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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.

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Bone Cement LV and HV are indicated for the fixation of joint prostheses to living bone in orthopedic musculoskeletal surgical procedures for rheumatoid arthritis, sickle cell anemia, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions and revision of previous arthroplasty.

Bone Cement Genta are intended for the fixation of prosthesis to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

The Bone Cement Genta are PMMA, radiopaque bone cements, containing gentamicin designed for the fixation of prosthesis to the living bone. The devices are a traditional bone cement product. The liquid is contained in a vial and the powder in a sachet; these components are packaged in unitary blister with Tyvek lid, which is placed in an aluminum bag. The components are manually mixed immediately prior to use. The devices are sold disposable and sterile. The Bone Cement Genta are available in a low and high viscosity version.

The Bone Cement are PMMA, radiopaque bone cements designed for the fixation of prosthesis to the living bone. The devices are a traditional bone cement product. The liquid is contained in a vial and the powder in a sachet; these components are packaged in unitary blister with Tyvek lid, which is placed in an aluminum bag. The components are manually mixed immediately prior to use. The devices are sold disposable and sterile. The Bone Cement are available in a low and high viscosity version.

The provided text is a 510(k) summary for polymethylmethacrylate (PMMA) bone cements. It details the device's characteristics, intended use, and comparison to predicate devices. However, this document does not contain the specific acceptance criteria or the study results in the format or level of detail requested for the device performance.

The section titled "PERFORMANCE DATA" (starting on page 9) lists the types of performance testing conducted but does not provide quantitative acceptance criteria or the reported device performance. It only states that the performance data demonstrate that the new devices are substantially equivalent to the predicate devices, and meet the requirements of the Special Controls Guidance Document.

Therefore, I cannot complete the table of acceptance criteria and reported device performance from the provided document. Similarly, details about sample sizes, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, or training set specifics for an AI/algorithm are not present as this document pertains to a bone cement, not an AI or imaging device.

If this were an AI/imaging device submission, the provided information would be insufficient to answer most of the requested points.

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The KYPHON™ VuE™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesing a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathological fracture may include a symptomatic microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.

KYPHON™ VuE™ Bone Cement is a polymethylmethacrylate (PMMA) acrylic resin intended for use for vertebroplasty or kyphoplasty procedures, and sacroplasty procedures. KYPHON™ VuE™ Bone Cement is a modification of the KYPHON® Xpede™ Bone Cement. Like the predicate, KYPHON™ VuE™ Bone Cement contains approximately 30% barium sulfate. However, KYPHON™ VuE™ Bone Cement contains barium sulfate in two forms (powder and granules) whereas the predicate has only the powder form of barium sulfate. The larger radio-opaque granules of barium sulfate increase visualization of the acrylic resin during delivery using fluoroscopy. KYPHON™ VuE™ Bone Cement is provided sterile in two components: 20 grams of powder and 9 grams of liquid. The powder contains methylmethacrylate-styrene copolymer, barium sulfate and benzoyl peroxide. The liquid contains methylmethacrylate (monomer), hydroquinone and N,N-dimethyl-p-toluidine. The components are manually mixed immediately prior to use.

This document is a marketing clearance (510(k)) for a medical device, KYPHON™ VuE™ Bone Cement, and as such, it primarily focuses on demonstrating "substantial equivalence" to a predicate device rather than providing detailed acceptance criteria and performance data in the format typically seen for an AI/ML medical device.

Key takeaway: This document describes a PMMA bone cement, not an AI/ML device. Therefore, the specific types of acceptance criteria and study designs (e.g., MRMC studies, ground truth establishment with experts, data provenance for test/training sets) that are applicable to AI/ML devices are not relevant to this 510(k) submission and are not present in the provided text.

The document discusses acceptance criteria and performance data related to the physical and chemical properties of the bone cement, its biocompatibility, sterility, and shelf life, comparing it to existing predicate devices.

However, to answer your request using the information available and adapting it to the framework you provided (even though it's designed for AI/ML), I will interpret "acceptance criteria" and "device performance" in the context of this traditional medical device.

Acceptance Criteria and Device Performance for KYPHON™ VuE™ Bone Cement

The acceptance criteria for KYPHON™ VuE™ Bone Cement, as described in this 510(k) submission, are primarily based on demonstrating substantial equivalence to legally marketed predicate devices, particularly KYPHON® Xpede™ Bone Cement and Spineplex™ Bone Cement. This equivalence is established through various performance tests that ensure the new device meets established standards for bone cements.

