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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 Lasya-Trinity diode laser system is intended for use in dermatology procedures requiring coagulation with the following indications:
The trinity applicator is indicated for benign vascular and vascular dependent lesions.
The 808 applicator is indicated for permanent reduction in hair regrowth.
Use on all skin types (Fitzpatric I-VI), including tanned skin.

The Subject device, Trinity-Lasya is a diode laser instrument that use diode as a medium to emit a laser beam of 755 & 808 & 1064nm wavelength.
There are two handpiece, the user can choose from. Moreover, a specific software controls the device functions and allows the user selections through the touchscreen display.
the system is intended to be used in user facilities such as hospitals, physicians' offices and medical spas, and its major components are the main console unit, foot switch, and individual modules.
The device is re-usable and non-sterile; instructions for cleaning its components between uses are provided in the labeling.
Lasya-Trinity Laser System consists of:

• System console (contains the system software, power supply, and various other electronic ● and mechanical parts)
• . Operator control panel with touch-screen technology (GUI)
• Trinity applicator(handpiece) with 1064 nm, 808nm and 755 nm wavelengths applied simultaneously
• . 808 applicator(handpiece) with 808nm wavelength
• . Footswitch and etc.

The provided text is a 510(k) summary for the Lasya-Trinity diode laser system, detailing its substantial equivalence to a predicate device. It does not contain information about the device's acceptance criteria, reported performance, or associated studies in the context of typical AI/software device evaluation (e.g., sensitivity, specificity, clinical endpoints, expert panel review).

Specifically, for the questions asked:

1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The 510(k) summary focuses on demonstrating substantial equivalence through technological characteristics and adherence to general safety and performance standards for laser devices, rather than explicit performance metrics or acceptance criteria for clinical outcomes.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document states, "Based on the similarities in the safety and effectiveness profiles of the subject, reference, and primary predicate devices, no animal or clinical studies were deemed needed to support this submission." Therefore, there was no clinical test set in the traditional sense discussed.

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 information is not provided as no clinical studies were deemed necessary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as no clinical studies were deemed necessary.

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 provided and is not applicable. The Lasya-Trinity is a laser surgical instrument, not an AI-assisted diagnostic or interpretation tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided and is not applicable. The device is a physical laser system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided as no clinical studies were deemed necessary for establishing ground truth regarding clinical outcomes. The "ground truth" for this submission would be regulatory compliance and successful demonstration of substantial equivalence based on technical specifications and safety standards for laser devices.

8. The sample size for the training set
This information is not provided. As no clinical studies were deemed necessary, there would not be a clinical training set in the context of device performance evaluation. Software verification and validation were performed, but details of "training sets" for such are not typically disclosed in 510(k) summaries unless it's a machine learning device.

9. How the ground truth for the training set was established
This information is not provided.

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The CoolSeal™ Trinity is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The CoolSeal™ Trinity can be used on vessels (arteries, veins, and vascular bundles) up to and including 7 mm in diameter. It is indicated for use in general surgery procedures including urologic, vascular, and gynecologic. It is indicated for use in adult and pediatric populations (infants, children, and adolescents). Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, etc. The CoolSeal™ Trinity has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the CoolSeal™ Trinity for these procedures. The device is contraindicated for use in ENT procedures.

The CoolSeal™ Trinity, a Maryland Laparoscopic Sealer, Divider, and Dissector, with a 5 mm diameter shaft, is designed for use with the CoolSeal™ Generator or any generator with the CoolSeal™ technology. The Trinity is provided sterile and is a single-use disposable instrument. The Trinity creates seals by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between its jaws. A blade within the instrument is surgeon-actuated to divide tissue. The double-action jaws have been designed to dissect tissue, which includes separating tissue planes and widening openings as necessary for the surgical procedure. The CoolSeal™ Trinity includes 3 shaft lengths: 30 cm, 37 cm, and 44 cm.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called "CoolSeal Trinity," an electrosurgical instrument. It details the device's indications for use, comparison to a predicate device, and performance data submitted to support its substantial equivalence.

