Search Results

This device is intended for use in total and hemi-hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:

1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis.
2. Previously failed hip surgery.
3. Proximal femoral neck fractures or dislocation.
4. Idiopathic avascular necrosis of the femoral head.
5. Non-union of proximal femoral neck fractures.
6. Treatment of fractures that are unmanageable using other forms of therapy.
7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

The subject device is a set of smaller stems that extends the size range of the previously cleared Trivicta® stems (K233758).

Trivicta® is a single-piece, tapered, collared and non-collared, hydroxyapatite (HA) and sintered bead commercially pure (Cp) Titanium coated femoral hip stem designed for single use. The stem has a neck with a 12/14 trunnion taper for modular attachment to femoral heads. Trivicta® is manufactured from titanium alloy and device fixation is achieved through uncemented press-fit in the medullary canal and through the use of biocompatible HA coating and porous sintered bead coating.

The size range of the subject device is: lengths (97-101mm), horizontal offsets (36-43mm), vertical offsets (27-29mm), resection angle of 41°, and neck angle of 132°. The stem is offered with both standard (STD) and extended (EXT) offsets and with and without a collar.

Trivicta® is compatible with the following Ortho Development® devices: CoCr Femoral Heads, Biolox Delta Ceramic Femoral Heads, Solitude™ Unipolar Head, Escalade Acetabular Cup System, Legend® Acetabular Liner, Escalade Legend® Acetabular Shell, and Tri-plus™ DCM Liner.

The provided text is an FDA 510(k) clearance letter and associated summary for a hip stem device. This type of document describes the device, its indications for use, and a comparison to predicate devices, along with performance data to demonstrate substantial equivalence.

However, the information requested in your prompt regarding acceptance criteria for a software device, specifically around AI performance metrics like sensitivity, specificity, MRMC studies, ground truth establishment, training data, etc., is not contained within this FDA clearance document.

The document states under "Clinical Testing" (Page 7): "No clinical testing is required to establish the safety and effectiveness of Trivicta." This indicates that the clearance was based on non-clinical performance data (sterilization, shelf life, biocompatibility, mechanical testing) and comparison to predicate devices, not on a study involving AI performance or human-in-the-loop assessments as would be typical for medical AI devices.

Therefore, I cannot fulfill your request for the specific AI-related acceptance criteria and study details because the provided document is for a mechanical orthopedic implant, not an AI-powered diagnostic or therapeutic device.

Ask a specific question about this device

• 1. Loss of joint configuration and joint function.
• 2. Osteoarthritis of the knee joint.
• 3. Rheumatoid arthritis of the knee joint.
• 4. Post-traumatic arthritis of the knee joint.
• 5. Valgus, varus, or flexion deformities of the knee joint.
• 6. Revision procedures where other treatments or devices have failed.

The BKS, BKS TriMax, and BKS Revision are intended for total knee arthroplasty procedures.

The BKS is indicated in the salvage of previously failed surgical attempts where bone loss does not require the use of augments or stem extensions and where collateral ligaments may be relied upon for medial/lateral (M/L) stability.

BKS TriMax is intended in the salvage of previously failed surgical attempts where bone loss does not require the use of augments or stem extensions, where collateral ligaments may be relied upon for medial/lateral stability, where postoperative flexion up to 150° may be desirable, and the patient meets all indications requirements.

The BKS Revision system is indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves or stem extensions.

The BKS Revision system is indicated for cemented use only. The porous-coated metaphyseal sleeves are intended for cemented and uncemented applications.

The BKS Revision CK Tibial Insert is indicated for use with the BKS Revision Modular femoral and Modular, Offiset, or Sleeve tibial components where collateral ligaments may not be relied upon for medial/lateral (M/L) stability.

The purpose of this special 510(k) submission is to request clearance for BKS Revision Sleeve Junction Box of the BKS Revision System which is an extension of Ortho Development's previously cleared predicate BKS Revision Sleeves System (K181569).

