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The Trident® II Acetabular System is intended for use in total hip arthroplasty and is intended for either primary or revision Total Hip Arthroplasty.

Indications for Use:
• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

When used with MDM Liners:
• Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

• Dislocation risks

When used with Constrained Liners:
• The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.

The Trident II Acetabular Shells are indicated for cementless use only.

The Trident® II Acetabular Shells, 6.5mm Low Profile Hex Screws and Hex Dome Hole Plug are sterile, single-use devices that are intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. The Trident® II Acetabular System is an extension of the Trident System product line and features the same locking mechanism as the current Trident® and Trident® II Tritanium® product lines. The Trident® II Acetabular Shells are intended to be used with existing Trident® polyethylene inserts, Trident Constrained Acetabular Inserts, MDM® liners and both new and existing surgical instruments.

The Trident® II Tritanium® implant consists of a unique configuration of both solid and porous sections that are simultaneously built using a Laser Rapid Manufacturing (LRM) method of additive manufacturing, applying Stryker's proprietary Tritanium® In-Growth Technology. Tritanium® is a novel highly porous titanium material designed for biological fixation. The Trident® II PSL® Clusterhole HA and Trident® II Clusterhole HA Acetabular Shells feature hydroxylapatite coating over a Commercially Pure Titanium plasma sprayed surface for cementless fixation.

This document describes a 510(k) premarket notification for the "Trident® II Acetabular System," a medical device for total hip arthroplasty. The submission asserts substantial equivalence to previously marketed predicate devices, and therefore, clinical testing was not required. The information provided focuses on non-clinical testing.

Here's an analysis of the provided text in relation to your request:

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

The document does not explicitly present acceptance criteria in a table format with corresponding reported performance for each criterion. Instead, it lists a series of non-clinical tests performed, implying that the device "meets the requirements" or was "characterized according to methods" outlined in various ASTM standards and FDA guidance documents.

Here's a partial reconstruction of what could be inferred as acceptance criteria and "device performance" based on the text:

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Bencox M Stem (Bencox Hip System) is intended for Cementless use in partial or total hip arthroplasty in primary or revision surgery for the following conditions:

a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis
b. Inflammatory degenerative joint disease, such as rheumatoid arthritis
c. Treatment of non-union, femoral neck fracture and trochantric fractures of the proximal femur with head involvement, unmanageable using other techniques
d. Patients with failed previous surgery where pain, deformity, or dysfunction persists
e. Revision of previously failed total hip arthroplasty

The Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug is intended for cemented use in total or partial hip arthroplasty and in primary or revision surgery for the following conditions,

a) Non-inflammatory. degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis
b) Inflammatory degenerative joint disease, such as rheumatoid arthritis
c) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
d) Patients with failed previous surgery where pain, deformity, or dysfunction persists
e) Revision of previously failed total hip arthroplasty

The Centralizer is intended to be used with Bencox ID Cemented Stem to centralize the femoral stem within the intramedullary canal.

The Bencox Bone Plug is intended to be used with cemented hip replacement procedures to control and restrict the flow of cement within the intramedullary canal.

Bencox M Stem (Bencox Hip System) - Sterile
The Bencox M Stem is a double tapered wedge shaped stem intended for press-fit partial or total hip arthroplasty. When used in total hip arthroplasty the stem is coupled to a Femoral Head and used with Bencox Acetabular Cups cleared under K103431, K112019, K120924. K121665 & K150007. When used in partial hip arthroplasty Bencox M Stem is coupled to a Femoral Head and used with Bencox Bipolar Cup cleared under K112019.

Bencox M Stem is made of Ti6AI4V alloy conforming to ASTM F136. The proximal half of the stem is plasma sprayed coating of pure titanium as per ASTM F1580. The materials used in subject device, Bencox M Stem, have been cleared for use in K112019 & K150007 for Bencox ID Stem & Bencox ID Stem (offset). The stem has a tapered rectangular section. The stem has a neck with a standard 12/14 conical taper to couple to Bencox Femoral Heads which have been cleared earlier. The Bencox M Stem is available 13 sizes with CCD angle of 132°. The stem is available in 13 sizes.

All the above described technological characteristics of subject device is similar to the identified predicate devices.

