Search Results

The A200 Knee System is intended for use in total knee arthroplasty for the following indications:

1. Painful and disabled knee joint resulting from osteoarthritis, traumatic arthritis, traumatic arthritis where one or more compartments are involved.
2. Correction of varus, valgus, or posttraumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
   This device is for cemented use only.

The Renovis A200 PS Knee System is a patellofemorotibial polymer/metal/polymer semiconstrained prosthesis intended to be implanted to replace a knee joint. The system consists of femoral, tibial and patella components intended for use with bone cement.

The subject of this 510k Premarket Notification are additional offerings to the Renovis A200 Knee System (K120038) resulting from customer requests to better meet patient need (anatomy and surgical technique). The additional offerings are part of the FDA cleared A200 Knee System and are called the A200 PS Knee System. The PS Knee System is a primary, posterior stabilized (PS), tri-compartmental knee replacement system to treat knee disorders resulting from degenerative diseases where the posterior cruciate ligament is absent.

The new A200 PS Knee System includes:

• Femoral components in nine (9) sizes (1, 2, 3, 3N, 4, 4N, 5, 6, and 7) in a posterior stabilized (PS) design, each for left and right sides, manufactured from CoCrMo in compliance with ASTM F75-18 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants
• Tibial insert components in three (3) footprint sizes; each for the left and right sides; with articulating thicknesses ranging from 10 mm to 23 mm; in two levels of constraint - PS and PS Plus. The tibial inserts have a mechanical lock to the tray (snap mechanism). Tibial inserts are manufactured from highly cross-linked UHMWPE (with and without 0.1% by wt Vit E), and 1020 UHMWPE in compliance with ASTM F648-14 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants and ASTM F2695 -12 Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
• Patellar components in five (5) sizes in sombrero and five (5) sizes in domed design. Patellar components are manufactured from highly cross-linked UHMWPE (with and without 0.1% by wt Vit E), and 1020 UHMWPE in compliance with ASTM F648-14 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants and ASTM F2695 -12 Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
• FDA cleared (K120038) Tibial tray (baseplate) components in (9) sizes, each for the left and right sides, and in each in two designs, a conical design (CoCrMo) and a keeled design (Ti6A14V)

The system also includes reusable instrumentation.

The provided text is a 510(k) Premarket Notification for the Renovis A200 PS Knee System. This document focuses on demonstrating substantial equivalence to a predicate device and provides details on the device description, indications for use, and performance testing. However, it does not include information about user studies or clinical trials with human participants, which would be necessary to derive acceptance criteria and performance data for AI-assisted human reading or standalone AI performance.

Therefore, I cannot fulfill the request as the information regarding acceptance criteria, reported device performance (in the context of AI), sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for an AI device is not present in the provided document.

The document discusses bench testing of the physical knee implant components, such as fatigue strength and locking mechanisms, to ensure the device performs as expected. This type of testing is relevant to the mechanical integrity and functionality of the surgical implant itself, not to the performance of an AI diagnostic/assistive tool.

In summary, the provided content is for a knee implant device and does not contain the information requested about the acceptance criteria and study proving an AI device's performance.

Ask a specific question about this device

The Renovis Tesera SC Stand-alone ACF System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2-T1. Renovis Tesera SC Stand-alone ACF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation.

The Renovis Tesera SC Stand-alone ACF System is a stand-alone system when used with the cover plate and screws provided, and requires no additional supplemental fixation. When used as a stand-alone system, the cages require the use of three (3) screws and the cover plate assembly. When used without the cover plate and three screws the Renovis Tesera SC Stand-alone ACF System is a non-stand-alone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability.

The Renovis Tesera C ACF System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2-T1. Renovis Tesera C ACF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation.

The Renovis Tesera C ACF System is a non-stand-alone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability.

Tesera (or T3) describes Renovis' proprietary Tesera Trabecular Technology™ Porous Structure for the manufacture of the porous titanium on the superior and inferior surfaces of the implant.

The Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System is a single, cervical implant System that includes two (2) "subsystems", the:

• Renovis Tesera C Anterior Cervical Fusion (ACF) System
• Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System .

The Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System cages are additively manufactured from Ti-6Al-4V and are available in a variety of sizes (widths, heights, and lordotic angles) to suit the individual pathology and anatomical conditions of the patient.

The Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System includes cages, and existing bone screws (self-drilling and self-tapping options) and anterior cover plate assembly. When used with the cover plate and screws, the Tesera SC ACF System cages require no supplementary fixation systems. The screws protrude through the interbody portion of the device into the adjacent vertebral bodies. The cages have windows in the side for visualization of the bone graft. When used without the cover plate and three screws the Renovis Tesera SC Stand-alone ACF cages require supplemental fixation.

The Renovis Tesera C Anterior Cervical Fusion (ACF) System is not stand alone and requires supplemental fixation.

The Renovis Tesera C/Tesera SC ACF System cages comply with ASTM F2924-14 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion.

The system also consists of reusable instrumentation. The instruments comply with ASTM A564/A64M-13e1 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes or ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.

The provided text describes a 510(k) premarket notification for the Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System. This submission focuses on establishing substantial equivalence to a predicate device through mechanical testing and does not involve a study evaluating AI performance. Therefore, many of the requested sections related to AI acceptance criteria, ground truth, expert involvement, and reader studies are not applicable.

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

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

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

This information is not applicable as the submission describes a medical device, not an AI/software device that would typically use a "test set" of data in the common sense. The testing described is bench testing of the physical implant.

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 information is not applicable. Ground truth, expert consensus, and expert qualifications are relevant for studies evaluating human or AI performance on diagnostic tasks. This submission is for a physical implant, where ground truth is established through standardized engineering and biological tests.

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

This information is not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations during diagnostic studies.

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. MRMC studies are used to evaluate the impact of an AI system on human reader performance. This submission is for a physical medical implant.

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

This information is not applicable. "Standalone" performance refers to an AI algorithm operating independently, which is not relevant to a physical medical implant.

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

The "ground truth" for the device's performance is established through adherence to recognized ASTM, AAMI/ANSI, and ISO standards for mechanical properties, biocompatibility, and sterilization. For example, the mechanical strength of the implant components and assemblies is evaluated against the parameters outlined in ASTM F2077. The porous structure's characteristics were "successfully tested," implying adherence to relevant specifications.

8. The sample size for the training set

This information is not applicable. A "training set" is used for machine learning. This submission is for a physical implant.

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

This information is not applicable. This is relevant for machine learning models.

Ask a specific question about this device

The Renovis S180 Lateral Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s). Patients should be skeletally mature and have at least six months of non-operative treatment with the devices.

The Renovis S180 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine. Renovis S180 System implants are to be used with autogenous bone graft.

The Renovis S180 Lateral Lumbar Interbody System is an additional offering to the Renovis system of interbody fusion devices. This application describes changes in lengths, widths, heights and lordosis configurations; material standard; packaging; and additive manufacturing device. The S180 LLIF System includes cages of a variety of lengths, widths, heights, and lordosis to suit the individual pathology and anatomical conditions of the patient. The different shape of the footprint allows for a lateral surgical approach for insertion. The S180 LLIF System cages are manufactured from Ti6A14V compliant with ASTM F2924 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion. The system also includes instruments which are manufactured from Stainless steel and Ti-6Al-4V.

This document describes the Renovis S180 Lateral Lumbar Interbody Fusion System, which is a medical device for spinal fusion. The information provided is from a 510(k) premarket notification. As such, the "study" referred to is primarily bench testing to demonstrate the device's mechanical and functional equivalence to predicate devices, rather than a clinical trial involving human subjects. Therefore, many of the typical acceptance criteria and study details discussed for AI/software devices (like sample size for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth for training) are not applicable in this context.

Here's the information parsed from the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. The document mentions "new worst-case S180 LLIF cages" were tested, implying physical units of the device were subjected to mechanical and functional tests. The specific number of units tested for each benchmark is not detailed.
• Data Provenance: Not applicable. This refers to bench testing of the physical device, not a study involving human data.

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

• Not applicable. Ground truth as typically defined for clinical effectiveness or diagnostic accuracy studies is not relevant here. The "ground truth" for this device's performance is adherence to established engineering standards and successful completion of specified mechanical and sterilization tests, which are objective measurements.

4. Adjudication method for the test set

• Not applicable. As this is bench testing against established standards, adjudication in the sense of expert consensus on clinical outcomes or diagnoses is not performed. Test outcomes are determined by instrumental measurements against predefined pass/fail criteria per the relevant ASTM/ISO standards.

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

• Not applicable. This is a physical intervertebral fusion device, not an AI or diagnostic imaging device that involves human readers.