However, the request asks for specific information regarding acceptance criteria and a study proving the device meets these criteria, particularly focusing on elements common in studies for AI/software-based medical devices (e.g., sample size for test/training sets, expert ground truth adjudication, MRMC studies, standalone performance).

Crucially, the provided document does NOT describe a study involving AI, machine learning, or software performance that would necessitate such detailed criteria or the specific study types listed in the prompt's requirements (e.g., sample sizes for training/test sets, expert ground truth for image data, MRMC studies, standalone algorithm performance).

The "performance data" mentioned in the document relates to:

• Electrical and Thermal Testing: Verifying the device performs as expected when connected to a new compatible generator (Da Vinci E-200).
• Ex-vivo Vessel Burst Pressure: Testing on excised fresh porcine blood vessels to demonstrate effective bipolar electrosurgical vessel sealing performance equivalent to the predicate device.

Therefore, many parts of your request about AI/software-specific study details cannot be answered from the provided text. The CoolSeal Trinity is a hardware electrosurgical instrument; the "study" described is a benchtop performance comparison to an existing predicate hardware device, not a clinical trial or AI model validation.

Based on the provided text, here is what can be inferred or stated regarding "acceptance criteria" and "study":

The core "acceptance criterion" for this 510(k) submission is substantial equivalence to a predicate device (CoolSeal™ Trinity K211579). This means demonstrating that the new device is as safe and effective as the predicate device and has the same technological characteristics. The only difference identified is the compatibility with a new electrosurgical generator (Da Vinci E-200).

The "study" described is a set of performance tests to support this substantial equivalence, particularly due to the identified difference.

Here's a breakdown based on your prompt, addressing what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of quantitative acceptance criteria with corresponding performance metrics in the way one would for an AI/software device (e.g., "sensitivity > X%", "specificity > Y%"). Instead, the acceptance is qualitative: "performs as expected" and "effective...equivalent to the predicate device."

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

• Sample Size: Not explicitly stated for either electrical/thermal testing or ex-vivo burst pressure testing. The term "excised fresh porcine blood vessels" implies biological material was used, but the quantity of vessels is not specified.
• Data Provenance:
  • Country of Origin: Not specified, but "porcine" suggests animal tissue.
  • Retrospective or Prospective: These are laboratory benchtop tests, not clinical studies on human subjects, so the terms "retrospective" or "prospective" in the clinical sense don't strictly apply. The tests were likely conducted prospectively as part of the validation for the 510(k).

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

• Not Applicable. This is a hardware device performance test, not an AI/software diagnostic accuracy study involving human expert interpretation for ground truth. The "ground truth" for electrical/thermal testing would be instrument readings against specifications, and for burst pressure, it would be measured burst pressure.

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

• Not Applicable. See point 3.

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 not an AI/software device; therefore, no MRMC study or AI assistance evaluation would be relevant or performed.

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

• Not Applicable. This is a hardware device. There is no "algorithm" or "standalone performance" in the sense of a software-based diagnostic tool. The performance measured is that of the physical device.

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

• For Electrical/Thermal Testing: The "ground truth" would be established engineering specifications derived from the predicate device and general safety standards for electrosurgical equipment.
• For Ex-vivo Vessel Burst Pressure: The "ground truth" is the empirically measured burst pressure of the sealed vessels, likely compared against a pre-defined threshold or against measurements from the predicate device under similar conditions. This is a direct physical measurement.

8. The sample size for the training set:

• Not Applicable. This is not an AI/software device; there is no "training set."

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

• Not Applicable. See point 8.

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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 (

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The CoolSeal™ Trinity is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The CoolSeal™ Trinity can be used on vessels (arteries, veins, and vascular bundles) up to and including 7 mm in diameter. It is indicated for use in general surgery procedures including urologic, vascular, and gynecologic. It is indicated for use in adult and pediatric populations (infants, children, and adolescents). Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, etc. The CoolSeal™ Trinity has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the CoolSeal™ Trinity for these procedures. The device is contraindicated for use in ENT procedures.