BENCOX ID Cemented Stem (with Centralizer) & Bone Plug - Sterile
Bencox ID Cemented Stem has bone plug and centralizer as accessories. The Collarless Bencox ID Cemented Stem consists of a polished double tapered distal geometry which generates the radial compressive load in distal body. The neck shape is similar to cleared Corentec's hip femoral stems in K103431, K122099 and K150007. The standard Morse taper (12/14) is used for femoral head assembly similar to cleared devices to couple to Bencox Femoral Heads and their compatible acetabular components which have been cleared in previous premarket notifications. The Bencox ID Cemented Stem is available 06 sizes with CCD angle of 132°. Bencox ID Cemented Stem is made of SS allov.

The deformable centralizer is made of PMMA with flexible wing like projections that extend outwards from the base of the centralizer and fits over the outside diameter of the stem tip. These projections contact the walls of the femoral canal, centralizing the hip stem within the canal. The hollow centralizer is designed to allow stem to engage distally within the cement mantle, subjecting the cement to compressive loading, and reducing end bearing of the stem directly onto the cement. The centralizer is a molded acrylic device manufactured from PMMA.

Bencox bone plug has a double flanged geometry very similar to the predicate devices. The plug blocks the propagation of the doughy bone cement downward in the medullary cavity. The proximal flange provides a proximal barrier, while the more flexible distal flange forms a secondary seal to prevent cement leakage. Bencox bone plug is manufactured from UHMWPE.

All the above described technological characteristics of subject device is similar to the identified predicate devices.

Accessory BENCOX Hip Instrumentation: (Non Sterile)
The Bencox Hip Instrumentation is a set of accessories to be used with Bencox Hip Implants. The instruments are designed to be simple, conventional, and accurate and all parts of which are used for their respective procedures by qualified orthopedic surgeons.

The parts of the instruments are made of stainless steel and/or polymers and/or silicon which are cleared for use in previous premarket notifications of Corentec.

Bencox Hip System Instrumentation to be used Bencox M Stem (Bencox Hip System) & Bencox ID Cemented Stem is same with Instrumentation cleared under K103431, K112019, K120924 & K122099 along with the inclusion of instruments specific to Bencox M Stem such as Rasp, Impactor etc.

The provided text is a 510(k) summary for the Bencox M Stem and Bencox ID Cemented Stem (with Centralizer) & Bone Plug. This document describes a medical device and its equivalence to previously approved predicate devices, primarily based on non-clinical performance data. It does not describe a study involving patient data, ground truth establishment, or clinical performance metrics in the way your request outlines for AI/software-based devices.

Therefore, for the specific questions related to acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types, the information is not applicable or not available within this document because it pertains to a different type of device evaluation (hardware instead of software/AI).

However, I can extract the relevant performance data based on the non-clinical testing conducted for this orthopedic implant.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is an orthopedic implant, the "acceptance criteria" and "reported device performance" are based on mechanical properties and material standards rather than diagnostic accuracy metrics. The document asserts that the device met these criteria through various tests, demonstrating substantial equivalence to predicate devices.

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

• Sample Size (Test Set): Not applicable in the context of diagnostic accuracy. For mechanical testing, "samples" would refer to the number of physical devices or components tested. This number is not specified in the 510(k) summary, but it would typically be a statistical minimum required by the testing standard.
• Data Provenance: Not applicable for clinical data. The performance data is derived from in vitro mechanical testing conducted by the manufacturer, Corentec Co., Ltd., in South Korea.

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

• Not applicable. This device is a physical implant, not a diagnostic AI/software. There is no "ground truth" derived from expert interpretation in the clinical diagnostic sense. The ground truth for mechanical properties is established by adherence to recognized engineering and material standards.

4. Adjudication method for the test set:

• Not applicable. There is no expert adjudication for mechanical testing of this nature. Test results are compared against predefined acceptance criteria from international 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. This is a physical orthopedic implant, not an AI/software.

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

• Not applicable. This is a physical orthopedic implant, not an AI/software.

7. The type of ground truth used:

• Ground Truth Type: For orthopedic implants, the "ground truth" is defined by adherence to established engineering and material standards (e.g., ISO and ASTM standards for mechanical properties, material composition, and sterilization validation). The device's performance is compared against the requirements and benchmarks set by these standards, and against the equivalent performance of legally marketed predicate devices.

