Search Results

The Renovis Tesera Trabecular Technologies (T) Acetabular Shell System components are to be used with components of the Renovis A400 Surgical Hip Replacement System, and are 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 Tesera Trabecular Technologies (T) Acetabular Shell System is intended for cementless applications.

The Renovis Tesera Trabecular Technology (T3) Acetabular Shell System ("T" Acetabular Shell System") acetabular shells ("T" shells") are modifications of the Renovis A400 Surgical Hip Replacement System acetabular shells cleared through premarket notification K112897. This submission proposes the following design change: The proposed T shells will be manufactured from the same titanium alloy using an additive manufacturing process to fabricate the implant and porous structure concurrently, and have a thicker solid substrate and porous layer. The T shells are to be used with polyethylene liners, femoral components, acetabular shell trials, and other system specific instruments originally cleared in the Renovis A400 Surgical Hip System (K112897). The T shell is available in multiple configurations (no hole shell; cluster hole shell) and sizes (44 - 66 mm diameter). The liners attach to the shells under impaction with a snap lock mechanism.

Here's a summary of the acceptance criteria and the study information for the Renovis Tesera Trabecular Technology (T3) Acetabular Shell System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set Sample Size: Not explicitly stated in the provided document. The performance tests (e.g., ASTM standards) imply defined sample sizes as per the respective standard protocols, but these specifics are not detailed here.
• Data Provenance: The document describes bench (laboratory) testing of the device. This is a controlled environment, not human-patient data. Therefore, notions of country of origin or retrospective/prospective study design are not applicable in the human clinical sense.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• Not Applicable. The ground truth for this device's performance is established by engineering tests against recognized industry standards (ASTM standards) and regulatory requirements (21 CFR 888.3358). There's no mention of human experts establishing ground truth for the test set in the context of diagnostic interpretation.

4. Adjudication Method (Test Set)

• Not Applicable. As the tests are based on objective engineering measurements against defined standards, an adjudication method for human interpretations is not relevant.

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

• No. This document describes a traditional 510(k) submission for a medical implant (acetabular shell system), which focuses on demonstrating substantial equivalence to predicate devices primarily through design comparison, material standards, and bench performance testing. It does not involve diagnostic imaging or human interpretation, and thus, an MRMC study is not relevant or reported.

6. Standalone Performance Study (Algorithm Only)

• Not Applicable. This is a physical medical device, not a software algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance listed in the table relates to the physical and mechanical properties of the implant itself.

7. Type of Ground Truth Used

• Engineering Standards and Regulatory Compliance: The ground truth for the device's performance is established by demonstrating compliance with established ASTM (American Society for Testing and Materials) standards for material properties, coating performance, and fatigue resistance, as well as adherence to specific regulatory requirements outlined in 21 CFR 888.3358 for porous coating characteristics.

8. Sample Size for the Training Set

• Not Applicable. This device is a manufactured physical implant. The concept of a "training set" typically applies to machine learning algorithms. Design, material selection, and manufacturing processes for this device are based on established engineering principles and materials science, not on a machine learning training set.

9. How Ground Truth for Training Set Was Established

• Not Applicable. As there is no "training set" in the context of a machine learning algorithm, there is no corresponding method for establishing its ground truth. The design and manufacturing are based on established validated engineering and materials science principles and previous regulatory clearances (predicate devices).

Ask a specific question about this device

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular . necrosis
• Rheumatoid arthritis .
• Correction of functional deformity .
• Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal . femur with head involvement, unmanageable using other technique

The Renovis Bipolar Hip System includes a bipolar head and 22 mm femoral heads. The Renovis Bipolar heads are offered in a range of inner and outer dimensions from 39 to 65 mm to fit either 22 or 28 mm femoral heads. Renovis already has FDA clearance for a 28 mm femoral head (K112897). The bipolar head is a sub-component of a hip replacement construct where it assumes the function of the natural femoral head and is combined with a femoral head and hip stem. It consists of a highly polished CoCr alloy outer shell and a polyethylene insert. The ultra-highmolecular weight polyethylene (UHMWPE) insert is comprised of an inner liner and a locking ring. The bipolar head has two articulation surfaces: the outer CoCr head articulates with the patient's natural acetabular cartilage and the inner UHMWPE liner articulates with the femoral head assembled to the femoral stem. The modular CoCr alloy femoral head, is held in place within the bipolar head by a retaining ring that is pre-assembled into the polyethylene insert. The bipolar heads and femoral heads are gamma sterilized. The system is offered with the full instrumentation required for the procedure.

