Search Results

The PLIF Lite and TLIF Lite Lumbar Interbody Fusion Devices are indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The PLIF Lite and TLIF Lite Lumbar Interbody Fusion Devices are designed for use with autograft bone to facilitate fusion and are intended for use with supplemental fixation systems cleared for use in the lumbar spine.

The PLIF Lite and TLIF Lite Lumbar Interbody Fusion Devices are made from PEEK. The PLIF Lite implants are available in lordotic and non-lordotic form, while the TLIF implants are provided with 7 degrees of lordosis only. The implants are available in various heights and lengths to accommodate patients' anatomy. The implants are provided sterile, and a set of instrument for implantation is provided to facilitate implantation. Three radiographic markers made of titanium alloy (ASTM F-136) are included in each implant to allow radiographic visualization.

The provided text describes the 510(k) summary for Sintea Plustek's PLIF Lite and TLIF Lite Interbody Fusion system, which is a medical device for spinal fusion. This specific document focuses on demonstrating substantial equivalence to existing predicate devices based on mechanical performance and design, rather than conducting a clinical study to establish new performance criteria. Therefore, the information requested for a clinical study assessing device performance against acceptance criteria is largely not applicable in this context.

Here's an analysis based on the provided text, highlighting what is available and what is not:

Acceptance Criteria and Device Performance

Explanation: In a 510(k) submission for substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating that the new device performs as well as, or better than, the legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness. The core "study" here is the performance testing conducted according to recognized ASTM standards (ASTM F2077 and ASTM F2267) to show mechanical equivalence.

Study Details (as far as applicable to a 510(k) for substantial equivalence)

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 refers to "Performance Testing" according to ASTM F2077 and ASTM F2267, which are mechanical testing standards. These standards typically involve a specific number of samples (e.g., 5 or 6 per test condition) of the device to be tested. The exact number of samples is not explicitly stated in this summary.
   • Data provenance: Not specified, but generally, such bench testing is conducted in a controlled laboratory environment by the manufacturer or a contracted testing facility. It is prospective in the sense that the tests are planned and executed to evaluate the new device. Country of origin is Miami, FL, implying the sponsor is U.S.-based.

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 device's evaluation is based on mechanical testing, not clinical or diagnostic performance that would require expert adjudication of "ground truth" for patient data. The "ground truth" for mechanical testing is established by the test procedures and measurements themselves, compared against the predicate device's performance.

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

   • Not applicable for mechanical testing. Adjudication methods are typically relevant for clinical studies or studies involving human interpretation (e.g., image reading).

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 is a medical implant device, not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was conducted.

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

   • Not applicable. This is a mechanical implant, not an algorithm.

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

   • For the mechanical performance testing, the "ground truth" is derived from the established mechanical properties and performance of the predicate devices as demonstrated through their own testing and regulatory clearance, and the adherence to the relevant ASTM standards for intervertebral body fusion devices. The goal is to show the new device meets or exceeds these established benchmarks.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of mechanical performance testing for a spinal implant device. This terminology relates to machine learning or AI algorithm development.

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

   • Not applicable, as there is no training set for this type of device submission.

In summary: The provided document is a 510(k) submission establishing substantial equivalence for a spinal implant. This process primarily relies on benchtop mechanical testing against recognized industry standards (ASTM F2077, ASTM F2267) and comparison to predicate devices, rather than clinical trials involving patient data, human reader performance, or AI algorithms. Therefore, many of the requested details about study design and ground truth establishment, which are typical for clinical performance studies, are not present or applicable.

Ask a specific question about this device

Ask a specific question about this device

The Spider System Kolibri Cement Needle is intended to be used as a system for the creation of a cavity in cancellous bone in the spine, in order to treat pathological compression fractures that may result from osteoporosis, benign lesions, and/or malignant lesions. This system is to be used with an already FDA cleared PMMA bone cement.

The needle has the following characteristics:

• . entirely cannulated needle;
• threaded proximal end to screw the needle into the pedicle to temporarily link the . needle to the pedicle during the cement injection; .
• . luer-lock to allow the easy connection with standard syringes and with other system of injection of the cement;
• . windows in the distal end that allow the outflow of cement and its optimal distribution around the needle.
  The device is supplied in an appropriately labeled sterile packaging.

