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The Idys™ ALIF (Anterior Lumbar Interbody Fusion) TiVac System is intended for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The Idys™ ALIF TiVac System should be used with the integrated fixation screws provided. The Idys™ ALIF TiVac System is intended to be used with autograft.

The Idys™ ALIF TiVac consists of interbody fusion devices intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the lumbar spine.

The Idys™ ALIF TiVac System is designed for use as a lumbar intervertebral body fusion device. The device is manufactured from medical grade polyetheretherketone (INVIBIO PEEK OPTIMA LT1) coated with titanium on its superior and inferior surfaces and is to be used with autograft.

The device has a shape which restores the intervertebral height and lordosis. The device contains two slots to receive the autologous bone graft to promote the fusion process between the endplates. The superior and inferior surfaces of the implant coated with titanium are designed with teeth which interact with the surface of the vertebral endplates and helps in resisting back out. The Idys™ ALIF TiVac System is a standalone system intended to be used with plate and four bone screws, autogenous bone graft and requires no additional supplementary fixation. The Idys™ ALIF TiVac System cages are made of ASTM F2026 compliant polyetheretherketone (PEEK) coated with compliant ASTM F1580 titanium and, markers made of Tantalum according to ASTM F560, the plate and screws are made of ASTM F136 titanium alloy. It is essential to insert implants with instrumentation specifically designed for this purpose. The cages, plates and screws are provided sterile and are for single use only.

This document describes the marketing clearance for a medical device implant, specifically an intervertebral body fusion device, not an AI/Software as a Medical Device (SaMD). Therefore, the typical "acceptance criteria" and study designs related to diagnostic accuracy, sensitivity, specificity, or reader performance for AI/SaMD are not directly applicable.

The performance criteria for this device, a physical implant, are primarily based on biocompatibility and mechanical testing to demonstrate its safety and effectiveness compared to a previously cleared predicate device.

However, I can extract the relevant information from the provided text regarding the closest equivalent to "acceptance criteria" and "proof of meeting these criteria" for this specific type of medical device.

Key Information regarding Device Evaluation:

• Device Name: Idys™ ALIF TiVac
• Product Type: Intervertebral Body Fusion Device (Implantable)
• Regulatory Class: Class II
• Product Code: OVD
• Regulatory Mechanism: 510(k) Premarket Notification (demonstrates substantial equivalence to a legally marketed predicate device, rather than requiring de novo clinical trials for novel devices).

Based on the provided text, here's a breakdown of the information, adapting the requested categories to fit the context of an implantable medical device undergoing 510(k) clearance:

1. Acceptance Criteria and Reported Device Performance (Adapted for an Implantable Device)

For this type of device, "acceptance criteria" are not framed as diagnostic accuracy metrics but rather as meeting established performance standards for implants to demonstrate functional equivalence and safety to a predicate device.

• Static and dynamic axial compression testing
• Static and dynamic compression shear testing
• Subsidence testing
• Expulsion testing
• Static torsion testing
• Wear testing (PEEK and titanium particles) |
  | Coating Integrity & Performance | The added plasma-sprayed titanium coating must meet established standards for adhesion, strength, and durability. This includes:
• Static tensile strength
• Static shear strength
• Shear fatigue strength
• Abrasion resistance
• Coating porosity/thickness |
  | Clinical Equivalence (Indications for Use) | The device must have the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device, with any differences not raising new safety or effectiveness issues. |

Reported Device Performance:

• Biocompatibility: "The modified device has been demonstrated to be biocompatible in accordance with ISO 10993-1 Part 1."
• Mechanical Testing (Device Functionality): "The results of these studies were determined to be substantially equivalent to legally marketed devices." (Referring to functional tests such as axial compression, shear, subsidence, expulsion, torsion, and wear).
• Mechanical Testing (Coating Performance): Coating tests (static tensile, static shear, shear fatigue, abrasion resistance, porosity/thickness) were performed "with satisfactory results."
• Clinical Equivalence: "The Idys™ ALIF TiVac is as safe and effective as the Idys™ ALIF (K172083). The Idys™ has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Idys™ ALIF TiVac and its predicate device do not raise any new issues of safety or effectiveness. Performance data demonstrate that the Idys™ ALIF TiVac is as safe and effective as its predicate."

