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The indications for the Trinity™ EVO Acetabular Shell as a total hip arthroplasty include:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• Rheumatoid arthritis.
• Correction of functional deformity.
• Developmental dysplasia of the hip (DDH)/Congenital dislocation of the hip (CDH)

The Trinity™ EVO acetabular shell is also indicated for use in revisions of a previously failed total hip arthroplasty.

The Trinity™ EVO Acetabular Shell is indicated for cementless use only.

The Trinity™ EVO acetabular shell forms part of a modular acetabular system. The Trinity™ EVO acetabular shell is a hemispherical press fit titanium alloy shell for use with cobalt chrome alloy (Trinity™ Dual Mobility only) or polyethylene liners and a dedicated range of ceramic and cobalt chrome alloy modular 12/14 taper femoral heads providing ceramic on polyethylene and metal on polyethylene articulations for use in total hip arthroplasty (THA) procedures using Corin metal stems with a 12/14 taper connection. The Trinity™ EVO acetabular shell has a porous structure manufactured from titanium alloy powder, produced via additive manufacturing using Laser Powder Bed Fusion (LPBF), and is available with or without an additional layer of electrochemically deposited calcium phosphate. The Trinity™ EVO acetabular shell is provided in sizes permitting the use of titanium bone screws to provide additional fixation, if required. The Trinity™ EVO acetabular shell is also available without screw holes. A titanium occluder is provided to occlude the apical introducer hole.

The Trinity™ EVO acetabular shell is intended for use in primary and revision THA in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged hip joint articulation when there is evidence of sufficient sound bone to seat and support the components.

The provided document is a 510(k) Clearance Letter for the Trinity EVO Acetabular Shell. This type of submission focuses on demonstrating substantial equivalence to a previously cleared device, not necessarily proving clinical efficacy through a direct comparative study like a Multi-Reader Multi-Case (MRMC) study for an AI-powered diagnostic device.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical performance testing conducted to show that the new device performs as safely and effectively as its predicate devices, rather than a clinical trial with human readers.

Here's a breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the standards and internal protocols cited for the non-clinical testing. The device is deemed to meet these criteria if the test results demonstrate comparable or acceptable performance to the predicate devices. The document states: "The results of this testing show that the Trinity™ EVO Acetabular Shell is substantially equivalent to the predicate devices."

Table of Acceptance Criteria and Reported Device Performance:

Study Information Specific to the Device Clearance (non-clinical)

The information provided in the 510(k) summary focuses on non-clinical testing. Questions related to "test set," "data provenance," "experts," "adjudication," "MRMC studies," "standalone algorithm performance," and "ground truth" are not applicable in the context of this specific regulatory submission as it's for a physical orthopedic implant, not a diagnostic AI software.

However, based on the general structure, here's what can be inferred or stated as "Not Applicable" for this type of device:

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

   • Test Set Sample Size: For mechanical testing, the "sample size" refers to the number of physical devices or representative specimens tested per condition, as per the respective ASTM/ISO standards. This specific number is not disclosed in the provided summary but would be detailed in the full submission.
   • Data Provenance: The data provenance is from the manufacturing and testing facility of Corin USA Limited, a medical device manufacturer. The tests are "non-clinical" and conducted on physical prototypes/products.

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

   • Not Applicable. This is a physical device, and "ground truth" is established by physical measurements and performance against established engineering standards and specifications, not expert interpretation of medical images or clinical outcomes in a diagnostic context. The "experts" involved would be engineers, materials scientists, and quality assurance personnel.

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

   • Not Applicable. Adjudication relates to resolving discrepancies in expert interpretations, which is relevant for diagnostic studies, not mechanical testing. Test results are objective measurements compared against predefined limits.

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

   • No. An MRMC study is relevant for evaluating the impact of AI algorithms on human reader performance in diagnostic tasks. This device is a passive, physical implant.

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

   • Not Applicable. This is a physical orthopedic implant, not a software algorithm.

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

   • Engineering Standards and Specifications. The "ground truth" for the device's performance is defined by established international standards (ASTM, ISO) and internal engineering design specifications that ensure the device's mechanical integrity, biocompatibility, and functional characteristics are met.

7. The sample size for the training set:

   • Not Applicable. This is a physical device, not an AI/ML algorithm that requires a "training set." The design and manufacturing processes are refined through engineering development and quality control, not machine learning.

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

   • Not Applicable. (See point 7).

In summary, the 510(k) for the Trinity EVO Acetabular Shell demonstrates "substantial equivalence" based on extensive non-clinical (mechanical, materials, and physical) testing to established engineering standards, asserting that it performs as safely and effectively as its predicate devices, rather than through clinical studies involving human readers or AI algorithms.

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The Trinity Plus Wrinkle Reducer is an over-the-counter hand-held for reduction of full-face fine lines and wrinkles, and increase in local circulation within the perioral region.

The Trinity Plus Wrinkle Reducer (hereinafter referred to as "TWR Plus") comprises the TWR Plus main body, a TWR Plus light attachment head, a charging cradle, and a wall-mount power adaptor. The device and all its associated components are reusable and provided non-sterile.

The TWR Plus is a hand-held phototherapy device that emits Red and Infrared (IR) light energy in the 605, 630, 645, 660 and 855 nanometer wavelengths via a light attachment head. The light attachment head comprises (34) Light Emitting Diodes (LED's) which are the source of the light energy. The Red and IR light energy is used in the treatment of fine lines and wrinkles around eyes, mouth, and forehead and promotes local blood circulation.