The subject device incorporates the same locking taper interface for mating with the BKS Revision Sleeves and the same principle of operation for locking the A/P position relative to the BKS Revision Modular Femoral Component. The subject device is manufactured in the same manner from the same material. The subject device also employs the same packaging components and sterilization method.

Differences between the subject and predicate device include small adjustments to the envelope geometry, internal configuration, and driving feature for assembly during use. These changes have been made to optimize the Sleeve Junction Box for use specifically with femoral sleeves. The mechanics of the connection and locking mechanism are the same as the predicate device.

This document describes Ortho Development's 510(k) submission for the BKS Revision System, specifically focusing on the BKS Revision Sleeve Junction Box. The submission is a "special 510(k)" which implies that the changes to the device are minor and do not alter its fundamental scientific technology or indications for use. Therefore, the acceptance criteria and the study proving the device meets them are based on demonstrating that the modified device performs equivalently to the predicate device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a special 510(k) for a modification to an existing device (BKS Revision Sleeves System, K181569), the acceptance criteria are implicitly that the modified device (BKS Revision Sleeve Junction Box) performs comparably to the predicate device and meets established consensus standards for orthopedic implants.

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

The document does not explicitly state the sample size for mechanical testing (e.g., number of devices tested for fatigue or disassembly). The evaluation performed involved testing of the device itself rather than a clinical study with patient data. Therefore, there is no "test set" in the context of patient data, nor is there data provenance in terms of country of origin or retrospective/prospective collection as this is a physical device testing study.

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

Not applicable. This is not a study involving expert review of medical images or clinical data to establish ground truth. The "ground truth" here is the established performance characteristics and safety profile of the predicate device, against which the modified device's mechanical properties are compared using established engineering test methods.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication process for this type of mechanical engineering study. The evaluation relies on standardized test methods (like ASTM F1814) and engineering analysis.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a medical implant (knee joint prosthesis components), not an AI-assisted diagnostic or prognostic device that would typically involve MRMC studiescomparing human readers with and without AI assistance. Therefore, there is no effect size of human readers improving with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable, as this is a physical medical device, not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for this special 510(k) is the established performance and safety profile of the predicate device (BKS® Revision Sleeves System, K181569) as demonstrated through its initial clearance and compliance with recognized consensus standards. The modified device is tested against these established benchmarks using engineering principles and standardized tests to confirm equivalence.

8. The Sample Size for the Training Set

Not applicable. There is no training set in the context of machine learning or AI models, as this is a physical medical device.

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

Not applicable, for the same reason as point 8.

Ask a specific question about this device

This device is intended for use in total hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:

• Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
• Previously failed hip surgery.
• Fractures of the femoral neck or head.
• Avascular necrosis of the femoral head.
• Congenital dysplasia or other structural abnormalities where stock exists to properly seat the prosthesis.

The Legend® Acetabular Shell is a one-piece, hemispherical shell prostheses, designed for single, uncemented use. Device fixation is achieved via press-fit into a prepared acetabulum, which maximizes contact between the shell and bone.

The Legend® Acetabular Shell is manufactured from titanium alloy Ti-6A1-4V ELI per ASTM F136. The outer surface of the shells are coated with commercially pure titanium (CPT)(ASTM F1580) sintered porous coating. The inner surface of the shell is designed to lock together with the Escalade® and Legend® Acetabular Liners which are made from extensively cross-linked polyethylene. The Legend® Acetabular Shell is also designed to be used with cancellous bone screws and apical plugs.

The existing Legend® Acetabular Shell (K161080) is coated with commercially pure titanium (CPT) sintered bead coating. This submission allows a similar sintered coating to be applied by an additional supplier: Avalign Thortex (MAF-2607) in addition to the original supplier.

This document is a 510(k) premarket notification for a medical device called the "Legend® Acetabular Shell." It describes a submission to add an additional supplier for a porous titanium coating that is applied to an existing device.

