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The Gladiator system contains three handpieces, each of which has its own indications for use.

The PiXel8-RF handpiece is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostatis.

The Bodysculp laser lipolysis handpiece intended for non-invasive lipolysis of the flank and abdomen to achieve disruption of adipocyte cells intended for non-invasive a desired a desired aesthetic affect. This treatment is intended for individuals with a Body Mass Index (BMI) of 30 or less.

The Body Tone handpiece is intended for Relaxation of muscle spasms, Prevention or disuse atrophy, Increasing local blood circulation. Muscle re-education. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, Maintaining or increasing range of motion. Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

The Gladiator is a multi-function system that combines RF Microneedling, Low Level Laser and Electronic Muscle Stimulation (EMS) technologies into a single console. The system is intended for dermatologic and general surgery purpose as well as pain relief. The system is comprised of a single console with three handpieces:

• PiXel8-RF - a bipolar radiofrequency micro needling handpiece with disposable tips
• . BodySculp - a low level laser
• . BodyTone (previously called Futura Pro) – an electronic muscle stimulator

The system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source.

The provided text is a 510(k) premarket notification FDA review letter for the "Gladiator" device. It outlines the device description, indications for use, comparison to predicate devices, and performance testing. However, it does not contain the kind of detailed information about acceptance criteria for an AI/ML diagnostic device, nor does it describe a study specifically proving that the device meets such criteria in terms of algorithm performance against a ground truth.

Specifically:

• There's no mention of an AI/ML component in the Gladiator device. The device is described as a multi-function system combining RF Microneedling, Low Level Laser, and Electronic Muscle Stimulation (EMS) technologies.
• The "Performance Testing" section focuses on electrical safety, EMC, software lifecycle processes, risk management, and thermal testing, which are standard for electrosurgical and laser devices. This is not performance testing for an AI algorithm's diagnostic accuracy.
• There is no ground truth establishment, multi-reader multi-case studies, or standalone algorithm performance data discussed.
• The testing described is primarily engineering and safety-related (e.g., thermal damage profiles in ex vivo tissues), not clinical diagnostic accuracy.

Therefore, I cannot provide the requested information as the input document does not describe a study involving performance assessment of an AI/ML algorithm against acceptance criteria for diagnostic accuracy. The document is for a physical medical device (Gladiator) that does not appear to have an AI/ML component requiring the type of performance evaluation outlined in your request.

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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 Gladiator Elite Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Gladiator Elite Balloon Dilatation Catheter is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

Gladiator Elite is an over-the-wire balloon catheter with a dual lumen shaft design. One lumen is used to pass the catheter over 0.035" guidewires. The second lumen communicates with the balloon and is used to inflate and deflate the balloon during the procedure. The guidewire lumen and the balloon lumen terminate at the proximal end of the catheter in a Y- connector manifold with luer lock fittings. There are radiopaque marker bands located under the balloon shoulders to aid in positioning the system during the procedure. A coating is applied to the balloon to enhance insertion and withdrawal performance. The tip of the catheter is gradually tapered to facilitate advancement of the catheter through the stenosis.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Gladiator Elite PTA Balloon Dilatation Catheter:

The document (K132810) is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria for a novel device. Therefore, the information you're requesting regarding acceptance criteria, sample sizes, ground truth establishment, and expert involvement is not explicitly detailed in this type of submission.

Instead, the submission states that "Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence." This means the testing aims to show the new device performs similarly to the predicate device, or meets established industry standards for such devices, rather than meeting specific performance metrics against a clinical ground truth.

Here's what can be extracted based on the provided text, and where the requested information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical "acceptance criteria" for each test in the way you might expect for a novel device's clinical performance. Instead, it lists types of tests performed to demonstrate that the device performs equivalently to the predicate and is safe for its intended use. The "reported device performance" is implicitly that the device passed these tests and was deemed substantially equivalent.

Missing Information Details:

Due to the nature of a 510(k) submission for a substantially equivalent device, many of the requested details for a performance study are not applicable or not provided.

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

• Sample Size: Not specified for any of the in-vitro or biocompatibility tests. These typically involve a number of units sufficient to meet statistical confidence for engineering and biological testing standards, but a specific "test set" in the context of clinical images or patient data is not relevant here.
• Data Provenance: Not applicable. The data is from laboratory (bench) and in-vitro biocompatibility testing, not human subjects or clinical data.