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

• Not applicable. This is a physical medical device, not a software algorithm.

7. The type of ground truth used

• For the bench testing, the "ground truth" is defined by established engineering and medical device standards (e.g., ASTM F2077 for dynamic axial compression, ASTM E8/E8M-15a for tensile testing, ISO 11607-2 for packaging, AAMI/ANSI/ISO 10993-1/5 for biocompatibility). The device's performance is compared against the requirements and specifications within these standards.

8. The sample size for the training set

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

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

• Not applicable. This is not an AI/machine learning device.

Ask a specific question about this device

The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Renovis S128 ALIF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The Renovis S128 ALIF System is a stand-alone device and is intended to be used with the cover plate and screws provided and requires no additional supplementary fixation. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided. Should the physician choose to use fewer than the four screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used. Supplemental fixation, cleared by the FDA for use in the lumbosacral spine, must be used with implants ≥20°.

The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is FDA cleared as K131122 and K140106 (sterile implants). This application describes additional cages offerings (new lengths, widths, and lordosis) and a packaging change.

The S128 ALIF System includes cages of a variety of lengths, widths, heights, and lordosis to suit the individual pathology and anatomical conditions of the patient. The different shape of the footprint allows for different surgical approaches for insertion. S128 ALIF System cages are standalone for devices

This document describes the FDA's decision regarding the Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System and focuses on its substantial equivalence to previously cleared devices rather than a study about AI performance. Therefore, many of the requested categories are not applicable.

Here's the information extracted and interpreted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "acceptance criteria" table with specific performance metrics for an AI device. Instead, it focuses on demonstrating substantial equivalence for a medical implant (ALIF System) by meeting established standards and performing tests relevant to its physical properties and function.

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

• Sample Size for Test Set: Not applicable. This document describes the substantial equivalence of a physical medical implant (ALIF System) based on engineering tests, not a software device or AI algorithm evaluated on a data test set. The "tests" mentioned (Dynamic Shear Compression, Expulsion) refer to physical testing of the device itself.
• Data Provenance: Not applicable for an AI or software study. The data is generated from physical material and mechanical testing of the device components.

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 expert consensus, is not relevant for this type of device submission. The "ground truth" for the device's physical properties is established by adherence to ASTM standards and validated engineering test methods performed by qualified laboratories.

4. Adjudication method for the test set:

• Not applicable. There is no human expert adjudication of test results in the sense of consensus on medical images or diagnoses for this device. The physical tests are governed by standardized protocols.

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 submission is for a physical medical implant, not an AI or software 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:

• Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

• The "ground truth" for this medical device's performance is based on established engineering standards and validated physical test methods. For example, ASTM F2077-14 for intervertebral body fusion devices sets the benchmark for acceptable mechanical performance. Material composition adherence to ASTM F136-13, F2026-17, F560-17, and A564/M564-13e1 provides the "ground truth" for material specifications. Sterilization validation using AAMI/ANSI/ISO standards establishes the "ground truth" for sterility.

8. The sample size for the training set:

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

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

• Not applicable. No training set is involved for this type of device.

Ask a specific question about this device

The Renovis Surgical Hip Replacement System is indicated for patients suffering from:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional deformity;
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and
5. Revision procedures where other treatment or devices have failed.
   The Renovis A400 Hip System is intended for cementless applications unless used with the Renovis Cemented Hip Stem.
   The Renovis Surgical Porous Coated Acetabular Shell System is intended for cementless applications.
   The Cemented Hip Stem is intended for cemented applications.
   The Renovis Tesera Trabecular Technologies (T3) Acetabular Shell System is intended for cementless applications.
   The Bipolar Head is for use in conjunction with Renovis femoral heads and femoral stems.
   Bipolar outer heads are not for use with acetabular shells and liners.

The subject of this application is Renovis Extended Lateral Offset Femoral Stems which are an expansion of the FDA cleared Renovis Surgical Hip Replacement System. Extended Lateral Offset Femoral Stems are provided in a variety of sizes to fit patient need. This application also includes a new device specific neck trial and X-ray template, and additional implants and instruments.
The Extended Lateral Offset Femoral Stems are manufactured from the same material as other FDA cleared Renovis femoral stems. The instruments are manufactured from the same material as other instruments included in FDA cleared submissions.