1. Table of Acceptance Criteria and the Reported Device Performance (Adapted for a Non-AI/ML Device):

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InterSpace Knee is indicated for temporary use (maximum 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process.

InterSpace Knee is applied on the femoral condyles and on the tibial plate following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection).

InterSpace Knee 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.). Because of the inherent mechanical limitations of the device material (gentamicin/polymethylmethacrylate), the is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period

InterSpace Knee ATS is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process, and where a large tibial defect is present.

InterSpace Knee ATS is applied on the tibial plate following removal of the existing implant and radical debridement. The device must be combined with the tibial component of InterSpace Knee. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

InterSpace Knee ATS 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.). Because of the inherent mechanical limitations of the device material (gentamicin/polymethacrylate), the Interspace Knee ATS is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.

The InterSpace Knee, cleared by FDA via K101356 and K062274, is a temporary spacer device available in three sizes (S-M-L). With this 510(k) submission, Tecres is adding the additional XL size to the FDA cleared range of InterSpace Knee sizes.

The InterSpace Knee ATS is a temporary spacer device available in four sizes, intended to be combined with the tibial component of InterSpace Knee. Specific sizes of the InterSpace Knee ATS are compatible with certain InterSpace Knee sizes.

The devices, as single device (InterSpace Knee, K101356 and K062274) or once InterSpace Knee is combined with the InterSpace Knee ATS, provide patients with a temporary, complete knee implant that allows for a natural range of motion and partial weight-bearing during treatment of the infection, and preserves the soft tissue to prevent further complications, such as muscular contraction, to facilitate the subsequent joint replacement procedure after systemic treatment of the underlying infection.

The InterSpace Knee XL size and InterSpace Knee ATS components are sterile, single-use device intended for temporary use (maximum 180 days) as a partial joint replacement. The devices are made of fully formed polymethylmethacrylate (PMMA), which is radio-opaque and contains gentamicin. The mass used to fill the molds (the unformed PMMA resin) is prepared from powder and liquid components. The liquid component consists of methylmethacrylate (MMA), N,N- dimethyl-p-toluidine and hydroquinone; the powder component consists of PMMA, barium sulphate, benzoyl peroxide and gentamicin sulphate.

The provided document is a 510(k) Premarket Notification from the FDA, and it describes a medical device called "InterSpace Knee Extra-Large Size" and "InterSpace Knee ATS." This document details the device's indications for use, its characteristics, and how it compares to predicate devices to establish substantial equivalence.

Crucially, this document focuses on establishing the substantial equivalence of new sizes/components of an existing knee spacer device based on engineering and material performance criteria, NOT on clinical diagnostic performance criteria for an AI/ML-driven device.

Therefore, most of the requested information regarding acceptance criteria and studies for AI/ML device performance (e.g., sample sizes for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) is not applicable to this document. This submission is for a physical medical implant, not a diagnostic or AI-powered device.

However, I can extract the relevant "acceptance criteria" (in the context of engineering performance) and reported performance from the document.

Acceptance Criteria and Reported Device Performance (Engineering/Material Focus):

The "acceptance criteria" in this context refer to passing various engineering and material tests, often by meeting the requirements of recognized standards (ISO, ASTM) or by demonstrating equivalence to a predicate device that has previously met these standards. The "reported device performance" indicates that the device did meet these criteria.

Since this document is for a physical orthopedic implant and not an AI/ML diagnostic tool, the following points are not applicable and cannot be answered from the provided text:

2. Sample sized used for the test set and the data provenance: Not applicable to a physical device performance study of this nature. Performance tests are typically conducted on a minimal number of samples to demonstrate compliance with standards.
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 an AI/ML diagnostic is typically based on clinical expert consensus or pathology; for this device, "ground truth" refers to physical and chemical properties confirmed by laboratory testing.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of diagnostic performance. "Ground truth" here is the adherence to material and mechanical specifications.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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Mendec Spine HV / Mendec Spine HV System is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Mendec Spine HV and Mendec Spine HV System are highly viscous, radioopaque acrylic resins (PMMA based) for percutaneous vertebroplasty or kyphoplasty. These devices are made with the same raw material, but are supplied in different ways: . Mendec Spine HV is a traditional bone cement product: the liquid is contained in a vial and the powder in a sachet; these components are packaged in unitary PVC-blister with Tyvek lid, which is placed in an aluminum bag. . Mendec Spine HV System holds the powder and liquid components separately within a closed syringe-like device haa serves as a mixing chamber. The device is packaged in unitary PVC-blister with tray, sealed with Tyvek lid, which is placed in an aluminum bag. The devices are sold disposable and sterile.