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

• Not Applicable: This device is a PTA Balloon Dilatation Catheter. The "tests" relate to its physical and biological properties. Ground truth in the sense of expert consensus on an imaging finding or clinical outcome is not relevant to this type of device submission. Experts involved would be engineers, material scientists, and toxicologists conducting and interpreting the tests according to established protocols.

4. Adjudication Method for the Test Set

• Not Applicable: There is no "adjudication method" in the sense of multiple readers reviewing clinical data. The tests performed are objective laboratory measurements and standardized biological assays.

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

• No: This is a physical medical device (a catheter), not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not applicable.

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

• No: This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• For Biocompatibility: Established biological safety standards and validated laboratory test methodologies (e.g., ISO 10993 series for biological evaluation of medical devices).
• For In-vitro Performance: Engineering specifications, device design parameters, industry standards for balloon catheters, and performance characteristics of the predicate device (K113681).

8. The Sample Size for the Training Set

• Not Applicable: There is no "training set" as this is not an AI/algorithm-based device.

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

• Not Applicable: There is no "training set" for this physical device.

In summary: The provided document is a 510(k) summary for a physical medical device (catheter) seeking substantial equivalence to a predicate. The "study" described consists of bench testing and biocompatibility testing designed to show the new device performs similarly and safely compared to the predicate, and meets general regulatory and industry standards. It does not involve clinical trials, AI, or human reader performance evaluations in the way one might see for diagnostic software or novel therapeutic devices.

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The Gladiator Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Gladiator Balloon Dilatation Catheter is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

The Boston Scientific Gladiator™ Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter is an Over-the-Wire (OTW) balloon catheter with a dual lumen shaft design. One lumen marked "WIRE" is used to pass the catheter over 0.035" (0.89mm) guidewires. The second lumen marked "BALLOON" communicates with the balloon and is used to inflate and deflate the balloon during the procedure. The guidewire lumen and the balloon lumen terminate at the proximal end of the catheter in a Y-connector manifold with luer lock fittings. There are two radiopaque markerbands located under the balloon shoulders to aid in positioning the system during the procedure. A coating is applied to the balloon to enhance insertion and withdrawal performance. The tip of the catheter is gradually tapered to facilitate advancement of the catheter through the stenosis.

· The Gladiator Balloon Dilatation Catheter will be available with balloon diameters 3.0 mm to 12.0 mm, balloon lengths 20 mm to 100 mm, and with shaft lengths of 40 cm and 75 cm.

The provided text focuses on the 510(k) summary for the Boston Scientific Gladiator™ PTA Balloon Dilatation Catheter, demonstrating its substantial equivalence to a predicate device. This type of submission relies on comparisons to an already approved device rather than clinical trials with specific acceptance criteria as might be seen for novel devices or AI/ML-based systems.

Therefore, many of the requested categories (such as sample size for test sets, expert qualifications, MRMC studies, training set details, etc.) are not applicable to this 510(k) submission document.

Here's an analysis of the available information:

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

The document does not present specific quantitative acceptance criteria in numerical form, as would be typical for performance specifications for new devices or AI models. Instead, it relies on demonstrating that the Gladiator device is substantially equivalent to the predicate device (Mustang PTA Balloon Dilatation Catheters, K103751) based on technological characteristics and performance data from bench and biocompatibility testing.

Here's a summary derived from the "Comparison of Technological Characteristics" and "Performance Data" sections:

• Manifold Hub: Same material (different colorant/additive), same design, same function.
• Bumper Tip: Same material (different colorant), same design, same function.
• Strain Relief: Same material, same design, same function.
• Proximal Dual Lumen Shaft: Same material, same design, same function.
• Proximal Shaft Outer Diameter: Same.
• Balloon: Same balloon material, same design, same function, same fundamental technology.
• Balloon Protector: Same material, similar design, same function.
• Pinch-off Tube: Same material, same design, same function.
• Markerbands: Same component, same function.
• Coating: Same coating, same function.
• Packaging Design: Similar design, same function (same carrier tube materials, different configuration).
• Sterilization Method: Same method.
• SAL (Sterility Assurance Level): Same level of assurance.
• Lumens: Same lumens, same function.
• Recommended Guidewire: Same compatibility.
• Balloon Diameters: Same.
• Balloon Lengths: Within range of predicate.
• Effective Length: Within range of predicate.
• Rated Burst Pressure (RBP): Same. |
  | Biocompatibility Testing | All tests completed successfully:
• MEM Elution Cytotoxicity
• Guinea Pig Maximization Sensitization
• Intracutaneous Reactivity
• Acute Systemic Toxicity
• Materials Mediated Rabbit Pyrogen
• Bacterial Mutagenicity (Ames Assay)
• Mouse Lymphoma Assay
• Hemolysis Direct Contact and Extract
• Partial Thromboplastin Time
• In Vitro Hemocompatibility Assay
• Complement Activation
• USP Physicochemical
• Natural Rubber Latex |
  | Bench/Performance Testing | Performed to assure conformance for intended use.
  (No new safety or performance issues raised.) |
  | Sterilization | Performed to assure conformance for intended use. |