The CoolSeal™ Trinity, a Maryland Laparoscopic Sealer, Divider, and Dissector, with a 5 mm diameter shaft is designed for use with the CoolSeal™ Generator or any generator with the CoolSeal™ technology. The Trinity is provided sterile and is a single-use disposable instrument. The Trinity creates seals by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between its jaws. A blade within the instrument is surgeon-actuated to divide tissue. The double action jaws have been designed to dissect tissue, which includes separating tissue planes and widening openings as necessary for the surgical procedure. The CoolSeal™ Trinity includes 3 different shaft lengths: 30 cm, 37 cm, and 44 cm.

This document (K211579) describes a 510(k) premarket notification for the CoolSeal™ Trinity, a bipolar electrosurgical instrument. The information provided heavily focuses on the device's technical specifications, indications for use, and a comparison to predicate devices, along with general statements about safety and performance testing. However, it does not contain the specific details regarding acceptance criteria and the comprehensive study that proves the device meets those criteria, especially in the context of an AI/ML-based device.

The document confirms that mechanical, electrical, and functional testing was carried out, along with ex-vivo and in-vivo vessel burst pressure studies, in-vivo thermal spread comparison, and chronic animal studies. While these are performance studies, they are geared towards demonstrating the safety and effectiveness of a physical electrosurgical medical device and not an AI/ML algorithm.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI/ML device's performance from this document. The document primarily addresses the substantial equivalence of a surgical instrument to its predicates.

To answer your request, the document would need to contain information about:

• A specific algorithm or AI component.
• Performance metrics like sensitivity, specificity, AUC, or accuracy (for classification tasks).
• Details on test datasets (sample size, provenance, ground truth establishment, adjudication).
• Details on training datasets.
• MRMC study results, if applicable.

Since this information is not present, I must state that the document does not provide the necessary data to answer the request in the context of an AI/ML device.

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The BiPolar-i is intended for use in the following indications: Non-inflammatory degencrative joint disease including osteoarthritis and avascular necrosis in which the acetabulum does not require replacement, Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur, Revision of failed partial hip replacements in which the acetabulum does not require replacement. The BiPolar-i is indicated for cementless use only.

The Trinity Acetabular System is indicated for use in non-intlammatory degenerative joint disease including osteoarthritis and avascular necrosis, rheumatoid arthritis, correctional deformity, developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH). The Trinity Acctabular System is intended for cementless, single use only.

The indications for the Corin MctaFixM Hip Stem as a total hip arthroplasty, and when used in combination with a Corin hemi arthroplasty head, as a hip hemi-arthroplasty, include: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, Rheumatoid arthritis, Correction of functional deformity, Treatment of non-union and femoral neck fractures, Developmental dysplasia of the hip (DDH) and congenital dysplasia of the hip (CDH). The Corin MetaFixTM Hip Stem is indicated for cementless use only.

The indications for the MiniHip Stem as a total hip arthroplasty include: Non-inflammatory degenerative joint disease including osteoarthriis and avascular necrosis Rheumatoid arthritis Correction of functional deformity. Developmental dysplasia of the hip (DDH) and congenital dysplasia of the hiniHip Stem is indicated for cementless use only.

The indications for the TrinityTM Accabular System as a total hip arthroplasty include: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, Rheunatoid arthritis, Correction of functional deformity, Developmental dysplasia of the hip (DDH), and congenital dysplasia of the hip (CDH). The Trinity Acctabular System is intended for cementless, single use only.

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 Trinity TM Dual Mobility System is indicated for cementless use only.

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

The MobiliT Cup, for cemented and cementless use, are indicated for primary replacement of the hip joint: - In degenerative pathologies: primary, secondary or post-traumatic osteoarthritis, rheumatoid arthritis - For patients who have a high risk of dislocation - In cases of necrosis of the femoral head - In cases of fracture of the neck of the femur - In cases of congenital luxation. The MobiliT Cup, for cemented and cementless use, are indicated for revision when the bone tissue remains sufficient after the removal of the previous acetabular cup. The cementless MobiliT standard Cup, with flanges or with flanges and hook are indicated for cementless use only. The cemented MobiliT Cup is indicated for cemented use only.

