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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.

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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.

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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.

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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 Porous Acetabular Cup System ("Porous shell") are titanium, hemispherical cups consisting of varying sizes (outer diameter of 44 - 66 mm) and screw hole options (no hole shell and cluster hole shells) to accommodate patient anatomy and/or surgical technique. Instrumentation is provided with the system.

The Renovis Porous Acetabular Cup System is part of the Renovis Surgical Hip Replacement System and is to be used with Renovis Surgical Hip Replacement System acetabular and femoral components.

The provided text is a 510(k) summary for the Renovis Surgical Porous Acetabular Cup System, a medical device. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a predicate device through design comparison, materials, and performance testing against recognized standards. It does not typically involve clinical studies with acceptance criteria in the same way a diagnostic AI device would.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable to this document. The document describes performance testing bench studies to ensure the device meets certain engineering and material standards, rather than clinical studies establishing diagnostic accuracy or efficacy in patients.

Here's an attempt to answer the questions based only on the provided text, acknowledging that much of the requested information is absent because it's not a clinical study for an AI device:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a way that would typically be seen for a diagnostic AI device. Instead, it states that "Performance testing was successfully completed" and lists various standards the device complies with. Compliance with these standards implies meeting their embedded acceptance criteria.

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 provided. The document describes bench testing rather than testing on a "test set" of patient data. The "samples" would refer to the physical devices or materials tested according to engineering standards. No information on data provenance (country, retrospective/prospective) is relevant or mentioned for this type of testing.

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

This information is not applicable and not provided. The "ground truth" for material and mechanical performance testing is established by engineering specifications and objective measurements, not by human expert consensus on clinical cases.

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

This information is not applicable and not provided. Adjudication methods are relevant for human interpretation in clinical studies, not for bench testing of medical 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

This information is not applicable and not provided. An MRMC study is designed for evaluating diagnostic devices, especially those involving human interpretation, and often with AI assistance. This document describes a physical hip implant, not a diagnostic AI device.

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

This information is not applicable and not provided. This question pertains to AI algorithm performance.

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

For the performance testing bench studies, the "ground truth" implicitly used is adherence to established engineering and material standards (e.g., tensile strength, shear strength, porosity characteristics, sterilization efficacy, packaging integrity). This is determined by standardized measurement techniques guided by the listed ASTM and ISO standards, rather than clinical outcomes or expert consensus on patient data.

8. The sample size for the training set

This information is not applicable and not provided. This question pertains to AI algorithm training, which is not relevant to this device submission.

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

This information is not applicable and not provided. This question pertains to AI algorithm training, which is not relevant to this device submission.

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The Renovis Lumbar Interbody Fusion (LIF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative 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 LIF 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.

The Renovis S134 ALIF System must be used with supplemental fixation cleared by the FDA for use in the lumbar spine.

The purpose of this submission is an additional offering to the Renovis lumbar interbody fusion system portfolio. The S134 Anterior Lumbar Interbody Fusion (ALIF) System implants (cages) are intervertebral body fusion devices with a screw-less design that requires supplemental fixation. The S134 ALIF 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 implants are manufactured from PEEK or additively manufactured and machined Titanium. The PEEK markers are manufactured from Tantalum.

The Renovis S134 ALIF System cages are to be used with supplemental fixation, and are intended to be used with autogenous bone graft.

The Renovis S134 ALIF System is used with device specific instruments including trials.

The Renovis S134 ALIF System implants comply with the following material standards:

• ASTM F2026-08 Standard Specification for PEEK Polymers for Surgical . Implant Applications
• ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
• ASTM F560-08, Standard Specification for Unalloyed Tantalum for Surgical Implant ● Applications

The S134 ALIF implants are provided gamma sterilized, and non-sterile (requiring sterilization by the end user).

The provided document, K142095, is a 510(k) premarket notification for the Renovis S134 Anterior Lumbar Interbody Fusion (ALIF) System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study proving a device meets specific acceptance criteria based on performance metrics that would typically apply to software or diagnostic devices (e.g., sensitivity, specificity, accuracy).

Intervertebral body fusion devices like the Renovis S134 ALIF System are typically evaluated based on mechanical testing, material compatibility, and similarity to previously cleared devices. The "acceptance criteria" here refer to the regulatory requirements for showing substantial equivalence, which primarily involve comparing design, materials, manufacturing, indications for use, and performance testing (often mechanical) against a predicate device.

Therefore, the requested information elements related to clinical study design, sample sizes for test and training sets, ground truth establishment, expert adjudication, and MRMC studies are not applicable in the context of this specific regulatory submission for an intervertebral body fusion device.

However, I can extract the relevant information regarding the demonstration of substantial equivalence.

