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The Universal Clamp System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone factures. The indications for use include, but are not limited to, the following applications:

1. Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;
2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as scoliosis, spondylolisthesis;
3. Spinal degenerative surgery, as an adjunct to spinal fusions;
   The Universal Clamp System may also be used in conjunction with other medical implants made of titanium alloy whenever "wiring" may help secure the attachment of other implants.

The Universal Clamp System is a temporary orthopedic implant intended to provide stabilization during the development of solid bony fusion and aid in the repair of bone fractures. The device system is designed to be incorporated into constructs and used in conjunction with other medical implants made of stainless steel whenever "wiring" may help secure the attachment of other implants.

This looks like a 510K submission document used to obtain FDA clearance for a medical device. These documents generally focus on demonstrating substantial equivalence to a predicate device, rather than presenting a full clinical study with acceptance criteria and detailed performance metrics as would be found in a PMA (Pre-Market Approval) application.

Therefore, the provided text does not contain the acceptance criteria or a detailed studyproving the device meets acceptance criteria in the way a clinical trial report would. The document focuses on demonstrating that the Abbott Spine Universal Clamp System is substantially equivalent to the CFix Cable System (K974020) through engineering evaluations and bench testing.

Here's an analysis based on the information provided, highlighting what is present and what is missing:

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

• Acceptance Criteria: Not explicitly stated as pass/fail criteria for a clinical or performance study. The "acceptance criteria" here is implicitly "demonstrate substantial equivalence to the predicate device."
• Reported Device Performance: The document states: "Engineering evaluations and bench testing were conducted to assess the physical and mechanical properties of the subject device. These results demonstrate that the performance of the Abbott Spine Universal Clamp System is substantially equivalent to the CFix Cable system."
  • Comment: The specific results of these "engineering evaluations and bench testing" (e.g., tensile strength, fatigue life, material compatibility) are not provided in this summary. Therefore, a table of acceptance criteria and specific performance values cannot be constructed from this text.

Remaining Information Categories (2-9):

The following information points are typically found in detailed clinical study reports or significant clinical trials. This 510(k) summary focuses on substantial equivalence based on bench testing, not on human clinical outcomes or the kind of performance metrics implied by these questions. Consequently, most of these details are not available in the provided text.

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

• Not available. The document refers to "engineering evaluations and bench testing," which implies tests on device units, not human subjects. The sample size for these bench tests (e.g., how many clamps were tested for their physical properties) is not specified. Data provenance is not applicable in the context of bench testing described here.

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/Not available. This type of information is relevant for studies involving human interpretation (e.g., image analysis by radiologists). For engineering evaluations and bench testing of physical properties, ground truth is established by standardized testing methods and measurements, not expert consensus in this context.

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

• Not applicable/Not available. Adjudication methods are used in clinical studies where expert opinions (e.g., diagnosis, outcome assessment) need to be resolved. This is not relevant for physical property bench testing.

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/Not available. This is a medical device, specifically a surgical implant, not an AI diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant to this device.

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

• Not applicable/Not available. As mentioned, this is a physical medical implant, not an algorithm or AI system.

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

• For bench testing: The "ground truth" would be established by the physical and mechanical properties measured according to recognized standards (e.g., ASTM, ISO). For example, the breaking strength of a clamp measured on a testing machine. Specific details are not provided.
• Not available for clinical outcomes: There is no mention of clinical outcomes data in this summary.

8. The sample size for the training set

• Not applicable/Not available. This concept relates to machine learning models. For a physical device, there isn't a "training set" in this sense. If referring to product development, it would be R&D testing, but "training set" is not the correct terminology.

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

• Not applicable/Not available. See point 8.

In summary:

This document is a 510(k) summary, which aims to demonstrate "substantial equivalence" of a new device to a legally marketed predicate device. The primary evidence presented for this equivalence comes from "engineering evaluations and bench testing" of the physical and mechanical properties of the device. It explicitly states that these results "demonstrate that the performance... is substantially equivalent to the CFix Cable system." However, the specific details, raw data, acceptance criteria, and methodologies of these tests are not included in this summary document. It does not describe a clinical study with human subjects, nor does it provide the detailed performance metrics or "acceptance criteria" that would be associated with such a study.

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