The provided text describes a 510(k) summary for the Tecres Mendec Spine HV and Mendec Spine HV System, which are polymethylmethacrylate (PMMA) bone cements for vertebroplasty/kyphoplasty. This type of submission relies on demonstrating substantial equivalence to predicate devices, rather than a novel study proving a device meets specific clinical acceptance criteria in the way an AI/ML device would.

Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable to this type of device submission.

Here's how the available information maps to your request:

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

For a PMMA bone cement, acceptance criteria are typically defined by demonstrating that the device has comparable material and mechanical properties to legally marketed predicate devices.

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

Not applicable for this type of device. The "test set" here refers to the actual physical devices undergoing laboratory testing for their material and mechanical properties, not a clinical data set. The provenance of the data is from Tecres S.P.A.'s own performance testing.

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

Not applicable. Ground truth, in the context of device performance, relates to laboratory measurements and conformity to recognized standards or comparison to predicate device specifications, not expert interpretation of clinical data.

4. Adjudication method for the test set

Not applicable. This is not a clinical study involving human readers or interpretations needing adjudication.

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

Not applicable. This is not an AI/ML device, and no MRMC study was performed.

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

Not applicable. This is a medical device (bone cement), not an algorithm.

7. The type of ground truth used

The "ground truth" for this device is based on established material science and engineering principles, and comparison to the specifications and performance of legally marketed predicate devices. This includes:

• Physical measurements of mechanical properties (e.g., strength, viscosity).
• Chemical analysis of material composition and properties (e.g., setting time, monomer release).
• Verification that the device meets safety and performance standards equivalent to the predicates.

8. The sample size for the training set

Not applicable. There is no AI/ML model, hence no training set.

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

Not applicable. There is no AI/ML model, hence no training set or ground truth establishment method for it.

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Interspace Shoulder is indicated for temporary use (maximum of 180 days) as a shoulder replacement (SR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The head and stem are inserted into the glenoideal cavity and the humeral medullary canal, respectively, following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection). Interspace Shoulder 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 Shoulder devices is a temporary device composed of fully formed PMMA bone cement with gentamicin and an inner stainless steel metal core. The design mimics a hemi-shoulder prosthesis.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Tecres Interspace Shoulder Temporary Shoulder Prosthesis:

Based on the provided 510(k) summary (K112983), this submission is for a modified medical device, not a new AI/software-as-a-medical-device (SaMD) or diagnostic device. As such, the typical "acceptance criteria" and "study" questions you'd ask for an AI model's performance metrics (like sensitivity, specificity, AUC) are not directly applicable in this context.

Instead, the "acceptance criteria" here refer to production specifications and performance adequate for in vivo application under temporary conditions of use, and the "study" is a performance testing conducted to demonstrate substantial equivalence to a previously cleared device.

Here's the breakdown of the information as requested, translated into the context of this medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the performance testing was to verify that the implant performance "continues to meet the production specifications and be adequate for in vivo application under the temporary conditions of use." The primary "acceptance criteria" seem to be demonstrating that the modified device is substantially equivalent to its predicate (K060535) despite the addition of a metal reinforcing structure and a new material supplier.

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

• Test Set Sample Size: Not explicitly stated. The "performance testing" described is likely mechanical and chemical testing of the device itself and its components, rather than a clinical trial with patient data. Therefore, the "test set" would refer to the number of devices or material samples subjected to laboratory tests (e.g., fatigue testing, tensile strength, gentamicin elution studies). Without further documentation, the exact number cannot be determined from this summary.
• Data Provenance: Not applicable in the sense of patient data. The testing would have been conducted in a laboratory setting by the manufacturer (Tecres S.p.A.).

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

• Number of Experts: Not applicable. For material and mechanical performance testing, "ground truth" is established through standardized engineering and chemical testing methods, not expert consensus on clinical cases.
• Qualifications of Experts: Not applicable. The testing would be performed by qualified engineers, chemists, and technicians following established protocols.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This type of testing involves objective measurements against predefined specifications, not human interpretation requiring adjudication.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI diagnostic tool on human reader performance, which is not the nature of this device.

• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. This device is an implanted prosthesis, not an algorithm or a software device.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the performance testing, the "ground truth" would be established by:
  • Engineering specifications and standards: For mechanical properties (e.g., ISO standards for implant materials, internal design specifications for strength and durability).
  • Chemical analysis standards: For gentamicin release and stability (e.g., pharmacopeial methods, validated analytical chemistry techniques).
  • Comparison to predicate device's established performance: To demonstrate substantial equivalence.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not an AI/machine learning device. The device itself is the product. The term "training set" is not relevant here.

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

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

Summary of the 510(k) Submission's Core Argument:

The K112983 submission for the Interspace Shoulder Temporary Shoulder Prosthesis argues for substantial equivalence to its own previously cleared version (K060535). The key modifications are the introduction of a metal reinforcing structure and a new material supplier. The manufacturer conducted performance testing (mechanical properties, gentamicin release, and stability data) to demonstrate that these changes did not negatively impact the device's ability to meet its production specifications and remain adequate for its temporary in vivo application. The FDA's clearance indicates that they found this demonstration of substantial equivalence sufficient without requiring complex clinical trials or new performance metrics beyond what was presented for the predicate device.

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Spacer-K is indicated for temporary use (maximum of 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process.

Spacer-K is applied on the femoral condyles and on the tibial plate following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

Spacer-K is not intended for use for more than 180 days, at which time it must be explanted and permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). Because of the inherent mechanical limitations of the device material (gentamicin/polymethylmethacrylate), Spacer-K is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.

Spacer-G is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process.

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

Spacer-G 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.).

Spacers are temporary joint prostheses. Spacer-G is a single piece device that mimics a hemi-hip prosthesis, and is available in six sizes. Spacer-K includes a femoral and tibial component, and is available in three sizes. Spacer-G and Spacer-K are made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin). Spacer-G contains an inner stainless steel (AISI 316L stainless steel) reinforcing structure. The mass used in the filling of the molds (the PMMA unformed resin) is prepared from a powder component and a liquid component. The liquid component consists of methylmethacrylate, N,N-dimethyl-p-toluidine, hydroquinone; the powder component consists of polymethymethacrylate, barium sulphate, benzovl peroxide, and gentamicin sulphate.

The Spacer devices provide patients, undergoing a two-stage revision procedure for an infected total joint, a temporary implant to 1) allow for partial weight bearing and 2) provide a natural range of motion. The devices also maintain a patient's soft tissue and joint space, preventing further complications such as muscular contraction. The gentamicin protects the device from bacterial colonization.

Here's a breakdown of the acceptance criteria and study information for the Tecres Spacer-G and Spacer-K, based on the provided documents:

Acceptance Criteria and Device Performance

The provided 510(k) summary (K101356) does not explicitly state specific quantitative acceptance criteria or detailed performance data in a table format. Instead, it relies on substantiating that the modified devices (Spacer-G and Spacer-K) are substantially equivalent to their previously cleared versions (K062274 for Spacer-K and K062273 for Spacer-G).

The core acceptance criterion implicitly stated is:

• The modified Spacer devices must perform equivalently to their previously cleared versions, ensuring continued safety and effectiveness for their intended temporary use.

The reported device performance is described as:

• "Performance testing was conducted to verify that implant performance continues to meet the production specifications and be adequate for in vivo applications under the temporary conditions of use."
• "Mechanical properties, gentamicin release and stability data were evaluated and found to support the substantial equivalence of the devices."

Without quantitative metrics provided in these documents, a table cannot be fully populated. However, we can infer the categories of assessment:

Study Information

The 510(k) summary for K101356 describes an evaluation for "substantial equivalence" rather than a de novo clinical study with patients. The study primarily involves performance testing to compare a modified device (minor material change) to an established, previously cleared device.

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

   • The document does not specify the sample size for any test set in terms of clinical data or patient cohorts. The performance testing appears to be conducted on the devices themselves (e.g., in vitro mechanical testing, elution studies).
   • Data provenance: Not explicitly stated as retrospective or prospective clinical data. Given the nature of a 510(k) for a minor material change to a previously cleared device, the testing would likely be bench testing and possibly some in vitro or ex vivo studies. No specific country of origin for clinical data is mentioned as such data doesn't appear to be the primary basis for this particular submission.