This document is a 510(k) summary for a medical device (Renovis Surgical Hip Replacement System), not a clinical study report. Therefore, it does not contain the information required to answer your questions regarding acceptance criteria and a study proving device performance in the context of an AI/human-in-the-loop system.

The document discusses the substantial equivalence of an expansion to an existing device (Extended Lateral Offset Femoral Stems) to previously cleared predicate devices. It relies on bench performance testing and material equivalence, rather than a clinical study with human subjects or AI-assisted diagnostic performance.

Here's why the requested information cannot be extracted from this document:

• AI/Machine Learning Context: The document is about a physical medical device (hip prosthesis components), not a software or AI-driven diagnostic/decision support system. Therefore, concepts like "acceptance criteria" for AI performance, "test set," "training set," "ground truth," "experts," or "MRMC studies" are not applicable in this context.
• Study Type: The "study" mentioned is "Performance Testing - Bench," which refers to laboratory tests of the device's physical properties and durability, not clinical trials or comparative effectiveness studies involving human readers or AI.
• Device Performance: The "reported device performance" refers to successful completion of specific ISO and ANSI/AAMI standards for physical and sterilisation properties, not diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC).

Summary of what can be extracted, and why the rest cannot:

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

   • Acceptance Criteria (implicit): Compliance with ISO 7206-4, ISO 7206-6, ANSI/AAMI/ISO 11137-1, ANSI/AAMI/ISO 11137-2, ANSI/AAMI ST72:2011(R)2016 for bacterial endotoxin testing, and material standards like ASTM F136-13, ASTM A564-13, ASTM A276-17.
   • Reported Device Performance: "Renovis successfully completed the following performance tests." (Lists the standards). "endotoxin limits are in compliance with ANSI/AAMI ST72:2011(R)2016." The results indicate the device met the requirements of these standards.
   • Why partial: These are engineering and material performance criteria for a physical implant, not diagnostic performance metrics for an AI system.

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

   • Cannot be provided. This refers to bench testing of physical components, not a clinical study or AI model evaluation. There is no "test set" of patient data in the sense you're asking about.

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):

   • Cannot be provided. This is not relevant to a physical device's bench testing. "Ground truth" in this context would be physical measurements and material properties confirmed by engineering and quality control experts, not clinical diagnosis.

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

   • Cannot be provided. This is for clinical or AI performance evaluation, not bench 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:

   • Cannot be provided. This type of study is for AI-assisted diagnostic tools, not physical implants.

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

   • Cannot be provided. This is about an algorithm's performance, which is not applicable to this device.

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

   • Cannot be provided (in the AI/clinical sense). For bench testing, the "ground truth" is adherence to established engineering standards (e.g., fatigue limits, material composition specifications).

8. The sample size for the training set:

   • Cannot be provided. There is no "training set" for a physical device in this context, as there is no AI model being trained.

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

   • Cannot be provided. Not applicable.

In conclusion, the provided FDA document is for a traditional medical device (hip prosthesis) and focuses on engineering, material, and sterilization compliance, not AI algorithm performance or clinical diagnostic accuracy.

Ask a specific question about this device

The Renovis S141 Lumbar Interbody Fusion is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s). Renovis S141 System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The Renovis S141 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.

The Renovis S141 Lumbar Interbody Cage System is FDA cleared as K143126. This application describes a manufacturing change to the K143126 S141 Ti6Al4Vcages; internal dimensional changes; additional cages geometries; and a packaging change. The new name of the system is the Renovis S141 Lumbar Interbody Fusion System (S141 System).

The S141 System includes cages of a variety of lengths, widths, heights, and lordosis to suit the individual pathology and anatomical conditions of the patient. The different shape of the footprint allows for different surgical approaches for insertion.

The Ti6Al4V is compliant with ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.

The system also includes instruments which are manufactured from stainless steel in compliance with ASTM A564-13 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes.

This document describes the Renovis S141 Lumbar Interbody Fusion System, a medical device, and primarily focuses on its substantial equivalence to a predicate device, rather than providing details on a study that proves its performance against acceptance criteria in the context of algorithm-based device performance. The information provided is for a 510(k) premarket notification, which establishes substantial equivalence to a legally marketed predicate device, not necessarily a performance study against predefined acceptance criteria for an AI/algorithm-driven device.

Therefore, many of the requested sections related to acceptance criteria for algorithmic performance, sample sizes for test sets, expert ground truthing, MRMC studies, and standalone algorithm performance cannot be extracted from this document, as they are not applicable to the type of information presented.