The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate: Femoral neck and trochanteric fractures of the proximal femur. Osteonecrosis of the femoral head, Revision procedures where other devices or treatments for these indications have failed.

The OMNI Hip system Ceramic Femoral Heads are intended for use in combination with the OMNI Hip System Stems as the femoral component in total hip replacement procedures. This ceramic head is intended to articulate with the OMNI Interface Acctabular System or bipolar component. This prosthesis is intended for single use may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Congenital dislocation; Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fiactures of the proximal femur.

The indications for use of the OMNI Modular Hip Stems in hip arthroplasty include the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis: Correction of functional deformity; Congenital dislocation: Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fractures of the proximal femur. The OMNI Modular Hip stems are indicated for cementless use only and single use implantation.

The indications for use of the OMNI Modular Hip Stems in hip arthroplasty include the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis: Correction of functional deformity; Congenital dislocation: Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fractures of the proximal femur. The OMNI Modular Hip stems are indicated for cementless use only and single use implantation.

The Revival Modular Revision Hip Stem is indicated in revision surgery of femoral components, following failure of primary cemented or un-cemented prosthesis. The REVIVAL™ Hip Stem 100mm distal component is also indicated in primary total hip arthroplasty. The indications for the Revival TM Modular Revision Hip Stem include: Non-inflammatory degenerative joint disease including primary and secondary osteoarthritis. Rheumatoid arthritis, Correction of functional deformity, Treatment of non-union and femoral neck fractment of traumatic dislocations of the hip, Failures of osteotomy, Treatment of arthrodesis. The Revival ™ Revision Hip Stem is indicated for cementless, single use only.

TaperFirM Hip Stem is indicated for the relief of pain and restoration following the effects of femoral neck fracture, osteo, theumatory arthritis, post- traumatic disease effects, avascular necrosis and total hip revision. The Taper it Hip Stem is indicated for hemi-arthroplasty when used in combination with Corin hemiarthroplasty femoral heads. The TaperFitTM Hip Stem is indicated for cemented, single use only.

The indications for use of the K 1 Hip arthroplasty include the following conditions, as appropriate: Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis: Rheumatoid arthritis: Correction of functional deformity: Congenital disfocation: Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fractures of the proximal femur. The K 1 Hip Stem is indicated for cementless use only and single use implantation.

The indications for the TriFit CF Hip Stem as a total hip arthroplasty and as a hip hemiarthroplasty include: Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, Rheumatoid arthritis, Correction of functional deformity, Treatment of non-union and femoral neck fractures, Developmental Dysplasia of the Hip (DDH), Previously failed hip surgery. The Trifit CF Hip Stem is indicated for cementless use only.

The indications for the Corin TriFit TSTM Hip atthroplasty, and when used in combination with a Corin hemi arthroplasty head, as a hip hemi-arthroplasty, include: Non-inflammatory degenerative joint disease including osteoadhritis and avascular necrosis, Rheumatoid arthritis, Correction of functional deformity, Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur, Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH). The Tril'it TS Hip is intended for cementless use only.

The subject and predicate devices are one in the same and are comprised of several legally marketed Corin Ltd. hip products, which include OMNIIfe Sciences and Apex Surgical hip products. The subject devices include acetabular cups and liners, bone fixation screws, screw hole occluders, cemented and cementless femoral hip stems for primary and revision hip arthroplasty, fixation screws, modular necks, CoCrMo alloy and ceramic femoral heads, dual mobility acetabular systems, and bipolar heads. The purpose of this 510(k) is to notify the FDA of Corin's engineering assessment of the cross-compatibility of the subject devices, identification of conflicts, and updates to the product labeling. The subject hip devices components are manufactured from a variety of materials which include cobalt-chromium-molybdenum alloy, stainless steel alloy, unalloyed titanium, calcium phosphate (Bonit™ coating) Alumina Matrix Composite ceramic (Biolox Delta), and ultrahigh molecular weight polyethylene (UHMWPE), all of which conform to ASTM or ISO standards, or internal standards. The subject femoral hip stems and heads possess the same 12/14 taper design and reference system for determining head and neck offsets.

