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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 InstaFAN device is intended for sampling targeted submucosal and extramural lesions within or adjacent to the gastrointestinal tract through the accessory channel of a curvilinear echo-endoscope. Use only with EUS endoscopes.

InstaFAN is an endoscopic ultrasound-guided fine needle aspiration/fine needle biopsy device that collects several samples from different locations in a single pass. The InstaFAN can be coupled to the biopsy channel of a Curvilinear Array (CLA) Echoendoscope and delivered to the gastrointestinal tract. The InstaFAN device is comprised of a central single 19-gauge needle and five peripheral 25-gauge needles. The device has a single handle design that contains two moving parts. The distal section of the handle controls the central needle, which can be activated first on its own or together with the proximal section of the handle to deploy all five needles simultaneously. The needles are used to acquire samples from lesions within and adjacent to the digestive system's major lumens that can be identified and targeted using the echoendoscope. Aspiration/biopsy samples are obtained by penetrating the lesion with the needle(s) while applying suction with the syringe.

The provided FDA 510(k) clearance letter for the InstaFAN device explicitly states that "Clinical testing was not required for the subject device; therefore, this section is not applicable." This means the document does not contain information about acceptance criteria, actual device performance (in terms of clinical outcomes), sample sizes for test or training sets, ground truth establishment methods, or details related to multi-reader multi-case (MRMC) studies.

The clearance was based on:

1. Non-Clinical Performance Testing:

   • Verification of needle performance (tensile, elasticity, bend strength).
   • Verification of overall device performance (EUS connection force, bend strength, force required to move needles, insertion force, and needle orientation).
   • The results showed the device met its specifications.

2. Animal Studies:

   • Conducted on the InstaFAN device.
   • Results met the safety and performance criteria to demonstrate substantial equivalence to the predicate.

Therefore, I cannot populate the requested tables or provide details based on a clinical study for this device, as one was not required or described in the provided text for its 510(k) clearance.

If this were a device requiring clinical data, the information you requested would typically be found in dedicated sections of the submission detailing the clinical study protocol, results, and statistical analysis.

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Onera STS 2 measures and records multiple physiological parameters from a patient during a sleep study, which are used by clinicians to decide on the diagnosis of sleep disorders.

Onera STS 2 is intended to be used on a patient who has been prescribed a polysomnography study by a healthcare professional. The device is designed to be used under the direction of a physician or trained technician but applied by a layperson.

The recorded data will be made available to the healthcare professional to assist in the diagnosis of sleep disorders.

The device is intended to be used for adults.

The device is not a life supporting physiological monitor.

Onera Sleep Test System 2 (Onera STS 2) is a hardware, wearable system for measuring physiological signals during a sleep study. The device can be used in the home (Home Healthcare Environment) as well as in Professional Healthcare Facilities.

The device measures EEG, EOG, EMG, ECG, respiratory signals, cannula based respiratory flow, oxygen saturation, activity, position, ambient light level and sound pressure level.

The ECG signal is not intended for diagnosis of cardiac disorders, except for the manual determination of arrhythmia during polysomnography studies.

The Onera STS 2 does not provide any automated output like heart rate, assessments of arrhythmia, heart rate variability, or other related heart rate measurement functions.

Onera STS 2 consists of five Sensors applied on the forehead, upper chest area, abdomen and lower leg area (both left and right leg).

The Sensors should be placed on intact skin. During the night measurement it is not needed to inspect the application sites. The Sensors encrypt the recorded signals and upload the measurement data during the night to the Patient App installed on the patient's phone via Bluetooth. The Patient App securely transfers the data to the cloud interface for further processing once all data has been uploaded. The output of the system is represented by a file in EDF format which contains the recorded (physiological) signals. EDF files can be read by any application software that accepts such files as input.

It is not possible to relocate the Sensors during a sleep study since the Sensor is single-use and for one sleep study only.

Here's a summary of the acceptance criteria and study information for the Onera STS 2, based on the provided FDA 510(k) clearance letter:

Onera STS 2: Acceptance Criteria and Performance Study Summary

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on the SpO2 measurement accuracy as a key performance metric with specific acceptance criteria.

Note: While other parameters are listed as "Identical" to the predicate, specific numerical acceptance criteria for those parameters are not explicitly stated in this document beyond their qualitative equivalence.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: 12 healthy subjects
  • 9 male, 3 female
  • Aged between 23 and 46 years old
• Data Provenance: The study was conducted in an "independent research laboratory." The country of origin is not explicitly stated in the provided text. The study involved "induced hypoxia," indicating a prospective, controlled experimental design.