The subject device includes three indicator LED's, one internal speaker and one vibration motor. These features provide visual, audible, and haptic feedback to the user during normal operation. The light attachment head includes a proximity sensor to detect when device is pressed onto the skin.

The subject device is turned on and turned off via a dedicated ON/OFF button. Once the subject device is ON, the user follows the provided Instructions for Use to start the treatment. The ON/OFF button also serves as a multi-function User Interface (UI) button by allowing the User to control other functions while the subject device is in Standby, Treating, Charging or Sleep modes. A long press of approximately one second on the ON/OFF button can stop treatment at any time.

Upon power up, the three indicator lights turn on and an ascending audible beep is emitted notifying the user that the device is ON. Once the device is ON, the light therapy LEDs are set to a visible, but significantly dimmed non-treatment state. As the device is placed in direct contact with the skin, the proximity sensor will turn the light therapy LEDs on to start the treatment. While in treatment, if the device is moved away from the skin, the device emits three beeps, and the LEDs revert to the significantly dimmed non-treatment state. The device also emits two beeps to inform the user when a treatment interval is complete and that it is time to treat another section of skin. The device automatically Shuts OFF after 24 minutes of use to indicate the treatment is complete.

The device is powered by one internal rechargeable, non-removable battery which is charged via a provided wireless charging cradle. The charging cradle is powered by a pre-approved wall-mount power supply. The light energy output power is zero watts while the device is in the charging cradle or when turned off. All charging circuitry is contained within the handheld unit itself.

The housings of TWR Plus main body, the light attachment head and the charging cradle are made from injection molded thermoplastic resins. The light attachment head, which is intended to come in contact with the skin, is made from a biocompatible polymer material. The TWR Plus, including the light attachment head, measures 5.4" H x 2.6" W x 1.7" D and weighs 7.8 oz. The charging cradle measures 2.3" H x 3.0" W x 2.7" D and weighs 7.30 oz.

The TWR Plus uses Bluetooth Low Energy (BLE) wireless technology to pair to and connect with compatible devices capable of running the NuFACE® App. The NuFACE® App allows the user to select and run pre-programmed treatment profiles stored in the device.

Device component list:

• 1 x TWR Plus Main Body
• 1 x TWR Plus Light Attachment Head
• 1 x Wireless Charging Cradle
• 1 x Pre-approved wall-mount power adaptor

The provided text is a 510(k) Summary for the NuFACE® Trinity Plus Wrinkle Reducer. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving the detailed performance metrics through rigorous clinical studies often associated with novel or high-risk devices. As such, the information typically requested in your prompt (e.g., acceptance criteria for clinical performance, sample sizes for test sets, expert qualifications, MRMC studies, specific ground truth types) is largely absent because it was not required for this type of submission.

Here's an analysis based on the provided document:

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

The document does not provide a specific table of acceptance criteria for clinical performance (e.g., specific percentage reduction of wrinkles, or circulation increase metrics) nor does it report device performance in those terms. Instead, the "acceptance criteria" for a 510(k) are typically met by demonstrating that the new device is as safe and effective as a predicate device.

The reported "performance" is concluded through:

• Biocompatibility Evaluation: The materials (ABS Thermoplastic and a Polymer for the lens) were deemed biocompatible for surface device, intact skin, limited (<24h) duration contact. Specific performance metrics are not given, only the conclusion of biocompatibility.
• Safety, Performance and Bench Testing (Optical Safety, Electrical Safety, EMC, Wireless Coexistence): The conclusion is that the device "meets and complies with the safety and performance of the applicable standards and bench testing requirements." No specific quantitative results or acceptance thresholds are provided in this summary.
• Software Verification and Validation: Concluded that the device "meets and complies with the applicable software requirements specifications." No detailed performance metrics are given.

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

• Test Set Sample Size: No information on a "test set" in the context of clinical performance is provided because no clinical testing was performed or deemed necessary to support substantial equivalence.
• Data Provenance: Not applicable as no clinical data for performance assessment (wrinkle reduction/circulation increase) was collected for this submission. The non-clinical testing data provenance is not specified (e.g., in-house labs, certified external labs).

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 "ground truth" establishment was performed or reported for this 510(k) submission.

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

Not applicable. No clinical test set requiring adjudication was performed.

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 device is a direct-to-consumer medical device for wrinkle reduction and local circulation increase, not an AI-assisted diagnostic or interpretative system that would involve human "readers" or MRMC studies.

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

This concept is not relevant to the device described. The device is a physical light therapy device, not an algorithm. Its performance is measured by its physical output and safety, and by comparing its technological characteristics to a predicate device, not by an algorithm's classification performance.

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

Not applicable for clinical performance. For the non-clinical tests (biocompatibility, electrical/optical safety, EMC, software), the "ground truth" is adherence to established industry standards and internal design specifications.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable.

Summary of Device Performance and 510(k) Claims:

The 510(k) submission for the Trinity Plus Wrinkle Reducer relies on demonstrating substantial equivalence to existing predicate devices (NuFACE® Trinity Wrinkle Remover K120560 and reVive Perioral LED Light Therapy System K172662). This regulatory pathway often does not require new clinical studies if the technological characteristics and indications for use are similar to a predicate device that has already established its safety and effectiveness.