However, I can provide information based on what is available in the document regarding the device's characteristics and the types of testing performed for substantial equivalence.

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

The document does not explicitly state acceptance criteria for the device in the format of a clinical or algorithmic performance study with specific metrics (e.g., sensitivity, specificity, AUC). Instead, it relies on substantial equivalence to a predicate device and bench testing results. The "performance" reported relates to the mechanical and biological safety of the modified device components.

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

This information is not provided in a way that aligns with an algorithmic device test set. The document refers to "testing" that was "successfully conducted" for mechanical and biological properties. No sample size for a "test set" in the context of data for an algorithm is mentioned. Data provenance (country of origin, retrospective/prospective) is also not applicable or mentioned.

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. This device is a physical implant, not an AI/algorithm-driven diagnostic or prognostic tool that would require expert ground truthing of data.

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

Not applicable, as there is no "test set" in the context of an algorithm's performance and associated ground truth 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 document is for a physical medical implant (lumbar interbody fusion system), not an AI-assisted diagnostic or therapeutic device. Therefore, MRMC studies are not relevant.

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

Not applicable. This device is a physical implant, not an algorithm.

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

Not applicable. The "ground truth" for this device would relate to its physical properties, material composition, and biological safety as measured by laboratory tests and adherence to standards, which are inherently objective measurements rather than interpretations requiring expert consensus on imaging or clinical data.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/algorithm-driven system.

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

Not applicable, as there is no training set for this device.

Ask a specific question about this device

The Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2-T1. Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation.

The Renovis Tesera SC ACF System is a stand-alone system when used with the cover plate and screws provided, and requires no additional supplemental fixation. When used as a stand-alone system, the cages require the use of three (3) screws and the cover plate assembly.

When used without the cover plate and three screws the Renovis Tesera SC ACF System is a non-stand-alone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability.

The Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System includes the Tesera Trabecular Titanium (T3) cages, bone screws (self-drilling and self-tapping options) and anterior cover plate assembly. When used with the cover plate and screws, the Tesera SC ACF System requires no supplementary fixation systems. The screws protrude through the interbody portion of the device into the adjacent vertebral bodies, stabilize the vertebral body and reduce the likelihood of expulsion of the implant. The Tesera Trabecular Titanium (T3) cages have windows in the side for visualization of the bone graft. The accompanying cover plate is designed to resist screw back-out and must be used when the screws are implanted. When used without the cover plate and screws, the Tesera SC ACF cages require supplemental fixation.

The Renovis Tesera SC ACF System cages are available in a variety of sizes (widths, height, depths, and bone screw sizes) to suit the individual pathology and anatomical conditions of the patient. The cages are additively manufactured then machined from Titanium alloy (Ti-6A1-4V). The bone screws are manufactured from Titanium alloy (Ti-6Al-4V) and the cover plate assembly is manufactured from Titanium alloy (Ti-6Al-4V) and Nitinol alloy. The implants are provided to the end user sterilized through gamma irradiation.

The system also consists of reusable instrumentation used to implant the cages, screws, and cover plate assembly.

This document describes the Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System, a medical device. The information provided focuses on its substantial equivalence to predicate devices rather than detailing specific acceptance criteria and study results for device performance against those criteria in a tabular format. The FDA 510(k) summary typically assesses substantial equivalence based on similar intended use, design, materials, and performance testing to legally marketed devices, rather than establishing new, specific performance acceptance criteria for each submission.

However, based on the provided text, I can infer the types of performance criteria addressed through mechanical testing and report the nature of these studies.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with corresponding performance results in the way one might see for a diagnostic AI algorithm. Instead, it lists the mechanical performance tests conducted and asserts that "Differences between the Renovis Tesera SC ACF System and the predicate devices do not raise new issues of safety or effectiveness." This implies that the device met the performance expectations established by the predicate devices and relevant ASTM standards.

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

The document describes bench testing, meaning the "test set" consists of physical devices subjected to mechanical and material property tests.

• Sample Size for Test Set: Not explicitly stated for each test, but standard ASTM methods typically define minimum sample sizes for such tests.
• Data Provenance: This is not applicable in the usual sense for clinical data, as this is mechanical bench testing of devices (not human data). The tests were conducted to evaluate the physical and mechanical properties of the device itself.