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

• Sample Size: Not applicable in the context of human patient data for an AI test set. This device's performance was evaluated via bench testing of physical prototypes/samples. The specific number of mechanical test specimens used for each test (e.g., how many devices were subjected to axial compression) is not stated in this summary but would be detailed in the full premarket notification.
• Data Provenance: The data primarily originates from laboratory bench testing performed by the manufacturer, CLARIANCE SAS, in France ("Beaurains, France"). This is not retrospective or prospective human patient data.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

• Not Applicable. For a physical implantable device, "ground truth" is not established by human expert interpretation of medical images or clinical outcomes in the same way as for AI/SaMD. Instead, it's based on objective, quantifiable physical and mechanical properties measured in a lab setting against established ASTM/ISO standards.
• The "experts" involved would be engineers, material scientists, and quality assurance personnel conducting the mechanical and biocompatibility tests.

4. Adjudication Method for the Test Set

• None. Adjudication methods like "2+1" or "3+1" are specific to establishing ground truth from multiple human readers for diagnostic AI/SaMD. In this context, the "ground truth" for the device's performance relies on direct physical measurements and compliance with engineering standards.

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

• No. This type of study is specifically designed for AI systems that aid human readers in diagnostic tasks. It is not relevant for an implantable medical device.

• Effect Size of Human Readers Improvement: Not applicable.

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

• No. This refers to the evaluation of AI algorithm performance. This product is a physical implant, not an algorithm.

7. Type of Ground Truth Used

• The "ground truth" for this device's performance is based on objective, quantifiable physical and mechanical properties measured through bench testing against established industry standards (e.g., ASTM, ISO) and comparison to the mechanical properties of the predicate device.
• Biocompatibility: In vitro and in vivo (animal, if applicable, though not specified here) testing against ISO 10993-1.

8. Sample Size for the Training Set

• Not Applicable. This is not an AI/machine learning device that requires a "training set." The device itself is the product, evaluated based on its physical properties.

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

• Not Applicable. As there is no AI training set, there is no ground truth establishment for it.

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The Idys™ TLIF TiVac cages are indicated for use with autologous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplementation, which has been cleared by FDA for use in the lumbar spine.

The Idys™ TLIF TiVac consists of interbody fusion devices intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the lumbar spine.

The Idys™ TLIF TiVac cages, which have various widths and heights, are designed for use as lumbar intervertebral body fusion devices. The device has a shape which restores the intervertebral height and lordosis. The device contains two slots to receive the autologous bone graft to promote the fusion process between the endplates. The device has to be used with autograft.

The superior and inferior surfaces of the implant are designed with "teeth" to help prevent the device from migrating once it is positionally, the rough plasma-sprayed titanium surface interacts with the surface of the vertebral endblates and helps resist back out. The Idys™ TLIF TiVac cages are made of compliant ASTM F2026 polyetheretherketone (PEEK Optima®) with markers made of compliant ASTM F560 Tantalum and are coated with plasma-sprayed titanium compliant with ASTM F1580. Idys™ TLIF TiVac cages are positioned using a set of surgical instruments common for transforaminal lumbar approach. It is essential to insert implants with instrumentation specifically designed for this purpose. The cages are provided sterile and are for single use only.

The provided text is a 510(k) summary for the Idys™ TLIF TiVac intervertebral body fusion device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results of new device performance against acceptance criteria. Therefore, much of the requested information regarding detailed acceptance criteria, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, and stand-alone algorithm performance is not typically part of a 510(k) submission for this type of device and is not present in the provided text.

However, based on the information available, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence of the Idys™ TLIF TiVac are primarily based on demonstrating comparable performance to the predicate devices through mechanical testing and biocompatibility assessments. The "reported device performance" is essentially the statement that the device met these comparability goals.

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

• Sample Size: Not specified in terms of number of devices or clinical cases. The tests described are bench mechanical and biocompatibility tests, not clinical performance tests on human subjects.
• Data Provenance: The tests are described as "bench mechanical testing" and "biocompatibility testing," implying laboratory-based studies. The context suggests these were conducted by the manufacturer, Clariance SAS, a French company. Therefore, the data would be from non-clinical, prospective laboratory testing (meaning the tests were designed and conducted to evaluate the device as part of the submission process).

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

Not applicable. The "ground truth" for mechanical and biocompatibility testing is defined by the standards (ASTM and ISO) and the physical properties of the materials and device under test, not by expert consensus on clinical cases.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically for clinical studies where human interpretation or classification is involved.