The "study that proves the device meets the acceptance criteria" in this context is the compilation of non-clinical performance data and the comparison to predicate devices:

• Biocompatibility Evaluation: Concluded the materials are biocompatible based on industry standards and prior use in other FDA-cleared devices.
• Safety, Performance and Bench Testing (Optical Safety, Electrical Safety, EMC, Wireless Coexistence): Concluded compliance with applicable standards.
• Software Verification and Validation: Concluded compliance with software requirements.

The core argument for acceptance is presented in Section 8, "Overall Conclusion":
"The documentation and test results provided in this submission and comparison of intended use, principle of operation, performance data, design and the overall technological characteristics, demonstrate that the NuFACE® Trinity Plus Wrinkle Reducer device is substantially equivalent to the predicate device."

Therefore, the "acceptance criteria" here relate to meeting the necessary non-clinical standards and successfully demonstrating equivalence to a predicate, rather than achieving specific performance thresholds in a de novo clinical trial.

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The Trinity ELE Plus and Trinity ELE Plus Pro devices are intended for facial stimulation and are indicated for over-the counter cosmetic use.

The Trinity ELE Plus comprises the Trinity ELE Plus device main body, a Trinity ELE Plus microcurrent attachment head, a charging cradle, and a wall-mount power adaptor. A tube of NuFACE® Gel Primer is provided with the subject device as an accessory. The subject device and all its associated components and accessories are reusable and provided non-sterile.

The Trinity ELE Plus is a hand-held device that produces low levels of microcurrent which is discharged through two dual chrome-plated precise wands for aesthetic purposes. The device provides audible feedback to inform the user to relocate the device to treat a new location on the skin. The device also includes "hum" features to guide the user during the treatment cycle.

The subject device is powered by one internal rechargeable, non-removable battery which is charged via a provided wireless charging cradle. The charging cradle connects to a provided wall-mount power adaptor. Microcurrent output is cut-off while the device is sitting on the charging cradle either charging the battery or when the battery is fully charged.

The enclosures of the subject device main body, the attachment head and the charging cradle are made from injection molded ABS thermoplastic material. The same ABS material is used in other FDA-cleared devices. The dual chrome-plated precise wands on the attachment head use chromium. The same chromium material is used in the predicate device dual chrome-plated precise wands.

The subject device, including the attachment head, measures 6.1" H x 2.4" W x 1.2" D. The charging cradle measures 2.3" H x 3.0" W x 2.7" D.

The device includes an 'ON/OFF' multi-function button to turn the device on and off, start and stop treatment, increase or decrease the microcurrent output level and pair with a smart device. The device also includes a "BOOST" button that temporarily increases the microcurrent output level.

The device includes indicator LED's to provide information to the user on the status of the device and the progress of the treatment.

The subject device is the capable of pairing with compatible smart devices using Bluetooth Low Energy (BLE) wireless communications technology. This technology allows the subject device to communicate with other devices running the NūFACE® App which allows the user to select and run pre-programmed treatment profiles.

The Trinity ELE Plus provides microcurrent output at selected frequencies from 0.3 to 50 Hz.

The Trinity ELE Plus is available in two models, a Standard model and a 'Pro'' model. The Trinity ELE Plus Standard model has a maximum output current without Boost of 170 uA, and the Trinity ELE Plus Pro model has a maximum output current without Boost of 200 uA. All other aspects of the Trinity ELE Plus except those related to maximum output current, are the same between the Standard model and Pro models.

I regret to inform you that the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

The document is a 510(k) premarket notification for the Trinity ELE Plus and Trinity ELE Plus Pro devices. It focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing and proving new acceptance criteria for the subject device itself.

Here's a breakdown of what the document does include and why it doesn't answer your specific questions:

• Indications for Use: The devices are intended for "facial stimulation" and are indicated for "over-the-counter cosmetic use."
• Technological Characteristics Comparison: There are tables comparing the subject device's features (Type of Energy Output, Energy Delivery, Energy Flow, Energy Output, Microcurrent Boost, Energy Power Source, Power Accessories, Charging Method, Charging Circuitry, Power Supply Type, Special Requirements, Wireless Technology, Output Frequency) and output specifications (Waveform Type, Shape, Max Output Voltage, Max Output Current, Output Tolerance, Pulse Period, Output Frequency, Beat Frequency, Symmetrical Phases, Phase Duration, Net Charge, Max Phase Charge, Max Current Density, Max Power Density, Burst mode information, ON time, OFF time) to those of a predicate device. Many of these are listed as "Same" or "Different," with explanations for why the "Different" aspects do not affect safety and effectiveness.
• Non-Clinical Performance Data:
  • Biocompatibility Evaluation: This describes the materials used and concludes they are biocompatible based on their use in other FDA-cleared devices or the predicate device.
  • Safety, Performance, and Bench Testing: This section states that EMC, Wireless Coexistence, and bench testing concluded the device "meets and complies with the safety and performance of the applicable standards and bench testing requirements." However, it does not list specific acceptance criteria for these tests or provide detailed results. It also mentions electrical safety tests are "currently being conducted and will be provided to the FDA before the subject device is released to market."
  • Software Verification and Validation: This states the software "meets and complies with the applicable software requirements specifications" but does not detail those specifications or acceptance criteria.
• No Animal Testing or Clinical Testing: The document explicitly states that substantial equivalence is not supported by animal or clinical testing.

Therefore, I cannot provide the requested table or answer the questions because the necessary data (specific acceptance criteria, detailed study results proving these criteria are met, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC study details) is not present in the provided text. The document focuses on demonstrating that the new device is substantially equivalent to a previously cleared device, not on proving its independent performance against new, explicit acceptance criteria.

