Search Results

The prodisc® L Instruments are intended for the placement, positioning, and removal of the prodisc® L implants.

The prodisc® L Instruments enable the Centinel prodisc® L disc to be implanted into the disc space. The purpose of this Traditional 510(k) is to seek marketing clearance for four additional prodisc® L Instruments:

• IN1575, Hemi Chisel +3mm, 10mm
• IN1576, Hemi Chisel +3mm, 12mm
• IN1570, Superior Impactor, Medium
• IN1571, Superior Impactor, Large
  These are new instruments, based on similar devices within the existing instrument set.

The provided text is a 510(k) clearance letter from the FDA for medical instruments. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for an AI/software device.

The device in question, "prodisc® L Instruments," falls under the product code QLQ, which is for "Manual Instruments Designed For Use With Total Disc Replacement Devices." This indicates it is a set of physical surgical tools, not a software or AI-powered device.

Therefore, I cannot provide the requested information because the provided document does not pertain to the evaluation of an AI or software device. The questions you've asked are typically relevant to the validation of diagnostic or predictive AI tools.

Ask a specific question about this device

The prodisc® L Instruments are intended for the placement, positioning, and removal of the prodisc® L implants.

The prodisc® L Instruments enable the Centinel prodisc® L disc to be implanted into the disc space. The purpose of this Traditional 510(k) is to seek marketing clearance for the prodisc® L Instruments.

This document is a 510(k) premarket notification for the prodisc® L Instruments. It does not present a study or acceptance criteria for device performance related to diagnostic accuracy or AI/algorithm performance.

Instead, this document is a regulatory submission demonstrating the substantial equivalence of surgical instruments (prodisc® L Instruments) to previously cleared predicate devices. The focus is on the instruments' design, materials, manufacturing, and intended use for placing, positioning, and removing prodisc® L implants.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the content of this 510(k) summary for surgical instruments.

Ask a specific question about this device

The M6-C™ Single Use, Disposable Instrumentation are intended for the placement and positioning of the M6-C Artificial Cervical Disc.

The M6-C™ Artificial Cervical Disc is an intervertebral disc prosthesis designed to permit motion of a functional spinal unit in the cervical spine when replacing a degenerated native disc (PMA P170036). The surgical implantation of the M6-C Cervical Artificial Disc requires specific surgical instruments including: a footprint template and a trial to determine the appropriate size and position of the implant; a fin cutter to create tracks in the superior and inferior vertebral endplates; and an implant inserter to place the artificial disc into the desired position to aid in and ensure correct placement within the intervertebral space. Additionally, these are general surgical instruments to assist in the distraction and mobilization of the disc space. The single use instruments are composed primarily of reinforced polyacrylamide (PAA+50%GF) with some structural components made from surgical stainless steel and are intended to be reusable.

The provided text focuses on the FDA's 510(k) clearance for the M6-C™ Single Use, Disposable Instrumentation. It details the device's intended use and design, emphasizing its equivalence to a predicate device. However, it does not contain information about acceptance criteria for an AI/ML device, details of diagnostic performance studies, sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details (effect size, human improvement).
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document describes a surgical instrumentation device, not an AI/ML diagnostic device. The performance testing mentioned (Impact Testing, Bend/Functional Testing, Sterilization and Biocompatibility Testing) are typical for physical surgical instruments, not for evaluating AI model performance.

Ask a specific question about this device

The Aesculap Implant Systems® activL® Next Generation Instrumentation are indicated for the successful implantation of the Aesculap activL® device. These instruments are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of the activL® device.

The activl ® Next Generation Instrumentation would allow successful implantation of the Aesculap activL® device. These are manual surgical instruments which aid in selecting, placing, and revising the activL® device. These activL® instruments device comprises of trial, trial holders, single and double chisels, implant inserter, depth stop, depth stop driver, and impaction caps.

This document is a 510(k) Premarket Notification from the FDA regarding the activL® Next Generation Instrumentation. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving a device meets specific acceptance criteria based on metrics like sensitivity, specificity, or AUC for an AI/CADe device.

Therefore, the requested information regarding acceptance criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found or inferred from the provided text. The document pertains to manual surgical instrumentation, not an AI or diagnostic device that would typically undergo such rigorous performance evaluation.

The "Performance Testing Summary" section (Page 4, {4}) briefly mentions:

• Simulated use/Functional testing
• Transit testing
• Sterilization/Cleaning validation

These are standard engineering and manufacturing performance tests for reusable surgical instruments, not clinical performance studies with human subjects or AI algorithm evaluations. The conclusion explicitly states the device is substantially equivalent based on "indication, design, materials, function, and performance" relative to predicate devices, and that performance testing demonstrated it "do not introduce any new question of safety or effectiveness."

Ask a specific question about this device

The prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo instruments are intended for the placement, positioning, and removal of the prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo devices.

The prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo Instruments enable the prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo devices to be implanted as a single unit into the disc space. Additional instruments are included to allow for the removal of the prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo. The purpose of this Traditional 510(k) is to seek marketing clearance for the prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo Instruments.

The provided text describes a 510(k) premarket notification for surgical instruments used with total disc replacement devices. It does not contain any information about an AI/ML powered device, acceptance criteria related to AI/ML device performance, or details of a study proving such a device meets acceptance criteria.

Therefore, I cannot provide the requested information, including the table of acceptance criteria, sample sizes, expert qualifications, ground truth establishment, or any details about a multi-reader multi-case (MRMC) study or standalone algorithm performance.

The document focuses on demonstrating substantial equivalence of the surgical instruments to previously approved predicate devices based on indications, design, materials, function, manufacturing, and performance (which includes user testing with cadaver studies, European clinical use report, cleaning validation, and steam sterilization). It explicitly states: "All completed tests met the pre-determined acceptance criteria." However, these acceptance criteria are not specified in terms of quantitative performance metrics for a diagnostic or AI/ML device.

The document is a regulatory approval letter and summary for manual surgical instruments, not an AI/ML medical device.

Ask a specific question about this device

The M6-C Artificial Cervical Disc Surgical Instruments are intended for the placement and positioning of the M6-C Artificial Cervical Disc.

The surgical implantation of the M6-C Artificial Cervical Disc requires specific surgical instruments including: a footprint template and a trial to determine the appropriate size and position of the implant; a fin cutter to create tracks in the superior and inferior vertebral endplates; and an implant inserter to place the disc into the desired position to aid in and ensure correct placement within the intervertebral space. Additionally, there is a tamp to independently adjust the posterior position of the M6-C endplates, a removal tool to remove the disc from the disc space, and general surgical instruments to assist in the distraction and mobilization of the disc space. The instruments are composed primarily of surgical stainless steel coated with ME-92 coating to increase corrosion resistance, with some instrument handles also featuring aluminum and Radel materials. Surgical instruments are provided nonsterile and are intended to be reusable. The instruments provided in the kit include Footprint Templates. Trials, Inserters, Fin Cutters, a Tamp, Removal Tools, an Intervertebral Distractor, a Paddle Distractor, a Distractor Spacer, a Slide Hammer, a Retainer, Retainer Pins and Locking Nuts. The M6-C Instrument Tray is multi-layered with various inserts to hold surgical instrumentation in place during handling and storage. The instrument tray is perforated to allow steam to penetrate which will allow sterilization of the contents to occur in a steam autoclave.

This document is a 510(k) submission for surgical instruments, not an AI/ML medical device. Therefore, it does not contain the information requested about acceptance criteria, study details, and AI performance metrics.

The document describes surgical instruments for the placement and positioning of an artificial cervical disc, not an AI-powered device. The performance testing summarized in the document (Impact testing, Bend/Functional testing, Transit testing, Sterilization validation) are typical for physical surgical tools and do not involve AI algorithms or data analysis.

Therefore, the requested information regarding AI device performance, sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone algorithm performance cannot be extracted from this submission.

Ask a specific question about this device

The Simplify Disc Inserter FP is intended for the placement and positioning of the Simplify Cervical Artificial Disc.

The instrument set includes a number of surgical instruments designed to facilitate Simplify Cervical Artificial Disc implantation. The Simplify Disc Inserter FP enables the Simplify Disc to be held as a rigid construct in extension and to be inserted as a single unit into the disc space. The instrument set is intended to be used only with the Simplify Cervical Artificial Disc.

The purpose of the 510(k) submission is to improve usability of the Simplify Disc Inserter with an updated version referred to as Simplify Disc Inserter FP.

This document is a 510(k) summary for the Simplify Disc Inserter FP. It details the device's intended use and design modifications, but it does not contain the kind of detailed information about acceptance criteria, study design, or AI performance that you are requesting.

The document states:

• Performance Testing: "Testing included user testing, dimensional analysis, cleaning validation, and steam sterilization. All completed tests met the pre-determined acceptance criteria."

However, it does not provide any specific acceptance criteria or detailed results from these tests. It also does not mention any AI component or related studies (like MRMC or standalone performance studies).

Therefore, based on the provided text, I cannot extract the information you requested regarding:

1. A table of acceptance criteria and the reported device performance: This information is not detailed.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth and their qualifications: Not mentioned.
4. Adjudication method: Not mentioned.
5. MRMC comparative effectiveness study, effect size: Not applicable, as no AI component is mentioned.
6. Standalone (algorithm only) performance: Not applicable, as no AI component is mentioned.
7. Type of ground truth used: Not applicable, as no AI component or clinical evaluation requiring such ground truth is detailed.
8. Sample size for the training set: Not applicable, as no AI component is mentioned.
9. How the ground truth for the training set was established: Not applicable, as no AI component is mentioned.

This document pertains to regulatory approval for a physical medical instrument (the Disc Inserter) and not an AI/software as a medical device (SaMD).

Ask a specific question about this device