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Jazz Classic is a clinical software application that captures images and data from Jazz intraoral xray sensors and various imaging sources (e.g., radiographic devices, digital still/video capture devices, and generic image devices such as scanners). Jazz Classic enables the storage of images, clinical notes, and clinical exam data. Jazz Classic is intended to be used for general populations which includes use for pediatric populations.

It is intended to acquire, display, edit (e.g., resize, enhance), review, print, and distribute images using standard PC hardware. Jazz Classic is intended for diagnostic and non-diagnostic purposes by dental professionals trained to provide dental care.

Jazz Classic is a dental imaging software application that equips trained dental professionals with the tools to capture, process, organize,save, and share diagnostic images of patients. The software operates on standard PC hardware and displays images on the PC's connected display or monitor. Images can be acquired from digital dental imaging devices, including intraoral x-ray sental panoramic and cephalometric scanners, and intraoral cameras. It stores images using lossless compression, and can export them as DICOM, PNG, JPEG, or TIF files. It enables dental practitioners to visualize, and manipulate patient images to assist in case diagnosis, review, and treatment planning to further enhance the diagnostic value of images.

Jazz Classic integrates with client-server practice management software, bridging patient information from the user's existing practice management solutions to be used for scheduling, clinical note-taking, and billing.

Jazz Classic neither contacts the patient nor controls any life sustaining devices. Diagnosis is not performed by the software but by dentists and other licensed dental professionals.

The provided text includes a 510(k) summary for the Jazz Classic device, a dental imaging software application. The summary outlines the device's intended use, comparison to a predicate device, and a brief description of non-clinical and clinical tests. However, it does not contain detailed information about specific acceptance criteria or a comprehensive study that proves the device meets those criteria in a quantitative manner.

Instead, the document primarily focuses on demonstrating substantial equivalence to a predicate device (CLIO/CLIOSOFT, K110886) through technological and indications for use comparisons, and general verification and validation activities.

Here's a breakdown of the available information based on your requests:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. The text mentions "verification testing confirmed that the software design requirements have been met" and that "Jazz Classic meets operational and clinical needs to acquire and evaluate dental images safely and effectively based on expert opinion," but no specific quantitative acceptance criteria or corresponding performance metrics are listed in a table format.

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

• Test Set Sample Size: The document mentions "bench testing was performed on Jazz Classic and the predicate device" using "images acquired from scientific phantom targets." It also states "Jazz Imaging also performed a clinical evaluation." However, specific sample sizes (e.g., number of images, number of patients) for either the bench testing or the clinical evaluation are not provided.
• Data Provenance: The document does not specify the country of origin for any data used. The bench testing used "scientific phantom targets," implying synthetic data. The clinical evaluation is mentioned, but whether it was retrospective or prospective is not stated.

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

• Number of Experts: For the clinical evaluation, it states "Based on expert opinion." The exact number of experts used is not specified.
• Qualifications of Experts: The qualifications of these experts are not provided. It only refers to them as "expert opinion."

4. Adjudication Method for the Test Set:

The document mentions "Based on expert opinion" for the clinical evaluation. This suggests a form of expert review, but the specific adjudication method (e.g., 2+1, 3+1, none) is not described.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human readers improving with or without AI assistance. The device is described as a "software only medical device" for imaging management and processing, with diagnosis performed by dental professionals, implying it's a tool, not an AI diagnostic aid.

6. Standalone (Algorithm Only) Performance:

The document states "Diagnosis is not performed by the software but by dentists and other licensed dental professionals." This indicates that the device is intended to assist human professionals and is not described as a standalone diagnostic algorithm. However, the "bench testing" compared Jazz Classic's "signal-to-noise ratio (SNR) and resolution" to the predicate device, which could be considered a form of standalone technical performance assessment on phantom images. But this is not specifically "algorithm-only diagnostic performance."

7. Type of Ground Truth Used:

• For the bench testing, "scientific phantom targets" were used, implying a known synthetic ground truth for evaluating technical image quality metrics like SNR and resolution.
• For the clinical evaluation, it was "Based on expert opinion," which suggests expert consensus was used as ground truth for assessing "operational and clinical needs." Pathology or outcomes data are not mentioned.

8. Sample Size for the Training Set:

The document does not provide any information regarding a training set sample size. This is typical for devices that are primarily image management and processing systems rather than complex AI models that require extensive training data.