Here's a breakdown of the acceptance criteria and study information for the Renovis Bipolar Hip System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the acceptance criteria in terms of compliance with specific ASTM and ISO standards for material properties, testing methods, and sterilization. It does not provide specific numerical acceptance criteria (e.g., minimum force for disassembly) or corresponding numerical performance values from the testing. Instead, it makes a general statement of successful compliance.

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

The document only states that the device "successfully undergone ASTM performance testing." It does not specify the sample size used for the mechanical testing (e.g., number of bipolar heads tested for disassembly force). The data provenance is not explicitly mentioned but implies laboratory testing, not clinical data, and therefore, country of origin is not relevant in this context.

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

This information is not applicable as the evaluation is based on in-vitro performance testing against engineering standards, not on clinical interpretation requiring expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation is based on in-vitro performance testing against engineering standards, not on clinical interpretation.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This document describes the premarket notification for a medical device (hip prosthesis) based on substantial equivalence, which primarily relies on engineering performance testing and comparison to predicate devices, not clinical effectiveness studies of human readers with or without AI assistance.

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

This concept is not applicable to this medical device submission. The "device" in this context is a physical hip prosthesis, not an algorithm or AI system. The performance testing described is mechanical, in-vitro testing.

7. Type of Ground Truth Used

The "ground truth" for this submission is established by engineering standards and specifications (ASTM and ISO). The device's components and overall system are tested against the requirements outlined in these standards.

8. Sample Size for the Training Set

There is no training set for this device submission as it is a physical medical device (hip prosthesis) and not an AI/algorithm-based product.

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

This question is not applicable as there is no training set mentioned or implied for this physical medical 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.

The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is to be used with the bone screws and anterior cover plate assembly and requires no additional supplementary fixation systems. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant. The Renovis S128 ALIF System contains both fixed and variable angle screw options. The fixed angle screw option provides a tight fit with the cage. The variable angle screw option provides a slight clearance between the cage and the screw which allows for a small amount of variable screw angulations.

The Renovis S128 ALIF System cages are intended to be used with autogenous bone graft. The accompanying cover plate is designed to prevent screw back-out and must be used when the screws are implanted. NOTE: The cover plate assembly and screw are part of the implant construct.

The Renovis S128 ALIF System implants 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 bone screws and coverplate assembly are both manufactured from Titanium alloy. The PEEK markers are manufactured from Tantalum. The Renovis Si28 ALIF System is used with trials and implant specific manual instruments, and includes other class I manual orthopedic instruments.

The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is an intervertebral fusion device. The acceptance criteria for the device were based on various mechanical performance tests as outlined by ASTM standards and specific FDA guidance documents. The study demonstrating the device meets these criteria involved physical performance testing of the device's components and the full implant system.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states that "worst case constructs" of the Renovis S128 ALIF System implants were used for mechanical testing and "sample coupons" of the Titanium porous structure were tested. However, the exact numerical sample sizes for each test are not specified in the provided text. The data provenance is pre-market performance bench testing, indicating it is prospective data obtained specifically for regulatory submission, and not from clinical trials or retrospective patient data. The country of origin for the data generation (e.g., in which lab/country testing was conducted) is not specified, though Renovis Surgical Technologies is located in Redlands, CA, USA.

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

This information is not applicable as the evaluation of this medical device's performance is based on standardized mechanical testing against pre-defined engineering criteria (ASTM standards and FDA guidance) rather than subjective expert assessment of clinical data or images. "Ground truth" in this context refers to the verifiable performance against these objective mechanical benchmarks.

4. Adjudication Method for the Test Set:

This information is not applicable as the device's performance was assessed through objective mechanical testing against established standards, not through a process requiring expert adjudication of subjective outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of how much human readers improve with AI vs without AI assistance:

This is not applicable as the document describes a pre-market notification for an intervertebral fusion device, which is an implantable medical device, not an AI-powered diagnostic tool. Therefore, no MRMC study involving human readers with or without AI assistance was conducted or would be relevant.