I am sorry, but the provided text does not contain information about the acceptance criteria and study proving device performance as typically seen in a medical device submission beyond general statements of substantial equivalence. The document is a 510(k) summary for hip replacement components, primarily focusing on cross-compatibility of various existing devices.

The text outlines:

• Device identification and manufacturer information.
• List of numerous predicate devices.
• Detailed descriptions of the indications for use for many hip components (e.g., Corin BiPolar-i, Trinity™ Acetabular System, MetaFix™ Hip, MiniHip™, Trinity™ Dual Mobility, MobiliT™ Cup, OMNI Bipolar Head, OMNI Delta Ceramic Femoral Head, OMNI MOD Hip System, OMNI K1/K2 Hip Systems, Revival™ Modular Hip Stem, TaperFit™, TriFit™ CF/TS Hip). These indications primarily relate to non-inflammatory degenerative joint disease, rheumatoid arthritis, correction of functional deformity, avascular necrosis, fractures, and revision surgeries.
• A "Performance Data" section which describes the types of engineering analyses and bench testing performed to establish cross-compatibility (e.g., ceramic head burst testing, head pull-off, fretting-corrosion, impingement testing, range of motion assessment, comparison of taper geometries, fatigue strength assessment, and contact stress/wear potential).

However, it does not provide:

1. A specific table of acceptance criteria and reported device performance for the types of tests mentioned (e.g., what burst pressure was required vs. achieved). It only lists the types of tests done.
2. Sample sizes used for test sets or data provenance.
3. Number of experts and their qualifications for establishing ground truth (as this pertains to clinical studies, which are not detailed here for performance).
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study information.
6. Standalone algorithm performance (as this is not an AI/algorithm-driven device).
7. Type of ground truth used (again, this is not a diagnostic device with "ground truth" in the typical sense).
8. Sample size for training set.
9. How ground truth for the training set was established.

The document's purpose is to demonstrate substantial equivalence of a range of hip components, including their cross-compatibility when used together. The "performance data" refers to the engineering and bench testing conducted to ensure this compatibility rather than clinical performance against specific metrics as one would find for a diagnostic or AI-driven device.

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The CoolSeal™ Trinity is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The CoolSeal™ Trinity can be used on arteries up to and including 6 mm, veins, and including 7 mm in diameter. It is indicated for use in general surgery procedures including urologic, vascular, and gynecologic. It is indicated for use in adult and pediatric populations (infants, children, and adolescents). The CoolSeal™ Trinity has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the CoolSeal™ Trinity for these procedures. The device is contraindicated for use in ENT procedures.

The CoolSeal™ Trinity, a Maryland Laparoscopic Sealer, Divider, and Dissector, with a 5 mm diameter shaft is designed for use with the CoolSeal™ Generator or any generator with the CoolSeal™ technology. The Trinity is provided sterile and is a single-use disposable instrument. The Trinity creates seals by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between its jaws. A blade within the instrument is surgeon-actuated to divide tissue. The double action jaws have been designed to dissect tissue, which includes separating tissue planes and widening openings as necessary for the surgical procedure. The CoolSeal™ Trinity includes 3 different shaft lengths: 30 cm, 37 cm, and 44 cm.

The provided text is a 510(k) summary for the CoolSeal™ Trinity electrosurgical device. It outlines the device's indications for use, technological characteristics, and performance data submitted to demonstrate substantial equivalence to predicate devices. However, this document primarily focuses on regulatory submission and does NOT contain information about an AI/ML-based medical device.

Therefore, I cannot extract the acceptance criteria or study details for an AI/ML device from this document as it describes a physical electrosurgical instrument and its testing. The questions posed in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance) are specific to the evaluation of AI/ML algorithms and are not relevant to the CoolSeal™ Trinity device described here.

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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 NuFACE® Trinity Plus Device is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.