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

This document discusses bench testing and biocompatibility testing, not clinical studies with "test sets" of patient data. The sample sizes for these engineering and lab tests are not specified in the summary. Data provenance for such engineering tests typically refers to laboratory conditions rather than patient data origin.

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. Ground truth for clinical data is not relevant to a device submission based on substantial equivalence through engineering and biocompatibility testing. The "ground truth" here is adherence to engineering specifications and biological safety standards.

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

Not applicable. Adjudication methods are used in clinical studies, not for the type of testing described here.

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 for a physical medical device (balloon catheter), not an AI/ML system that assists human readers.

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

Not applicable. This is for a physical medical device.

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

For the Gladiator device, the "ground truth" relates to:

• Engineering Specifications: The design and material characteristics of the predicate device (Mustang PTA Balloon Dilatation Catheters) serve as the benchmark for comparison.
• Biocompatibility Standards: Established international and national standards for biocompatibility testing (e.g., ISO 10993 series) define the "ground truth" for safety in this area.
• Performance Standards: Industry-accepted test methods and performance criteria (e.g., for Rated Burst Pressure, guidewire compatibility) define the "ground truth" for bench testing.

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.

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

Indications for Use:

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.

The PROFEMUR® Gladiator HA Hip Stem is intended for cementless hip arthroplasty.

The PROFEMUR® GLADIATOR® HA stems are hydroxyapatite coated hip stems that couple with modular necks. Design features of the stems are summarized below:

• Cementless stem with hydroxyapatite plasma spray coating
• Available in 10 sizes
• Manufactured from Ti alloy (Ti-6Al-4V) conforming to ASTM F620
• Hydroxyapatite coating conforming to ASTM F1185
• Available with and without collar

I am sorry, but based on the provided text, there is no information about an AI/ML device, its acceptance criteria, or a study proving that it meets those criteria. The document describes the PROFEMUR® GLADIATOR® HA Hip Stems, which are a mechanical medical device (a hip implant). The evaluation for this device was based on mechanical testing (fatigue, fretting, and distraction evaluation) and a comparison to predicate devices, not on AI/ML performance metrics.

Therefore, I cannot provide a response to the requested subsections as they pertain to AI/ML device evaluation, which is not present in the given text.

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The Gladiator Hip Stems are intended for use in uncemented total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Indications for Use:

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.
   The Gladiator cpTi Plasma Sprayed hip stem is intended for cementless hip arthroplasty. The Cemented hip stem is intended for cemented hip arthroplasty.

The Gladiator stems are modular hip stems that couple with modular necks. Design features of the stems are summarized below:

• Cementless stem with proximal cpTi plasma spray coating.
• Available in 10 sizes
• Manufactured from Ti alloy
• Cemented
• Available in 5 sizes
• Manufactured from CoCr alloy
• Distal centralizers available

Acceptance Criteria and Study for PROFEMUR® Gladiator Hip Stems

This section details the acceptance criteria and the study conducted to demonstrate the safety and effectiveness of the PROFEMUR® Gladiator Hip Stems.