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The indications for the Corin Trinity™ PLUS Acetabular Shell as a total hip arthroplasty include:
o Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
o Rheumatoid arthritis,
o Correction of functional deformity,
o Revision of previously failed total hip arthroplasty
o Developmental dysplasia of the hip (DDH),
The Trinity™ PLUS Acetabular Shell is indicated for cementless use only.

The Trinity™ PLUS Acetabular Shell is a component of a modular cup system consisting of a hemispherical press fit, titanium alloy shell for use with cobalt chrome alloy (Dual Mobility articulations only) or polyethylene liners and a dedicated range of ceramic and cobalt chrome alloy modular 12/14 taper femoral heads providing ceramic on polyethylene and metal on polyethylene articulations for use in total hip replacement procedures using any Corin femoral stem with a 12/14 taper connection. The acetabular shell has an outer porous structure produced by additive manufacturing using titanium alloy powder (ASTM F3001). The shell is available with or without a layer of electrochemically deposited biomimetic calcium phosphate coating. The Trinity™ PLUS acetabular shell is available with or without screw holes which permit the use of dedicated titanium screws to provide additional fixation if required.

The provided text describes a 510(k) premarket notification for a hip implant device, the Corin Trinity™ PLUS Acetabular Shell. The notification focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than proving that the device meets specific acceptance criteria based on a study of its performance in a clinical setting against defined metrics.

Therefore, many of the requested categories (acceptance criteria, reported device performance, sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, ground truth type, training set size, how ground truth for training set was established) are not applicable to this type of submission.

Here's a breakdown based on the information available:

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

This information is not provided in the document as this is a 510(k) submission for substantial equivalence, not a clinical trial report with performance metrics. The "acceptance criteria" here are essentially proving the device is as safe and effective as predicate devices. The document details non-clinical testing to demonstrate this.

Non-Clinical Testing Conducted to Demonstrate Substantial Equivalence:

Conclusion from Non-Clinical Testing: The culmination of the results of the mechanical testing, characterization, and animal data indicate that the devices perform within their intended use and are substantially equivalent to the predicate devices.

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 for this 510(k) submission, as it relies on non-clinical testing and comparison to predicates, not a clinical test set with human subjects. The non-clinical tests would have their own sample sizes for mechanical specimens, but these are not specified in the document.

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

Not Applicable. Ground truth, in the context of clinical studies, is not established for this type of submission. The "ground truth" for a 510(k) is the performance and safety profile of the predicate devices.

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

Not Applicable. There is no clinical test set requiring adjudication in this 510(k) submission.

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 medical device for total hip arthroplasty, not an AI-assisted diagnostic or imaging device for human readers. No MRMC study was conducted.

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

Not Applicable. This is a physical implantable device, not a software algorithm.

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

Not Applicable in the traditional sense of a clinical study. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices, which the new device is being compared against.

8. The sample size for the training set:

Not Applicable. There is no "training set" in the context of a clinical study for this 510(k) submission. Non-clinical tests were performed on device samples.

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

Not Applicable. As there is no training set, there's no ground truth to establish for it in this context.

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The Trinity™ Dual Mobility System is intended for use in the following indications:

• 1. Non-inflammatory degenerative joint disease, including osteoarthritis & avascular necrosis
• 2. Rheumatoid Arthritis
• 3. Correction of functional deformity
• 4. Revision of previously failed total hip arthroplasty,
• 5. Patients at increased risk of dislocation
• 6. Developmental dysplasia of the hip (DDH)

The TrinityTM Dual Mobility System is indicated for cementless use only.

The Trinity™ Dual Mobility System is a modular system consisting of two articulating surfaces in the same joint space. The system includes a highly polished Cobalt Chromium Alloy (CoCr) liner that articulates with an ECiMa™ (Vitamin E Ultra-High-Molecular-Weight Polyethylene) mobile insert. A Trinity™ femoral head, 22mm or 28mm CoCr or 28mm BIOLOX® delta heads, articulates within the ECiMa™ mobile insert to allow for a second articulation. The Trinity™ Dual Mobility System is intended to be used only with compatible Trinity™ acetabular Shells. The Trinity™ Dual Mobility System is designed for use with any Corin femoral stem with a 12/14 taper connection. The Trinity™ Dual Mobility System is intended for use in primary and revision total hip arthroplasty (THA) to provide increased stability and reduce pain by replacing the hip joint articulation where there is evidence of sufficient sound bone to seat and support the components.

The Trinity™ Dual Mobility System is intended to be used with the following approved devices:

• Trinity™ Acetabular Shells (Sizes 2- 5) (K093472, K123705, K122305, K130128) .
• 28mm CoCr heads (K110087, K131647) .
• . 28mm BIOLOX® delta Ceramic Heads (K103120)

This document is a 510(k) premarket notification for a medical device called the "Trinity Dual Mobility System," which is a hip prosthesis. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy in a de novo manner. Therefore, the information provided does not detail an acceptance criteria table or a study proving the device meets an algorithm's acceptance criteria in the way one might expect for a digital health or AI-driven device.

Based on the provided text, here's an analysis of the "acceptance criteria" and "study" that relate to this medical device:

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

The document does not present a formal table of acceptance criteria with specific numerical targets for performance in the context of an algorithm or diagnostic accuracy. Instead, the "acceptance criteria" for this device's FDA clearance revolved around demonstrating substantial equivalence to existing predicate devices through non-clinical testing.