The provided text is a 510(k) summary for the Sintea Plustek's Spider System KOLIBRI Cement Needle. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with acceptance criteria for device performance in the way a clinical trial for a complex diagnostic or therapeutic device might.

Therefore, many of the requested elements regarding acceptance criteria, performance studies, expert involvement, and ground truth are not applicable or not provided in this type of submission.

Here's a breakdown based on the information available:

Acceptance Criteria and Reported Device Performance

Study Details

The provided document describes a 510(k) Pre-Market Notification, which aims to demonstrate that a new device is as safe and effective as an already legally marketed device (predicate device). It is not a clinical study or a performance study in the sense of establishing new performance metrics or efficacy. Instead, it relies on demonstrating equivalence through comparison of design, materials, and intended use.

Therefore, the following information is not applicable or not provided in this 510(k) summary:

1. Sample size used for the test set and the data provenance: Not applicable. No "test set" of patient data or samples was used for a performance study.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established from expert review for a performance test set.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 cement needle, not an AI-powered diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical instrument, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. There was no "ground truth" used in the context of a performance study. The "truth" here is the prior FDA clearance of predicate devices and the demonstration that the new device is sufficiently similar.
7. The sample size for the training set: Not applicable. This device is a physical medical instrument, not a machine learning model requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The Sintea Plustek Anterior Cervical Plate systems in indicated for use in the cervical spine (C3-C7) for the following conditions:

• Degenerative Disc Disease (defined as neck pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
• . Spondylolisthesis
• . Trauma (fracture or dislocation)
• . Spinal stenosis
• Deformities or curvatures (scoliosis, kyphosis, lordosis) ●
• . Tumor
• . Pseudarthrosis
• . Failed previous fusion

The Sintea Plustek Anterior Cervical Plate system is made of medical grade titanium alloy Ti-6Al-4V according to ASTM-F136 and consists of plate and screws of various lengths to accommodate single or multilevel fusion and various patients' anatomy. All of the plates have 2.5mm thickness. One level plates are available from 18-38mm, two level plates from 34-56mm, three level plates from 68-112mm and 4 level plates from The screws are available in three configurations: 4mm diameter self 103-128mm. tapping screws in lengths of 10, 12, 14, 16 and 18mm. 4.5 diameter self tapping screws in lengths of 10, 12, 14, 16, and 18mm, 4mm diameter self drilling screws in lengths of 10, 12, 14, 16 and 18mm. The plates have an anti-backout feature based on an elastic ring The elastic ring is inserted into a (made titanium alloy Ti-6AI-4V as well). circumferential slot in the holes present on the plates. The ring can be deformed by the screw during the insertion in order to allow the screw to fit the hole of the plate. Once the screw it is completely inserted the ring return elastically to its original shape in order to prevent screw backout.

The provided text describes a medical device, the Sintea Plustek Anterior Cervical Plate System, and its 510(k) summary for FDA clearance. It focuses on the device's physical properties, indications for use, and a comparison to predicate devices, but does not describe an AI/ML-driven device or study parameters related to AI/ML performance.

Therefore, I cannot extract the information required to answer your prompt, as the prompt's questions pertain to acceptance criteria and studies for an AI/ML device, which are not present in the provided document.

The document only states:

1. Acceptance Criteria and Device Performance (Mechanical Testing):
The study for this device was a mechanical performance test to demonstrate substantial equivalence, not an AI/ML performance study.

2. Sample size and data provenance (for AI/ML test set): Not applicable, as this is a mechanical medical device, not an AI/ML device.

3. Number of experts and qualifications (for AI/ML ground truth): Not applicable.

4. Adjudication method (for AI/ML test set): Not applicable.

5. Multi-reader multi-case (MRMC) comparative effectiveness study (for AI/ML): Not applicable.

6. Standalone performance (for AI/ML algorithm): Not applicable.

7. Type of ground truth used (for AI/ML): Not applicable. The "ground truth" in this context refers to established mechanical testing standards (ASTM F1717-09) and performance of legally marketed predicate devices.

8. Sample size for the training set (for AI/ML): Not applicable.

9. How ground truth for the training set was established (for AI/ML): Not applicable.

Ask a specific question about this device