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

   • Not applicable in the context of this 510(k) submission. The evaluation is based on engineering and material science performance testing, not on interpretation of patient data by medical experts. "Ground truth" here refers to established material properties and performance benchmarks.

3. Adjudication method for the test set:

   • Not applicable as there is no mention of a human expert review or adjudication process for a test set of clinical cases. The evaluation is against engineering specifications and pre-established performance of the predicate 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:

   • Not applicable. This device is a temporary orthopedic implant, not an AI-powered diagnostic or assistive tool.

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

   • Not applicable. This device is a physical medical device.

6. The type of ground truth used:

   • Engineering specifications and performance characteristics of the previously cleared predicate devices (K062274 and K062273). The "ground truth" for the modified device's performance is that it matches or exceeds the established performance of its predecessors, as demonstrated through mechanical, gentamicin release, and stability testing.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning study, so there is no concept of a "training set."

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

   • Not applicable.

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Cemex Genta/Cemex Genta System/Cemex Genta System Fast bone cement is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

All Cemex Genta bone cements contain the same individual chemical constituents. The liquid components contain methylmethacrylate, N-N dimethy] p-toluidine and hydroquinone. The dry powder component contains polymethylmethacrylate, barium sulphate, benzoyl peroxide and gentamicin sulphate.

The provided text does not contain information about specific acceptance criteria with numerical performance targets for the device (Cemex Genta bone cement) or a detailed study proving its direct performance against such criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices through performance testing based on established standards.

Here's a breakdown of what can be extracted and what is not available in the given document:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not explicitly provided in the format requested. The document states that "Performance testing was conducted to verify that the modified bone cement performance continue to be adequate for in vivo applications and meet the requirements of ISO5833 and ASTM 451-99." However, it does not list specific numerical acceptance criteria (e.g., tensile strength > X MPa) or the precise performance values achieved by the Cemex Genta devices against those criteria. It only states that the properties were "evaluated and found to support the substantial equivalence of the device."

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

• Sample Size: The document does not specify the sample size used for performance testing.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only mentions "in vivo applications," which implies testing relevant to biological systems.

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

This information is not applicable as the document describes performance testing of a physical medical device (bone cement) against engineering standards (ISO and ASTM), not a diagnostic or AI-driven system requiring expert-established ground truth from a test set of images or clinical cases.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3.

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

MRMC studies are relevant for diagnostic devices that involve human readers interpreting data, often with AI assistance. This document describes a bone cement, which is a therapeutic device. Therefore, an MRMC study was not done, and the concept of human readers improving with AI assistance is not relevant here.

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

This concept is also not applicable to a bone cement. The "device" itself is the bone cement, not an algorithm. Its performance is evaluated through material and mechanical testing, not as a standalone algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for evaluating the bone cement's performance was based on meeting the requirements of ISO 5833 and ASTM 451-99. These are international and American standards for "Implants for surgery – Acrylic resin cements" and "Standard Specification for Acrylic Bone Cement," respectively. These standards define the physical, chemical, and mechanical properties expected of such cements.

8. The Sample Size for the Training Set:

This information is not applicable. Bone cement is a physical product, not an AI model that requires a training set.

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

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

Summary of available information regarding the study:

• Study Type: Performance testing of chemical-physical and mechanical properties, gentamicin release, and stability data.
• Purpose: To verify that the modified bone cement's performance remains adequate for in vivo applications and meets the requirements of ISO 5833 and ASTM 451-99.
• Conclusion: The properties were "evaluated and found to support the substantial equivalence of the device."
• Comparison: The modified Cemex Genta cements were found substantially equivalent to predicate devices (Cemex Genta and Cemex Genta System cleared via K033596; Cemex Genta System Fast cleared via K043403).

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Spacer-K is indicated for temporary use (maximum 180 days) as an adjunct in total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. Spacer-K is only indicated for an implantation period of 180 days or less. Because of the inherent mechanical limitations of the device material (gentamicin/polymethilmethacrylate), Spacer-K is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes ) throughout the implantation period.

The Spacer-K is a temporary device that mimics a "total knee prosthesis". The two-component unconstrained design incorporates a femur and tibial component, it's fully formed by gentamicin/polymethyImethacrylate (PMMA) bone cement.

This 510(k) summary for the Spacer-K knee prosthesis modification does not include the detailed information required to describe acceptance criteria and a study proving device performance in the way you've outlined. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a performance study with acceptance criteria.