1. Table of Acceptance Criteria and Reported Device Performance

"The GLADIATOR® Hip Stems have been tested in distal and proximal fatigue evaluation per the loading regimen prescribed by ISO 7206-4, -6 and -8." (Implies meeting the standards set by these ISO specifications, which are designed to ensure mechanical integrity for hip implants.) |
| Material Compatibility | Use of materials identical to those used in predicate devices with established safety and performance records. | "The materials used for the GLADIATOR® Hip Stems are identical to the materials used for the predicate devices." |
| Technological Equivalence| The fundamental scientific technology and design features (e.g., modular design, cross-section, tapered profile) are substantially equivalent to predicate devices. | "The GLADIATOR® Hip Stems have the same technological characteristics as the predicate device. GLADIATOR® Hip Stems are straight cemented and uncemented hip stems with a modular design. They feature a proximal trapezoidal cross-section and a distal rectangular cross-section. For fixation stability in three planes, the stem has a vertically tapered profile in the frontal and lateral planes." "The fundamental scientific technology of the modified devices has not changed relative to the predicate devices." |
| Intended Use & Indications| The intended use and indications for use are identical to previously cleared predicate devices. | "The indications for use of the Gladiator Hip Stems are identical to the previously cleared predicate devices." |

2. Sample Size and Data Provenance for the Test Set

• Sample Size: Not applicable. This submission relies on non-clinical (mechanical) testing and comparison to predicate devices, not a clinical test set with human subjects.
• Data Provenance: The mechanical testing data would be generated from laboratory experiments. The country of origin for this testing is not specified, but it would presumably be conducted by or for Wright Medical Technology, Inc., located in Arlington, TN, USA. The data is prospective in the sense that the tests were conducted specifically for this device submission.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

• Number of Experts: Not applicable. The ground truth for mechanical testing is established by adherence to international standards (e.g., ISO 7206 series) and engineering principles, not expert consensus on clinical cases.
• Qualifications of Experts: Not applicable in the context of clinical ground truth. However, the testing would be overseen by qualified engineers and scientists specialized in biomechanical testing of orthopedic implants.

4. Adjudication Method (Test Set)

• Adjudication Method: Not applicable. No clinical test set requiring adjudication of findings was used.

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

• Was an MRMC study done? No.
• Effect size of human reader improvement: Not applicable, as no MRMC study was conducted. This device is an implantable orthopedic device, and its approval relies on mechanical performance and substantial equivalence to predicate devices, not on the interpretation of medical images or data by human readers.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

• Was a standalone study done? Yes, in the context of mechanical testing. The device's performance was evaluated in isolation through fatigue, fretting, and distraction tests as per ISO standards. This is a "standalone" evaluation of the physical device's mechanical integrity.
• Details of the study: The GLADIATOR® Hip Stems underwent "distal and proximal fatigue evaluation per the loading regimen prescribed by ISO 7206-4, -6 and -8," in addition to fretting and distraction evaluation. The results demonstrated equivalence to predicate devices and the capability to withstand in vivo loading.

7. Type of Ground Truth Used (Test Set)

• Type of Ground Truth: The ground truth for this submission is based on adherence to international mechanical testing standards (ISO 7206-4, -6, and -8) and the established safety and effectiveness profile of predicate devices through direct comparison of design features, materials, and mechanical performance. There is no clinical or pathology-based ground truth from a test set of human cases.

8. Sample Size for the Training Set

• Sample Size: Not applicable. This device approval is based on a 510(k) submission demonstrating substantial equivalence, primarily through mechanical testing and comparison to existing predicate devices. It does not involve machine learning algorithms or a "training set" in the computational sense.

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

• How Ground Truth Was Established: Not applicable. As there is no training set for a computational model, there is no ground truth to establish for it. The "ground truth" in the broader sense for this submission is derived from the established performance and safety of the predicate devices and the robust mechanical testing standards it adheres to.

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The GLADIATOR® Plasma Classic Hip Stem is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Indications for Use:

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

GLADIATOR® Plasma Classic Hip Stems are intended for use during uncemented hip arthroplasty.

The GLADIATOR® Plasma Classic Hip Stem is a straight uncemented stem, and features a rectangular cross-section, proximally a trapezoidal section manufactured from base material of Titanium alloy (Ti6Al4V - ASTM F620, equivalent to ISO 5832-3). The profile tapers vertically both in frontal and lateral view, to achieve fixation stability in three planes. The stem possesses a 0.5mm thick titanium plasma spray coating on the proximal third of the stem surface, conforming to ASTM F1580. The stem length ranges from 125 mm in length, is available in 10 sizes (1-10), and features 0.5mm thick titanium plasma spray on the proximal third of the stem surface. The stem is available in standard and extended neck offsets.

