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The VersaD Delivery Catheter is intended for use with compatible guide catheters in facilitating the insertion and guidance of catheters into selected blood vessels in the neuro and peripheral vascular systems.

The VersaD™ Delivery Catheter is a single-lumen, variable stiffness catheter with a long, tapered tip delineated by radiopaque markers. The catheter has a polytetrafluoroethylene (PTFE etched liner), the proximal end has a luer hub, and the distal portion has a hydrophilic coating to reduce friction. The delivery catheter is designed specifically for use with compatible catheters.

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The UV5000W Handle is to be used with UroViu Cannula Uro-G HD, Uro-G, Uro-V, Uro-N, and Hystero-V and is intended to be used to permit viewing of the urethra and bladder or cervical canal and uterine cavity for the purpose of performing diagnostics.

The UroViu Cannula Uro-G HD, Uro-G, Uro-V, Uro-N, and Hystero-V connect to the UV5000W Handle to become an endoscopic system that is intended to allow visualization of the urethra and bladder or cervical canal and uterine cavity for the purpose of performing diagnostics. This 510(k) discloses the modifications made to the UV5000 Handle (K250797) with the capability of transmitting the images captured wirelessly to an external monitor.

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This device is indicated in knee arthroplasty in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral joint surface erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion contraction. This device is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock and/or require increased stabilization for tibiofemoral joint due to soft tissue imbalance. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws.

Note: In the US, this device is for cemented use only.

"UNITED" U2 Total Knee System – Posterior Stabilized Augmentable (PSA) type is a patellofemorotibial polymer/ metal/ polymer, semiconstrained, cemented knee prosthesis, which has a metallic femoral component and a tibial component composed of a polyethylene insert and a metallic tibial baseplate. Tibial inserts are available in two design configurations: for the PSA type insert, it is intended for use in patients who require constrained stabilization of the tibiofemoral joint due to soft tissue imbalance. While the PSA low constrained type (PSA, LC) insert provides less constrained stabilization than the PSA type insert.

This system is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock. There are a variety of components including femoral augment set, tibial augment, stem extension and offset stem adapter that provide more choices for surgeon to treat their patients. In addition, this system provides more stability for patients with inadequate medial-lateral, anterior-posterior or varus-valgus soft tissue imbalance. For total knee replacement, "UNITED" patella components are intended to be used with the U2 Total Knee System—PSA Type.

For the subject device, it's a line extension of the 510(K) cleared device U2 Total Knee System—PSA Type (K082424), which introduces the variation, Straight Stem, Cross Slot, PSA, with stem lengths from 75mm to 200mm, diameters from Ø10 to Ø24mm.

The compatibility of the Straight Stem, Cross Slot, PSA is the same as that of the 510(k) cleared U2 Total Knee System—PSA Type (K082424).

The Straight Stem, Cross Slot, PSA is an extension of the geometric characteristics of the 510(k) cleared device, U2 Total Knee System—PSAType (K082424). Its materials, size, locking mechanism, and manufacturing process are identical to that of the 510(k) cleared Straight Stem, PSA.

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The unscented menstrual three-piece applicator tampons are inserted into the vagina to absorb menstrual discharge.

The unscented menstrual three-piece applicator tampon consists of a tampon, including an absorbent pledget ("absorbent core") completely surrounded by an overwrap ("security veil") and a removal string ("withdrawal cord"), and an applicator. The tampon design is cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion.

According to different composition materials, the unscented menstrual three-piece applicator tampon of this submission are divided into 4 categories (Cotton tampon with three piece applicator, Organic cotton tampon with three piece applicator, Viscose tampon with three piece applicator, Viscose +Cotton tampon with three piece applicator).

The Tampon are provided in 4 absorbency: Light (L) (absorbency ≤6g), Regular (R) (6-9g), Super (S) (9-12g) and Super Plus (SP) (12-15g).

Each device is individually wrapped and then packaged in sealed multi-unit containers for retail sale. All tampons and applicators are provided non-sterile and for single use only.

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Zener® (model ZEN-001-B1) is an ultraviolet (UV) air purifying device intended for the reduction of bacteria in air in medical facilities. Zener has demonstrated the ability to reduce Klebsiella aerogenes in air by 4.73 net log-reduction at 50% ± 10% relative humidity and 23°C ± 3°C (73°F ± 5°F). Zener is non sterile.