The acceptance criteria are implied by the types of non-clinical tests performed and their successful outcomes, which showed the device is "expected to be safe and effective."

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

For this type of device (hip prosthesis), the "test set" refers to the physical prototypes and materials subjected to non-clinical mechanical and biological testing.

• Sample Size: The document does not specify the exact sample size for each non-clinical test (e.g., how many liners were subjected to wear testing or how many components to push-out tests). This level of detail is typically found in the full test reports, not the 510(k) summary.
• Data Provenance: The tests were conducted to evaluate the device itself. There's no "country of origin for data" in the sense of patient data. The tests would have been performed in a laboratory setting, likely in the country of manufacture or a certified testing facility.

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):

This question is not applicable to a physical medical device like a hip prosthesis in the context of its 510(k) submission for substantial equivalence. "Ground truth" and "experts" in this sense typically refer to the validation of diagnostic accuracy for software or imaging devices. For this device, standard engineering and materials science testing methods are used, and the "ground truth" is established by adherence to recognized ASTM or ISO testing standards. The experts involved would be qualified engineers and scientists in fields such as mechanical engineering, materials science, and biocompatibility testing. Their qualifications are not specified in this summary.

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

Not applicable. Adjudication methods like "2+1" are used in studies involving human interpretation (e.g., radiologists reviewing images) to resolve discrepancies. The non-clinical tests for this device involve objective measurements against predetermined acceptance limits based on engineering standards.

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

Not applicable. MRMC studies are associated with the evaluation of diagnostic performance for imaging systems or AI algorithms where human interpretation plays a role. This document concerns a physical implant.

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

Not applicable. This device is not an algorithm.

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

The "ground truth" for the non-clinical testing of this device is established by:

• Engineering Standards: Compliance with industry-recognized ASTM, ISO, or other relevant standards for mechanical strength, wear, corrosion, and material properties.
• Predicate Device Performance: The performance characteristics of the legally marketed predicate devices serve as an established baseline that the new device must meet or exceed to demonstrate substantial equivalence.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of a physical hip prosthesis device or its 510(k) clearance process. This terminology applies to machine learning algorithms.

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

Not applicable. As there is no training set, there is no ground truth for it.

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Ultrasound System TRINITY and its embedded 3D PROSTATE SUITE software are intended to be used by clinicians and their assistants. qualified to perform ultrasound diagnosis and ultrasound-guided procedures, in public or private hospitals. TRINITY is indicated to: · Generate ultrasound images for structural analysis and fluid flow analysis for o urology, o gynecology, o vascular. o abdominal, o small organs. o soft tissues and o musculoskeletal exams TRINITY is not indicated for ophthalmic and cranial ultrasonography. Medical Imaging Processing System 3D-PROSTATE SUITE, embedded on TRINITY or other KOELIS systems that do not integrate a 3D ultrasound module, is indicated to: · Process, visualize and record various 2D and 3D image modalities (such as Ultrasound images, MRI) · Fuse images of various modalities · Display organ and perform measurements · Display cartographies of prostate interventions (instrument positions) · Manage patient data · Import and export of data and images

TRINITY is an electro medical system considered as a system composed of: - A mobile workstation composed by a central unit with ultrasound beamformer, a tactile ● screen, a mouse, a touch pen and a footswitch, all assembled on a mobile cart. Options, as keyboard and trackball mouse, can be delivered. - 0 Ultrasonic probe: 2D/3D end-fire endocavity probe and/or 2D/3D side-fire endocavity probe. 2D probes can be optionally delivered. - 3D PROSTATE SUITE software composed of the base software and PROMAP –Ty that drives the 0 ultrasound module and performs additional measuring functions. The system generates ultrasound waves in the low megahertz range, typically from 1 Mhz to 20 Mhz. Two main ultrasound modes are provided by the system: B-mode imaging for structural analysis and Doppler imaging (including color flow sub-mode and power sub-mode) for body fluid flow analysis. - B-mode imaging measures the time and waveform differences between wave emission and o wave reception to reconstruct an image. - 0 Doppler imaging uses in addition the Doppler Effect to show flow direction and to inform about relative velocity (no measurement) (color flow sub-mode) or to show flow strength (power sub-mode). The system also provides 3D B-mode imaging for high quality ultrasound acquisition of anatomical volumes. The technology employed is volume-swept 3D ultrasound.

This document is a 510(k) Summary for the KOELIS TRINITY / 3D PROSTATE SUITE device. It establishes substantial equivalence to previously cleared devices rather than providing performance data against specific acceptance criteria for new features or AI-driven improvements. As such, it does not contain the detailed study information typically associated with proving a device meets acceptance criteria for novel algorithms, especially those involving AI.

Therefore, many of the requested fields cannot be directly populated from the provided text. The device is primarily an ultrasound system with associated software for processing and visualizing images, and the application focuses on expanding its indications for use and adding a new probe. The "Summary of Clinical Tests" explicitly states: "The subject of this premarket submission did not require clinical studies to support substantial equivalence."

Based on the provided text, here's an attempt to answer the questions:

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

The document does not provide a table of acceptance criteria with reported quantitative performance metrics for the TRINITY / 3D PROSTATE SUITE in the context of novel algorithmic performance or AI. The acceptance is based on demonstrating substantial equivalence to existing predicate devices for similar clinical applications and modalities, and compliance with various safety and performance standards.