Therefore, the submission does not involve the development or testing of an AI/ML device. The performance data section refers to mechanical testing of the coating material to ensure it meets established orthopedic implant standards, not the performance of an AI model.

As such, I cannot provide details regarding acceptance criteria and studies for an AI/ML device, as this documentation pertains to a traditional orthopedic implant. There are no mentions of AI, machine learning, deep learning, algorithms, or any related terms.

The sections you requested (acceptance criteria table, sample sizes, expert qualifications, ground truth, MRMC, etc.) are applicable to AI/ML device submissions, which are not present in this document.

Ask a specific question about this device

This device is intended for use in total and hemi-hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:

1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis.
2. Previously failed hip surgery.
3. Proximal femoral neck fractures or dislocation.
4. Idiopathic avascular necrosis of the femoral head.
5. Non-union of proximal femoral neck fractures.
6. Treatment of fractures that are unmanageable using other forms of therapy.
7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

Trivictal is a single-piece, tapered, collared and non-collared, hydroxyapatite (HA) and sintered bead commercially pure (Cp) Titanium coated femoral hip stem designed for single use. The stem has a neck with a 12/14 trunnion taper for modular attachment to femoral heads. Trivicta is manufactured from titanium alloy and device fixation is achieved through uncemented press-fit in the medullary canal and through the use of biocompatible HA coating and porous sintered bead coating. The stem has a variety of sizes to accommodate most patients encountered: lengths (101-119mm), horizontal offsets (38-53mm), vertical offsets (29-36mm), resection angle of 41°, and neck angle of 132°. The stem is offered with both standard (STD) and extended (EXT) offsets and with and without a collar. Trivicta™ is compatible with the following Ortho Development devices: CoCr Femoral Heads, Biolox Delta Ceramic Femoral Heads, Solitude™ Unipolar Head, Escalade Acetabular Cup System, Legend® Acetabular Liner, Escalade Legend® Acetabular Shell, and Tri-plus™ DCM Liner.

This looks like a 510(k) summary for a medical device (Trivicta Hip Stem), not an AI/ML powered device. Therefore, the questions related to AI/ML performance criteria, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," training set information, and adjudication methods for ground truth, are not applicable.

The document focuses on demonstrating substantial equivalence to predicate devices through design, materials, indications for use, and performance testing related to the physical characteristics and safety of the hip stem, not software performance.

Here's an analysis of the provided information, focusing on the available details:

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

The document does not present acceptance criteria in a structured, quantitative table with specific target values for performance attributes, as would be typical for an AI/ML device. Instead, it outlines the types of non-clinical mechanical tests performed and states that the device was found to be "safe for its intended use" and "performs as well as the legally marketed predicates" based on these tests.

However, based on the categories of testing performed, we can infer some general "acceptance criteria" and "reported performance":

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

This document details tests on the physical medical device (hip stem), not a data-driven AI/ML model. Therefore, "sample size for the test set" typically refers to the number of physical device units or test specimens used in mechanical testing. The document does not specify the exact number of samples for each mechanical test, nor does it refer to "data provenance" in the context of patient data. The tests are in vitro (laboratory) tests on the device itself.

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. "Ground truth" in the context of AI/ML refers to expert labels on data. For a physical medical device like a hip stem, ground truth is established by objective engineering and scientific measurements and adherence to established material and mechanical standards. There are no human "experts" establishing ground truth in the AI/ML sense for these in vitro physical tests.

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

This question is not applicable as it relates to expert review for AI/ML ground truth, which is not relevant to the physical testing of a hip stem.

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 question is not applicable. MRMC studies are used to evaluate the diagnostic performance of AI-assisted systems compared to human readers. This document describes a physical medical device, not an AI system.

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

This question is not applicable as it pertains to AI/ML algorithm performance.