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

No. This type of study is for evaluating diagnostic or screening devices involving human readers interpreting medical images. The Idys™ TLIF TiVac is an intervertebral body fusion device (implant), not an imaging diagnostic tool.

6. Standalone Performance (i.e. algorithm only without human-in-the-loop performance)

Not applicable. This device is an implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for these tests is the quantitative and qualitative outcomes expected under the specified ASTM and ISO standards for mechanical stability, durability, and biocompatibility. For example, "satisfactory results" for coating tests imply meeting predefined thresholds or performance levels dictated by the standards.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not a machine learning or AI device. The submission is based on engineering testing and comparison to predicate devices.

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

Not applicable for the same reason as above.

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The TIVA™ device is attached to a peripheral IV catheter for use as a direct blood draw device into a vacuum tube or a syringe.

The TIVA™ device is a sterile, single use device. It is a needle- free blood collection device that attaches to a peripheral IV system (PIV). The device is comprised of an inner tube with plunger, proximal flexible tube with female luer, and outer barrel with male luer. The male luer attaches to the PIV system. The female luer attaches to a blood transfer device or syringe. The device is then advanced to collect a blood sample. Once complete, the device is retracted and removed from the PIV. The device comes in two sizes compatible with 20 and 22 gauge PIV's, respectively.

The provided document is a 510(k) summary for the TIVA™ blood specimen collection device (K152924). It compares the subject device to a predicate device (K142946). The document does not include information about AI/ML models or clinical studies involving human readers or comparative effectiveness studies of AI vs. human readers. Therefore, I can only address aspects related to the device's functional and safety testing as described.

Based on the provided information, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document details performance testing for both the predicate and subject devices. The "acceptance criteria" are implied by successful completion of these tests, demonstrating the device meets its functional and safety requirements.

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

The document does not specify the exact sample sizes (number of devices tested) for the functional and safety tests. It generally refers to "representative samples of the device." The data provenance is internal testing conducted by Velano Vascular, Inc. (the manufacturer). The testing is retrospective in the sense that it's performed on manufactured devices as part of product verification.

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

This information is not provided. The ground truth for functional and safety testing is typically established by engineering specifications, recognized industry standards (like ISO standards), and internal quality control protocols. The "experts" would be the engineers and technicians performing and validating these tests, ensuring they follow established procedures and standards.

4. Adjudication Method for the Test Set

Not applicable in the context of functional and safety testing of a medical device. The tests have predefined pass/fail criteria based on engineering specifications and industry 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. The TIVATM device is a mechanical blood collection device, not an AI/ML-driven diagnostic or interpretative tool. Therefore, no MRMC study or AI-related comparative effectiveness study was performed.

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

Not applicable, as the device is a mechanical blood collection tool and does not involve any algorithm or AI.

7. The Type of Ground Truth Used

For the functional and safety testing described, the ground truth is based on:

• Engineering Specifications: Defined parameters for device performance (e.g., specific thresholds for leak testing, joint strength).
• Recognized Standards: International standards like ISO 10993 (biocompatibility) and ISO 11137-1 (sterilization).
• User Feedback: The document explicitly states the addition of the clamp was based on "user feedback that a clamp is preferred when using blood control devices with a syringe." This indirectly influences the "ground truth" for a desirable functional feature.

8. The Sample Size for the Training Set

Not applicable, as the device is a mechanical one and does not involve AI/ML requiring a training set.

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

Not applicable, as no training set for AI/ML was used.

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The TIVA™ device is attached to a peripheral IV catheter at the time of IV catheter placement for use as a direct blood draw device into a vacuum tube or a syringe.

The TIVATM device is a sterile, single use device. It is a needle-free blood collection device that attaches to a peripheral IV system (PIV). The device is comprised of an inner tube with plunger, proximal flexible tube with female luer, and outer barrel with male luer. The male luer attaches to the PIV system. The female luer attaches to a blood transfer device or syringe. The device is then advanced to collect a blood sample. Once complete, the device is retracted and removed from the PIV. The device comes in two sizes 20 and 22 gauge.

The provided text is a 510(k) summary for the TIVA™ blood specimen collection device. It describes the device, its intended use, and its substantial equivalence to a predicate device based on functional and performance requirements and a comparison of design specifications.

However, the document does not contain specific acceptance criteria, a detailed study proving performance against those criteria, or information regarding sample sizes for training/test sets, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC).

