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S1 is intended for the following uses:
· Augmentation or reconstructive treatment of the alveolar ridge;

• · Filling of infrabony periodontal defects
• · Filling of defects after root resection, apicocectomy, and cystectomy
• · Filling of extraction sockets to enhance preservation of the alveolar ridge
• · Elevation of the maxillary sinus floor
  · Filling of periodontal defects in conjuncts intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and
  · Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

S1 is intended for filling and augmentation of bony voids and gaps in maxillofacial surgery, implantology, and periodontology according to the intended use of the product.
S1 is serving as a matrix consisting of interconnected macro- and micropores. The material is porous and has inner surface area.
S1 is a mixture of Hydroxyapatite (HAp) and hydroxypropyl methylcellulose (HPMC). Hydroxyapatite (HAp) is made from bovine cancellous bone and is mineralized hydroxyapatite.
The bone particle size is 0.2 ~ 1.0mm for the powder type and 1.0 ~ 2.0 mm for the chip type. S1 is packaged in vials and it is supplied sterile by gamma irradiation and is for single use only.

The provided text describes a 510(k) submission for a bone grafting material called "S1," manufactured by MedPark Co., Ltd. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

However, the document does not contain any information about an AI/ML-based medical device or a study proving its performance against specific acceptance criteria for such a device. The device "S1" is a physical bone grafting material, and the tests described are non-clinical (physical, chemical, biocompatibility, sterilization, packaging, and animal studies) typically performed for such medical implants.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are relevant to AI/ML device evaluations, not to the physical bone grafting material described in this document.

The document focuses on comparing the physical, chemical, and biological properties of S1 to predicate bone grafting materials (Geistlich Bio-Oss® and MBCP Gel™) to demonstrate substantial equivalence for regulatory clearance.

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The S10 Kirra is indicated to provide CPAP and Bi-level therapy for the treatment of obstructive sleep apnea (OSA) in patients (female patients with mild to moderate OSA when using AfH treatment mode) weighing more than 66 lb (30 kg). ASV and ASVAuto modes are also indicated for the treatment of central and/or mixed apneas, or periodic breathing. It is intended for home and hospital use.

The S10 Kirra is a prescription only Positive Airway Pressure (PAP) ventilator device intended to treat individuals that are diagnosed with sleep apnea conditions. The S10 Kirra uses a micro-processor controlled blower, along with pressure and flow sensors, to achieve pressure, flow and time regulation of air delivery. It includes optional humidification, with air delivery to the patient via heated or non-heated breathing circuits. The device provides both therapeutic (e.g. tidal volume) and technical data (e.g. system fault), and a user interface allowing adjustment of device parameters. The device uses an external AC power supply, and allows the addition of low flow supplemental oxygen.

The provided text describes the S10 Kirra, a non-continuous ventilator, and its substantial equivalence to predicate devices, but it does not contain the detailed information necessary to answer all parts of your request about acceptance criteria and a specific study proving the device meets them.

The document focuses on demonstrating substantial equivalence to previously cleared predicate devices (S9 Greenhills, S9 Wanda, S9 Elouera), rather than detailing a new study with acceptance criteria for a novel device.

Here's a breakdown of what can be extracted and what is missing:

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

The document states:
"Verification confirmed the S10 Kirra met the predetermined acceptance criteria as defined in the relevant compliance standards and as defined in the system verification protocols."

However, it does not provide a table listing specific acceptance criteria values and the reported performance for each criterion. It broadly mentions areas of testing:

• Pressure performance
• Breath events (flow limitations, snore, apneas)
• Response to periodic breathing
• Humidification

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 available in the provided text. The document refers to "verification bench testing" and "comparative predicate testing" but does not specify sample sizes for test sets or data provenance (country of origin, retrospective/prospective).

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 available. The document focuses on bench testing and comparison to predicate devices, not human expert evaluations for ground truth.

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

This information is not available. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed 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

The document explicitly states:
"Clinical performance data is not required as the subject device uses established therapeutic technology and bench testing is sufficient to demonstrate substantial equivalence."

Therefore, no MRMC comparative effectiveness study was done as the device relies on established technology, and its performance was evaluated through non-clinical bench testing.