The provided text describes a 510(k) premarket notification for the GLADIATOR® Plasma Classic Hip Stem. This submission aims to demonstrate substantial equivalence to existing predicate devices, not to prove the device meets specific acceptance criteria through a clinical study in the way a new drug or high-risk medical device might.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not specify a "test set" in the context of clinical data for the new device. The testing mentioned in the nonclinical section (fatigue and range of motion) would typically involve a small number of physical samples of the device components, rather than patient data. The document does not provide the number of samples used for these nonclinical tests.
• Data Provenance: The data provided is purely nonclinical (mechanical testing). Therefore, there is no country of origin for patient data and it is not retrospective or prospective clinical data.

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

• Not applicable. This is not a clinical study involving diagnosis or outcome assessment where expert consensus on "ground truth" would be established. The "ground truth" for the nonclinical tests would be the predetermined international standards (ISO 7206, ISO 21535) and the results of the physical tests against these standards.

4. Adjudication Method for the Test Set:

• Not applicable. There is no "test set" in the clinical sense requiring an adjudication method. The nonclinical tests follow established international standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data was not provided for the class III hip stem." This indicates that no human factors or reader performance studies were conducted.

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

• Not applicable. This device is a physical hip stem, not an algorithm or AI product.

7. The Type of Ground Truth Used:

• For the nonclinical tests, the "ground truth" is the compliance with established international standards (ISO 7206 series for fatigue and ISO 21535 for range of motion). These standards define acceptable performance parameters for hip joint prostheses.

8. The Sample Size for the Training Set:

• Not applicable. There is no training set in the context of a machine learning model or clinical trial for this device. The "training" for this type of device involves engineering design, material selection, and manufacturing processes guided by established engineering principles and prior knowledge from predicate devices.

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

• Not applicable. As there's no training set for a data-driven model, there's no ground truth to establish for it. The underlying "ground truth" for the device's design and manufacturing is the body of medical engineering knowledge, regulatory requirements, and the successful performance history of its predicate devices.

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The GLADIATOR™ Bipolar System is indicated for the following conditions:

• 1. pathological fractures of the femoral neck
• 2. non-union of femoral neck fractures
• 3. aseptic necrosis of the femoral head and neck
• 4. primary pathology in the young involving the femoral head but with a non-deformed acetabulum.

The design features of the GLADIATOR™ Bipolar System are summarized below:

• . Shells manufactured from cast CoCr allov
• . Shells available in O.D. sizes 36-65mm
• . Bearing insert manufactured from cross-linked UHMWPE
• Bearing insert available in I.D. (femoral head) sizes 22, 28, 32, 36mm .
• Locking and support rings manufactured from UHMWPE .
• All components permanently assembled during production .

The provided document is a 510(k) summary for the GLADIATOR™ Bipolar System, a Class II medical device. However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of performance metrics (like sensitivity, specificity, accuracy, etc.) typically associated with AI/software devices.

Instead, this 510(k) focuses on demonstrating substantial equivalence to existing predicate devices. This means the manufacturer is asserting that their device is as safe and effective as a legally marketed device that does not require premarket approval (PMA).

Here's why the requested information is absent and what the document does provide:

• Type of Device: The GLADIATOR™ Bipolar System is a hip prosthesis, a physical implant. The questions you've asked are most relevant to software-as-a-medical-device (SaMD) or AI-powered diagnostic/prognostic devices, which rely on data analysis for performance measurement.
• Regulatory Pathway: The 510(k) pathway for substantial equivalence does not typically require the type of clinical performance study to establish specific numerical acceptance criteria (e.g., sensitivity, specificity) for a physical implant device in the same way it would for a diagnostic algorithm. Instead, it relies on demonstrating similar design features, materials, and intended use as a predicate device, along with verification and validation (V&V) testing to ensure the device performs as intended and is safe. The document states, "The indications for use of the GLADIATOR™ Bipolar System are identical to the previously cleared predicate device. The design features and materials of the subject device are substantially equivalent to those of the respective predicate devices. The fundamental scientific technology of the modified device has not changed relative to the predicate devices."

Therefore, I cannot populate the requested table or answer the specific questions about sample size, expert ground truth, adjudication methods, MRMC studies, or standalone performance for an AI/software device, as this information is not present in the provided submission for a physical hip implant.

What the document does confirm is that the GLADIATOR™ Bipolar System was deemed "substantially equivalent" to a legally marketed predicate device by the FDA (K062693). This regulatory determination is the primary "acceptance criterion" for this type of device and submission.

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