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

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

7. The Type of Ground Truth Used:

The ground truth used for this device's evaluation is defined by established engineering and material standards and FDA guidance documents. Specifically, successful performance in physical and mechanical tests (e.g., static/dynamic compression, shear, expulsion, subsidence) as per ASTM F2077, ASTM F2267, ASTM F1044, ASTM F1147, ASTM F1978, ASTM F1854, and various material specifications (e.g., PEEK, Titanium, Tantalum). The device's substantial equivalence is based on its ability to meet these objective, measurable criteria, indicating it performs comparably to predicate devices in mechanical integrity and material properties.

8. The Sample Size for the Training Set:

This information is not applicable. The context provided is for a traditional medical device (spinal implant) undergoing a 510(k) submission, which relies on demonstrating substantial equivalence through engineering testing and material characterization, not machine learning or AI models that require training sets.

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

This information is not applicable for the reasons stated in point 8.

Ask a specific question about this device

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, rheumatoid 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 intended for cemented use only.

The A200 Knee System consists of the following components: Femoral Components - nine (9) sizes in a cruciate-retained (CR) design, each for left and right sides, manufactured from Co-Cr-Mo allov: Tibial Tray Components - nine (9) sizes, each for the left and right sides, and each in two stem designs, a conical design manufactured from Co-Cr-Mo alloy, and a keeled design manufactured from Ti 6Al 4V alloy: Tibial Insert Components - three (3) footprint sizes, each for the left and right sides, with articulating thicknesses ranging from 10 mm to 20 mm, all in CR designs, in standard and deep dish configurations, manufactured from highly crosslinked ultra-high molecular weight polyethylene with and without vitamin E: Patellar Components five (5) sizes, in dome design, manufactured from highly crosslinked ultra-high molecular weight polvethylene with and without vitamin E: and A200 Knee Instrumentation including instruments for use with the system components, trial implant components, and general instruments.
The A200 Knee System implants are manufactured from Co-Cr-Mo alloy conforming to ASTM F75, Ti-6A1-4V alloy conforming to ASTM F136, and ultra-high molecular weight polyethylene conforming to ASTM F648 and ASTM F2695. All UHMWPE is crosslinked by gamma irradiation. The metallic implant components (femoral components and tibial tray components) are sterilized by Co6 gamma irradiation, and all UHMWPE components are sterilized by ethylene oxide.

The provided 510(k) summary for the Renovis Surgical Technologies, LLC A200 Knee System (K120038) does not contain the acceptance criteria or a study proving the device meets those criteria in the format requested.

This document is a premarket notification for a medical device (a knee prosthesis system) and focuses on demonstrating substantial equivalence to legally marketed predicate devices. This type of submission generally does not involve a clinical study with a test set, ground truth, or expert adjudication in the way typically seen for AI/software-as-a-medical-device (SaMD) clearances.

Instead, the "proof" is based on non-clinical testing data and a comparison of technological characteristics to existing devices.

Here's a breakdown of why the requested information cannot be fully provided from this document:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds in the document. The general acceptance criterion for a 510(k) is "substantial equivalence" to predicate devices, meaning it is as safe and effective.

• Reported Device Performance: The document lists several types of non-clinical tests performed, such as:

  • Component testing (tibial tray fatigue, contact area, contact stress, constraint, and tibial insert-tray interlock strength)
  • UHMWPE material characterization (density, swell ratio, oxidation index, trans-vinylene index, melting point, crystallinity, vitamin E content, free-radical content, assessment of consolidation, and analysis of extraction residues)
  • UHMWPE mechanical testing (Izod impact resistance, tensile properties, compressive properties, small punch testing, fatigue crack propagation, and environmental stress cracking)
  • Force-control wear testing according to ISO 14243-1 and ISO 14243-2.

  The performance is described qualitatively as "demonstrated the A200 Knee System to be substantially equivalent" or "was substantially equivalent to the predicate devices." No specific numerical results or thresholds are given.