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

For the physical device, the "ground truth" for its performance is based on:

• Adherence to recognized international and national standards (e.g., ISO 11137 for sterilization, ISO 11607 for shelf life/packaging, ISO 10993-1 for biocompatibility, ISO 21535, ASTM F1160, ISO 7206-6, ISO 7206-4, ASTM F2582 for mechanical testing).
• Objective physical and chemical measurements obtained during laboratory testing.
• Comparison to predicate devices that have established safety and effectiveness.

8. The sample size for the training set

This question is not applicable as this is not an AI/ML device.

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

This question is not applicable as this is not an AI/ML device.

Ask a specific question about this device

The Ibis™ Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, noncervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (TI - S1/Illium) for the following indications:

1. Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
2. Degenerative Spondylolisthesis with objective evidence of neurologic impairment
3. Trauma (fracture or dislocation)
4. Spinal tumor
5. Failed previous fusion (pseudarthrosis)
6. Spinal stenosis
7. Spinal deformities or curvatures such as scoliosis, kyphosis, or lordosis

The Ibis™ Pedicle Screw System consists of bulleted rods; cannulated polyaxial, and extended tab screws; and set screws; which can be variously assembled to provide immobilization of the thoracolumbar and lumbosacral spine. The Ibis™ Pedicle Screw System maintains compatibility with the Pagoda™ Pedicle Screw System. All components are made from Titanium Alloy (Ti6Al4V).

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria, specifically concerning AI/ML performance metrics, a test set, expert involvement, or training data.

The document is a 510(k) premarket notification from the FDA to Ortho Development Corporation for their Ibis™ Pedicle Screw System. It primarily focuses on the substantial equivalence of this pedicle screw system to previously marketed predicate devices. The information provided is standard for a medical device clearance and includes:

• Device Description: What the Ibis™ Pedicle Screw System is made of and how it works.
• Indications for Use: The medical conditions it is intended to treat.
• Technological Characteristics: How it compares to predicate devices in terms of materials, screw types, and mechanisms.
• Non-Clinical Testing: References to static and dynamic compression and torsion testing performed according to ASTM F1717.
• Conclusion of Substantial Equivalence: Based on similarities in intended use, design, materials, manufacturing, packaging, and mechanical test results.

This document does not involve any AI/ML components, and therefore, the specific questions regarding acceptance criteria for AI/ML performance, test sets, ground truth establishment, expert adjudication, or MRMC studies are not applicable to the content provided.

Ask a specific question about this device

The Encompass® 10/12 Hip Stem is intended for use in total hip replacement surgery. Total hip arthroplasty is intended to provide increased patient mobility and to decrease pain by replacing the damaged hip joint in patients having sufficiently sound bone to support the implants.

The device is intended for use in total hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:

1. Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis
2. Previously failed surgery
3. Proximal femoral neck fractures or dislocation
4. Idiopathic avascular necrosis of the femoral head
5. Non-union of proximal femoral neck fractures
6. Treatment of fractures that are unmanageable using other forms of therapy
7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis

The Encompass® 10/12 Hip Stem is a one-piece, straight femoral stem, designed for single, uncemented use. Device fixation is achieved via press-fit in the medullary canal, which maximizes contact between the stem and bone. The stem is manufactured from wrought titanium alloy Ti-6Al-4V EU per ASTM F136. The proximal portion of the stem is subsequently plasma-sprayed with Commercially Pure Titanium per ASTM F1580. The stem has a neck with a 10/12 trunnion taper for modular attachment to femoral heads. To accommodate various patient anatomies, the stem is offered with and without collars and in a variety of sizes, including the following ranges: lengths (115-143mm), horizontal offsets (32-46mm), and vertical offsets (29-36mm), with a resection angle of 130°, and neck angle of 132°.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. The document does not report any clinical studies or human test subjects. The performance testing was non-clinical (mechanical testing of the device itself).
• Data Provenance: Not applicable. All testing mentioned is non-clinical laboratory testing.