8. The sample size for the training set:

• Not applicable. This is a physical orthopedic implant. There is no "training set" in the context of machine learning. Design and manufacturing processes would be informed by engineering principles and historical data on similar devices, but not a "training set" in the requested sense.

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

• Not applicable. As above, there is no training set. Design and manufacturing are based on established engineering principles and compliance with international standards.

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The Anato™ Hip Stem is a sterile, single-use device intended for use in primary and revision total and hemi-hip arthroplasty to alleviate pain and restore function. The stem is designed for use with the currently available compatible Howmedica Osteonics' V40™ femoral heads and their compatible acetabular components. Head compatibility with the stems includes: V40130 Biolox Delta, Biolox Delta Universal Taper Heads and Sleeves, V40™ CoCr Heads, V40™ LFITM CoCr Heads, C-Taper Alumina Heads when used with the V40TM /C-taper Adapter, C-Taper Delta Heads when used with C-taper Adaptor, UHR® Universal Head, Unitrax® Heads when used with the Unitrax® V40™ Modular Adapter.

The indications for use for total hip arthroplasty include:

• noninflammatory degenerative joint disease, including osteoarthritis . and avascular necrosis;
• rheumatoid arthritis; .
• correction of functional deformity; .
• revision procedures where other treatments or devices have failed; and, ●
• nonunions, femoral neck fractures, and trochanteric fractures of the . proximal femur with head involvement that are unmanageable using other techniques.

Additional indication specific to use of Anato™ Hip Stem with compatible Howmedica Osteonics Constrained Liners:

• When the stem is to be used with compatible Howmedica Osteonics . Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
  The Anato™ Hip Stem is intended for cementless use only and is intended for total and hemi-arthroplasty procedures.

Howmedica Osteonics is introducing a monolithic, non-porous coated femoral hip prosthesis, which is intended for cementless, press-fit application. The basic design of the Anato™ Hip Stem is similar to two other commerically distributed total hip systems, which are Howmedica Osteonics' ABG® II Monolithic and Accolade® II Hip Stems.

The Anato™ and the Accolade® II stem are both made from the same material combinations. The subject device is similar in design to the ABG® II Monolithic stem as they are both anatomic stems with a 130 degree neck angle. There are normalization patterns (scales) on the anterior and posterior aspects of the proximal end of the stem to facilitate press-fit stability and load transmission. Based on 3-Dimensional simulations, these normalizations are designed to convert medial and lateral shear stresses to compressive forces, which may facilitate proximal loading.

The subject stem is manufactured from titanium (Ti-6Al-4V) alloy, commercially pure (CP) titanium coating, and PureFix® hydroxylapatite (HA) coating identical to the previously cleared Accolade® II Hip Stem.

The Anato™ Hip Stem has a shot peened neck and will be available in 8 sizes ranging from size 1 through 8 with two different neck versions (neutral and anteverted). As the stem is anatomic, there will be a right and left component for each size. The stem is designed only for use with compatible Howmedica Osteonics' femoral heads and acetabular components.

Here's the breakdown of the acceptance criteria and the study information based on the provided text, categorized as you requested.

The provided document describes a 510(k) premarket notification for a hip stem, which primarily relies on substantial equivalence to predicate devices rather than independent clinical efficacy studies. Therefore, many of the typical elements of AI/software device evaluation (like ground truth, expert consensus, MRMC studies, training set details) are not applicable in this context.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. The evaluation was based on non-clinical testing (mechanical fatigue) and comparison to predicate devices, not on a "test set" of clinical data.
• Data Provenance: Not applicable for clinical data. For non-clinical testing, it would refer to the testing facilities and methods as described by ISO standards.

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

• Not applicable. This device relies on mechanical testing standards and comparison to predicate devices, not on expert consensus or ground truth derived from expert review of individual cases. Decisions on substantial equivalence are made by regulatory bodies based on submitted documentation.

4. Adjudication Method for the Test Set

• Not applicable. There was no "test set" in the sense of clinical cases requiring adjudication. Mechanical test results are objective measurements against a standard.

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

• No, an MRMC comparative effectiveness study was not done. This is a medical device (hip stem), not an AI or imaging diagnostic tool that would typically involve human readers.
• Effect size of human readers with/without AI assistance: Not applicable.

