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Spacer-G is indicated for temporary use (maximum 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and radical debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection). Spacer-G is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.).

Spacer-G is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) bone cement. The one piece design mimics a hemi-hip prosthesis.

This 510(k) summary for the Spacer-G device primarily focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a study with specific acceptance criteria and performance data for the device itself.

Therefore, many of the requested sections about acceptance criteria, study design, and performance metrics are not explicitly detailed in this document. The core of this submission is to show that the modified Spacer-G is just as safe and effective as already approved devices by having similar design, materials, performance characteristics, and gentamicin release profile.

Here is an attempt to address your requests based on the provided text, highlighting where information is absent:

Acceptance Criteria and Study to Prove Device Meets Criteria: Spacer-G Modification

The provided 510(k) summary for the Spacer-G device demonstrates substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria directly linked to a novel performance claim for the modified device. The "acceptance criteria" can be inferred as the standard for substantial equivalence, meaning the device must perform comparably to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the 510(k) summary. Given the nature of a substantial equivalence submission relying on comparison to existing devices, it is unlikely a large "test set" in the sense of a clinical trial was used for this specific modification. The "performance" assessment appears to be based on engineering principles and potentially laboratory testing rather than human clinical outcomes data.

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

This information is not applicable/provided. The submission focuses on substantial equivalence based on technical and material characteristics, not on a clinical ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not applicable/provided. There is no mention of a clinical test set requiring adjudication in this 510(k) summary.

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

This information is not applicable. This device is a temporary hip prosthesis, not an AI or imaging diagnostic device that would involve human readers or AI assistance.

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

This information is not applicable. This device is a medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the performance characteristics of the legally marketed predicate devices. The modified Spacer-G is evaluated against these established benchmarks. No pathology, outcomes data, or expert consensus specific to the modified device's novel performance is referenced as a "ground truth" to meet new performance criteria.

8. The Sample Size for the Training Set

This information is not applicable. This device is not an AI algorithm requiring a training set.

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

This information is not applicable. This device is not an AI algorithm.

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Spacer-G is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) in patients undergoing a two-stage procedure due to a septic process.

The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

Spacer-G is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.).

The Spacer-G is a "hemi-hip" style device. The one-piece design incorporates a load bearing endoskeleton of AISI 316L stainless steel and an outer coating of fully formed gentamicin/polymethylmethacrylate (PMMA) bone cement. The implants are supplied sterile to an assurance level (SAL) of 10-6.

This document is a 510(k) premarket notification for the "Tecres Spacer-G" medical device. It describes the device, its indications for use, contraindications, and a summary of performance data. However, it does not provide a detailed "acceptance criteria and the study that proves the device meets the acceptance criteria" in the format requested.

The document states:
"PERFORMANCE DATA
Performance testing was conducted to verify that the implant performance would be adequate for anticipated in vivo load applications under the temporary conditions of use. The fatigue strength, static strength, wear characteristics and antibiotic release rate were evaluated and found to support the safety and effectiveness of the device."

This is a very high-level summary and does not contain the specific information required to complete the table or answer the detailed questions about the study design, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot extract the requested information from the provided text. The document confirms that performance testing was conducted and found to support safety and effectiveness, but it does not detail:

1. A table of acceptance criteria and the reported device performance: No specific criteria or performance values are listed.
2. Sample sizes used for the test set and the data provenance: Not mentioned for any of the performance tests (fatigue, static strength, wear, antibiotic release).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as the performance tests described are mechanical/material characteristic tests, not clinical studies involving expert interpretation of data like images or patient outcomes.
4. Adjudication method: Not applicable.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No, this is not a study type described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a medical implant, not an algorithm.
7. The type of ground truth used: For mechanical and material tests, the ground truth would be the measured physical properties against established standards. The document does not specify these standards or the measured values. For the antibiotic release, it would likely be laboratory measurements of gentamicin concentration over time.
8. The sample size for the training set: Not applicable as there is no "training set" for physical performance testing of an implant in this context.
9. How the ground truth for the training set was established: Not applicable.

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