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 applicable in the context of this 510(k) submission. There is no "test set" of patient data in the sense of a clinical trial used to evaluate an AI algorithm. The device is a physical implant. The "testing" refers to laboratory-based, non-clinical mechanical and material characterization.

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. There is no "ground truth" established by experts in this context. The "proof" is based on engineering and material science standards and comparisons to accepted devices.

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

• Not applicable. There is no adjudication in this type of submission.

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

• Not applicable. This device is a physical knee implant, not an AI software. Therefore, an MRMC study related to human readers and AI assistance is entirely irrelevant to this submission.

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

• Not applicable. This is not an algorithm or software.

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

• Not applicable in the typical sense. The "ground truth" for a knee implant's safety and effectiveness in a 510(k) context is established by adherence to recognized standards (e.g., ASTM, ISO), mechanical properties, material biocompatibility, and demonstrated performance (e.g., wear rate, fatigue strength) compared to devices already on the market that have a known safe and effective history.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable.

Summary of what the document does provide regarding "proof" of meeting requirements:

The "study that proves the device meets the acceptance criteria" in this context is the compilation of non-clinical testing data that demonstrates the A200 Knee System is substantially equivalent to legally marketed predicate devices.

• Acceptance Criteria (Implicit): The device must be as safe and effective as the predicate devices, and any differences in technological characteristics must not raise new issues of safety or efficacy.
• Study Design/Methodology: Non-clinical (benchtop) testing, material characterization, and comparison to predicate devices.
• Key Findings: The document states that:
  • Constraint, contact area, and contact stress testing demonstrated substantial equivalence to predicate devices K923277, K892800, K932837, and K935080.
  • Wear rate testing of the UHMWPE with vitamin E was substantially equivalent to predicate devices K103223 and K100048.
  • Overall, the device "has the same intended use," "uses the same operating principles," "incorporates the same basic designs," "incorporates the same or very similar materials," and "has similar packaging and is sterilized using the same materials and processes" as the predicate devices.

In essence, for a physical implant like the A200 Knee System, "meeting acceptance criteria" in a 510(k) means successfully proving substantial equivalence through a battery of engineering tests and a detailed comparison to existing, cleared devices.

Ask a specific question about this device

The Renovis A400 Surgical Hip Joint Replacement Prosthesis is indicated for patients suffering from the following:

1. Noninflammatory 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 Surgical Hip Joint Replacement Prosthesis is intended for cementless applications.

The Renovis Surgical Technologies, Inc. A400 Surgical Hip Replacement System (Renovis A400 Hip System) is a family of components designed in a variety of standard clinically usable sizes for cementless total hip replacements (i.e. replacements where both the femur and acetabulum are replaced).

The system consists of four main components available in a variety of clinically usable sizes.

A) Femoral Stem (titanium alloy)

B) Femoral Head (CoCr and Biolox delta ceramic)

C) Acetabular Cup (titanium alloy)

D) Acetabular Liners (Mechanically annealed HXL polyethylene with and without alphatocopherol)

The Renovis A400 Hip System implant components are provided sterile and are for single use.

The provided text describes a 510(k) submission for the RENOVIS A400 Surgical Hip Replacement System. The submission focuses on demonstrating substantial equivalence to predicate devices, primarily through comprehensive performance testing, rather than reporting on a study to meet pre-defined acceptance criteria with device performance results in a standalone clinical setting.

Therefore, many of the requested elements for acceptance criteria, device performance, and study details like sample size for test sets, expert involvement for ground truth, and comparative effectiveness studies are not applicable or not explicitly detailed in this 510(k) summary.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance results in the format typically seen for a new clinical study with pre-defined metrics. Instead, the "Performance Testing" section lists various tests performed to demonstrate safety, efficacy, and substantial equivalence to predicate devices. The implicit acceptance criterion for each test is that the Renovis A400 Hip System's performance meets the standards or guidance documents referenced (e.g., ISO, ASTM, FDA Guidance) and is comparable to the predicate devices, thereby raising no new questions of safety or effectiveness.

Study Details

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

   • Sample Size (Test Set): Not specified in the document. The document refers to "comprehensive bench performance testing" and "the following device tests were performed," implying specific quantities of components were tested for each standard. For example, fatigue testing would involve multiple samples, but the exact number is not provided.
   • Data Provenance: The tests are benchtop "performance testing" and in-vitro/in-vivo biocompatibility testing, not human-patient data. The document does not specify the country of origin for the actual testing, but the submission is to the U.S. FDA.