3. Number and Qualifications of Experts for Ground Truth

• The document does not mention the use of experts to establish ground truth for the SpO2 accuracy test.
• The ground truth for SpO2 was established by "laboratory co-oximeter" measurements of arterial hemoglobin oxygen (SaO2) values from blood samples.

4. Adjudication Method for the Test Set

• The document does not describe any adjudication method. The SpO2 accuracy was determined by direct comparison of the device's SpO2 measurements to SaO2 values from a laboratory co-oximeter.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in this document. The device primarily measures physiological parameters, and the study focused on the accuracy of these measurements rather than human reader interpretation with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance study was conducted for SpO2 measurement accuracy. The device's SpO2 readings were directly compared to reference SaO2 values without human intervention in the SpO2 measurement process itself. The Onera STS 2 is described as measuring and recording parameters, with the output as an EDF file to be read by other software. The SpO2 accuracy assessment is specifically for the device's measurement capability.

7. Type of Ground Truth Used

• Objective Measurement (Laboratory Co-oximeter): For SpO2 accuracy, the ground truth was established by arterial hemoglobin oxygen (SaO2) values determined from blood samples using a laboratory co-oximeter, which is considered a gold standard for blood oxygen saturation.

8. Sample Size for the Training Set

• The document does not provide information regarding the sample size for a training set. This is likely because the performance study described (SpO2 accuracy) is a validation of the device's sensor capabilities, not an evaluation of a machine learning algorithm that would typically require a training set. The device outputs raw physiological signals in EDF format for clinicians to interpret, rather than providing automated diagnoses based on an internal algorithm.

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

• As no training set is mentioned or implied for the device's core functionality (measuring and recording parameters for clinician interpretation), this information is not applicable and not provided in the document.

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Under the direction of a healthcare professional, the Rx product is indicated for the management of partial and full thickness wounds, post-surgical wounds, 1st and superficial 2nd degree burns, diabetic foot ulcers, venous stasis ulcers, and pressure ulcers.

Bonvadis® is a non-sterile water based, preserved, semi-viscous formulation, for prescription use. Bonvadis® contains methyl and propyl parabens which act as preservatives to inhibit the growth of microorganisms within the product before opening and between uses.

Bonvadis® is multiple use and supplied in a 15 g aluminum tube.

The formulation is to maintain a moist wound environment, the moist wound environment being conducive for wound healing.

Ingredients: Purified water, liquid petrolatum, white petrolatum, propylene glycol, cetyl stearyl alcohol, span 60, tween 60, Centella Asiatica extract, Mexican Mint extract, Methyl Paraben, and Propyl Paraben.

The provided FDA 510(k) clearance letter and summary for Bonvadis® do not contain any information regarding clinical performance studies, such as those involving human readers or expert panels, nor do they specify acceptance criteria for such studies.

The acceptance criteria mentioned in the document are primarily related to non-clinical performance tests proving the device's physical properties, safety, and functionality.

Here's the information that can be extracted or deduced from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As no clinical performance acceptance criteria or corresponding results are provided in the document, the table below focuses on the non-clinical tests mentioned. The document states that the results "meet the criteria" or "demonstrated that the device is as safe, effective, and performs as well as the predicate devices," implying successful completion of these tests against internal or regulatory standards, though specific numerical criteria are not detailed.

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

Not applicable/Not provided for clinical performance. The document exclusively refers to non-clinical tests on the device itself (e.g., stability, physical properties, biocompatibility). There is no mention of a "test set" of patient data or images.

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

Not applicable/Not provided. As there are no clinical performance studies or test sets involving patient data, no experts were used to establish ground truth for such a purpose.

4. Adjudication method for the test set

Not applicable/Not provided. No adjudication method is mentioned as there were no clinical performance studies requiring expert review of data.

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

Not applicable/Not provided. This device is a topical wound dressing, not an AI-assisted diagnostic or treatment planning tool. Therefore, an MRMC study related to human readers and AI assistance is irrelevant and not mentioned.

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

Not applicable/Not provided. This device is a physical product (wound dressing), not a software algorithm.

7. The type of ground truth used

Not applicable/Not provided for clinical performance. For the non-clinical tests, the "ground truth" refers to established scientific and regulatory standards (e.g., USP monographs for microbial limits, pH, preservative efficacy) against which the device's physical and chemical properties were measured.

8. The sample size for the training set

Not applicable/Not provided. This refers to clinical or AI model training data, neither of which are mentioned or relevant to the non-clinical tests described for this wound dressing.