However, I can extract information related to the device's characteristics and the basis for its clearance:

Here's what can be gathered, and what is explicitly missing from the provided text:

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

• Missing from the document. The 510(k) summary states that the modified Spacer-K has "equivalent performance and mechanical characteristics" to the predicate Spacer-K (K032522) and a "similar gentamicin release profile" to another predicate (K050210). However, it does not provide specific acceptance criteria (e.g., minimum tensile strength, specific drug release rates) or reported numerical performance data from a study.

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

• Missing from the document. There is no description of a specific test set or clinical study with patient data. The equivalence is based on design, materials, and mechanical characteristics (likely bench testing or literature review, but details are not provided).

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)

• Missing from the document. This type of information is relevant for studies involving subjective assessment (e.g., image interpretation), which is not the primary focus of this 510(k) application.

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

• Missing from the document. Not applicable given the type of submission.

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

• Missing from the document. Not applicable. The Spacer-K is a physical medical device (a temporary knee prosthesis), not an AI-assisted diagnostic tool.

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

• Missing from the document. Not applicable.

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

• Missing from the document. For a device like this, "ground truth" would typically refer to established engineering standards for materials and mechanical properties, or validated methods for drug release testing. The document refers to "equivalent performance and mechanical characteristics" and "similar gentamicin release profile," implying that these aspects were compared to predicate devices, but the specific methodologies for determining this "truth" are not detailed.

8. The sample size for the training set

• Missing from the document. Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

• Missing from the document. Not applicable.

Summary of what the document DOES provide regarding clearance:

The device (Spacer-K Modification) received 510(k) clearance (K062274) based on a demonstration of substantial equivalence to legally marketed predicate devices.

• Predicate Devices:
  • Spacer-K device (K032522): The modified Spacer-K has the "same design, incorporates the same materials, has equivalent performance and mechanical characteristics, and has the same shelf and packaging" as this predicate.
  • Biomet Stage One Disposable Cement Spacer Mold for Temporary Knee Prosthesis with Reinforcement Stem (K050210): The modified Spacer-K has a "similar gentamicin release profile" when used with Biomet Cobalt G HV Bone Cement (K051532).

Key Takeaway: This 510(k) summary is typical for a device modification, where the primary goal is to show that the new version is as safe and effective as a previously cleared device. It does not contain the kind of detailed performance study and acceptance criteria you would expect from a de novo submission or a product requiring extensive clinical trials. The "study" here is essentially the comparison against the predicate devices across defined parameters (design, materials, mechanical characteristics, drug release).

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

Spacer-G is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) bone cement. The one piece design mimics a hemi-hip prosthesis.

This 510(k) summary for the Spacer-G device primarily focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a study with specific acceptance criteria and performance data for the device itself.

Therefore, many of the requested sections about acceptance criteria, study design, and performance metrics are not explicitly detailed in this document. The core of this submission is to show that the modified Spacer-G is just as safe and effective as already approved devices by having similar design, materials, performance characteristics, and gentamicin release profile.

Here is an attempt to address your requests based on the provided text, highlighting where information is absent:

Acceptance Criteria and Study to Prove Device Meets Criteria: Spacer-G Modification

The provided 510(k) summary for the Spacer-G device demonstrates substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria directly linked to a novel performance claim for the modified device. The "acceptance criteria" can be inferred as the standard for substantial equivalence, meaning the device must perform comparably to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the 510(k) summary. Given the nature of a substantial equivalence submission relying on comparison to existing devices, it is unlikely a large "test set" in the sense of a clinical trial was used for this specific modification. The "performance" assessment appears to be based on engineering principles and potentially laboratory testing rather than human clinical outcomes data.

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

This information is not applicable/provided. The submission focuses on substantial equivalence based on technical and material characteristics, not on a clinical ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not applicable/provided. There is no mention of a clinical test set requiring adjudication in this 510(k) summary.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This device is a temporary hip prosthesis, not an AI or imaging diagnostic device that would involve human readers or AI assistance.

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

This information is not applicable. This device is a medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the performance characteristics of the legally marketed predicate devices. The modified Spacer-G is evaluated against these established benchmarks. No pathology, outcomes data, or expert consensus specific to the modified device's novel performance is referenced as a "ground truth" to meet new performance criteria.

8. The Sample Size for the Training Set

This information is not applicable. This device is not an AI algorithm requiring a training set.

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

This information is not applicable. This device is not an AI algorithm.

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