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

• Not applicable. This device is a physical hip stem, not an algorithm or software. Its performance is evaluated through mechanical testing and material properties.

7. Type of Ground Truth Used

• Mechanical Testing Standards and Predicate Device Performance Data: Performance was established against recognized international standards (ISO 7206-4 and ISO 7206-6) for mechanical fatigue, and by demonstrating identical material compositions and similar design characteristics to legally marketed predicate devices. The "ground truth" for substantial equivalence is the proven safety and effectiveness of the predicates and compliance with relevant engineering standards.

8. Sample Size for the Training Set

• Not applicable. This is a physical device, not an AI model that requires a training set.

9. How 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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The device is used for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
3. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
4. Correction of functional deformity.
5. Treatment of nonunion femoral neck and trochanteric fracture of the proximal femur with head involvement that is unmanageable using other techniques.
   The device is intended for cementless use.

The subject device designed for total hip arthroplasty includes acetabular components and femoral components. The acetabular components are composed of a highly crosslinked ultra - high - molecular - weight - polyethylene articulating bearing surface fixed in a metal shell acetabular cup, while metal shell could be fixed with acetabulum by Ti Cancellous Screw and optional screw hole cover. The femoral component is composed of a ceramic femoral head.
U-Motion II Acetabular Cup includes U-Motion II HA Cup and U-Motion II PS Cup. It is manufactured from titanium alloy forging (ASTM F620) which are forged by titanium alloy bars conforming to ASTM F136. The outer surface of U-Motion II HA Cup is coated with dual coatings, CP Ti powder (ASTM F1580) for the inner layer and HA (ASTM F1185) for the outer layer. The materials of substrate and coating layers are identical to previous cleared "UNITED" U2 Acetabular Component (K050262, K12177). The outer surface of U-Motion II PS Cup is coated with CP Ti power. There are nineteen sizes of acetabular shell available, ranging from 44 through 80 mm outer diameter in 2 mm increments. U-Motion II Cup has a snap fit locking groove for acceptance of the U-Motion II XPE Cup Liner.
Clustered-hole and multi-hole series of U-Motion II Cup have shell holes for Ti Cancellous Screw fixation to the acetabulum. Ti Cancellous Screw are self tapping and in a 6.5 mm diameter with length of 15 to 60 mm in 5 mm increments. The designs of screw are identical with the cleared screws (K050262), except for the design of screw head. This subject device also has screws and hole covers available to cover the shell holes if desired. Screw and hole covers are manufactured from Ti-6Al-4V bar (ASTM F136).
U-Motion II XPE Cup Liner is manufactured from highly crosslinked UHMWPE which conforms to ASTM F2565 and the UHMWPE raw material is in accordance with ASTM F648 and ISO 5834. The materials are identical to previous cleared "UNITED" XPE liners of U2 Hip System (K111546). U-Motion II XPE Cup Liner includes 0° and 20° hood designs, which are available in 28 mm. 32 mm. 36 mm and 40 mm inside diameter (ID), The 28 mm inserts fit the acetabular shells with outer diameter (OD) ranging from 44-80 mm, the 32 mm inserts fit the acetabular shells ranging from 48-80 mm, the 36 mm inserts fit the acetabular shells ranging from 52-80 mm, and the 40 mm inserts fit the acetabular shells ranging from 56-80 mm.
40 mm Ceramic Femoral Head - Delta is an additional size extension to the previously cleared "UNITED" Ceramic Femoral Head--Delta (K103497, K112463). The materials, design, safety and effectiveness of this subject are identical to the previously cleared device (available in sizes 28 mm, 32 mm and 36 mm), except for its larger diameter. 40 mm Ceramic Femoral Head - Delta, developed by CeramTec AG, is made from an alumina matrix composite in accordance with ISO 6474-2 and is available in -3, +1, +5 and +9 mm of neck length.
U-Motion II Cup will be used with U-Motion II XPE Cup Liner, 40 mm Ceramic Femoral Head - Delta, previously cleared 28 mm, 32 mm metal Femoral Head (K022520, K111546) and Ceramic Femoral Head (K103479, K112463) in corresponding size. This device should not be used with those of another manufacturer's hip components since the articular and dimensional compatibility cannot be assured. The 40 mm Ceramic Femoral Head may be used with UTF Stem (K110245) and the stems made of titanium alloy in U2 Hip Stem series (K003237, K062978, K111546).