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

Since no training set information is provided, how its ground truth was established is not applicable/not mentioned.

In summary, while the document confirms that Jazz Imaging conducted design verification, bench testing, and a clinical evaluation, it lacks the detailed quantitative information typically found in a robust study proving specific acceptance criteria. The focus is on demonstrating substantial equivalence and general safety/effectiveness through comparison to a predicate device and expert opinion, rather than presenting a detailed performance study against predefined numerical acceptance criteria.

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The EVAC is indicated to facilitate the evacuation of a chronic or subacute hematoma or hygroma in the cranium. The EVAC is intended for draining of fluid accumulated in the subdural space, including chronic or subacute hematomas and hygromas. The EVAC is also intended for removing air and fluid from the subdural space following open surgical procedures to remove subdural collections.

The Borvo EVAC System is intended for the drainage of subdural fluid accumulations. The EVAC System is designed to gradually drain fluid to an external reservoir by creating a low negative pressure in the subdural space. It consists of 3 components:

• 1. EVAC Port (Ergo or Classic)
• 2. Tubing
• 3. Vacuum bulb
     An optional Cranial Access Kit can be purchased with the EVAC System, or a commercially available Cranial Access Kit with a 5.31mm drill bit can be used.

The provided text is a 510(k) premarket notification letter and summary for the Borvo EVAC System. It describes the device, its intended use, and a comparison to a predicate device. However, it does not include information about acceptance criteria or a study proving that the device meets those criteria, as typically found in clinical performance or software validation reports for AI/ML-driven devices.

The document focuses on demonstrating substantial equivalence to a predicate device based on:

• Same intended use.
• Similar technological characteristics (with detailed comparisons of materials, dimensions, etc.).
• Performance data from non-clinical testing.

Therefore, I cannot provide the requested information about acceptance criteria, device performance against those criteria, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided text.

The "Performance Data" section (Section 1.7 on page 3 of 4) lists the types of non-clinical testing performed, such as:

• Dimensional
• Tensile
• Pull-Out Force
• Simulated Use
• Sterile Barrier/Packaging Testing
• Shelf Life
• Biocompatibility (ISO 10993-1)

These tests are typically used to demonstrate the physical and biological safety and performance of a medical device, but they are not related to an AI/ML algorithm's analytical or clinical performance requiring ground truth, expert review, or statistical performance metrics.

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Phoenix Contact Lens Case is indicated for storage of soft (hydrophilic), rigid gas permeable and hard contact lenses during chemical disinfection.

There are three models of the Phoenix Contact Lens Case:
CL-01 "Dome Top Flat Pack" - made with LDPE and has 1.5ml wells on each side
CL-02 "Classic Flat Pack" - made with LDPE and has 1.5 ml wells on each side
CL-03 "Sunglass Shape Flat Pack" made with Polypropylene and has 2.0 ml wells on each side
All three models have hinged self sealing caps and are available in white, black, blue, orange, green, and natural.
The Phoenix contact lens cases are intended for storage during chemical disinfection of soft, rigid gas permeable or hard contact lenses. It is not to be used with heat disinfection.

The provided document is a 510(k) premarket notification for Phoenix Contact Lens Cases (CL-01, CL-02, CL-03). It outlines the device's substantial equivalence to legally marketed predicate devices.

Based on the provided text, the device in question is a contact lens case, not an AI/ML medical device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies proving the performance of AI/ML medical devices, is not applicable to this submission.

The document details non-clinical tests performed on the contact lens cases to demonstrate their substantial equivalence. These tests primarily focus on the biocompatibility and safety of the materials used in the contact lens cases, not on the performance of a diagnostic or therapeutic algorithm.

Here's a summary of the non-clinical tests and their conclusions, which serve as the "acceptance criteria" and "device performance" for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

The following numbered points are not applicable to this device, as it is a physical contact lens case and not an AI/ML software device.