Demonstration of Substantial Equivalence for Renovis S134 ALIF System

The Renovis S134 Anterior Lumbar Interbody Fusion (ALIF) System obtained 510(k) clearance by demonstrating substantial equivalence to a predicate device, the Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System (K140106). The acceptance criteria for this type of submission involve showing that the new device does not raise new questions of safety or effectiveness when compared to the legally marketed predicate.

1. Table of Acceptance Criteria (Substantial Equivalence) and Reported Device Performance

Materials: Both use PEEK and additively manufactured/machined Titanium, with Tantalum markers. Materials comply with ASTM F2026, ASTM F136, and ASTM F560.

Manufacturing: Not explicitly detailed as different; implied to be similar. |
| Performance Testing (Mechanical) | For implants, mechanical testing (e.g., fatigue, static strength) is generally required to ensure durability and safety under simulated physiological loads. | Engineering Rationale and FEA: "Comparison of technological characteristics, engineering rationale and FEA were used to determine that this design change does not introduce a new worst case." This implies that mechanical performance was assessed and deemed equivalent or superior to the predicate through engineering analysis. Specific test values are not provided in this summary. |
| Sterilization | The sterilization methods of the new device should be compatible with the materials and design, and validated. | Similar Offerings: The S134 ALIF implants are provided gamma sterilized, and non-sterile (requiring sterilization by the end user), similar to the predicate offerings. |
| Effect on Safety & Effectiveness | The new device should not raise new questions of safety or effectiveness compared to the predicate. | Conclusion: "The offering of implants that are not standalone and require supplemental fixation does not raise new issues of safety or effectiveness." The submission concludes that the S134 ALIF System is substantially equivalent to the predicate device based on the similarities. |
| Need for Supplemental Fixation | The primary difference is the S134 requires supplemental fixation, whereas the S128 can be used stand-alone with its cover plate and screws, or with supplemental fixation if fewer than four screws are used. | The S134 ALIF System is explicitly "a screw-less design that requires supplemental fixation" and "must be used with supplemental fixation cleared by the FDA for use in the lumbar spine." This difference in fixation strategy from the S128 (which included integrated fixation for stand-alone use) was assessed and deemed not to raise new issues of safety or effectiveness, as supplemental fixation is a known clinical practice. |

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 (N/A). This is a 510(k) premarket notification for an implantable medical device, not a performance study for a diagnostic or AI/software device. The submission relies on comparative analysis, engineering rationale, and mechanical testing (not detailed) rather than a clinical trial with a "test set" of patients or data in the way a diagnostic device would.

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)

N/A. The concept of "ground truth" established by experts for a test set of data is not applicable to this type of device submission. The evaluation is based on engineering principles, materials science, and regulatory compliance.

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

N/A. Adjudication methods are relevant for clinical trials or diagnostic performance studies involving human interpretation. This is not applicable here.

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

N/A. This is a physical implantable device, not an AI or diagnostic software.

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

N/A. This is a physical implantable device, not an algorithm.

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

N/A. As explained above, the concept of "ground truth" in this context is not applicable. The basis for safety and effectiveness is substantial equivalence to a predicate device, supported by design comparisons, material standards compliance, and engineering rationale/testing.

8. The sample size for the training set

N/A. This is not a study involving a training set for an algorithm.

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

N/A. Not applicable, as there is no training set mentioned in this context.

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The Renovis A400 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 Cemented Hip Stem is intended for cemented applications.

The Renovis Cemented Hip Stem is for use with bone cement only, is offered in multiple sizes, and is manufactured from CoCr. The taper connection of the Renovis Cemented Hip Stem is the same as the existing Renovis FDA cleared Renovis uncemented hip stems (K112897) to allow use with the existing FDA cleared femoral heads (CoCr and ceramic femoral heads; K112897 and K131354). A distal plug and distal centralizers are also offered and are manufactured from PMMA.

The provided document describes the Renovis Cemented Hip Stem and its substantial equivalence to predicate devices, but it does not detail acceptance criteria and a study proving those criteria are met in the way typically expected for an AI/CADe device. Instead, the document focuses on the regulatory clearance process for a hip implant.

Therefore, many of the requested items (e.g., sample size for AI test sets, number of experts for ground truth, MRMC study, training set details) are not applicable to this particular type of medical device submission.

However, I can extract information related to the performance testing and materials that serve as the "acceptance criteria" and "study" for this orthopedic implant.

Here's a summary tailored to the provided document, addressing the applicable points and noting where information is not present or relevant:

Acceptance Criteria and Device Performance Study for Renovis Cemented Hip Stem

The Renovis Cemented Hip Stem received 510(k) clearance based on demonstrating substantial equivalence to predicate devices through material compliance, design similarity, and successful performance testing according to recognized international standards. These standards implicitly define the "acceptance criteria" for the mechanical and material integrity of the implant.