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

The entire non-clinical data section describes performance of the device itself (hardware and software), which can be considered a standalone performance assessment in a bench testing environment. The listed performance areas (pressure, breath events, humidification) are intrinsic to the device's function.

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

For the non-clinical bench testing, the "ground truth" would be established by engineering specifications, compliance standards, and the performance characteristics of the predicate devices. The tests evaluate if the S10 Kirra performs according to these pre-defined, measurable engineering and physiological parameters. It is not based on expert consensus, pathology, or outcomes data in the way these terms are typically used for clinical evaluations.

8. The sample size for the training set

This information is not applicable/available. The S10 Kirra is a medical device (ventilator) with microprocessor control, not an AI/machine learning algorithm that requires a "training set" in the computational sense. The device's "training" involves design, engineering, and calibration to meet its specifications, rather than data-driven model training.

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

This information is not applicable/available for the same reason 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. 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 <20° when implanted with the coverplate and screws. Implants are offered in Ti6A14V and PEEK with Tantalum marker pins. Titanium cages are additively manufactured then machined to the final cage dimensions. PEEK implants are manufactured using traditional methods.

The Ti6Al4V conforms to the chemical and mechanical requirements of ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
The PEEK is compliant with ASTM F2026-17 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications.The Tantalum is compliant with ASTM F560-17 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications.

The S128 ALIF System cages that are the subject of this application are gamma sterilized.

The system also includes instruments to allow for implant determination, trialing and disc preparation. Instruments are manufactured from stainless steel in compliance with ASTM A564/M564-13e1 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes.

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 SonoScape S12 system is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Fetal, Abdominal, Pediatric, Small Organ (specify), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Other (Ob/GYN), Other (Urology), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.

This SonoScape S12 Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.

The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body.

This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array with a frequency range of 1.0 MHz to 15.0 MHz. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes.

This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes, Elastography, 3D/4D.

The subject of this submission is the addition of new probes to the legally marketed SonoScape S12.

New probes Add 3C-A, 4P-A and 10l2 probes.

Here's a breakdown of the acceptance criteria and study information for the SonoScape S12 Digital Color Doppler Ultrasound System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary for the SonoScape S12 Digital Color Doppler Ultrasound System does not explicitly list specific numerical acceptance criteria (e.g., specific accuracy percentages, sensitivity/specificity thresholds) or detailed reported device performance in terms of these metrics.

Instead, the submission focuses on demonstrating substantial equivalence to a previously cleared predicate device (SonoScape S12 K142474) and compliance with relevant industry standards. The performance is assessed by confirming that the device meets its design specifications and conforms to applicable medical device standards, which implies satisfactory performance for its intended use.

Qualitative Acceptance Criteria (Implied by the 510(k) Summary):

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

The document does not specify a sample size for a test set in the context of clinical performance evaluation. The submission relies on non-clinical tests (laboratory and phantom tests) to verify design specifications and compliance with standards.

The data provenance is implied to be from internal laboratory testing conducted by SonoScape Medical Corp. in China. The study is not a retrospective or prospective clinical study on patient data in the typical sense for demonstrating diagnostic accuracy or clinical effectiveness.

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

This information is not provided in the document as there was no clinical testing requiring expert review for ground truth establishment. The document refers to non-clinical laboratory and phantom tests.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided, as the submission did not involve clinical testing or human reader studies requiring adjudication.

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 clinical testing was required." (Page 25). Therefore, there is no effect size reported for human readers improving with or without AI assistance, as AI assistance is not mentioned or evaluated in this context.

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

This aspect is not applicable as the SonoScape S12 is a diagnostic ultrasound system and does not appear to feature AI algorithms requiring standalone performance evaluation in this 510(k) submission. The document primarily focuses on hardware and core imaging modalities.

7. The Type of Ground Truth Used

For the non-clinical tests (laboratory and phantom tests), the "ground truth" would have been established by:

• Known physical properties of phantoms: For acoustic output, imaging resolution, penetration, etc., phantoms with well-defined characteristics serve as the ground truth.
• Engineering specifications and standards: Compliance with IEC and ISO standards dictates the expected performance and limits.
• Comparison to predicate device's established performance: The primary method for demonstrating safety and effectiveness is substantial equivalence to the predicate device (K142474), implying that the predicate's performance serves as an established baseline.

