Search Results

1. Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) where massive resection and transplantation are needed.

2. Severe knee joint damage resulting from trauma where massive resection and transplantation are needed.

3. Non-inflammatory degenerative joint disease such as avascular necrosis, osteoarthritis, or traumatic arthritis.

4. Revision of previously failed total joint arthroplasty, osteotomy, or arthrodesis.

5. Joint instability resulting from excessive bone resection

For Femoral component, Hinged/ Tibial baseplate, Hinged/ Cemented tibial stem/ Cemented Straight stem, RHS, non coated/ Cemented Curved stem, RHS, non coated/ Cemented Straight stem, RHS/ Cemented Curved stem, RHS/ Tibial Augment: These devices are single use implant and intended for cemented use only.

For Distal Femoral Component, RHS/ Proximal Tibial Component, RHS/ Tibial stem/ Segment Part, RHS/ Segment Part, RHS, Bridge: These devices are single use implant and PSC and intended for cementless use only.

"United" USTAR II System is used for patients who present large quantity of bone loss and deformity associated with previous failed arthroplasty, ligament deficiencies, tumor resection, or trauma and may require a further operation or reconstruction. The USTAR II System includes implanted arthroplasty components of both the USTAR II Knee System and USTAR II Hip System.

For the subject device, it's an extension line of 510(K) cleared device USTAR II System (K190100), which introduces two new variations:

1. Cemented curved stem, RHS, non-coated: diameter 17×200 mm
2. Tibial stem: stem length from 30mm to 150 mm by stem diameter from diameter 9 to diameter 24

The compatibility of cemented curved stem, RHS, non-coated and tibial stem is same as that of the 510(k) cleared USTAR II system (K190100).

Cemented Curved Stem, RHS, non-coated is an extension in terms of sizes to 510 (k) cleared device USTAR II system (K190100). Its design, materials, geometrical characteristic, locking mechanism, and manufacturing process are identical to that of the 510(k) cleared Cemented Curved Stem, RHS, non-coated.

Tibial stem's design, materials, geometrical characteristic, locking mechanism, and manufacturing process are identical to that of the 510(k) cleared Tibial Stem while the only difference lies in its specification

Please note: The provided FDA 510(k) clearance letter and summary describe a medical device (Stem Extension Line for the USTAR II System), which is an orthopedic implant. This document does not describe an AI/Software as a Medical Device (SaMD).

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/SaMD, including details like "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone performance," "training set size," and "ground truth establishment for training set," are not applicable to this type of device submission.

The provided text focuses on the mechanical and design equivalence of the new implant variations to a previously cleared predicate device. The "study" mentioned refers to non-clinical mechanical analyses.

Below is an interpretation of the requested points adapted to the context of this orthopedic implant:

Acceptance Criteria and Study for the Stem Extension Line (USTAR II System)

1. Table of Acceptance Criteria and Reported Device Performance

For this orthopedic implant, the acceptance criteria are based on established international standards for the mechanical performance of prosthetic components and demonstrate equivalence to the predicate device.

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

• Sample Size for Test Set: Not explicitly stated as a number of physical implants or test articles in the provided summary. For mechanical testing, typically a defined number of test samples are used per standard, but the specific quantity is not given here.
• Data Provenance: The studies are non-clinical mechanical analyses performed to international standards (ISO, ASTM). The origin of the "data" itself would be the laboratory where these mechanical tests were conducted. It's a prospective design verification process, not a retrospective or prospective clinical study with human 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 non-clinical, mechanical device clearance. "Ground truth" in the context of clinical interpretation or diagnosis by experts (e.g., radiologists) is not relevant here. Ground truth is established by standardized material properties, engineering specifications, and mechanical test results per the referenced ISO and ASTM standards. Experts involved would be engineers and material scientists responsible for the design, testing, and analysis, ensuring compliance with manufacturing and performance standards.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 typically refer to consensus readings or evaluations by multiple human experts in studies involving subjective interpretation (e.g., imaging, clinical outcomes). For mechanical testing, the results are quantitative and objective, measured against predefined acceptance criteria from engineering standards.

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

• Not Applicable. MRMC studies are specific to evaluating the clinical performance of diagnostic aids, particularly those involving human interpretation, and are commonly used for AI/ML in medical imaging. This submission concerns the mechanical safety and functionality of an orthopedic implant. No human reader involvement or AI assistance is relevant.

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

• Not Applicable. "Standalone performance" refers to the performance of an AI algorithm independent of human input. This device is a physical orthopedic implant, not an algorithm or software.

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

• The "ground truth" for this type of device is based on engineering standards and specifications. This includes:
  • Material properties: Verifying components meet specified material strengths and compositions.
  • Geometric tolerances: Ensuring dimensions align with design specifications.
  • Mechanical performance: Demonstrating the implant can withstand anticipated loads and stresses as defined by the ISO and ASTM test standards (e.g., fatigue life, static strength).
  • Equivalence to Predicate Device: The primary "ground truth" is that the new variations perform equivalently to or better than the already cleared predicate device under the same test conditions.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device where a "training set" of data is used to develop an algorithm. The "design" and "manufacturing process" are based on established engineering principles and prior validated designs (the predicate device).