Zener is a ceiling-mounted and mains-powered ultraviolet (UV) air purifying device intended to reduce bacteria in air in medical facilities. The device functions autonomously by exposing air in the room to UV light.

Physically, Zener measures 7" x 7" x 3.2", weighs 2.1 lbs, and mounts to ceilings using its backplate and an included ceiling bracket. The device's exterior surfaces are constructed with quartz glass, metal, and plastic. Device management is supported through a mobile and web application.

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The UV5000 Handle is to be used with UroViu Cannula Uro-G HD, Uro-G, Uro-V, Uro-N, and Hystero-V and is intended to be used to permit viewing of the urethra and bladder or cervical canal and uterine cavity for the purpose of performing diagnostics.

The Uro-G Cystoscope System is comprised of a cannula and handle that is intended to allow visualization of the urethra, bladder, cervical canal, and uterine cavity for the purpose of performing diagnostics. This 510(k) discloses the modifications made to the handle of the Uro-G HD Cystoscope System (K232837), UV5000 Handle. The Uro-G HD Flexible Cystoscope System is a handheld, battery-operated portable cystoscope consisting of a disposable steerable endoscopic cannula with a 2.2 mm channel for fluid infusion and instrument advancement, and a reusable handle with a video monitor.

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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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1. Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) where massive resection and transplantation are needed.

2. Severe knee joint damage resulting from trauma where massive resection and transplantation are needed.

3. Non-inflammatory degenerative joint disease such as avascular necrosis, osteoarthritis, or traumatic arthritis.

4. Revision of previously failed total joint arthroplasty, osteotomy, or arthrodesis.

5. Joint instability resulting from excessive bone resection

For Femoral component, Hinged/ Tibial baseplate, Hinged/ Cemented tibial stem/ Cemented Straight stem, RHS, non coated/ Cemented Curved stem, RHS, non coated/ Cemented Straight stem, RHS/ Cemented Curved stem, RHS/ Tibial Augment: These devices are single use implant and intended for cemented use only.

For Distal Femoral Component, RHS/ Proximal Tibial Component, RHS/ Tibial stem/ Segment Part, RHS/ Segment Part, RHS, Bridge: These devices are single use implant and PSC and intended for cementless use only.

"United" USTAR II System is used for patients who present large quantity of bone loss and deformity associated with previous failed arthroplasty, ligament deficiencies, tumor resection, or trauma and may require a further operation or reconstruction. The USTAR II System includes implanted arthroplasty components of both the USTAR II Knee System and USTAR II Hip System.

For the subject device, it's an extension line of 510(K) cleared device USTAR II System (K190100), which introduces two new variations:

1. Cemented curved stem, RHS, non-coated: diameter 17×200 mm
2. Tibial stem: stem length from 30mm to 150 mm by stem diameter from diameter 9 to diameter 24

The compatibility of cemented curved stem, RHS, non-coated and tibial stem is same as that of the 510(k) cleared USTAR II system (K190100).

Cemented Curved Stem, RHS, non-coated is an extension in terms of sizes to 510 (k) cleared device USTAR II system (K190100). Its design, materials, geometrical characteristic, locking mechanism, and manufacturing process are identical to that of the 510(k) cleared Cemented Curved Stem, RHS, non-coated.

Tibial stem's design, materials, geometrical characteristic, locking mechanism, and manufacturing process are identical to that of the 510(k) cleared Tibial Stem while the only difference lies in its specification

Please note: The provided FDA 510(k) clearance letter and summary describe a medical device (Stem Extension Line for the USTAR II System), which is an orthopedic implant. This document does not describe an AI/Software as a Medical Device (SaMD).

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/SaMD, including details like "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone performance," "training set size," and "ground truth establishment for training set," are not applicable to this type of device submission.

The provided text focuses on the mechanical and design equivalence of the new implant variations to a previously cleared predicate device. The "study" mentioned refers to non-clinical mechanical analyses.

Below is an interpretation of the requested points adapted to the context of this orthopedic implant:

Acceptance Criteria and Study for the Stem Extension Line (USTAR II System)

1. Table of Acceptance Criteria and Reported Device Performance

For this orthopedic implant, the acceptance criteria are based on established international standards for the mechanical performance of prosthetic components and demonstrate equivalence to the predicate device.