Here's a breakdown of the acceptance criteria and the study information for the U-Motion II Acetabular System, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The provided document describes a bench performance testing approach to demonstrate the device's safety and effectiveness. The acceptance criteria are implicitly met by showing that the device is "capable of withstanding expected in vivo loading without failure" and that "there are no new issues related to the safety and effectiveness" as confirmed by these tests. The device performance is deemed satisfactory if it passes these tests.

No explicit quantitative acceptance criteria (e.g., a specific threshold for shear strength, a maximum wear rate) are provided in this summary section, nor are specific reported performance values for each test type. Instead, the document states generally that a "review of the mechanical data indicates that the U-Motion II Acetabular System is capable of withstanding expected in vivo loading without failure."

Study Details

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

   • Sample Size: Not explicitly stated as a numerical count of individual devices tested. The document refers to "the U-Motion II Acetabular System" and its components being evaluated against various ASTM and ISO standards for mechanical testing. These standards typically specify sample sizes for such tests.
   • Data Provenance: The studies were bench tests (laboratory simulations), not clinical data from patients. The document does not specify the country of origin for the data; however, the manufacturer is in Taiwan.

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

   • This question is not applicable to this type of study. For bench testing of medical devices like an acetabular system, the "ground truth" is defined by established engineering and materials science standards (ASTM, ISO), and the performance is evaluated by engineers/technicians against these predefined criteria, not by medical experts establishing a diagnostic ground truth.

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

   • This is not applicable as there was no expert adjudication process for this type of bench test. The results are based on objective measurements and adherence to specified test methods.

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:

   • This is not applicable. This submission is for a physical orthopedic implant (hip replacement components), not a diagnostic imaging AI device. Therefore, no MRMC study was performed.

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

   • This is not applicable. This is a physical device, not an algorithm. However, the bench tests performed are akin to "standalone" performance evaluations in that they assess the device's inherent mechanical properties and durability without human interaction (beyond setting up and running the tests).

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

   • The "ground truth" for this device's performance relies on compliance with recognized international and national standards for medical device mechanical testing (ASTM F1854, F1160, F1044, F1147, F1978, F1820, F2759, ISO 14242-1, ISO 6474-2). These standards define the acceptable mechanical properties and testing methodologies for such implants. There is no biological or diagnostic "ground truth" in this context.

7. The sample size for the training set:

   • This is not applicable. This filing is for a physical medical device (orthopedic implant), not a machine learning or AI algorithm. Therefore, there is no "training set."

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

   • This is not applicable as there is no training set for a physical medical device.

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Indications for use include:

1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. rheumatoid arthritis;
3. correction of functional deformity;
4. revision procedures where other treatments or devices have failed; and,
5. nonunions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Additional indication specific to use of Secur-Fit Advanced Hip Stems with compatible Howmedica Osteonics Constrained Liners:

1. When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.

Secur-Fit Advanced Hip Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Howmedica Osteonics is introducing the Novel Fit and Fill Hip Stem (aka Secur-Fit Advanced), a tapered non-porous coated femoral stem intended for cementless, press-fit application. The basic design of the Secur-Fit Advanced is similar to other total hip stems that have been commercially distributed such as the Accolade II, Secur-Fit and Rejuvenate Monolithic Hip Stems. The Novel Fit and Fill and the Accolade II stem are both made from the same material combinations. The subject device is similar in design to Secur-Fit and Rejuvenate Monolithic as they are straight stems with a normalization pattern. Three dimensional simulations have shown the normalizations on the anterior and posterior aspects of the proximal end of the stem to facilitate press-fit stability and load transmission in the proximal region of the femur. These normalizations are designed to convert medial and lateral shear stresses to compressive forces, which may facilitate proximal loading.

The stem is manufactured from a Ti-6Al-4V substrate material, Commerically Pure (CP) Titanium coating and Purefix hydroxylapatite (HA) coating identical to the previously cleared Accolade II Hip Stem (K103479, K120578).