The NuFACE® Trinity Plus comprises the Trinity Plus device main body, a Trinity Plus microcurrent attachment head, a charging cradle and a wall-mount power adaptor. A tube of NuFACE® Gel Primer is provided with the device as an accessory. The device and all associated components are reusable and provided non-sterile. The NuFACE® Trinity Plus is a hand-held device that produces low levels of microcurrent which is discharged through two dual-plated chrome spheres 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 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 device main body, the attachment head and the charging cradle are made from injection molded ABS thermoplastic material. The dual spheres on the attachment head use chromium. The device includes an 'ON/OFF' multifunction 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 device is the capable of pairing with compatible smart devices using Bluetooth Low Energy (BLE) wireless communications technology. This technology allows the device to communicate with other devices running the NuFACE® App which allows the user to select and run pre-programmed treatment profiles. The NuFACE® Trinity Plus provides microcurrent output at selected frequencies from 0.3 to 50 Hz.

This document is a 510(k) summary for the NuFACE® Trinity Plus Device. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. The document focuses on demonstrating that the new device is as safe and effective as the predicate, not on proving new clinical efficacy or superiority through rigorous clinical trials.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/Machine Learning (ML) device, which typically involves performance metrics like sensitivity, specificity, accuracy, and detailed clinical study designs with human readers and ground truth, is not applicable to this document.

This FDA submission is for a physical medical device (Transcutaneous Electrical Nerve Stimulator for Pain Relief, used for cosmetic facial and neck stimulation) and primarily relies on a comparison of technological characteristics, safety data (biocompatibility, electrical safety, EMC), and software verification and validation to demonstrate substantial equivalence to a predicate device.

Here's why the AI/ML-centric questions are not applicable:

• No AI/ML Component: The document describes a device that "produces low levels of microcurrent" and has "indicator LED's," a "multifunction button," and Bluetooth Low Energy for app connectivity to select pre-programmed treatment profiles. There is no mention of an AI or ML algorithm making diagnostic or therapeutic decisions, interpreting data, or providing automated recommendations.
• Safety and Substantial Equivalence, Not Efficacy Proof: The core purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a predicate device. This typically involves showing that its indications for use, technological characteristics, and safety and effectiveness profiles are similar enough that it doesn't raise new questions of safety or effectiveness. It's not a P-value seeking clinical trial to prove a new mechanism or superior efficacy.
• "Clinical Testing" was not performed: The document explicitly states under section 9, "Clinical Testing: The substantial equivalence for the subject device will not be demonstrated by results of clinical testing. Therefore, no clinical testing was performed." This clearly indicates that no human-subject efficacy study was conducted for this submission.

In summary, this document does not describe the kind of study (e.g., MRMC, standalone performance) that would be conducted for an AI/ML device requiring rigorous clinical performance validation against acceptance criteria based on metrics like sensitivity or specificity. The "acceptance criteria" here implicitly relate to demonstrating safety and similar performance to the predicate device through non-clinical testing.

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CoolSeal™ Trinity: The CoolSeal™ Trinity is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The CoolSeal™ Trinity can be used on arteries up to and including 6 mm, veins, and vascular bundles up to and including 7 mm in diameter. It is indicated for use in general surgery procedures including urologic, vascular, and gynecologic. The CoolSeal™ Trinity has not been shown to be effective for tubal coagulation for sterilization for sterilization procedures. Do not use the CoolSeal™ Trinity for these procedures.

CoolSeal™ Mini: The CoolSeal™ Mini is intended for use in open and laparoscopic general surgical procedures to seal blood vessels and vascular bundles up to and including 5 mm in diameter for use in adult and pediations, wherever vessel ligation is required. The device is contraindicated for use in ENT procedures.

CoolSealTM Generator: The CoolSeal™ Generator is intended to provide Radio Frequency (RF) energy to compatible CoolSeal™ instruments for vessel-sealing applications. The specific application will depend on the compatible surgical device that is connected to the generator. This generator is designed to be used with only surgical devices compatible with the CoolSeal™ technology.

CoolSeal™ Generator: The CoolSeal™ Generator is a non-sterile, reusable device used outside the sterile field. The generator is designed to provide lower power bipolar Radio Frequency (RF) energy to CoolSeal™ vessel sealing devices for tissue-sealing applications.