2. Sample sizes used for the test set and the data provenance: Not applicable. The tests involved in vitro cell cultures and in vivo animal models, with sample sizes determined by the respective ISO standards and USP guidelines for biocompatibility testing (e.g., specific numbers of cells, guinea pigs, rabbits, or mice as per the standard). The provenance is "laboratory testing conditions" and "experimental conditions." These are typically prospective in nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these tests is based on objective biological responses measured in a laboratory setting per standardized protocols, not human expert consensus on images or clinical data.
4. Adjudication method for the test set: Not applicable. The tests evaluate direct biological and material responses, not subjective interpretations requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This study type is for AI/ML diagnostic performance, not for a physical medical device like a contact lens case.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to AI/ML algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI context. The "ground truth" for these biocompatibility tests is the presence or absence of a specific biological or toxicological reaction as defined by the international standards (e.g., cell viability, skin erythema/edema, systemic toxicity, fever induction, ocular irritation).
8. The sample size for the training set: Not applicable. This document describes pre-market testing for a physical device, not an AI/ML algorithm that requires training data.
9. How the ground truth for the training set was established: Not applicable.

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Savewo ClassicMASKs are intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.

Savewo ClassicMASKs are intended for use in infection control practices to reduce the potential exposure to blood and body fluids.

This is a single use, disposable device(s) and provided non-sterile.

Savewo ClassicMASK is a 3-layered mask. The outer layer is made of spunbond polypropylene with white color, the inner layer is made of hydrophilic polypropylene/polyethylene non-woven fabric, and the middle layer with filtration function is made of melt-blown polypropylene. The mask contains ear loops to secure the mask over the users' mouth and face and the metal nose strip over the top edge which secures the mask to stay firmly in place. Savewo ClassicMASK is single use, disposable, non-sterile and ASTM Level 3 certified.

Here's an analysis of the acceptance criteria and study detailed in the provided document for the Savewo ClassicMASK:

Description of the Acceptance Criteria and Study

The Savewo ClassicMASK is a 3-layered surgical mask intended to protect both patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The device underwent non-clinical testing to demonstrate its performance against established standards, specifically the ASTM F2100-19 standard for Level 3 surgical masks, and to ensure biocompatibility and flammability compliance. The study aims to prove substantial equivalence to a predicate device (Single-use Surgical Mask, K200923) by meeting the outlined acceptance criteria for various performance characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

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Nitrylex® Classic Powder Free Nitrile Blue Examination Gloves Tested for use with Chemotherapy Drugs are disposable devices intended for medical propose that are worn on the examiner's hands to prevent contamination between patent and examiner.

The proposed device was tested for use with Chemotherapy Drugs as per ASTM D678-05 Standard Practice for Assessment Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drugs Permeation.

Nitrylex® Classic Powder Free Nitrile Blue Examination Gloves Tested for use with Chemotherapy Drugs are disposable devices intended for medical propose that are worn on the examiner's hands to prevent contamination between patent and examiner.

Here's a breakdown of the acceptance criteria and the study information for the Nitrylex® Classic Powder Free Nitrile Blue Examination Gloves, based on the provided FDA 510(k) clearance document:

1. Table of Acceptance Criteria and Reported Device Performance

The device meets the acceptance criteria for all listed chemotherapy drugs by demonstrating a breakthrough detection time of greater than 240 minutes, with the explicit exception of Carmustine and Thiotepa, for which a warning is issued.

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

The document states that the proposed device was "tested for use with Chemotherapy Drugs as per ASTM D678-05 Standard Practice for Assessment Resistance of Medical Gloves to Permeation by Chemotherapy Drugs."

• Sample Size: The document does not explicitly state the number of gloves (samples) tested for each chemotherapy drug. However, ASTM D6978-05 generally specifies a minimum of three individual test specimens per drug for permeation testing.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It implies the data was collected specifically for this submission through testing.

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

This section is not applicable to this type of device and study. The "ground truth" here is objective scientific measurement (chemical breakthrough time) performed by laboratory testing according to a recognized standard (ASTM D6978-05), not expert interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set

This section is not applicable. As mentioned above, the "truth" is determined by objective laboratory measurements and standardized methodology, not through human adjudication of differing opinions.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) and the impact of AI on their performance. This device is an examination glove, and its performance is measured through physical and chemical interaction, not human interpretation.

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

This concept is not applicable to this device. A "standalone" study (algorithm only) refers to the performance of an AI algorithm independent of human input. This device is a physical product (gloves) whose performance is evaluated through material testing against chemical permeation, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used is objective laboratory measurement of chemical permeation. Specifically, it is the "Breakthrough Detection Time" as measured according to the ASTM D6978-05 standard. This is a direct physical measurement of the glove's resistance to different chemotherapy drugs.