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

• Not Applicable. As there is no "training set" in the context of an AI/ML algorithm for this physical device, there is no method for establishing its "ground truth." The design and manufacturing processes are validated through engineering analyses and quality control processes to meet the required specifications and standards.

Ask a specific question about this device

Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:

• Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
• Inflammatory joint disease including rheumatoid arthritis
• Correction of functional deformity including congenital hip dysplasia & fracture non-union or mal-union
• Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
• Failed previous hip surgery including internal fixation or joint fusion, hemiarthroplasty, surface replacement, or total hip replacement
• Dislocation risks (when used with SignaSure Dual Mobility System)

Signature Orthopaedics' Longboard Revision Stem is intended for individuals undergoing revision surgery of the hip only.

Signature Orthopaedics' Origin, Origin TT, Aria, Remedy, Origin-NS, Pegasus, Spartan, World, Everglade and Longboard Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only.

The Longboard Revision Stem is a femoral stem and a partially threaded distal locking screw intended for single use and cementless fixation for revision hip arthroplasties. The components are manufactured from titanium alloy as per ISO 5832-3 and ASTM F136 and the stem has a titanium alloy grit blast along the body. The Longboard Revision Stem is a symmetrical with a neck angle of 135°. The stem body is tapered and finned, while the distal tip is finless to allow for initial version adjustments. The stem neck features a 12/14 taper which allows for compatibility with Signature Orthopaedics' range of previously cleared femoral head components.

This FDA 510(k) Clearance Letter for the Longboard Revision Hip Stem describes a medical device (an orthopedic implant), not a software or AI/ML-based device. Therefore, the questions regarding acceptance criteria and study design for performance evaluation of algorithms and AI/ML systems (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by experts) are not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing for mechanical properties and material characteristics, as is standard for orthopedic implants.

Here's an analysis of the provided information relevant to the device's acceptance criteria and the study that proves it meets them, framed within the context of a physical medical device:

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

For physical medical devices like the Longboard Revision Hip Stem, acceptance criteria primarily revolve around:

1. Safety and Effectiveness: Ensuring the device is safe for its intended use and performs as expected.
2. Biocompatibility: Materials used must be compatible with the human body.
3. Mechanical Performance: The device must withstand anticipated physiological loads and stresses without failure for its expected lifespan.
4. Conformity to Standards: Compliance with established industry and regulatory standards.
5. Substantial Equivalence: Demonstrating that the device is as safe and effective as a legally marketed predicate device.

The study described to prove the device meets these criteria is the non-clinical performance testing and engineering evaluations.

1. Table of Acceptance Criteria and the Reported Device Performance

The document doesn't provide a precise "table" of numerical acceptance criteria in the format typically seen for AI/ML performance (e.g., "Sensitivity >= X%"). Instead, acceptance is inferred from the successful completion of specified engineering tests and adherence to industry standards, followed by a conclusion of substantial equivalence.

• ISO 21535 (Hip Joint Replacement Implants)
• ASTM F2996 (FEA for Hip Femoral Stems)
• ISO 7206-4 (Endurance of Stemmed Femoral Components)
• ISO 7206-6 (Endurance of Neck Region)
• ASTM F543 (Metallic Medical Bone Screws) |
  | Substantial Equivalence: The device is as safe and effective as existing legally marketed predicate devices. | "The Longboard Revision Hip Stem have the same intended use and same indications for use as the predicate devices. The subject devices use the same operating principle, incorporate the same basic design, and are manufactured using the same materials as the predicate devices. Any differences do not raise new questions of safety and effectiveness as established with performance testing. The subject devices are at least as safe and effective as the legally marketed predicate devices." |

Information Not Applicable/Provided for a Physical Device:

The following points are primarily relevant to software, AI/ML, or diagnostic devices, and therefore are not applicable to this 510(k) for a physical orthopedic implant:

2. Sample size used for the test set and the data provenance: Not applicable. Testing is primarily mechanical/physical on device samples, not on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical implant is its physical behavior under load, measured by engineering methods, not expert consensus on images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is for diagnostic interpretation, not an implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm here.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of image interpretation. Ground truth for this device is mechanical integrity, material properties, and functionality under specified conditions, verified by laboratory testing.
8. The sample size for the training set: Not applicable as there is no training set for a mechanical device.
9. How the ground truth for the training set was established: Not applicable.

In summary: The clearance of the Longboard Revision Hip Stem relies on non-clinical, laboratory-based mechanical and materials testing of physical device samples against established industry standards and comparison to predicate devices, to demonstrate its safety and effectiveness for its intended use, rather than on clinical data or AI/ML performance metrics.

Ask a specific question about this device

The InterSpace GV Hip Spacer is indicated for temporary use (maximum 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin and vancomycin are the most appropriate antibiotics based on the susceptibility pattern of the infecting micro-organism(s).

The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

The InterSpace GV Hip Spacer is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.).

The InterSpace GV Hip Spacer is manufactured from PMMA with gentamicin and vancomycin and includes a stainless-steel core as well as a tapered wedge design. The InterSpace GV Hip Spacer is single-use, disposable, and provided sterile. The InterSpace GV Hip Spacer is inserted into the femoral medullary canal and acetabular cavity following the removal of the existing femoral and acetabular implants and debridement as part of a two-stage procedure due to a septic process. The device is protected from bacterial colonization due to the presence of gentamicin and vancomycin.