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

Not applicable. For mechanical bench testing, "ground truth" is established by the standardized test methods (e.g., ASTM standards) themselves, which define the conditions, measurements, and interpretation of results. Experts are involved in designing and conducting the tests according to these standards, but there isn't a "ground truth" established by expert consensus on, for example, an image reading.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or expert reviews where there's variability in interpretation (e.g., of medical images) that needs to be resolved to establish a robust ground truth. For mechanical tests, the results are quantitative measurements against predefined standards.

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

Not applicable. This is a medical device for surgical implantation, not a diagnostic AI algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.

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

Not applicable. This device is a physical implant, not an algorithm.

7. Type of Ground Truth Used

For the performance testing mentioned:

• Mechanical Performance: The "ground truth" is established by adherence to recognized ASTM (and ISO) standards for material properties and mechanical performance. These standards define acceptable ranges for strength, fatigue life, corrosion resistance, etc., for intervertebral body fusion devices.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning algorithms. The design and manufacturing process are refined through engineering principles, material science, and iterative testing, not through a "training set" of data.

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

Not applicable, as there is no training set for a physical device. The design and manufacturing are based on established engineering principles, material science, and adherence to relevant industry standards for safety and efficacy of medical implants.

Ask a specific question about this device

The Renovis Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7).The system is indicated for use in the temporary stabilization of the anterior spine during the development of fusion in patients with the following conditions:

· degenerative disc disease(DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)

• · spondylolisthesis
• · trauma (i.e., fracture or dislocation)
• · spinal stenosis
• · tumor
• · pseudoarthrosis
• · failed previous fusion

WARNING: The Renovis Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

The Renovis Anterior Cervical Plate System consists of various shapes and sizes of plates and screws, and associated instruments. The plates are available in multiple lengths to accommodate single or multi-level surgeries. The plates and screws are manufactured from titanium alloy and the locking clip is manufactured from nickel-titanium alloy.

The provided document describes a 510(k) premarket notification for the Renovis Anterior Cervical Plate System. This is a medical device submission, and the content focuses on demonstrating substantial equivalence to a predicate device rather than describing a study with acceptance criteria and device performance in the way one might for an AI/algorithm-based diagnostic product.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not provided in this type of document. This document details the physical and mechanical performance of an implantable medical device, not the diagnostic performance of a software or AI.

However, I can extract the relevant information from the performance testing section.

Acceptance Criteria and Study for Renovis Anterior Cervical Plate System

The Renovis Anterior Cervical Plate System is a physical medical device. Its "performance" refers to its mechanical and material properties, not diagnostic accuracy. The "acceptance criteria" are implicitly met by passing the specified ASTM standards and internal protocols.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. For mechanical testing of medical devices, sample sizes are typically determined by statistical methods for engineering testing (e.g., to achieve a certain confidence level or power for a material property) but are usually much smaller than clinical study sample sizes.
• Data Provenance: Not applicable in the context of this device's performance testing. These are laboratory-based mechanical and material tests.

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

• Not Applicable. This is a mechanical device, and "ground truth" as it relates to expert consensus for diagnostic performance does not apply. The "truth" is determined by standardized laboratory measurements.

4. Adjudication method

• Not Applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No. This is a mechanical device, not a diagnostic tool requiring human interpretation.

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

• Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• N/A (for "ground truth" in diagnostic terms). The "truth" is established by adherence to specified ASTM standards and internal engineering protocols for mechanical and material properties. For example, for corrosion testing, the "ground truth" is that the device passes or fails the specified electrochemical impedance parameters defined by ASTM F2129.

8. The sample size for the training set

• Not Applicable. This is a physical medical device. There is no "training set" in the context of machine learning or algorithms. Its design and manufacturing process are validated, but not "trained."

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

• Not Applicable.

Ask a specific question about this device

The Renovis Surgical Hip Replacement System is indicated for patients suffering from:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;

2. Rheumatoid arthritis;

3. Correction of functional deformity;

4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and

5. Revision procedures where other treatment or devices have failed.

The Renovis A400 Hip System is intended for cementless used with the Renovis Cemented Hip Stem.

The subject of this application are Renovis 4.5mm femoral stems (and a 5.25 mm broach) which are an expansion of the FDA cleared Renovis A400 Surgical Hip Joint Replacement Prosthesis (K112897) which is now known as the Renovis Surgical Hip Replacement System. The 4.5mm and 5.25mm femoral stems are the same material, the same configuration and will be offered in the same standard and lateralized offsets, as are the FDA cleared Renovis A400 femoral stems.