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

Not applicable/Not provided. As there is no mention of a training set for an AI model or clinical study, this information is not available.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs and fentanyl citrate per ASTM D6978-05 (Reapproved 2019) Standard Practices for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

GLOVEONE™, Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for Use with Chemotherapy Drugs and Fentanyl] are Class I patient examination gloves, bearing the product codes LZA, LZC, OPJ, QDO (21 CFR 880.6250). They meet all current specifications listed under the ASTM D6319-19 (2023), Standard Specification for Nitrile Examination Gloves for Medical Application and comply with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs per ASTM D6978-05. The powder-free gloves are made from Nitrile (NBR) latex and are green in color. The product is non-sterile, fingertip textured, ambidextrous with beaded cuff, and single use only. The product is not manufactured using natural rubber latex.

GLOVEONE™, Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for Use with Chemotherapy Drugs and Fentanyl] include glove sizes: X-Small, Small, Medium, Large, and X-Large.

This document is a 510(k) clearance letter for medical examination gloves and contains no information about an AI/ML powered device. Therefore, it's impossible to extract the requested information related to acceptance criteria, study details (sample sizes, data provenance, expert ground truth), MRMC studies, or standalone algorithm performance.

The provided text focuses on the performance characteristics of gloves (e.g., resistance to chemotherapy drugs, physical dimensions, biocompatibility) and their substantial equivalence to a predicate device.

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The Sovereign Posterior Cervical System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The Sovereign Posterior Cervical System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Sovereign Posterior Cervical System may be connected to the Xultan 5.5 system using rod-to-rod connectors or transition rods. Please refer to the individual system's Instructions for Use for a list of indications for use for each system.

The Met One Technologies Sovereign Posterior Cervical System is an implant device designed for the posterior stabilization of the cervical and upper thoracic spine. The system includes implants such as polyaxial screws, blocker screws, rods, crosslinks, lateral connectors, and rod to rod connectors to form a unique construct to match patient anatomy.

Polyaxial screws are offered in a range of sizes in both standard and reduction tulips for ease of use. All screws are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136).

Straight, pre-bent, and transition rods are offered in 3.5mm and 4.0mm diameters and in two different materials, titanium alloy (Ti-6Al-4V ELI per ASTM F136) and cobalt chrome (Co-Cr28-Mo6 per ASTM F1537). Transition rods are fully compatible with Met One Technologies Xultan 5.5 Pedicle Screw System line of implants.

A variety of connectors and crosslinks are offered for surgeons to create the desired construction. Rod to rod crosslinks improve the torsional stability of the construct. Lateral connectors are provided in open and closed configurations, 3.5mm and 4.0mm diameters, and in long and short lengths. Rod to rod connectors are offered in several configurations to join rods together. All connectors are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136).

I am sorry, but the provided text is an FDA 510(k) clearance letter for a Sovereign Posterior Cervical System, which is a physical medical device (spinal implant system), not an AI/Software as a Medical Device (SaMD).

Therefore, the document does not contain any information about:

• Acceptance criteria for an AI/SaMD's performance.
• A study proving the device meets AI/SaMD acceptance criteria.
• A test set (sample size, provenance).
• Experts establishing ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Types of ground truth.
• Training set details.

The non-clinical testing described (ASTM F1717 and ASTM F1798) refers to mechanical testing of the physical implant's strength and durability, not software performance.

As such, I cannot fulfill your request for information related to AI/SaMD acceptance criteria and study details based on the provided input.

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The b-ONE® Total Hip System is intended for primary or revision total hip replacement in skeletally mature patients with a severely disabled hip joint and/or hip damage due to the following conditions: Osteoarthritis, traumatic arthritis, avascular necrosis of the femoral head, noninflammatory degenerative joint disease (NIDJD), slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis and congenital dysplasia: treatments of nonunion, acute traumatic fracture of the femoral head or neck; failed endoprosthesis, femoral osteotomy, or Girdlestone resection: and fracture-dislocation of the hip.

The b-ONE® Total Hip System KOSMO™ HA coated stems and Grit-Blasted stems are intended for cementless use only.

The b-ONE® Total Hip System KOSMO™ Stainless Steel stems are intended for cemented use only.