The provided text is a 510(k) clearance letter for a medical device called the "InterSpace GV Hip Spacer." This type of document is a regulatory approval and outlines the device's intended use, regulatory classification, and a summary of the reasons for its clearance (often by showing substantial equivalence to a predicate device).

However, this document does not contain the specific information required to answer your detailed questions about acceptance criteria and the study that proves the device meets those criteria, particularly regarding AI/algorithm performance and clinical validation.

The document states that "The information summarized in the Design Control Activities Summary demonstrates that the subject InterSpace GV Hip Spacer met the pre-determined acceptance criteria for the verification activities." It then lists the types of performance tests conducted (Mechanical Testing, Analysis of Antibiotic Content, Biocompatibility Assessment, Sterilization Validation, Shelf-Life Validation, Packaging Validation).

These tests are standard for a physical medical device (a hip spacer) to ensure its mechanical integrity, material compatibility, and sterile delivery, which are critical for its safety and function. They are not related to the performance of an AI/algorithm.

Therefore, I cannot populate the table or answer the specific questions related to AI/algorithm performance, ground truth establishment, sample sizes for AI training/testing, or MRMC studies, as the provided text does not describe a study involving an AI or algorithm.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document only generically states that "pre-determined acceptance criteria" were met for these categories. It does not provide the specific numerical or qualitative criteria themselves, nor the detailed results for each test.

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

• Not applicable / Not provided. This document does not describe a study involving a "test set" in the context of an AI/algorithm. The "tests" mentioned are physical and chemical characterizations of the device itself.

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

• Not applicable / Not provided. No AI/algorithm study is described where ground truth would be established by experts.

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

• Not applicable / Not provided.

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, an MRMC study was not done for this device. This is a physical hip spacer, not an AI-assisted diagnostic tool.

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

• No, a standalone algorithm performance study was not done. This device is a physical implant.

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

• Not applicable / Not provided. The "ground truth" for this device's performance would be engineering specifications, material science standards, and in-vitro or in-vivo testing results to confirm physical and biological properties.

8. The sample size for the training set:

• Not applicable / Not provided. No AI/algorithm training set is mentioned.

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

• Not applicable / Not provided. No AI/algorithm training set is mentioned.

In summary: The provided FDA clearance letter pertains to a conventional medical device (a hip spacer) and its physical and material properties, not a software or AI-driven device. Therefore, the questions related to AI/algorithm performance and clinical validation through sophisticated study designs (like MRMC) are not relevant to this document.

Ask a specific question about this device

Mfinity femoral stems are indicated in patients requiring hip arthroplasty.

Total or partial hip arthroplasty is indicated in the following cases:

• Severely painful and/or disabled joint as a result of osteoarthritis, post-traumatic arthritis, inflammatory arthritis or hip dysplasia.
• Avascular necrosis of the femoral head.
• Acute fracture of the femoral head.
• Acute fracture of the proximal femur, suitable to be treated by means of hip arthroplasty.
• Non-union of proximal femur fracture, suitable to be treated by means of hip arthroplasty.
• Primary pathology involving the femoral head but with a non-deformed acetabulum.
• Failure of previous hip surgery:
  • Conservative hip surgery.
  • Internal fixation.
  • Arthrodesis.
  • Partial or total hip arthroplasty.
  • Hip resurfacing replacement.

The Mfinity Femoral System includes implantable devices provided individually packed, sterile and single-use intended for cementless use in total or partial hip arthroplasty to replace the native femoral neck for primary or revision surgery. The product range is composed of three different versions (Mfinity collarless, Mfinity collared and Mfinity L) available in standard and lateral offset.

The Mfinity femoral stem can be combined with the CoCr ball head (K072857, K080885 and K103721), Endo Head (K111145), the MectaCer BIOLOX® forte (K073337), MectaCer BIOLOX® Delta Femoral Heads (K112115) or MectaCer BIOLOX® Option Heads (K131518).

The subject devices are made of titanium alloy according to ISO 5832-11 and coated with Titanium plasma spray according to ASTM F1580 and Hydroxyapatite according with ASTM F1185.

The provided text is an FDA 510(k) clearance letter for the Mfinity Femoral System, which is a hip prosthesis, not a diagnostic AI device. Therefore, the information requested regarding acceptance criteria and studies that prove a device meets those criteria, specifically concerning AI performance metrics, expert adjudication, training set, and test set details, is not applicable to this document.

The document discusses the substantial equivalence of the Mfinity Femoral System to predicate devices based on non-clinical performance data (fatigue tests, ROM evaluation, surface analyses, biocompatibility, shelf-life, pyrogenicity) and states that no clinical studies were conducted.

The acceptance criteria for this type of medical device (hip prosthesis) would typically involve demonstrating mechanical strength, durability, biocompatibility, and sterilization effectiveness based on recognized standards (e.g., ISO, ASTM, European Pharmacopoeia, USP). The "reported device performance" would consist of the results of these non-clinical tests meeting the specified limits of those standards.

Below is a general interpretation of what "acceptance criteria" and "reported device performance" would entail for a hip prosthesis based on the provided document, acknowledging that specific numerical details of these criteria and results are not explicitly stated in this letter but would be in the full 510(k) submission.