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

• Not applicable. As no clinical studies were performed, there was no human test set requiring expert adjudication for ground truth. The "ground truth" for non-clinical performance testing is based on established engineering standards (ISO).

4. Adjudication Method for the Test Set

• Not applicable. No clinical studies were performed.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a hip stem prosthesis, not an AI or imaging-based diagnostic tool that would typically involve human readers.

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

• Not applicable. This device is a medical implant, not an algorithm, so the concept of "standalone performance" in the context of AI does not apply.

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

• For the non-clinical performance studies, the "ground truth" is established by adherence to internationally recognized engineering and medical device standards (e.g., ISO 7206-6, ISO 7206-4, ISO 21535). These standards define acceptable performance parameters for hip stem prostheses.

8. The Sample Size for the Training Set

• Not applicable. As no clinical studies or AI/algorithm development are reported, there is no "training set." The device is a physical implant.

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

• Not applicable. There is no training set.

Ask a specific question about this device

The Ovation Tribute and Ovation Narrow Hip Stems are intended for use in a total hip replacement surgery. Total hip arthroplasty is intended to provide increased patient mobility and to decrease pain by replacing the damaged hip joint in patients having sufficiently sound bone to support the implants.

Indications for Use:

1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
2. Previously failed hip surgery.
3. Proximal femoral neck fractures or dislocation.
4. Idiopathic avascular necrosis of femoral head.
5. Non-union of proximal femoral neck fractures.
6. Treatment of fractures that are unmanageable using other forms of therapy.
7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

The Ovation Tribute and Ovation Narrow Hip Stems are one-piece, tapered prostheses, designed for single, uncemented use. Device fixation is achieved via press-fit in the medullary canal, which maximizes contact between the stem and bone. The stems are manufactured from titanium alloy Ti-6Al-4V ELI per ASTM F136. Proximally, the stems are coated with titanium plasma spray per ASTM F1580. The stems have a neck with a 12/14 trunnion taper for modular attachment to femoral heads. To accommodate varying patient anatomy, the stems are available in a variety of sizes: lengths (74-142mm), horizontal offsets (34-49mm), vertical offsets (29-36mm), resection angle of 130°, and neck angle of 132°.

The provided document is a 510(k) summary for the Ovation Tribute and Ovation Narrow Hip Stems. It describes the device, its intended use, indications for use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

This document describes a hip stem prosthesis, which is a physical implant, not a software or AI/ML device. Therefore, the questions related to AI/ML device performance (like accuracy, sensitivity, specificity, ground truth, expert adjudication, MRMC studies, or standalone algorithm performance) are not applicable to this submission.

The "study" mentioned in the document is non-clinical performance testing conducted on the physical hip stems, not a study of an AI/ML algorithm's effectiveness.

Here's a breakdown of the relevant information from the document, recognizing that it's for a physical device:

K133386 - Ovation Tribute Hip Stem; Ovation Narrow Hip Stem

1. Table of Acceptance Criteria and the Reported Device Performance

Note: The document states that "Non-clinical performance testing has been conducted in accordance with ISO 7206-6:1992 and distal fatigue in accordance with ISO 7206-4:2010. Range of motion analysis was performed per ISO 21535:2007(E). The plasma spray coating underwent testing for mechanical properties and microstructure analysis." The specific numerical acceptance criteria and detailed performance results are not provided in this summary, but are implicitly met by "in accordance with" and "underwent testing for".

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

• Not applicable. This submission is for a physical medical device (hip stem), not an AI/ML device that uses digital data for testing. The "test set" refers to physical samples of the hip stems subjected to mechanical testing. The sample size for these non-clinical mechanical tests is not specified in this summary.

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

• Not applicable. Ground truth, in the context of AI/ML, refers to human-labeled data. For a physical device, testing against international standards does not involve expert adjudication of "ground truth" in the same way. The standards themselves define the criteria.

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

• Not applicable. Adjudication methods are relevant for resolving discrepancies in human expert labeling for AI/ML ground truth. This is not pertinent to mechanical testing of a physical device.