The section titled "Functional and Safety Testing" briefly mentions that "representative samples of the device underwent biocompatibility, sterilization, and mechanical testing in accordance with the following industry standards," but it does not provide the results of these tests or specific acceptance criteria for them.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information on the study specifics as the input document does not contain this level of detail.

In summary, the document states that functional and safety testing was performed according to industry standards, but it does not report the acceptance criteria or the specific performance results for the TIVA™ device.

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The Universal Locking System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including:

• Comminuted fractures
• Supracondylar fractures
• Extra-articular fractures
• Fractures in osteopenic bone
• Nonunions
• Malunions

The Zimmer Universal Locking System is a plate and screw system intended for internal fracture fixation. The plate selection consists of dual compression, reconstruction, tubular, straight "T" and "L" plate configurations. Plates accommodate either standard or locking screws via figure-8 shaped holes.

This document is a 510(k) summary for the Zimmer Universal Locking System: 2.7 mm Locking Plates and Screws. It describes a medical device, its intended use, and its comparison to a predicate device. The review of this document indicates some limitations in providing a comprehensive answer to the detailed questions about acceptance criteria and a study that proves device meets criteria, as the document does not contain that level of detail, especially concerning clinical study methodology, statistical analysis, or ground truth establishment relevant for AI/software-as-a-medical-device (SaMD) evaluations.

Here's a breakdown of the information available and what is not explicitly stated in the provided text:

Key Takeaway: This document is a 510(k) premarket notification for a traditional medical device (bone plates and screws), not a software or AI-driven medical device. Therefore, many of the questions related to AI/SaMD study methodologies (like ground truth, expert consensus, MRMC studies, training/test set sample sizes, data provenance for AI models) do not apply directly to this submission. The "Performance Data" section specifically mentions "Non-Clinical Performance and Conclusions," indicating laboratory testing, not clinical studies in the context of typical AI/SaMD evaluations.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable in the context of typical AI/SaMD test sets. The "performance data" refers to non-clinical (laboratory) testing, which would involve a number of physical device samples tested under controlled conditions. The specific number of samples tested is not provided in this summary.
• Data Provenance: Not applicable in the context of clinical data for AI/SaMD. The performance data comes from "non-clinical (laboratory) performance testing." The country of origin for this testing is not specified, but the submitter is based in the USA.

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

• This question is not applicable to this 510(k) submission. Ground truth established by experts is a concept relevant to the evaluation of AI/software medical devices, which process and interpret data (e.g., images, signals). This device is a physical implant (bone plates and screws). The "ground truth" for its performance would be established through engineering specifications, material science testing, and biomechanical evaluations, not expert clinical consensus on data interpretation.

4. Adjudication Method for the Test Set

• This question is not applicable to this 510(k) submission. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert interpretations of data in AI/SaMD studies. The performance assessment here is based on physical/mechanical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance

• This question is not applicable to this 510(k) submission. MRMC studies are specific to evaluating the impact of AI in clinical workflows, typically with human readers interpreting cases. This device is a physical implant; it does not involve human readers interpreting data.

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

• This question is not applicable to this 510(k) submission. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

• This question is not directly applicable in the AI/SaMD sense. For a physical device like bone plates and screws, the "ground truth" for its safety and effectiveness is established through:
  • Engineering specifications and material properties: Conformance to industry standards, material strength, fatigue life, corrosion resistance, etc.
  • Biomechanical testing: Laboratory simulations to demonstrate adequate strength, stiffness, and stability for internal fixation, often comparing against predicate devices or known clinical requirements for bone fixation.
  • Clinical experience with predicate devices: The "substantial equivalence" claim relies on the predicate device's established safety and effectiveness.

8. The Sample Size for the Training Set

• This question is not applicable to this 510(k) submission. Training sets are used to develop AI/machine learning models. This is a physical device, not an AI model.

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

• This question is not applicable to this 510(k) submission, for the same reasons as (8).

Summary of the Study:

The "study" referenced in this 510(k) summary is non-clinical (laboratory) performance testing. The document states:

"The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective."

This testing would have involved evaluating the physical and mechanical properties of the Zimmer® Universal Locking System: 2.7 mm Locking Plates and Screws to ensure they met the required specifications for bone fixation. The safety and effectiveness are also substantiated by demonstrating substantial equivalence to a legally marketed predicate device (Zimmer Universal Locking System, 2.7mm Plates and Screws, K063303). The specific details of these laboratory tests (e.g., types of tests, number of samples, exact methodology, detailed results, specific acceptance criteria beyond "safe and effective") are not provided in this public summary document.