Based on the provided FDA 510(k) Clearance Letter for the Mfinity Femoral System:

This document describes the clearance of a hip prosthesis, not an AI-powered diagnostic device. Therefore, the typical elements of acceptance criteria and study designs relevant to AI (such as sensitivity, specificity, AUC, expert consensus, training/test set sizes, etc.) are not applicable to this submission.

The "acceptance criteria" for this device would generally refer to meeting established mechanical, material, and biological performance standards for medical implants. The "study that proves the device meets the acceptance criteria" refers to the non-clinical performance testing conducted.

Here's an attempt to populate the requested table and answer the questions based on the information available, while highlighting the irrelevance of AI-specific questions:

1. Table of Acceptance Criteria and the Reported Device Performance

• Pull-off strength of femoral head
• Range of Motion (ISO 21535) | - Mfinity Fatigue tests performed according to ISO 7206-4 and ISO 7206-6 (Results are assumed to have met specified limits)
• Pull-Off Test On CoCr Femoral Head performed (Results are assumed to have met specified limits)
• Evaluation of ROM according to ISO 21535 performed (Results are assumed to have met specified limits) |
  | Material Performance | - Coating characteristics (cross-section, SEM, XRD) | - Cross sectioned area evaluation of double coated implant surfaces performed
• Scanning Electron Microscopy pictures of double coated implant surfaces taken
• XRD analyses comparing HA coating on Mfinity stem and planar samples performed (Results are assumed to demonstrate acceptable coating properties) |
  | Biocompatibility | - Material safety
• Cytotoxicity, sensitization, irritation, genotoxicity, chronic toxicity, etc. | - Biocompatibility assessment performed (Results are assumed to demonstrate compliance with standards) |
  | Sterilization & Endotoxin| - Bacterial endotoxin levels (European Pharmacopoeia §2.6.14 / USP )
• Pyrogenicity (USP ) | - Bacterial endotoxin test (LAL test) performed
• Pyrogen test performed (Results are assumed to meet requirements, though note indicates not labeled as non-pyrogenic or pyrogen free) |
  | Shelf-Life | - Maintain integrity and performance over specified shelf-life | - Shelf-life evaluation performed (Results are assumed to demonstrate acceptable shelf-life) |

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

• Sample Size for Test Set: Not specified in the FDA letter. For non-clinical tests (like fatigue or material analysis), sample sizes would be determined by the specific ISO/ASTM standards referenced, but these are not diagnostic "test sets" in the AI context.
• Data Provenance: The data comes from the "Non-Clinical Studies" and "Performance Testing" conducted by Medacta International S.A. No country of origin is explicitly stated for the testing labs or data generation, but the company is based in Switzerland. The studies are by nature prospective in that they are conducted specifically to test the device's performance against standards.

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 hip prosthesis, not an AI diagnostic device. There is no concept of "ground truth" established by experts in the context of interpreting images or medical conditions for this device. The "ground truth" for the performance tests would be the established scientific and engineering principles and the limits defined by the relevant ISO/ASTM standards.

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

• Not Applicable. As this is not an AI diagnostic device, no adjudication method was used. Performance is assessed directly against objective engineering and material 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 hip prosthesis, not an AI-assisted diagnostic tool. No MRMC study was performed, and there is no AI assistance involved. The letter explicitly states: "No clinical studies were conducted."

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

• Not Applicable. This is not an algorithm or AI device. The device (a physical implant) is evaluated standalone based on its inherent properties and performance against physical and material standards.

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

• The "ground truth" for the non-clinical performance tests is based on established engineering and material science standards and specifications (e.g., ISO 7206, ISO 21535, ASTM F1580, ASTM F1185, European Pharmacopoeia, USP). The device's performance is compared against the requirements and acceptance limits set forth in these standards.

8. The sample size for the training set

• Not Applicable. This device did not involve machine learning or a "training set."

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

• Not Applicable. This device did not involve machine learning or a "training set."

Ask a specific question about this device

The Hip Spacer with gentamicin preserves the joint space and the length of the affected limb, which results in the maintenance of the entire abductor and stabilizer apparatus of the hip. Its use is indicated for a limited period, in patients who require a Two-stage Revision Arthroplasty. A systemic antibiotic therapy should also be prescribed while the spacer remains implanted. The Hip Spacer is implanted after the removal of the infected implant, as a regular Hemiarthroplasty. The spacer is inserted into the femoral canal, and a handmade ring of PMMA bone cement with antibiotic may be added to the base of the spacer's neck in order to increase stability. The spacer is kept "in place" until it is replaced by the final prosthesis according to medical criteria. The Hip Spacer must not remain implanted for more than 6 months. Once this period has elapsed, it must be explanted and a permanent device implanted or another appropriate treatment performed.

The Knee Spacer with gentamicin maintains the articular space, the length of the affected limb, and the ligament apparatus of the knee. Its use is indicated for a limited period, in patients who require a Two stage Revision Arthroplasty. A systemic antibiotic therapy should also be prescribed while the spacer remains implanted. The Knee Spacer is placed like a regular arthroplasty, after the removal of the original implant. This knee spacer consists of two independent parts: a tibial plate and a femoral component. The first has a flat base where the femoral component articulates. It is recommended that both components be adapted to the bone by means of a small amount of bone cement with antibiotic. The Knee Spacer must not remain implanted more than 6 months. Once this period has elapsed, it must be explanted and a permanent device implanted or another appropriate treatment performed.