The Secur-Fit Advanced Hip Stem has a shot peened neck and includes 16 implant sizes 4-12 (nine 132° stems & seven 127° stems) that provide dual head offsets. The stem is designed only for use with compatible Howmedica Osteonics' femoral heads and acetabular components.

The provided document describes the K122853 510(k) submission for the Secur-Fit Advanced Hip Stem, which is a medical device. This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific clinical acceptance criteria in the manner one might find for a software or AI device.

Therefore, the requested information geared towards AI/software device studies (like sample size for test sets, data provenance, ground truth establishment, MRMC studies, standalone performance, and training set details) is not applicable to this submission. This is a traditional mechanical medical device submission.

Here's the information derived from the document, tailored to the context of a mechanical medical device:

Acceptance Criteria and Device Performance (Mechanical Device)

Study Details (Mechanical Device)

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

   • The document refers to "mechanical testing" (Distal Stem Fatigue Testing and Neck Fatigue Testing). For such tests, the "sample size" would typically refer to the number of physical device units tested according to the specified ISO standards. This specific number is not provided in the summary.
   • Data provenance: Not explicitly stated, but mechanical testing is generally performed in a laboratory setting by the manufacturer or a contracted lab. This is standard pre-market testing for mechanical medical devices. It is not retrospective or prospective in a clinical sense.

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

   • Not applicable. For mechanical device testing, the "ground truth" is adherence to predefined engineering specifications and performance standards (e.g., ISO 7206-4, ISO 7206-6). Expert clinical consensus is not typically used to establish this type of ground truth.

3. Adjudication method for the test set:

   • Not applicable. Test results are typically compared directly against the pass/fail criteria of the specified international standards. There is no "adjudication" in the sense of reconciling human reader opinions.

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:

   • Not applicable. This is a mechanical hip stem, not an AI or software device. MRMC studies are for assessment of reader performance, typically with imaging or diagnostic devices.

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

   • Not applicable. This is a mechanical hip stem, not an AI or software device.

6. The type of ground truth used:

   • Compliance with international mechanical testing standards (ISO 7206-4 and ISO 7206-6) and demonstration of material and design equivalence to legally marketed predicate devices.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

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

   • Not applicable.

Ask a specific question about this device

This device is indicated for use in total hip arthroplasty or bipolar arthroplasty undergoing primary and revision surgery for the following conditions:

• Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia
• Inflammatory degenerative joint disease such as rheumatoid arthritis
• Correction of functional deformity
• Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
• Revision procedures where other treatments or devices have failed

UTF Stem is designed for cementless use.

UTF Stem is a modular, wedge-shaped stem with 12/14 neck taper, which is made from forging Ti-6A1-4V alloy conforming to ASTM F 620 and the proximal part of each femoral stem is coated with CP Ti plasma spray. The net-shape of stem was forged by the titanium bar (ASTM F136). Circumferential titanium plasma coating sprayed with CP Ti powder (ASTM F1580) provides biological fixation. This device is collarless to allow for self-seating of the implant between the lateral and medial cortices of the femoral canal. UTF Stem is available with standard offset and high offset options to restore hip biomechanics. Each type of offset is available in 10 sizes ranging.

For total hip replacement, UTF Stem can be used in conjunction with UNITED Femoral Head (K994078, K022520 and K111546), U2 Acetabular Cup Liner (K050262), XPE Cup Liner (K111546), U2 HA/Ti Plasma Spray Cup (K050262), U2 Ti Plasma Spray Cup (K050262) and U2 Ti Porous Coated Cup (K111546). As using with the U2 Acetabular Cup Liner (K050262), UTF Stem can be used with 26 mm and 28 mm Femoral Head (K994078 and K022520) and 28 mm ceramic Femoral Head (K103479). As using with XPE Cup Liner (K111546), UTF Stem can be used with 28 mm, 32 mm and 36 mm metal Femoral Head (K022520, K111546), and 28 mm and 32 mm Ceramic Femoral Head (K103479). Only U2 Ti Porous Coated Cup (K111546) and XPE Cup Liner (K111546) can be used in conjunction with the 32 mm and 36 mm Femoral Head (K111546, K103479). For bipolar hip replacement, UTF Stem also can be used in conjunction with 26 mm. 28 mm. 32mm and 36mm Femoral Head (K994078, K022520, K111546) and Bipolar implants (K050269, K101670). UNITED Femoral Head and Binolar Cap are made of Co-Cr-Mo alloy, while Ceramic Femoral Head is manufactured from alumina. Acetabular Cup Liner and Bipolar Cap Liner are made of UHMWPE, while U2 Acetabular Cup shells are manufactured from forged Titanium alloy.