8. The Sample Size for the Training Set

This section is not applicable. This device is a physical product and its performance is evaluated through direct physical/chemical testing, not by training an algorithm on a dataset. Therefore, there is no "training set" in the context of machine learning.

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

This section is not applicable for the same reason as point 8.

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Classic is a Mandibular Advancement Device (MAD) indicated for mild to moderate obstructive sleep apnea (OSA) and to alleviate or reduce snoring in adults.

Classic device is an intraoral device specially indicated for the treatment of snoring and obstructive sleep apnea syndrome. Its design makes it simple to use and comfortable to wear. It is intended for single-patient use by adults who are 18 years or older.

Classic device consists of two splints united to each other by a screw that allows controlled advancement of the mandible by the increase of the muscular tone at the airway level. Consequently, the flow of air through the upper airway is increased, and reducing snoring and apnea events.

The maximum protrusion of Classic arch form is 10 mm, measuring from patient's plate. This device needs an external controlling component such as screwdriver included in the kit. The device is according arches, maximizes tongue space and allow open, close and laterality movements during wear. These movements can be personalized by the doctor.

Each Classic device has the following components:

1. Upper splint
2. Lower splint
3. Activation key
4. Guide (Bar)
5. OrthoApnea screw

This document is an FDA 510(k) Premarket Notification for the "Classic" Mandibular Advancement Device (MAD). It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving a specific performance metric against a set of acceptance criteria derived from a novel clinical study.

Therefore, many of the requested elements regarding acceptance criteria, study design, expert involvement, and ground truth for demonstrating device performance are not applicable in the context of this 510(k) submission document. The submission relies heavily on non-clinical testing and comparison to predicates to assert safety and effectiveness.

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

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

This document does not present acceptance criteria in the typical sense of numerical thresholds for clinical performance metrics (e.g., sensitivity, specificity, accuracy) derived from a specific clinical study aimed at proving the device meets those criteria. Instead, the "acceptance criteria" for a 510(k) submission are fundamentally about demonstrating substantial equivalence to a predicate device.

The closest one gets to "performance" here is demonstrating adherence to established standards and similar characteristics to the predicate.

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

• Not Applicable. This submission is for a physical medical device (intraoral device) and relies on non-clinical (bench) testing and comparison to predicates, not a clinical test set of patient data with a defined sample size as would be used for an AI/software device.
• Data Provenance: The bench testing likely occurred at the manufacturer's facility or a certified lab. The document does not specify the country of origin for the data or whether it was retrospective or prospective, as it's not clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. No clinical test set with human data requiring expert ground truth establishment was used in this 510(k) submission.

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

• Not Applicable. No clinical test set with human data requiring adjudication was used.

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

• Not Applicable. This is a physical device, not an AI or software-as-a-medical-device (SaMD) product. No MRMC study was performed or required for this type of submission.

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

• Not Applicable. This is a physical device, not an algorithm.

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

• Not Applicable. For the non-clinical testing performed, the "ground truth" would be the established physical and chemical properties of the materials and the performance specifications of the device components as defined by the international standards (e.g., ISO, ASTM). Biocompatibility is assessed against the absence of toxic reactions as per ISO standards. There is no patient-level "ground truth" for disease state or outcomes.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of this device. It's not an AI/machine learning device.

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

• Not Applicable. As there is no training set, this question is not relevant.

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• To temporarily increase local blood circulation in healthy leg muscles
• To stimulate healthy muscles in order to improve and facilitate muscle performance

BEMER therapy systems are a family of noninvasive physical medicine devices that can be used as a supportive therapy to increase local blood circulation. BEMER systems improve local blood distribution via electromagnetic stimulatory principles. The indications for use allow application to increase local blood circulation or stimulate healthy muscles in order to improve and facilitate muscle performance. The BEMER devices are noninvasive, fully reusable (no disposable components such as electrodes), and have configurations allowing both patient/home and professional/office use. This submission is specifically requesting to add the applicators, B.BODY and B.SIT to the already cleared BEMER Therapy System. The device contains firmware that controls the user interface. It also contains that controls the pulse generator, battery charger, audion and pushbutton controller.

The provided text is a 510(k) premarket notification document for a medical device, the BEMER Classic Set and BEMER Pro-Set, specifically requesting to add new applicators (B.BODY and B.SIT) to an already cleared system.