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: The document mentions "worst case Renovis stems" were tested for femoral stem fatigue. However, it does not specify the exact number of stems or individual components tested.
• Data Provenance: The document does not specify the country of origin for the data, but it is implied to be from Renovis Surgical Technologies, Inc. internal testing or contracted labs, as part of their submission to the US FDA. The studies are prospective in the sense that they were conducted specifically for the regulatory submission to demonstrate compliance with standards.

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

• This question is not applicable as the ground truth for mechanical testing of an orthopedic implant is established by compliance with a predetermined engineering standard, not by expert consensus on interpretations of data in the way an AI/CADe device would be evaluated. The "experts" are the engineers and material scientists defining and performing the tests per ISO/ASTM standards.

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

• This question is not applicable. Mechanical and material testing of implants typically relies on direct measurement and comparison against predefined thresholds within the standards, not on expert adjudication of ambiguous cases.

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, as the Renovis Cemented Hip Stem is a physical implant, not an AI/CADe device intended for interpretation by human readers.

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

• This question is not applicable, as the Renovis Cemented Hip Stem is a physical implant, not a standalone algorithm.

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

• The "ground truth" for this device is derived from established international and national engineering standards for materials, mechanical performance (fatigue life), and sterilization. Successful compliance with the specifications and performance metrics outlined in these standards serves as the ground truth for the device's safety and effectiveness.

8. The sample size for the training set:

• This question is not applicable. There is no "training set" in the context of an AI algorithm, as this is a physical medical device. The design and manufacturing processes are informed by engineering principles and prior device designs, but not in the sense of a machine learning training set.

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

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

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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.

The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is cleared under K131122. The SI28 ALIF implants (cages) are to be used with the bone screws and anterior cover plate assembly and requires no additional supplementary fixation systems. The Renovis S128 ALIF System implants are available in a variety of sizes (widths, height, depths, and bone screw sizes; see below) to suit the individual pathology and anatomical conditions of the patient. The implants are manufactured from PEEK or additively manufactured and machined Titanium. The bone screws and cover plate assembly are both manufactured from Titanium alloy. The PEEK markers are manufactured from Tantalum.

This Special 510(k) Premarket Notification is submitted for the additional offering of gamma sterilized S128 implants (PEEK cages; titanium cages, screws and cover plates).

This document is a 510(k) Special Premarket Notification for the Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System, focusing on the addition of gamma sterilization for its implants. It primarily addresses the safety and effectiveness of the sterilization method and its impact on the device's materials, rather than a clinical study of the device's performance in patients.

Therefore, the requested information focusing on clinical performance metrics, sample sizes for test/training sets, expert ground truth, and comparative effectiveness with AI is not directly applicable to this specific regulatory submission. This is because the submission is about a manufacturing change (sterilization method) to an already cleared device (K131122), not a new device or a clinical outcome study.

However, I can extract the information relevant to the performance data for the sterilization process, which is the core of this submission.

Acceptance Criteria and Reported Device Performance (for Gamma Sterilization)

Regarding the other requested information:

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

   • This document does not describe a clinical test set with human subjects. The "test set" here refers to material samples (Titanium and PEEK) and packaging subjected to sterilization and aging simulations. The sample sizes for these material tests are not explicitly stated but are part of standard validation protocols for ISO 11137-1 and internal Renovis testing.
   • Data provenance is from internal testing and validation performed by Renovis Surgical Technologies, Inc. and its sterilization/packaging validation partners. No country of origin for clinical data is applicable.

2. 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 as this is not a clinical study involving human expert interpretation of medical images or outcomes. Ground truth for material testing is based on established materials science and engineering principles and validated sterilization/packaging standards by qualified engineers and scientists.

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

   • Not applicable. Adjudication methods are relevant for subjective assessments (like image interpretation) where there might be disagreement among experts. Material and sterilization testing follows objective, quantifiable methods against pre-defined specifications.

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

   • Not applicable. This submission is about a medical device (surgical implant) and a manufacturing process change (sterilization), not an AI-powered diagnostic tool or image analysis software.

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

   • Not applicable for the same reason as above.

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

   • The "ground truth" for this submission is based on established international and national standards for medical device sterilization (ISO 11137-1, ANSI/AAMI/ISO 11137-2), packaging (ISO11607-2, ASTM F1980-07), and material specifications (ASTM F2026, ASTM F136, ASTM F 560-08). This is objective, measurable data comparing post-sterilization/aging material properties to baseline and specified requirements.

7. The sample size for the training set:

   • Not applicable. There is no machine learning or AI training set described in this document.

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

   • Not applicable.

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