The criteria for acceptance appear to be:

• Substantial Equivalence: Demonstrated through comparison of intended use, imaging capabilities, technological characteristics, scientific backgrounds, safety, and effectiveness to predicate devices (K160357 TRINITY and K160182 Logiq S7 expert).
• Safety Standards Compliance: Meeting voluntary standards for acoustic output, biocompatibility, cleaning/disinfection, thermal, electromagnetic, and mechanical safety (e.g., AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971, NEMA DICOM Set).
• Quality Assurance Measures: Application of risk analysis, requirements reviews, design reviews, varying levels of testing (unit, integration, final acceptance, performance, safety).

Since no new algorithmic performance (e.g., AI accuracy) is being claimed or evaluated, there are no reported quantitative performance metrics against these criteria beyond the statement that the device is "as safe, as effective, and performance is substantially equivalent to the predicate devices."

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

As stated, "The subject of this premarket submission did not require clinical studies to support substantial equivalence." Therefore, there is no clinical "test set" with patient data in the typical sense for evaluating a novel algorithm's performance. The "testing" referred to is against engineering and safety standards, not clinical performance on a dataset of images with ground truth.

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

Not applicable, as no clinical test set with ground truth established by experts for algorithmic performance evaluation was described as part of this submission.

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

Not applicable.

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 such study was conducted or reported in this 510(k) summary. The device's substantial equivalence is based on its core functionality as an ultrasound system and imaging processing system, not on AI assistance to human readers.

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

This is not an AI-driven diagnostic algorithm. It's an imaging system and processing software. Therefore, the concept of "standalone performance" for an AI algorithm is not applicable here. The system's performance is intrinsically tied to its ability to generate, process, and display images for human interpretation and procedures.

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

Not applicable, as no clinical performance study involving ground truth for an algorithm was conducted.

8. The sample size for the training set

Not applicable, as this is not an AI/ML submission describing a model trained on a dataset.

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

Not applicable.

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TRINITY® Ultrasound and Medical Imaging Processing System is intended to be used by clinicians and their assistants.

The device is indicated to generate, visualize and record 2D and 3D ultrasound images.

In the particular context of prostate biopsy, the device embedding the 3D PROSTATE SUITE SOFTWARE is indicated to process, visualize and record 3D digital ultrasound images in a view to map the organ.

Additional features include 2D/3D image and organ display, measurement, data management, multimodal image fusion (ultrasound, MRI, etc.).

Patient population: all patients requiring an ultrasound scan or ultrasound-based intervention particularly in urology.

TRINITY is an electro medical system considered as a system composed of:

• A mobile workstation composed by a central unit with ultrasound beamformer, a tactile . screen, a mouse, a touch pen and a footswitch. All these components are assembled on a mobile cart. Optionally a keyboard can be delivered and a trackball mouse can be delivered instead of the mouse.
• Ultrasonic probe: 2D/3D end-fire endocavity probe. Optionally 2D probes can be delivered: linear probe and abdominal probe.
• 3D PROSTATE SUITE PROMAP software composed of the base software and PROMAP –Ty that drives the ultrasound module and perform additional measuring functions.

The system generates ultrasound waves in the low megahertz range, typically from 1 Mhz to 20 Mhz.

Two main ultrasound modes are provided by the system: B-mode imaging for structural analysis and Doppler imaging for body fluid flow analysis.

• B-mode imaging measures the time and waveform differences between wave emission and . wave reception to reconstruct an image.
• . Doppler imaging uses in addition the Doppler Effect to show flow direction and to inform about relative velocity (no measurement).

The system also provides 3D B-mode imaging for high quality ultrasound acquisition of anatomical volumes. The technology employed is volume-swept 3D ultrasound.

The clinician can control acoustic output intensity with the TI and MI indices provided by the system. They indicate the level of thermal and mechanical stress that the system causes to the tissues, allowing the clinician to apply an ALARA-principle based exposure reduction strategy.

This document is a 510(k) Premarket Notification from the FDA regarding the TRINITY Ultrasound and Medical Imaging Processing System. While it provides detailed information about the device's intended use, technological characteristics, and compliance with safety standards, it explicitly states that "The subject of this premarket submission did not require clinical studies to support substantial equivalence."

Therefore, I cannot provide information regarding acceptance criteria and a study proving the device meets those criteria because a clinical study was not performed as part of this submission. The submission relies on demonstrating substantial equivalence to predicate devices, not on a new clinical study.

Here's what can be inferred from the document regarding the information requested, based on the absence of a clinical study:

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

• This information is not provided because no clinical study was conducted. The document focuses on demonstrating equivalence to predicate devices based on technical specifications and non-clinical tests.

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

• Not applicable, as no clinical test set was used for a study proving device performance.

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

• Not applicable, as no clinical test set requiring ground truth was used for a study proving device performance.

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

• Not applicable, as no clinical test set requiring adjudication was used for a study proving device performance.

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. No MRMC study was performed. The device is an ultrasound system and processing software, not an AI-assisted diagnostic tool in the typical sense that would necessitate an MRMC study comparing human readers with and without AI assistance for a specific clinical task.

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

• Not applicable. The TRINITY system is an ultrasound and medical imaging processing system intended to be used by clinicians. It is not an algorithm-only standalone diagnostic tool. Its performance is inherent to the generation, visualization, and recording of ultrasound images, and processing of 3D digital ultrasound images for tasks like organ mapping (with the 3D PROSTATE SUITE SOFTWARE).

