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When used as a cervical intervertebral body fusion device, the Ackermann Intervertebral Body Fusion Device cispine implants are indicated for spinal fusion procedures in skeletally mature patients. Cervical interbody fusion implants are intended for use at one level in the cervical spine, from C2 to T1, for treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment. Additionally, the clspine implants are to be used with autogenous bone graft and supplemental fixation via an open, anterior approach.

When used as a lumbar intervertebral body fusion device, the Ackermann Intervertebral Body Fusion Device tispine implants are indicated for spinal fusion procedures in skeletally mature patients. Lumbar interbody fusion implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for treatment of lumbar degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment. The tlspine implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implanted via a transforaminal approach. These implants are to be used with autogenous bone graft and supplemental fixation.

Ackermann Intervertebral Body Fusion Device c|spine and t|spine is an intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. Components are offered in a variety of shapes and sizes to meet the requirements of the individual patient anatomy. Components are manufactured from implant grade PEEK (polyetheretherketone, VESTAKEEP® i4 R bv Evonik).

The provided document is a 510(k) summary for a medical device called the "Ackermann Intervertebral Body Fusion Device." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results to establish acceptance criteria for an AI/algorithm-based device.

Therefore, many of the requested points regarding acceptance criteria, specific study designs (like MRMC or standalone performance), sample sizes for test and training sets, and expert ground truth establishment are not applicable to this document as it describes a physical implant device, not an AI or algorithmic diagnostic tool.

However, I can extract the relevant "performance data" which refers to mechanical testing as opposed to clinical or algorithmic performance.

Here's the information that can be extracted from the document:

1. A table of acceptance criteria and the reported device performance
The document refers to adherence to ASTM standards for mechanical testing, which implies the acceptance criteria were defined by these standards. Specific numerical acceptance criteria or reported performance values (e.g., specific load resistance in Newtons) are not detailed in this summary. Instead, it states that the device was "tested in accordance with" specific ASTM standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document describes mechanical testing of a physical device, not an AI/algorithmic device with a "test set" of patient data. The "test set" would refer to the number of physical devices or components tested. This detail is not provided. The manufacturer is Ackermann Instrumente GmbH, located in Rietheim-Weilheim, Germany.

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. Ground truth, in the context of AI/algorithms, refers to expert-validated labels. For mechanical testing, the "ground truth" is adherence to ISO/ASTM standards and physical measurements, not expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for resolving discrepancies in expert labeling for AI/algorithm ground truth.

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
No. This is a physical medical device, not an AI algorithm. Therefore, an MRMC study is not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for a physical device's performance is objective measurement based on mechanical testing standards (ASTM F2077, ASTM F2267).

8. The sample size for the training set
Not applicable. This is not an AI/algorithmic device, so there is no "training set."

9. How the ground truth for the training set was established
Not applicable. There is no "training set" for this physical device.

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The Europclip®is indicated for use in surgical procedures on vessels or other tubular structures where a metal ligating clip is required. The device is intended to occlude the tubular structure by compression.

The Europclip is a chevron-shaped clip having a heart-shaped cross-section and transverse grooves across the inner surface of the clip. The clips are supplied sterile, available in four sizes and pre-loaded in a disposable cartridge.

This document describes a 510(k) submission for the Europclip®, a ligating clip device. The submission focuses on demonstrating substantial equivalence to predicate devices rather than independent performance studies with detailed acceptance criteria and clinical trials typically used for AI/ML devices.

Therefore, many of the requested details about acceptance criteria, specific study designs (like MRMC or standalone AI studies), ground truth establishment for AI models, and sample sizes for training/test sets are not applicable to this type of medical device submission.

Here's an attempt to address the request based on the provided information, noting where information is not available due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. This submission relies on demonstrating substantial equivalence to legally marketed predicate devices through a comparison of design, materials, and intended use, rather than a clinical trial with a "test set" of patient data.
• Data Provenance: Not applicable. The "data" primarily consists of technical specifications and comparisons to existing devices, not clinical data from patients.

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

• Not applicable. There was no "test set" of data requiring expert ground truth establishment for this device submission.

4. Adjudication Method for the Test Set

• Not applicable.

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

• No, a MRMC comparative effectiveness study was not done. This device is a medical instrument (a ligating clip), not an AI/ML diagnostic or assistive tool for human readers.

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

• No, a standalone performance study as would be done for an AI algorithm was not conducted. This device is a physical surgical instrument.

7. The Type of Ground Truth Used

• Not applicable in the context of AI/ML ground truth. The "ground truth" for this submission is effectively the established performance and safety profile of the predicate devices and the direct comparison to their specifications.

8. The Sample Size for the Training Set

• Not applicable. There is no AI/ML training set for this device.

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

• Not applicable.

Summary of the Study (as presented in the 510(k) Summary):

The study described for the Europclip® is a demonstration of substantial equivalence to predicate devices (Nexus Ligating Clips, Miltex Ligating Clips, Titanium Ligation Clip). This is a regulatory pathway for medical devices that are similar in intended use, technological characteristics, and safety/effectiveness to a legally marketed predicate device.

The "study" asserts that:

• The Europclip functions in the same manner as the predicates to occlude blood vessels.
• It possesses the same technological characteristics as one or more predicate devices, including:
  • Identical intended use.
  • Basic design (chevron-shaped with heart-shaped cross-section).
  • Material (titanium).
  • Sizes (dimensions are comparable to those offered by predicate systems).
• The fundamental scientific technology of the Europclip is the same as previously cleared devices.

Based on these comparisons, the sponsor concludes that the Europclip is substantially equivalent to the predicate devices and thus meets the necessary criteria for FDA clearance. The FDA's outcome (K111930) confirms their agreement with this assessment, finding the device substantially equivalent.

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The device is intended for use in providing access to and visualization of body cavities, organs, and canals to perform various diagnostic and therapeutic surgical procedures.

The device is a line of general and minimally invasive surgical instruments and accessories.

This document is a 510(k) premarket notification decision letter from the FDA for Ackermann Surgical Instruments, classifying it as substantially equivalent to previously marketed devices. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies for any AI/ML-driven medical device.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance study results.
7. Type of ground truth used.
8. Training set sample size.
9. How training set ground truth was established.

The provided text describes a regulatory approval process for conventional surgical instruments, not an AI/ML device.

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