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The TivaMed Cooled RF System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.

TivaMed Cooled RF System uses radiofrequency (RF) energy to selectively heat a given volume of tissue beneath the surface, while cryogen is delivered to the inside of the treatment tip to cool and protect the surface tissue.

The provided text describes the TivaMed Cooled RF System, but it does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data against specific acceptance criteria.

Here's a breakdown of what is and is not present in relation to your request:

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

• Not present. The document mentions "functional and performance requirements" were met, but it does not specify these requirements as acceptance criteria or provide quantitative performance metrics.

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

• Not present. The document states "representative samples of the device underwent biocompatibility, electrical, and mechanical testing," but it does not specify the sample size for these tests or the data provenance.

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

• Not applicable/Not present. As there's no clinical performance study described, there's no mention of ground truth established by experts. The testing described (biocompatibility, electrical, mechanical) are engineering/bench tests, not clinical evaluations requiring expert interpretation of results in a diagnostic context.

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

• Not applicable/Not present. No clinical test set requiring adjudication is described.

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/Not present. This device is an electrosurgical unit, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study and AI performance improvement are not relevant to this submission.

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

• Not applicable/Not present. This is hardware, not an algorithm.

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

• Not applicable/Not present. For the functional and safety testing, "ground truth" would be established by adherence to the specified engineering standards (e.g., IEC 60601-1, ISO 10993-1). There is no clinical "ground truth" mentioned.

8. The sample size for the training set:

• Not applicable/Not present. This is not a machine learning or AI device that would have a training set.

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

• Not applicable/Not present. See point 8.

Summary of available information regarding testing:

The device underwent:

• Functional and Safety Testing:
  • Biocompatibility testing
  • Electrical testing
  • Mechanical testing
• Standards Adhered to:
  • IEC 60601-1: Medical Electrical Equipment - General Requirements for Safety
  • IEC 60601-1-2 (Likely electromagnetic compatibility)
  • IEC 60601-1-4: Medical Electrical Equipment - General Requirements for Safety - Programmable Electrical Medical Systems (though the device itself doesn't appear to be "programmable" in a complex sense, this standard covers certain aspects)
  • IEC 60601-2-2: Medical Electrical Equipment - Particular Requirements for the Safety of High Frequency Surgical Equipment
  • AAMI/ANSI/ISO 11135-1:2007: Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
  • ISO 10993-1: Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
  • Federal Register, Volume 43, No. 122, 1978 (likely for regulatory context or specific test methods)
  • FDA "ETO, ECH, and EG Proposed Maximum Residue Limits and Maximum Limits of Exposure" (for sterilization by-products)

The conclusion is based on the device's "similarities in principles of operation, technology, materials, and indications for use" to its predicate devices, suggesting that the compliance with these standards and functional tests provides the basis for substantial equivalence, rather than a specific clinical performance study against acceptance criteria.

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The NCB Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones.

The Tivanium 3.5mm Locking Screws are intended to be used with the NCB Polyaxial Locking Plate System.

The NCB Polyaxial Locking Plate System is an extramedullary internal fixation plate system to be used for proximal humeral fractures. It is intended to be implanted either percutaneously or by a traditional open method.

The Tivanium 3.5mm locking screws are used to engage the proximal locking screw holes within the NCB Polyaxial Locking Plate System, Proximal Humeral Plates.

This document describes the Zimmer NCB® Polyaxial Locking Plate System and Zimmer® Universal Locking System with 3.5mm Tivanium® Ti-6Al-4V Alloy Locking Screws. It's a 510(k) premarket notification for a Class II medical device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (bone fixation plates and screws), the "acceptance criteria" are primarily related to safety, effectiveness, and substantial equivalence to predicate devices, rather than specific performance metrics like accuracy, sensitivity, or specificity commonly seen in diagnostic AI/software devices. The performance is assessed through non-clinical (laboratory/performance) testing.

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

This device is a hardware implant (plates and screws for bone fixation). The performance testing described is non-clinical (laboratory/performance) testing, not clinical trials involving human subjects or data sets in the way AI/software devices are typically evaluated.