CoolSeal™ Trinity: The CoolSeal™ Trinity, a Maryland Laparoscopic Sealer, Divider, and Dissector, with a 5 mm diameter shaft is designed for use with the CoolSeal™ Generator or any generator with the CoolSeal™ technology. The Trinity is provided sterile and is a single-use disposable instrument. The Trinity creates seals by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between its jaws. A blade within the instrument is surgeon-actuated to divide tissue. The double action jaws have been designed to dissect tissue, which includes separating tissue planes and widening openings as necessary for the surgical procedure. The CoolSeal™ Trinity includes 3 different shaft lengths: 30 cm, 37 cm, and 44 cm.

CoolSeal™ Mini: The CoolSeal™ Mini a Maryland Jaw Sealer, with a 3 mm diameter shaft is designed for use with the CoolSeal™ Generator or any generator with the CoolSeal™ technology. The Mini is provided sterile and is a single-use disposable instrument. The Mini creates seals by application of radiofrequency (RF) electrosurgical energy to vascular structures or tissue bundles interposed between its jaws. The double-action jaws have been designed to dissect tissue, which includes separating tissue planes and widening openings as necessary for the surgical procedure. The CoolSeal™ Mini is only available in one shaft length: 20 cm.

The provided text describes the regulatory submission for the CoolSeal System, a set of electrosurgical devices. It focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and efficacy through strict acceptance criteria and a single, overarching study.

Therefore, the concept of a single "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the way one might evaluate a diagnostic AI system with specific performance metrics is not directly applicable here. Instead, a series of performance data and testing were conducted to show that the new device performs "as well as" or "equivalent to" the predicate devices.

However, I can interpret the request by outlining the types of performance tests conducted and the implied acceptance by demonstrating equivalence to existing, legally marketed devices.

Here's an attempt to structure the information based on your request, understanding that the context is a 510(k) submission for substantial equivalence:

Implied Acceptance Criteria and Reported Device Performance

Here are the answers to your specific questions based on the provided text, noting that much of this information is designed for software/AI device evaluation and not directly applicable to this hardware electrosurgical device submission:

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

   • See table above. The "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices, and the "reported device performance" are the results of the various tests summarized in the "Performance Data" section.

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

   • The text describes ex-vivo (fresh excised porcine blood vessels) and in-vivo (porcine model) testing.
   • Specific sample sizes for these animal studies (e.g., number of vessels tested, number of animals) are not detailed in this summary.
   • The provenance is non-human animal studies (porcine model). The country of origin of the data is not specified. All studies appear to be prospective animal studies, as they were conducted specifically for this submission.

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 this type of device submission. Ground truth for an electrosurgical device's performance often relates to physical measurements (e.g., burst pressure, thermal spread histology) rather than expert interpretation of images. The evaluation likely involved veterinary and surgical experts for performing the animal studies and pathologists for histological assessments, but their numbers or specific qualifications are not mentioned.

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

   • This is not applicable to this type of device submission. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in human-in-the-loop or diagnostic imaging studies when there are multiple expert opinions. Physical performance tests do not typically involve such adjudication.

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

   • This is not applicable. This is an electrosurgical device, not a diagnostic imaging AI device that would involve human readers. Clinical studies (which might involve such comparative effectiveness) were explicitly stated as "not necessary to support this premarket notification."

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

   • This is not applicable in the context of an AI algorithm. For this device, "standalone performance" essentially refers to its performance in the ex-vivo and in-vivo tests, as described under "Performance Data." These tests evaluate the device's physical and functional characteristics.

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

   • For vessel burst pressure, the ground truth is a direct physical measurement.
   • For thermal spread, the ground truth was established through histological assessments (pathology) performed on excised samples from the animal model.
   • For the chronic animal study, the ground truth relates to observed biological outcomes (survival, presence/absence of complications, maintenance of hemostasis, healing as anticipated).

8. The sample size for the training set

   • This is not applicable. This is a hardware electrosurgical device, not a machine learning model that requires a training set.

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

   • This is not applicable, as there is no training set for a machine learning model.

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