This document does not contain information about a study proving the device meets acceptance criteria related to a diagnostic AI or imaging-based device. The context is for a powered muscle stimulator. Therefore, the questions about acceptance criteria for AI algorithms, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and effect sizes are not applicable to this document's content.

The document focuses on demonstrating substantial equivalence to a predicate device (K151834) for new accessories (applicators B.BODY and B.SIT). The "acceptance criteria" here are based on similarity to the predicate device and compliance with relevant electrical safety, EMC, and biocompatibility standards.

Here's a breakdown of the relevant information from the document, tailored as much as possible to the spirit of your request, but acknowledging the difference in device type:

Device Type: Powered Muscle Stimulator (Non-invasive tissue stimulation via magnetic field induction)

Indications for Use:

• To temporarily increase local blood circulation in healthy leg muscles.
• To stimulate healthy muscles in order to improve and facilitate muscle performance.

Instead of "Acceptance Criteria for AI Performance," the document discusses "Substantial Equivalence" to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance (as inferred from "Comparison of Technological Characteristics" and "Non-clinical Testing"):

2. Sample Size and Data Provenance:

• This document describes non-clinical performance testing of electrical and magnetic outputs, not a clinical study with human subjects or a test set of patient data.
• Therefore, concepts like "sample size used for the test set" (in the context of patient data) and "data provenance (e.g. country of origin of the data, retrospective or prospective)" are not applicable. The testing was laboratory-based, comparing the new applicators' performance characteristics to the already cleared predicate.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable. Ground truth in the context of AI/medical imaging refers to expert interpretation of patient data. This document describes performance validation of physical device characteristics against engineering specifications and predicate device performance. No expert human interpretation of medical images or patient outcomes data for ground truth establishment is mentioned or required for this type of device and submission.

4. Adjudication Method:

• Not applicable. This refers to methods for resolving discrepancies in expert ground truth for medical data. Not relevant here.

5. MRMC Comparative Effectiveness Study:

• Not applicable. This is a study design for evaluating the impact of AI on human reader performance. This submission is for a physical therapy device, not a diagnostic AI system, and does not involve human readers interpreting AI output.

6. Standalone Performance (Algorithm Only):

• Not applicable. This relates to AI algorithm performance without human intervention. The BEMER device is a physical therapy device; there is no "algorithm only" performance in the sense of an AI model's output.

7. Type of Ground Truth Used:

• For this device, the "ground truth" (or basis for comparison) is the technical specifications and measurable electromagnetic outputs of the predicate device, along with adherence to recognized international standards for medical electrical equipment (e.g., IEC 60601 series, ISO 10993 series). No patient pathology or outcomes data is used as "ground truth" for this type of submission.

8. Sample Size for the Training Set:

• Not applicable. There is no AI training set involved in this 510(k) submission for a physical therapy device.

9. How the Ground Truth for the Training Set was Established:

• Not applicable. As above, no training set or its ground truth establishment is relevant to this document.

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PROFEMUR® GLADIATOR® Cemented Classic Stems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

The PROFEMUR® GLADIATOR® Cemented Classic Stems present a tapered-wedge design and a reduced distal stem tip, identical to the legally marketed modular PROFEMUR® GLADIATOR® Cemented Stem (K111910, SE 10/14/2011) with PROFEMUR® Cobalt Chrome Modular Necks (K091423, SE 08/25/2009; K100866, SE 04/28/2010). The subject stems are intended to be cemented and have a glass-beaded body, medial collar, proximal shoulder and neck region with a surface roughness identical to the legally marketed modular PROFEMUR® GLADIATOR® Cemented Stem (K111910, SE 10/14/2011) with PROFEMUR® Cobalt Chrome Modular Necks (K091423. SE 08/25/2009; K100866. SE 04/28/2010). The subject stems possess a proximal medial collar designed to assist rotational stability and offer protection against subsidence, identical to the cleared predicate PROFEMUR® GLADIATOR® Cemented Stem (K111910, SE 10/14/2011) with PROFEMUR® Cobalt Chrome Modular Necks (K091423, SE 08/25/2009; K100866, SE 04/28/2010). The trunnion is a MicroPort 12/14 SLT taper, with an as-machined geometry to form a taper lock with a mating femoral head implant. The trunnion is identical to the MicroPort femoral stem tapers of the predicate and reference devices. The subject stems possess an oval impaction feature on the proximal shoulder for proper femoral stem insertion into the femoral canal, identical to the cleared reference PROFEMUR® GLADIATOR® Thin HA Classic Stem w/ Collar (K200007, SE 04/25/2020). The subject PROFEMUR® GLADIATOR® Cemented Classic Stems are manufactured from forged cobalt chromium alloy (ASTM F799). The PROFEMUR® GLADIATOR® Cemented Classic Stems were designed to accommodate a wide range of patient anatomy and to provide an optimized fit to adequately restore the biomechanics of the respective hip (including restoration of the natural leg length and head center offset). The subject PROFEMUR® GLADIATOR® Cemented Classic Stems are offered in sizes 4, 6, 8, 10, and 12 with the stem length ranging from 125mm to 170mm, identical to the cleared reference PROFEMUR® GLADIATOR® Cemented Stems (K111910, SE 10/14/2011). The subject classic stem possesses two different neck options: standard (with a CCD neck angle of 135°) and extended/Varus 8° (with a CCD angle of 127°).