The Shoulder Spacer with gentamicin preserves joint space and length of the affected limb, resulting in maintenance of the entire shoulder muscle and stabilizer complex. Its use is indicated for a limited period, in patients who require a Two-stage Revision Arthroplasty. A systemic antibiotic therapy should also be prescribed while the spacer remains implanted. The Shoulder Spacer is placed as a hemiarthroplasty after the original implant has been removed. The spacer is inserted into the humeral canal and a ring of bone cement with antibiotic can be added to the base of the neck of the spacer for added stability. The Shoulder Spacer should not remain in place for more than 6 months. Once this period has elapsed, it must be explanted and a permanent device implanted or another appropriate treatment performed.

The Synicem Hip, Knee, and Shoulder Spacers are combination products made from fully formed polymethylmethacrylate (bone cement) with gentamicin. The bone cement is prepared from a powder component and a liquid component. The hip and shoulder spacers contain a stainless steel core of 316L in accordance with ASTM F138. The spacers are temporary implants utilized to maintain the joint space during two-stage revision arthroplasties. The spacer implant is placed as part of the first stage of the two-stage revision when the original prostheses are removed due to joint infection. Once the infection is cleared, the spacers are removed and replaced with a permanent prosthesis as part of the second stage of the revision process. The joint spacers are not intended to be implanted for longer than 6 months. They are a single use device and supplied sterile.

This document is a 510(k) clearance letter for the Synicem Hip, Knee, and Shoulder Spacers. These are medical devices, specifically temporary implants used in two-stage revision arthroplasties following joint infections.

The information provided outlines the substantial equivalence of the Synicem Spacers to previously cleared predicate devices. It describes the device, its intended use, technological characteristics, material composition, sizes, and various performance tests conducted.

However, a critical point to understand is that this document DOES NOT describe an AI/ML-based device. It is a clearance for a traditional medical device (joint spacers). Therefore, many of the requested criteria related to AI/ML systems (such as test set sample size, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this submission.

The document focuses on demonstrating that the new Synicem Spacers are "substantially equivalent" to existing, legally marketed predicate devices in terms of safety and effectiveness, based on non-clinical performance testing (mechanical, antibiotic elution), biocompatibility, and MRI safety.

Here's an analysis based on the provided document, addressing the applicable criteria and explicitly stating where information is not available due to the nature of the device:

Device: Synicem Hip Spacer, Synicem Knee Spacer, Synicem Shoulder Spacer
Type of Device: Traditional Medical Device (Non-AI/ML)

Acceptance Criteria and Reported Device Performance

Given that this is a traditional medical device (joint spacer) and not an AI/ML algorithm, the "acceptance criteria" are based on demonstrating substantial equivalence to predicate devices through various non-clinical performance tests and adherence to relevant standards. There isn't a "performance metric" in the sense of accuracy, sensitivity, or specificity as one would expect for a diagnostic AI.

The acceptance criteria are implicitly met by demonstrating that the Synicem Spacers "met performance requirements and is substantially equivalent to the predicate device" across several categories.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

• Knee Spacers: Fatigue performance and wear testing performed. Results showed equivalence to predicate.
• Shoulder Spacers: Static and dynamic fatigue testing performed. Results showed equivalence to predicate. |
  | Antibiotic Elution Profile | Elution kinetics of gentamicin are equivalent to predicate devices. | Antibiotic Elution Kinetics testing conducted. Results demonstrated elution kinetics equivalent to predicate spacers. |
  | Biocompatibility | Biological safety suitable for intended use, in accordance with ISO 10993 standards and FDA guidance. | - Cytotoxicity (ISO 10993-5)
• Sensitization (ISO 10993-10)
• Irritation (ISO 10993-23)
• Acute systemic toxicity (ISO 10993-11)
• Material mediated pyrogenicity (ISO 10993-11)
• Genotoxicity (ISO 10993-3)
• Intramuscular implantation (ISO 10993-6)
• Local Effects after Bone Implantation / Subchronic Systemic Toxicity (ISO 10993-6 and ISO 10993-11)
• Chemical characterization (ISO 10993-18)
• Toxicological risk assessment (ISO 10993-17)
  Conclusion: Materials are biologically safe and suitable for intended use. |
  | MRI Safety | Meet MR safety classifications as "MR Safe" or "MR Conditional" as determined by testing. | - Synicem Knee Spacer: "MR Safe"
• Synicem Hip and Shoulder Spacers: "MR Conditional"
  (Testing conducted according to FDA guidance) |
  | Sterilization & Shelf Life | Sterilization methods validated according to international standards and FDA guidance; packaging maintains functionality and safety. | Sterilized using well-established methods; validations performed following international standards and FDA guidance. Compatibility between packaging and sterilization ensured; packaging preserves functionality and safety throughout declared shelf-life. |

Study Details (Applicability to AI/ML context)

Since this is a non-AI/ML device submission, most of the requested study details pertinent to AI/ML performance validation are not applicable (N/A). The "study" here refers to the non-clinical performance testing done to establish substantial equivalence.