The provided text describes a 510(k) summary for the "UTF Stem" total hip prosthesis. The acceptance criteria and supporting studies are limited to bench testing to demonstrate substantial equivalence to predicate devices. It does not contain information about clinical studies with human participants, expert review processes, or multi-reader multi-case studies.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the 510(k) was prepared in accordance with several guidance documents, including "Class II Special Controls Guidance Document-Hip Joint Metal Polymer Constrained Cemented or Uncemented Prosthesis" and "Guidance for Non-clinical Information for Femoral Stem Prostheses." This implies that the tests performed adhered to the acceptance criteria outlined in these guidance documents, even if the specific numerical thresholds are not explicitly listed in this summary. The successful clearance by the FDA (K110245) indicates that the device was deemed to meet these criteria.

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

• Sample Size: Not specified. The document only mentions that the listed tests "have been performed." For bench testing, the sample size would typically refer to the number of physical samples of the device components tested for each specific test.
• Data Provenance: Not applicable in the context of clinical data. For bench testing, the data would originate from laboratory experiments conducted by the manufacturer or a contracted lab. The manufacturer is United Orthopedic Corporation, located in Hsinchu, Taiwan.

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

• Not applicable. This summary only describes non-clinical, bench testing. There is no indication of a "ground truth" established by human experts for these mechanical or material property tests. The "ground truth" for bench tests is typically defined by engineering specifications, material standards (e.g., ASTM), and regulatory guidance documents.

4. Adjudication Method for the Test Set

• Not applicable. This summary pertains to non-clinical bench testing, where adjudication by multiple experts is not typically a component of determining test outcomes.

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

• No. This document focuses solely on the substantial equivalence through bench testing (mechanical and material properties) of a hip prosthesis. It does not involve human readers or image interpretation, thus no MRMC study was conducted.

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

• Not applicable. This device is a physical medical implant, not a software algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

• Engineering Specifications and Standardized Test Methods: The "ground truth" for the bench tests would be the established performance criteria and thresholds defined in relevant ASTM standards (e.g., ASTM F 620, ASTM F136, ASTM F1580), FDA guidance documents (e.g., "Guidance for Non-clinical Information for Femoral Stem Prostheses"), and the manufacturer's internal design specifications for a hip prosthesis.

8. The Sample Size for the Training Set

• Not applicable. This report describes the performance of a physical device, not an AI or machine learning model that would require a training set.

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

• Not applicable. As above, there is no training set for a physical medical device.

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This device is indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

For use as a Total Hip Replacement

1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
3. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

For use as a Bipolar Hip Replacement

1. Femoral head/neck factures or non-unions.
2. Aseptic necrosis of the femoral head.
3. Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
   Cemented stem is designed for cemented use only.

The U2 Hip System for hip arthroplasty is a metal/polymer/metal semi-constrained prosthesis with femoral components and acetabular components. The femoral components are composed of a ball mechanical locked with a stem by means of a Morse taper, while the acetabular components are composed of an highly crosslinked ultra - high - molecular - weight - polyethylene articulating bearing surface fixed in a metal shell. Components of this premarket notification include the following components:

• Ti Porous Coated Cup
• XPE Cup Liner
• 32 mm and 36 mm Femoral Head
• U2 Hip Stem, Press-fit
• U2 Hip Stem, Cemented

The titanium bar (ASTM F136) was forged into a net-shape of acetabular cup and then the forged part was machined into the final shape of Ti Porous Coated Cup. The outer surface is porous coated with three layers of CP Ti beads (ASTM F1580). XPE Cup Liner is manufactured from highly crosslinked UHMWPE which conform to ASTM F2565 and the UHMWPE raw material is in accordance with ASTM F648 and ISO 5834. The first series of XPE Cup Liner with the sizes of 44 to 80 mm has an inner diameter of 28 mm. The second series with the sizes of 50 to 80 mm have an inner diameter of 32 mm. The third series with the sizes from 54 to 80 mm have an inner diameter of 36 mm. The 32 and 36 mm Femoral Head is manufactured from CoCrMo alloy (ASTM F1537) with neck length of -3, +0, +5, and +10 mm. U2 Press-fit Stem is manufactured from titanium alloy (ASTM F620) which is intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty. U2 Cemented Hip Stem manufactured from forging CoCrMo alloy (ASTM F799) is intended for cement fixation. Moreover, this device is available to use with an accessory, called "Cement Restrictor, Full PE" made of Ultra-High Molecular Weight Polyethylene (ASTM F648).