This document describes a 510(k) premarket notification for the "PROFEMUR® GLADIATOR® Cemented Classic Stem," a hip joint prosthesis. The submission aims to demonstrate substantial equivalence to a predicate device.

1. Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence through mechanical testing and engineering analyses. The acceptance criteria are implicitly that the subject device performs equivalently to the predicate devices under standardized tests.

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

The document states that "worst-case constructs" were used for mechanical testing. However, it does not specify the exact sample size (e.g., number of stems tested per condition) for the mechanical tests.

The data provenance is not explicitly mentioned as "country of origin" or "retrospective/prospective." Given this is a 510(k) submission for a medical device (hip stem), the testing data is typically generated in a controlled laboratory environment by the manufacturer (MicroPort Orthopedics Inc., located in Arlington, Tennessee, USA). It is not clinical data but rather benchtop mechanical testing.

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

This information is not applicable to this document. The "ground truth" for the test set is established by industrial standards (e.g., ASTM, ISO) and engineering analysis, not by human expert consensus or clinical observation for this type of device submission. The performance is objectively measured against predefined criteria in these standards.

4. Adjudication Method for the Test Set:

This information is not applicable. As the evaluation is based on objective mechanical testing against engineering standards, an adjudication method for human interpretation is not relevant.

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

This information is not applicable. This submission is for a hip replacement implant (a physical medical device) and does not involve AI, human readers, or image interpretation.

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

This information is not applicable. This submission is for a hip replacement implant and does not involve an algorithm.

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

The "ground truth" for the performance evaluation in this context is based on standardized mechanical testing protocols and design specifications compliant with recognized industry standards (ASTM, ISO). The performance is measured directly and objectively against these standards.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" as this is a physical medical device and not an AI/machine learning model.

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

This information is not applicable for the same reason as point 8.

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PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2. inflammatory degenerative joint disease such as rheumatoid arthritis;
3. correction of functional deformity; and,
4. revision procedures where other treatments or devices have failed
   Hydroxyapatite coatings applied to implant surfaces are intended for uncemented arthroplasty.

The PROFEMUR® GLADIATOR® Thin Hydroxyapatite-coated (HA) Classic Stems with Collar present a monolithic, tapered-wedge design and a reduced distal stem tip. The 'Thin' description is a relative word MicroPort uses as an internal descriptor to clearly identify the difference in product between the currently cleared US-offered HA coating thickness (65um) and the coating thickness offered in outside US (OUS) markets. The subject stems are coated with a 65um HA coating (ASTM 1185), and the uncoated medial collar, proximal shoulder and neck regions of the stem possess a glass-beaded finish (Ra=0.8μm). The subject stems possess a proximal medial collar designed to assist in discouraging subsidence and maximizing rotational stability. The proximal anterior, posterior, and medial surfaces possess grooves perpendicular to the stem's longitudinal axis and parallel with each other. The proximal grooves are designed to provide a maximized bone-stem contact surface for bone apposition and assist in discouraging stem subsidence. The distal anterior and posterior surfaces of the subject stem possess vertical grooves parallel to the stem's longitudinal axis. The distal grooves are designed to assist the stem in resisting against rotational loads. The subject classic stems possess an oval impaction feature on the proximal shoulder for stem insertion into the femoral canal. The PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar are designed for use in total hip arthroplasty.
The PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar are manufactured from forged Ti6Al4V alloy (ASTM F620) and come in 10 sizes, with the stem length ranging from 125mm to 175mm. The subject stems features two different neck options: standard (with a CCD neck angle of 135°) and extended/Varus 8° (with a CCD angle of 127°). The PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar were designed to accommodate a wide range of patient anatomy and to provide an optimized fit to adequately restore the biomechanics of the respective hip (including restoration of the natural leg length and head center offset).