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. This is a mechanical and biocompatibility testing submission for a hip implant, not an AI or diagnostic device requiring expert consensus for a "ground truth" on patient data. The "ground truth" for these tests is defined by the technical specifications and performance criteria within the referenced ISO, ASTM, and FDA guidance documents.

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

   • Not Applicable. This type of adjudication is typically used for clinical study endpoints or image interpretation, not for standard bench and biocompatibility testing results. The results of these tests (e.g., fatigue life, wear rate, toxicity) are objectively measured against established standards.

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

   • No. An MRMC study is completely irrelevant for this 510(k) submission, which concerns a physical hip implant.

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

   • Not Applicable. This device is a surgical implant, not an algorithm.

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

   • The "ground truth" for this submission are the established international and national standards (ISO, ASTM, FDA Guidance) for mechanical properties, wear characteristics, and biocompatibility of orthopedic implants. The device's performance is compared against these engineering and biological benchmarks, and against the known characteristics of the predicate devices.

7. The sample size for the training set

   • Not Applicable. This is not an AI/machine learning device; there is no "training set" in the conventional sense. The "training" for the design might refer to iterative design and testing, but no formal training set size is mentioned.

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

   • Not Applicable. See point 7.

Ask a specific question about this device

The Renovis S 100 Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: failed previous fusion (pseudoarthrosis), spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors or trauma (fracture and dislocation).

When used as a pedicle screw system, the Renovis S 100 Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

As a posterior pedicle screw system designed for temporary stabilization of the posterior spine during the development of spinal fusion, the Renovis S 100 Pedicle Screw System is comprised of polyaxial pedicle screws, rods, and crosslinks. The S 100 System can be used for single or multiple level fixations

The screws are a top loading tulip design and are available in multiple diameters and lengths. Reduction screws are available for cases of spondylolisthesis where the short arms of the tulip of the standard screw are not long enough to engage the rods are available in straight and pre-lordosed (curved) configurations. The system also has variable and fixed crosslinks.

The purpose for this Premarket Notification is for the addition of iliac screws and connectors.

Here's a breakdown of the acceptance criteria and the study that proves the S 100 Pedicle Screw System meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • The document does not specify the sample size for the test set (number of devices tested).
   • The data provenance is not explicitly mentioned, but the tests were performed "per ASTM F1717," which is an international standard for mechanical testing of spinal implant constructs. Without further information, it's presumed these were laboratory tests rather than human subject data.

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):

   • This is not applicable as the study involved mechanical testing against a standard (ASTM F1717) rather than human interpretation or clinical outcomes requiring expert ground truth.

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

   • Not applicable for mechanical testing. The results are quantitative and objective based on the ASTM standard.

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

   • No MRMC study was conducted. The document explicitly states: "No clinical studies were performed." This is a mechanical device, not an AI-driven diagnostic tool.

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

   • Not applicable. This is a mechanical pedicle screw system, not an algorithm.

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

   • The "ground truth" for the mechanical performance was the established mechanical properties and performance of legally marketed predicate devices, as well as the specifications outlined in ASTM F1717. The device's performance was compared to these existing standards and predicate devices.

7. The sample size for the training set:

   • Not applicable. This is a mechanical device, not a machine learning algorithm requiring a training set.

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

   • Not applicable as there was no training set.

Summary of the Study:

The study conducted for the S 100 Pedicle Screw System was a non-clinical, mechanical testing study designed to demonstrate substantial equivalence to predicate devices. The tests were performed according to ASTM F1717, which covers static and dynamic compression, and static torsion for spinal implant constructs.

The acceptance criteria were met by demonstrating that the mechanical performance (static and dynamic compression, static torsion) of the S 100 Pedicle Screw System was equal to, or higher than, the predicate devices. This means the device met or exceeded the established safety and performance benchmarks.

Since this was a physical medical device and not an AI or diagnostic tool, concepts like ground truth established by experts, clinical studies, MRMC studies, or training/test sets for algorithms are not applicable and were explicitly stated as not performed (e.g., "No clinical studies were performed"). The regulatory approval (510(k)) was based solely on demonstrating substantial equivalence through these non-clinical, mechanical tests.