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

   • N/A. This is not an AI/ML device. The "test set" would refer to the physical samples of the spacers used for mechanical, biocompatibility, and elution testing. The provenance would be the manufacturing site (United Kingdom).

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

   • N/A. This is not an AI/ML device requiring expert-labeled ground truth data. Performance for this device is based on objective measurements from mechanical and chemical tests, and biological assays.

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

   • N/A. Not applicable for objective non-clinical performance testing of a physical device.

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

   • No. This is a physical medical device (joint spacer), not an AI system designed to assist human readers. MRMC studies are not relevant.

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

   • N/A. There is no "algorithm" in this device. Its performance is inherent in its physical and chemical properties.

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

   • N/A. The "ground truth" for this device's performance is established by validated engineering and scientific test methods (e.g., ASTM standards for material properties, ISO standards for biocompatibility, gravimetric analysis for elution profiles). It's based on physical measurements and biological reactions, not subjective interpretation requiring "expert consensus" in the diagnostic sense.

7. The sample size for the training set:

   • N/A. This is not an AI/ML device; there is no "training set."

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

   • N/A. Not an AI/ML device; no "training set" or "ground truth for training."

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.

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

Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:

• Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
• Inflammatory joint disease including rheumatoid arthritis
• Correction of functional deformity including congenital hip dysplasia
• Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
• Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

Signature Orthopaedics' Origin, Origin TT, Aria, Remedy, Origin-NS, Pegasus, Spartan, World and Everglade Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only.

Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants), and Origin Cemented femoral stems and SignaSure Cemented Cups are intended for cemented fixation only.

Signature Orthopaedics' SignaSure Logical/World Metal Insert is indicated for use with a cementless Signature Orthopaedics' Logical/World Acetabular Cup to provide dual mobility articulation.

Signature Orthopaedics' constrained liner components are indicated particularly for 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.

Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head and BiPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:

• Acute femoral head or neck fracture
• Fracture dislocation of the hip
• Avascular necrosis of the femoral head
• Non-union of femoral neck fractures
• Certain high subcapital and femoral neck fractures in the elderly
• Degenerative arthritis involving only the femoral head

Signature Orthopaedics' Origin™ Cemented Hip Stems are manufactured from nitrogen stainless steel per ASTM F1568 and ISO 5832-9. The subject stem is straight and tapered with a lateral chamfer. The Cemented Origin™ stem is polished and intended for cemented use in total hip arthroplasty. It features a 12/14 taper which allows for compatibility with Signature Orthopaedics' range of previously cleared femoral head components including the Signature CoCr Femoral Heads (K121297 and K163081), Signature Ceramic Femoral Heads (K190704), Signature BiPolar Head (K133370 and K163081) and Evolve UniPolar Head (K143184). Compatible acetabular cups and liners including the Logical Cup (G-Series K121297, PX-Series K121297 and C-Series K153131) and the Logical Liners (Neutral and 10º Hooded, Lateralised K121297), Logical Liners (20º Hooded, Lateralised 20º Hooded K153131), Logical Constrained Liners (K153131) and Logical Liners Vit-E (Neutral and 10º Hooded, Lateralised, 20º Hooded, Lateralised 20º Hooded, High Wall, 10º Face Changing (K241690).

Based on the provided FDA 510(k) Clearance Letter for the Origin™ Cemented Hip Stem, there is no information present regarding acceptance criteria or a study proving that the device meets specific acceptance criteria in the context of an AI/human reader performance study.

This document is a 510(k) clearance for a physical medical device (a hip stem), not a software or AI-enabled device that would typically involve acceptance criteria related to accuracy, sensitivity, specificity, or human reader performance. The "Performance Testing" section refers to non-clinical mechanical and fatigue testing of the physical hip stem, not a clinical or human-in-the-loop study as described in your request.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, sample sizes for test sets, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment for AI/human reader studies.

If you have a document related to an AI/software device, please provide that, and I would be happy to analyze it against your criteria.

Ask a specific question about this device

Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:

• · Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
• · Inflammatory joint disease including rheumatoid arthritis
• · Correction of functional deformity including congenital hip dysplasia
• · Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
• Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

Signature Orthopaedics' Origin TT, Aria, Remedy, Origin-NS, Pegasus, Spartan, World and Everglade Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only.

Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants), Origin Cemented femoral stems and SignaSure Cemented Cups are intended for cemented fixation only.

Signature Orthopaedics' SignaSure Logical/World Metal Insert is indicated for use with a cementless Signature Orthopaedics' Logical/World Acetabular Cup to provide dual mobility articulation.

Signature Orthopaedics' constrained liner components are indicated particularly for 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.

Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi- hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:

• · Acute femoral head or neck fracture
• · Fracture dislocation of the hip
• · Avascular necrosis of the femoral head
• · Non-union of femoral neck fractures
• · Certain high subcapital and femoral neck fractures in the elderly
• · Degenerative arthritis involving only the femoral head

The Signature Orthopaedics Origin™ TT Stem is intended for single use and cementless fixation. It is manufactured from titanium alloy as per ISO 5832-3 and has a proximal plasma spray coating of titanium as per ASTM F1580 and hydroxyapatite as per ISO 13779-2. It features a 12/14 taper and is compatible for use with Signature CoCr Femoral Heads (K121297 and K163081), Ceramic Femoral Heads (K190704), Logical™ PX, G and C Series Acetabular Cups (K121297 and K153131), Logical™ Liners (K121297, K153131 and K241690), Logical™ Constrained Liners (K153131), BiPolar Heads (K133370 and K163081) and Evolve™ UniPolar Heads (K143184).