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

• Sample Size for Test Set: Not explicitly stated as a number of physical implants or test articles in the provided summary. For mechanical testing, typically a defined number of test samples are used per standard, but the specific quantity is not given here.
• Data Provenance: The studies are non-clinical mechanical analyses performed to international standards (ISO, ASTM). The origin of the "data" itself would be the laboratory where these mechanical tests were conducted. It's a prospective design verification process, not a retrospective or prospective clinical study with human data.

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

• Not Applicable. This is a non-clinical, mechanical device clearance. "Ground truth" in the context of clinical interpretation or diagnosis by experts (e.g., radiologists) is not relevant here. Ground truth is established by standardized material properties, engineering specifications, and mechanical test results per the referenced ISO and ASTM standards. Experts involved would be engineers and material scientists responsible for the design, testing, and analysis, ensuring compliance with manufacturing and performance standards.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 typically refer to consensus readings or evaluations by multiple human experts in studies involving subjective interpretation (e.g., imaging, clinical outcomes). For mechanical testing, the results are quantitative and objective, measured against predefined acceptance criteria from engineering standards.

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. MRMC studies are specific to evaluating the clinical performance of diagnostic aids, particularly those involving human interpretation, and are commonly used for AI/ML in medical imaging. This submission concerns the mechanical safety and functionality of an orthopedic implant. No human reader involvement or AI assistance is relevant.

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

• Not Applicable. "Standalone performance" refers to the performance of an AI algorithm independent of human input. This device is a physical orthopedic implant, not an algorithm or software.

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

• The "ground truth" for this type of device is based on engineering standards and specifications. This includes:
  • Material properties: Verifying components meet specified material strengths and compositions.
  • Geometric tolerances: Ensuring dimensions align with design specifications.
  • Mechanical performance: Demonstrating the implant can withstand anticipated loads and stresses as defined by the ISO and ASTM test standards (e.g., fatigue life, static strength).
  • Equivalence to Predicate Device: The primary "ground truth" is that the new variations perform equivalently to or better than the already cleared predicate device under the same test conditions.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device where a "training set" of data is used to develop an algorithm. The "design" and "manufacturing process" are based on established engineering principles and prior validated designs (the predicate device).

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

• Not Applicable. As there is no "training set" in the context of an AI/ML algorithm for this physical device, there is no method for establishing its "ground truth." The design and manufacturing processes are validated through engineering analyses and quality control processes to meet the required specifications and standards.

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Unimed Reusable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 30 kg and pediatric patients weighing 10-50 kg. These devices are for prescription use only.

The subject devices are Unimed Reusable SpO2 Sensors intended for non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in clinical settings. The sensors are designed for compatibility with GE B40i, and are supplied non-sterile.

Each sensor consists of a connector, a cable, and a reusable patient-contacting sensor element incorporating a light-emitting diode (LED) and photodetector (PD). The sensors are available in multiple configurations, including finger clip, wrap, and soft-tip types, to accommodate various patient needs and anatomical sites.

The subject devices operate on the same principle and share similar design features, materials, and performance characteristics as the predicate device.

Here's a breakdown of the acceptance criteria and the study details for the Unimed Reusable SpO2 Sensors, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Device Performance

Study Information

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

   • Sample Size: Twelve human adult volunteers were enrolled for the clinical study. The study contains more than the minimum 200 data points.
   • Data Provenance: The study was conducted on human adult volunteers and includes sufficient darkly pigmented subjects (three dark subjects with Fitzpatrick Type 5-6). It is a prospective clinical study. The country of origin is not explicitly stated but implies testing in a controlled clinical environment, likely linked to the manufacturer's location or a designated clinical trial site.

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

   • The document implies that arterial oxygen saturation (SaO2) as determined by co-oximetry was used as the ground truth. This is a direct measurement from blood samples. Therefore, typical "experts" in the sense of human readers adjudicating images are not applicable here. The accuracy of co-oximetry itself is the standard.

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

   • Not applicable. The ground truth (SaO2 by co-oximetry) is a direct, objective measurement, not subject to human interpretation or adjudication in the same way as an imaging study.

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 device is a sensor (hardware) for SpO2 and pulse rate measurement, not an AI-assisted diagnostic tool or an imaging system that would involve human reader interpretation. No MRMC study was conducted.

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

   • Not applicable. The device is a sensor that measures physiological parameters. Its performance is inherent to its design and function, not an algorithm's performance. The "clinical test data" section describes the validation of the sensor's accuracy in vivo.

6. The type of ground truth used:

   • Arterial oxygen saturation (SaO2) as determined by co-oximetry. This is an objective "gold standard" for blood oxygen measurement.