Ask a specific question about this device

The Renovis Cannulated Screw System is intended for long and small bone fracture fixation, including: fractures of the tarsals and metatarsal and phalangeal osteotomies; fractures of the carpals and metacarpals; carpal and metacarpal arthrodesis; small fragments of the hand and wrist; ligament fixation as appropriate; sacroiliac joint disruptions; fractures of the distal femur and proximal tibia; intracapsular fractures of the hip; ankle arthrodesis; and pelvis and acetabulum fractures. This system is not indicated for use in the spine.

The Renovis Cannulated Screw System includes cannulated screws and washers, designed to provide secure fixation for various fracture, osteotomy and arthrodesis indications. All screws are cannulated for use over guide pins, allowing for accurate placement. Screws are available in a range of diameters and lengths in partially threaded designs. The system also includes washers to prevent the screw head from pulling through the cortex. The Renovis Cannulated Screw System implants are made from 316L stainless steel.

The provided text describes the Renovis Cannulated Screw System, a bone fixation device. The 510(k) submission states that "No performance testing is included in this application." Therefore, there is no study that proves the device meets acceptance criteria detailed in this document.

The submission focuses on establishing substantial equivalence to a predicate device (Synergy Cannulated Screw System) based primarily on similar intended use, operating principle, design, dimensions, packaging, sterilization directions, and biocompatibility, despite a difference in material composition. The manufacturer justifies this by stating that the use of 316L stainless steel for the Renovis system (compared to the predicate's 23Mn-21Cr-1Mo low nickel stainless steel alloy or Ti-6AL-4V titanium alloy) "does not raise issues of safety or effectiveness."

Given this, the following sections cannot be fully answered as no performance study was conducted.

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

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

No test set was used as no performance testing was conducted.

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

Not applicable, as no test set requiring ground truth was used.

4. Adjudication method for the test set

Not applicable, as no test set requiring adjudication was used.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states, "No performance testing is included in this application."

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

Not applicable, as this device is a physical medical implant (cannulated screw system), not a software algorithm.

7. The type of ground truth used

Not applicable, as no performance testing requiring ground truth was conducted.

8. The sample size for the training set

Not applicable, as this information pertains to machine learning models, and the device is a physical medical implant.

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

Not applicable, as this information pertains to machine learning models, and the device is a physical medical implant.

Ask a specific question about this device

The Renovis T 710 Large External Fixation System is indicated for the following:

• Stabilization/fixation of:
  • o Long bone fractures in tibia and femur
  • o Fractures of pelvis and ankle
  • Peri-articular and intra-articular fractures of knee and ankle o
• . Joint arthrodesis
• Non-unions and mal-unions .
• Osteotomies

The Renovis T 710 Large External Fixation System is an external fixation device consisting of bone pins, connecting rods, clamps, posts and related accessories used for the management of bone fractures and reconstructive orthopedic surgery. The device is a modular system designed to provide a broad range of frame construction options. The connecting rods are made from unidirectional carbon fiber reinforced epoxy. Pins and clamp components are made from materials conforming to ASTM F136 and ASTM F138.

This 510(k) summary describes a traditional medical device (external fixation system), not an AI/ML powered device. As such, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (like accuracy, sensitivity, specificity, and MRMC studies) are not applicable here.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting that their device is as safe and effective as devices already legally marketed. The "proof" for this comes from comparing the new device's intended use, design principles, materials, and overall dimensions to those of predicate devices, along with engineering analysis.

Here's how the provided information relates to your request, interpreted for a traditional medical device:

1. A table of acceptance criteria and the reported device performance:
   This document does not present acceptance criteria in terms of quantitative performance metrics (e.g., accuracy, sensitivity) for the device's function, nor does it report such performance.
   Instead, the "acceptance criteria" implicitly revolve around demonstrating that the new device is substantially equivalent to existing predicate devices. The "reported device performance" in this context refers to the characteristics of the device itself (materials, design, intended use) that are compared to those of the predicate devices.