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

• Not applicable, as no clinical study required establishing ground truth for performance evaluation of "new" clinical results.

8. The sample size for the training set:

• Not applicable, as no clinical study with a training set was performed for this submission. The device leverages existing technology and previously cleared software (UROSTATION - 3D PROSTATE SUITE, K131448).

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

• Not applicable, as no clinical study with a training set was performed for this submission.

Summary from the document:

• Basis for Approval: Substantial equivalence to predicate devices (LOGIQ S7 Expert and LOGIQ S7 Pro (GE Healthcare) K141261, and UROSTATION - 3D PROSTATE SUITE (KOELIS) K131448).
• Non-Clinical Tests: Acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety were evaluated and found compliant with applicable medical device safety standards (e.g., AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971, NEMA DICOM Set).
• Clinical Studies: None were required or performed for this premarket submission to support substantial equivalence.

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The Trinity ELE is intended for facial stimulation and is indicated for over-the-counter cosmetic use. (21 CFR 801 Subpart C).
The Trinity ELE is intended for facial stimulation and is indicated for over-the-counter cosmetic use (21 CFR 807 Subpart C).

The Trinity ELE is a non-invasive at home, over-the-counter facial stimulation device. The dual spheres of the Trinity ELE are designed for optimal contact with smaller surface areas of the face. The Trinity ELE is extremely responsive as it delivers soft wave micro-current in the millionths of an ampere and has the ability to increase facial contour and firm the skin and muscles. The Trinity ELE continually alternates between the positive and negative probes, and allows the user to adjust settings from approximately 53 to 192 microamps for a personalized comfort level.
The Trinity ELE measures 2.8" W x 6.2" L x 1.3" D. Its outer case is injection molded of thermoplastic resin. The device comes with a Charging Cradle, which measures 3.1" W x 4.0" L x 3.3" D, to charge the internal batteries of the main body when not in use. The Charging Cradle is powered by DC power from a pre-approved wall adapter Power Supply provided with the device. All charging circuitry is contained within the main body unit itself.
An ascending sequence of beeps informs the customer the Trinity ELE is ready for use. When the user turns off the device, a descending tone is emitted.
To promote proper use, a single audio beep informs the user to relocate the device to treat a new location on the skin. The user can also adjust output by pressing the + or - intensity buttons to increase or decrease the micro-current output.

The provided text is a 510(k) summary for the Trinity ELE Device, which is a facial stimulation device. The document primarily focuses on establishing substantial equivalence to a predicate device (NuFACE® Trinity) through a comparison of technological characteristics and output specifications. It does not describe a clinical study or performance data against specific acceptance criteria for efficacy in the same way a diagnostic or therapeutic device might.

Instead, the "acceptance criteria" here are based on demonstrating that the new device (Trinity ELE) is substantially equivalent to a previously cleared device (NuFACE® Trinity), meaning it is as safe and effective. The study that proves this is a non-clinical performance assessment, specifically a direct comparison of the electrical output characteristics of the new device to the predicate device.

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

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

Since this is a substantial equivalence submission based on technical characteristics, the "acceptance criteria" can be interpreted as the characteristics of the predicate device. The "reported device performance" is how the Trinity ELE compares to those.

Summary of Device Performance against "Acceptance Criteria": The Trinity ELE device was found to have identical waveform type, waveform shape, pulse width, frequency, burst mode characteristics, ON/OFF times, and (according to the narrative) output tolerance, maximum current density, maximum output voltage, maximum output current, maximum phase charge, and maximum power density after accounting for the smaller electrode size to achieve the same current density. The output voltage, current, phase charge, and power density are listed as lower than the predicate, which the applicant justifies as a necessary consequence of smaller electrodes to maintain identical current density, which is the key metric for tissue interaction.

2- Sample sized used for the test set and the data provenance

• Sample Size for Test Set: Not applicable. This was a non-clinical performance assessment comparing device specifications, not a study involving human subjects or real-world data to generate a test set.
• Data Provenance: The data is technical specification comparison between the Trinity ELE (new device) and the NuFACE® Trinity (predicate device), presumably obtained through laboratory testing of both devices. There is no mention of country of origin for data or whether it's retrospective/prospective in the context of clinical data, as this is hardware specification testing.

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

• Number of Experts: Not applicable. Ground truth, in this context, would be the measured electrical output specifications of the predicate device, which are inherent to the device's design and operation, not derived from expert consensus on observations.
• Qualifications of Experts: Not applicable.

4- Adjudication method for the test set

• Adjudication Method: Not applicable. This was a comparison of device specifications, not a clinical study requiring adjudication of outcomes or diagnoses.

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

• MRMC Study: No, entirely not applicable. This is a submission for a Transcutaneous Electrical Nerve Stimulator, not an AI-assisted diagnostic or imaging device.

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

• Standalone Performance: Not applicable. This is a physical stimulating device, not a software algorithm. The comparison was of the device's inherent electrical output.

7- The type of ground truth used

• Type of Ground Truth: The "ground truth" for this substantial equivalence claim is the measured electrical output specifications and physical design characteristics of the legally marketed predicate device (NuFACE® Trinity). The new device's specifications are compared directly against these established characteristics to demonstrate equivalence.

8- The sample size for the training set

• Sample Size for Training Set: Not applicable. This device does not involve machine learning or a training set in the conventional sense.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set described.

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The indications for the Trinity Acetabular System as a total hip arthroplasty include:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)
  The Trinity Acetabular System is intended for cementless, single use only.

