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Streamline Navigated Instruments are intended to be used during the preparation and placement of screws from the Streamline TL and MIS Systems and preparation of screws from the Streamline OCT System during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT- or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Streamline Navigated Instruments are non-sterile, reusable instruments for use with the Medtronic StealthStation Navigation System to assist surgeons in precisely locating anatomical structures in either open or minimally invasive (MIS) procedures for preparation and placement of screws from the Streamline TL Spinal Fixation System and Streamline MIS Spinal Fixation System and preparation of screws from the Streamline OCT Occipito-Cervico-Thoracic System. The Streamline Navigated Instruments include pedicle finders, modular handle, taps, drills, and screw inserters designed for use with Streamline TL, Streamline MIS, and Streamline OCT Systems. The instruments are manufactured from stainless steel (ASTM F899).

Here's a breakdown of the acceptance criteria and the study details for the Streamline Navigated Instruments, as extracted from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

(Note: The document doesn't provide specific numerical thresholds for acceptance, only that the device was tested against the standard and deemed sufficient.)

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

The document does not specify a distinct "test set" in the traditional sense of a clinical or observational study with human participants. The performance evaluation was based on non-clinical testing.

• Sample Size: Not applicable in the context of a clinical test set. The evaluation involved testing the instruments themselves according to a standard.
• Data Provenance: Not applicable. The "data" comes from engineering and laboratory testing.

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

This is not applicable as the evaluation was based on non-clinical testing of device accuracy and compatibility with a navigation system, not on medical image interpretation or clinical outcomes requiring human expert ground truth.

4. Adjudication Method for the Test Set

None. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes where discrepancies might arise. This non-clinical performance evaluation does not involve such a process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The study described is a non-clinical performance evaluation of device accuracy and compatibility, not a comparative effectiveness study involving human readers or AI assistance.

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

This question is not applicable as the device (Streamline Navigated Instruments) is a physical surgical instrument designed to be used with a navigation system and by a human surgeon. It is not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation was defined by:

• ASTM F2554-18 "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems": This standard serves as the benchmark for evaluating positional accuracy.
• Dimensional comparison and tolerance analysis: This establishes whether the instruments meet the required specifications for functionality and compatibility with the Medtronic StealthStation System.

8. The Sample Size for the Training Set

Not applicable. The Streamline Navigated Instruments are physical instruments, not an AI or machine learning model that requires a training set.

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

Not applicable. As the device is not an AI model, there is no training set or associated ground truth for it.

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When Fortilink®-C is used as cervical interbody fusion (IBF) implants, these devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the cervical spine and are placed via an anterior approach from C2-C3 to C7-T1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The IBF devices are intended to be used with supplemental fixation cleared for the implanted level. Patients should have at least six (6) weeks of non-operative treatment with an interbody fusion device.

When Fortilink®-TS and Fortilink®-L are used as lumbar interbody fusion (IBF) implants, these devices are indicated for intervertebral body fusion of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L1-L2 to L5-S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The IBF devices are intended to be used with supplemental fixation cleared for the implanted level. Patients should have at least six (6) months of non-operative treatment prior to treatment with an interbody fusion device.

The Fortilink® interbody fusion (IBF) devices are designed to be inserted into the intervertebral body space of the spine, and are intended for intervertebral body fusion. The purpose of this 510(k) is to seek marketing clearance for modifications to the straight and angled inserter tools for the Fortilink®-L device. The modifications include the following:

Straight Inserter: Improve opening mechanism and disassembly prevention features

Angled Inserter:

• Apply an offset and angle to the inserter handle to align it with the Fortilink®-L . implant
• Apply the same design changes (improved opening mechanism and disassembly ● features) as applied for the straight inserter

This document describes a 510(k) premarket notification for the Fortilink® IBF System with TETRAfuse®3D Technology, specifically focusing on modifications to inserter tools. It does not contain information about a study proving the device meets acceptance criteria related to clinical performance, nor does it involve an AI/ML component.

Therefore, I cannot provide the requested information as the document *does not contain details about acceptance criteria or a study related to device performance in the context of clinical outcomes or AI/ML. *

The information present in the document pertains to:

• Device cleared: Fortilink® IBF System with TETRAfuse®3D Technology, with modified straight and angled inserter tools.
• Purpose of 510(k): Seeking marketing clearance for modifications to inserter tools, not for the underlying interbody fusion device's clinical efficacy or safety, which would have been established in previous clearances (referenced by K172343).
• Assessment of modifications: The substantial equivalence is based on engineering analysis and testing, including:
  • Risk analysis
  • Simulated insertion/removal testing
  • Tissue blocking opening testing
  • Reuse testing
  • Stack-up of design drawings
• Acceptance Criteria for the Modifeid Inserter Tools: "All completed tests met the pre-determined acceptance criteria." However, the specific quantitative acceptance criteria for these engineering tests are not detailed in this summary.
• Type of Ground Truth: For the mechanical/engineering tests, the "ground truth" would be the successful completion of the tests according to design specifications and pre-determined mechanical/functional requirements. This is not clinical ground truth.