   Characteristic	Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (Renovis T 710)
   Intended Use	Must be the same as or very similar to predicate devices.	- Stabilization/fixation of long bone fractures (tibia, femur), pelvis, ankle fractures, peri-articular and intra-articular fractures (knee, ankle)

• Joint arthrodesis
• Non-unions and mal-unions
• Osteotomies
  (Stated to be the "same intended use" as predicates) |
  | Design Principles | Must be the same as or very similar to predicate devices. | - Modular system for broad range of frame construction options
• Consists of bone pins, connecting rods, clamps, posts, accessories
• Creates rigid construct (frame) to stabilize instabilities
• Implantable bone pins (titanium alloy or stainless steel, distally or centrally threaded)
  (Stated to incorporate "the same basic design" and "same operating principle" as predicates) |
  | Materials | Must use the same or very similar materials as predicate devices, conforming to relevant standards (e.g., ASTM F136, ASTM F138). | - Connecting rods: unidirectional carbon fiber reinforced epoxy
• Pins and clamp components: materials conforming to ASTM F136 and ASTM F138
• Implantable bone pins: titanium alloy or stainless steel
  (Stated to incorporate "the same or very similar materials" as predicates) |
  | Overall Dimensions | Must have similar overall dimensions or variations that do not raise new safety/efficacy concerns compared to predicate devices. | Not explicitly detailed but implied by the statement: "The intended use, design principles, materials and overall dimensions of the subject and predicate devices are substantially the same." Differences in technological characteristics "do not raise new issues of safety or efficacy." |
  | Sterilization & Packaging | Must use similar or same sterilization and packaging methods as predicate devices. | - Similar packaging
• Sterilized using the same materials and processes
  (Stated in comparison to predicates) |
  | Safety & Efficacy Differences | Any differences in technological characteristics must not raise new issues of safety or efficacy. | "Any differences in the technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy."
  "Data are provided to demonstrate substantial equivalence including detailed engineering analysis of the subject and predicate designs." (This is the "study" proving it meets the implicit criterion). |

2. Sample sized used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI/ML model for this type of medical device submission. The evaluation is based on engineering analysis and comparison to predicate devices, not on data analysis for a diagnostic or predictive algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML model is not relevant here. The "ground truth" equivalent would be established medical knowledge and regulatory standards for mechanical devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set where adjudication is needed.

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 traditional mechanical medical device, not an AI-assisted diagnostic or therapeutic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device with no algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the AI/ML sense. The "ground truth" for this submission is established through:

   • Regulatory Precedent: The existence of legally marketed predicate devices with known safety and effectiveness.
   • Engineering Principles: Sound biomechanical and material science principles ensuring the device functions as intended.
   • Standardized Testing: Implicitly, the components meet industry standards (e.g., ASTM F136, ASTM F138).
   • Clinical Experience: The long-standing use and understanding of external fixation systems in orthopedic surgery.

8. The sample size for the training set: Not applicable. There is no training set for a mechanical device.

9. How the ground truth for the training set was established: Not applicable. No training set for a mechanical device.

Study Proving Device Meets Acceptance Criteria (Substantial Equivalence Documentation):

The document states: "Data are provided to demonstrate substantial equivalence including detailed engineering analysis of the subject and predicate designs."

This "detailed engineering analysis" serves as the "study" proving the device meets the implicit acceptance criteria for substantial equivalence. It would involve:

• Material Characterization: Testing of the carbon fiber, titanium alloy, and stainless steel to ensure they meet the specified ASTM standards and have properties comparable to predicate devices.
• Mechanical Testing:
  • Static Loading Tests: Evaluating the strength and stiffness of individual components (pins, rods, clamps) and the assembled frame under various loads (e.g., compression, tension, bending, torsion) to simulate physiological forces.
  • Fatigue Testing: Assessing the durability of components and the frame under cyclical loading to simulate long-term use and ensure they do not fail prematurely.
  • Pin Pull-out Strength: Measuring the force required to dislodge pins from bone surrogates, ensuring adequate fixation.
  • Clamp Slippage Resistance: Verifying that clamps maintain their position on rods under load.
• Dimensional Conformance: Measuring components to ensure they meet design specifications and are compatible with surgical techniques and existing predicate systems where relevant.
• Biocompatibility Testing: (Though not explicitly mentioned for this specific device in the summary, it's a standard requirement for all implantable components unless predicate materials have established biocompatibility).
• Sterilization Validation: Ensuring the chosen sterilization method is effective and doesn't degrade materials.