8. The Sample Size for the Training Set

This information is not applicable as the submission does not describe an AI or machine learning model that would require a "training set." The device is a traditional ultrasound imaging system.

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

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

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The SonoScape S12 system is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

This SonoScape S12 Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array with a frequency range of 2.0 MHz to 15.0 MHz. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes, Elastography, 3D/4D.

This document describes the safety and performance evaluations for the SonoScape S12 Digital Color Doppler Ultrasound System (K142474) and its transducers, in comparison to predicate devices, to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SonoScape S12 Digital Color Doppler Ultrasound System are primarily demonstrated through conformance to established international and national standards, and by showing substantial equivalence to predicate devices for its intended uses and technological characteristics. The document doesn't present a specific table of numerical performance acceptance criteria and reported performance values in a typical AI/software context. Instead, it relies on a comparison of technical specifications and functionalities with predicate devices.

However, based on the provided text, we can infer some "acceptance criteria" through comparison to predicate devices and adherence to standards. Since direct numerical performance metrics are not given, the "Reported Device Performance" for equivalence is qualitative, stating "Same" or "Substantially Equivalent (SE) with detailed analysis".

Here's a summarized view of the comparisons:

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

The document states, "Laboratory tests were conducted to verify that the S12 system met all design specifications... Phantom test was conducted to verify that the strain Elastography function was effective and Elastography performance met design specifications, including accuracy and repeatability of strain ratio measurement and etc."

However, the specific "sample size" for these laboratory and phantom tests (e.g., number of phantom measurements, specific dataset sizes) is not provided. The data provenance (country of origin, retrospective/prospective) is also not specified/mentioned for these tests.

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)

The document does not mention the use of experts to establish ground truth for testing. The evaluation appears to be based on technical specifications, direct comparison to predicate devices, and phantom testing, rather than human expert interpretation of images. The "phantom test" mentioned for Elastography implies a physical standard or controlled environment rather than expert-labeled cases.

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

Since the document does not describe the use of human experts or clinical data for a test set that would require ground truth adjudication, there is no adjudication method mentioned or applicable in the context presented.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study being done. The device is a diagnostic ultrasound system, and the submission focuses on establishing substantial equivalence based on technical characteristics and safety standards, not on AI-assisted diagnostic improvement.

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

The document describes a diagnostic ultrasound system and its transducers, which are hardware devices with embedded software for image acquisition and processing. It is not an AI-based standalone diagnostic algorithm. The phrase "algorithm only without human-in-the-loop performance" is not applicable in this submission. The system produces images for human interpretation.

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

For the Elastography function (the only feature specifically mentioned with a "test"), the ground truth was established using phantom tests. This suggests a physical phantom with known properties (e.g., stiffness) was used as the reference, rather than expert consensus on clinical cases, pathology, or outcomes data. For other aspects of the ultrasound system, the "ground truth" seems to be adherence to engineering specifications and performance matching that of the predicate devices.

8. The sample size for the training set

The document is for a traditional diagnostic ultrasound system and does not mention machine learning or AI algorithms requiring a "training set." Therefore, no training set size is provided or applicable.

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

As there is no mention of a training set (see point 8), the method for establishing its ground truth is also not applicable.

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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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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.

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The S12X Cortical Stimulator is intended for Intraoperative cortical stimulation mapping to aid in cortical resections in the vicinity of essential cortex. The device is intended for use only by medically trained and qualified personnel, within a hospital or medical environment. The ESAx option is intended for use with the S12X for facilitating the switching of the patient electrodes.

The S12X Stimulator supplies a bi-phasic, constant current electrical pulse sequence that is suitable for cortical stimulation. Currents can be applied to the surface of the cortex either with a Manual Probe or through a Set of Electrodes (using the ESAx) option. Electrodes, either the Manual Probe or the Set of Electrodes are not considered part of the S12X.

The S12X is intended to replace and discontinued S12 Stimulator in the product line of Grass Instruments, Inc. (now Grass-Technologies, an Astro-Med, Inc. Product Group), marketed prior to May 28. 1976 and sold as a research device thereafter. The essential functions of the S12 have been retained, but appropriate isolation and insulation features have been added to meet modern requlatory requirements for use with human patients. In order to provide for applications and expansions of function compatible with modern medical data systems, hardware timing circuits have been replaced with an embedded controller whose crystal controlled counters replace the hardware timing functions, and the panel controls have been largely replaced with a touch screen graphical user interface (GUI).