In summary, the provided document is a regulatory clearance letter and 510(k) summary for a device modification (inserter tools), not a clinical study report or performance evaluation of a device (especially not an AI/ML device) that would typically involve the detailed acceptance criteria and study information you've requested.

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The Unison-C Anterior Cervical Fixation System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2 to T1. Degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The system is intended to be used with autograft bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion, and is implanted via an anterior approach. Implants must be used with two of the provided bone screws. This system is to be used in patients who have had six weeks of non-operative treatment.

The Unison-C Anterior Cervical Fixation system is intended for stand-alone cervical interbody fusion procedures to provide structural stability in skeletally mature individuals following discectomy. The system includes intervertebral body implants (with an integrated locking mechanism and radiographic pins) and screws, and does not require the use of supplemental fixation.

These implants are manufactured from a radiolucent polymer (PEEK-OPTIMA® LT1 polymer from INVIBIO® Biomaterial Solutions (polyether ether ketone) (ASTM F2026)), to allow radiographic imaging inside the implant to evaluate fusion status. The implants are assembled with radiographic markers composed of tantalum (ASTM F560) to facilitate proper implant positioning. The screws and locking mechanism are manufactured from of titanium alloy (ASTM F136). Sterile implants are provided sterile by gamma irradiation.

Implants are supplied with instrumentation necessary to facilitate the insertion and removal of the implants, as well as general manual surgical instruments. Cases and caddies are supplied for sterilization and transport of the non-sterile implants and instruments.

The purpose of this submission is to obtain clearance of modifications to the predicate system (K152793).

The provided text describes a medical device, the "Unison®-C Anterior Cervical Fixation System," and its clearance by the FDA. However, it does not detail a study proving the device meets specific acceptance criteria in the context of AI/ML performance.

The document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance (mechanical testing) rather than clinical studies or performance against specific AI/ML criteria. Therefore, most of the requested information regarding AI/ML device performance and ground truth establishment cannot be extracted from this document.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information (Not present in the provided document):

The document does not describe an AI/ML device or a study involving an AI algorithm. Therefore, the following information cannot be provided:

2. Sample size used for the test set and the data provenance: Not applicable as it's a physical device, not an AI/ML algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The Tritium Sternal Cable Plate System is intended for use in the stabilization of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures.

The Tritium Sternal Cable Plate System includes implants of various sizes; plates and cable plugs comprised of commercially pure titanium, Grade IV (ASTM F67), and cables and screws comprised of Titanium 6Al 4V Alloy (ASTM F136). The system also includes needles comprised of Custom 470 stainless steel, 420 stainless steel (ASTM F899, Custom 470 SST) and leader comprised of Titanium 3Al/ 2.5V Alloy (ASTM F2146).

The system is designed to enhance the stability and strength of traditional sternal closure techniques. Utilizing a unique load-sharing concept, the device can be implanted to distribute lateral force across the osteotomy. The system can be used with traditional monofilament wire or Pioneer Sternal Cable. The device system should be implanted using only the manual surgical instruments designed specifically for this system of implants, which may be implanted via an open or minimally invasive approach.

I am sorry, but based on the provided text, I cannot provide the requested information. The document is a 510(k) premarket notification for a medical device (Tritium® Sternal Cable Plate System) and primarily focuses on establishing substantial equivalence to a predicate device.

Here's why I cannot fulfill your request:

• No acceptance criteria or device performance data: The document states, "Engineering analysis was completed for the subject line extension product and demonstrated no new performance data was required for a determination of substantial equivalence." It also explicitly mentions, "No clinical performance data was required for a determination of substantial equivalence." This means there are no specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) or reported device performance values available in this document.
• No details on clinical studies: Since no clinical performance data was required, there are no details about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
• No ground truth establishment for a study: As no studies are described with performance outcomes, there's no information on how ground truth would have been established for a test or training set.
• No training set information: The document discusses a device (implants, plates, cables, screws) used in surgical procedures, not an AI/ML algorithm that would require a training set.

The document mainly covers:

• The device's intended use and indications.
• Its components and materials.
• Its classification and product codes.
• Its substantial equivalence to a predicate device based on design, materials, and mechanical strength (without providing specific test results in this summary).

Therefore, I cannot extract the information requested as it is not present in the provided text.

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