The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell; acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW; and BIOL.OX delta™ ceramic and CoCrMo modular heads. The ceramic and CoCrMo modular heads are compatible with Corin utanium femoral stems.
The purpose of this submission is to add 28mm (-5mm offset), 32mm (-6mm offset), 36mm (-8mm offset), and 40mm (-8mm offset) CoCrMo extra short femoral heads to the Trinity Acetabular System, and complete the line of extra long heads with the addition of a 28mm (+7mm offset) CoCrMo heads.

This document describes the Corin Trinity Acetabular System with Extra short Heads and 28mm Extra long Head (K131647).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain explicit acceptance criteria in the traditional sense of performance metrics with specific thresholds (e.g., sensitivity, specificity, accuracy for an AI device). Instead, the submission focuses on demonstrating substantial equivalence to predicate devices for new components being added to an existing system.

The "performance" demonstrated for these new components is primarily through non-clinical testing.

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

This submission pertains to the addition of new components (extra short and extra long femoral heads) to an existing hip prosthesis system. The evaluation relies on non-clinical testing (mechanical tests) rather than human clinical data. Therefore, the concepts of "test set" and "data provenance" as typically applied to AI/software performance studies are not directly applicable here. The "sample size" would refer to the number of physical components tested in the lab, but this detail is not provided in the summary.

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

Not applicable. As this is a medical device (hip prosthesis components) and the evaluation relies on non-clinical mechanical testing, there is no "ground truth" established by human experts in the context of diagnostic or interpretive performance. The "ground truth" for mechanical testing would be derived from engineering standards and test protocols.

4. Adjudication Method for the Test Set

Not applicable. Since the evaluation is based on non-clinical mechanical testing, 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

Not applicable. This submission is for physical medical device components, not an AI or software device that assists human readers.

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

Not applicable. This submission is for physical medical device components, not an AI or software algorithm.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" would be established by engineering specifications, established test methods, and industry standards for mechanical performance of hip prosthesis components. For example, fatigue tests would have pre-defined failure criteria based on regulatory guidance or consensus standards.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" in this type of physical medical device submission, as it does not involve machine learning or data-driven model development.

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

Not applicable, as there is no training set involved.

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The Trinity Acetabular System is intended for use in total hip arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged hip joint articulation where there is evidence of sufficient sound bone to seat and support the components.

The indications for the Trinity Acetabular System as a total hip arthroplasty include:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)

The Trinity Acetabular System is indicated for cementless, single use only.

The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell with, ultra high molecular weight polyethylene (UHMWPE), highly cross-linked polyethylene (HXLPE) and vitamin E highly cross-linked polyethylene (ECiMa) acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW. The Trinity system also includes, BIOLOX delta™ ceramic and CoCr modular heads which are intended for use with Corin titanium femoral stems. The acetabular shell comes in two variants, a standard Trinity (K093472 and K110087) and a Trinity-i (K122305) shell, both coated with a rough titanium plasma spray with an additional top layer of electrochemically deposited calcium phosphate (BONIT™). The Trinity and Trinity-i acetabular shells are provided with screw holes and come assembled with titanium occluders in place. Dedicated titanium screws are also provided for additional fixation if required.

The purpose of this submission is to add two more acetabular shell variants to the Trinity Acetabular System, the standard Trinity No Hole acetabular shell and the Trinityi No Hole acetabular shell. Both of these variants, subject of this submission, are similar to the standard Trinity Acetabular shells previously cleared (K093472, K110087 and K122305) with the only difference being the shells subject of this submission do not have screw holes in them.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Corin Trinity Acetabular System (K130128):

1. Table of Acceptance Criteria and Reported Device Performance & 6. Standalone Performance:

No explicit acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy, precision) or a standalone performance study of the device's diagnostic or therapeutic efficacy are presented in this 510(k) summary.

Instead, the acceptance criteria are met through demonstrating:

The study underpinning this submission focuses on non-clinical testing to demonstrate substantial equivalence to predicate devices, rather than a standalone clinical performance study verifying new performance metrics for the modified device.

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

No specific "test set" in the context of clinical trials or data analysis is mentioned because this submission relies on demonstrating substantial equivalence to previously cleared devices. The testing conducted was "non-clinical testing" including comparisons of designs, materials, intended use, indications, and dimensions. Therefore, there is no sample size for a test set or data provenance from a patient population.

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

Not applicable. As described above, there was no clinical test set or ground truth established by experts in the context of diagnosing or categorizing patient data.

4. Adjudication Method for the Test Set:

Not applicable. There was no clinical test set or adjudication process for diagnostic outcomes.

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

No. An MRMC study was not performed. The submission relies on establishing substantial equivalence through non-clinical testing and comparison to predicate devices, not on proving improved human reader performance with AI assistance. The device in question is a physical medical device (hip prosthesis components), not an AI-powered diagnostic tool.

7. Type of Ground Truth Used:

For the purpose of this 510(k) submission, the "ground truth" is effectively the established safety and effectiveness of the predicate devices (Corin Trinity Acetabular System K093472, K110087, K122305, and DePuy Pinnacle 100 Acetabular Shell K001534). The current device's "no hole" variants are considered substantially equivalent if they match the predicates in key aspects.

8. Sample Size for the Training Set:

Not applicable. This device is a modified physical implant, not an algorithm that requires a training set of data.

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

Not applicable. As stated above, there is no training set for an algorithm.

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