The provided document describes a 510(k) premarket notification for a medical device (PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar) and focuses on demonstrating its substantial equivalence to previously cleared predicate devices. It does not contain information about a study that proves the device meets acceptance criteria in the context of AI/ML device performance (e.g., diagnostic accuracy, sensitivity, specificity, or human-in-the-loop performance).

Instead, the document details nonclinical testing performed on the hip stem to demonstrate its mechanical properties, safety, and equivalence to existing devices. Therefore, I cannot provide all the requested information, particularly those related to AI/ML device performance studies like sample size for test sets, data provenance, expert ground truth, MRMC studies, or standalone algorithm performance.

Here's an analysis of the information available in the document regarding "acceptance criteria" and "study" in the context of this orthopedic implant:

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

The document describes various nonclinical tests and their successful completion, implying that passing these tests served as the acceptance criteria for substantial equivalence. However, it does not present a formal table with specific quantitative acceptance criteria alongside exact reported performance values from the tests. Instead, it generally states that the device "met all mechanical testing requirements" and "were successfully performed."

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

• Sample Size: The document does not specify the exact number of hip stems or components used for each nonclinical test (e.g., how many stems were subjected to fatigue testing). It refers to "worst-case construct testing" and "worst case implants" for endotoxin testing, suggesting a representative, but unspecified, sample size.
• Data Provenance: Not applicable in this context. The "tests" are laboratory-based mechanical and biological evaluations, not clinical studies with human patient data.

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

This information is not applicable as the evaluation involved nonclinical laboratory testing against pre-defined engineering standards, not expert interpretation of clinical data to establish ground truth.

4. Adjudication method for the test set:

This information is not applicable for nonclinical laboratory testing. The evaluation is based on meeting the quantitative or qualitative criteria of the respective ISO, ASTM, and EN 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:

This information is not applicable. The device is a hip implant, not an AI/ML-based diagnostic or assistive technology for human readers.

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 hip implant, not an AI/ML algorithm.

7. The type of ground truth used:

The "ground truth" in this context refers to the established international and national standards (e.g., ISO 7206 series, EN ISO 21535, ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2503, ANSI/AAMI ST72, USP ) against which the hip stem's mechanical, safety, and material properties were evaluated. Compliance with these standards indicates acceptable performance.

8. The sample size for the training set:

This information is not applicable as the device is a physical hip implant. There is no "training set" in the context of an AI/ML algorithm.

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

This information is not applicable for the same reason as point 8.

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The ReliOn™ Premier Classic Blood Glucose Monitoring System consists of the The ReliOn™ Premier Classic Blood Glucose Meter and the ReliOn™ Premier Blood Glucose Test Strips. The ReliOn™ Premier Classic Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternate sites such as the forearm, palm, thigh, and calf. Alternate site testing should be used only during steady-state blood glucose conditions. The ReliOn™ Premier Classic Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

The ReliOn™ Premier Classic Blood Glucose Monitoring System consists of the The ReliOn™ Premier Classic Blood Glucose Meter and the ReliOn™ Premier Blood Glucose Test Strips.

Here's a breakdown of the acceptance criteria and study information for the ReliOn™ Premier Classic Blood Glucose Monitoring System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text only touches upon the regulatory approval and indications for use. It does not include a table explicitly stating acceptance criteria or detailed performance results against those criteria. Clinical performance data, often presented in tables conforming to ISO standards (e.g., ISO 15197 for blood glucose monitoring systems), would typically be found in the full 510(k) submission but are not present in this summary.

To illustrate what such a table would look like for a blood glucose monitoring system, I'll describe typical acceptance criteria based on ISO 15197 (a common standard for such devices), and then indicate that the provided document does not contain the performance data.

Hypothetical Table (Based on typical ISO 15197 standards; performance data not in document):

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