) and not for an AI/software device. Therefore, the specific questions related to AI performance metrics, sample sizes for AI training/test sets, expert adjudication, and MRMC studies are not applicable to this submission. The "acceptance criteria" are demonstrated through non-clinical bench testing proving compliance with relevant industry standards and substantial equivalence to a predicate device.

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K5 is intended to supply power to and serve as a base for dental devices and accessories. This product is intended for use by dentist and dental assistance to assist dental treatment of patients for adjusting the position of the patient seat, operating the instruments, and supplying water into the oral cavity through a water line in dental clinical environments.

The K5 Cart, K5 Mount and K5 Swing are designed for dental treatment and are intended for dental use only and are intended for use by trained medical personnel only.

These devices consist of a foot controller, headrest, backrest, seat, armrest, doctor table, unit, dental light, auxiliary table and doctor stool.

These are an AC-powered dental operative unit with accessories, intended to supply power to and serve as a base for other dental devices. It includes a treatment chair, dentist element, assistant element and a dental light as offering several additional options and electronically-controlled chair movements with software and water unit functions.

The provided FDA 510(k) clearance letter and summary for the K5 Cart, K5 Mount, K5 Swing devices (K251491) indicate that these devices are Class I Dental Operative Units and Accessories. Class I devices are generally considered to be low-risk and often demonstrate substantial equivalence through non-clinical testing rather than extensive clinical studies.

The document extensively compares the proposed devices to a predicate device (K5, K233805) to establish substantial equivalence. It does not describe specific acceptance criteria in terms of performance metrics with numerical thresholds for the device's function as a whole. Instead, it relies on compliance with recognized consensus standards and a detailed comparison of technological characteristics.

Therefore, many of the requested details about acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity, or improvement over human readers) are not applicable or not explicitly stated in this type of 510(k) submission for a Class I mechanical device. The "acceptance criteria" here are primarily met by demonstrating compliance with safety and performance standards relevant to dental operative units and showing that any differences from the predicate device do not raise new questions of safety or effectiveness.

Here's an analysis based on the provided document, addressing the points where information is available and noting where it's not applicable for this type of device and submission.

Acceptance Criteria and Device Performance

As a Class I dental operative unit, the "acceptance criteria" are primarily established by compliance with recognized electrical safety, electromagnetic compatibility, and performance standards for dental equipment, along with demonstrating that any differences from a predicate device do not introduce new safety or effectiveness concerns. The performance is assessed qualitatively through compliance with these standards and by direct comparison of functionalities and specifications with the predicate device.

Table of Acceptance Criteria and Reported Device Performance

Study Details

It's important to differentiate that this 510(k) submission is for a mechanical/electrical dental operative unit, not an AI/software as a medical device (SaMD). Therefore, many of the questions related to AI performance metrics, clinical study design for accuracy/sensitivity, expert readers, and ground truth establishment (common for imaging AI) do not apply to this clearance. The "study" here is primarily a series of non-clinical tests and a detailed comparison to a predicate device.

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

• Test Set Sample Size: Not applicable in the context of typical AI/imaging studies. Performance was demonstrated through compliance with recognized standards (IEC 60601-1, IEC 60601-1-2, IEC 80601-2-60, IEC 60601-1-6, ISO 7494-1, ISO 7494-2) and direct engineering measurements and comparisons. This involved testing the physical device(s).
• Data Provenance: Not applicable in the sense of patient data. The testing involves engineering and safety evaluations of the manufactured devices.

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

• Not applicable. The device is a dental operative unit, not an AI diagnostic tool requiring expert-established ground truth from medical images. Compliance with engineering standards and functional specifications constitutes the "ground truth" for this device type.

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

• Not applicable. This is not a study involving human reader adjudication of diagnostic outputs.

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 not an AI diagnostic or assistive device for human readers.

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

• Not applicable, as it's not an algorithm-based device in the diagnostic sense. The device performs its intended functions independently (e.g., moving chair, supplying water/air, powering instruments).

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

• For this device, "ground truth" is established by:
  • Compliance with recognized consensus standards: e.g., IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (EMC), ISO 7494-1 (Dental Units), ISO 7494-2 (Dental Chairs).
  • Engineering specifications and measurements: Verifying that the device meets its design specifications for things like air pressure, water pressure, chair movement ranges, and patient load.

7. The sample size for the training set:

• Not applicable. This is not a machine learning/AI device requiring a training set.

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

• Not applicable. No training set is used.

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For implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair, or reinforcement in plastic or reconstructive surgery.

Kerecis SurgiBind (50241) is a part of a family of devices manufactured by Kerecis® Limited. The device is lyophilized, terminally sterilized, fish skin medical device comprised of biocompatible, resorbable fish skin (Wild North Atlantic Cod). The device is intended for single use only.

Analysis of Kerecis SurgiBind (K251844) Acceptance Criteria and Study

This FDA 510(k) clearance letter details the Kerecis SurgiBind device, which is essentially a re-submission of the Kerecis Reconstruct (K202430) with an updated label to include additional rehydration fluid options. Due to this, the performance testing for this submission primarily focuses on demonstrating that the change (new rehydration fluids) does not negatively impact the device's performance.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative sense for this 510(k) submission, as it largely leverages prior testing of the predicate device. Instead, the focus is on demonstrating that the new rehydration fluids do not compromise the device's existing performance characteristics. The implicit acceptance criterion is that performance using the expanded rehydration fluids (including autologous body fluids) is comparable to performance using the previously cleared rehydration fluids (saline and Ringer's solution).

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

The document states: "Performance testing... was largely leveraged from the Kerecis predicate device... As a result, performance testing is not required, except for rehydration and suture retention tests using autologous body fluid."

• Sample Size for this submission's additional tests: Not explicitly stated. The nature of these tests (bench testing) suggests a relatively small, controlled sample size, but the exact number is not provided.
• Data Provenance: The new tests (rehydration and suture retention with autologous body fluids) are presumed to be prospective bench testing conducted specifically for this submission. The origin of the "autologous body fluids (such as blood)" used for testing is not detailed (e.g., human, animal, synthetic proxy).

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

• Experts: Not applicable for this type of bench testing. The "ground truth" for these tests would be the established scientific and engineering principles for material properties and device function.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Performance testing for this submission involves objective physical measurements (e.g., rehydration rate, suture pull-out force) rather than subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• MRMC Study: No. This device is a biological surgical mesh (fish skin), not an AI/software device. Therefore, MRMC studies are not relevant.

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

• Standalone Performance: Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the specific tests conducted for this submission (rehydration and suture retention with autologous body fluids), the ground truth is based on bench testing measurements against established parameters or comparison to the predicate device's performance. For the broader substantial equivalence claim, the ground truth is the performance and safety profile of the legally marketed predicate device (K202430).

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is a medical device, not an AI/machine learning model that requires a "training set." The manufacturing process for the fish skin material itself has an inherent "training" through its development and validation, but this is not typically referred to as a "training set" in this context.

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

• Ground Truth for Training Set: Not applicable. See point 8.

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