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

• Not applicable. MRMC studies are used to evaluate diagnostic imaging devices, often with AI assistance. This submission is for a hip stem implant.

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

• Not applicable. This question pertains to AI/ML algorithm performance.

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

• Not applicable. For this physical device, the "ground truth" for its performance is determined by established engineering principles and international standards (ISO standards for mechanical testing).

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of a physical hip stem being submitted under 510(k). This term is exclusive to machine learning.

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

• Not applicable. As there is no training set, this question is irrelevant.

Ask a specific question about this device

KASM® is intended for use in temporary total knee arthroplasty procedures with the following indications:

1. Active sepsis which requires a two-stage revision arthroplasty procedure
2. Skeletally mature patients who will consistently use limited mobility assistive devices such as a walker, canes, crutches, etc., for the entire implantation period
3. Implantation period of 180 days or less
   Use only with polymethylmethacrylate/gentamicin bone cement.
   The articulating cement spacer prosthesis fashioned using the KASM® mold is intended for cemented fixation only.

KASM® knee articulating spacer molds include two single-use molds: one tibial and one femoral. Both molds are comprised of a translucent, firm but flexible USP class VI medical-grade thermoplastic urethane. Multiple sizes are offered for both the femoral and tibia! KASM® molds, in order to accommodate a wide range of patient anatomies. The femoral and tibial molds are to be used in the first stage of a two-stage revision knee arthroplasty. The KASM® knee articulating spacer molds are designed to facilitate a surgeon to intraoperatively fashion a polymethylmethacrylate (PMMA) articulating cement spacer (both femoral and tibial components) which contains gentamicin that will serve as a temporary knee prosthesis for an implantation period not to exceed 180 days. The KASM® cement spacers are for cemented use only.

The provided text describes a medical device, the KASM® Knee Articulating Spacer Molds, and its performance evaluation for regulatory approval. Here's a breakdown of the requested information:

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

The document doesn't explicitly state "acceptance criteria" as quantitative thresholds. Instead, it demonstrates substantial equivalence to a predicate device (StageOne™ Knee Cement Spacer Molds) through various non-clinical tests. The "acceptance criterion" in this context is achieving "substantial equivalence" for each tested property.

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

The document primarily describes non-clinical testing (bench testing) rather than studies involving human subjects or medical imaging data. Therefore, the concepts of "test set sample size" and "data provenance" in the usual clinical study sense are not directly applicable.

• Sample Size for Testing: The specific number of molds or cement spacers tested for each property (e.g., how many were used for the elution rate study or wear study) is not provided in the document.
• Data Provenance: The data originates from the manufacturer's (Ortho Development Corporation) non-clinical testing. No country of origin for data is specified, as these are lab tests. The testing itself would have been conducted by or for the manufacturer. It is inherently retrospective in the sense that it evaluates the manufactured device prototypes.

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 the provided document. The evaluation of KASM® Knee Articulating Spacer Molds is based on non-clinical, mechanical, and material performance studies compared to a predicate device, not on expert interpretation of clinical data or images. Ground truth is established by objective measurements in laboratory settings, not by expert consensus.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies when multiple human readers interpret data (e.g., medical images) and their decisions need to be reconciled. As stated above, this submission focuses on non-clinical performance data.

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 question is not applicable. An MRMC study is a clinical study design used to compare diagnostic accuracy of different methods (e.g., with and without AI assistance) based on multiple readers interpreting multiple cases. The provided document concerns a physical medical device (spacer molds) and its non-clinical performance, not an AI-based diagnostic tool or clinical effectiveness study involving human readers.

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

This question is not applicable. The device is a physical medical device (molds), not an algorithm or software. It does not have "standalone" performance in the context of an algorithm. Its performance is evaluated through material properties and mechanical function.