In addition, this application includes an update of Letter-to-File expansions and changes to the Renovis Surgical Hip Replacement System.

Renovis implants and instruments comply with the following material standards:

• ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-. 4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
• ASTM A564-13 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes
• ASTM F1537-11 Standard Specification for Wrought Cobalt-28Chromium-● 6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
• ASTM A276-13a Standard Specification for Stainless Steel Bars and Shapes
• ASTM A240-14 Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and for General Applications

The document provided is a 510(k) premarket notification decision letter from the FDA to Renovis Surgical Technologies, Inc., regarding their "Renovis Surgical Hip Replacement System." This document primarily focuses on the regulatory clearance of a medical device and describes its intended use, design, and comparison to a predicate device.

It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm's performance. The document is for a traditional surgical implant (hip replacement system), not a software device or an AI/ML-driven diagnostic or therapeutic tool.

Therefore, I cannot extract the requested information based on the provided text. The questions posed in your prompt (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set size, ground truth for training set) are relevant to the evaluation of AI/ML-based medical devices, which this document does not cover.

The "Non-clinical Testing" section (G) refers to bench testing of the femoral stems according to ISO 7206-4 and coating characterization, but this directly relates to the mechanical performance and material properties of the physical implant, not the diagnostic accuracy or performance of a software algorithm.

Ask a specific question about this device

The Renovis S141 Lumbar Interbody Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s). Renovis S141 System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The Renovis S141 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.

The Renovis S141 Lumbar Interbody Cage System consist of 3 designs and each design is available in either PEEK or titanium alloy. The PLIF implants are available as a lordotic form, while the OLIF implants are provided with no lordosis. The implants are available in various heights and lengths to accommodate patients' anatomy. The implants are provided sterile, and a set of instrument for implantation is provided to facilitate implantation. Two radiographic markers made of tantalum per ASTM F650 are included in the PLIF and OLIF PEEK implants, and three radiographic markers made of tantalum per ASTM F560 are included in the TLIF PEEK implant to allow radiographic visualization.

This document is a 510(k) summary for the Renovis S141 Lumbar Interbody Cage System. It primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use, materials, dimensions, function, and mechanical testing. It is not a study that proves a device meets acceptance criteria in the sense of a clinical trial or an AI/software performance study.

Therefore, many of the requested items related to AI/software performance, ground truth, expert adjudication, and clinical study details are not applicable or cannot be extracted from this type of regulatory submission. This document describes mechanical performance testing against established standards, not a clinical study with human subjects, AI algorithms, or expert readers.

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

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

Note: The document states the device was tested to these standards and found substantially equivalent, but it does not provide specific numerical acceptance criteria or performance metrics for each test (e.g., "subsidence must be less than X mm, and observed subsidence was Y mm"). It only states the overall conclusion of substantial equivalence.

Regarding the other requested information:

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

  • Not Applicable / Not Provided. This document describes mechanical testing of physical devices, not a study involving human patient data or software/AI. The "test set" here refers to the physical samples of the interbody cage system tested mechanically. The sample size for these mechanical tests is not specified, nor is data provenance in the context of clinical/patient 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)

  • Not Applicable. Ground truth in the context of expert review applies to diagnostic devices or AI, not mechanical orthopedic implants. The "ground truth" for mechanical testing is defined by the physical properties and performance characteristics measured against engineering standards.

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

  • Not Applicable. Adjudication is relevant for expert review or clinical event assessment, not for mechanical testing of physical devices.

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

  • Not Applicable. This is a mechanical device, not an AI or diagnostic imaging device. Therefore, no MRMC study, human readers, or AI assistance is involved.

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

  • Not Applicable. This is a physical medical device (lumbar interbody cage system), not an algorithm or software. No standalone algorithm performance was assessed.

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

  • Not Applicable. For mechanical testing, the "ground truth" is defined by the established engineering standards (ASTM F2077 and ASTM F2267) and the measured physical performance (axial compression, subsidence, expulsion).

• 8. The sample size for the training set

  • Not Applicable. This document does not describe a machine learning algorithm, so there is no "training set."

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

  • Not Applicable. As there is no training set for a machine learning algorithm, this question is not relevant.

Ask a specific question about this device