• Sample size for the test set: Not applicable in the context of clinical data. The document does not specify sample sizes for mechanical or laboratory tests, which would typically involve testing a certain number of devices or components under simulated conditions.
• Data provenance: Not applicable. The "data" comes from laboratory and performance testing, not human-derived data like images or patient records.

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

Not applicable. Ground truth for clinical data is not relevant here as the evaluation relies on non-clinical, laboratory performance testing of the hardware. The "ground truth" for such devices is established through engineering standards, biomechanical principles, and documented performance of predicate devices.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically used for clinical data interpretation (e.g., in diagnostic studies) where human experts might disagree. This device was evaluated through non-clinical laboratory testing.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices to assess the impact of AI on human reader performance. This document pertains to a bone fixation hardware device, for which MRMC studies are not applicable.

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, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on engineering specifications, biomechanical testing standards, and performance characteristics established for bone fixation devices. It relies on laboratory test results demonstrating mechanical strength, fatigue resistance, biocompatibility (often implicitly covered by material commonality), and other physical properties under simulated conditions.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware product, not a machine learning model. There is no "training set" in this context.

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

Not applicable, as there is no training set.

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This device is indicated for patients with severe knee pain and disability due to:
• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
· Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
· Moderate valgus, varus, or flexion deformities. · The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
Specific uses with LPS-Flex femorals: · Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. · The LPS-Flex femoral, when used with the LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees.

The LPS-Flex Fixed Bearing Knee is a semiconstrained, condylar system for use without the cruciate ligaments when additional stability is required to prevent anterior subluxation of the femur relative to the tibia in flexion.

This document is a 510(k) premarket notification for a medical device modification, specifically for the NexGen® Complete Knee Solution Legacy® Posterior Stabilized (LPS)-Flex Fixed Bearing Tivanium® Ti-6Al-4V Alloy Femoral Components. It seeks to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

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

   This document does not explicitly list quantitative acceptance criteria in a table format in the way one might expect for a software or diagnostic device. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence through non-clinical (laboratory) performance testing. The main criterion is that the modified device performs comparably to the predicate device and meets safety and effectiveness standards for its intended use.

   Acceptance Criteria (Implicit)	Reported Device Performance
   Device is safe and effective.	The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective.
   Device is substantially equivalent to the predicate device (NexGen® Complete Knee Solution Legacy® Posterior Stabilized (LPS)-Flex Fixed Bearing Femoral and Articular Surface Components, K991581).	The results of non-clinical (laboratory) performance testing demonstrate that the device is substantially equivalent to the predicate device. The modifications (change in material and surface hardening processing) do not change the intended use or the fundamental scientific technology. Device is packaged using the same materials and processes.

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

   The document states: "The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective and substantially equivalent to the predicate device."

   • Sample Size for Test Set: The document does not specify the sample size for the non-clinical (laboratory) performance testing.
   • Data Provenance: The data provenance is "non-clinical (laboratory) performance testing." There's no information about the country of origin or whether it was retrospective or prospective, as these terms typically apply to clinical data.

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

   This is not applicable. The study conducted was non-clinical (laboratory) performance testing of a mechanical device (femoral components for a knee replacement). There was no "ground truth" to be established by human experts in the context of interpreting medical images or data. Performance was likely evaluated against engineering specifications and comparison to the predicate device's characteristics.

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

   This is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in studies involving human interpretation or clinical outcomes, typically for diagnostic devices or AI algorithms. This submission pertains to a mechanical orthopedic implant, where "adjudication" in this sense is not relevant.

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

   This is not applicable. An MRMC study is relevant for evaluating the impact of an AI algorithm on human reader performance, particularly in diagnostic imaging. The device in question is a knee implant component, not a diagnostic AI tool.

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

   This refers to a mechanical device, not an algorithm. Therefore, "standalone algorithm only" testing is not applicable. The "standalone performance" was the non-clinical laboratory testing of the physical components.

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

   This is not explicitly stated in terms of a "ground truth" as it would be for a diagnostic device. For a mechanical implant, "ground truth" generally relates to adherence to design specifications, material properties, mechanical strength, wear characteristics, and biocompatibility, as confirmed through laboratory testing. The implicit ground truth would be that the modified device's performance characteristics (e.g., strength, durability, wear resistance) are equivalent or superior to the predicate device, and meet a predefined set of engineering and biocompatibility standards.

8. The sample size for the training set

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

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

   This is not applicable, as there is no training set for a mechanical implant.

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