(64 days)
The Space-OR Retractor is a flexible internal retractor intended for the retraction of organs and tissues during abdominal surgery.
The Space-OR is a flexible retractor which can be formed by the user into the desired shape for retraction of organs or tissues during abdominal surgery. The Space-OR can be left in position for a complete abdominal procedure.
In the relaxed position, the Space-OR is malleable and can be placed along a wound edge or in the abdominal cavity. The device can be shaped around the desired organs forming an optimum retractor. The Space-OR includes a connector for wall vacuum. When vacuum is pulled, the device then solidifies, staying in the position formed by the user. The Space-OR will maintain its shape, retracting the desired organs or areas until the clamp is released.
The vacuum applied to the Space-OR must be greater than 150 mmHg for the device to become solid. Once applied, the evacuation tubing is clamped and the vacuum pump removed. The device may be maintained in place for the duration of the surgery. If desired, the user can release the clamp on the vacuum, reposition the Space-OR and re-apply the vacuum.
The provided text describes a 510(k) summary for the Advanced Surgical Concepts Space-OR Retractor, a manual surgical instrument. It is exempt from providing detailed performance testing results typically seen in AI/ML device submissions. Therefore, many of the requested details related to acceptance criteria, ground truth, and expert evaluation are not available in this document.
However, based on the information provided, here's a summary of the available "acceptance criteria" and "study" information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maintain solid state at >150 mmHg vacuum | "The vacuum applied to the Space-OR must be greater than 150 mmHg for the device to become solid. Once applied, the evacuation tubing is clamped and the vacuum pump removed. The device may be maintained in place for the duration of the surgery." |
| Biocompatibility | "The patient-contacting materials used in the Space-OR have been subjected to and passed biocompatibility testing according to ISO-10993." |
| Function as intended in vivo (animal model) | "Animal testing has been performed showing that the Space-OR functions as intended." |
| No adverse effects/complications in clinical use | "Additionally, the Space-OR has been in commercial distribution in Europe for over nine years with no complications or adverse effects." |
2. Sample Size Used for the Test Set and Data Provenance
- Animal Testing: The document states "Animal testing has been performed," but does not specify the number of animals or the exact study design.
- Clinical Use in Europe: "in commercial distribution in Europe for over nine years." No specific "test set" size is provided; this refers to real-world usage. The data provenance is described as clinical use in Europe, which is retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a manual surgical instrument, not an AI/ML imaging device requiring expert ground truth for image interpretation. The "ground truth" for its performance is its physical function and clinical safety.
4. Adjudication Method for the Test Set
Not applicable. No expert review leading to adjudication is mentioned for this type of device.
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. This is not an AI/ML device, and no MRMC study information is provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used
- Bench Testing: The ability to "become solid" at a specified vacuum level would have been verified through bench testing.
- Biocompatibility Testing: Performed per ISO-10993 standards.
- Functionality: Assessed in animal models.
- Safety/Effectiveness: Observed via "no complications or adverse effects" during nine years of commercial distribution in Europe.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML 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 device.
§ 876.4730 Manual gastroenterology-urology surgical instrument and accessories.
(a)
Identification. A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop. A manual surgical instrument that is intended specifically for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures are classified under § 884.4910 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.