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

The "ground truth" for the non-clinical tests was established through objective laboratory measurements and tests designed to assess material properties (e.g., elution rate) and mechanical performance (e.g., strength, fatigue, wear). The comparison was made against either the cement manufacturer's reported elution rates or the performance of the predicate device (StageOne™).

8. The sample size for the training set

This question is not applicable. This document describes the evaluation of a physical medical device. There is no concept of a "training set" as would be used for machine learning models or algorithms.

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

This question is not applicable for the same reasons as in point 8.

Ask a specific question about this device

The Ovation 10/12 Hip Stem is intended for use in a total hip replacement surgery. Total hip arthroplasty is intended to provide increased patient mobility and to decrease pain by replacing the damaged hip joint in patients having sufficiently sound bone to support the implants.

The Ovation 10/12 Hip Stem is indicated for use in uncemented total hip arthroplasty procedures in cases of:

1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
2. Previously failed hip surgery.
3. Proximal femoral neck fractures or dislocation.
4. Idiopathic avascular necrosis of femoral head.
5. Non-union of proximal femoral neck fractures.
6. Treatment of fractures that are unmanageable using other forms of therapy.
7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

The Ovation 10/12 Hip Stem is a one-piece press-fit tapered femoral stem, designed for single, uncemented use. The system consists of a variety of sizes to accommodate the majority of patients encountered, lengths (98-142mm), horizontal offsets (34-49mm), vertical offsets (29-36mm), resection angle of 130°, and neck angle of 132°.

The Ovation 10/12 Hip Stem has a rectangular cross-section and provides stability through a 3point fixation. The femoral stem is manufactured from Titanium Alloy (ASTM F-136, Ti-6Al-4V ELI). The proximal portion of the stem is plasma-sprayed with titanium alloy (ASTM F-1580).

The provided text describes the regulatory clearance for the Ovation 10/12 Hip Stem, which is a medical device (hip prosthesis), not an AI/ML clinical decision support tool. Therefore, much of the requested information (e.g., sample sizes for test/training sets, adjudication methods, MRMC studies, ground truth establishment by experts, AI performance metrics) is not applicable to this type of device and is not present in the document.

The document primarily focuses on demonstrating substantial equivalence to existing predicate devices based on design, materials, manufacturing, intended use, and most importantly, mechanical performance through physical testing.

Here's a breakdown of the relevant information from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For physical devices, "acceptance criteria" are typically defined by the performance requirements outlined in the referenced ISO standards. A "Pass" result indicates that the device met these criteria.

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

• Test Set Sample Size: The document specifies "Size 1 Ovation 10/12 Hip Stem EXT (100-1001)" for the fatigue tests. This indicates that a specific size/model of the hip stem was tested. The exact number of samples tested for each fatigue and range of motion test is not explicitly stated, but it would typically involve a small number of physical prototypes (e.g., n=3 or n=5) to demonstrate compliance with the mechanical standards.
• Data Provenance: The data comes from internal testing conducted by Ortho Development Corporation, likely in a laboratory setting according to the specified ISO standards. It is not patient data (retrospective or prospective) from a country of origin.

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

• Not Applicable. This is a physical device. "Ground truth" in the context of AI/ML models (e.g., image annotation by radiologists) does not apply here. The "ground truth" for mechanical testing is adherence to the specified ISO standard requirements under laboratory conditions.

4. Adjudication Method for the Test Set

• Not Applicable. See point 3. Testing is conducted according to a standard protocol, and results are objectively measured.

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

• No. This is a physical orthopedic implant. MRMC studies are relevant for diagnostic devices or AI tools that assist human interpretation.

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

• Not Applicable. This is a physical device, not an algorithm. The mechanical tests (fatigue, range of motion) are standalone performance evaluations of the device itself.

7. The Type of Ground Truth Used

• Mechanical Performance Standards. The "ground truth" is defined by the performance parameters and acceptance limits specified in the referenced ISO standards (ISO 7206-6, ISO 7206-4, ISO 21535). These are objective, quantifiable criteria for the physical properties of the implant.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical device, not a machine learning model that requires a training set. The design of the device is based on engineering principles and existing knowledge of hip prostheses, not on "training data."