The b-ONE® Cement Restrictor is intended to restrict bone cement migration into the distal medullary canal and aid in cement pressurization during total hip arthroplasty.

b-ONE® Total Hip System components are not intended for use with other total hip systems.

b-ONE Total Hip System KOSMO Femoral Stem consists of cementless and cemented bone compacting stem options. The b-ONE KOSMO Femoral Stems Sizes are offered in 12 femoral stem sizes ranging from size 0 to 10 with half size of 4.5 for Cementless Collared Standard, High, and Proportional Offset families and 11 femoral stem sizes ranging from size 1 to 10 with half size of 4.5 for Cementless Collarless/Collared Coxa Vara families and Cemented Standard and Proportional Offset families.

The subject stems are laser marked with the catalog number, company logo, size, and material. The KOSMO Femoral Stem is composed of titanium alloy Ti-6A1-4V-ELI (ASTM F136) for cementless stems and Stainless Steel (ASTM F1586) for cemented stems. The cementless stems are offered as either HA coated or Grit-blasted.

The b-ONE Cement Restrictor is made from UHMWPE (ASTM F648/ISO 5834-1). The restrictor is offered in 7 different sizes with a major diameter of 9, 11, 13, 15, 17, 20, and 23mm and have a total length of 17mm. The cement restrictor is to be used for cement implantation. This b-One Cement Restrictor is intended to restrict bone cement migration into the distal medullary canal and aid in cement pressurization during total hip arthroplasty.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for the b-ONE® Total Hip System, which primarily discusses the substantial equivalence of the subject device to legally marketed predicate devices.

The content focuses on:

• The FDA's decision regarding the 510(k) submission (K240528).
• Regulatory information, classifications, and requirements for the device.
• Indications for Use for the b-ONE® Total Hip System.
• A comparison of technological characteristics with predicate devices.
• A list of non-clinical performance tests conducted, but not the acceptance criteria for these tests, nor the detailed results proving they were met.

Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported device performance, or describe the study details (sample size, ground truth, expert qualifications, adjudication, MRMC, or standalone performance) because that information is not present in the provided text.

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The VACUETTE® QUICKSHIELD Complete is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. They are for single-use only and should be used by properly trained healthcare professionals only in accordance with these instructions.

The VACUETTE® QUICKSHIELD Complete PLUS is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. VACUETTE® VISIO PLUS Needles are designed for use in the daily blood collection routine when delegated by a qualified practitioner. The flashback window is situated in the transparent part of the cannula hub, which assists the user to recognize successful vein penetration. They are for single- use only and should only be used by adequately trained healthcare personnel in accordance with these instructions.

The sterile VACUETTE®QUICKSHIELD Complete is a single packed VACUETTE®QUICKSHIELD Safety Tube Holder with pre-threaded VACUETTE® Multiple Use Drawing Needle in a blister pack. It is a sterile, single-use plastic tube holder, designed with a safety shield, which can be activated to cover the needle immediately following venipuncture.

The sterile VACUETTE® QUICKSHIELD Complete PLUS is a single packed VACUETTE® QUICKSHIELD Safety Tube Holder with pre-threaded VACUETTE® VISIO PLUS Blood Collection Needle in a blister pack. It is a sterile, single-use plastic tube holder, designed with a safety shield, which can be activated to cover the needle immediately following venipuncture.

This document is an FDA 510(k) Premarket Notification summary for a medical device, not a study describing AI algorithm performance. Therefore, most of the requested information regarding acceptance criteria for AI algorithms, sample size, ground truth expert establishment, MRMC studies, and training set details are not applicable.

However, I can extract the acceptance criteria and performance data for this physical medical device based on the provided text.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Requirement" and "Outcome" columns in the "PERFORMANCE DATA" section. The document states that performance testing was conducted to demonstrate substantial equivalency and that the device performs as intended. All listed requirements passed.

Additionally, the following were met:

• Sterility: Achieved a Sterility Assurance Level (SAL) of 10⁻⁶ via e-beam irradiation, in accordance with ISO 11137-1 and ISO 11737-1.
• Biocompatibility: Demonstrated compliance with ISO 10993 series standards and FDA guidance for:
  • Cytotoxicity (ISO 10993-5)
  • Sensitization (ISO 10993-10)
  • Irritation (ISO 10993-23)
  • Hemocompatibility (ISO 10993-4)
  • Material mediated pyrogenicity (ISO 10993-11)
  • Acute Systemic Toxicity (ISO 10993-11)

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

The document does not explicitly state the sample sizes used for each specific test (e.g., how many devices were tested for "Force to remove shield"). It refers to "Simulated use tests" and "Performance testing" in general.