The provided text describes the regulatory review for a medical device called the "Origin™ TT Stem," which is a femoral hip prosthesis. However, the document does not contain any information regarding acceptance criteria, study methodologies for device performance, sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies.

The document primarily focuses on:

• Regulatory classification and product codes for the device.
• Indications for Use of the hip replacement system, including various components beyond just the Origin™ TT Stem.
• Comparison to predicate devices to establish substantial equivalence.
• Non-clinical performance testing (Range of Motion, Stem and Neck Fatigue FEA, Stem and Neck Fatigue Testing) conducted according to established ISO and ASTM standards to demonstrate the strength and safety of the device.

Therefore, I cannot provide the requested table or answer the specific questions about the study that proves the device meets acceptance criteria, as this information is not present in the provided text.

The document states:

• "Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Signature Orthopaedics Origin™ TT Stem is adequate for anticipated in-vivo use."
• "The results of non-clinical testing show that the strength of the Signature Orthopaedics Origin™ TT Stem is sufficient for their intended use and substantially equivalent to the legally marketed predicate device."

This indicates that internal testing was performed, but the details of the "acceptance criteria" and the specific data from these tests are not provided in the 510(k) summary. The document focuses on demonstrating that the device meets existing standards (ISO, ASTM) and is substantially equivalent to predicate devices, rather than presenting a clinical study with detailed performance metrics against specific acceptance thresholds.

Ask a specific question about this device

Indications for Restoration Modular Hip System

• · 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.
  · The RESTORATION Modular Hip System is intended for primary and revision total hip arthroplasty as well as in the presence of severe proximal bone loss. These femoral stems are designed to be proximal femur.

Indications for Accolade C, Accolade HFx, SYSTEM 12 CROSSFIRE, ACCOLADE DISTAL SPACER, CITATION TMZF, PCA Duration Insert, PCA Femoral Head

• · 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

Indications for Accolade II Stems
The indications for use of the total hip replacement prostheses 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 and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
  Additional indication specific to use of ACCOLADE II Femoral Stems 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 intraoperative instability.
  ACCOLADE II Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Indications for OMNIFIT SERIES Acetbular Inserts, Omnifit Crossfire 10 Deg Inserts, Crossfire Inserts, Omnifit Crossfire Inserts, Trident Crossfire Inserts, Trident X3 Inserts, Trident X3 Eccentric Inserts
· Painful, disabling joint disease of the hip from: degenerative arthritis, theumatoid 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 techniques are less likely to achieve satisfactory results.
· Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Indications for ALL POLY CONSTRAINED INSERT, TRIDENT 0 DEG CONSTRAINED INSERT, TRIDENT CONSTRAINED INSERT
A Constrained Acetabular Insert is indicated for use as a component of a total hip prosthesis 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.

Indications for UHR Bipolar

• · Femoral head/neck fractures or non-unions.
• · Aseptic necrosis of the femoral head.
  · Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
  Other Considerations:
  · Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
  · Salvage of failed total hip arthroplasty

Indications for Artisan Bone Plug
These bone plugs are intended to be placed in the femoral canal prior to the introduction of bone cemented hip procedure.
The plug is placed distally to the femoral stem to help allow cement pressurization and to help prevent cement migration further down the femoral canal.

Indications for C-Taper Alumina Ceramic Heads, V40 Taper Alumina Ceramic V40™ Femoral Head
• Painful, disabling joint disease of the hip from: degenerative arthritis, theumatoid 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 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

Indications for BIOLOX Delta Ceramic Heads, C-Taper to Universal Taper Adapter Sleeve, Universal V40™ Taper Adapter Sleeve
For Use as a Total Hip Replacement:
· Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis.
• Revision of previous cup arthroplasty or other procedures
· Clinical management problems where arthrodesis or alternative 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 in the acetabulum.
For Use as a Bipolar Hip Replacement

• · Femoral head/neck fractures or non-unions.
  · Aseptic necrosis of the femoral head.
  • Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
  · Pathological considerations or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
  · Salvage of failed total hip arthroplasty

Indications for ADM/MDM X3 Inserts, MDM Acetabular Inserts, MDM Acetabular Liners
The indications for use for total hip arthroplasty 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. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
6. Dislocation risks
   MDM Liners are intended for cementless use only.

The devices included in this submission are femoral heads, acetabular inserts, distal spacers, and bone plugs, used in hip arthroplasty procedures. All devices have been previously deemed substantially equivalent in prior premarket submissions and are commercially available.

This document, K243784, is a 510(k) premarket notification from Stryker Orthopaedics for a "Hip Devices Labeling Update." It states that the purpose of the submission is to add a contraindication to the labeling of existing Stryker Orthopaedics Hip Devices.

Based on the provided document, the device in question is a physical medical device (hip implants and components) and the 510(k) submission is for a labeling update, specifically adding a contraindication. This is not an AI/ML-enabled medical device. Therefore, the questions regarding acceptance criteria and studies proving the device meets those criteria, particularly those related to AI/ML device performance (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, standalone algorithm performance, ground truth establishment), are not applicable to this submission.