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

• Not Applicable. See point 8.

Ask a specific question about this device

The Balanced Knee® System High Flex Vitamin E PS tibial insert and patella are intended for use in cemented total knee arthroplasty procedures with the following.indications:

1. Loss of knee joint configuration and joint function.
2. Osteoarthritis of the knee joint.
3. Rheumatoid arthritis of the knee joint.
4. Post-traumatic arthritis of the knee joint.
5. Valgus, varus, or flexion deformities of the knee joint.
6. Revision procedures where other treatments or devices have failed.

The Balanced Knee® System High Flex Vitamin E (High Flex Vit E) PS tibial insert and patella are machined from extensively crosslinked, compression molded, Vitamin E UHMWPE. Both components are single use only. The High Flex Vit E PS tibial insert must be used in conjunction with the High Flex PS femoral component (K123457). Used together, these components are designed to accommodate increased range of motion up to 150° of flexion. The High Flex Vit E patella may be used in conjunction with the Balanced Knee® System (BKS) femoral components (K994370), the BKS modular femoral components (K060569), or the High Flex PS femoral components (K123457). Both the High Flex Vit E PS tibial insert and patella may be used in conjunction with the BKS standard and modular tibial trays, tibial augments, and stems to complete the semi-constrained modular knee prosthesis. The tibial trays, tibial augments, and stems were approved under K994370 and K031201.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Balanced Knee® System High Flex Vitamin E PS Tibial Insert and Patella:

The provided document is a 510(k) summary for a medical device seeking substantial equivalence to existing predicate devices. It focuses on the technological characteristics and performance data to demonstrate this equivalence, rather than a clinical study with human patients. This is common for devices that are modifications of already approved devices.

1. Table of Acceptance Criteria and Reported Device Performance

The "Performance Data" section (page 2) lists various properties tested. Since this is a 510(k) summary demonstrating substantial equivalence, the "acceptance criteria" are implicitly that the device's performance is "Substantially Equivalent" or "Substantially equivalent or better than" the predicate device(s).

Note: The last item, "High Flex Knee Wear," is reported as a "Decrease in wear over BKS," which suggests an improvement rather than just equivalence. This would still be considered meeting an implicit acceptance criterion of being at least as good as the predicate (or better).

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

The document does not specify sample sizes in terms of number of patients or clinical cases because the studies described are non-clinical (benchtop) tests. The "test set" here refers to the physical samples of the device and predicate devices used in the mechanical and material characterization tests. The provenance of this data is from the manufacturer's internal testing. There is no information about country of origin for data or whether it's retrospective/prospective, as these terms apply to clinical studies.

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

This document describes non-clinical (benchtop) testing rather than studies that require expert-established ground truth from medical imaging or clinical observations. Therefore, there were no medical experts (e.g., radiologists) involved in establishing ground truth for the test set in the way this question implies. Ground truth for these types of tests is established by engineering and material science standards and measurements.

4. Adjudication Method for the Test Set

Not applicable. As this is non-clinical benchtop testing, there is no "adjudication method" involving human experts in the context of clinical studies (e.g., 2+1, 3+1). The results are based on objective physical measurements and comparisons to predicate devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, as this device is not an AI-assisted diagnostic tool. No effect size of human readers improving with AI vs. without AI assistance is reported.

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

No. This is a medical implant (total knee replacement components), not a software algorithm or AI device. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Objective mechanical and material property measurements: Standards for flexion, constraint, contact area, fatigue, crosslinking, and Vitamin E content.
• Comparison to predicate devices: The "ground truth" for substantial equivalence is the established performance characteristics and safety profile of the legally marketed predicate devices. The new device must meet or exceed these established benchmarks.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

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

Ask a specific question about this device