The results of these engineering analyses would be compared directly to the known characteristics and performance of the specified predicate devices (Howmedica Hoffmann Fixation Pin System, Apex Fixation Pins, Hoffmann II External Fixation System, Synthes Adjustable Large Fixator System, and TransFx External Fixation System) to demonstrate that the Renovis T 710 "does not raise new issues of safety or efficacy."

Ask a specific question about this device

The Renovis S 100 Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion {pseudoarthrosis}, spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors.

When used as a pedicle screw system, the Renovis S 100 Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

As a posterior pedicle screw system designed for temporary stabilization of the anterior spine during the development of spinal fusion, the Renovis S 100 Pedicle Screw System is comprised of polyaxial pedicle screws, rods, and crosslinks. The S 100 System can be used for single or multiple level fixations

The screws are a top loading tulip design and are available in multiple diameters and lengths. Reduction screws are available for cases of spondylolisthesis where the short arms of the standard screw are not long enough to engage the rod. The rods are available in straight and pre-lordosed (curved) configurations. The system also has variable and fixed crosslinks.

The provided text describes a 510(k) summary for the Renovis S 100 Pedicle Screw System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies that would establish acceptance criteria and device performance in the same way as an AI/ML medical device.

Therefore, many of the requested categories are not applicable to this document. The "acceptance criteria" here refers to demonstrating equivalence to predicate devices through mechanical testing and comparison of design and materials.

Here's a breakdown of the information as it relates to the provided text:

Acceptance Criteria and Device Performance (as applicable for a 510(k) of this nature)

• Testing per ASTM F1717
• Testing per ASTM F1798
• Component dissociation testing
  The results “were equal or higher than the predicate system” (ZODIAC™ Polyaxial Spinal Fixation, and other predicates for specific components). This indicates the device meets or exceeds the mechanical performance of established similar devices. |

Study Information (Based on the provided K101682 document):

Because this is a 510(k) for a pedicle screw system, the "study" is primarily a non-clinical, mechanical testing comparison to predicate devices, rather than a clinical trial or AI/ML model validation.

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

   • The document does not specify the exact sample sizes (e.g., number of screws, rods, or crosslinks) used for the mechanical tests (ASTM F1717, ASTM F1798, component dissociation testing).
   • Data Provenance: The tests conducted are standard ASTM (American Society for Testing and Materials) standards, implying laboratory-based mechanical testing. No geographical origin of the data is specified beyond the company's location (Redlands, CA, USA). The testing is prospective for this device, comparing its new components against existing standards and predicates.

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. For mechanical performance testing of a physical medical device, "ground truth" is established by adherence to recognized national/international standards (like ASTM) and comparison to the published properties/performance of legally marketed predicate devices. Expert consensus in the clinical sense is not directly relevant here. The manufacturing and testing would be performed by qualified engineers and technicians.

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

   • Not Applicable. Mechanical testing under ASTM standards typically involves precise measurements and quantitative outcomes. There isn't an "adjudication" process in the sense of resolving disagreements among human observers for image interpretation or diagnosis. The "acceptance" is based on meeting the quantitative performance metrics relative to the predicate devices and applicable standards.

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

   • Not Applicable. This device is a pedicle screw system, a physical orthopedic implant. It is not an AI/ML-driven diagnostic or assistive technology, so MRMC studies involving human "readers" or AI assistance are irrelevant.

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

   • Not Applicable. As above, this is a physical implant, not an algorithm or software device.

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

   • The "ground truth" for this 510(k) submission is based on established mechanical engineering principles, recognized industry standards (ASTM F1717, F1798), and the performance characteristics of legally marketed predicate devices. The claim of "substantial equivalence" is the central "truth" being established through these comparisons.

7. The sample size for the training set:

   • Not Applicable. There is no "training set" in the context of a physical medical device like a pedicle screw system. This term is relevant for AI/ML models.

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

   • Not Applicable. As there is no training set, this question is not relevant.

Ask a specific question about this device