The Ti Porous Coated Cup will be used with 510k cleared cup liner of the U2 Acetabular Component (K050262) and currently submission XPE Cup Liner. As using with the existing cup liner (K050262), the Ti Porous Coated Cup may be used with 26 mm and 28 mm Femoral Head (K994078 and K022520) and 28 mm Ceramic Femoral Head (K103479). As using with currently submission XPE Cup Liner, this component may be used with currently submission 32 mm and 36mm Femoral Head, the 28 mm Femoral Head (K022520) and 28 mm and 32 mm Ceramic Femoral Head (K103479). Besides, XPE Cup Liner may also be used with existing U2 Acetabular Cup (K050262). The 32 mm and 36 mm Femoral Head may also be used with U2 Bipolar Implant (K101670), Revision Stem (K062978) and current submission Cemented Stem and Press-fit Stem.

The Press-fit Stem and Cemented Stem will be used with currently submission 32mm and 36 mm metal Femoral Head and may be used with 26 mm and 28 mm metal Femoral Head (K994078 and K022520). The Press-fit Stem which made from Ti alloy can also be used with Ceramic Femoral Head (K103479).

The provided text describes the U2 Hip System, a semi-constrained hip prosthesis. It details the device components, materials, and indications for use. The document focuses on demonstrating substantial equivalence to predicate devices through comparisons of design, operational principles, material composition, and extensive bench performance tests. There is no information about acceptance criteria or a study proving the device meets acceptance criteria in the sense of clinical performance or diagnostic accuracy. Instead, the "performance test - bench" section outlines mechanical tests conducted to ensure the device's safety and effectiveness regarding its physical properties and mechanical integrity.

Here's an analysis based on the provided text, addressing the user's questions where applicable, and noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as pass/fail thresholds for clinical performance or diagnostic accuracy. Instead, it describes mechanical tests performed to demonstrate the device's ability to withstand expected in vivo loading. The "reported device performance" is that these tests were performed and a "review of the mechanical data indicates that the U2 Hip System is capable of withstanding expected in vivo loading without failure." No specific numerical results of these tests and their comparison against predefined limits are provided in this summary.

Here's a summary of the tests performed and the general conclusion:

The document states: "A review of these tests has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices."

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

Not applicable. The study described is a series of bench performance tests on the device's components, not a clinical trial or a study involving human subjects or data. Therefore, there is no "test set" in the context of patient data.

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 medical device (hip prosthesis), and the "study" involves mechanical testing, not interpretation of data by experts for ground truth establishment.

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

Not applicable. This is a medical device (hip prosthesis) and the "study" involves mechanical testing.

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 document pertains to a medical device (hip prosthesis), not an AI algorithm or a diagnostic tool that would involve human readers.

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

Not applicable. This document pertains to a medical device (hip prosthesis), not an algorithm.

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

Not applicable in the conventional sense of diagnostic accuracy studies. For mechanical tests, the "ground truth" is defined by the objective physical properties and performance characteristics as measured against established ASTM and ISO standards for medical implants. The tests themselves are designed to evaluate whether the components meet these engineering standards for safety and effectiveness.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning algorithm.

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

Not applicable. There is no "training set" as this is not an AI/machine learning algorithm.

Additional Information from the document:

• Clinical Data: "Clinical data was not needed to support the safety and effectiveness of the subject devices." This implies that the substantial equivalence argument was entirely based on non-clinical (bench) testing and comparison to predicate devices.
• Regulatory Basis: The 510(k) was prepared in accordance with several FDA guidance documents for hip joint prostheses and orthopedic implants, reinforcing that the testing conducted (as detailed in the "Performance Test - Bench" section) is the accepted method for demonstrating safety and effectiveness for this type of device.

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