The S12X device consists of an external medical grade power supply, the S12X Stimulator Unit, and the optional ESAx electrode selector adapter. The S12X front panel consists of hardware switches for controlling the "Stimulate" and "All Stop" functions, and a color LCD touch screen display with instrumentstyle controls for setting up the stimulation parameters, calibrating the stimulation log file contents, and for selecting electrodes for stimulation. User input is via a stylus (for touch panel use) or via a standard mouse. The optional ESAx unit connects to a multi-pin connector on the side panel of the S12X.

The S12X accumulates a log of stimulation events, their time-of-day, and their parameters. The log file can be easily transferred to a USB flash drive or equivalent for electronically filing or printing of the stimulation log.

No transient voltage can exceed 34 volts on the patient electrodes (limited by a Zener diode across the patient leads). Further, if after two pulses the internal voltage monitor detects pulse voltages greater than 30 volts, the pulse train will terminate.

No sustained direct current can pass through the patient leads since the output stimulus is entirely transformer coupled. The unit is powered by an external regulated 12 volt DC medical-grade supply powered by standard mains voltage of 120V or 250V AC, and meets U.S. and European requlatory standards: IEC 60601-1-1, and IEC 60601-1-2.

ESAx Electrode Switch Array:

The ESAx is an optional accessory to the S12X which facilitates rapid functional brain mapping during presurgical workups and during surgery. The ESAx is an array of optically coupled relays that can select electrodes from an electrode grid array when more than one electrode pair is in contact with the cerebral cortex, usually in the form of strips or grids. Note that the cortical electrode strips or grids are not part of the device, and they are purchased by the user from other vendors. The ESAx connects the desired electrode pair to the stimulator and simultaneously disconnects the corresponding EEG amplifier leads from the amplifier. The choice of electrodes to be stimulated is controlled from a touch screen display on the S12X,

The ESAx has no buttons or switches, and consists of multi pin connectors for connecting to the S12X and for connecting EEG electrode iack boxes and EEG amplifier unit(s). Note that the EEG jack boxes and the multi-channel EEG amplifiers which can connect to the ESAx are not part of the S12X device, and therefore are not part of this 510(k) submission.

Here's a breakdown of the acceptance criteria and study information for the S12X with ESAx Option device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a particular sample size for a "test set" in the context of clinical or human subject testing. The "test data" mentioned refers to in-house engineering and functional testing of the S12X device itself.

• Sample Size: Not applicable for a human-subjects test set. The testing was on the device's functional performance.
• Data Provenance: The data comes from "in-house testing" performed by Chatten Associates, Inc. This indicates it's internal engineering and verification testing. It does not refer to clinical trial data or data collected from human subjects.

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

Not applicable. The "ground truth" for this device's performance is based on its technical specifications and functional output as designed, and comparison to the technical specifications of predicate devices. There is no mention of experts establishing a ground truth for a clinical "test set" or a labeled dataset for an AI algorithm.

4. Adjudication Method for the Test Set

Not applicable. There's no mention of an adjudication method as no expert-labeled test set was used in the described testing.

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

No. The document describes technical verification and validation against the device's design and a comparison of its specifications to predicate devices. It does not mention any MRMC study involving human readers or AI assistance.

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

The device itself is a piece of hardware (a cortical stimulator and an electrode switch array), not an AI algorithm. Therefore, the concept of a "standalone" algorithm performance study is not applicable here. The device's performance was assessed based on its functional output against its design specifications.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on:

• Design and Performance Functional Requirements: The device's ability to meet its own internal hardware and software design specifications.
• Technical Specifications of Predicate Devices: Comparison of parameters like maximum current, charge per pulse, and maximum power output to the Ojemann Cortical Stimulator (K924226).
• Regulatory Standards: Compliance with standards like IEC 60601-1-1 and IEC 60601-1-2.

8. The Sample Size for the Training Set

Not applicable. This device is hardware and does not employ AI or machine learning algorithms that would require a "training set."

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

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

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