7. The sample size for the training set:

   • Not applicable. This device is a hardware sensor, not a machine learning model that requires a training set. The clinical study described is for validation/testing, not training.

8. 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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The Unscented Menstrual Tampons are inserted into the vagina to absorb menstrual discharge.

The unscented menstrual tampons consist of a tampon, including an absorbent pledget ("absorbent core") completely surrounded by an overwrap ("security veil") and a removal string ("withdrawal cord"), and an applicator (only for the applicator tampon). The tampon design is cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion.

According to different composition materials and design styles, the unscented menstrual tampons of this submission are divided into 3 categories (Unscented menstrual long applicator tampon, Unscented menstrual Cardboard Applicator Tampon, Unscented menstrual Digital Tampons) and 6 sub-categories (Organic cotton + Two Plastic tube, Cotton + cardboard tube, Organic cotton + cardboard tube, Cotton (digital style), Organic cotton(digital style), viscose(digital style).

The tampons are provided in 4 absorbencies: Light(L) (≤6g), Regular(R) (6-9g), Super (S)(9-12g) and Super Plus (SP)(12-15g). Only some sub-categories of tampons contain all absorbencies. Each device is individually wrapped and then packaged in sealed multi-unit containers for retail sale. All tampons and applicators are provided non-sterile and for single use only.

The provided FDA 510(k) clearance letter and summary for K251033 pertains to unscented menstrual tampons, which are medical devices designed for absorbing menstrual discharge. This documentation focuses on demonstrating the substantial equivalence of the new tampons to a predicate device (K232598) primarily through material composition, design, and physical performance characteristics, rather than performance metrics related to diagnostic accuracy or clinical outcomes that would typically involve AI/ML models or human reader studies.

Therefore, many of the requested points regarding acceptance criteria and study details for AI/ML device performance (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, etc.) are not applicable to this type of device submission. The "acceptance criteria" here relate to meeting established safety and performance standards for tampons.

Here's an analysis based on the provided document:

Device Type: Unscented Menstrual Tampons (medical device, not AI/ML driven)

Purpose of the Study (as described): To demonstrate substantial equivalence of the subject device (new tampons) to a legally marketed predicate device (existing tampons) by showing that differences in material composition and design do not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a tampon submission, the "performance" relates to physical and biocompatibility characteristics, not diagnostic accuracy. The acceptance criteria are implicit in the standards followed and the successful completion of the tests.

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

• Sample Size for Test Set: Not explicitly stated in the provided summary for any of the biocompatibility, microbiology, or chemical residue tests. These tests are typically performed on a representative sample of units to demonstrate compliance with standards.
• Data Provenance: The manufacturing company is Unibeauty (Hubei) Technology Co.,Ltd. in Xiantao City, Hubei Province, China. The document does not specify the country of origin for the data itself (e.g., where the lab testing was performed) beyond the company's location. The studies described are "nonclinical performance testing." implicitly prospective, as they were conducted to support the 510(k) submission.

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

Not applicable. This submission is for a physical medical device (tampons), not an AI/ML diagnostic device that requires expert human interpretation to establish ground truth for testing. The "ground truth" here is established by standardized laboratory testing methods (e.g., chemical analysis, microbiological assays, physical measurements) interpreted by qualified laboratory personnel, not by medical experts forming a consensus on image interpretation.

4. Adjudication Method for the Test Set

Not applicable. As this is not a study involving human readers or interpretation, there is no adjudication method in the sense of resolving discrepancies between expert opinions. Laboratory results are typically verified through standard lab practices and quality control processes.

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

No. An MRMC study is relevant for AI/ML diagnostic tools to assess the impact of AI assistance on human reader performance. This submission is for a physical device, so no such study was conducted or is relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this type of device is established through:

• Standardized Laboratory Testing Results: Biocompatibility (cytotoxicity, sensitization, irritation), microbiology (growth of bacteria, toxin production), chemical residue analysis, and physical property measurements (dimensions, weight, absorbency).
• Compliance with Recognized Standards: The tests were conducted according to international standards like ISO 10993 series and FDA guidance documents specific to menstrual tampons.

8. The Sample Size for the Training Set

Not applicable. This device does not involve an AI/ML model that requires a training set.

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

Not applicable. As there is no AI/ML model, there is no training set and therefore no ground truth establishment for a training set.

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