Data provenance is not specified in terms of country of origin for the testing, and the testing described is prospective for demonstrating compliance with standards for the device being submitted.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable. The document describes the testing of a physical medical device (blood collection system) against engineering and biological performance standards, not an AI algorithm requiring expert ground truth for classification or detection.

4. Adjudication Method for the Test Set

This information is not applicable as the device performance is measured against objective engineering and biological standards, not requiring human adjudication of subjective data.

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

This information is not applicable. MRMC studies are typically performed for imaging diagnostics or AI-assisted diagnostic tools to assess the impact on human reader performance. This document is for a physical blood collection device.

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

This information is not applicable. The device is a physical product, not an algorithm. The performance tests ("Torque to rotate shield," "Puncture force," etc.) are inherent to the device's design and function in a standalone manner.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by recognized consensus standards (e.g., ISO 23908, ISO 7864, ISO 9626, ISO 11137-1, ISO 11737-1, ISO 10993 series) and internal specifications. This means that the device was tested to meet predefined physical, mechanical, and biological properties, not a "ground truth" derived from expert consensus, pathology, or outcomes data in the context of an AI study.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI algorithm; there is no training set.

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

This information is not applicable.

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Oneday Implant Abutment is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Implants with diameters larger than 5 mm are intended to be used in the molar region.

The Oneday Implant Abutment is a material for dental surgery and is an abutment used to support and maintain prosthetic restored teeth in case of partial or total loss of teeth. It is used in combination with a fixture implanted in the jawbone.

This document describes a 510(k) premarket notification for the "Oneday Implant Abutment," a dental device. The primary purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics, or if there are differences, those differences do not raise new questions of safety and effectiveness.

The provided text details the device description, indications for use, comparison to predicate devices, and non-clinical test data. It is crucial to understand that this document does NOT describe the acceptance criteria and a study proving a device meets those criteria in the context of clinical performance or AI/software validation. Instead, it describes mechanical, material, and biocompatibility testing for a physical dental implant component to demonstrate its substantial equivalence to an existing device.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth establishment for AI systems, training set sample size) are not applicable to this type of device submission. This is a traditional medical device submission, not a submission for a software-as-a-medical-device (SaMD) or an AI/ML-driven device that would involve performance metrics related to diagnostic accuracy or clinical outcomes.

Here's an analysis of the provided information relative to your request:

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

The acceptance criteria here are standards for mechanical performance, biocompatibility, and sterilization, rather than performance metrics for an AI algorithm.

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

• Sample Size: The document does not specify exact sample sizes for the non-clinical tests (e.g., number of abutments tested for fatigue, sterilization, or biocompatibility). This information is typically detailed in the full test reports referenced in the submission, not summarized in the 510(k) summary letter.
• Data Provenance: The tests are non-clinical (laboratory-based) performed on "subject device" or "worst-case test article" samples. There is no patient data involved for these tests. The country of origin for the data generation (the testing laboratories) is not specified in this summary. These are prospective tests performed specifically for this submission.

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

• This is not applicable. The "ground truth" for mechanical testing, sterilization, and biocompatibility is based on established ISO and ANSI standards. There are no "experts" establishing a "ground truth" in the clinical imaging or diagnostic sense. The evaluations are objective measurements against predefined thresholds.

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

• This is not applicable. Adjudication methods are typically used in clinical studies, particularly for subjective assessments (e.g., image interpretation). These are objective non-clinical tests.

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

• This is not applicable. The device is a physical dental implant abutment, not an AI-powered diagnostic or assistive tool. No MRMC study would be performed for this type of device.

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

• This is not applicable. There is no algorithm or software for which standalone performance would be relevant for this physical device.

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

• For the non-clinical tests, the "ground truth" is defined by the objective pass/fail criteria specified by the referenced ISO/ANSI standards for mechanical properties, sterility assurance levels, and biocompatibility endpoints. There is no clinical "ground truth" in the sense of pathology or outcomes data for this specific submission, as it relies on non-clinical testing for substantial equivalence.

8. The sample size for the training set:

• This is not applicable. This is a physical medical device, not a software/AI product requiring a training set for model development.

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

• This is not applicable. See point 8.

In summary: The provided document is a 510(k) summary for a physical medical device, the Oneday Implant Abutment. It demonstrates substantial equivalence primarily through comparisons of design, materials, intended use, and adherence to established performance standards through non-clinical (laboratory) testing. It does not involve AI/ML technology or associated validation studies typically seen in software medical device submissions, and therefore, many of the detailed questions regarding AI performance criteria and study design are not relevant to this specific document.