The document explicitly states under "Non-Clinical Testing" and "Clinical Testing":

• "Non-Clinical testing was not required as a basis for substantial equivalence."
• "Clinical testing was not required as a basis for substantial equivalence."

This indicates that no performance studies (clinical or non-clinical in the context of device performance metrics) were conducted or needed to be submitted for this specific 510(k) approval, as the change is solely a labeling update concerning a contraindication, and the device itself (the physical hip implant) has previously been deemed substantially equivalent.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria and performance studies for an AI/ML device, as this context does not apply to the provided document.

Ask a specific question about this device

Hip Spacer Molds with stainless-steel reinforcement stems, centralizers and Hip Head Inserts are indicated for use to mold a temporary hemi-hip spacer for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary hemi-hip spacer is molded using Cemex Genta LV, and inserted into femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection). The temporary hemi-hip spacer made from Hip Spacer Molds is not intended for use more than 180 days, at which time it must be explanted, and permanent devices implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). Due to the inherent mechanical limitations of the temporary hemi-hip spacer material (Cemex Genta LV) the temporary hemi-hip spacers is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers) throughout the implant period.

Femoral Knee Spacer Molds and Tibial Knee Spacer Molds are indicated for use to mold a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using Cemex Genta LV and inserted into the joint space following removal of the existing total knee replacement implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The temporary total knee spacer made from the Femoral Knee Spacer Molds and Tibial Knee Spacer Molds is not intended for use more than 180 days, at which time it must be explanted, and permanent devices implanted, or another appropriate treatment performed (e.g., resection arthroplasty fusion, etc.). Due to the inherent mechanical limitations of the temporary total knee spacer material (Cemex Genta LV), the temporary total knee spacer is only indicated for patients who will consistently use traditional mobility devices (e.q., crutches, walkers) throughout the implant period.

Shoulder Spacer Molds with stainless-steel reinforcement stems, centralizers and Shoulder Head Inserts are indicated for use to mold a temporary hemi-shoulder spacer for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary hemi-shoulder spacer is molded using Cemex Genta LV, and inserted into femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection). The temporary hemi-shoulder spacer made from Shoulder Spacer Molds is not intended for use more than 180 days, at which time it must be explanted, and permanent devices implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). Due to the inherent mechanical limitations of hemi-shoulder prothesis material (Cemex Genta LV) the temporary hemi-shoulder prothesis is only indicated for patients who will consistently follow activity limitations throughout the implant period.

The Hip Spacer Molds are sterile, single use molds used for forming of interim prothesis from bone cement. These interim prothesis are intended as temporary hemi-hip spacers in a two-stage septic hip joint endoprosthesis. The Hip Spacer Molds are available as modular system, which is combinable to obtain different sized spacers.

The Femoral and Tibial Knee Spacer Molds are sterile, single use molds used for forming of interim prothesis from bone cement. These interim prothesis are intended as temporary knee spacers in a two-stage septic knee joint endoprosthesis. The Knee Spacer Molds are available as modular system, which is combinable to obtain different sized spacers.

The Shoulder Spacer Molds are sterile, sinqle use molds used for forming of interim prothesis from bone cement. These interim prothesis are intended as temporary hemishoulder spacers in a two-stage septic glenohumeral joint endoprosthesis. The Shoulder Spacer Molds are available as modular system, which is combinable to obtain different sized spacers.

This FDA 510(k) clearance letter pertains to medical device molds (Hip, Knee, Shoulder Spacer Molds) used to create temporary orthopedic spacers. The submission does not describe an AI/ML powered device and therefore, the information requested about acceptance criteria and studies proving the device meets the criteria in the context of AI/ML is not available in the provided text.

The document discusses performance data related to the physical characteristics of the molds and the resulting spacers, but not in the context of an AI/ML algorithm's performance. Therefore, I cannot provide information on:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample size and data provenance for an AI/ML test set.
• Number and qualifications of experts for AI/ML ground truth.
• Adjudication method for an AI/ML test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study for AI assistance.
• Standalone AI algorithm performance.
• Type of ground truth used for AI/ML.
• Sample size and ground truth establishment for an AI/ML training set.

The performance data mentioned in the document relates to:

• Sterilization and Shelf Life: Validation according to ISO 11135, shelf life of 2 years.
• Biocompatibility: Categorized per ISO 10993-1, with tests performed including Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Intracutaneous reactivity (ISO 10993-23), Pyrogenicity (ISO 10993-11), and Acute systemic toxicity (ISO 10993-11).
• Mechanical Performance Testing:
  • Endurance properties of stemmed femoral hip components according to ISO 7206-4 and ISO 7206-6.
  • Wear of total knee-joint prosthesis according to ISO 14243-1.
  • Endurance properties of tibial trays according to ASTM F1800.
  • Endurance properties of shoulder spacer stem and neck region based on ISO 7206-4 and ISO 7206-6.
  • Antibiotic (gentamicin) elution testing.

These tests are designed to demonstrate the physical and biological safety and effectiveness of the medical device molds and the spacers they produce, showing substantial equivalence to predicate devices, rather than evaluating the performance of an AI/ML algorithm.

Ask a specific question about this device