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The Oneday Mini Implant System is intended for two-stage surgical procedures in the following situations and with the following clinical protocols:

• The intended use for the 3.0mm, 3.3mm diameter Oneday Mini Implant is limited to the replacement of maxillary lateral incisors and mandibular incisors.

• Immediate placement in extraction situations with a partially or completely healed alveolar ridge.

• It is intended for delayed loading.

The Oneday Mini Implant System is used to replace missing teeth in various situations ranging from a single tooth loss to the complete loss of incisors teeth. This system is restricted to substitute the maxillary lateral incisors and mandibular incisors. It is two stage endosseous screw type implant with internal hexagonal connection. This system consists of the fixture, cover screw, and various abutments. Only the subject abutments can be used with the subject fixtures. The Fixture is made of Pure Titanium of ASTM F67 and the surface of the fixture is treated with the SLA(Sand-blasted, Large grit, Acid-etched surface). Fixture is provided sterile.

This document is a 510(k) summary for the Oneday Mini Implant System, primarily focused on demonstrating substantial equivalence to a predicate device (UF(II) Narrow Implant System by DIO Corporation, K161987) rather than proving performance against specific acceptance criteria for an AI/ML device.

Therefore, many of the requested details related to AI/ML device acceptance criteria, study design (like MRMC, training/test set ground truth, expert adjudication), and performance metrics (e.g., AUC, sensitivity, specificity) are not present in this document because it is for a traditional dental implant device, not an AI/ML powered device.

However, I can extract the information relevant to a traditional medical device's acceptance criteria and performance proof, focusing on the equivalence to a predicate device.

Acceptance Criteria and Study for the Oneday Mini Implant System (A Traditional Medical Device)

1. Table of Acceptance Criteria and Reported Device Performance:

For a traditional medical device like a dental implant, "acceptance criteria" are typically demonstrated through various non-clinical tests (mechanical, material, sterilization, biocompatibility) and comparison to a legally marketed predicate device. The performance is assessed by showing substantial equivalence to this predicate, meaning it is as safe and effective as the predicate.

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

• Test Set (for performance evaluation): For a traditional device showing substantial equivalence, there isn't a "test set" in the sense of a distinct dataset used to calculate performance metrics like sensitivity/specificity for an algorithm. Instead, the "testing" involves performing specific engineering and biological tests (e.g., fatigue testing on a sample of implants, sterilization validation on a sample of devices) and comparing the design specifications and materials to a predicate device.
  • Fatigue Testing: "Fatigue Testing under the worst-case scenario according to ISO 14801:2016." The standard dictates sample sizes.
  • End User Sterilization Validation: Performed on the "subject Healing Abutment Mini with the greatest surface area" to be representative. Standards dictate sample sizes.
  • Data Provenance: The document does not specify the country of origin for the testing data. Test results are generally from controlled laboratory environments using product samples. Most data is "leveraged" from previous 510(k) clearances (K192294 and K161987) for similar devices, suggesting a retrospective use of existing data to support the current claim of equivalence.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable in the context of this 510(k) summary for a traditional medical device. Ground truth for device performance is established through adherence to recognized international standards (e.g., ISO, ASTM) for material properties and mechanical testing, and through comparison to a device already cleared by the FDA (the predicate). There is no "expert panel" establishing a clinical ground truth for a diagnostic output as there would be for an AI/ML imaging device.

4. Adjudication Method for the Test Set:

• Not applicable. There is no "adjudication" of results in the sense of reconciling differing expert opinions, as this is not an AI/ML diagnostic device with human readers. Testing results are objective measurements against pre-defined engineering and biological standards.

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

• No, an MRMC study was not done. This type of study is relevant for diagnostic devices, particularly AI/ML-powered ones, to assess the impact of the AI on human reader performance. This document is for a physical medical implant.

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

• No, a standalone evaluation was not done. This concept applies to AI/ML algorithms that might provide a diagnostic output without human intervention. This document is for a physical medical implant.

7. The type of ground truth used:

• The "ground truth" for the Oneday Mini Implant System is based on:
  • Adherence to recognized international standards: e.g., ISO 14801:2016 for fatigue, ISO 11137 for sterilization, ISO 10993 for biocompatibility, etc.
  • Demonstrated equivalence to a legally marketed predicate device: The predicate device (UF(II) Narrow Implant System, K161987) has already been determined to be safe and effective by the FDA. The substantial equivalence argument posits that since the new device is fundamentally similar and meets performance parameters, it is also safe and effective.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. There is no "training set" as this is not an AI/ML device.

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